College of American Pathologists
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  CLA Underscores Consistency
  and Accountability


February 2005
Originally published in CAP TODAY

Desiree A. Carlson, MD, Editor, Laboratory Accreditation News

The Commission on Laboratory Accreditation met in Atlanta on Nov. 4 and 5. An inspector training seminar was held on Nov. 6. Highlights of the CLA meeting follow.

Consistency in inspections

The Commission on Laboratory Accreditation discussed the need to improve consistency among volunteer inspectors. The College will be holding a greater number of inspector training seminars for team leaders this year to address this need. The CAP will soon require all new team leaders to participate in inspector training. The CLA will decide at its next meeting when this requirement will take effect. Beginning in January 2006, all team leaders will be required to periodically undergo inspector training. The schedule for such training is not yet finalized.

CAPstaff will help Laboratory Accreditation Program state commissioners make inspector assignments to ensure that inspectors are peers and that the assignments are made on time. Transitioning inspector assignment responsibilities to CAP staff will give state commissioners more time to teach and mentor inspection teams. The state commissioners will be conducting more followup and calling team leaders after inspections. They also will be conducting a greater number of team leader inspector training seminars.

Role of the laboratory medical director

The commission is addressing the issue of medical directors not adequately documenting when they delegate the responsibility for such activities as procedure manual or quality control review. The LAP is formulating checklist questions that the pathologist on the inspection team would ask the medical director. These questions will cover the 15 requirements in the "Standards on Laboratory Accreditation" that apply to the responsibilities of the medical director. Team leaders will review these responsibilities during the interviews they conduct with the organization's administrator and medical staff representative.

Assessing bench-level lab operations

The LAP will soon require inspectors to completely examine the data for several analytes in each laboratory section, including paper instrument tapes for proficiency testing samples, quality control records, run reports, verification of calibration and analytic measurement range determinations, and procedure manuals, including comparisons to the manufacturer's instructions, as well as to hold discussions with bench technologists about test performance. The analytes will be selected based on previous problems the lab may have had with PT and based on quality management systems data, PT exception reports, and complaints. In addition, the process by which bench-level technologists report complaints, such as concerns involving unresolved patient care or safety issues, will be posted in all laboratories. Bench-level technologists are encouraged to contact the CAP to report quality concerns if the laboratory cannot resolve the problems using standard procedures.

Inspection techniques

The commission is developing additional tools and techniques to help inspectors more accurately assess laboratories. The LAP will conduct a pilot test using such tools as a process-oriented checklist to supplement each laboratory section's checklists. The former will provide the inspector with detailed guidelines regarding how to gather data that supports a laboratory's ability to comply with a particular program requirement.

Relationship with AABB

The CAP has modified the laboratory general and transfusion medicine checklists to be equivalent to the American Association of Blood Banks' assessor tools. Consequently, either tool can be used to inspect and accredit a transfusion service for both agencies in a single on-site inspection. The facility can select which agency it wants to conduct the inspection. The mechanics of the inspection process are being worked out.

Relationship with UNOS

The commission announced that the United Network for Organ Sharing will now recognize the CAP accreditation program in histocompatibility. Until now, CAP-accredited histocompatibility laboratories that were UNOS members had to enroll in and prepare for inspections by the CAP as well as the American Society for Histocompatibility and Immunogenetics, or ASHI, the only other accrediting body recognized by UNOS. Now labs can fulfill all UNOS requirements solely through the CAP inspection process.

Inspection process

The inspector summation report will be expanded to include more detailed information for the inspection team, including prior deficiencies and a list of analytes with newly added analytes flagged. Inspectors will be asked to document that deficiencies from the prior inspection have been corrected. Including such information in the checklists will ensure that inspectors are aware of the lab's history and current scope of services. Laboratories may also be expected to provide more information for review before the inspection, such as their complete quality management plan. Furthermore, the time frame for the post-inspection review will be shortened, with the goal of the CAP reaching an accreditation decision within 75 days of the inspection date.

Master inspectors

The LAP is working to identify inspectors in each region and for subspecialty areas who can conduct inspections on short notice. These people will inspect laboratories that are at risk of losing their accreditation due to a high number of phase II deficiencies.

Grossing of anatomic pathology specimens

LAP will add questions to the anatomic pathology checklist to clarify the CLIA requirements for testing personnel to be qualified to do high-complexity testing. The Centers for Medicare and Medicaid Services is concerned that the checklist requirements for these personnel are less stringent than the CLIA requirements, which classify gross examinations as high-complexity testing.

Critical checklist questions

Some checklist questions, particularly those involving proficiency testing and quality management, have been identified as possible leading indicators of problems in laboratories if deficient. The CLA is identifying a list of candidate questions to identify problems earlier in the accreditation process.

Notification of accreditation status

To improve communications with other accreditation organizations that have laboratory responsibilities as well as with hospital administration, the commission will now report accreditation actions, as applicable, to hospital chief executives and hospital accrediting organizations such as the Joint Commission on Accreditation of Healthcare Organizations, state health departments, and CMS. In addition to notifying these entities that accreditation has been established or renewed, the CAP will notify them, as appropriate, of denial, probation, suspension of accreditation, and accreditation with conditions.

Educating laboratory staff

The commission approved, in concept, developing an inspection video for laboratories. The video would provide an overview of the CAP Laboratory Accreditation Program and detail what will happen on the inspection day and what inspectors will be looking for. It would also encourage laboratory staff to be open and honest with CAP inspectors. The video would be sent to laboratories several months before their inspection.

Next meeting

The commission will hold its next meeting in Seattle on Feb. 3 and 4. An inspector training seminar will be conducted on Feb. 5.