CLA probes problems, reacts to new rules and regs
Queries and comments
Stephen J. Sarewitz, MD
on Laboratory Accreditation met in Chicago on July 10 and 11 to
explore ways to better address problems and poor performance and
to pursue and review policies. An accompanying state commissioners
meeting was held on July 12. Highlights of the CLA meeting follow.
PT performance problems
Because of changes imposed on all proficiency testing providers
by the Centers for Medicare and Medicaid Services and changes in
specific criteria from the CLA, the CAP Laboratory Accreditation
Program has seen a significant increase in the number of unacceptable
The most frequently
reported cause of poor performance is clerical error. While these
are often transcription errors, they also arise from an apparent
failure to read, understand, or follow the directions for completing
the result forms that must be returned to the PT provider. Other
common causes of error are inappropriate reconstitution of materials,
failure to convert units of measurement from the laboratory’s
method to those required to complete the answer sheet, and returning
responses too late to be graded.
When a laboratory
reports PT results that do not meet the criteria for acceptable
performance—that is, unsatisfactory or unsuccessful performance—the
LAP sends it a proficiency testing exception summary report. The
lab must use this form to record the results of its investigation
of the problem, including identifying its causes and any corrective
action taken. The medical director must sign the completed form
before returning it to the College. The special commissioner and
CAP staff review these reports, as well as the last five PT events
for the involved analyte, to determine whether the investigation
and resolution are adequate.
At the time
of the next on-site inspection, the inspector is also expected to
review PT testing results and failures. Included in the inspection
packet is a report that shows the scores from the last six PT events
and all analytes for which there has been a score of less than 100
percent. Those that resulted in a proficiency testing exception
summary report are highlighted. Other PT failures can quickly be
identified in this report as well, making it easier for the lab
and inspector to locate them for review.
The special commissioner for nonroutine processes, Gerald Hoeltge,
MD, reviewed the process for investigating complaints related to
CAP accreditation. The CAP’s analyst for regulatory affairs
receives all complaints, whether by patients, physicians, or employees,
conducts an initial investigation, and assembles the information
necessary for resolution. Once the initial review is completed,
the complaint and the supporting information are forwarded to the
appropriate regional commissioner for review. The special commissioner
then adjudicates the issue, occasionally involving the CLA executive
committee for final resolution. When the investigation is complete,
the commission informs the complainant of this by letter. At the
discretion of the special commissioner, more specific information
may be disclosed in this communication.
FDA blood safety rule
The FDA is proposing a change for hospitals transfusing blood. Only
fatalities confirmed to be due to blood transfusion currently must
be reported. The wording would be changed to fatalities “related
to transfusion.” In addition, the FDA is proposing that every
serious suspected adverse reaction to transfusion be reported. This
is defined as any reaction that requires immediate medical intervention
or followup medical attention. Implementing this change would result
in a massive increase in the amount of reporting. The proposed changes
can be found in the Federal Register (March 14, 2003;68(50):12406-12497).
The FDA has extended the comment period until Oct. 14.
with New York
The College continues its dialog with the New York State Department
of Health. The College is seeking to have its Laboratory Accreditation
Program recognized by the state, with the goal of reducing duplicative
inspections and subscriptions to PT programs.
While the CAP Laboratory Accreditation Program is not recognized
by the state of California, the College regularly communicates with
representatives of the state’s Division of Laboratory Science.
To help labs in California understand and comply with that state’s
regulations, the College now includes in its application and reapplication
materials an information sheet prepared and maintained by the California
Department of Health Services.
The Joint Commission on Accreditation of Healthcare Organizations
has announced that institutions participating in its cooperative
accreditation agreement, by which the JCAHO recognizes the inspections
and accreditation of partnering accreditation organizations, such
as the CAP, will have to comply with three new requirements in order
for their agreement to be renewed. The partners will have to conduct
their inspections on an unannounced basis by 2006; require institutions
to develop and implement programs meeting the intention of the JCAHO’s
national patient safety goals; and impose a periodic performance
review on accredited institutions.
The CAP Laboratory
Accreditation Program already complies with the second and third
requirements: specific safety-related questions in the checklists
satisfy the second requirement, while the self-inspection and the
College’s process of continuously monitoring PT results satisfy
the third. Because the length of the accreditation cycle for laboratories
is set at two years by federal regulation, however, inspections
must occur within the 30-day window prior to the lab’s anniversary.
Until the details of this requirement have been worked out by the
JCAHO, the College will continue to inspect on an announced basis.
The commission believes that to achieve the maximum consultative
value from an inspection, appropriate laboratory staff must be present.
The JCAHO is
also abandoning its process of developing and publicizing a numerical
grade for its inspections. Consequently, the CLA has asked CAP staff
to conduct a market review to determine whether laboratories consider
the College’s grades to be beneficial. The commission will
consider the results of this study before determining whether to
retain or abandon its grading process.
policy on eligibility for accreditation
The CLA has proposed, and the CAP Board of Governors has approved,
a new policy whereby the College will not inspect or accredit a
laboratory whose test menu consists substantially of tests outside
the College’s areas of medical expertise.
laboratories will retain their accreditation status until their
menu can be evaluated during reapplication for accreditation. Laboratories
seeking accreditation for the first time will be required to submit
a catalog of services so the CAP can assess whether they comply
with the requirements of the new policy.
documents on the Web
The CAP has added a significant amount of information to the accreditation
section of its Web site, .
All of the forms laboratories need for the accreditation process
can be downloaded and completed. Examples of available forms include
change in director, release of data, test menu changes, PTES summary
information with examples of acceptable responses, business associate
agreements, CAP inspector forms, and guidelines for retention of
records. More changes are under way, including the development of
a security system that will allow laboratories to retrieve their
own PTES and accreditation information from the CAP Web site, www.cap.org,
in a secure manner.
Some hospitals allow patients to perform glucose and coagulation
testing during their hospitalization using equipment brought from
home, and they use data provided by the patient in managing that
person’s health care. The commission determined that while
institutions should have a policy for such testing, the testing
is beyond the scope of the laboratory’s accreditation.
CMS has held lab directors responsible for laboratories sharing
proficiency testing information prior to submitting results to the
PT provider, even when the lab director did not know that information
had been exchanged. This has led to laboratories’ CLIA licenses
being revoked and directors being barred from directing a laboratory
for two years. Such decisions recently were appealed based on their
impact on patient care for laboratories located in remote or underserved
should have a policy in place that prohibits the sharing of PT information
and should ensure that all personnel comply with it. The CAP is
considering how best to bring this information to the attention
of laboratory directors.
The CAP Safety Committee reported that the clinical lab safety guideline
NCCLS GP17-A, which addresses the monitoring of formaldehyde levels,
is being revised by the NCCLS.
historically had to provide documentation that they periodically
monitor formaldehyde levels. Today, the CAP’s inspection checklist
requires initial monitoring, with subsequent testing if there are
architectural, equipment, or personnel changes. Commissioners pointed
out that changes in ventilation ductwork outside the laboratory
could adversely affect the removal of vapors. To minimize exposure,
the laboratory should check with the building maintenance department
on an annual basis to determine if any changes have been made.
The CAP has developed a CD-ROM, which will be included with each
application and reapplication packet and will be available at inspector
training seminars. The CD-ROM includes change forms, inspector documents,
education-related documents, checklists and commentary, deficiency
response forms, PT-related documents, and self-evaluation documents.
The information included on the CD-ROM can also be found in the
laboratory accreditation section of the CAP Web site.
of document e-mail message
The Laboratory Accreditation Program recently introduced a new service
to acknowledge by e-mail the receipt of important documents submitted
The new service
confirms by e-mail that the CAP has received any of the following:
response to validation inspections, response to complaints, applications,
reapplications, self-evaluations, responses to deficiencies, responses
to proficiency testing exception summaries, and acceptance of responses
to proficiency testing summary reports. This feature may also be
used by other areas of the College to acknowledge receipt of documents.
make sure they provide the CAP with correct e-mail addresses. Forms
for updating e-mail addresses are available on the CAP Web site.
CAP staff reviews test menus for smaller laboratories to determine
if they need discipline-specific checklists, such as hematology,
chemistry, or microbiology, or if they can use the limited service
checklist. In doing so, they take into consideration the organization
chart, types of reportable assays, number and scope of supervisory
personnel, and test volume. Bringing numerous inspectors with discipline-specific
checklists to a small lab with only a few supervisory personnel
would be impractical. The limited service checklist can help the
inspection team leader assemble a team that is the appropriate size.
inspector inspectionof specific hospitals
A new checklist question has been added to the frozen section group
of questions in the anatomic pathology checklist requiring the inspector
to examine and evaluate frozen section slides. With the addition
of this question, staff inspectors will no longer be able to inspect
this limited anatomic pathology service without the assistance of
For some small
hospitals this is not an issue since they send their frozen section
slides to a larger pathology department in a CAP-accredited facility,
and those slides are evaluated at the CAP-accredited facility. If
a small lab does not fit into the preceding scenario, an approved
pathologist inspector or CAP commissioner could review examples
of frozen section slides during the post-inspection phase of accreditation,
before making an accreditation decision.
The CAP marketing department has been improving the brochure that
is left with hospital administrators during the interview with team
leaders on inspection day. Many team leaders consider this a valuable
and informative brochure.
also planning to develop a quarterly newsletter to keep laboratory
directors and managers current on changes in the accreditation process.
of checklist notes and commentary
The LAP is making numerous edits to its checklists in collaboration
with the CAP resource committees. To reduce redundancy, the commission
approved consolidating the information in the “commentary”
portion of questions into the “note” section in future
versions of checklists. This change will ensure that inspectors
have in one document all the necessary information to conduct an
review of pathology specimens
In many settings, qualified physicians who are not pathologists
review pathology specimens—for example, dermatologists review
Moh’s surgery frozen section slides and specially trained
ophthalmologists examine ocular pathology specimens. The laboratory
general checklist now allows other physicians, who are qualified
by training and experience, to provide these services at the discretion
of the laboratory director.
To further educate laboratories about accreditation, the CAP has
planned eight audioconferences on inspection topics for next year.
Two of these will address how laboratories can prepare for an inspection.
Two other audioconferences will be offered to only those laboratories
currently enrolled in the systems inspection option, whereby one
inspection team inspects a network of labs as one inspection conducted
over several days.
A number of
inspector training seminars are also being planned nationwide in
conjunction with specialty society annual meetings. And the CAP
education department is exploring the possibility of sending team
leaders information throughout the year to keep them updated. This
information would be presented as scenarios of possible problems
encountered during an inspection and ways to address these issues.
The systems inspection option is available only to systems of laboratories
that are currently participating in this program. The systems inspection
option process will continue to be refined and will be discussed
further at the next commission meeting in anticipation of reopening
the option to new enrollees in the near future.
Laboratories are reminded that everyone who performs lab testing
must have an annual competency assessment. This also applies to
supervisory or management level personnel, even though they may
perform testing only rarely. Some labs may have overlooked this
Laboratory directors are reminded that labs must participate in
a CAP-approved PT program for each analyte in their test menus.
For most proficiency testing providers, the order-renewal period
begins this fall. Directors are advised to submit orders early in
the order-renewal period to ensure that their laboratories are enrolled
in the appropriate PT programs for next year.
test menu catalogs
The CLA now requires that laboratories, when completing an application
or reapplication for accreditation, include a copy of their test
menu catalog in the materials returned to the College. This requirement
was added to complement the test menu completed as part of the application
Four breakout sessions were held on the second day of the CLA meeting
to discuss specific issues in greater depth. Each group generated
a report, which was then discussed by the entire commission. Details
of each of the breakout sessions follow.
commissioners’ role in monitoring PT. As part of the
ongoing evaluation of laboratory performance between inspections,
the CAP reviews proficiency testing results for regulated and unregulated
analytes. While the monitoring process is automated, CAP staff prepares
reports on laboratories that have experienced failures. The special
commissioner for nonroutine processes works closely with CAP staff
to review responses to failures. Mechanisms are being developed
to better share this information with regional commissioners and
review their performance, it is important to identify systemic trends
and review non-evaluated challenges to determine if a laboratory’s
results match the majority of participant and referee diagnoses.
The CAP plans to include more information with PT results to remind
laboratories of what steps they should be taking to investigate
failures. An explanatory note will be added to the laboratory general
checklist in the laboratory accreditation manual and to the CAP
Web site explaining the various code numbers assigned to failures
and what response is expected in each case.
about documentation of review and corrective action for PT will
be standardized across all checklists. Other mechanisms to increase
communication with team leaders are also being investigated, such
as including laboratory-specific information in the lab’s
customized checklist or on the pink deficiency forms in the inspection
laboratory proficiency testing. Materials sent to laboratories
outside the United States can encounter problems: The materials
may never arrive or they may arrive damaged and be unusable. Businesses
in some countries facilitate the timely transportation of PT materials
through customs. But for those countries where importation is a
problem, the commission plans to identify the Surveys that may be
unstable and thus may pose a problem if they do not arrive on schedule.
education prior to inspection day. Preparing appropriately
for team member education is important, in part because the CAP
doesn’t know in advance who will serve as the team members
for an inspection. Therefore, the College must rely on team leaders
to educate team members about CAP philosophy and what to look for
during an inspection. Team leaders must not wait until the last
minute to open the inspection packet and review its contents with
The CLA plans
to develop a team member check-off list and highlight this with
a “new materials” sticker. Additional related information
can also be obtained from the CAP Web site. A CD-ROM containing
recent and important information for team members will be sent with
the inspection packet. The College may also use the inspector database
to mail information to team members.
assistance for inspector assignments. It is important that
all inspections occur on time. The commission reviewed ways that
the CAP can help assigning commissioners to fulfill this requirement.
One strategy would be to assign similar laboratories to round robin
groups, with oversight of the assignment process provided by the
state or assigning commissioner, who is familiar with local issues,
perceived conflicts of interest, and the affiliations of team leaders
with groups that serve more than one institution.
should not inspect laboratories under the same ownership or having
the same pathology group as their own lab. It may be necessary to
cross state and regional boundaries to have a pool of laboratories
with similar characteristics. Commissioners also recommended resurrecting
the evening inspector training seminar for team leaders to increase
the pool of pathologists trained to perform inspections. And the
commissioners recommended that better reminder systems be implemented
at the CAP to ensure that all assignments are made far in advance.
Statistics show that laboratories assigned to a team leader months
in advance tend to be inspected on time more frequently than those
assigned at the last minute.
The commission will hold its next regular meeting in Short Hills,
NJ, on Nov. 6 and 7. A planning session will be held on Nov. 8.