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