Master. Team Leader Assessment of Director & Quality Checklist. Every patient deserves the GOLD STANDARD... CAP Accreditation Program

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1 Master Every patient deserves the GOLD STANDARD... Team Leader Assessment of Director & Quality Checklist CAP Accreditation Program College of American Pathologists 325 Waukegan Road Northfield, IL

2 2 of 22 Disclaimer and Copyright Notice On-site inspections are performed with the edition of the Checklists mailed to a facility at the completion of the application or reapplication process, not necessarily those currently posted on the website. The checklists undergo regular revision and a new edition may be published after the inspection materials are sent. For questions about the use of the Checklists or Checklist interpretation, accred@cap.org or call or (international customers, use country code 001). The Checklists used for inspection by the College of American Pathologists' Accreditation Programs have been created by the CAP and are copyrighted works of the CAP. The CAP has authorized copying and use of the checklists by CAP inspectors in conducting laboratory inspections for the Commission on Laboratory Accreditation and by laboratories that are preparing for such inspections. Except as permitted by section 107 of the Copyright Act, 17 U.S.C. sec. 107, any other use of the Checklists constitutes infringement of the CAP's copyrights in the Checklists. The CAP will take appropriate legal action to protect these copyrights. All Checklists are College of American Pathologists. All rights reserved.

3 3 of 22 Team Leader Assessment of Director & Quality Checklist TABLE OF CONTENTS SUMMARY OF CHANGES...4 UNDERSTANDING THE CAP ACCREDITATION CHECKLIST COMPONENTS... 6 INSTRUCTIONS... 6 DEFINITION OF TERMS... 9 LABORATORY DIRECTOR ASSESSMENT QUALIFICATIONS AND GENERAL REQUIREMENTS LABORATORY DIRECTOR RESPONSIBILITY AND OVERSIGHT LABORATORY DIRECTOR NOT ON-SITE FULL TIME... 21

4 4 of 22 ON-LINE CHECKLIST AVAILABILITY Participants of the CAP accreditation programs may download the checklists from the CAP website ( by logging into e-lab Solutions. They are available in different checklist types and formatting options, including: Master contains ALL of the requirements and instructions available in PDF, Word/XML or Excel formats Custom customized based on the laboratory's activity (test) menu; available in PDF, Word/XML or Excel formats Changes Only contains only those requirements with significant changes since the previous checklist edition in a track changes format to show the differences; in PDF version only. Requirements that have been moved or merged appear in a table at the end of the file. SUMMARY OF CHECKLIST EDITION CHANGES 07/28/2015 Edition The information below includes a listing of checklist requirements with significant changes in the current edition and previous edition of this checklist. The list is separated into three categories: 1. New 2. Revised: Modifications that may require a change in policy, procedure, or process for continued compliance; or A change to the Phase 3. Deleted/Moved/Merged: Deleted Moved Relocation of a requirement into a different checklist (requirements that have been resequenced within the same checklist are not listed) Merged The combining of similar requirements NOTE: The listing of requirements below is from the Master version of the checklist. The customized checklist version created for on-site inspections and self-evaluations may not list all of these requirements. NEW Checklist Requirements Requirement TLC TLC Effective Date 07/28/ /21/2014 REVISED Checklist Requirements Requirement TLC TLC TLC TLC TLC TLC TLC TLC Effective Date 07/28/ /28/ /28/ /28/ /28/ /21/ /28/ /28/2015 DELETED/MOVED/MERGED Checklist Requirements

5 5 of 22 Requirement TLC TLC Effective Date 04/20/ /20/2014

6 6 of 22 UNDERSTANDING THE CAP ACCREDITATION CHECKLIST COMPONENTS All checklist requirements contain a requirement number, subject header, phase, and a declarative statement. Some requirements also contain a NOTE and/or Evidence of Compliance. The NOTE portion of a checklist requirement provides additional detail to assist in interpreting the requirement. Evidence of Compliance (EOC) is intended to: Suggest specific examples of acceptable records; some elements are required Assist in inspection preparation and for managing ongoing compliance Drive consistent understanding of requirements If a policy or procedure is referenced within a requirement, it is only repeated in the Evidence of Compliance if such statement adds clarity. All policies or procedures covered in the CAP checklists must be a written document. A separate policy or procedure may not be needed for items in EOC if it is already addressed by an overarching policy. The Master version of the checklist also contains references and the inspector R.O.A.D. instructions (Read, Observe, Ask, Discover), which can provide valuable insight for the basis of requirements and on how compliance will be assessed. INSTRUCTIONS This checklist will help you evaluate the qualifications of the laboratory director and the effectiveness of the director in implementing the Standards of the Laboratory Accreditation Program, including the laboratory's quality management plan. Record any major or systemic deficiencies detected during the on-site inspection that reflect lack of director oversight in areas such as QC, QM, proficiency testing, employee qualifications and records, competence and training, and the maintenance of a safe work environment. Record any major or systemic issues identified, and elaborate on these findings in the Inspector's Summary Report, Part A (ISR-A). This checklist must be completed by the team leader or a team member who is qualified and trained to be a team leader. It is important to cite IN THIS CHECKLIST, any systemic issues identified, and to elaborate on these findings in the Inspector's Summary Report, Part A (ISR-A). The following activities provide the information needed to complete the requirements in this checklist: Interview the laboratory director. Interview laboratory supervisory personnel and other laboratory personnel as appropriate. Observe the operation of the laboratory during your time on-site. Review the laboratory organizational chart, quality management plan and records, committee minutes, and other relevant documents for appropriate director involvement. 5. Interview the hospital administrator. If the laboratory is an independent organization, interview an executive from the organization. 6. Interview the chief of the medical staff (for laboratories associated with a medical staff). 7. Discussion with members of the inspection team to assess the extent of deficiencies. Deficiencies that directly affect patient safety, or are pervasive in the laboratory, may warrant a deficiency in the Director Oversight Responsibilities section of this checklist. Interviews with the laboratory director, hospital or organization administrator, and representative of the medical staff are essential parts of the inspection. If for any reason one of these interviews was not performed, discuss the circumstances in the Inspector's Summation Report.

7 7 of 22 Meeting with the Laboratory Director Purpose: To help determine if the laboratory director has sufficient responsibility and authority for operation of the laboratory. Allow a minimum of minutes for the meeting. The interview is an opportunity to: Evaluate the director's activities as listed in the Standards for Laboratory Accreditation Review any problems that the inspection experience might serve to resolve (e.g. space problems, staffing shortages) Determine whether the laboratory director also functions as a technical supervisor, clinical consultant, general supervisor, or as a testing personnel. If so, review the Personnel section of the Laboratory General Checklist for qualifications and responsibilities. Meeting with the Organization/Hospital Administrator/Chief Executive Officer (CEO) For hospital-based laboratories, the inspector should meet with the hospital administrator/ceo. Allow at least minutes for the meeting. Avoid scheduling the meeting early in the inspection to have a sense of the laboratory's operations first. For independent laboratories, meet with an executive from the laboratory organization. Purpose: To extend the College's appreciation for participating in the accreditation program, to record an evaluation of the laboratory from the administration's viewpoint, and help assess the director's involvement in the administration of the laboratory. Points to communicate during the interview are: The goals of the CAP Laboratory Accreditation Program: education and laboratory improvement; establishing best practices in laboratory medicine, based on input from national experts Inspection method: two-year accreditation cycle; use of active laboratorians as inspectors; educational value to inspector and inspected laboratory The role of proficiency testing in the program Laboratory director: the laboratory director is responsible for the overall operation of the laboratory, under the requirements of the CAP Laboratory Accreditation Program The interview is an opportunity to: Ascertain the administration's perception of the laboratory service Discuss administration's view of the laboratory director's role in ensuring high quality laboratory services to fulfill the needs of the institution's patients and clinicians Determine if the institution gives the director the authority to fulfill the director's responsibilities under CAP Address the effectiveness of the working relationship among the laboratory, its director and administration Identify any areas of conflict Discuss all laboratories being inspected. Do not discuss any financial and/or contractual arrangements. When speaking with the hospital administrator, ask if the laboratory service level is appropriate to the needs of the institution. Ask how the pathologists participate in hospital-wide committees, how effective they are in working with the medical and administrative staffs, and whether they meet the expectations of the administration. Record key findings from this interview in Part A of the Inspector's Summation Report. Meeting with a Representative of the Medical Staff

8 8 of 22 For laboratories associated with organized medical staffs, it is important for the team leader to interview the chief of the medical staff (or other knowledgeable medical staff representative, such as the chief medical officer, or a physician who uses the laboratory's services frequently). Allow for a minute discussion, and come prepared with a general understanding of the laboratory's operations beforehand. Purpose: To determine whether the director and the laboratory staff have established an effective working relationship with the medical staff and are effectively supporting patient care. The interview is an opportunity to: Evaluate how effectively the scope, quality, and timeliness of laboratory services meet the patient care needs of the hospital Assess the contribution of the pathologist and laboratory staff to teaching conferences and meetings Determine the cooperation of medical staff and pathologist in problem resolution Judge the medical community's perception of the effectiveness of the laboratory director and other pathologists, and determine if the laboratory director has sufficient authority to fulfill the needs of the medical staff and patients When meeting with the chief or other active member of the medical staff, ask questions about the scope, quality and timeliness of laboratory services. The team leader should ask the medical staff representative for input on pathologist participation in medical staff committees, participation in institutional quality management (performance improvement) and patient safety activities, and participation in teaching conferences. Include all laboratories being inspected, including special function and satellite laboratories. The inspector may record information from this interview in Part A of the Inspector's Summation Report. Pre-Summation Conference Prior to the summation conference, allow minutes to meet privately as a group with the inspection team members to discuss and record inspection findings. The goal of the meeting is to ensure that both verbal and written inspection reports are complete and consistent. During the meeting: Resolve team members' questions Ensure consistency in recording similar findings (e.g. deficiency versus recommendation) Identify serious deficiencies that may jeopardize patient care and systemic problems where inspectors cited the same or related deficiencies in multiple laboratory sections Review the Part A Questions in the Inspector's Summation Report If serious deficiencies or systemic issues are identified or any question from Part A is answered "NO," cite the appropriate checklist requirements relating to the issue and the TLC Checklist requirement for the laboratory director responsibility. Common examples include:

9 9 of 22 Issue Observed Lack of laboratory director involvement QM plan not properly implemented Inconsistent quality control/lack of corrective action Improper handling of proficiency testing materials/lack of follow-up for unacceptable results Lack of validation/verification records for new tests or instruments Insufficient numbers of personnel or incomplete records for personnel qualifications and/or training Unsafe laboratory practices compromise the safety of personnel Incomplete records for delegation of duties or duties not effectively carried out by designee(s) (e.g. competency assessments not performed as required by designee) or delegation of functions to individuals who lack the necessary qualifications Related TLC Requirement TLC TLC TLC TLC TLC TLC TLC TLC Summation Conference Citations in this checklist are optional for discussion at the summation conference to which laboratory staff, hospital administration, and others may be invited. The team leader may instead choose to discuss them with the laboratory director in a private summation meeting. DEFINITION OF TERMS Alternative assessment - A system for determining the reliability of laboratory examinations for which no commercial proficiency testing products are available, are not appropriate for the method or patient population served by the laboratory, or participation is not required by the accrediting organization. Analytical validation - The process used to confirm with objective evidence that a laboratory-developed or modified FDA-cleared/approved test method or instrument system delivers reliable results for the intended application. Analytical verification - The process by which a laboratory determines that an unmodified FDA-cleared/ approved test performs according to the specifications set forth by the manufacturer when used as directed. Annual - Every 12 calendar months Biennial - Every 24 calendar months Authority - The power to give orders or make decisions: the power or right to direct someone or control a process Calibrator, historical - The set of archived results of a single-point calibrator that demonstrates stability of the assay over time Check - Examination to determine the accuracy, quality or presence of any attribute of a test system Clinical validation - The determination of the ability of a test to diagnose or predict risk of a particular health condition or predisposition, measured by sensitivity, specificity, and predictive values Confirmation - Substantiation of the correctness of a value or process Corrective Action - Action taken to eliminate the cause of a detected nonconformity or other undesirable situation

10 10 of 22 Correlation - Establishment of agreement between two or more measured values Credentialing - The process of obtaining, verifying, and assessing the qualifications of a practitioner to provide care in a health care organization Device - Any reagent, reagent product, kit, instrument, apparatus, equipment or related product, whether used alone or in combination, intended by the manufacturer to be distributed for use in vitro for the examination of human specimens Digital image analysis - The computer-assisted detection or quantification of specific features in an image following enhancement and processing of that image, including immunohistochemistry, DNA analysis, morphometric analysis, and in situ hybridization Equipment - Single apparatus or set of devices or apparatuses needed to perform a specific task Examination - In the context of checklist requirements, examination refers to the process of inspection of tissues and samples prior to analysis. An examination is not an analytical test. FDA - In the context of checklist requirements, FDA should be taken to mean the national, state, or provincial authority having jurisdiction over in vitro diagnostic test systems. Function Check - Confirmation that an instrument or item of equipment operates according to manufacturer's specifications before routine use, at prescribed intervals, or after minor adjustment (e.g. base line calibration, balancing/zero adjustment, thermometer calibration, reagent delivery). High complexity - Rating given by the FDA to commercially marketed in vitro diagnostic tests based on their risks to public health. Tests in this category are seen to have the highest risks to public health. Instrument - An analytical unit that uses samples to perform chemical or physical assays (e.g. chemistry analyzer, hematology analyzer) Instrument platform - Any of a series of similar or identical analytical methods intended by their manufacturer to give identical patient results across all models Laboratory Director - The individual who is responsible for the overall operation and administration of the laboratory, including provision of timely, reliable and clinically relevant test results and compliance with applicable regulations and accreditation requirements. This individual is listed on the laboratory's CAP and CLIA certificate (as applicable). Maintenance - Those activities that prolong the life of an instrument or minimize breakdowns or mechanical malfunctions. Examples include cleaning, changing parts, fluids, tubing, lubrication, electronic checks, etc. Moderate complexity - Rating given by the FDA to commercially marketed in vitro diagnostic tests based on their risks to public health Modification of manufacturer's instructions - Any change to the manufacturer's supplied ingredients or modifications to the assay as set forth in the manufacturer's labeling and instructions, including specimen type, instrumentation or procedure that could affect its performance specifications for sensitivity, specificity, accuracy, or precision or any change to the stated purpose of the test, its approved test population, or any claims related to interpretation of the results Nonwaived - Tests categorized as either moderately complex (including provider-performed microscopy) or highly complex by the US Food and Drug Administration (FDA), according to a scoring system used by the FDA

11 11 of 22 Performance verification - The set of processes that demonstrate an instrument or an item of equipment operates according to expectations upon installation and after repair or reconditioning (e.g. replacement of critical components) Policy - 1) Set of basic principles or guidelines that direct or restrict the facility's plans, actions, and decisions; 2) Statement that tells what should or should not be done Preventive action - Action taken to eliminate the cause of a potential nonconformity or any other undesirable potential situation Primary specimen - The body fluid, tissue, or sample submitted for examination, study or analysis. It may be within a collection tube, cup, syringe, swab, slide, data file, or other form as received by the laboratory. Procedure - 1) Specified way to carry out an activity of a process (also referred to by ISO as "work instructions"; 2) Set of steps performed that tells "how to do it" to achieve a specified outcome, including decisions to be made Process - 1) Set of interrelated or interacting activities that transforms inputs into outputs; 2) Series of events, stages, or phases that takes place over time that tells "what happens" or "how it works" Proficiency testing - Evaluation of participant (laboratory or individual) performance against pre-established criteria by means of interlaboratory comparisons. In some countries, the PT programs for clinical laboratories are called "external quality assessment" programs. Reagent - Any substance in a test system other than a solvent or support material that is required for the target analyte to be detected and its value measured in a sample. Report errors - A report element (see GEN.41096) that is either incorrect or incomplete Responsibility - A duty or task that an individual is required or expected to do Secondary specimen - Any derivative of the primary specimen used in subsequent phases of testing. It may be an aliquot, dilution tube, slide, block, culture plate, reaction unit, data extract file, image, or other form during the processing or testing of a specimen. (The aliquots or images created by automated devices and tracked by internal electronic means are not secondary specimens.) Section Director - The individual who is responsible for the medical, technical and/or scientific oversight of a specialty or section of the laboratory. Semiannual - Every 6 calendar months Subject to U.S. Regulations - Laboratories located within the United States and laboratories located outside of the US that have obtained or applied for a CLIA certificate to perform laboratory testing on specimens collected in the US for the assessment of the health of human beings. Telepathology - The practice in which the pathologist views digitized or analog video or still image(s), and renders an interpretation that is included in a formal diagnostic report or is recorded in the patient record. Testing personnel - Individuals responsible for performing laboratory assays and reporting laboratory results Test - A qualitative, semiqualitative, quantitative, or semiquantitative procedure for detecting the presence of, or measuring an analyte Test system - 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. A test system may encompass multiple identical analyzers or devices. Different test systems may be used for the same analyte.

12 12 of 22 Waived - A category of tests defined as "simple laboratory examinations and procedures which have an insignificant risk of an erroneous result." Laboratories performing waived tests are subject to minimal regulatory requirements.

13 13 of 22 LABORATORY DIRECTOR ASSESSMENT Inspector Instructions: Laboratory director s qualifications Laboratory director's licensure as applicable Laboratory director s job description Laboratory director s record of delegation of responsibilities Organizational chart Agreement and records for the frequency of and duties performed during onsite visits (if director is off-site). Ensure actual practice matches agreement. Interaction of laboratory director with laboratory supervisory personnel and laboratory staff Whether the entire laboratory is included in this inspection Technical staff recognition of the role and involvement of the laboratory director in setting expectations and service needs Laboratory Director: What quality improvement initiatives have been most successful during the past two years? Which are works in progress? What educational programs have been made available to staff during the past two years? Have you had any complaints that would indicate the laboratory is perceived as an unsafe working place for personnel and the patients it serves? How did your laboratory conduct the mid-cycle self-inspection? How do you ensure the laboratory meets the expectations of hospital administration and medical staff? When was the last time your laboratory provided an inspection team? How did you ensure that all team members were trained? How do you ensure that the laboratory has adequate numbers of properly trained staff? Organization Administrator: What level of involvement do pathologists have in organization-wide committees? How does the laboratory communicate important laboratory information to administration? How well does the laboratory meet the operational, financial and clinical needs of the organization? Medical Staff Representative: How is the laboratory involved in hospital-wide quality management activities, including patient care improvements, patient safely activities and teaching conferences? What level of involvement do pathologists have in medical staff committees? How does the laboratory communicate important laboratory information to medical staff? How well does the laboratory meet the patients care needs (TAT, accuracy, responsiveness) of the organization?

14 14 of 22 If the administrator and/or the medical staff representative gave examples indicating the laboratory did not meet their expectations, further evaluate laboratory leadership s responses, corrective actions and resolutions. Whether QC failures reflect systemic problems or involve patient safety; if so, was the laboratory director involved in the resolution? How well the laboratory director is involved in key quality processes (proficiency testing, root cause analysis, procedure manual review, etc.) QUALIFICATIONS AND GENERAL REQUIREMENTS **REVISED** 07/28/2015 TLC Laboratory Director Qualifications The laboratory director satisfies the personnel requirements of the College of American Pathologists. NOTE: The qualifications required by the CAP for the position of laboratory director depend on the testing performed in the laboratory.* The qualifications are also dependent upon whether the laboratory is subject to US regulations. The following table contains the laboratory director qualifications based on complexity of testing and US regulatory status: Laboratories Subject to US Regulation Complexity of Testing 1. High complexity testing or Moderately complex and/or waived testing with test volume exceeding 500,000 tests/year Qualifications a. MD, DO, or DPM licensed to practice (if required) in the jurisdiction where the laboratory is located, and have one of the following: i. Certification in anatomic or clinical pathology, or both, by the American Board of Pathology or American Osteopathic Board of Pathology, or possess qualifications equivalent to those required for certification; or ii. Have at least one year of laboratory training during residency; or iii. Have at least two years of experience supervising high complexity testing; OR b. Doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution, and have current certification by a board approved by HHS** 2. High complexity testing limited to a particular a. MD or DO certified in that specialty by one specialty (e.g. hematology, dermatopathology, of the following boards, or who possesses oral pathology, neuromuscular pathology, qualifications equivalent to those required for ophthalmic pathology) certification: A board that is a member of the American Board of Medical Specialties The American Board of Oral and Maxillofacial Pathology An American Osteopathic board

15 15 of Moderately complex (including providera. Qualified as in (1) above performed microscopy (PPM) and/or waived OR testing with test volume not exceeding 500,000 b. MD, DO or DPM, licensed to practice in the tests/year: jurisdiction where the laboratory is located (if required) and have one of the following: i. At least 20 hours of continuing medical education credit hours in laboratory medicine; or ii. Equivalent training during medical residency; or iii. At least one year of experience supervising nonwaived laboratory testing OR c. Doctoral degree with one of the following: i. At least one year of experience supervising nonwaived laboratory testing; or ii. Certified by a board approved by HHS** 4. Waived testing and provider-performed microscopy (PPM) with annual test volume not exceeding 500,000 tests/year a. Qualified as in (1), (2) or (3) above OR b. MD or DO, or DPM, licensed to practice in the jurisdiction in which the laboratory is located, if required Laboratories not subject to US regulations All Complexity Levels a. MD, DO, PhD or have commensurate education and experience necessary to meet personnel requirements as determined by the CAP For laboratories subject to US regulations, additional qualifications for grandfathered individuals and for the subspecialty of oral pathology may be found in the CLIA regulation 42CFR (b)(6). For laboratories subject to US regulations that perform moderately or highly complex tests, a single individual may direct no more than five such laboratories. For laboratories subject to US regulations, credentials for all personnel trained outside of the US must be reviewed to ensure that their training and qualifications are equivalent to CLIA requirements, with records of the review available onsite. The equivalency evaluations should be performed by a nationally recognized organization. *Qualifications for director of the embryology laboratory and for scientific director of the forensic drug testing laboratory are given in the Reproductive Laboratory and Forensic Drug Testing checklists, respectively. Qualifications for histocompatibility laboratory directors, including continuing clinical laboratory education requirements, can be found in the Histocompatibility Checklist. **A list of boards approved by CMS for doctoral scientists may be found at

16 16 of 22 Records of director qualifications appropriate to the type of laboratory and level of complexity 2) 3) 4) 5) 6) 7) TLC amendments of 1988; final rule. Fed Register. 1992(Feb 28):7175 [42CFR ]. Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2004(Oct 1):1050 [42CFR ] Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2004(Oct 1):1049 [42CFR ] Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2004(Oct 1):979 [42CFR493.19] College of American Pathologists, Commission on Laboratory Accreditation. Standards for laboratory accreditation; Standard I. Northfield, IL: CAP, 1998 Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2004(Oct 1):1052 and 1057 [42CFR (d) and 1445(d)] (information on non-us boards) Provision of AP Services Anatomic pathology services are provided by a pathologist certified in anatomic pathology or possessing qualifications equivalent to those required for certification. NOTE: In facilities where anatomic pathology services are provided, a pathologist certified in anatomic pathology (or possessing qualifications equivalent to those required for certification) must perform such services. The services of a consulting anatomic pathologist shall be retained if necessary. At the discretion of the director, subspecialties of anatomic pathology may be provided by physicians who are qualified under paragraph 2 of the Note to TLC.10100, above. Records of director qualifications (e.g. current CV, degree, license, board certification, training and experience) AND Listing of AP services provided by the institution amendments of 1988; final rule. Fed Register. 2004(Oct 1): CFR (l) TLC Section Director Qualifications If the laboratory director is not qualified to direct any of the individual sections of the laboratory, the laboratory retains the services of individuals qualified to direct those sections. Records of section director qualifications (e.g. current CV, degree, license, board certification, training and experience) appropriate for the specialty LABORATORY DIRECTOR RESPONSIBILITY AND OVERSIGHT NOTE TO THE INSPECTOR: Appropriate checklist requirements in this subsection should be cited if the inspection reveals serious deficiencies that may impact patient care or systemic problems where inspectors cited the same or related deficiencies in multiple laboratory sections. If the Team Leader marks "NO" to any of the Part A questions in the Inspector's Summation Report, one or more related TLC requirements must also be cited. TLC Director Responsibility/Authority The laboratory director has sufficient responsibility and authority to implement and maintain the standards of the College of American Pathologists.

17 17 of 22 NOTE: Examples of how the team leader may obtain information on the laboratory director's responsibility and authority include: interviews with the laboratory director, institution's administration, medical staff, laboratory management and laboratory supervisory staff; review of the laboratory organizational chart; and review of minutes of quality management and other laboratory meetings. 2) amendments of 1988; final rule. Fed Register. 1992(Feb 28):7173 [42CFR ], 7175 [42CFR ] College of American Pathologists, Commission on Laboratory Accreditation. Standards for laboratory accreditation; Standard I. Northfield, IL: CAP, 1998 **REVISED** 07/28/2015 TLC Effective QM The laboratory director ensures an effective quality management program for the laboratory. NOTE: The laboratory director must be involved in the design, implementation and oversight of the laboratory's quality management program. This includes all aspects of test performance, including the preanalytic, analytic, and postanalytic phases of testing. Written QM plan covering all areas of the laboratory AND Records of laboratory director approval of the QM plan and the selection of quality indicators AND Records (e.g. reports, QM meeting minutes) of laboratory director review of quality indicators, annual assessment of QM plan, complaints, and incidents with development and implementation of plans of corrective action amendments of 1988; final rule. Fed Register. 1992(Feb 28):7173 [42CFR (e)(5-6), 7176 [42CFR (e)(5,13)] 2) TLC th Clinical and Laboratory Standards Institute. Quality Management System: A Model for Laboratory Services; Approved Guideline. 4 ed. CLSI Document QMS01-A4. Clinical and Laboratory Standards Institute, Wayne, PA; Director Responsibility - PT/QC The laboratory director ensures proficiency testing, alternative assessment, and QC procedures are sufficient for the extent of testing performed in the laboratory. Records of PT and alternative assessment data attesting to completeness AND Records of investigation and corrective action, as applicable AND Written QC procedures for all areas of the laboratory AND Records of laboratory director or designee review of QC and corrective actions **NEW** 07/28/2015 TLC Director Responsibility - New Method Validation/Verification The laboratory director ensures that the performance specifications for new tests, instruments, and methods introduced to the laboratory have been properly validated or verified prior to being used for patient testing. NOTE: Specific requirements are in the All Common Checklist (Instruments & Equipment, Test Method Validation/Verification, and Method Performance Specifications sections) and in other checklists. Written procedures for validation/verification studies AND Records of new method validation/verification approval and supporting data

18 18 of 22 2) TLC amendments of 1988; final rule. Fed Register. 1992(Feb 28): 7173[42CFR (e)(3), 7175[42CFR (e)(3)]. College of American Pathologists, Commission on Laboratory Accreditation. Standards for laboratory accreditation; Standard III. Northfield, IL: CAP, Director Responsibility - Communication The laboratory director ensures communication of laboratory data and appropriate patient result reporting. Records of oversight of computer services and changes AND Evidence of chart review AND Lab communications, newsletters, etc. 2) amendments of 1988; final rule. Fed Register. 1992(Feb 28):7173 [42CFR (c), (e)(809)], 7175 [42CFR ] College of American Pathologists, Commission on Laboratory Accreditation. Standards for laboratory accreditation; Standard I. Northfield, IL: CAP, 1998 **REVISED** 07/28/2015 TLC Director Responsibility - Consultations The laboratory director provides for intralaboratory consultations and clinical consultations regarding the ordering of appropriate tests and the medical significance of laboratory data. NOTE: Only physicians or doctoral scientists may provide clinical consultations. The laboratory director must be accessible to the laboratory for on-site, telephone, or electronic consultations, as needed, or ensure that a qualified designee is available in the director's absence. Laboratory director's authorization for activities of consultant(s) AND Listing of laboratory contacts/consultant(s) available to the clinical services AND Records of laboratory director's involvement in resolution of problems relating to inappropriate test ordering practice AND Records of discussions between consultants and clinical services 2) 3) TLC amendments of 1988; final rule. Fed Register. 1992(Feb 28):7173 [42CFR (e)(8-9)], 7175 [42CFR ] College of American Pathologists, Commission on Laboratory Accreditation. Standards for laboratory accreditation; Standard I. Northfield, IL: CAP, 1998 Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2004(Oct 1):1067 [42CFR ] Director Responsibility - Education/R&D The laboratory director ensures provision of educational programs, strategic planning, and research and development appropriate to the needs of the laboratory and institution. Schedule or description of available educational activities AND Records or minutes from strategic planning sessions demonstrating participation and role of laboratory director AND Policy for assessing clinical needs, implementing and evaluating solutions amendments of 1988; final rule. Fed Register. 1992(Feb 28):7173 [42CFR (e)(12)], 7176 [42CFR (e)(12)]

19 19 of 22 2) rd ed. CLSI Document Clinical and Laboratory Standards Institute. Training and Competence Assessment; Approved Guideline. 3 QMS03-A3. Clinical and Laboratory Standards Institute, Wayne, PA, **REVISED** 07/28/2015 TLC Director Responsibility - Personnel The laboratory director ensures sufficient numbers of personnel with appropriate educational qualifications, documented training and experience, and adequate competency to meet the needs of the laboratory. NOTE: For laboratories subject to US regulations, all personnel must meet the personnel requirements of CLIA or other US equivalent regulations (e.g. Clinical Laboratory Improvement Program Procedures for Department of Defense laboratories, Veterans Health Administration Handbook). For laboratories not subject to US regulations, all personnel requirements must be defined and met. Staffing should be considered insufficient if there is clear evidence from quality monitoring records, data derived from complaints or concerns, turnaround time, and error statistics, etc. Records indicating personnel meet requirements for the level of testing (complexity) performed AND Records of employee training, competency assessment, and continuing education in personnel files amendments of 1988; final rule. Fed Register. 1992(Feb 28):7173 [42CFR (e)(10-11)], 7176 [42CFR (e)(12)] 2) 3) TLC rd ed. CLSI Document Clinical and Laboratory Standards Institute. Training and Competence Assessment; Approved Guideline. 3 QMS03-A3. Clinical and Laboratory Standards Institute, Wayne, PA, Boyd JC, Savory J. Genetic algorithm for scheduling of laboratory personnel. Clin Chem. 2001;47: Director Responsibility - Safe Environment The laboratory director ensures implementation of a safe laboratory environment in compliance with good practice and applicable regulations. NOTE: The laboratory director must ensure compliance with OSHA and national, state, and local regulations, as well as other applicable safety regulations. Details may be found in the Safety and Transport Services sections of the Laboratory General checklist. Records of review of safety procedures AND Records of safety audits with corrective action taken to correct violations, as applicable AND Safety meeting minutes AND Chemical hygiene plan up-to-date with annual evaluation for effectiveness amendments of 1988; final rule. Fed Register. 1992(Feb 28):7173 [42CFR (e)(2)], 7176 [42CFR (e)(2)] **REVISED** 07/28/2015 TLC Director Responsibility - Delegation of Functions Delegation of the laboratory director's functions or responsibilities is in writing. NOTE: 1. Functions that may be delegated include review of QC data, proficiency testing performance, and test methodology performance studies. The laboratory director remains responsible [A] that

20 20 of 22 all persons performing delegated functions are qualified to do so; and [B] that the delegated functions are properly carried out. 2. Functions that may not be delegated include provision of appropriately trained supervisory and technical staff and the identification of their responsibilities. The laboratory director must document personal, on-site assessment of physical and environmental conditions and the adequacy of staffing. 3. The responsibilities and duties of supervisors, consultants, and testing personnel involved in preanalytic, analytic, and postanalytic phases of testing must be defined in writing, with records of authorization to perform testing, and the level of supervision required, as applicable. 4. If a delegated duty is not being properly performed by the designee, with no evidence of corrective action, the team leader should cite this requirement as a deficiency, in addition to the specific checklist requirement(s) that relates to the duty not being performed (e.g. monthly QC review, approval of method validation/verification studies). Policy or statement signed by the laboratory director authorizing individuals by name or job title to perform tasks on behalf of the laboratory director AND Records showing that delegated tasks are performed by designee, as required TLC Director Responsibility - Interaction with Government or Regulatory Interaction The laboratory director or designee interacts with government and other agencies as appropriate. NOTE: The laboratory director or designee must interact with agencies such as national, state and local health departments, as appropriate, for laboratory-related matters. Records of any required reports of infectious diseases to the federal, state or local health department AND Response to any inquiry by government and other agencies, as appropriate AND Reports to OSHA, FDA or other agency, as required **REVISED** 04/21/2014 TLC Director Responsibility - Equipment/Services Phase I The laboratory director or designee is directly involved in the selection of all laboratory equipment, supplies, and services with respect to quality. NOTE: The intent is to ensure that the laboratory director has appropriate control over the process. The fact that economic issues are a major factor in these selections does not relieve the laboratory director of responsibility for ensuring the quality of the technical, clinical and operational aspects of the laboratory. The director must ensure that reagents, fluids, parts, materials, and other items supplied by the laboratory meet the requirements for use with instruments and equipment. Meeting minutes indicating the laboratory director's presence when purchases are discussed OR Written approval from the laboratory director to purchase equipment amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR (a)] **NEW** 04/21/2014

21 21 of 22 TLC New Director Procedure Approval Following a change in laboratory directorship, the new laboratory director approves the laboratory policies and procedures over a reasonable period of time. NOTE: 1. The approval of the policies and procedures must be recorded. 2. The format of such documentation is at the discretion of the laboratory director. It must include an itemization of the documents reviewed and approved, signatures and dates, and demonstrate that all procedure manuals have been approved. 3. The approval should be completed within three months of the change of directorship for most laboratories. 4. Different requirements for approval of new and substantially changed policies and procedures and for routine reviews (at least every 2 years) appear in the All Common Checklist. amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR (d)], [42CFR (e)] LABORATORY DIRECTOR NOT ON-SITE FULL TIME NOTE TO THE TEAM LEADER: The following two requirements apply to laboratory directors who are not present full-time at the laboratory. Off-site laboratory directors must ensure that all laboratory director responsibilities defined in the other sections of the checklist are carried out as required. Refer to TLC for information on delegation of duties and duties that may not be delegated. **REVISED** 07/28/2015 TLC Director Off-Site There is a written agreement or policy defining the frequency of, and responsibilities for activities to be performed by the laboratory director during on-site visits and remotely, with records of the director's activities. NOTE: If activities are conducted remotely, the policy or agreement must define the communication mechanisms that will be used and how records of the communications will be maintained. Records for frequency of on-site visits AND Meeting minutes showing director participation AND Laboratory director review of quality management records AND Records of electronic review or consultation **REVISED** 07/28/2015 TLC Director Visits and Remote Consultation The involvement of the laboratory director, including activities conducted during on-site visits and remote consultation, follows the written policy or agreement and is considered adequate by the laboratory and medical staff and the inspection team. NOTE: The requirement is not met if the hospital administrator, the chief of staff, laboratory supervisors, or most technical staff desire greater personal involvement on the part of the laboratory director. If activities are conducted remotely, the laboratory director must ensure that there is an effective communication mechanism in place between the laboratory director and laboratory management and staff.

22 22 of 22 The requirement is also not met if the laboratory director is not performing duties as defined in the policy or agreement or if the inspector identifies that the visits and remote involvement are not sufficient to carry out the laboratory director responsibilities or provide sufficient oversight of the laboratory. Such situations may include, but are not limited to, serious quality or safety issues that are not addressed in a timely manner, duties delegated by the laboratory director to other staff that are not being carried out in an effective manner, and improper implementation of new laboratory practices.