2015 focus on compliance - college of american … folders...2015 focus on compliance . ... (ascp)...

2015 Focus on Compliance

Demystify CAP Accreditation Requirements: What you need to know to maintain CAP accreditation outside of the main laboratory

Adrienne M. Malta, MBA MT(ASCP) Bessie S. Motley, MHSA, MBA, MT(ASCP) Nancy A. Sheffer, MT(ASCP)

February 18, 2015

OBJECTIVES After participating in this webconference you will be able to:

• Recognize the most commonly cited deficiencies• Determine whether waived or nonwaived requirements are applicable to testing methods• Define quality control, calibration, analytical measurement range, and calibration verification• Prepare for a CAP inspection• Conduct a thorough self-inspection

CE (CONTINUING EDUCATION FOR NON-PHYSICIANS) The CAP designates this educational activity for a maximum of 1.0 credit/hour of continuing education. Each participant should only claim those credits/hours he/she actually spent in the activity.

ASCP STATEMENT The American Society for Clinical Pathology (ASCP) Board of Certification (BOC) Certification Maintenance Program (CMP) accepts this activity to meet the continuing education requirements.

CALIFORNIA AND FLORIDA STATEMENT This activity is approved for continuing education credit in the states of California and Florida.

2015 Focus on ComplianceDemystify CAP Accreditation Requirements

2/18/2015

1© 2015 College of American Pathologists. Materials are used with the permission of the faculty.


Demystify CAP Accreditation Requirements:

What you need to know to maintain CAP

accreditation outside of the main laboratory

Adrienne M. Malta, MBA MT(ASCP)

Bessie S. Motley, MHSA, MBA, MT(ASCP)

Nancy A. Sheffer, MT(ASCP)

February 18, 2015

Housekeeping

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redial the number.

Keep in mind the toolkit is available with the link your site coordinator has received

Accreditation Statement

CE (CONTINUING EDUCATION FOR NON-PHYSICIANS)The CAP designates this live internet educational activity for a maximum of 1 credit/hour of continuing education. Each participant should only claim those credits/hours he/she actually spent in the activity.

ASCP STATEMENTThe American Society for Clinical Pathology (ASCP) Board of Certification (BOC) Certification Maintenance Program (CMP) accepts this activity to meet the continuing education requirements.

CALIFORNIA AND FLORIDA STATEMENTThis activity is approved for continuing education credit in the states of California and Florida.

© 2015 College of American Pathologists. All rights reserved. 3


2/18/2015


DisclosureThe following speaker/planners have the following financial relationships to disclose: None

The following speaker/planners have no financial relationships to disclose:

The following In-Kind Support has been received for this activity: None

The following Commercial Support has been received for this activity: None



Demystify CAP Accreditation Requirements:

What you need to know to maintain CAP

accreditation outside of the main laboratory

Adrienne M. Malta, MBA MT(ASCP)


Nancy A. Sheffer, MT(ASCP)

February 18, 2015

Today’s PresentersAdrienne M. Malta, MBA, MT(ASCP)

Adrienne Malta is the Senior Manager, Inspection Services at the College of

American Pathologists (CAP). Ms. Malta received her baccalaureate degree in

Clinical Laboratory Science from Michigan State University in East Lansing, MI,

USA, in June 1991, and received her MBA with a concentration in Project

Management from DeVry University’s Keller Graduate School of Management in

Chicago, IL, USA, graduating with Honors in June 2003.

Ms. Malta began her career as a Medical Technologist at St. Lawrence Hospital in

Lansing, Michigan working as a generalist. From there, she moved to Chicago,

Illinois to work at Northwestern Memorial Hospital as a generalist Medical

Technologist, supervising the second shift for the Immediate Response

Laboratories and Liver Transplant Laboratory.

Ms. Malta joined CAP in 1996 as a Laboratory Accreditation Programs (LAP)

Technical Specialist. Shortly thereafter she began performing inspections for the

LAP as a full-time Staff Inspector as a part of the LAP’s initiative to expand the

eligibility of laboratories seeking accreditation by CAP. Currently, Ms. Malta is the

Senior Manager of Inspection Services, and is responsible for managing the Staff

Inspection Team, performing inspections worldwide, and providing support to peer

inspection teams and laboratories undergoing inspection.

Ms. Malta has presented a wide variety of topics at regional, national and

international Inspector Training Seminars and webinars for CAP, and has

presented on various laboratory improvement and continuing education topics at

numerous regional Clinical Laboratory Management Association (CLMA) meetings

and Point of Care Testing networking group meetings.© 2015 College of American Pathologists. All rights reserved.

6


2/18/2015


Today’s Presenters


Bessie Motley is an Inspection Analyst, at the College of American Pathologists

(CAP). Mrs. Motley received her baccalaureate degree in Medical Technology from

the Medical College of Georgia in Augusta GA, USA, June 1990. She received a

Masters Degree in Business Administration from Georgia College and State

University’s School of Business in Milledgeville, GA, USA, December 1998 and a

Master’s of Science in Health Care Management from Troy University’s Graduate

School, Troy Al, USA in May 2010.

Mrs Motley began her career as a Medical Technologist at the Medical Center ofMrs. Motley began her career as a Medical Technologist at the Medical Center of

Central Georgia in Macon, GA working as a generalist. She then held the position of

Laboratory Manager for several years at Bleckley Memorial Hospital in Cochran, GA

followed by Dodge County Hospital, in Eastman, GA. Prior to joining CAP, she

worked as a the Administrative Director of the Lab at Central State Hospital.

Mrs. Motley joined CAP in 2006 as a full time Inspection Specialist (Staff Inspector)

performing routine and non-routine accreditation inspections including complaint

investigations of Clinical Pathology Laboratories and Biorepositories as well as CAP

Accreditation Readiness Assessment.

Currently, Mrs. Motley is an Inspection Analyst. In addition to her duties as an

Inspection Specialist, she assists with training of new staff, maintain departmental

procedures, and participate in all inspection initiatives.

Mrs. Motley has presented and developed content for Inspector Training Seminars

and webinars for CAP and Point of Care Testing networking group meetings.© 2015 College of American Pathologists. All rights reserved.

7

Today’s Presenters

Nancy A. Sheffer, MBA, MT(ASCP)

Ms. Sheffer received her baccalaureate degree in Medical Technology from

Avila College, Kansas City, Missouri in 1981 and has worked in laboratory

medicine for more than 30 years. She worked as a generalist and in the

microbiology department at Physicians Reference Lab in Kansas City, MO.

She started as a bench technologist and was promoted through the years to

supervisor of microbiology and to manager of the regional microbiology

laboratory. Nancy’s areas of expertise include laboratory services

consolidation and lean, patient centered practices.

• Add photo

co so dat o a d ea , pat e t ce te ed p act ces

Ms. Sheffer joined the College of American Pathologists in 2010 as an

Inspection Specialist, and inspects community hospital laboratories, physician

office laboratories, assists with volunteer System inspections, as well as

performs CAP Accreditation Readiness Assessments both nationally and

internationally. She also performs non-routine inspections, including complex

complaint investigations and validation inspections. Nancy has participated in

more than 300 inspections since joining the CAP. She has presented various

laboratory improvement and continuing education topics to diverse groups of

medical personnel as well as Point of Care Testing networking group

meetings.


Objectives

• Recognize the most commonly cited deficiencies

• Determine whether waived or nonwaived

requirements are applicable to testing methods

• Define quality control, calibration, analytical q y , , y

measurement range, and calibration verification

• Prepare for a CAP inspection

• Conduct a thorough self-inspection



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Types of Laboratories

• Satellite Off-Campus- a small branch laboratory

that is affiliated with, but not physically located at

the same address as the central laboratory. They

also have their own CLIA number

• Satellite On-Campus- a small branch laboratory

that is affiliated with and located at the same

address as the central laboratory. They can have

their own CLIA number or the same as the main lab

10© 2015 College of American Pathologists. All rights reserved.

Types of Laboratories

• Special Function- Any laboratory not under the

direct jurisdiction of the director of the main

laboratory, but which provides services that fall

within the general definition of clinical laboratory

services. Examples include:

o blood gas studies performed by the respiratory therapy

department

o special hematology procedures provided by the

pediatrics department


Most Common Deficiencies

Competency

10

12

14

16

18

Satellite Off-Campus

Report Elements Reference intervals

Procedure Manual Personnel files

0

2

4

6

8

GEN.55500 GEN.41096 LSV.36940 COM.10000 GEN.54400

Satellite Off-Campus



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Competency

Reagent Storage10

12

14

16

18

Satellite On-Campus

Prodedure Manual Document control

PT attestation

0

2

4

6

8

GEN.55500 COM.10000 COM.30350 GEN.20375 COM.01400

Satellite On-Campus



Competency

Personnel files50

60

70

80

90

Special Function

Personnel files

Document controlPT attestation

Reagent labeling

0

10

20

30

40

50

GEN.55500 GEN.54400 GEN.20375 COM.01400 COM.30300

Special Function


Most Common Safety Deficiencies for Satellite & Special Function Laboratories

Top 5 Safety Deficiencies in 2013:

5. GEN.77200 - Ergonomics

4. GEN.61300 – Climate Control

3. GEN.76000 – Chemical Hygiene Plan

2. GEN.77400 – Eye Wash

1. GEN.75400 – Fire Drills



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GEN.75400 – FIRE SAFETY TRAINING, PHASE II**

• Fire safety training is performed for new employees, with a fire safety

review conducted at least annually.

NOTE: Fire safety training must be documented for all employees to

show that they have been instructed on use and response to fire alarms

and to execute duties as outlined in the fire safety plan. While fire exit

drills are not required, physical evaluation of the escape routes must be

performed annually, to ensure that fire exit corridors and stairwells are

clear and that all fire exit doors open properly (i.e., not rusted shut,

blocked, or locked). Paper or computerized testing of an individual's fire

safety knowledge on the fire safety plan is acceptable; all personnel must

participate at least once a year.

**Requirement changed in 4/21/2014 Checklist Edition

© 2015 College of American Pa 16 thologists. All rights reserved. 16

Waived vs. Non-Waived

Requirement Waived Non-Waived

Reagents Lot to Lot reagent verification- not required

Lot to Lot reagent verification - required

Competency Training before testing-required

Training before testing-required

S i l t S i l i dSemi annual – not required

Semi-annual - required for new lab staff

Annual assessment -required

Annual assessment –required

Laboratory choice of element to assess

Must use all 6 elements for assessment

17

© 2015 College of American Pathologists. All rights reserved.



Correlation –instrument/method

Not required Required

Quality Control Follow manufacturer instructions

Min - 2 levels every 24 hours (coag/ABG more ( gfrequently)

Must be acceptable External every 30 days

Must be acceptable

18



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Calibration/AMR Follow manufacturer instructions

At least every 6 months

Method Performance Specifications

Must verify reference range

Accuracy/precision/sensitivity/reportable Specifications g y prange/carryover and interfering substances

Follow manufacturer instructions

19



Waived Non-Waived

Follow manufacturer instructions Refer to checklist for requirements

20


Training vs. Competency

• Documentation that all staff have satisfactorily

completed initial training on all

instruments/methods applicable to their

designated job is required (GEN.55450)

• The competency of each person performing

patient testing is assessed for his/her duties –

multiple methods are utilized with appropriate

documentation (GEN.55500)



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Training vs. Competency

Training

• Occurs before patient testing begins

• Usually once unless employee fails successful

demonstration of skill to trainer and retraining is required

• Does not require use of six elementsDoes not require use of six elements

Competency

• Occurs after patient testing begins

• Ongoing assessments

• Does require use of six elements for non-waived testing


Competency Assessment –Waived Testing

• Must be performed at least one year after training

is complete

• Reassessed annually

• Does not require use of all six elements

• Laboratory Director and staff decide which

elements are appropriate


• During first year of patient testing after training is complete and

employee is performing testing on his/her own, competency must be

assessed semi-annually

o Six month assessment is for new employees only

Si th t i NOT i d f t l

Competency Assessment Non-Waived Testing

o Six month assessment is NOT required for current employees

trained on new methods/instruments

• Must be reassessed at least annually

• Requires all six elements of competency be assessed (when

applicable) for each test system



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Required Six Elements

• Direct observation patient testing

• Recording and reporting of test results

• Review of worksheets, quality control, proficiency testing

results, and maintenance records

• Direct observation of maintenance and function checks

• Previously analyzed samples, proficiency testing materials,

or internal blind samples

• Problem solving

Making the statement that the six elements are being utilized

for assessment in the competency policy is not sufficient

documentation


Test Systems

• The process that includes pre-analytic, analytic, and post-analytic

steps used to produce a test result or set of results

• A test system may be manual, automated, multi-channel, or single

use and can include reagents, components, equipment, or

instruments required to produce results

• May encompass multiple identical instruments or devices

• Tests performed on the same instrument or device may be defined

as a single test system

• Any tests with unique aspects, problems, or procedures within the

same testing platform (eg, pretreatment of samples prior to

analysis), competency must be assessed as a separate test system

to ensure staff are performing those aspects correctly


A reasonable test system grouping would be:

Polling Question 1

27


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Who May Assess Competency

• High Complexity Testing - Testing personnel performing high

complexity testing must be assessed by the section

director/technical supervisor or individual meeting general

supervisor requirements for high complexity testing if

delegated in writing by the section director/Technical g g y

Supervisor.

• Moderate Complexity Testing - Testing personnel performing

moderate complexity testing must be assessed by an

individual meeting the qualifications of a technical consultant

for moderate complexity testing.


New Requirement for 2014 - GEN.55525

GEN.55525 Performance Assessment of Supervisors/Consultants

The performance of section directors/technical supervisors, general

supervisors, and technical consultants is assessed and satisfactory.

• Laboratory Director must delegate responsibilities in writing

• Perform and document the performance assessment

• Document all corrective action required• Document all corrective action required

• If the individual is performing non-waived testing must

document competency assessments including the six elements

(GEN.55500)

• Recommend including all regulatory responsibilities in the

individual’s job description


GEN.54400 Personnel RecordsPersonnel files must be maintained on all current technical

personnel and personnel records include all of the following:• Copy of academic diploma or transcript

• Laboratory personnel license, if required by state, province, or country

• Summary of training and experience

• Certification, if required by state or employer

• Description of current duties and responsibilities as specified by the laboratory director:

a) Procedures the individual is authorized to perform, b) Whether supervision is required

for specimen processing, test performance, or result reporting, c) Whether supervisory

or section director review is required to report patient test results

• Records of continuing education

• Records of radiation exposure where applicable (such as with in vivo radiation testing),

but not required for low exposure levels such as certain in-vitro testing

• Work-related incident and/or accident records

• Dates of employment



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A quality control program must be designed to detect, reduce,

and correct deficiencies in the analytic process• Quality control includes instrument maintenance/function checks,

temperature checks, pipettes and diluters in addition to internal and external

quality control material performance

• Must be performed at frequencies defined in checklist requirements, but NO

Quality Control

less frequently than required by the manufacturer instructions

• Quality control checks must be documented

• Quality control must be reviewed and be acceptable prior to reporting patient

results

• Quality control must be reviewed and evaluated at least monthly by the

laboratory director or designee – including follow-up for outliers, trends, or

omissions that were not previously addressed


Quality control material must be:

• Labeled and stored per manufacturer instructions and All

Common Checklist requirements

• Used within expiration date – original or revised date if

reconstitution or change in storage conditions changes

Quality Control

reconstitution or change in storage conditions changes

expiration date. Revised expiration dates must be recorded on

container or traceable to a log

• Quality control ranges and thresholds must be established

per written procedure or manufacturer ranges and verified for

each lot


• Calibration: the set of operations that establish, under specified conditions, the relationship between reagent system/instrument response and the corresponding concentration/activity values of an analyte.

Calibration/Verification Definitions

• Calibration Verification: denotes the process of confirming that the current calibration settings for each analyte remain valid for a test system.



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• Calibrate according to manufacturer’s instructions

• Criteria for calibration verification:o At least every six monthso At complete change of reagents

Calibration or Calibration Verification

o When indicated by quality control datao After major maintenanceo When recommended by manufacturer


Analytical Measurement RangeDefinitions

• Analytic measurement range (AMR): The range of analyte

values a method can directly measure on the specimen

without any dilution, concentration, or other pretreatment not

part of the usual assay process

• AMR verification: The process of confirming that the assay

system will correctly recover the concentration or activity of

the analyte throughout the AMR


Verification of the Analytical Measurement RangeCalibration may satisfy the AMR verification requirement

When:

• Calibrators span the full range of the AMR

• Calibrators have at least 3 points (low, mid, high)

• Calibration is performed at least every 6 monthsp y

• Acceptance criteria must be defined

If AMR Verification is required because calibration does not meet

requirements:

• Matrix appropriate materials are required

• Material must include low, mid, and high concentration

• Target values must be appropriate

• Acceptance criteria must be defined



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How to prepare for a CAP Inspection

• Why prepare?

o Continued inspection readiness

o Reduce stress

o Maximize efficiency

o Limit the element of surprise

o Gain support of administration

o Involvement of non laboratory departments



• Key Preparation Points

o Rehearse the arrival of the inspection team

o Identify backup staff to laboratory leaders in case of

absence

o Laboratory Director involvement (interview and contract o abo ato y ecto o e e t ( te e a d co t act

review)

o Review the checklist for new and revised requirements

o Ensure applicable Evidence of Compliance is available

o Organize Policy and Procedure manuals and

documentation

o Test the time needed to retrieve offsite documentation


• Action Plan

o Notification of Security, Administration, Human Resources, Biomedical/Plant Operations, Nursing, Offsite Storage, Dietary and LIS/IT

o One hour notice contact phone number is manned

o Check for the availability of extra staff to cover during the inspection


inspection

o Remind the CMO and CEO of Interview with the Team Leader

o Assess workspace for the inspection team

o Meet and greet the inspection team

o Review Security procedures

o Provide instructions for parking

o Remind staff of the inspection window timeframe



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• Staff Preparation

o CAP team member training

o Part time and PRN staff

o Call center

o Office staff

o Test staff knowledge



• ROAD

o Identify when policies and procedures do not match

actual practices

o Identify areas where staff need re education or re

trainingg

o Identify outdated Policies and Procedures

o Identify Polices and Procedures that need revising

o Identify lack of or insufficient Evidence of Compliance

o Identify work process inefficiencies

o Identify Performance Improvement projects


Follow the Specimen • Pre-Analytical

o Requisitions

o Specimen collection

o Accessioning

o Referrals

• Analytical

o Policies and procedures

o Safety

o Proficiency testing

o Quality control

o Training and competency

o Instrument maintenance & calibration

o Carryover studies, AMR, reagent validation

• Post-Analytical

o Result reporting

o Detection of clerical errors

o Communication



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Which question style is best to ask when using

the ROAD technique in preparing for your CAP

inspection?

Polling Question 2

43

Common documents the inspector will ask to see

• Laboratory Director

o Delegation of Duties

o Visits

• Proficiency Testing• Proficiency Testing

o Evaluations

o Corrective Action

o Raw Data


Common documents the inspector will request

• Personnel Files

o Diploma /Transcript

o List of staff and what tests they can perform

• Report ExamplesReport Examples

• Allen’s Test Documentation

• Self-Inspection

• Procedures

o Technical

o Safety© 2015 College of American Pathologists. All rights reserved. 45


2/18/2015


Common documents the inspector will request

• Quality Management

o QM Plan

o Performance Indicators

− Corrective Action

• Quality Control

o Calibration

o AMR

o Daily and Monthly QC

o Annual Evaluation

o Meeting Minutes

o Patient/Physician

Survey

• Maintenance

o Instrument

o Temperatures

o Eyewash


Self-Inspection

GEN.23584 Interim Self-Inspection

• The laboratory conducts an interim self-inspection

and documents efforts to correct deficiencies

identified during that process.g p

• Evidence of Compliance:

Written evidence of self-inspection findings with

records of corrective action.


Self-Inspection

• Why do a self inspection?

o Continuing education

o Laboratory improvement

o Identify and remedy deficiencies

A dit for compliance ith CAP req iremento Audit for compliance with CAP requirement

• How to approach

o Real event

o Formal process

o Unannounced



2/18/2015


How to conduct a Self-Inspection

• Conducted by departmental staff or peer staff within the

organization

• Identify deficiencies and document on an ISR

• Respond to deficiencies with corrective action

• Set time limit for response (30 days )

• Involve all staff as inspectors and inspectees

• Review deficiencies cited during the last onsite inspection and

check for continued compliance

• Review recommendations commented during the last onsite

inspection and determine if they should be implemented


• Assess your laboratory director’s involvement using the Team Leader

Assessment of Director & Quality Checklist

• Hold a summation conference requiring attendance of staff and

laboratory director

• Review requirements and tag each with the location of applicable policy

or procedure and/or supporting documentation

How to conduct a Self-Inspection

• Use Inspection techniques typically used by the Inspectors – ROAD,

follow the specimen

• Always do more than a paper review – Observe and Ask

• Focus review on new tests and methods, low volume tests, and tests

with unacceptable PT results

• Ensure personnel records include the required elements listed in GEN.

54400


Continuous Compliance

The mission statement of the CAP Accreditation

Programs is: The CAP Accreditation Program

improves patient safety by advancing the quality of

pathology and laboratory services through

education and standard setting, and ensuring

laboratories meet or exceed regulatory

requirements



2/18/2015


Questions?

Questions

2015 focus on compliance - college of american … folders...2015 focus on compliance . ... (ascp)...

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