The Commission on Laboratory Accreditation met
in Toronto Nov. 9 and 10, 2000. An advanced inspector training seminar
was held Nov. 11.
Complaint investigation policy
A complaint is defined as any allegation or apparent discovery that
an accredited laboratory does not meet the Standards for Laboratory
Accreditation. Such complaints are investigated by the special
commissioner for complaint investigations, PTES oversight and equivalency.
The so-called complaints commissioner reviews each case and, when
appropriate, convenes a conference call with the executive committee
of the Commission on Laboratory Accreditation. The commission reviewed
and approved language modifications for the policy on complaint
Staff conducts an initial investigation in conjunction with the
complaints commissioner, who may conclude, based on the evidence
assembled during the initial investigation, that the complaint is
not substantiated and choose to close the case. If the complaints
commissioner does not close the case, the laboratory is given an
opportunity to respond. If the laboratory's response is inadequate,
the complaints commissioner may call a meeting of the CLA executive
committee to determine further action, which may include a focused
or comprehensive reinspection.
If the reinspection fails to substantiate the allegations, the
complainant will be notified of this, and the case will be closed.
If substantial evidence is found to support the complaint, the laboratory
will have an opportunity to resolve the identified issues. If the
laboratory fails to correct the problem to the satisfaction of the
complaints commissioner and the executive committee, accreditation
may be revoked. In such a case the laboratory director may proceed
with an appeal process, first to the commission, then to the Board
of Governors. Final reports of investigation of sustained complaints
are sent to the laboratory director. Actions of revocation are reported
immediately to the laboratory director and appropriate oversight
agencies. Information about substantiated complaints is provided
to the inspection team leader for the next on-site inspection.
The complaints commissioner, Gerald A. Hoeltge, MD, discussed
several recent examples referred to the LAP for resolution. He pointed
out that some complaints are accreditation issues that the commission
must address, whereas other complaints are problems of customer
service that may be outside CAP jurisdiction. Although sympathetic
to customer service problems, the College can intervene on behalf
of individual patients only when there are indications that the
Standards for Laboratory Accreditation may have been violated.
Use of CAP logo
As reported in the November "LAP News," staff, with counsel, is
developing a policy regarding use of the CAP logo and the CAP accreditation
number by accredited laboratories. Their use could be construed
as indicating the College guarantees the precision and accuracy
of every individual test result. By College policy, use of the CAP
logo is restricted to the College. The commission requested further
revisions to clarify the designation of the CAP accreditation number
and its approved use and will review the final version at its March
Staff inspections of small rural hospital labs
Edgar H. Pierce Jr., MD, reported on the ongoing use of staff inspections
of small rural hospital laboratories in Tennessee. This has been
well received by labs in this region, following a pilot study. The
criteria used in the pilot study to identify candidate laboratories
The pilot project was directed to these specific laboratories to provide
more expertise in covering these labs and to provide relief for the
voluntary inspection force. The program supplements the ongoing staff
inspections of office laboratories and other small labs.
- Size did not exceed 100 beds.
- Scope of testing did not include specialty areas, cytopathology,
or anatomic pathology, unless the anatomic pathology was limited
to frozen sections.
- Inspection could be completed by one or two inspectors in two
days or less.
considered several options for expanding the present program, including
a review of an existing policy that allows regional and state commissioners
to assign nonpathologist inspectors to small labs not performing
anatomic pathology. Loyd Wagner, MD, offered a motion to extend
this policy further: "At the discretion of the assigning commissioner,
inspection teams for small hospitals may be led by staff or well-qualified
nonpathologist inspectors who will select team members from the
region." The assigning commissioner must secure permission from
the laboratory director before assigning a nonpathologist as the
Staff will modify the current policy. These changes will provide
options in addition to CAP staff inspectors for appropriate peer
review of smaller and remotely located laboratories.
Staff inspection scheduling
As a related issue, laboratories undergoing on-site inspections
by CAP staff inspectors have sometimes objected to the scheduled
inspection date. To minimize travel expenses, staff inspectors will
be scheduled to inspect groups of laboratories that are clustered
geographically. Well in advance of their anniversary date, staff-inspected
laboratories will be notified of the week when their inspection
will be scheduled. If a laboratory does not agree to be inspected
during this week, it may be charged an additional fee to cover the
inspector's travel expenses. Although somewhat sympathetic to the
problems with staffing that small laboratories may have, the commission
concluded this policy permitted the most effective use of staff
Military laboratory directors
CLA vice chair Robert Rickert, MD, discussed the problems associated
with correspondence addressed to directors of military laboratories.
In many cases, correspondence directed by agreement with the Department
of Defense to the "chief, laboratory services" fails to reach the
appropriate person. To alleviate this problem, future correspondence
will be directed to the "chief, laboratory services," with copies
sent to the base or the hospital commanding officer, the laboratory
medical director, the consulting pathologist, if available, and
the clinical laboratory improvement program office.
Performance assessment report update
To date, just over 400 laboratories have received performance assessment
reports. There have been no complaints and few inquiries related
to the program.
The commission discussed whether to include the Forensic Urine
Drug Testing program. The program will not be expanded for now,
but staff will begin to develop the support systems.
Discontinuance of the athletic drug testing program
The commission voted to discontinue the athletic drug testing program.
Enrollment decreased from seven to four laboratories in the last
two years; two of the laboratories currently accredited indicate
they will drop accreditation within the next two years.
The commission decided to include remote phlebotomy sites in the
inspection process for accredited laboratories. If the inspector
determines that test procedures such as bleeding time or waived
testing are being performed at a phlebotomy site and have not been
declared on the laboratory's application, the site should be treated
as a "by the way" laboratory or a laboratory unprepared for inspection
and not be included in the current inspection.
Inspectors should use the phlebotomy-related questions from the
Lab General checklist. Applicable safety and preanalytical checklist
questions are appropriate to use during the inspection. Procedural
deficiencies should be entered on the Lab General section of the
inspector's summary report.
Overseas versus international laboratories
Dr. Rickert requested and the commission agreed to change the nomenclature
of the presently designated overseas labs to "international laboratories."
Inspectors assigned to international laboratories should arrange
all travel through the CAP travel office. Dr. Rickert also proposed
the appointment of additional deputy commissioners to positions
representing the Laboratory Accreditation Program in their countries.
These appointees are CAP fellows who have long experience and familiarity
with the program. Dr. Rickert anticipates these deputy commissioners
will promote the program and supplement inspection teams coming
from the United States with qualified members drawn from the area.
Aaron Lupovitch, MD, reported on his visit to Taiwan, on which
he was accompanied by Peter Howanitz, MD. There are about 400 laboratories
in Taiwan, ranging from huge governmental facilities to small labs.
The Taiwanese pathologists, many of whom trained in the United States,
are extremely enthusiastic about the College program. They seek
accreditation and regard the LAP as the gold standard, Dr. Lupovitch
Hans Peters, MD, expanded the list of countries in which laboratories
have expressed interest in accreditation to include India, Pakistan,
Taiwan, China, Dubai, and Greece. He and Dr. Rickert also plan to
develop lists of potential inspectors in these countries to assist
with the inspection workload and to decrease travel and other costs
of sending U.S.-based team members.
The commission directed staff to investigate alternative methods
for shipping Surveys to international laboratories to avoid delays
that might compromise the quality of Surveys materials.
Update on audioconferences
The new Laboratory Accreditation Program audioconferences have been
well received. Participants have signed on and taken part in live
question-and-answer sessions following the lecture. Topics have
included the inspection process, checklist updates, meeting QC/QI
requirements, and solutions to most common deficiencies. Those who
miss the live presentations can find them on the CAP Web site under
online education, where they can download the handout, listen to
the audio, and receive CME/CLME for completing the exercise. LAP
staff and members of the commission or scientific resource committees
will update each audioconference as it comes up for repeat presentation.
Uniformity of results reported by system labs
John Harbour, MD, suggested a new requirement for system laboratories.
The issue was, Should different laboratories within a system be
required to have a defined mechanism for test correlation that would
verify comparability of results throughout the system, similar to
the expectation to perform correlation of tests performed on different
equipment/by different methods within an institution? Following
discussion, the commission decided to encourage, but not require,
laboratories to ensure comparability of results among laboratories
within a system, for the present time.
During the CAP business meeting at the House of Delegates last fall,
CAP president Paul Bachner, MD, presented awards to several commissioners
and staff. Robert Baisden, MD, received the Blumberg award, and
commissioners Albert Rabinovitch, MD, PhD, and Dr. Peters received
awards for long and distinguished service. LAP staff Peter Mockridge,
Roxanne Schwoch, and Denise Driscoll received awards for their excellent
work on the SCORES project, in which the new client server-based
computer software support accreditation activities was designed
Conflicts of interest
The commission's policy on conflicts of interest primarily addresses
commercial business-related conflicts to avoid improprieties in
personal profit from CAP-related activities. One of the breakout
groups addressed additional potential conflict issues that may arise
related to the assignment of inspection teams.
Several safeguards prevent conflicts of interest in the assignment
The breakout group recommended further instructions to inspectors
to help avoid public perceptions of an unfair inspection and accreditation
process. The group defined an unfair inspection as a situation in
which an otherwise neutral inspection becomes predictably biased toward
permissiveness or harshness in the inspection report. Upon recommendations
by the group and with the commission's approval, certain changes will
be included in the next update of the Laboratory Accreditation Manual:
- Commissioners do not assign inspection team leaders for their
own laboratories; instead, team leaders for these laboratories
are assigned by other commissioners.
- The accreditation decision is made by the regional commissioner,
not by the inspection team leader; this may temper the actions
of individual inspectors and teams.
- Checklist items deal only with scientific/technical items, not
business arrangements. Inspectors are specifically constrained
from discussing contract issues during an inspection or in interviews
with administrators or others.
- The inspection team leader and members are identified prior
to the inspection, and assignments are made to avoid consecutive
cycle assignments to the same team or cross-assignments within
a year's time frame.
The commission can do only so much in terms of safeguards. As with
any regulation or attempt to control human activities, there may always
be exceptions to the rule as well as exceptional persons who may strive
to bend the rule one way or another.
- Commissioners should be sensitive to client satisfaction issues
when assigning inspectors.
- Commissioners must avoid assigning business partners to inspect
one another. Affiliated hospitals may provide teams to inspect
affiliates, depending on the affiliation and nature of the relationship
between the pathologists and the institutions.
- State and regional commissioners should evaluate and judge the
reasonableness of assignments.
The group also reviewed the role of paid or informal consultants
and made further recommendations as follows:
- Any receipt of money for consultation should lead commissioners
to excuse themselves from decisions or actions involving that
- When commissioners offer informal or paid consultation, they
must state that their opinions are personal and disclaim that
they have been endorsed by the CAP.
- Members of inspection teams should avoid solicitations for consultation
services before, during, and up to one year following an on-site
Assigning commissioners should bear in mind this program is voluntary,
but that peer review is a key element. The commission will continue
to monitor and to revisit the issue of conflicts of interest.
Cytopathology checklist language
During the meeting and via e-mail the CLA engaged in a dialogue
with members of the Cytopathology Committee. The principal point
of interest was use of the term "diagnosis" within the checklist,
with members of the Cytopathology Committee preferring the less
explicit term "interpretation." Both groups have exercised considerable
thought and communication on the subject and wound up in a compromise.
The checklist commissioner, Dr. Rabinovitch, will adjudicate the
final language, in which either "diagnosis" or "interpretation"
will appear in the next iteration of proposed checklist changes.
Since the Health Care Financing Administration recently renewed
its approval of the College as a deemed organization, these revisions
can now be submitted for approval by HCFA and released for field
Laboratory directors should understand that checklist terminology
should not direct their preferences in reporting their own cases.
The commissioners generally favored the premise that a positive
Pap test constitutes a diagnosis, as validly as a positive biopsy.
The committee members said even a positive finding constitutes only
an interpretation, the purpose of which is to direct the clinician
to perform more definitive studies, i.e. a biopsy, recognizing the
possibility of false negative biopsy results due to sampling errors.
Both groups agree that accurate communication to the clinician,
not only describing the findings but also suggesting appropriate
followup, is imperative.
CAP's position on waived testing appeared in the Oct. 25, 2000,
issue of "Statline" and remains available on the CAP Web site under
www.cap.org/html/advocacy/issues/waivlett. html. The commission
reaffirmed support for the principle that all patient care testing
should be subject to QC and PT procedures. While challenging the
basis of HCFA's test classification system, the commission strongly
urges that manufacturers of waived test devices be held accountable
for their proper use. Manufacturers are urged to build in appropriate
measures to ensure accurate and precise test results.
Record retention guidelines
Participants at inspector training seminars frequently ask for guidelines
regarding retention of various records and materials. The recommendations
at left are from the College-not just the Commission on Laboratory
Accreditation. As with all such documents regarding the practice
of pathology, neither CAP nor the commission mandates adherence
to the letter of the recommendations. Directors may set their own
time limits as well as method for retaining various records and
materials. Inspectors should use good judgment in determining if
the stated retention periods are enforced and if they meet the needs
for patient care within the inspected facility. Directors whose
retention policies differ markedly from the CAP's consensus guidelines
are advised to document their reasons for such variances, as well
as any circumstances that might compromise adherence to the commonly
accepted periods of retention.