cms hospital conditions of participation (cops) 2011 what pps hospitals need to know

CMS HOSPITAL CONDITIONS OF PARTICIPATION (COPS) 2011

What PPS Hospitals Need to Know

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Speaker

Sue Dill Calloway RN, Esq. CPHRM AD, BA, BSN, MSN, JD

President Patient Safety and Healthcare Education 5447 Fawnbrook Lane Dublin, Ohio 43017

[email protected]

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Regulations first published in 1966

Many revisions since with final interpretive guidelines June 5, 2009 (Tag 450 Medical Record) and anesthesia (December 11, 2009, February 5, 2010, May 21, 2010 and February 14, 2011) and Respiratory and Rehab Orders August 16, 2010 and Visitation 2011

First regulations are published in the Federal Register first-42 CFR Part 4821

CMS then publishes Interpretive Guidelines2

Hospitals should check this website once a month for changes

1www.gpoaccess.gov/fr/index.html 2www.cms.hhs.gov/SurveyCertificationGenInfo/PMSR/list.asp

The Conditions of Participation

Respiratory and Rehab Orders Published in the August 16, 2010 Federal Register

Allows a qualified licensed practitioner who is responsible for the care of the patient (such as a PA or NP)

Who is acting within their scope of practice under state law

Can order respiratory or rehab order (physical therapy, occupational therapy, speech)

Must be privileged (authorized) by the MS

Must have hospital P&P to allow also6

Visitation Effective January 19, 2011

Must rewrite policy on visitation including visiting hours in ICU

Must inform each patient of their visitation rights

Must include any restrictions on those rights

Can not restrict or deny visitation privileges on the basis of race, color, national origin, religion, sex, sexual orientation, gender identity or disability

For example same sex partner may present visitation advance directive

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Federal Register Visitation Changes

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CMS Proposed New Rule

CMS proposed new rule for notifying beneficiaries of their right to file a quality of care complaint

Give beneficiaries written notice of their right to contact their state QIO or Quality Improvement Organization

Also include

Currently, only hospital inpatients receive this information

Includes 10 facilities such as clinics, CAH, LTC, hospices, home health agencies, ASCs, comprehensive outpatient rehab facilities, portable X-ray services and rural health clinics

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Medicare Patients, Complaints and the QIO

The proposed rule was published in the Federal Register on February 2, 2011

at http://www.gpo.gov/fdsys/pkg/FR-2011-02-02/pdf/2011-2275.pdf

QIOs must conduct a review of all written complaints about the quality of care for Medicare patients only

Current hospital CoP includes a requirement that the grievance process must include a mechanism for timely referral to the QIO of beneficiary concerns regarding quality of care

Must also give Medicare patients a copy of their IM Notice

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Medicare Patients, Complaints and the QIO

Since 9th scope of work started August 1, 2008, QIOs have received 6,379 inpatient and 4,1116 outpatient requests

Feel number is inadequate because Medicare patients do not know they can complain to their QIO

Expanding now that Medicare patients, or their representative, will receive written notice at the start of their care, of their right that they can complain about quality of care issues to the QIO in other settings

Such as time of admission or in advance of furnishing care11

Medicare Patients, Complaints and the QIO Medicare patient who is competent can also decide to have

the written notice given to their surrogate such as a friend or family member

Remember if need to use an interpreter for limited English proficiency (LEP) or deaf/hard of hearing patients

Unless patient signs a waiver declining interpreter

Remember the 2011 TJC patient centered communication standards

Also 7 of the 10 providers must include information to contact the state agency

Hospitals, HH, RHC, CORF, FQHCs, Hospices, clinics12

Specific Requirements

For example an ASC, hospice, hospitals, home health, hospice etc. would have to do the following;

Give the patient a written notice of their right to notify the QIO

Must include at the time of admission or in advance of furnishing care

Must include name, telephone number, email address, and mailing address

Must document in the medical record that the notice was given

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Proposed FR February 2, 2011

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TJC has published many changes over the past two years

Many of the changes reflected in their standards is to be in compliance with the CMS CoP

Standards are for hospitals that use them to get deemed status to allow payment for M/M patients

This means hospitals do not have to have a survey by CMS every 3 years

Can still get a complaint or validation survey

So now TJC standards crosswalk closer to the CMS CoPs (not called JCAHO any more)

TJC Revised Requirements

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http://www.cms.hhs.gov/manuals/downloads/

som107_Appendicestoc.pdf

4th Anesthesia Changes February 14, 2011

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Respiratory and Rehab Changes

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Hospitals that participate in Medicare or Medicaid must meet the COPs for all patients in the facilities and not just those patients who are Medicare or Medicaid

Hospitals accredited by TJC, AOA, or DNV Healthcare have what is called deemed status

These are the only 3 that CMS has given deemed status to for hospitals

This means you can get reimbursed without going through a state agency survey

States can still institute a survey and be more restrictive

Mandatory Compliance

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All Interpretative guidelines are in the state operations manual and are found at this website1

Appendix A, Tag A-0001 to A-1163 and 370 pages long

You can look up any tag number under this manual

Manuals

Manuals are now being updated more frequently Still need to check survey and certification website

once a month and transmittals to keep up on new changes 2

1http://www.cms.hhs.gov/manuals/downloads/som107_Appendicestoc.pdf

2 http://www.cms.gov/Transmittals/01_overview.asp

CMS Hospital CoPs

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http://www.cms.hhs.gov/manuals/downloads/som107_Appendicestoc.pdf

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Important interpretive guidelines for hospitals and to keep handy

A- Hospitals and C-Critical Access Hospitals

C-Labs

V-EMTALA (Rewritten May 29, 2009 and amended July 2010)

Q-Determining Immediate Jeopardy

I-Life Safety Code Violations

All CMS forms are on their website

Conditions of Participation (CoPs)

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Resource is your state department of health or regional CMS office

The American Hospital Association or state hospital association may be of assistance

Note that when changes are published in the Federal Register there is always the name and phone number of a contact person at CMS

Contact for Questions

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Step one is publication in Federal Register

Step two is where CMS publishes the interpretive guidelines

The interpretive guidelines provide instructions to the surveyors on how to survey the CoPs

These are called survey procedure

Not all the standards have survey procedures

Questions such as “Ask patients to tell you if the hospital told them about their rights”

Survey Procedure

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Surveyors use the information contained in the interpretive guidelines

They do not replace or supersede the law

Should not be used as basis for citation

They do contain authoritative interpretations and clarifications which can assist surveyors in making determinations of compliance

Interpretive Guidelines

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Assign each section of the hospital CoPs to the manager of that department

Do a side by side gap analysis like the TJC PPR for each section

Have standard on left side and go line by line and document compliance on the right side

Keep a hard copy of CoP and analysis

Designate someone in charge if a validation, complaint, or unannounced survey occurs

Commonly referred to as the CoP king or queen

Compliance Recommendation

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These will be discussed throughout presentation:

Restraint and seclusion (annual)

Abuse, neglect and harassment (annual)

Infection control

Advance directive

Organ donation

IVs and blood and blood products

ED common emergencies, IVs and blood and blood products for ED

CMS Required Education

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Life Safety Code Compliance

Infection Control and CMS gets $50 million grant to enforce in 2011

Patient Rights especially R&S and grievances

EMTALA

Performance Improvement (CMS calls it QAPI)

Medication Management

Dietary and cleanliness of dietary

What’s Really Important

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What’s Really Important Verbal orders

History and physicals

Need order for respiratory and rehab (such as physical therapy)

Need order for diet, medications, and radiology

Anesthesia (updated four times)

Standing orders and protocols

Medications within 30 minute time frame

Outpatient under one person (Tag 1078)

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First 37 pages list the survey protocol, including sections on:

Off-survey preparation

Entrance activities

Information gathering/investigation

Exit conference

Post survey activities

Survey Protocol

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Survey done through observation, interviews, and document review

Usually surveys are done Monday - Friday but can come on weekends or evenings

Federal law allows CMS or department of health surveyors access to your facility

CAH rehab or psych (behavioral health) is surveyed under this section even though CAH has separate manual

Survey Protocol

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Mid-sized hospital with a full survey

Two to four surveyors for three or more days and at least one RN with hospital survey experience

Team based on complexity of services offered

SA (state agency) decides or RO (regional office) for federal teams

Have an organized plan for an unannounced survey with designated persons to accompany surveyors

Include education of security or those who attend to the front desk where surveyors could enter in the morning

Survey Team

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Team coordinator gathers information about provider (ownership, types of services offered, locations)

Determines if provider based, remote locations, PPS-exempt services offered

Information collected from CMS database such as previous surveys and findings, size of facility, and average daily census

Team should enter together and usually goes to administration

Task 1 – Off Site Survey Prep

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Team will explains purpose and scope of survey

ENTRANCE CONFERENCE – sets the tone for entire survey

Give surveyors conference room, telephone

Give names of department heads, their location and phone numbers

CMS has a list of documents they may ask for so be ready and know what is on this list

Provide organizational chart

Task 2 – Entrance Activities

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Provide additional information

Infection control plan

Names and addresses of all off-site locations and provider numbers

List of employees

Medical staff bylaws, rules and regulations

List of contracted services

Copy of floor plan

List of current patients with room numbers, doctors

Give preliminary date and time for exit conference

Task 2 – Entrance Activities

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Purpose is to determine compliance with CoPs thru observation, interviews, and document review

Will visit patient care areas including ED and outpatient, Imaging, rehab, and remote locations

Observe actual care (IV, tube feeding, wound dressing changes)

May observe a nurse pass medications

Review copies of materials

Use interpretive guidelines to guide survey

Task 3 – Information Gathering

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Use Appendix Q if Immediate Jeopardy is suspected

Surveyor has discretion whether to allow staff to accompany the surveyor

All significant adverse events should be brought to the team coordinator’s attention immediately

Surveyors must respect patient privacy and confidentiality

Work with surveyor so they do not take peer-review protected documents with them

Task 3 – Information Gathering

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If surveyor makes copies of documents ask to make one for the hospital

No federal review law but if in PSO surveyor can not see

Review and analyze all information gathered

Determine if CoPs are met and if PPS exclusionary criteria (42 CFR Part 412, subpart B) or swing bed (42 CFR 482.66)

Prepare exit conference report

If noncompliance with CoP then determine if at standard or condition level and how dangerous it is

Task 4 Analysis of Finding

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Condition level - (NOT GOOD) due to noncompliance with requirement in a single standard or several standards within the condition or single tag but represents a severe or critical health breach, (need to have conversation)

Standard level - noncompliance as above but not of such a character to limit facility’s capacity to furnish adequate care - no jeopardy or adverse effect to health or safety of patient

Try and work with the surveyor to resolve the issue before CMS leaves the building

Deficiency

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Objective - inform facility of preliminary findings

Policy is to do exit conference

Can refuse if hostile environment or

Counsel tries to turn into evidentiary hearing

If recorded, must provide two tapes and tape recorders

Tape at same time and give surveyor one

Official findings are provided in writing on Form CMS 2567 (all forms on CMS website now)

Task 5 Exit Conference

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Surveyor can set ground rules

Present findings of noncompliance

Statement of deficiencies will be mailed and have 10 working days to fix (Form 2567)

This form is made public no later than 90 days after survey

So try and fix before the surveyor leaves

List deficiencies, plans for correction, timelines and opportunity to refute findings

Task 5 Exit Conference

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Objective is to complete the survey and certification requirements and notify staff regarding survey results

Complete hospital restraint/seclusion death reporting worksheet as appropriate

Enter information into hospital Medicare database

Certification of providers with deficiencies if acceptable plan of correction

Task 6 Post-Survey Activities

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Starts with a tag number, example A-0001

“A” refers to the hospital CoPs

Goes from 0001 to 1163

The three sections from Federal Register (CFR) include the regulation, interpretive guidelines and survey procedure

Survey procedure

Not in every section

Explains survey process, policies that will be reviewed, questions that will be asked and documents reviewed

Interpretive Guidelines

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The hospital must be in compliance with all federal, state, and local laws

Survey procedure tells surveyor to interview CEO or other designated by hospital

Refer non-compliance to proper agency with jurisdiction such as OSHA (TB, blood borne pathogen, universal precautions, EPA (haz mat or waste issues), or Rehabilitation Act of 1973

Will ask if cited for any violation since last visit

Compliance with Laws A-0020

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Hospital must be licensed or approved for meeting standards for licensure, as applicable Personnel must be licensed or certified if required by state

(doctors, nurses, PT, PA, etc.)

If telemedicine used must be licensed in state patient located and where practitioner is located See proposed changes on telemedicine

Verify that staff and personnel meet all standards (such as CE’s) required by state law

Review sample of personnel files to be sure credentials and licensure is up to date

Compliance with Laws 0023, 0022

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Hospital must have an effective governing body responsible for the conduct of the hospital as an institution

Written documentation identifies an individual as being responsible for conduct of hospital operations

Board makes sure MS requirements are met

Board must determine which categories of practitioners are eligible for appointment to medical staff (MS), as allowed by your state law (CRNA, NP, PA’s, nurse midwives, chiropractors, podiatrists, dentists, etc.)

Governing Body (Board) A-0043

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Board appoints individuals to the MS with the advice and recommendation of the MS (0046)

Will review board minutes to make sure they are involved in appointment of MS

Board must assure MS has bylaws and they comply with the CoPs (0047)

Board must make sure they have approved the MS bylaws and rules and regulations (0048) and any changes

TJC MS.01.01.01 as to what goes into a bylaw or R/R

Medical Staff and Board

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Board must ensure MS is accountable to the board for the quality of care provided to patients (0049)

All care given to patients must be by or in accordance with the order of practitioner who is operating within privileges granted by the Board

Need order for any medications

Need to document the order even if there is a protocol approved by the medical board for it

ED nurse starts IV on patient with chest pain and documents it in the order sheet

Discussed later under section 407 and 450

Medical Staff and Board

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Board ensures that criteria for selection of MS members is based on (0050)

MS privileges describe privileging process and ensure there is written criteria for appt to MS

Individual character, competence, training, experience and judgment

Make sure under no circumstances is staff membership or privileges based solely on certification, fellowship, or membership in a specialty society (0051)

TJC has a tracer now on this

Board and Medical Staff

TJC Tracer MS Credentialing and Privileging

Will look at the design of the MS and look at verification of credentials, limitations or relinquishing privileges, health status, morbidity and mortality, peer recommendations etc

Consistent process for all practitioners

Scope of the MS process to determine if all LIPs and other practitioners are reviewed

The link between results of ongoing professional practice evaluation and focused professional performance evaluation and the adherence to criteria.

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TJC Tracer MS Credentialing and Privileging

How the organization is monitoring the performance of all licensed independent practitioners on an ongoing basis

How does the hospital evaluates performance of LIPs who do not have current performance documentation (FPPE)?

How does the hospital evaluate LIPs who performance has raised concerns regarding safe quality care?

Will look to see if state opted out supervision with CRNAs, P&Ps for supervision of CRNAs, etc

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CMS Guidance issued to clarify it is a recommendation that MS must conduct appraisals of practitioners at least every 24 months Need to do every 24 months if TJC accredited

MS must examine each practitioner’s qualifications and competencies to perform each task, activity, or privilege

Included current work, specialized training, patient outcomes, education, currency of compliance with licensure requirements MS section repeated in tag 338-363 so will not duplicate

Board and the Medical Staff

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Board must appoint a CEO who is responsible for managing the hospital

Verify CEO is responsible for managing entire hospital

Verify the board has appointed a CEO

CEO is a very important position and CMS has only a small section

TJC in the leadership standard has more detailed information on the role of the CEO

CEO A-0057

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Board must make sure every patient has to be under the care of a doctor (or dentist, podiatrist, chiropractor, psychologist, et. al.)

Practitioners must be licensed and a member of MS

If LIPs can admit (NP, Midwives) still need to see evidence of being under care of MD/DO –

If state law allows needs policies and bylaws to ensure compliance

Exception is a separate federal law where no supervision required by midwives for Medicaid patients

Care of Patients 0063-0068

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Evidence of being under care of MD/DO must be in the medical record

Verify with your state department of health what documentation is required

Board and MS establish P&P and bylaws to ensure compliance

Board must make sure doctor is on duty or on call at all times, doctor of medicine or osteopathy is responsible for monitoring care M/M patient Interview nurses and make sure they are able to call the

on-call MD/DO and they come to the hospital when needed


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Patient admitted by dentist, chiropractor, podiatrist etc., needs to be monitored by a MD/DO, as allowed by state law Each state has a scope of practice which talks about what

they can do

The board and MS must have policies to make sure Medicare/Medicaid patient is responsible for any care OUTSIDE the scope of practice of the admitting practitioner

What is the scope of practice in your state for NP, CRNAs, Midwifes, and PAs?


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Need institutional plan

Include annual operating budget with all anticipated income and expenses

Provide for capital expenditures for 3 year period

Identify sources of financing for acquisition of land improvement of land, buildings and equipment

Must be submitted for review TJC has similar standards in its leadership chapter

Plan and Budget 0073-0077

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Plan and Budget

Need institutional plan

Must include acquisition of land and improvement to land and building

Must be reviewed and updated annually

Must be prepared under direction of board and a committee of representatives from the Board administrative staff, and MS (077)

Verify that all 3 participated in the plan and budget

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Board responsible for services provided in hospital (0083) Whether provided by hospital employees or under

contract

Board must take action under hospital’s QAPI program to assess services provided both by employees and under direct contract

Identify quality problems and ensure monitoring and correction of any problems TJC has more detailed contract management standards

in LD chapter, revised 7-1-10

Contracted Services

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Board must ensure services performed under contract are performed in a safe and efficient manner

Increased scrutiny on contracted services

Review QAPI plan to ensure that every contracted service is evaluated

Maintain a list of all contracted services (85)

Contractor services must be in compliance with CoPs Consider adding section to all contracts to address CoP

requirements

Contracted Services

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Remember to see the EMTALA separate CoP

Revised May 29, 2009 and amended July 2010 and now 64 pages

Consider doing yearly education on EMTALA to your ED staff and for on call physicians

If hospital has an ED, you must comply with section 482.55 requirements

If no ED services, Board must be sure hospital has written P&P for emergencies of patients, staff and visitors

Emergency Services 0091

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Qualified RN must be able to assess patients

Verify that MS has P&P on how to address emergency procedures

Need P&P when patient’s needs exceed hospital’s capacity

Need P&P on appropriate transport

Train staff on what to do in case of an emergency

Should not rely on 911 for on-campus and need trained staff to respond to the code or emergency


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If emergency services are provided at the hospital but not at the off campus department then you need P&P on what to do at the off-campus department when they have an emergency

Do whatever you can to initially treat and stabilize the patient etc

Call 911 (off campus only!)

Provide care consistent with your ability

Includes visitors, staff and patients

Make sure staff are oriented to the policy


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Changes many standards related to grievances and restraint and seclusion (R&S)

Sets forth standards regarding R&S staff training and education

Sets forth standards on R&S death reporting

TJC also has chapter on 14 patient rights or RI “Rights and Responsibilities of the Individual” starting with RI.01.01.01 thru 02.02.01

Patient Rights

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Minimum protections and rights for patients

Right to notification of rights and exercise of rights

Privacy and safety

Confidentiality of medical records

Restraint issues (50 pages of restraint standards)

Grievances

Advance directives

Visitation rights

Patient Rights Standards 0115-0214

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Notice of Patient Rights and Grievance Process

Hospital must ensure the notice of patient rights are met

Provide in a manner the patient will understand

Remember issue of limited English proficiency (LEP) as with patients who does not speak English and low health literacy

20% of patients read at a fifth grade level

Must have P&P to ensure patients have information necessary to exercise their rights

Standard # 1

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Rule #1 - A hospital must inform each patient of the patient’s rights in advance of furnishing or discontinuing care

Must protect and promote each patient’s rights

Must have P&P to ensure patients have information on their rights and this includes inpatients and outpatients

Must give Medicare patient IM Notice within two days of admission and in advance of discharge if more than two days

Notice of Patient Rights 116

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Confidentiality and privacy

Pain relief

Refuse treatment and informed consent

Advance directives

Right to get copy for Medicare patients of Important Message from Medicare (IM Notice) or detailed notice)

Right to be free from unnecessary restraints

Right to determine who visitors will be

Notice of Patient Rights

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When appropriate, this information is given to the patient’s representative

Document reason, patient unconscious, guardian, DPOA, parent if minor child et. al.

Consider having a copy on the back of the general admission consent form and acknowledgment of the NPP

Have sentence that patient acknowledges receipt of their patient rights

Right to contact the QIO or state agency of problems

Notify Patient of Their Rights

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Rule #2 - A hospital must ensure interpreters are available

Make sure communication needs of patients are meet

Recommend qualified interpreters

Must comply with Civil Rights law

Be sure to document that the interpreter was used See TJC 2011 Patient Centered Communications Standards

Interpreters

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Consider posting a sign in several languages that interpreting services are available

Include in yearly skills lab for nurses to make sure your staff knows what to do and they understand P&P

Review your policy and procedure and the five 2011 standard TJC requirements

If hospital owned physician practices ensure interpreters are present in prescheduled appointments

Interpreters

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Rule #3 - The hospital must have a process for prompt resolution of patient grievances

Hospital must inform each patient to whom to file a grievance

Provides definition which you need to include in your policy

If TJC accredited combine P&P with complaint section complaint standard at RI.01.07.01 in which is similar to CMS now with one addition

Use the CMS definition of grievance

Grievance Process A-0118

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Definition: A patient grievance is a formal or informal written or verbal complaint

when the verbal complaint about patient care is not resolved at the time of the complaint by staff present

by a patient, or a patient’s representative,

regarding the patient’s care, abuse, or neglect, issues related to the hospital’s compliance with the CMS CoP or a Medicare beneficiary billing complaint related to rights


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Remember it is not a grievance if resolved by “staff present”

Document this in medical record

Expanded definition of what is meant by “staff present”

Now includes any hospital staff present at the time of the complaint or who can quickly be at the patient’s location

Such as nursing administration, nursing supervisors, patient advocates or anyone else who can resolve the patient’s complaint

“Staff Present” Grievances

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Hospitals should have process in place to deal with minor request in more timely manner than a written request Examples: change in bedding, housekeeping of room,

and serving preferred foods

Does not require written response

If complaint cannot be resolved at the time of the complaint or requires further action for resolution then it is a grievance

All the CMS requirements for grievances must be met

Grievances A-0118

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If someone other than the patient complains about care or treatment

Contact the patient and ask if this person is their authorized representative

Get the patient’s permission to discuss protected health information with designed person because of HIPAA

Document in the file that the patient’s permission was obtained– Some facilities get a HIPAA compliant form signed

Patient or Their Representative

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Not a grievance if patient is satisfied with care but family member is not

Billing issues are not generally grievances unless a quality of care issue

A written complaint is always a grievance whether inpatient or outpatient (email and fax is considered written)

Information on patient satisfaction surveys generally not a grievance unless patient asks for resolution or unless the hospital usually treats that type of complaint as a grievance

Grievances 0118

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If complaint is telephoned in after patient is dismissed then this is also considered a grievance

All complaints on abuse, neglect, or patient harm will always be considered a grievance

Exception is if post hospital verbal communication would have been routinely handled by staff present

If patient asks you to treat as grievance it will always be a grievance

Grievances 0118

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Review the hospital policy to assure its grievance process encourages all personnel to alert appropriate staff concerning grievances

Hospital must assure that grievances involving situations that place patients in immediate danger are resolved in a timely manner

Conduct audits and PI to make sure your facility is following its grievance P&P

Grievance Process - Survey Procedure

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Surveyor will interview patients to make sure they know how to file a complaint or grievance

Including right to notify state agency (state department of health and QIO with phone numbers)

Remember to add email address and address of both

Document that this is given to the patient

Remember the TJC APR requirements

Should be in writing in patient rights section

Grievance Process - Survey Procedure

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Rule #4 – The hospital must establish a process for prompt resolution

Inform each patient whom to contact to file a grievance by name or title

Operator must know where to route calls

Make form accessible to all

Grievance Process 0119

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Rule #5 – The hospital’s governing board must approve and is responsible for the effective operation of the grievance process

Elevates issue to higher administrative level

Have a process to address complaints timely

Coordinate data for PI and look for opportunities for improvement

Read this section with the next rule

Most boards will delegate this to hospital staff


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The hospital’s board must review and resolve grievances

Unless it delegates the responsibility in writing to the grievance committee

Board is responsible for effective operation of grievance process

Grievance process reviewed and analyzed thru hospital’s PI program

Grievance committee must be more than one person and committee needs adequate number of qualified members to review and resolve

Rule #6 A-0119-120

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Go back and make sure your governing board has approved the grievance process

Look for this in the board minutes or a resolution that the grievance process has been delegated to a grievance committee

Does hospital apply what it learns?

Grievance Survey Procedure

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Rule #7 – The grievance process must include a mechanism for timely referral of patient concerns regarding the quality of care or premature discharge to the appropriate QIO

Each state has a state QIO under contract from CMS and list of QIOs1

QIO are CMS contractors who are charged with reviewing the appropriateness and quality of care rendered to Medicare beneficiaries in the hospital setting

1http://www.qualitynet.org/dcs/ContentServer?pagename=Medqic/MQGeneralPage/GeneralPageTemplate&name=QIO%20Listings

Grievance Process-A-0120

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Hospital to provide a Medicare patient with an Important Message from Medicare ( IM notice ) within 48 hours of admission

The hospital must deliver to the patient a copy of this signed form again if more than two days and within 48 hours of discharge

About 1% of Medicare patients voice concern about being discharge prematurely

These patients must be given a more detailed notice and request the QIO to review their case

New forms IM “You Have the Right” and “Detailed Notice”

Website for beneficiary notices1

1www.cms.hhs.gov/bni

IM and Detailed Notice Forms

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Hospital must have a clear procedure for the submission of a patient’s written or verbal grievances

Surveyor will review your information to make sure it clearly tells patients how to submit a verbal or written grievance

Surveyor will interview patient to make sure information provided tells them how to submit a grievance

Must establish process for prompt resolution of grievances

Grievance Procedure 121

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Rule #8 – Hospital must have a P&P on grievance

Specific time frame for reviewing and responding to the grievance

Grievance resolution that includes the patient with a written notice of its decision, IN MOST CASES

The written notice to the patient must include the steps taken to investigate the grievance, the results and date of completion

Hospital Grievance Procedure 0122

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Facility must respond to the substance of each and every grievance

Need to dig deeper into system problems indicated by the grievance using the system analysis approach

Note the relationship to TJC sentinel event policy and LD medical error standards, CMS guidelines for determining immediate jeopardy, HIPAA privacy and security complaints, and risk management/patient safety investigations

Hospital Grievance Procedure

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Timeframe of 7 days would be considered appropriate and if not resolved or investigation not completed within 7 days must notify patient still working on it and hospital will follow up

Most complaints are not complicated and do not require extensive investigation

Will look at time frames established

Must document if grievance is so complicated it requires an extensive investigation

Grievances

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Explanation to the patient must be in a manner the patient or their legal representative would understand

The written response must contain the elements required in this section - not statements that could be used in legal action against the hospital

Written response must the steps taken to investigate the complaint

Surveyors will review the written notices to make sure they comply with this section

Grievances A-0123

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CMS says if patient emailed you a complaint, you may email back response Be careful as many hospital policy on security do not

allow this since email is not encrypted

Must maintain evidence of compliance with the grievance requirements

Grievance is considered resolved when patient is satisfied with action or if hospital has taken appropriate and reasonable action

Grievances A-0123

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TJC has complaint standard RI.01.07.01 with changes 7-01-09 and 2 010 and continued in 2011

Will not cover but provided for reference

TJC calls them complaints

CMS calls them grievances

TJC has eliminated several standards in 2011 that are still CMS standards

More closely cross walked now

TJC Complaint Standard

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RI.01.07.01 Complaints & Grievances

Standard: patient and or her family has the right to have a complaint reviewed, (RI 2.120 previously),

EP1 Hospital must establish a complaint and grievance (C&G) resolution process

See also MS.09.01.01, EP1

EP2 Patient and family is informed of C&G resolution process

EP4 Complaints must be reviewed and resolved when possible

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RI.01.07.01 Complaints & Grievances

EP6 Hospital acknowledges receipt of C&G that cannot be resolved immediately

Hospital must notify the patient of follow up to the C&G

EP7 Must provide the patient with the phone number and address to file the C&G with the relevant state authority

EP10 The patient is allowed to voice C&G and recommend changes freely with out being subject to discrimination, coercion, reprisal, or unreasonable interruption of care

100

RI.01.07.01 Complaints and Grievances

EP 17 Board reviews and resolves grievances unless it delegates this in writing to a grievance committee (eliminated but still CMS requirement)

EP 18 Hospital provides individual with a written notice of its decision which includes (DS);

Name of hospital contact person

Steps taken on behalf of the individual to investigate the grievance

Results of the process

Date of completion of the grievance process

101

RI.01.07.01 Complaints

EP19 Hospital determines the time frame for grievance review and response(DS)

EP20 Process for resolving grievances includes a timely referral of patient concerns regarding quality of care or premature discharge to the QIO

EP21 Board approves the C&G process (eliminated but still CMS standard)

102

Have a Policy to Hit All the Elements

103

Right to participate in the development and implementation of their plan of care

Right to refuse care and formulate advance directives

Right to have a family member or representative of his or her choice notified if requested

Called support person in the final visitation regulations

Right to have his or her physician notified promptly of the patient's admission to the hospital if patient requests this

2cd Standard Exercise of Rights

104

Rule #1 – Patients have the right to participate in the development and implementation of their plan of care

Includes inpatients and outpatients

Includes discharge planning and pain management

Requires hospital to actively include the patient in developing their plan of care including changes

Standard #2 Exercise of Rights 0129

105

If patient refuses to participate, document this

Include patient’s legal representative if patient minor or incompetent

Plan of care is frequently cited

Patients needing post-hospital care are given choice home health or nursing homes

Includes choice to pain management, patient care issues, and discharge planning

Section 1802 of SSA guarantees free choice by Medicare patients for LTC or home health

Patient Participate in Plan of Care

106

To make informed decision regarding their care

Being informed of their diagnosis and prognosis

To request or refuse treatment Right to sign out AMA

Remember EMTALA requirements if patient is transferred

Have patient sign the transfer agreement

Rule #2 - Patients Have a Right:

107

CMS has 3 sections in the hospital CoP manual on informed consent

Section on informed consent in patient rights on informed decisions, medical records and surgical services

The patient has the right to make informed decisions

Informed Consent 0131

108

Right to delegate the right to make informed decisions to another (DPOA, guardian)

Patient has a right to an informed consent for surgery or a treatment

Right to be informed of health status and to be involved in care planning and treatment

Informed decision on discharge planning to post acute care

Right to request or refuse treatment and P&P to assure patient’s right to request or refuse treatment


109

Right to informed decisions about planning for care after discharge

Right to receive information in a manner that is understandable (issue of healthcare literacy)

Right to get information about health status, diagnosis and prognosis

Hospital has to have process to ensure these rights

Required to have policies and procedures on all of these

Informed Consent

110

There are two disclosures that must be in writing

If physician owned hospital

If a doctor or an ED physician is not available 24 hours a day to assist in emergencies

Must provide information at beginning of inpatient stay or visit

Includes notice in your general consent form/notice of privacy practice that all inpatients and outpatients sign

Disclosures to Patients 131

111

Right to make and have the advance directives followed when unconscious or incapacitated

Staff must provide care that is consistent with these directives

P&P must include delegation of patient rights to representative if patient incompetent

Note rights as inpatient outpatient AD requirements of Joint Commission

Patient Rights 0132

112

Your policy should have clear statement of any limitations such as conscience

At a minimum, clarify any difference between facility wide conscience objections and those raised by individual doctors

You must provide written information to the patient on their rights under state law, at time of admission

Both inpatients and outpatients have rights but don’t have to give it in writing to outpatients

Document whether or not they have an AD

Advance Directives

113

Cannot condition treatment on whether or not they have one

Not construed as a mechanism to demand inappropriate or medically unnecessary care

Ensure compliance with state laws on AD Inform patients they may file with state survey and

certification agency

Provide and document advance directives education

Staff on P&P and community

Advance Directives 132

114

Includes the right for medical decisions such as pain management

Disseminate policy on advance directive, identify state authority permitting an objection

Includes Psychiatric or behavioral health AD

The visitation regulations are one of the newest patient rights

Patient Rights

115

The right to personal privacy

To receive care in a safe setting

To be free from all forms of abuse or harassment

Rule #1 – The right to personal privacy

Right to respect, dignity, and comfort

Privacy during personal hygiene activities (toileting, bathing, dressing, pelvic exam)

3rd Standard Privacy and Safety 143

116

Person not involved with care may not be present while exam is being done unless consent required (medical students who are observing not those caring for patient)

Need consent for video/electronic monitoring

Such as cameras in patient rooms (sleep lab, ED safe room, eICU) and not in hallways or lobbies

Include in your general admission consent form that all patients sign on admission or make sure patients are aware such in ICU

Personal Privacy

117

Surveyor will conduct observations to determine if privacy provided during exams, treatments, surgery, personal hygiene activities, etc.

Surveyor will look to see if names or patient information is posted in plain view

Survey procedure will ask if patient names are posted in public view No white boards with patient names and other PHI

Personal Privacy

118

Rule #2 – The right to receive care in a safe setting

Includes following standards of care and practice for environmental safety, infection control, and security such as preventing infant abductions, preventing patient falls and medication errors

Very broad authority for patient safety issue

Right to respect for dignity and comfort

Privacy and Safety 144

119

Includes washing hands between patients - see CDC or WHO hand hygiene and TJC Measuring Hand Hygiene Adherence

Review and analyze incident or accident reports to identify problems with a safe environment

Review policies and procedures

How does facility have P&P to curtail unwanted visitors or contraband materials

Care in a Safe Setting

120

Rule #3 – The patient has the right to be free from all forms of abuse or harassment and neglect

Must have process in place to prevent this

Criminal background checks as required by your state law

Must provide ongoing (yearly) training on abuse, harassment, and neglect


121

Consider annual training in yearly skills lab

Must have P&P on this

Adequate staffing section

Have proactive approach to identify events that could be abuse

TJC and CMS have definitions of what is abuse and neglect


122

Abuse is defined as the willful infliction of injury, unreasonable confinement, intimidation, or punishment, with resulting physical harm, pain, or mental anguish

Includes staff neglect or indifference to infliction of injury or intimidation of one patient by another

Include state laws in your P&P on abuse and neglect

Remember TJC has standard and definitions, RI.01.06.03

Freedom From Abuse and Neglect

123

Neglect is defined as the failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness

Investigate all allegations of abuse or neglect

Do not hire persons with record of abuse or neglect

Report all incidents to proper authority, board of nursing, etc.


124

Includes freedom abuse from not just staff but other patients and visitors

Hospital must have a mechanism in place to prevent this

Effective abuse program includes prevention Adequate number of staff who have been screened

Identify events that could lead to or contribute to abuse

Protect during investigation

Investigate and report and respond


125

Make sure you have a policy in place for investigating allegations of abuse

Make sure staffing sufficient across all shifts

Make sure appropriate action taken if substantiated

Make sure staff know what to do if they witness abuse and neglect

Abuse and Neglect

126

Remember to include Joint Commission’s standard, RI.01.06.03, and definitions of abuse and neglect into your policy also if accredited

Patients have the right to be free from abuse, neglect, and exploitation This includes physical, sexual, mental, or verbal

abuse and Joint Commission has definitions for all of these terms

TJC Abuse and Neglect

127

Determine how you will protect patients while they are receiving care from abuse and neglect

Evaluate all allegations that occur within the hospital

Report to proper authorities as required by law

TJC Abuse and Neglect

128

Rule #1 – Patients have a right to confidentiality of their medical records and to access of their medical records (0146) Sufficient safeguards to ensure access to all information

HIPPA compliant authorization for release

MR are kept secure and only viewed when necessary by staff involved in care

Do not post patient information where it can viewed by visitors

TJC IM.02.01.01 standard requires that hospital protects the privacy of health information, maintain security of same (white boards)

Standard #4 Confidentiality

129

Rule #2 – Patients have the right to access the information contained within their medical records

Right to inspect their record or to get a copy

30 day rule under HIPAA unless state law or P&P more stringent

Limited exceptions such as psychotherapy notes, prisoners if jeopardize health of themselves or others, information could cause harm to another, under promise of confidentiality, etc.

Patient Records

130

Rule #3 – Access to the medical record must be within a reasonably time frame and hospitals can not frustrate efforts of patients to get records

If patient is incompetent then to the personal representative and should sign as the personal representative such as guardian, parent, or DPOA

Reasonable cost for copying, postage or summary no retrieval fee allowed under federal law

Access to Medical Records (PHI)

131

Many changes were made

Combined the two sections on medical surgical and behavioral restraints into one section

Changes went into effect January 8, 2007 and 50 pages of interpretive guidelines April 11, 2008 and 10-17-08 and references added 6-5-09

Need to rewrite policies and procedures and train all staff

5th Standard Restraints 0154-0214

132

CMS has restraint worksheet1 which is not an official OMB form Cannot mandate hospital fill out but will save time on

phone from them asking you the information

Must still notify regional office by phone the next business day Document this in medical record

CMS has manual to address complaint surveys

Put regional office contact information in your P&P1

1www.cms.hhs.gov/SurveyCertificationGenInfo/downloads/SCLetter06-31.pdf

1www.cms.hhs.gov/RegionalOffices/01_overview.asp

Restraint Worksheet

134

New changes only affect regular hospitals and Critical Access Hospitals have own manual

CAH do not have a patient rights section and not required to follow new R&S section

CAH must have P&P so they can either use TJC standards or select some or all of hospital ones Some CAH have adopted all if in system with regular

hospitals

Restraints

135

Rule #1 – Patients have a right to be free from physical or mental abuse, and corporal punishment

This includes that restraint and seclusion (RS)

Will only be used when necessary

Not as coercion, discipline, convenience or retaliation

Only used for patient safety and discontinued at earliest possible time

R&S guidelines from CMS apply to all hospital patients even those in behavioral health

Standard #5 Restraints

136

Hospitals should consider adding it to their patient rights statement if not already there

Patients are required to be provided a copy of their rights (staff must document or have patient sign that they received their rights) Could include information in admission packet

If patient falls do not consider using R&S as routine part of fall prevention (154)

Right to be Free From Restraint

137

Like TJC, leadership is responsible for creating a culture that supports right to be free from R&S

LD must make sure systems and processes in place to eliminate inappropriate R&S and monitors use thru PI process

LD makes sure only used for physical safety of patient or staff

LD ensure hospital complies with all R&S requirements (154)

Rule #2 Hospital Leadership’s Role

138

CMS previously did not recognize or allow the use of protocols like Joint Commission does

Protocols are now not banned by the new regulations (168) but still need separate order for R&S

Must contain information for staff on how to monitor and apply like intubation protocol

Restraints Protocols

139

Requires an order even with a protocol is basically the same process hospitals were doing previously

Medical record must include documentation of individualized assessment, symptoms and diagnosis that triggered protocol

Need MS involvement in developing and review and quality monitoring of their use

Protocols

140

If a patient becomes violent or has self destructive behavior (V/SD) in the ICU or ED, CMS has one set of standards that apply

Decision to use R&S is not driven from diagnosis but from assessment of the patient

TJC standards changed July 1, 2009 10 new standards

All the 2009 R&S standards were eliminated except two (forensic and one on behavioral management) for hospital who use TJC for deemed status

Restraint Standards

141

Joint Commission calls it behavioral health and non-behavioral health

CMS calls it violent and or self destructive (V/SD) and non-violent and non-self destructive

CMS says it is not the department in which the patient is located but the behavior of the patient

Restraint Standards Medical Patients

142

New definition: Physical restraint is any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely

Mechanical restraints include belts, restraint jackets, cuffs, or ties

Manual method of holding the patient is a restraint

Rule #3 Know Definition 159

144

A drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or standard dosage for the patient's condition (160)

Use of PRN drug is only prohibited if medication meets definition of drug Ativan for ETOH withdrawal symptoms is okay

Restraint Definition

145

Medication is within pharmacy parameters set by FDA and manufacturer for use

Use follows national practice standards

Used to treat a specific condition based on patient’s symptoms

Standard treatment would enable patient to be effective or appropriate functioning

When Drug is not a Restraint

146

Seclusion is the involuntary confinement of a patient alone in a room or area from which the patient is physically prevented from leaving (162)

Seclusion may only be used for the management of violent or self-destructive behavior (V/SD behavior) that jeopardizes the immediate physical safety of the patient, a staff member, or others

Is not being on a locked unit with others or for time out if patient can leave area (162)

Definition of Seclusion

147

It is when they are alone in a room and physically prevented from leaving

May only use seclusion for management of V/SD behavior that is danger to patient or others

Seclusion

148

Learning from Each Other - Success stories and Ideas for Reducing Restraint/Seclusion in Behavioral Health, tools and forms in appendix

Published in 2003 by many organizations such as American Psychiatric Nurses Assn, National Association of Psychiatric Health Systems (NAPHS) with support of AHA

See NAPHS and AHA guiding principlesSources: www.naphs.org; www.apna.org, www.psych.org, or

www.apna.org, www.naphs.org/catalog/ClinicResources/index.html

Learning From Each Other

149

Time limits on length of order apply such as four hours for an adult

One hour face to face evaluation must be done (183)

Therapeutic holds to manage V/SD patients are a form of restraint

Restraint and Seclusion

150

Forensic restraints such as handcuffs, shackles, or other restrictive devices applied by law enforcement or police are not R&S (0154)

Closely monitor and observe for safety reasons

Orthopedically prescribed devices, surgical dressings or bandages, protective helmets (161)

Methods that involve the physical holding of a patient for the purpose of conducting routine physical examinations or tests (161)

Restraints Do Not Include

151

Protecting the patient from falling out of bed Cannot use side rails to prevent patient from getting out

of bed if patient can not lower

Striker beds or the narrow carts and their use of side rails are not a restraint

IV board unless tied down or attached to bed

Postural support devices for positioning or securing (161)

Device used to position a patient during surgery or while taking an x-ray


152

Recovery from anesthesia is part of surgical procedure and medically necessary (161)

Mitts unless tied down or pinned down or unless so bulky or applied so tightly patient can not use or bend their hand (161)

Mitts that look like boxing gloves are a restraint

Padded side rails put up when on seizure precaution

Giving child a shot to protect them from injury (161)

Physically holding a patient for forced medications is a physical restraint


153

Tucking in a sheet so tight patient could not move (159)

Use of enclosed bed or net bed unless the patient can freely exit the bed such as zipper inside the bed

Freedom splint that immobilizes limb

Remember that is it not the thing but what the thing does to the patient in which their movement is restricted

Restraints Do Include

154

Devices with multiple purposes - such as side rails or Geri chairs, when they cannot be easily removed by the patient

Restrict the patient’s movement constitute a restraint

If belt across patient in wheelchair and he can unsnap belt or Velcro then it is not a restraint (159)

If patient can lower side rails when she wants then it is not a restraint but document this

If a patient can remove a device it is not a restraint

Restraints

155

Stroller safety belts, swing safety belts, high chair lap belts, raised crib rails, and crib covers (161) are okay as long as age or developmentally appropriate

Use of these safety intervention must be addressed in your policy

Holding an infant or toddler is not a restraint

Restraints

156

CMS does not consider the use of weapons by hospital staff on patients as safe in the application of restraint (154)

Could use on criminal breaking into building

Weapons include pepper spray, mace, nightsticks, tazers, stun guns, pistols, etc.

Okay if patient is arrested and use by law enforcement such as non-employed staff like police as state and federal laws

Weapons 154

157

Should do comprehensive assessment and assess to reduce risk of slipping, tripping or falling

To identify medical problems that could be causing behavioral changes (0154) such as increased temp, hypoxia, low blood sugar, electrolyte imbalance, drug interactions, etc.

Use of restraint is not considered routine part of a falls prevention program (154)

Assessment

158

Surveyor will look to see if there is evidence that staff determined the reason for the R&S (154)

This should be documented and be specific

Consider a field on the order sheet to include this

Usually to prevent danger to the patient or others

Danger to self, maintain therapeutic environment such as to prevent patient from removing vital equipment, physically attempting to harm others or property, patient demonstrated lack of understanding to comply with safety directions

Determine Reason for R&S

159

(Check all that apply)

Unable to follow directions

High risk of falls

Aggressive

Disruptive/combative

History of hip fracture/falls

Self injury

Interference with treatments

Removal of medical devices

Other: ____________________________

Reasons to Restrain

161

Restraints can only be used when less restrictive interventions have been determined to be ineffective to protect the patient or others from harm (154, 164, 165,)

Type or technique used must also be least restrictive

Is what the patient doing a hazard? Allowing sundowners to walk or wander at night (154)

Request from patient or family member is not sufficient basis for using if not indicated by condition of patient

Rule #4

162

Must do an assessment of patient

Must document that restraint is least restrictive intervention to protect patient safety based on assessment

What was the effect of least restrictive intervention

You must train on what is least restrictive interventions

Less Restrictive

163

Side rails…………...

Hand mittens……….

Lap board…………..

Roll belt/lap belt……

2 point soft restraint..

Wrap IV site ………..

Hand mitten………...

Freedom splint is a restraint!

Net bed

soft extremity restraint

Geri chair

vest restraint

3 or 4 point soft

arm board

soft wrist restraint

Least Restrictive Restraint to More

164

Alternatives should be considered along with less restrictive interventions (186)

What are other things you could do to prevent using R&S such as sitter or family member stays with patient

Distractions such as watching video games or working on a laptop computer

Try nonphysical intervention skills (200)

Considering having a list of alternatives in the toolkit

Rule # 5 Alternatives

165

Bed sensor

Close to nurses station

Activity apron

E-Z release hugger (if can release)

Reality orientation/familiarize patients to room

Verbal instructions/support

Frequent visits with patient (hourly except night shift)

Consider Alternatives

166

Skin sleeves

Sensor alarm

Posey lateral wedges

Access to call cordLower chairs

Allow wandering, if possible

Food/hydration

Low beds or mattress on floor

Encourage family visits

Pain/discomfort relief

Diversion activities such as TV, CDs, DVDs, music therapy, picture books, games

Provide structured, quiet environment

Exercise/ambulate

Toileting routine

Consider Alternatives

167

Be calm and reassuring

Approach in non-threatening manner

Wrap around Velcro band while in wheelchair (if can release)

Relaxation tapes

Do photo album

Back rubs or massage therapist

Wanderguard system

Limit caffeine

Alternatives to Restraints

168

Watching TV

Massage or family can hire massage therapist

Punching bag

Avoid sensory overload

Fish tanks

Tapes of families or friends

Alternatives to Restraints

172

Rule #6 LIPs can write orders for restraints

Any individual permitted by both state law and hospital policy for patients independently, within the scope of their licensure, and consistent with granted privileges, to order restraint, seclusion

NP, licensed resident, PA, but not a medical student

Remember must specify who in your P&P (168)

Restraints LIP Can Write Orders

173

Rule #7 - Any established time frames must be consistent with asap (not in 1 or 3 hours)

Hospital MS policy determine who is the attending physician

Hospital P&P should address the definition of asap (182,170)

RN or PA who does 1 hour face-to-face must notify attending physician and discuss findings (182)

Be sure to document if LIP or nurse notifies physician

Restraints Notify Doctor ASAP 170

174

Rule #8 An order must be received for the restraint by the physician or other LIP who is responsible for the care of the patient (168)

Include in P&P use in an emergency

P&P to include category of who can order (PA, NP, resident, can not be med student)

PRN order prohibited if for medication used as a restraint, okay if not a restraint

No PRN order for restraints either (167, 169), except for 3 exceptions (169)

Restraints Order needed

175

Repetitive self-mutilating behavior (169), such as Lesch-Nyham Syndrome

Geri chair if patients requires tray to be locked in place when out of bed

Raised side rails if requires all 4 side rails to be up when the patient is in bed

Do not need new order every time but still a restraint

PRN Order 3 Exceptions

176

Restraints must be used in accordance with a written modification to the patient's plan of care (166)

What was the goal of the plan of care

Use of restraint should be in modified plan of care

Care plan should be reviewed and updated in writing

Within time frame specified in P&P (166)

Plan reflects a loop of assessment, intervention, evaluation and reevaluation

Rule #9 Plan of Care

178

Orders are time limited and this is included in the plan of care

For patient who is V/SD may want to debrief as part of plan of care but not mandated by CMS

Debriefing no longer mandated by TJC for behavioral patients (deemed status)

Can add information on debrief to R&S toolkit

Restraints - Plan of Care

179

Restraints must be discontinued at the earliest possible time (154, 174)

Regardless of the time identified in the order

If you discontinue and still time left on clock and behavior reoccurs, you need to get a new order

Temporary release for caring for patient is okay (feeding, ROM, toileting) but a trial release is seen as a PRN order and not permitted (169)

Rule #10 End at Earliest Time

180

Restraints only used while unsafe condition exists

The hospital policy should include who has authority to discontinue restraints (154, 174)

Under what circumstances restraints are to be discontinued and who is allowed to take them off

Based on determination that patients behavior is no longer a threat to self, staff, or others (put this in your P&P)

Surveyors will look at hospital policy

Policy should also include procedures to follow when staff need to apply in an emergency

Restraints - End at Earliest Time

181

Staff must assess and monitor patient’s condition on ongoing basis (0154, 174, 175)

Physician or LIP must provide ongoing monitoring and assessment also (175)

One reason to determine is if R&S can be removed

Took out word continually monitored except for V/SD patients and says at an interval determined by hospital policy

Rule #11 Assessment of Patient

182

Intervals are based on patient’s need, condition and type of restraint used (V/SD or not)

CMS doesn’t specify time frame for assessment like TJC use to (TJC use to say every 2 hours for medical patients and every 15 minutes for behavioral health patients)

CMS says this may be sufficient or waking patient up every 2 hours in night might be excessive

This must be in your hospital P&P frequency of evaluations and assessments (175) and document to show compliance

Rule #11 Assessment of Patient

183

Most hospital use special documentation sheet for assessment parameters, including frequency of assessment, and hospital policy should address each of these (175, 184)

If doctor writes a new order or renews order need documentation that describes patients clinical needs and supports continued use (174)

Document; fluids offered (hydration needs), vital signs

Toileting offered (elimination needs)

Removal of restraint and ROM and repositioning

Mental status, circulation

Rule #12 Documentation

184

Attempts to reduce restraints, skin integrity, and level of distress or agitation, et. al.

Document the patient’s behavior and interventions used

Behavior should be documented in descriptive terms to evaluate the appropriateness of the intervention (185)Example, patient states the Martians have landed and

attempting to strike the nurses with his fists. Patient attempting to bite the nurse on her arm. Patient picked up chair and threw it against the window


185

Document clinical response to the intervention (188)

Symptoms and condition that warranted the restraint must be documented (187)

Have the restraint toolkit where you have the documentation sheet with the requirements, the order sheet, manufacturer instructions for the restraints, articles, etc.Many have separate order sheets for V/SD (behavioral

health) and non V/SD (non behavioral health)


186

Document Type of Restraint

189

Hospital take actions thru QAPI activities

Hospital leadership should assess and monitor use to make sure medically necessary

Consider log to record use-shift, date, time, staff who initiated, date and time each episode was initiated, type of restraint used, whether any injuries of patient or staff, age and gender of patient

Log and QAPI

192

Restraints and seclusion must be implemented in accordance with safe, appropriate restraining techniques (167)

As determined by hospital policy in accordance with state law

Use according to manufacturer’s instructions and include in your policy as attachment

Follow any state law provision or standards of care and practice

Was there any injury to patient and if so fill out incident report

Rule #13 Use as Directed

193

The lighting rod for public comment and AHA sued CMS over this provision

Standard for behavioral health patients or V/SD

Time limits for R&S used to manage V/SD behavioral and drugs used as restraint to manage them(178)

Must see (face to face visit) and evaluate the need for R&S within one hour after the initiation of this intervention

Rule #14 One Hour Rule

194

Big change is face to face evaluation can be done by physician, LIP or a RN or PA trained under 482.13 (f)

Physician does not have to come to the hospital to see patient now, telephone conference may be appropriate

Training requirements are detailed and discussed later

To rule out possible underlying causes of contributing factors to the patient’s behavior

One Hour Rule 178

195

Must see the patient face-to-face within 1-hour after the initiation of the intervention, unless state law more restrictive (179)

Practitioner must evaluate the patient's immediate situation

The patient's reaction to the intervention

The patient's medical and behavioral condition

And the need to continue or terminate the restraint or seclusion

Must document this (184) and change documentation form to capture this information

One Hour Rule Assessment 482.13 (f)

196

Include in form evaluation includes physical and behavioral assessment (179)

This would include a review of systems, behavioral assessment, as well as

Patient’s history, drugs and medications and most recent lab tests

Look for other causes such as drug interactions, electrolyte imbalance, hypoxia, sepsis etc. that are contributing to the V/SD behavior

Document change in the plan of care

Must be trained in all the above (196)

One Hour Rule Assessment 482.13 (f)

197

Time limits apply- written order is limited to (171)

4 hours for adults 2 hours for children (9-17) 1 hour for under age 9

Related to R&S for violent or self destructive behavior and for safety of patient or staff

Standard same now for Joint Commission time frame for how long the order is good for and closely aligned now

Rule #15 Time Limited Orders

199

The original order for both violent or destructive may be renewed up to 24 hours then physician reevaluates

Nurse evaluates patient and shares assessment with practitioner when need order to renew (171, 172)

Unless state law if more restrictive

After the original order expires, the MD or LIP must see the patient and assess before issuing a new order

Rule #16 Renew Order

200

Each order for non violent or non-destructive patients may be renewed as authorized by hospital policy (173)

Remember TJC requires an order to renew restraints on medical patients (which they now call non-behavioral health patients) every 24 hours

Not daily but every 24 hours

CMS and TJC the same

Rule #16 Renew Order

201

Will interview staff to make sure they know the policy (154)

Consider training on policy in orientation and during the annual in-service and when changes made

Remember hitting restraints hard in the survey process

Surveyor to look at use of R&S and make sure it is consistent with the policy

Rule #17 Need Policy on R&S

203

New staff training requirements

All staff having direct patient contact must have ongoing education and training in the proper and safe use of restraints and able to demonstrate competency (175)

Yearly education of staff as when skills lab is done

Document competency and training

Hospital P&P should identify what categories of staff are responsible for assessing and monitoring the patient (RN, LPN, Nursing assistant, 175)

Rule #18 Staff Education

204

Patients have a right to safe implementation of RS by trained staff (194)

Training plays critical role in reducing use (194)

Staff, including agency nurses, must not only be trained but must be able to demonstrate competency in the following:

The application of restraints (how to put them on), monitoring, and how to provide care to patients in restraints


205

This must be done before performing any of these functions (196)

Training must occur in orientation before new staff can use them on a patient

Training must occur on periodic basis consistent with hospital policy

Have a form to document that each of the education requirements have been met


206

Again consider yearly during skills lab

Remember that the Joint Commission PC.03.03.03 and 03.02.03 requires staff training and competency now

The hospital must require appropriate staff to have education, training, and demonstrated knowledge based on the specific needs of the patient population in at least the following

Techniques to identify staff and patient behaviors, events, and environmental factors that may trigger circumstances that require RS


207

Consider document in your tool kit although not required by CMS or TJC now (deemed status)

Teach staff what is de-escalation and not just staff on the behavioral health unit

Avoid confrontation and approach in a calm manner

Active listening

Valid feelings such as “you sound like you are angry”

Some have personal de-escalation plan that lists triggers such as not being listening to, feeling pressured, being touched, loud noises, being stared at, arguments, people yelling, darkness, being teased, etc.

De-escalation

209

The use of non-physical intervention skills (200)

Choosing the least restrictive intervention based on an individualized assessment of the patient's medical, or behavioral status or condition (201)

The safe application and use of all types of R&S used in the hospital, including training in how to recognize and respond to signs of physical and psychological distress (for example, positional asphyxia, 202)

Staff Education

210

Clinical identification of specific behavioral changes that indicate that restraint or seclusion is no longer necessary (204)

Monitoring the physical and psychological well-being of the patient who is restrained or secluded, including but not limited to, respiratory and circulatory status, skin integrity, vital signs, and any special requirements specified by hospital policy associated with the 1-hour face-to-face evaluation (205)

Staff Education

211

Including respiratory and circulatory status, skin integrity, VS, and special requirements of 1 hour face to face

The use of first aid techniques and certification in the use of cardiopulmonary resuscitation, including required periodic recertification (206) Patients in R or S are at higher risk for death or injury

All staff who apply, monitor, access, or provide care to patient in R must have education and training in first aid technique and certified in CPR

To render first aid if patient in distress or injured

Develop scenarios and develop first aid class to address these

Staff Education

212

Staff must be qualified as evidenced by education, training, and experience

Hospital must document in personnel records that the training and competency were successfully completed (208)

Security guards respond to V/SD patients would need to train

Many give a 8 hour CPI course

Don’t want someone going into the room of a V/SD patient without training to prevent injury to staff and patient

Staff Education

213

Individuals doing training program must be qualified (207)

Trainers must have high level of knowledge and need to document their qualifications

Train the trainer programs are done by many facilities

CMS said need to revise your training program every year which should take person 4 hours to do

Can have librarian do literature search for new articles on evidenced based restraint research

Training Cost

214

National Association of Psychiatric Health Systems (NAPHS), initial training in de-escalation techniques, restraint and seclusion policies and procedures

Recommended 7-16 hours of training but number of hours not mandated by CMS

In fact, in Federal Register recommended sending one person to CPI training class as a train the trainer

1http://www.crisisprevention.com

Training Time and Time Spent

215

Physician and other LIP training requirements must be specified in hospital policy (176)

At a minimum, physicians and other LIPs authorized to order R or S by hospital policy in accordance with State law must have a working knowledge of hospital policy regarding the use of restraint or seclusion

Hospitals have flexibility to determine what other training physicians and LIPs need

Education Physicians and LIPs

216

The following requirements will be superseded by existing state laws that are more restrictive (180)

State laws can be stricter but not weaker or they are preempted

States are always free to be more restrictive

Many states have a state department of mental health which has standards for patients that are in a behavioral health unit

Rule #19 Stricter State Laws

217

For behavioral health patients- which CMS now calls violent or self destructive behavioral that is a danger to self or others

Can’t use R&S together unless the patient is visually monitored in person face to face or by an audio and video equipment

Person to monitor patient face to face or via audio & visual must be assigned and a trained staff member

Must be in close proximity to the patient (183)

There must be documentation of this in the medical record

Rule #20 1:1 Monitoring R&S 0183

218

Documentation will include least restrictive interventions, conditions or symptoms that warranted RS, patient’s response to intervention, and rationale for continued use

This needs to be in hospitals P&P

Modify assessment sheets to include this information

Consider sitter policy to ensure does not leave patient unsupervised

Rule #20 1:1 Monitoring RS 0183

219

Report any death associated with the use of restraint or seclusion

Remember, the SMDA also requires reporting

Sentinel event reporting to Joint Commission is voluntary but need to do RCA within 45 days

See Hospital Reporting of Deaths Related to RS, OIG Report, September 2006, OEI-09-04-003501

1www.oig.hhs.gov

Rule #21 Deaths

220

The hospital must report to CMS each death that occurs while a patient is in restraint or in seclusion at the hospital

Must report every death that occurs within 24 hours after the patient has been removed from R&S

Each death known to the hospital that occurs within 1 week after R&S where it is reasonable to assume that use of restraint or placement in seclusion contributed directly or indirectly to a patient's death

Rule #21 Deaths 0214

221

“Reasonable to assume” includes, but is not limited to, deaths related to restrictions of movement for prolonged periods of time, or death related to chest compression, restriction of breathing or asphyxiation

Must be reported to CMS regional office by telephone no later than the close of business the next business day following knowledge of the patient's death

This is in the regulation even though some of the regional offices are telling hospitals just to fax in the form


222

Staff must document in the patient's medical record the date and time the death was reported to CMS

This includes patients in soft wrist restraints

Hospitals should revise post mortem records to list this requirement

Hospitals need to rewrite their policies and procedures to include these requirements


223

CMS issued new hospital COPs for QA and Performance Improvement

Effective March 25, 2003 and amended 4-11-08 and 10-17-08 and no changes 6-5-09

Starts with tag number 0263

Short section because the hospital compare program is not part of the CMS CoPHospital compare is the indicators that must be sent to

CMS to receive full reimbursement rates

Hospital CoPs for QI

224

Must have PI program that is ongoing and shows measurable improvements, that identifies and reduces medical errors

Diagnostic errors, equipment failures, blood transfusion injuries, or medication errors

Medical errors may be difficult to detect in hospitals and are under reported

Make sure incident reports filled out for errors and near misses

Hospital CoPs for QI)

225

Triggers can help hospitals find errors

Trigger tools available on IHI website1

Program must incorporate quality indicator data including patient data (274)

Look at information submitted to or from QIO

1www.ihi.org

CMS Hospital CoPs

226

QIO to advance quality of care for Medicare patients

Sign up with your state QIO to get newsletters and other information

Use data to monitor safety of services and quality of care (275)

Identify opportunities for improvement (276)

Board determines frequency and detail of data collection (277)

Focus on high risk, high volume, or problem prone (285)

CMS Hospital CoPs

227

Must not only track medical errors and adverse events but also analyze their causes (287, 310)

RCA is one tool to measure causes

Hospital must take action based on data (289) and measure its success (290)

Example; process hospitals took to get MI patient timely thrombolytics and timely antibiotics and blood culture for pneumonia patients

TJC moving toward accountability measures and CMS toward value based purchasing

QAPI

228

Hospital needs to document and track performance to make sure improvements are sustained (291)

Continue to track antibiotics given timely in the OR before surgical procedure and prophylactic treatment to prevent DVT/PE in major surgery patients

Number of PI projects depends on scope and complexity of hospital services so large hospital doing CABG would measure indicators on this

Hospital may want to develop and implement IT system to improve patient safety and the quality of care (299)

QAPI

229

Hospital must document what PI projects are being done and the reason for doing them (301) and progress on it (302)

Board, MS, and administration are responsible for and accountable for ongoing program (309)

Decide which are priorities (312) and address issues to improve patient safety (313)

Clear expectations for patient safety are established (314)

Need adequate resources for PI and patient safety (315, 316)

QAPI

230

This means people who can attend meetings, data so analysis can be made and other resources

Safer IV pumps, new anticoagulant program, implement central line bundle, sepsis, and VAP bundle, preventing inpatient suicides, wrong site surgery, retained FB, new processes for neuromuscular blocker agents, implement policy on Phenergan administration and Fentanyl patches

So what’s in your PI and Safety Plans?

QAPI Patient Safety

231

Medical staff

Dietary

Nursing services

Laboratory services

Radiology

Medical records services

Autopsies

Pharmacy services

Next Sections

232

Hospital must have an organized MS that operates under bylaws approved by Board

May only have one MS for entire hospital campus (all campuses, provider based-locations, satellites and remote locations)

Integrated into one governing body with the MS bylaws that apply equally to all

See previous MS sections 0044-94

These have been discussed previously

Medical Staff 482.22(A) 0338

233

MS must periodically conduct appraisals of its members

MS bylaws determine frequency of appraisals

Recommends at least every 24 months (TJC is 24 months)

To be sure they are suitable for continued membership

Medical Staff 0340

234

Must evaluate MS qualifications and competencies, within scope of practice or privileges requested

Look at special training, current work practice, patient outcomes, education, maintenance of CME, adherence to MS rules, certification, licensure and compliance with licensure requirementsWant to be sure the MS is credentialed and privileged to

do what they are competent to perform

Medical Staff 0340

235

Appraisal procedures must evaluate each member

To determine if should be continued, revised, terminated or changed

If requests for privileges goes beyond the specified list for that category of practitioners need appraisal by MS and approval by the board

Must keep separate credentials file for each MS member

If limit privileges must follow laws such as reporting to NPDB

MS bylaws need to identify process for periodic appraisals

Medical Staff Appraisals

236

MS must examine credentials and make recommendations to the board on appointment of the candidates and must look at the following

Request for privileges, evidence of current licensure, training and professional education, documented experience, and supporting references of competence

Can’t make a recommendation based solely on presence or absence of board certification although can require board certification

Medical Staff 0341

237

MS is accountable to Board for quality of medical care provided

If MS has executive committee, majority of members must be MD/DO

MS must be well organized-formalized organizational structure and lines are delineated between the MS and the Board

MS must have bylaws and must enforce bylaws and Board must approve bylaws

Medical Staff Organization 347

238

MS must adopt and enforce bylaws (353)

Board must approve bylaws and any changes also (354)

TJC has MS.01.01.01 which tells when to put things in the by-laws, rules or responsibilities or policies

TJC does C&P tracer since such an important area

MS bylaws must include statement of duties and privileges in each category, ( eg. participate in PI, evaluate practitioner on objective criteria, promote appropriate use of health care resources, 355)

Medical Staff

239

Privileges for each category ( eg. active, courtesy, consulting, referring, emergency case)

Can not assume every practitioner can perform every task/activity/privilege that is specified for that category of practitioner

Individual ability to perform each must be individually assessed (core privileging, 355)

Medical Staff

240

MS bylaws must describe organizational structure of the MS (356)

Lay out R&R which make it clear what are acceptable standards of patient care for diagnosis, medical, surgical care, and rehab

Survey procedure-describe formation of MS leadership

Survey procedure-verify bylaws describe who is responsible for review and evaluation of the clinical work of MS

Medical Staff

241

MS bylaws must describe the qualifications to be met by a candidate for membership on the MS (eg. provide level of acceptable care, complete medical records timely, participate in QI, be licensed, Tag 357)

Survey procedure-MS bylaws describe qualifications as character, training, experience, current competence, and judgment

Medical Staff

242

Repeated in tag number 461 and 463

CMS changes standard to be consistent with TJC standard

MS must adopt bylaws to carry out their responsibilities on H&Ps

The bylaws must include a requirement that a H&P be completed no more than 30 days before or 24 hours after admission on each patient

Must be on chart before surgery

H&P 358

243

There needs to be an updated entry in the medical record to reflect any changes

Person who does the H&P must be licensed and qualified

Example, family physician does H&P 2 weeks ago for patient having CABG today

Surgeon would review, update, and determine if any changes since it was done and authenticate document

H&P Admission

244

Can include in progress notes or has stamp sticker, check box, or entry on H&P form

Should say that H&P was reviewed, the patient examined, and that “no change” has occurred in the patient’s condition since the H&P was completed

There needs to be a complete H&P in the chart for every patient except in emergencies and can make entry in progress notes

History and Physicals

245

New regulation expands the number of categories of people who can do a H&P

If state law and the hospital allows (which most do) a PA or NP may perform

Physician is still responsible for the contents and must sign off the H&P when done by one of these allied health professionals

Need to do PI to make sure all H&P are on the chart especially when the patient goes to surgery

History and Physicals

246

EP4 requires H&P no more than 30 days old and done within 24 hours

EP5 if done within 24 hours update, update prior to surgery (also RC.01.03.01)

EP7 that requires an update to a history and physical (H&P) at the time of the admission

RC.02.01.03 EP3 document H&P in MR for operative or high risk procedure and for moderate and deep sedation

MS.01.01.01 requires H&P process be in MS bylaws (2010)

TJC PC.01.02.03 H&P

247

EP6 Specifies minimal content (can vary by setting, level of service, tx & services

EP7 MS must monitor the quality of the H&Ps

EP8 Medical staff requires person be privileged to do H&P and requires updates

EP9 As permitted by state law, allow individuals who are not LIPs to perform part or all of the H&P

EP10 MS defines when it must be validated and countersigned by LIP with privileges

MS defines scope of H&P for non inpatient services

TJC MS.03.01.01 H&P

248

MS should attempt to secure autopsies in all cases of unusual deaths

Must define mechanism for documenting permission to perform an autopsy

Must be system for notifying MS and attending doctor when autopsy is performed

TJC has similar section

Autopsies 0364

249

Must have an organized nursing service that provide 24 hour nursing services

Must have at least one RN furnishing or supervising 24 hours

SSA at 1861 (b) states you must have a RN on duty at all times (except small rural hospitals under a waiver)

Survey procedures-determine nursing services is integrated into hospital PI

Make sure there is adequate staffing

Survey procedure - look for job descriptions including director of nursing

Nursing Services 0385

250

DON must be RN, A-386 (often referred to as chief nursing officer)

DON responsible for determining types and numbers of nursing personnel

DON responsible for operation of nursing service

Survey procedure-look at organizational chart

May read job description of DON to make sure it provides for this responsibility

May verify DON approves patient care P&P’s

Director of Nursing Service

251

Nursing service must have adequate number of nurses and personnel to care for patients

Must have nursing supervisor

Every department or unit must have a RN present (not available if working on two units at same time)

Survey procedure-look at staffing schedules that correlate number and acuity of patients

Nurse Staffing 392

252

There are 3 recent evidenced based studies that show the importance of having adequate staffing which results in better outcomes

Study said patients who want to survive their new hospital visit should look for low nurse-patient ratio

Nurse Staffing and Quality of Patient Care, AHRQ, Evidence Report/Technology Report Number 151, March 2007, AHRQ Publication No. 07-E0051 1http://www.ahrq.gov/downloads/pub/ evidence/pdf/nursestaff/nursestaff.pdf

Nurse Staffing 392

253

IOM study also linked adequate staffing levels to patient outcomes

Limits to number of hours worked to prevent fatigue

Suggests no mandatory overtime for nurses

Never work a nurse over 12 hours or 60 hours in one week (or will have 3 times the error)

Nursing Linked to Safety

254

Also showed medication error rate, falls, pressure ulcers, UTI, surgery site infections, gastric ulcers, codes, LOS, etc. linked to staffing

Redesigning the work forceSee Keeping Patients Safe:Transforming the Work Environment of Nurses 20041

1www.nap.edu/openbook/0309090679/html/23/html

Nursing Linked to Safety

255

AHRQ 2008 has published 3 volume, 51 chapter handbook for nurses at no cost

Great resource that every hospital should have

Nurse Staffing and Patient Care Quality and Safety

Again shows that patient safety and quality is affected by short staffing

Patient Safety and Quality: An Evidence-Based Handbook for Nurses, 20081

1http://www.ahrq.gov/qual/nurseshdbk

Nursing Staffing Linked to Safety

256

Must have procedure to ensure nursing personnel have valid and current license

Survey procedure-review licensure verification P&P

Can verify licensure on line by most state boards of nursing onlineConsidered primary source verification

Can print out information for employee file

Verify Licensure 394

257

A RN must supervise and evaluate the nursing care for every patient

RN must do admission assessment

Must use acceptable standard of care

Evaluation would include assessing each patient’s needs, health status and response to interventions

RN for Every Patient A-395

258

Hospital must ensure that nursing staff develop and keeps a current, nursing care plan for each patient

Starts upon admission, includes discharge planning, physiological and psychosocial factors

Based on assessing the patient’s needs

Care plan is part of the patient’s medical records and must be initiated soon after admission, revised and implemented

Nursing Care Plan A-396

259

Agency nurses (CMS calls them non-employee nurses) must adhere to P&P’s

DON must provide adequate supervision and evaluate (once a year) activities of agency nurses

Includes other personnel such as volunteers

Orientation must include to hospital and to specific unit, emergency procedures, nursing P&P, and safety P&P’s

Agency Nurses 398

260

Drugs must be prepared and administered according to state and federal law (404)

Need an practitioner’s order

Surveyor will observe nurse prepare and pass medications

Medications must be prepared and administered with acceptable national standards of practice (TJC MM chapter), manufacturer’s directions and hospital policy

Preparation/Admin of Drugs 404

261

Medication management is a hot topic with CMS and TJC

All drugs administered under the supervision of nursing or other personnel if permitted by law

In accordance with approved medical staff P&P’s

Surveyor will review sample of medication records to ensure it conforms to physician’s order

Administration of Meds 0405

262

Surveyor will make sure medication given within 30 minutes of scheduled time

So if medication ordered at 9 am must give between 8:30 am and 9:30 am

Check QAPI activities to see if administration of drugs is monitored

Many hospitals have changed to this 30 minute time frame but some still have one hour on either side and feel this is appropriate since only a survey procedure

Administration of Meds 0405

263

CMS issues standing order memo 10-24-08

Also includes preprinted orders and use of stamps

Flu and pneumovax can be given by protocol approved by the MS after assessment of contraindications

Orders for drugs must be documented and signed by practitioners allowed to write them

Doctors and if allowed NP and PAs

Rubber stamps - will not be paid for order for M/M patients and some insurance companies so many hospitals do not allow rubber stamps

Physician Order 406

264

Order must have name of patient, age and weight (if applicable), date and TIME of order, drug name, strength, frequency, dose, route, quality and duration, and special instructions for use, and name of pre scriber

Have a culture so can ask questions

Now allowed to have written protocol or standing orders with drugs and biologicals that have been approved by MS

Can implement them but be sure provider signs, dates, and times the order

Physician Order 406

265

Chest pain protocol or asthma protocol with Albuterol and Atrovent are an example of initiation of orders

Code teams gives ACLS drugs in an arrest

Timing of orders should not be a barrier to effective emergency response

Preprinted order - should send memo so doctors and providers are aware of new guidelines

Physician Order 406

266

Must date and time when the order set is signed

Must indicate on last page the total number of pages in the order set

If want to strike out something in the order sheet or delete it or add order on blank line then physician needs to initial each place

Should add this to the MR audit sheet to make sure there is compliance with this guideline

Preprinted Order Sets

267

Verbal orders are a patient safety issue

Have lead to many errors

Joint Commission has standard and NPSG, CMS has standard in CMS hospital CoPs, QIO 7th scope of work, National Coordinating Council recommendations

Rewrite your P&P and Medical staff by-laws to be consistent with these standards

Repeated VO section in MR starting with tag 454 and reiterated area of verbal orders offer too much room for error

Changed language from prescribing to ordering practitioner

Verbal Orders 407

268

Emphasizes to be used infrequently and never for convenience of the physicians

This means that physician should not give verbal orders in nursing station if he or she can write them

Can be used in emergency or if surgeon is scrubbed in during surgery

New regulation broadens category of practitioners who can sign orders off

CMS Verbal Orders

269

Limitations on VO such as not for chemotherapy

List the elements for a complete VO (such as patient name, drug, dose, frequency, name of person giving and taking order, et al.)

Define who can receive VO and the method to ensure authentication

Provide guidelines for clear and effective communications

Verbal Orders P&P Should Include

270

Physician must sign off a verbal order, date, and time it when signed off

Any physician on the case can sign off any VO

This practice must be addressed in the hospital’s P&P

Now a NP or PA may sign off a verbal order, if within their scope (where they had authority to write order) and allowed by state law, hospital policy and delegated to this by the physician

Signing Off Verbal Orders

271

New regulation states that verbal orders should be authenticated based on state law

Some states require order to be signed off in 24 hours or 48 hour and if no state law then within 48 hours

Need hospital P&P to reflect these guidelines

Write it down and repeat it back

Verbal Orders

272

RC.02.03.03 (IM 6.50) requires that qualified staff receive and record VO

Define in writing who can receive and record VO

Date and document identity of who gave, received, and implemented the order

Authenticated within time frame law/regulation

Write it down and read back the completed order or test result (NPSG 2009)

Joint Commission Verbal Orders

273

Blood Transfusions and IVs 409

Blood transfusions and IV medications must be administered with state law and MS bylaws

Must have special training for this and within scope of practice

Survey procedure- determine if personnel have special training which should include fluid and electrolyte imbalance and blood and blood components, and venipuncture technique

274

There must be procedure for reporting transfusion reactions, adverse drug reactions and errors in administration of drugs (410)

Survey procedure - request procedure for reporting-they may review the incident reports or other documentation through QAPI program

Incident Reports

275

Must have MR services and have an administrator responsible for MR and will sample 10% of daily census and at least 30 records

Must keep MR on every patient and have one unified MR service responsible for all MR, both inpatient and outpatient

MR includes radiology films and scans, pathology slides, computerized information, et al

Medical Record Services 0432

276

Organization must be appropriate for size and must employ adequate personnel to ensure prompt completion, filing, and retrieval

Must have proper education, skills, qualifications and experience to meet state and federal law

Ensure proper coding and indexing of records

Surveyor will look at job descriptions and staffing schedules

Staffing of Medical Records 432

277

MR on each patient

Both inpatients and outpatients

MR must be accurate (contains all orders, test results, care plans, treatment and response to treatment), complete, retained and accessible (accessible 24 hours a day)

Use a system of author identification and protect security of all records

Protected from fire, water damage and other threats

Retention of Record A-438

278

Must be promptly completed and within 30 days

Kept at least 5 years (439) in original, microfilm, computer memory or other electronic storage

Certain medical records may be retained longer if required by state or federal law (OSHA, EPA, FDA)

See retention law memo from AHIMA

Will request records from 48-60 months ago

Medical Records

279

Retrieval A-0440

Must have a system of coding and indexing that allows timely retrieval of MR

Must be able to retrieve by diagnosis and procedure to support medical care studies

MR have to be accessible for departments that need them like the emergency department

280

Must have a procedure for ensuring confidentiality of MR

Copies may only be released to authorized individuals and written authorization by proper person, DPOA, guardian, etc.

Surveyor will ask for policy

Release only for court orders, subpoenas, in house education purposes, etc.

Confidentiality 441 and 442

281

Contain records, notes, reports assessment to justify

Admission

Continued hospitalization

Support the diagnosis

Describe the patient’s progress

Describe response to medications and to interventions, care, and treatment

Records must be promptly filed in chart

Content of Records A-449

282

All entries must be legible, complete, dated and timed

Must be authenticated by the person responsible for ordering, providing, or evaluating the service provided

Specify in MS or hospital policy who can make entries in medical record

Need method to identify author (written signatures, initials, computer key, or other code) and a list of written signatures must be available

Legible and Authenticated 450 6-5-09

283

Legible and Authenticated

Must have P&P if electronic medical record

If non MD does H&P or document exams, must be authenticated

MS R&R address countersignature when required by policy or state law and this is defined in MS R&R

Section on standing orders (preprinted order sets)

Sign, date, and time the last page

Include total number of pages such as page 3 of 3

Initial any changes, additions, or deletions

284

If rubber stamp used-must have signed statement only that individual will use it, but do not allow for signature or you may not be paid for care

Just don’t allow stamps for signatures on orders

Also CMS issued in a separate Program Integrity manual April 2010 stamps are not allowed

If electronic MR must demonstrate how alterations are prevented

Can’t use system of auto authentication that says can not review because not transcribed yet

Medical Records 450

CMS Signature Guidelines April 16, 2010 CMS issues new signature guidelines and says no rubber

stamps

CMS issued a change request updating the Program Integrity Manual on signature guidelines for medical review purposes

Requires legible identifier in form of handwritten or electronic signature

Third exception is cases where national coverage determination (NCD), local coverage determination (LCD) or if CMS manual has specific guidelines takes precedence over above

285

289

Verbal Orders 454 and 457Recall verbal order section starting in MS section at tag

number 407 is repeated and already discussed

All doctor can sign VO for any other doctor on case for five years

Person who takes VO must read it back and write it down with date and time

When doctor or LIP authenticates and signs off order must date and time it also

Sign off 48 hours unless state law specifies specific time frame, even all lab orders

Can’t sign off within 30 days unless state law is that specific and not just records be completed within this time frame

290

Repeats same provisions on H&P as in medical staff section under tag number 358 and 359

H&P done within 24 hours, not older than 30 days old and updated within 24 hours and updated and on chart before patient goes to surgery

PA and NP can do if allowed by hospital and all state laws allow and physician reviews and authenticates with date, time, and signature

History and Physical 458 and 461

291

Must have admitting diagnosis in chart (463)

All consults and findings by clinical staff and others must be documented (464)

Information must be promptly filed in the MR so staff has access to it (464)

Must document complications and hospital acquired infections (HAI) and unfavorable reactions to drugs and anesthesia (465)

It is important for all practitioners to be aware of the need to document complications and how to do this correctly

MR Must Contain 464 and 465

292

Interpretive guidelines issued on April 13, 2007, and minor changes October 17, 2008

Now three separate sections related to informed consent in patient rights, medical record and surgical services

Properly executed informed consent for procedures and treatments specified by MS

Need list of all surgeries (as defined now by ACS and AMA) and procedures with yes or no

Informed Consent A-466

293

Minimum elements in an informed consent

Name of hospital

Name of procedure or treatment

Name of responsible practitioner who is performing

Statement that benefits, material risks and alternatives were explained

Signature of patient

Date and time form is signed

Informed Consent MR Mandatory

294

CMS has list of optional elements which they call a well designed consent form

Medical record must contain an informed consent for procedures and treatments specified as requiring on and MS by-laws should address this

Consider state laws requiring informed consent such as for invasive procedures and any federal laws such as informed consent for research

Medical Records 466

295

Procedure Name Requires Informed Consent

Ablations Yes

Amniocentesis Yes

Angiogram Yes

Angiography Yes

Angioplasties Yes

Arthrogram Yes

Arterial Line insertion (performed alone) Yes

Aspiration Cyst (simple/minor) No

Consider List of Procedures

296

Procedure Name Requires Informed Consent

Aspiration Cyst (complex) Yes

Blood Administration Yes

Blood Patch Yes

Bone Marrow Aspiration Yes

Bone Marrow Biopsy Yes

Bronchoscopy Yes

Capsule Endoscopy Yes

Consider List of Procedures

297

Need for all surgeries

Exception is emergencies

All inpatients and outpatients

For all procedures specified

Needs to reflect a process

Form must follow policies

Must include state or federal requirements

Must contain minimum requirements (mandatory)

Informed Consent Forms

298

Medical record must contain an informed consent for procedures and treatments specified as requiring one

Medical staff by-laws should address this

Consider state laws requiring informed consent such as for invasive procedures

Consider any federal laws such as informed consent for research, and state laws on informed consent

Medical Records

299

Name of the practitioner who conducted the informed consent discussion with the patient or the patient’s representative

It is required to tell the patient this but optional to put it in writing

Date, time, and signature of witness

Indication or listing of the material risks of the procedure or treatment that were discussed with the patient or the patient’s representative

Well designed (optional) may also include:

300

Statement, if applicable, that physicians other than the operating practitioner, including but not limited to residents, will be performing important tasks related to the surgery, in accordance with the hospital’s policies and, in the case of residents, based on their skill set and under the supervision of the responsible practitioner

Still have to inform patient if someone is doing important parts of the surgery but having it in writing is optional

Well designed (optional) may also include

301

Statement, if applicable, that QMP who are not physicians who will perform important parts of the surgery

or administration of anesthesia will be performing only tasks that are within their scope of practice,

as determined under State law and regulation,

and for which they have been granted privileges by the hospital

Well designed (optional) may also include:

302

Verify hospital has assured MS has list of procedures and treatments that require consent

Verify informed consent forms six mandatory elements

Compare the hospital standard informed consent form to the P&Ps to make sure consistent

Make sure any state law requirements are included

Survey Procedure

303

Medical record must contain all orders, nursing notes, reports, medication records, radiology, lab reports, and vital signs

Orders must be authenticates or signed off

All reports of treatment which includes complications

Any other information used to monitor the patient’s condition

Chart Must Contain 467

304

All medical records must have a discharge summary with outcome of hospitalization

Disposition of the patient

Provisions for follow up care

Follow-up care includes post hospital appointments, how care needs will be met, and any plans for home health care, LTC, hospice or assisted living

Can delegate to NP or PA if allowed by state law but physician must authenticate and date it and time it

Discharge Summary 468

305

Every medical record has to have a final diagnosis

Medical records must be completed within 30 days (same as TJC)

NQF 2010 34 Safe Practices recommends discharge summaries be dictated at discharge and sent promptly to PCP

Includes inpatient and outpatient charts

Final Diagnosis 469

306

Hospital must have a pharmacy to meet the patient’s needs and need to promote safe medication use process

Must be directed by registered pharmacist or drug storage area under constant supervision

MS is responsible for developing P&P to minimize drug error

Function may be delegated to the pharmacy service

Pharmaceutical Services 490

307

Provide medication related information to hospital personnel

Medication Management is important to CMS and TJC and TJC has a medication management chapter

Contains list of functions of the pharmacist (collect patient specific information, monitor effects, identify goals, implement monitoring plan with patient, et.al.)

Flag new types of mistakes

Pharmacy 0490

308

High alert medication-dosing limits-packaging, labeling and storage (policy at www.wpsi.org and ISMP (Institute for Safe Medication Practice) and USP have list of high alert medications)

Limiting number of medication related devices and equipment-no more that 2 types of infusion pumps (490)

Availability of up to date medication information

Pharmacist on call if not open 24 hours

Pharmacy Policies include:

309


Avoid dangerous abbreviations

All elements of order; dose, strength, route, units, rate, frequency

Alert system for sound alike/look alike (LASA)

Use of facility approved pre-printed order sheets whenever possible

“Resume preop orders” is prohibited

Voluntary, non-punitive reporting system to monitor and report adverse drug events

310

Preparation, distribution, administration and disposal of hazardous medications (chemotherapy)

Drug recall

Patient specific information that should be readily available (TJC tells you exactly what this is, like age, sex, allergies, current medications, etc.)

Means to incorporate external alerts and recommendation from national associations and government for review and policy revision (Joint Commission, ISMP, FDA, IHI, AHRQ, Med Watch, NCCMER, MEDMARX)


311

Identification of weight based dosing for pediatric populations

Requirements for review based on facility generated reports of adverse drug events and PI activities

Policy to identify potential and actual adverse drug events (IHI trigger tool, concurrent review, observe med passes etc.)

Must periodically review all P&P’s

Pharmacy Policies Include (490)

312

Pharmacy Policies Include

Need a multidisciplinary committee - committee of medicine, nursing, administration, and pharmacy to develop P&P

MS must develop P&P or have policy that this function is fulfilled by pharmacy

Surveyors will make sure staff is familiar with all the medication P&P’s

Need policies to minimize drug error

313

Pharmacy or drug storage must be administered in accordance with professional principles (TJC 03.01.01 and problematic standard)

This includes compliance with state laws (pharmacy laws), and federal regulations (USP 797), standards by nationally recognized organizations (ASHP, FDA, NIH, USP, ISMP, etc.)

Pharmacy director must review P&P periodically and revise

Pharmacy Management 0491

314

Drugs stored as per manufacture’s

Pharmacy employees provide services within the scope of their licensure and education

Sufficient pharmacy records to follow flow from order to dispensing/administration

Maintain control over floor stock

Pharmacy Management 491

315

Pharmacist A-491

Ensure drugs are dispensed only by licensed pharmacist

Must have pharmacist to develop, supervise, and coordinate activities of pharmacy

Can be part time, full time or consulting

Single pharmacist must be responsible for overall administration of pharmacy

316

Pharmacist A-491

Job description should define development, supervision, and coordination of all activities

Must be knowledgeable about hospital pharmacy practice and management

Must have adequate number of personnel to ensure quality pharmacy service, including emergency services

Sufficient to provide services for 24 hours, 7 days a week

317

Pharmacy Delivery of Service 500

Keep accurate records of all scheduled drugs

Need policy to minimize drug diversion

Drugs and biologicals must be controlled and distributed to ensure patient safety

In accordance with state and federal law and applicable standards of practice

Accounting of the receipt and disposition of drugs subject to COMPREHENSIVE DRUG ABUSE PREVENTION AND CONTROL ACT OF 1970

318

Delivery of Service A-0500

Pharmacist and hospital staff and committee develop guidelines and P&P to ensure control and distribution of medications and medication devices

System in place to minimize high alert medication (double checks, dose limits, pre-printed orders, double checks, special packaging, et.al.)

And on high risk patients (pediatric, geriatric, renal or hepatic impairment)

High alert meds may include investigational, controlled meds, medicines with narrow therapeutic range and sound alike/look alike

319

All medication orders must be reviewed by a pharmacist before first dose is dispensed

Includes review of therapeutic appropriateness of medication regime

Therapeutic duplication

Appropriateness of drug, dose, frequency, route and method of administration

Real or potential med-med, med-food, med-lab test, and med-disease interactions

Allergies or sensitivities and variation from organizational criteria for use

Delivery of Service 500

320

Sterile products should be prepared and labeled in suitable environment

Pharmacy should participate in decisions about emergency medication kits (such as crash carts)

Medication stored should be consistent with age group and standards (such as pediatric doses for pediatric crash cart)

Must have process to report serious adverse drug reactions to the FDA


321

Policy to address use of medications brought in

P&P to ensure investigational meds are safely controlled and administered

Medications dispensed are retrieved when recalled or discontinued by manufacturer or FDA (eg. Vioxx)

System in place to reconcile medication that are not administered and that remain in medication drawer when pharmacy restocks

Will ask why it was not used?

Not the same as medication reconciliation as in the TJC NPSG which all hospitals should still do from a patient safety perspective


322

All compounding, packaging, and disposal of drugs and biologicals must be under the supervision of pharmacist

Must be performed as required by state of federal law

Staff ensure accuracy in medication preparation

Staff uses appropriate technique to avoid contamination

Compounding of Drugs 501

323

Use a laminar airflow hood to prepare any IV admixture, any sterile product made from non-sterile ingredients, or sterile product that will not be used within 24 hours (see USP 797)

Meds should be dispensed in safe manner and to meet the needs of the patient

Quantities are minimized to avoid diversion, dispensed timely, and if feasible in unit dose

All concerns, issues, or questions are clarified with the individual prescriber before dispensing

Compounding of Drugs

324

Locked Storage Areas A-502

Drugs and biologicals must be kept in a secure and locked area

Would be considered a secure area if staff actively providing care but not on a weekend when no one is around

Schedule II, III, IV, and V must be kept locked within a secure area (see also 503)

Only authorized person can get access to locked areas

325

Persons without legal access to drugs and biologicals can have not have unmonitored access

They can not have keys to storage rooms, carts, cabinets or containers with unsecured medications (housekeeping, maintenance, security)

Critical care and L&D area staffed and actively providing care are considered secure

Setting up for patients on OR is considered secure such as the anesthesia carts but after case or when OR is closed need to lock cart


326

Securing Medications

So all controlled substances must be locked

Hospitals have greater flexibility in determining which non controlled drugs and biologicals must be kept locked

Medications should not be stored in areas readily accessible to unauthorized persons such in a private office unless visitors are not allowed without supervision of staff

P&P need to address security of any carts containing drugs

327

May allow patients to have access to urgently needed drugs such as Nitro and inhalers

Need P&P on competence of patient, patient education and must meet elements in TJC MM standard on self administration

Measures to secure bedside medications


328


Saline flushes need to be secure to prevent tampering so under constant supervision or locked up

Consider having safe injection practices P&P and follow CDC 10 guidelines

If medication cart is in use and unlocked, then someone with legal access must be close by and directing monitoring the cart, like when the nurse is passing meds

Need policy for safeguarding, transferring and availability of keys

329


Drugs and biologicals must be kept in a secure and locked area

Would be considered a secure area if staff actively providing care but not on a weekend when no one is around

Schedule II, III, IV, and V must be kept locked within a secure area (see also 503)

Only authorized person can get access to locked areas

330

Persons without legal access to drugs and biologicals can have not have unmonitored access

They can not have keys to storage rooms, carts, cabinets or containers with unsecured medications (housekeeping, maintenance, security)

Critical care and L&D area staffed and actively providing care are considered secure

Setting up for patients on OR is considered secure such as the anesthesia carts but after case or when OR is closed need to lock cart


331


So all controlled substances must be locked

Hospitals have greater flexibility in determining which non controlled drugs and biologicals must be kept locked

Medications should not be stored in areas readily accessible to unauthorized persons such in a private office unless visitors are not allowed without supervision of staff

P&P need to address security of any carts containing drugs

332

May allow patients to have access to urgently needed drugs such as Nitro and inhalers

Need P&P on competence of patient, patient education and must meet elements in TJC MM standard on self administration

Measures to secure bedside medications


333


Saline flushes need to be secure to prevent tampering so under constant supervision or locked up

If medication cart is in use and unlocked, then someone with legal access must be close by and directing monitoring the cart, like when the nurse is passing meds

Need policy for safeguarding, transferring and availability of keys

335

These are available off the ASA website1

Security of medications in the operating room

See also preanesthesia and post anesthesia position statements

1http://www.asahq.org/publicationsAndServices /sgstoc.htm

ASA Standards, Guidelines, Statements

337

CMS states that they expect hospital P&P to address

The security and monitoring of any carts including whether locked or unlocked if contains drugs and biologicals

In all patient care areas to ensure safe storage and patient safety

P&P to keep drugs secure, prevent tampering, and diversion

Policy and Procedure

338

Self administered medications are safely and accurately administered

If you allow self administration, need procedure to manage, train, supervise, and document process

TJC MM stands for medication management standard MM 5.20 or MM.06.01.03

TJC Self Administered Meds

339

If non-staff member administers (patient or family) must train and make sure competent to do so (give info on nature of med, how to administer, side effects, and how to monitor effects)

Patient has to be determined to be competent before allowed to self administer

Mentioned TJC in Federal Register but not in IG

TJC Self Administered Meds

340

Outdated or Mislabeled Drugs 505

Outdated, mislabeled or otherwise unusable drugs and biologicals must not be available for patient use

Hospital has a system to prevent outdated or mislabeled drugs

Surveyor will spot check individual drug containers to make sure have all the required information including lot and control number, expiration date, strength, etc.

341

If no pharmacist on duty, drugs removed from storage area are allowed only by personnel designated in policies of MS and pharmacy service

Must be in accordance with state and federal law

Routine access to pharmacy by non-pharmacist for access should be minimized and eliminated as much as possible

E.g. night cabinet for use by nurse supervisor

Need process to get meds to patient if urgent or emergent need

No Pharmacist on Duty A-0506

342

No Pharmacist on Duty A-0506

TJC does not allow nurse supervisor in pharmacy so would need to call the on call pharmacist

Access is limited to set of medications that has been approved by the hospital and only trained prescribers and nurses are permitted access

Quality control procedures are in place like second check by another or secondary verification like bar coding

Pharmacist reviews all medications removed and correlates with order first thing in the morning

343

Medications Errors A-0508

Hospital must monitor, implement, and enforce the automatic stop order system

Drug errors, adverse drug reaction, and incompatibilities must be immediately reported to the attending MD/D and to the hospital PI program

Definition of med error or ADE should be broad enough to include NEAR MISSES

Recommend use of definition by National coordinating council medication error reporting and prevention definition

344

Medications Errors A-0509

Hospital must proactively identify med errors and ADE and can not rely solely on incident reports

Proactive includes observation of med passes, concurrent and retrospective review of patient’s clinical record, ADR surveillance, evaluation of high alert drugs and indicator drugs (Narcan, Romazicon, Benadryl, Digibind, et al) or generate a review for potential ADE

Remember FMEA (failure mode and effect analysis) and IHI adverse event trigger tool is great

345

Abuses and losses of controlled substances must be reported pharmacist and CEO and in accordance with any state or federal laws

Surveyor will interview pharmacist to determine their understanding of controlled substances policies

What is procedure for discovering drug discrepancies?

Abuses and Losses 509

346

Drug Interaction Information 510

Information on drug interactions and information on drug side effects, toxicology, dosage, indication for use and routes of administration must be available to staff

Texts and other resources must be available for staff at nursing stations and drug storage areas

Staff development programs on new drugs added to the formulary and how to resolve drug therapy problems

347

Formulary system must be established by the MS to ensure quality pharmaceuticals at reasonable cost

Formulary lists the drugs that are available

Processes to monitor patient responses to newly added medication

Process to approve and procure meds not on the list

Process to address shortages and outages including communication with staff, approving substitution and educating everyone on this, and how to obtain medications in a disaster

Formulary A-0511

348

Radiology A-529

Hospital has radiology services to meet needs of patients

Radiology services should be provided in accordance with accepted standards of practice

Radiology, especially ionizing procedures, must be free from hazards for patients and personnel

Must have policy that provides for safety of both

349

Safety 535 Proper safety precautions maintained against

radiology hazards

Including shielding for patients and personnel as well as storage, use, and disposal of radioactive materials

Need order of practitioner with privileges or practitioners outside the hospital who have been authorized by MS to order as allowed by state law

Period inspection of equipment and fix any hazard (537)

Check radiation workers by use of badge tests or exposure meters (538)

350

Personnel

Qualified radiologist must supervise ionizing radiology services

Must interpret those tests that are determined by the MS to require a radiologist’s specialized knowledge

Written policy approved by MS to designate which tests require interpretation by radiologist

If telemedicine is used, radiologist interpreting must be licensed and meet state law requirements (state medical board requirements), (546, see 023)

351

Personnel A-546

Supervision of radiology by radiologist who is member of the MS, Supervision should include the following

Ensure reports are signed by the practitioner who interpreted them

Assign duties to personnel based on their level of training, experience and licensure

Enforce infection control standards

Ensure emergency care if patient experience ADR to diagnostic agent

352

Radiology A-547 Ensure files, records are kept in secure area and

retrievable, train staff on how to operate equipment safely

Written policy, approved by the MS on who can use radiology equipment and administer procedures

Only qualified personnel may use radiology equipment

Surveyor will review personnel folders to make sure they are qualified as established by the MS for the tasks they perform

353

Radiology Records

Radiology records must be maintained for all procedures performed (553)

Must contain copies of all reports and printouts and any films, scans, or other image records

Must have written P&P that ensure the integrity of authentication and protect privacy of radiology records - must be secure and retrievable for five years

Radiologist or other practitioner who performs radiology services must sign the report of his or her interpretation

They have to be signed by the one who read and evaluated the x-ray (not the partner who is reviewing the dictated report ), A-0554

354

Laboratory Services A-0576

Must have adequate lab services to meet the needs of the patient

All lab services must in any hospital department has to meet these guidelines

All services must be provided in accordance with CLIA requirements (Clinical Laboratory Improvement Act) and have CLIA certificate

Can provide lab services directly or as contracted service

355

Lab Services

All lab services, including contracted services, must be integrated into hospital wide PI

Lab results are considered medical records and must meet all MR CoPs

Must have lab services available either directly or indirectly

Must meet needs of its patients and in each location of the hospital

TJC has lab standards also

356

Emergency Lab-Services available 583 Must provide emergency lab services 24 hours a

day, 7 days a week - directly or indirectly (contracted)

Hospital with multiple campuses must have available 24/7 at each campus

MS must determine what lab tests will be immediately available

Should reflect the scope and complexity of the hospital’s operations

Written description of emergency lab services available

Written description of test available are provided to MS on routine and stat basis

357

Tissue Specimens A-0584

Written instructions for the collection, preservation, transportation, receipts, and reporting of tissue specimen results

MS and pathologist determine when tissue specimens need macroscopic (gross) and microscopic examination

Need written policy on this

TJC has new chapter in 2009 on transplant safety and FAQs which continues into 2010

358

Blood Banks A-592

Potentially infectious blood and blood components

This section completely rewritten so have person in charge of P&P in this area and the look back program to review these changes

Will need to update P&Ps

TJC has similar sections in transplant safety chapter starting with TS.01.01.01 through TS.03.03.01 and PC chapter for blood and blood components

360

Blood and Blood Components

Potentially HIV infectious blood and hepatitis C virus (HCV) and blood products are collected from a donor who tests negative

If on a later donation tests positive then more specific test or follow up testing is done as required by FDA

If services provided by outside blood collecting establishment (blood bank) then need agreement to govern procurement, transfer and availability of blood and blood products

Agreement with blood bank must require blood bank to notify hospital promptly (HIV and added HCV)

361

Blood Banks A-592 Time depends on if tested positive on this unit or

tested negative but on later donation tested positive

Within 3 calendar days if blood tested is positive later

Follow up of notification within 45 calendar days after reactive screening test was positive for additional tests

See look back procedures required by 21 CFR 610.45 et seq. and FDA regulations

Hospital will dispose any contaminated blood from donor if not given (TJC PC.05.01.01)

362

Patient Notification

If administered potentially HIV/HCV infected blood hospital must make reasonable attempts to notify patient over period of 12 weeks unless patient already notified or unable to locate in 12 weeks

Records of the source and disposition of all units of blood and blood components must keep records ten years

363

Patient Notification

A fully funded plan to transfer these records to another hospital if the hospital closes (TJC PC.05.01.05 maintains records on receipt, testing and disposition of all blood and blood components and fully funded plan to transfer records to another organization if hospital ceases operation for any reason)

Must have P&P that meet federal and state laws on notification of patients

364

Patient Notification Must document in MR

Must conform to confidentiality requirements

Must have 3 things in the content of the notice; explanation of need for HIV and HCV testing and counseling

Enough written or oral information so can make an informed decision

List of programs where can get counseled and tested

If minor or incompetent or deceased then notify legal representative

365

Food and Dietetic Services 618

Hospital must have organized dietary services

Must be directed and staffed by qualified personnel

If contract with outside company need to have dietician and maintain minimum standards and provide for liaison with MS on recommendations on dietary policies

Dietary services must be organized to ensure nutritional needs of the patient are met in accordance with physician orders and acceptable standard of practice

366

Dietary A-618

Availability of diet manual and therapeutic diet menus

Frequency of meals served

System for diet ordering and patient tray delivery

Accommodation of non-routine occurrences (parenteral nutrition (tube feeding), TPN, peripheral parenteral nutrition, early/late trays, nutritional supplements

367

Dietary A-0618)

Integration of food and dietetic services into hospital wide QAPI and infection control programs

Guidelines on acceptable hygiene practices of personnel and kitchen sanitation

Compliance with state or federal laws

368

Organization A-0620

Must have full time director who is responsible for daily management of dietary services

Must be granted authority and delegation by the Board and MS for the operation of dietary services

Job description should be position specific and clearly delineate authority for direction of food and dietary services

Includes training programs for dietary staff and ensuring P&Ps are followed

369

Dietary Policies

Safety practices for food handling

Emergency food supplies

Orientation, work assignment, supervision of work and personnel performance

Menu planning

Purchase of foods and supplies

Retention of essential records (cost, menus, training records, QAPI reports)

Service QAPI program

370

Dietitian 621 Qualified dietician must supervise nutritional aspects

of patient care and approve patient menus and nutritional supplements

Patient and family dietary counseling

Perform and document nutritional assessments

Evaluate patient tolerance to therapeutic diets when appropriate

Collaborate with other services (MS, nursing, pharmacy, social work)

Maintain data to recommend, prescribe therapeutic diets

371

Personnel 622

Must have administrative and technical personnel competent in their duties

Menus must be nutritional, balanced, and meet special needs of patients

Screening criteria should be developed to determine what patients are at risk

Once patient is identified nutritional assessment should be done (TJC PC.01.02.01)

Patient should be evaluated

372

Nutritional Assessment 628

TJC requires to be done within 24 hours (PC.01.02.03)

If require artificial nutrition by any means (tube feeding, TPN)

If medical or surgical condition interferes with ability to digest, absorb, or ingest nutrients

If diagnosis or signs and symptoms indicate a compromised nutritional status such as anorexia, bulimia,electrolyte imbalance, dysphagia, malabsorption, ESRD

Adversely affected by nutritional intake (diabetes, CHF, taking certain meds)

373

Therapeutic Diets 629 Therapeutic diets must be prescribed by practitioner in

writing by the practitioner responsible for patient’s care

Dietician can make recommendations but diet must be ordered by doctor

Document in the MR including information about the patient’s tolerance

Evaluate for nutritional adequacy

Manual must be available for nursing, FS, and medical staff

Dieticians can only make recommendations and can’t order

374

Nutritional Needs 630

Must be met in accordance with recognized dietary practices

Follow recommended dietary allowances -current Recommended Dietary Allowances (RDA) or Dietary Reference Intake (DRI) of Food and Nutritional Board of the National Research Council

“Dietary Guidelines for Americans 2005”1

Surveyor will ask hospital what national standard you are using

1www.heathierus.gov/dietaryguidelines

375

Next Sections

Utilization review

Infection Control

Discharge Planning

Organ and Tissue

Surgery and Anesthesia

Nuclear Medicine

Emergency Services

Respiratory

Rehab

376

Utilization Review A-0652

Hospital must have a UR plan that provides for review of services furnished by the institution and the members of the MS to Medicare and Medicaid beneficiaries

UR plan should state responsibility and authority of those involved in the UR process

Surveyor will make sure activities performed as in UR plan

UR important to determine medical necessity especially with increased RACs

CMS issue UR CoP Memo June 22, 2007

377

Two Exceptions

Hospital has an agreement with the QIO in their state to assume binding review

Many hospitals have K with QIO to review admissions, quality, appropriateness and diagnostic information related to Medicare inpatients, will look to see signed contract

CMS has determined that the UR procedures established by the state are superior to the ones required under this section and state requires hospital to meet UR requirements for Medicaid program (there are none approved)

378

Composition of UR Committee 654

Consists of 2 or more practitioners who carry out UR function

At least 2 members must be doctors

The UR committee must be either a staff committee of the hospital or an group outside that has been established by the local medical society for hospitals in that locale and established in a manner approved by CMS

379

UR Committee 654

A committee may not be conducted by an individual who has a direct financial or ownership interest (5% or more)

Who was professionally involved in the care of the patient whose case is being reviewed

Surveyor will look to see if the governing board has delegated UR function to a outside group if impracticable to have a staff committee

380

Frequency of Review 655

UR plan must provide review for Medicare/Medicaid (M/M) patients with respect to medical necessity

Admissions (before, at, or after admission)

Duration of stay

Professional services furnished including drugs and biologicals

381

Scope of Reviews A-0655

Reviews may be on a sample basis except for reviews of cases assumed to outlier cases because of extended stay cases or high costs

Surveyor will examine UR plan to determine if medical necessity is reviewed for admission, duration of stay and services provided

If IPPS hospital there should be a review of the duration of stay in cases assumed to be outlier

382

Admissions or Continued Stay

Determination that admission or continued stay is not medically necessary is made by one member of UR committee if MD concurs with determination of fails to present their views when afforded the opportunity

Must be made by two members in all other cases (656)

383


Before determination not medically necessary, UR committee must consult the MD responsible for the care and afford opportunity to present their views

Then committee must provide written notification no later than two days after determination to the hospital, patient and practitioner responsible for care

384


If attending doctor does not respond or contest the findings of the committee, the findings are final

If physician of UR committee finds not medically necessary no referral of committee is necessary and he may notify the attending doctor

If non-physician makes the determination it must go to the committee

A non-physician can not make this final determination

385

Physical Environment A-0700

Hospital must be constructed, arranged, and maintained to ensure the safety of patient

And to provide diagnosis and treatment and for services appropriate for the community

This CoP applies to all locations of the hospital, all campuses, all satellites

386

Physical Environment

Hospital’s maintenance and hospital departments responsible for the buildings and equipment must be incorporated into the QAPI program

Must also be in compliance with the QAPI requirements

Survey of physical environment should be conducted by one surveyor

LIFE SAFETY CODE survey may be conducted by specially trained surveyor

LS code very important and being hit hard in the surveys

387

Life Safety Code

Separate CoP

Both Joint Commission and CMS using 2000 version

Hospitals should do review of LSC for gap analysis

Joint Commission hospitals will all have separate life safety surveyor and larger hospitals might have one for two days

Also TJC surveyors have had training on LSC

No cluttered hallways in the nursing units

388

Buildings A-0701

Condition of physical plant and overall hospital environment must be developed and maintained for the safety and well being of patients

Making sure that a routine and PM activities are done, as manufacturer requires and by state and federal law

Conduct ongoing maintenance inspections

Routine and PM and testing activities should be incorporated into hospital QAPI plan

389

Buildings A-0701 Includes developing and implementing emergency

preparedness plans and capabilities

Must coordinate with federal, state, and local emergency preparedness and health authority (dept of health)

To identify risks for their area (natural disasters, bio-terrorism threats, disruption of utilities like water, sewer, electrical, communication, fuel, nuclear accident)

Lists 14 things to consider in developing this

390

Buildings

Transfer of hospital equipment to another facility

Transfer or discharge of patients to home or other hospitals

Security of patients and walk in patients and supplies from misappropriation

Pharmacy, food, and other supplies and equipment that may be needed

Communication among staff

Training needed to implement emergency procedure

391

Emergency Power and Lighting

Must be emergency power and lighting in OR, PACU, ED, and stairwells

All other areas must have emergency supply source, battery lamps, and flashlights available

Must comply with 2000 LSC-National Fire Protection amendment NFPA 101, and NFPA-99 on Health care facility for emergency lighting and emergency power

Doors with no roller latches, need positive latching

392

Emergency Gas and Water

Must be facilities for emergency gas and water supply (703)

To provide care to inpatients

Includes making arrangements with local utility company for emergency sources of gas/water

One source of water is Federal Emergency Management Agency (FEMA)

Gas includes propane, natural gas, fuel oil, as well as gases used such as oxygen, nitrous oxide, nitrogen

393

Life Safety from Fire A-709

Must meet 2000 LSC of the NFPA

CMS may waive specific provisions, after consideration by state survey agency, if would result in unreasonable hardship but only if waiver will NOT adversely affect the health and safety of patients

Must follow state fire and safety code and CMS may allow surveyor to apply instead of LSC

394

Trash A-0713

Proper storage and disposal of trash

Trash includes bio-hazardous waste

Storage of trash must be in accordance with state and federal law (EPA, CDC, OSHA, state environmental health and safety regulations)

Need policies for storage and disposal of trash

H2E program - no fee (waste reduction, mercury, et al.)1

1 www.h2e-online.org

395

Fire Control Plan A-715

Need fire control plan

Must contain section on prompt reporting of fires, extinguishing fires, protection of patients and guests, evacuation and cooperation with fire fighting authorities

Surveyor will review fire plan

Verify all fires are reported to state officials

Will interview staff to make sure they know what to do during a fire

Amended for alcohol based hand dispensers

396

Facilities

Keep written evidence of regular inspections and approval by state or local fire control agencies

Maintain adequate facilities for its service - designed and maintained in accordance with federal, state, and local laws

Toilets, sinks, and equipment should be accessible

Make sure water acceptable for its intended use - drinking, lab water, irrigation - review water quality monitoring

397

Ventilation, Light, Temperature

Proper ventilation in areas using ethylene oxide, nitrous oxide, guteraldehydes, or other hazardous substances

Temperature controls in pharmacy and food preparation

Ventilation where O2 is transferred, in isolation rooms and lab

Adequate lighting in patient rooms and food and medication preparation areas (shown to reduce medication errors)

398

Ventilation, Light, Temperature

Temperature, humidity, and airflow in OR within acceptable standards to inhibit bacterial growth

Each OR room should have a separate temperature control - have temp and humidity tracking logs

Incorporate AORN – American Association of Perioperative Registered Nurses should be incorporated into hospital policy

399

Infection Control 747

Updated to reflect changing infectious and communicable disease threats

Including current knowledge and best practices

Very important in today’s healthcare environment

CDC estimates there are 1.7 million HAI in hospitals every year and 99,000 deaths

CMS gets $50 million dollar grant to enforce

Interpretive guidelines are 12 pages long1www.cms.hhs.gov/SurveyCertificationGenInfo/PMSR/list.asp

400

Infection Control)

TJC has chapter on Infection Prevention and Control

APIC now calls infection preventionists (IPs)

Hospital must have sanitary environment to avoid sources and transmission of infection and communicable diseases (750)

Active IC program for prevention, control, and investigation of infections and communicable diseases

401

Infection Control (IC) A-0750

Standards apply to all departments of hospitals both on and off campus

Infection prevention must include monitoring of housekeeping and maintenance including construction activities

Areas to monitor include food storage preparation, serving and dish rooms, refrigerators, ice machines, air handlers, autoclave rooms, venting systems, inpatient rooms, supply storage and equipment cleaning

402


Must all standards of care and practice (APIC (Association for Professionals in Infection Control and Epidemiology), CDC, SHEA (Society for Healthcare Epidemiology of America), OSHA, etc.

Need to investigate infections and communicable diseases for inpatients and from personnel working in hospitals including volunteers

Must have active surveillance program that includes specific measures for infection detection, data collection, analysis monitoring, and evaluations of preventive interventions

403

Infection Control

Must have sampling or other mechanism in place to identify and monitor infections and communicable diseases

Infection control must be integrated in PI

Surveillance activities should be conducted in accordance with recognized surveillance practices such as those used by CDC NHSN (National Healthcare Safety Net)

Requirement for hospitals to report central line infections to NHSN

404

IC Officer’s Responsibilities

Many have added these to their job descriptions

Maintain sanitary hospital environment (ventilation and water controls, construction - make sure safe environment, safe air handling in areas of special ventilations such as the OR and isolation rooms, techniques for food sanitation, cleaning and disinfecting surfaces, carpeting and furniture, how is pest control done, and disposal of trash along with non-regulated waste)

405


Develop and implement IC measures (hospital staff, contract workers, volunteers)

Mitigation of risks associated with patient infections present upon admission and risks contributing to HAI

Active surveillance

Monitoring compliance with all P&Ps, protocols and other infection control program requirements

406


Program evaluation and revision of the program, when indicated

Coordination as required by law with federal, state, and local emergency preparedness and health authorities to address communicable disease threats, bioterrorism and outbreaks

Complying with the reportable disease requirements of the local health authority

Make sure IC program is integrated into hospital wide QAPI

407


Long list of IC policies that hospitals must have

Maintain a sanitary physical environment

Hospital staff related measures (evaluate hospital staff immunization status for infectious diseases as per CDC and APIC, how you screen hospital staff for infections likely to cause significant infectious disease to others, policy on when staff are restricted from working)

408

IC Policies to Include: New employees and what they need in orientation

(including handwashing)

P&P to mitigate risk when patient admitted with infection - must be consistent with the CDC isolation guidelines, staff knowledge of PPE

Mitigate risk that cause or contribute to HAI such as SCIP measures, appropriate hair removal, timely antibiotics in OR, DC in 24 hours except 48 hours for cardiac patients, beta blockers during perioperative periods for select cardiac patients, proper sterilization of equipment, etc.

411

Medical Equipment and Supplies Resources

Multi-Society Guidelines for Reprocessing Flexible Gastrointestinal Endoscopes by APIC at www.apic.org/AM/Template.cfm?Section=Guidelines_and_Standards&template=/CM/ContentDisplay.cfm&section=Topics1&ContentID=6381

Disinfection of Healthcare Equipment Chapter in Guidelines for Disinfection and Sterilization in Healthcare Facilities Nov 2008 at www.cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_Nov_2008.pdf

Single Use Device Reprocessing at http://cms.h2e-

online.org/ee/waste-reduction/waste-minimization/

412

IC Policies

Isolation procedures for highly immuno-suppressed patients (HIV or chemo patients)

Isolation procedures for trach care, respiratory care, burns, and other similar situations

Other HAI risk mitigation includes promotion of hand hygiene, and measures to prevent organisms that are antibiotic resistant such as MRSA and VRE

Things such as central line bundle, VRE bundle or sepsis bundle, prompt removal of foley catheter

Disinfectants, antiseptics, and germicides must be used in accordance with manufacturers instructions

413

IC Policies

Appropriate use of facility and medical equipment (hepa filters and negative pressure room, UV lights and other equipment to prevent the spread of infectious agents

Patients, visitors, care givers, and staff must receive education on infection and communicable diseases

There must be active surveillance system, method for getting data to determine if there is a problem

Policy on getting cultures from patients, etc.

414

Policies and Organization

Need IC officer and IC committee

IC officer must develop and implement policies on control of infection and communicable diseases

Person must be designated in writing who is qualified through education and experience

Lists the responsibilities of this person - consider putting into job description

415

Log of Incidents 750

Must maintain a log related to infections and communicable diseases, including HAI

Includes information from patients and staff so need information from employee health nurse

Includes employees, contract staff such as agency nurses, and volunteers

Includes surgical site infections, patients or staff with MDRO, patients who meet isolation requirements

Log can be paper or electronic, TJC IC.01.01.01

416

CEO, DON, and MS A- 756

The CEO, DON, and MS must ensure that there is hospital wide QA and training program that address problems identified by IC officer

And implement a successful corrective action plan in affected problem areas

Train staff in problems identified

Problems must be reported to nursing, MS, and administration

417

Discharge Planning A-800

Must have a discharge planning process that applies to all patients (inpatients and outpatients)

P&P must be in writing

Written discharge planning process must reveal a clear process to be followed

Necessary to prevent readmission

Surveyor will review patient care plans for discharge planning interventions

418

Identification of Patients 806

Must identify at early stage of hospitalization, all patients who are likely to suffer adverse consequences if no discharge planning

No national tool to do this

May include factors as functional status, cognitive ability and family support

Patients at high risk should be identified from screening process

419

Discharge Planning Evaluation

Hospital must provide a discharge planning evaluation to patients or upon the request of the physician

Needs assessment can be formal or informal

Assess factors on what the patient will need when discharged; bio-psychosocial needs and patient and caregiver’s understanding of discharge needs

Can be a tool or protocol

Surveyor will ask how patients are made aware of their right to request a discharge plan

Are they given the pamphlet “important message from Medicare”

420

Discharge Planning Responsibility

RN, SW, or qualified person must develop and supervise the development of the evaluation (807)

Person who does discharge planning evaluation needs to have experience and knowledge of social and physical factors that affect functional status to meet patient needs (emphysema -coordinate respiratory therapy, nursing care, financials for home health)

Ideally, discharge planning is interdisciplinary process

421

Evaluation 809

Discharge planning evaluation must include likelihood of needing post-hospital services and availability of services

Keep complete file on community based services such as LTC, sub acute care, and home care

Is physical, speech, OT or RT needed

Use QAPI program to determine if discharge planning process is effective

422

Self Care Evaluation

Discharge planning evaluation must include if patient can do self care and return to pre-hospital environment

Willingness of patient and family to do

Inform patient of freedom to choose providers or post hospital care (823)

Give list of Medicare certified HHA that serve your area (SSA 1861) including ownership information

Must assess if need hospice and give list of Medicare certified hospices and LTC (809)

Counsel patient and family for post hospital care (822)

423

Discharge Plan

If in MCO hospital must indicated which ones have contract with home health or LTC (825)

Hospital must now document in the medical record that the list of home health or LTC facilities was presented to the patient (827)

Rewrite your P&P to include this

Hospital must inform patient of freedom to choose post hospital provider (828) and respect their wishes (829)

HHA must request to be on the list

424

Timely Discharge Evaluation

Hospital must complete the evaluation timely

So appropriate arrangements can be made

Assessment should start soon after admission

Surveyor will review several patient discharge plans for appropriate coordination of health and social resources

Also need to reassess discharge planning process on an ongoing basis (843)

425

Transfer or Referral 837

Must transfer or refer patients to appropriate facilities, agencies, or outpatient services for follow up care

Must send along necessary medical records

Make sure patients get appropriate post hospital care

Must document if patient refuses discharge planning services

Written authorization before release of information

426

Organ, Tissue, and Eye A-884

Hospital must have written P&P to address its organ procurement

Must have agreement with OPO

Must timely notify OPO if death is imminent or patient has died

OPO to determine medical suitability for organ donation

Defines what must be in your written agreement (definitions, criteria for referral, access to your death record information)

TJC has similar standards in TS or transplant safety chapter

427

Organ, Tissue, and Eye)

Board must approve your organ procurement policy

Must integrate into hospital’s PI program

Surveyor will review written agreement with the OPO to make sure it has all the required information

Check off the long list to ensure all elements are present

428

Tissue and Eye Bank

Need an agreement with at least one tissue and eye bank

OPO is gatekeeper and notifies the tissue or eye bank chosen by the hospital

OPO determines medical suitability

Don’t need separate agreement with tissue bank if agreement with OPO to provide tissue and eye procurement

429

Family Notification

Once OPO has selected a potential donor, person’s family must be informed of the donor’s family’s option

OPO and hospital will decide how and by whom the family will be approached

Have to work cooperatively with the OPO and in educating staff

OPO can review death records

430

Organ Donation

Person to initiate request must be a designated requestor or organized representative of tissue or eye bank

Designated requestor must have completed course approved by OPO

Encourage discretion and sensitivity to the circumstances, views and beliefs of the families

Surveyor will review complaint file for relevant complaints

431

Organ Donation Training

Patient care staff must be trained on organ donation issues

Training program at a minimum should include: consent process, importance of discretion, role of designated requestor, transplantation and donation, QI, and role of OPO

Train all new employees, when change in P&P, and when problems identified in QAPI process

432

Organ Donation

Hospital must cooperate with OPO to review death records to improve id of potential donors

Surveyor will verify P&P that hospital works with OPO

Maintain potential donors while necessary testing and placement of donated organs take place

Must have P&P to maintain viability of organs

Ensure patient is declared dead within acceptable timeframe

433

Organ Transplantation

Hospital in which organ transplants are performed must be member of OPTN-Organ Procurement and Transplantation Network

Must abide by its rules - 42 USC 274, section 372 of the Public Health Service Act

Must provide data to OPTN, Scientific Registry and OPO (Organ Procurement Organization)

434

Surgical Services 940 If provide surgical services, service must be well

organized

If outpatient surgery, must be consistent in quality with inpatient care

Must follow acceptable standards of practice, AMA, ACOS, APIC, AORN

Must be integrated into hospital wide QAPI

Will inspect all OR rooms

Access to OR and PACU must be limited to authorized personnel

435

Surgical Services 940

Conform to aseptic and sterile technique

Appropriate cleaning between cases

Room is suitable for kind of surgery performed

Equipment available for rapid and routine sterilization

And it is monitored, inspected and maintained by biomed program

Temperature and humidity controlled

ACS and AORN have P&P on many of these

436

Surgery 942

OR must be supervised by experienced RN or MD/DO

Must have specialized training in surgery and management of surgical service operation

Will review job description

LPN’s and OR techs can serve as scrub nurses under supervision of RN

Qualified RN may perform circulating duties in OR - LPN or surg tech may assist in circulating duties - if allowed by state law

437

Surgical PrivilegesSurgical privileges must be delineated for all

practitioners performing surgery, in accordance with competence of each practitioner

Surgery service must maintain roster specifying the surgical privilege

Privileges must be reviewed every two years

Current list of surgeons suspended must also be retained Discussed in the earlier sections

438

Surgical Privileges

MS bylaws must have criteria for determining privileges

Surgical privileges are granted in accordance with the competence of each

MS appraisal procedure must evaluate each practitioner’s training, education, experience, and demonstrated competence

As established by the QAPI program, credentialing, adherence to hospital P&P, and laws

439

Surgical Privileges 945

Must specify for each practitioner that performs surgical tasks including MD, DO, dentists, oral surgeon, podiatrists

RNFA, NP, surgical PA, surgical tech, et. al.

Must be based on compliance with what they are allowed to do under state law

If task requires it to be under supervision of MD/DO this means supervising doctor is present in the same room working with the patient

440

Surgery Policies 951 Aseptic and sterile surveillance and practice,

including scrub technique

Id of infected and non-infected cases

Housekeeping requirements/procedures

Patient care requirements pre-op work area

patient consents and releases

safety practices

patient identification process and clinical procedures

441

Surgery Policies A-0951

Duties of scrub and circulating nurses

Safety practices

Surgical counts

Scheduling of patients for surgery

Personnel policies in OR

Resuscitative techniques

DNR status

Care of surgical specimens

442

Surgery Policies A-0951

Malignant hyperthermia

Protocols for all surgical procedures

Sterilization and disinfection procedures

Acceptable OR attire

Handling infectious and biomedical waste

Outpatient surgery post op planning

443

Preventing OR Fires 951

Read detailed section on use of alcohol based skin prep and how to prevent an OR fire

AORN has very detailed policy on flammable prep in the OR and how to prevent fires

Special precautions developed by NFPA and incorporated into NPSG by TJC

ASA has good document on preventing fires in the OR

Pa Patient Safety Authority has great recommendations

444

H&P A-0952

See prior sections on H&P

H&P must be on the chart before the patient goes to surgery

Except in emergencies

P&P specify what is an emergency

445

Consent 955

Informed consent is in three sections of the CoPs and each is different and not a repeat

Third section in the surgery chapter

Surgical services

Consent must be in chart before surgery

Exception for emergencies

446

Informed Consent

Recommend anesthesia consent now (955)

Lists elements for well designed process, which are the optional elements

Mandatory elements were under MR section

Specifies what must be in the consent policy

Who can obtain

Which procedures need consent

447

Informed Consent Policy

When is surgery an emergency

Content of consent form

Process to obtain consent

If consent obtained outside hospital how to get it into medical records

448


Must disclose if residents, RNFA, Surgical PAs Cardiovascular Techs are doing important tasks

Important surgical tasks include: opening and closing, dissecting tissue, removing tissue, harvesting grafts, transplanting tissue, administering anesthesia, implanting devices and placing invasive lines

But requirement to have this in writing in under optional list or well designed list

449

Surgery Equipment A-0956

Call-in system

Cardiac monitor

Defibrillator

Aspirator (suction equipment)

Trach set (cricothyroidotomy is not a substitute)

TJC PC.03.01.01 includes this plus ventilator, and manual breathing bags

450

PACU 957

Must be adequate provisions for immediate post-op care

Must be in accordance with acceptable standards of care

Separate room with limited access

P&P specify transfer requirements to and from PACU

PACU assessment includes level of activity, respiration, BP, LOC, patient color (Aldrete)

Follow ASPAN standards

451

OR Register A-0958

Patient’s name, id number

Date of surgery

Total time of surgery

Name of surgeons, nursing personnel, anesthesiologist, and assistants

Type of anesthesia

Operative findings, pre-op and post-op diagnosis

Age of patient

See TJC RC.02.01.03 which are now the same

452

Operative Report A-959

Name and id of patient

Date and time of surgery

Name of surgeons, assistants

Pre-op and post-op diagnosis

Name of procedure

Type of anesthesia

453

Operative Report A-959

Complications and description of techniques and tissue removed

Grafts, tissue, devises implanted

Name and description of significant surgical tasks done by others (see list-opening, closing, harvesting grafts

454

Anesthesia A-1000 Must be provided in well organized manner under qualified

doctor

Optional service

Must be integrated into hospital PI

MS establish criteria for director’s qualifications

Revised December 11, 2009, Feb 5, 2010, May 21, 2010 and February 14, 2011

Will review job description of director - see elements

Wherever anesthesia is done - radiology, OB, OR, outpatient surgery areas

State exemption process of MD supervision for CRNA

CMS Anesthesia Standards Changes

Hospitals are expected to have P&P on when medications that fall along the analgesia-anesthesia continuum are considered anesthesia

P&P must be based on nationally recognized guidelines

Must specify the qualifications of practitioners who can administer analgesia

CMS further clarified pre-anesthesia and post-anesthesia evaluations

CMS added FAQs which are very helpful Hospitals should review these as many changes and clarifications

were made455

4th Change Effective February 14, 2011

456

CMS Added FAQs

457

458

Epidural or Spinal in OB The administration of a regional (epidural or spinal)

for the purpose of analgesia during labor and delivery

Is not considered anesthesia

Therefore, it is not subject to the supervision requirements for CRNA

Unless subsequent administration of medication for operative delivery like a C-section then the anesthesia standards apply

This section was removed even though this has always been CMS’s position

459

Anesthesia A-1000 If hospital provides any degree of anesthesia service

must comply with all CoPs

Anesthesia involves administration of medication to produce a blunting or loss of;

pain perception (analgesia)

Voluntary and involuntary movements

Memory and or consciousness

Analgesia is use of medication to provide pain relief thru blocking pain receptor in peripheral and or CNS where patient does not lose consciousness

It is a continuum

460

Monitored Anesthesia Care (MAC)

Anesthesia care that includes monitoring of patient by an anesthesia professional (like anesthesiologist or CRNA)

Include potential to convert to a general or regional anesthetic

Deep sedation/analgesia is included in a MAC

Deep sedation where drug induced depression of consciousness during which patient can not easily be aroused but responds purposefully following repeated or painful stimulus

461

Anesthesia Services 1000

Services not subject to anesthesia administration and supervision requirements

Topical or local anesthesia ; application or injection of drug to stop a painful sensation

Minimal sedation; drug induced state in which patient can respond to verbal commands such as oral medication to decrease anxiety for MRI

Moderate or conscious sedation; in which patients respond purposely to verbal commands, either alone or by light tactile stimulation

462


Rescue capacity

Sedation is a continuum and not always possible to predict how patient will respond so need intervention by one with expertise in airway management

Must have procedures in place to rescue patients whose sedation becomes deeper than initially intended

Anesthesia services must be under one anesthesia services under direction of qualified physician no matter where performed

Operating room, both inpatient and outpatient

OB, radiology, clinics, ED, psychiatry, endoscopy etc.


There is no bright line between anesthesia and analgesia

TJC has standards also on how to safely perform moderate or procedural sedation and anesthesia in the PC chapter

Also references the need to follow nationally standards of practice such as ASA (American Society of Anesthesiologists), ACEP (American College of Emergency Physicians) and ASGE (American Society for GI Endoscopy), AGA etc.

463


Hospitals need to determine if sedation done in the ED or procedures rooms is anesthesia or analgesia

This standard also sets forth the supervision requirements for staff who administer anesthesia

P&Ps need to establish minimum qualifications and supervision requirements including moderate sedation

MS credentialing standards and the nursing standards exist to make sure staff are qualified and competent

Must have P&P to look at adverse events, medication errors and other safety and quality indicators

464

465

Anesthesia Services and Policies 1002

Anesthesia must be consistent with needs of patients and resources

P&P must include delineation of pre-anesthesia and post-anesthesia responsibilities

Policies include;

Consent

Infection Control measures

Safety practices in all areas

How hospital anesthesia service needs are met

466

Anesthesia Policies Required 1002

Policies required (continued);

Protocols for life support function such as cardiac or respiratory emergencies

Reporting requirements

Documentation requirements

Equipment requirements

Monitoring, inspecting, testing and maintenance of anesthesia equipment

Pre and post anesthesia responsibilities

467

Pre-Anesthesia Assessment 1003

Pre-anesthesia evaluation must be performed with 48 hours prior to the surgery

Including inpatient and outpatient procedures

For regional, general, and MAC

Not required for moderate sedation but still need to do pre sedation assessment

Preanesthesia assessment must be done by some one qualified person to administer anesthetic (non-delegable)

468

Organization and Staffing 1003

Pre-anesthesia assessment done by someone who can administer anesthesia such as;

Qualified anesthesiologist or CRNA, Qualified doctor other than anesthesiologist

Anesthesiology assistant (AA) under the supervision of anesthesiologist who is immediately available if needed

Dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under state law

CRNA may not require supervision if state got an exemption1

1 List of 16 state exemptions at www.cms.hhs.gov/CFCsAndCoPs/02_Spotlight.asp Iowa, Nebraska, Idaho, Minnesota, New Hampshire, New Mexico, Kansas, North Dakota, Washington, Alaska, Oregon, South Dakota, Wisconsin, Montana, Colorado, and California.

Pre-anesthesia Evaluation 1003

Can not delegate the pre-anesthesia assessment to someone who is not qualified

Must be done within 24hours

Delivery of first dose of medication for inducing anesthesia marks end of 48 hour time frame

However, some of the elements in the evaluation can be collected prior to the 48 hours time frame but it can never be more than 30 days

o if you saw a patient on Friday for Monday surgery would need to show that on Monday there were no changes

469

470

Pre-Anesthetic Assessment 1003 Must include;

Review of medical history, including anesthesia, drug, and allergy history (within 48 hours)

Interview and exam the patient – Within 48 hours and rest are updated in 48 hours but can be

collected within 30 days

Notation of anesthesia risk (such as ASA level)

Potential anesthesia problems identification (including what could be complication or contraindication like difficult airway, ongoing infection, or limited intravascular access)

471

Pre-Anesthetic Assessment 1003

Pre-anesthetic Assessment to include (continued);

Additional data or information in accordance with SOC

Including information such as stress test or additional consults

Develop plan of care including type of medication for induction, maintenance, and post-operative care

Of the risks and benefits of the anesthesia

472

ASA Physical Status Classification System

ASA PS I – normal healthy patient

ASA PS II – patient with mild systemic disease

ASA PS III – patient with severe systemic disease

ASA PS IV – patient with severe systemic disease that is a constant threat to life

ASA PS V – moribund patient who is not expected to survive without the operation

ASA PS VI – declared brain-dead patient whose organs are being removed for donor purposes

473

Survey Procedure Pre-anesthesia Evaluation

Surveyor to review sample of inpatient and outpatient records who had anesthesia

Make sure pre-anesthesia evaluation done and by one qualified to deliver anesthesia

Determine the pre-anesthesia evaluation had all the required elements

Make sure done within 48 hours before first does of medication given for purposes of inducing anesthesia for the surgery or procedure

ASA and AANA has pre-anesthesia standards

474

Pre-anesthesia ASA Guideline Preanesthesia Evaluation 1

Patient interview to assess Medical history, Anesthetic history, Medication history

Appropriate physical examination

Review of objective diagnostic data (e.g., laboratory, ECG, X-ray)

Assignment of ASA physical status

Formulation of the anesthetic plan and discussion of the risks and benefits of the plan with the patient or the patient’s legal representative

1 www.asahq.org/publicationsAndServices/standards/03.pdf

477

Intra-operative Anesthesia Record 1004

Need policies related to the intra-operative anesthesia

Need intra-operative anesthesia record for patients who have general, regional, or MAC

Intra-operative Record must contain the following:

Include name and hospital id number

Name of practitioner who administer anesthesia

Techniques used and patient position, including insertion of any intravascular or airway devices

478

Intra-operative Anesthesia Record

Intra-operative Record must contain the following (continued):

Name, dosage, route and time of drugs

Name and amount of IV fluids

Blood/blood products

Oxygenation and ventilation parameters

Time based documentation of continuous vital signs

Complications, adverse reactions, problems during anesthesia with symptom, VS, treatment rendered and response to treatment

Post-anesthesia Evaluation 1005

Post-anesthesia evaluation must be done by some one who is qualified to give anesthesia

Must be done no later than 48 hours after the surgery or procedure requiring anesthesia services

Must be completed as required by hospital policies and procedures

Must be completed as required by any state specific laws

P&Ps must be approved by the MS

P&Ps must reflect current standards of care479

480

Post Anesthesia Evaluation 1005

Document in chart within 48 hours for patients receiving anesthesia services (general, regional, MAC)

For inpatients and outpatients now

So may have to call some outpatients if not seen before they left the hospital

Note different for CAH hospitals under their manual

Does not have to be done by the same person who administered the anesthesia

481

Post Anesthesia Evaluation

Has to be done only by anesthesia person (CRNA, AA, anesthesiologist) or qualified doctor

48 hours starts at time patient moved into PACU or designated recovery area (SICU etc.)

Evaluation can not generally be done at point of movement to the recovery area since patient not recovered from anesthesia Patient must be sufficiently recovered so as to participate

in the evaluation e.g. answer questions, perform simple tasks etc.

Post Anesthesia Evaluation

For same day surgeries may be done after discharge if allowed by P&P and state law

If the patient is still intubated and in the ICU still need to do within the 48 hours

Would just document that the patient is unable to participate

If patient requires long acting anesthesia that would last beyond the 48 hours would just document this and note that full recovery from regional anesthesia has not occurred

482

483

Post-Anesthesia Assessment to Include

Respiratory function with respiratory rate, airway patency and oxygen saturation

CV function including pulse rate and BP

Mental status,

Temperature

Pain

Nausea and vomiting

Post-operative hydration

Post-Anesthesia Survey Procedure

Surveyor is review medical records for patients having anesthesia and make sure post-anesthesia evaluation is in the chart

Surveyor to make sure done by practitioner who is qualified to give anesthesia

Surveyor to make sure all postanesthesia evaluations are done within 48 hours

Surveyor to make sure all the required elements are documented for the postanesthesia evaluation

484

485

Post Anesthesia ASA Guidelines

Patient evaluation on admission and discharge from the postanesthesia care unit

A time-based record of vital signs and level of consciousness

A time-based record of drugs administered, their dosage and route of administration

Type and amounts of intravenous fluids administered, including blood and blood products

Any unusual events including postanesthesia or post procedural complications

Postanesthesia visits

487

American Association of Nurse Anesthetists

AANA has excellent website1

Information on how to become a CRNA

Has position statement on documenting the standard of care for the anesthesia record

Sample forms

1www.aana.com/resources.aspx?ucNavMenu_TSMenuTargetID=51&ucNavMenu_TSMenuTargetType=4&ucNavMenu_TSMenuID=6&id=713

Six FAQs

How can the same drugs be used in the OR for anesthesia but in the ED for a sedative?

What nationally recognized guidelines are available for hospitals to use to develop their P&Ps?

What is the appropriate training for a sedation nurse?

Why is there a particular mention in the interpretive guidelines on ED sedation policies?

Can hospital adopt a P&P that all anesthesia agents in lower doses can be used for sedation (NO!)

489

493

Nuclear Medicine A-1026

Services must meet needs of patients

Optional service

Radioactive material must be prepared, labeled, uses, transported, stored and disposed of in accordance with acceptable standards of practice

Will not discuss but be sure to provide to your director if you do nuclear medicine

494

Nuclear Medicine Hospital must have written safety standards for

radioactive material

Handling of equipment and material

Protection of patients and staff from radiation hazards

Labeling of materials and waste

Transportation of same

Security of radioactive material

Testing of equipment for radioactive hazards, et. al.

495

Equipment and Supplies

Must be appropriate for types of nuclear med services offered

Must function in accordance with federal and state laws governing radiation safety - see 21 CFR Subpart J, Radiological Health

See 10 CFR. Chapter 1, Part 20, US Nuclear Regulatory Commission Standards for Protection against Ionizing Radiation

496

Nuclear Med

Must be maintained in safe operating condition

Inspected, tested, and calibrated annually by qualified person

Sign and date reports of nuclear interpretation, consults, and procedures

Keep copies for five years of records

497

Nuclear Med

Practitioner who interprets test must sign and date the test and be approved by MS to interpret

Must maintain records of the receipt and distribution of radio pharmaceuticals

Nuclear med studies must be ordered by practitioners who scope of federal or state licensure allow such referrals and who has staff privileges to perform

498

Outpatient Services A-1076

Services must meet the needs of the patient

Optional service

Must be in accordance with standards of practice

Both on and off campus

Outpatient services must be integrated into hospital QAPI

Theme in rest of slides with being involved in PI, qualified director, follow SOCs, and met needs of patients

499

Outpatient Services

Must be integrated with inpatient services

Medical records, radiology, lab, anesthesia, including pain management, diagnostic tests

Hospital must coordinate the care of the patient

Make sure pertinent information in medical record

500

Outpatient Services

Assign person responsible for this dept.

Have appropriate professional and nonprofessional personnel

Define in writing the qualifications and competencies necessary to direct the department

Will review P&P to determine person’s responsibility

Need to be sure that one person is overlooking all of ambulatory patients care and treatment (1079)

Outpatient Tag 1079

The outpatient services department must be accountable to a single individual

who directs the overall operation of the hospital’s entire outpatient services (all locations, all outpatient services).

Survey Procedures 482.54(b)

Verify that one person is assigned to manage and be responsible for outpatient services.

Review the organization’s policies and procedures to determine the person’s responsibility.

501

502

Emergency Services A-1100

Hospital must meet needs of patients

Optional for Medicare

Must follow acceptable standards of practice


Need qualified MS director

503

Emergency Services

Services must be integrated with other dept in hospital

Surgery, lab, medical records, et al.

Includes communications between departments

Immediate availability of services, equipment, and resources of hospital

Length of time to transport between departments is appropriate

504

Emergency Services

Other departments must provide emergency patients the care within safe and appropriate times

If offer urgent care on premises or in provider based clinics must follow these regulations

Remember there is a separate COP on EMTALA

Will review policies, including triage policy

505

Emergency Services

Must have appropriate equipment

Periodic assessments of its needs

Work with state and feds in emergency preparedness

Surveyor will interview staff to see if knowledgeable about blood, IV fluid, parenteral administration of electrolytes, injuries to extremities, CNS and prevention of infection

506

Rehab Services A-1123

If provides rehab, PT, OT, speech language pathology, audiology, must be staffed and organized to ensure safety of patients

These staff must be qualified as specified by MS and state law

Meet standards - American Physical Therapy Association, American Speech and Hearing Association, American Occupational Therapy Association, American College of Physicians, AMA

507

Rehab Services


Must have proper equipment and personnel

Scope of service should be defined in writing

Review medical records to verify each person documents

Director must be knowledgeable and experience and capable

Will review job description

Services must be furnished in accordance with written plan of care

508

Rehab Services

Must be given in accordance with order of practitioner (no longer says physician only)

Orders must be incorporated in the medical record

Plan of care must meet criteria such as based on assessment, measurable short and long term goals, updated as needed

509

Respiratory Services A-1151

Must meet needs of patients

Acceptable standard of practice

Appropriate equipment and number of qualified personnel

Scope of service should be defined in writing

Director who is doctor with experience to supervise service

List of written policies you must have

510

Respiratory Policies

Equipment assembly, operation, PM

Safety practices including IC for sterile supplies, biohaz waste, posting of signs and gas line id

CPR

Pulmonary function testing

Procedure to follow for adr

Therapeutic percussion and vibration

Bronchopulmonary drainage

511

Respiratory Policies Mechanical ventilation

Aerosol, humidification, and therapeutic gas administration

Storage, access and control of medications

ABG procedure for analyzing

CMS working on changes to respiratory and rehab section so stayed tuned

Need order but can be from physician or LIP as allowed by state (scope of practice) and hospital and PA or NP credentialed by Medical Staff

512

Respiratory Services 1163 (Last CoP)

If blood gases or other clinical lab tests are performed in unit then the applicable lab standards must be met

Need order of practitioner

Will review medical records

Will review to make sure all required policies and procedures are written

513

Statement of Deficiencies and Plan of corrections

Based on documentation of surveyor worksheet or notes and form CMS-2567

514

Condition Level Requirement Noncompliance

515

The End Questions?


Medical Legal Consultant 5447 Fawnbrook Lane Dublin, Ohio 43017

614 [email protected]

516

Websites

Center for Disease Control CDC – www.cdc.gov

Food and Drug Administration - www.fda.gov

Association of periOperative Registered Nurses at AORN - www.aorn.org

American Institute of Architects AIA - www.aia.org

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Websites (continued)

Occupational Safety and Health Administration OSHA – www.osha.gov

National Institutes of Health NIH - www.nih.gov

United States Dept of Agriculture USDA - www.usda.gov

Emergency Nurses Association ENA - www.ena.org

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American College of Emergency Physicians ACEP - www.acep.org

Joint Commission Joint Commission - www.JointCommission.org

Centers for Medicare and Medicaid Services CMS - www.cms.hhs.gov

American Association for Respiratory Care AARC - www.aarc.org

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American College of Surgeons ACS -www.facs.org

American Nurses Association ANA - www.ana.org

AHRQ is www.ahrq.gov

American Hospital Association AHA - www.aha.org

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CMS Life Safety Code page - http://new.cms.hhs.gov/CFCsAndCoPs/07_LSC.asp

COPs available in word and PDR at http://www.access.gpo.gov/nara/cfr/waisidx_04/42cfr485_04.html

American College of Radiology- www.acr.org

Federal Emergency Management Agency (FEMA)- www.fema.gov

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Drug Enforcement Administration –www.dea.gov (copy of controlled substance act)

US Pharmacopeia - www.usp.org, (USP 797 book for sale)

National Patient Safety Foundation at the AMA -www.ama-assn.org/med-sci/npsf/htm

The Institute for Safe Medication Practices - www.ismp.org

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U.S. Pharmacopeia (USP) Convention, Inc. - www.usp.org

U.S. Food and Drug Administration MedWatch -www.fda.gov/medwatch

Institute for Healthcare Improvement - www.ihi.org

AHRQ at www.ahrq.gov

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Sentinel event alerts at www.jointcommission.org

American Pharmaceutical Association - www.aphanet.org

American Society of Heath-System Pharmacists -www.ashp.org

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Enhancing Patient Safety and Errors in Healthcare -www.mederrors.com

National Coordinating Council for Medication Error Reporting and Prevention - www.nccmerp.org,

FDA's Recalls, Market Withdrawals and Safety Alerts Page: www.fda.gov/opacom/7alerts.html

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Infection Control Websites

Association for Professionals in Infection Control and Epidemiology (APIC) infection control guidelines at www.apic.org

Centers for Disease Control and Prevention - www.cdc.gov

Occupational Health and Safety Administration (OSHA) at www.osha.gov

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Infection Control Websites (continued)

The National Institute for Occupational Safety and Health NIOSH at www.cdc.gov/niosh/homepage.html

AORN at www.aorn.org

Society for Healthcare Epidemiology of America (SHEA) at www.shea-online.org

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Resources

To obtain a copy of Survey and Certification Memo 9-10 go to the CMS website at www.cms.hhs.gov/SurveyCertificationGenInfo/PMSR/itemdetail.asp?filterType=dual,%20date&filterValue=30|d&filterByDID=-1&sortByDID=4&sortOrder=ascending&itemID=CMS1216415&intNumPerPage=10

To see a copy of the final interpretive guidelines issued on October 17, 2008 for hospitals, Appendix A (the regular hospital conditions of participation) which is also part of the State Operations Manual (SOM) go to www.cms.hhs.gov/transmittals/downloads/R37SOMA.pdf

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The End Questions


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cms hospital conditions of participation (cops) 2011 what pps hospitals need to know

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