complying with the team leader checklist - presentation · complying with the team leader checklist...

Laboratory Accreditation Program Audioconference

Complying with the Team Leader Checklist

Paul Bachner, MD, FCAP February 17, 2010

2010 College of American Pathologists. Materials are used with the permission of the faculty.

Every number is a life.™2

Professor & Chair, UK Department ofPathology & Laboratory Medicine& Director of Hospital Laboratories

Commission on Laboratory Accreditation

Regional Commissioner For KY, TN, IL

CAP Council on Accreditation

CAP Past President & Member ofBoard of Governors

FIRST LAB ACCREDITATIONINSPECTION IN 1969

(MANY SINCE)

Paul Bachner, MD, FCAP


University of Kentucky, Lexington, KY


New UK HOSPITAL (2011)


CAP Headquarters, Northfield, IL


Audioconference ObjectivesAfter participating in this audioconference,

you will be able to:• Enhance the effectiveness of the director

in meeting the Standards of the Laboratory Accreditation Program.

• Illustrate techniques to improve communication with physicians and institutional administration.

• Evaluate critical documents that are required to implement an effective Quality Management Plan.


LAP Philosophy• Promote a quality culture through

(Traditional)• Peer review• Performance improvement• Quality control• Proficiency testing (new: sanctions for failure)

• Regulatory role (New emphasis)• Assess compliance with CAP requirement and

those mandated by CLIA-88


CAP Accreditation Requirement

Ensure that the laboratory participates in the monitoring and evaluation of the quality and appropriateness of services rendered within the context of the quality assurance program appropriate for the institution, regardless of testing site(s).


CAP Accreditation Requirement

Director must assume responsibility for implementation of the quality management plan. The director and professional laboratory personnel must participate as members of the various quality management committees of the institution.


Expectations of CAP-Accredited Labs• Commitment to continuous improvement• Meeting CAP Accreditation and CMS (CLIA)

requirements• Increased emphasis on role & responsibility

of director including explicit documentation of delegation of duties

• Requirement for inspection of other labs of similar size and scope


Inspection Techniques: Instructions for Inspectors• Read

• Records/documents: complete, current, reviewed, available

• Observe• Does practice match policy?• Is there follow-up of problems and documentation of

resolution?• Ask open-ended questions

• How do you ensure communication and dialog with administration? With medical staff?

• Consider rehearsal or role-play prior to actual inspection


Team Leader’s Checklist for TLC*• Interview with laboratory director• Interviews with laboratory supervisory personnel, and

other laboratory personnel as appropriate• Observation of the operation of the laboratory

during the on-site inspection• Review of the laboratory organizational chart,

quality management plan and records, committee minutes, and other relevant documents

• Interview with hospital administrator. If the laboratory is an independent organization, an executive from the organization should be interviewed

• Interview with the chief of the medical staff (for laboratories associated with a medical staff).

* See Attachment A.


Preparation for Inspection• Inform administration, medical staff and your

laboratory colleagues and staff that they will be interviewed• Location: comfortable and secure• Timing• Back-up plans• You should not be present but best to take TL to

interview and make introductions• Inform about purpose of inspection and

CAP/LAP process but do not “prep”


Your Interview with Team leader• Your office if possible• Consider tour of laboratory• Not a group therapy session!• Be candid (but this is not a confessional)• Avoid personal or contract issues• Identify concerns but do not try to influence

deficiency identification process• Always remember that team (and TL) are

fact finders, not final authority


Specific Checklist Questions• TLC.10100 Phase II Does the laboratory director

satisfy the personnel requirements of the College of American Pathologists?• Determined by test volume and test complexity• Terminal degree, boards, AP, CP, documentation of

delegation of specific functions • TLC.10420 Phase I Is the laboratory director or

designee directly involved in the selection of all laboratory equipment and supplies?

• TLC.10430 Phase II Does the laboratory director have sufficient responsibility and authority to implement and maintain the Standards of the College of American Pathologists?


Standards of Accreditation*

I. Director and PersonnelII. Physical ResourcesIII. Quality ManagementIV. Administrative Requirements

* See Attachment B


Standard I – Director and Personnel

• Responsibilities• Delegation of functions• Part-time director• Anatomic pathologist• Technical consultant


Standard II – Physical Resources

• Addresses need for sufficient resources• Space, instrumentation, furnishings,

communication systems, ventilation, gases, water, security

• To support the lab’s activities• To minimize the risk of injury and

occupational illness


Standard III – Quality Management

• Performance improvement• Instrument maintenance• Quality control• Proficiency testing• Clinical validity


Standard IV – Administrative Requirements

• Submit to periodic on-site inspection• Notify CAP of significant changes• Comply with the Terms of

Accreditation


Specific Checklist Questions• TLC.10440 Phase II Does the director ensure an

effective quality management program for the laboratory?

• TLC.10450 Phase II Does the director ensure quality control procedures sufficient for the extent of testing performed in the laboratory?

• TLC.10460 Phase II Does the director ensure proficiency testing and alternative assessment procedures sufficient for the extent of testing performed in the laboratory?

• TLC.10700 Phase II Does the director ensure provision of consultations regarding the ordering of appropriate tests and the medical significance of laboratory data?


Specific Checklist Questions• TLC.11200 Phase II Does the director ensure

provision of educational programs, strategic planning, and research and development appropriate to the needs of the laboratory and institution?

• TLC.11300 Phase II Does the director ensure sufficient personnel with adequate documented training and experience to meet the needs of the laboratory?

• TLC.11400 Phase II Does the director ensure implementation of a safe laboratory environment in compliance with good practice and applicable regulations?


Director Not On-site Full Time

• Agreement documenting frequency & duration

• Responsibilities of visits• Documentation of involvement/activities

• Responsibilities performed & documented• Administrative/medical staff involvement


Quality Laboratory Practice

• Structure (people, equipment, facilities)• Staff qualifications, training, evaluation• Policies and procedures• Calibration & Process (QC) Control• External QC (PT)• Licensure & Accreditation• Cost Management


Quality laboratory Practice

• Analytic parts of testing cycle (the “test”)• Pre-analytic and post-analytic component

• Patient, specimen, results & data management• Leadership & external relations• Emphasis on Continuous Improvement

• Patient safety• “Customer” needs

• Outcomes & Patient Safety


Role of Administrative Management (lab manager)• Support lab director• Provide administrative support• Encourage leadership role for director• Ensure that the Lab director fulfills

responsibilities and grows in job• Lab management is a team sport!• No director is better than his/her lab manager!


Good Relations of Director with Administration and Medical Staff• Ingredients of success:

• Professional competence• Integrity• Diligence• Availability

• Specifics:• Attend meetings and pay attention (stay awake)• Do what you promise; if you cannot, apologize!


The Quality Management Plan

• Why is the QM Plan important?• CAP and CLIA accreditation requirement• Will improve patient care and safety• Will help you to improve lab services

(quality, timeliness, efficiency)• Helps you to ensures continuing surveillance

& active, engaged management


The Quality Management Plan

• What are the key compliance issues?• Plan format• Components (entire analytic cycle, all sections)• Metrics, benchmarks and indicators• Corrective action and follow-up to problems• How does plan contribute to patient safety?

• Many templates for QM Plan


Quality Management Basics

• High emphasis by CAP (important deficiency)• Written Quality Plan (CAP & CLIA)• Annual review & approval by director

• 2.2% of CAP labs had not performed (2009)• Specific information/reporting method• Accuracy of results (analytic)• Active surveillance of pre & post-analytic

processes in all sections


Quality Management Formats

• Format may be laboratory designed• CLSI (NCCLS) guideline (GP-22 or GP-26)• ISO 9000 series• CAP(ISO)15189 accreditation and standards• TJC model for improvement of

organizational performance• AABB quality program• Safety plan integrated or separate


Key Quality Management Components• Statement affirming commitment to quality

and patient safety• Risk assessment• Monitoring and control activities (identify

indicators and metrics)• Response to identified problems• Information and communication• Continuous improvement


Essentials of Quality Management Implementation• Implemented as designed• Explicit delegation of responsibility• Specify frequency of activities• Create quality committee(s)• Evidence and documentation

• Committee minutes• QI reports• Documents responding to complaints, problems,

adverse events


What are Inspectors Looking For?

• Written QM Plan• Lab director involvement• Monitoring of process and

improvement• Communication within organization• Documentation!


What are Inspectors Looking For?

• Incorporation of PT data & corrective action

• Attention to employee and “client” concerns

• Use of incident reports to improve process and practice

• All shifts, All sections


12 Key Quality Elements*• Organization• Personnel Resources• Equipment• Supplier and customer Issues• Procedure control (QC, PT)• Documents and Records

* Elizabeth Wagar, MD, FCAP


12 Key Quality Elements*• Occurrence Management• Assessments and Audits • Process & Performance Improvement• Facilities and Safety• Information Management• Customer Service and Satisfaction

*Elizabeth Wagar, MD, FCAP


TLC Most Common Deficiencies*

• TLC.10400: Documentation of delegation and ensuring delegated functions are carried out (3.7%)

• TLC.11700: Documentation of activities during visits (2.1%)

• TLC.10900: Ensuring an effective quality management program (2.1%)

• TLC.11600: Agreement defining frequency of on-site visits by lab director (1.8%)

* From laboratories accredited 01/01/09 to 12/31/09


Why Does “Leadership” Matter?

• Institutional expectations• Pathologists are seen as leaders• Nature abhors a vacuum – if you don’t lead,

someone else will• Scientific and clinical knowledge is no longer

sufficient to validate leadership• If choices are to be made, priorities will be

set – explicitly or by default


Impediments to Leadership• Diminishing resources• Regulatory & administrative overload• Institutional bureaucracy & incompetence• Decreasing pool of trained personnel• Knowledge excess• Clinical responsibilities• Previous experience clinical and scientific• Lack of management & strategic training


Attributes of Good Leaders

• Energy, enthusiasm, experience• Desire to contribute and make a difference• Balance between stewardship and vision• Ability to identify and communicate reality• Communication and listening skills• Capacity for integrative thinking (go beyond

“either – or” thinking)


Attributes of Good Leaders

• Respect for culture and individuals• Seek consensus but make difficult decisions• Keep ego under control• Develop political skills and relationships• Communicate with internal & external publics• Are open to learning, new ideas and change


How to be a Good Director• Link clinical care to lab results & performance

• Patients come first!• Interact with the clinicians – eat lunch!• Work with administration, nursing and others• Mentor and stay involved with your staff• Delegate whenever you can• Seek consensus but don’t abdicate responsibility• Don’t put off difficult decisions• Be available• Use meetings wisely – and sparingly!


How to be a Very Good Director• Know your job, do your job and like your job• Know what you know• Know what you don’t know• Learn and grow• Praise others when appropriate• Don’t take credit for the work of others• Admit your mistakes• Remember that you will be judged by what you do,

not what you say you will do!• Identify reality, correct and set limits when needed• Don’t procrastinate but don’t be impulsive!• Don’t panic; maintain a sense of humor


References and Links (1)• CAP Laboratory Accreditation Manual

http://www.cap.org/apps/docs/laboratory_accredi tation/2009_lapmanual.pdf

• Nakhleh RE, Fitzgibbons PL. Quality Management in Anatomic Pathology: Promoting Patient Safety through Systems Improvement & Error Reduction. CAP 2005.

• Valenstein P. Quality Management in clinical Laboratories: Promoting Patient Safety Through risk Reduction and Continuous Improvement. CAP 2005.

http://www.cap.org/apps/docs/laboratory_accreditation/2009_lapmanual.pdf

http://www.cap.org/apps/docs/laboratory_accreditation/2009_lapmanual.pdf


References and Links (2)• New webinar 11-17-2010: Wagar, E.

The Quality Management Plan – Why Do We Need One?

• CAP/LAP: Virtual Library of Past Audioconferences (www.cap.org)• Williams, B. Quality Management from the Top

Down – Lab director’s Role, 5/16/07.• Velazquez, FR. Quality Management from the Top

Down – Lab Managers & supervisors, 6/20/07• Bachner, P. How to Prepare and Comply with

your Quality Management Plan, 2/18/09.

http://www.cap.org/


Assistance

http://www.cap.orgEmail: [email protected], ext. 6065

[email protected]


Questions?

Thank you!