CLA cultivates relationships and grooms checklists
Desiree A. Carlson, MD
From accepting proficiency testing providers to rejecting checklist questions, the Commission on Laboratory Accreditation tackled a wide range of issues during its March 11 through 13 meeting in Boston. Highlights of the meeting follow.
CAP-approved PT providers
The commissioner for nonroutine processes presented a list of PT providers whose programs meet the College’s requirements regarding acceptability of materials, scoring processes, and transmission of data to the CAP in a timely manner. Eight providers were approved, the newest of which is the American Association of Bioanalysts. Others are Accutest, the American Society for Clinical Pathology’s ASCPSTAR gynecologic cytology program, American Society for Histocompatibility and Immunogenetics, Midwest Institute for Medical Education, South-Eastern Organ Procurement Foundation, the state of Maryland for gynecological cytology, and the Wisconsin State Laboratory of Hygiene.
Not all analytes offered by these providers are approved, so laboratories that
want to use their materials to meet the CAP Laboratory Accreditation Program’s
PT requirements must first check with the appropriate PT providers. Furthermore,
not all PT providers approved by the Centers for Medicare and Medicaid Services
have been approved by the College.
Running control materials
CMS, in the recently released draft version of the State Operations Manual,
published new rules that reduce the frequency with which quality control materials
are run. The commission has requested that CMS release the data used to establish
these new rules to help the CLA understand the scientific basis for the changes
and to determine whether the checklists should be revised to reflect these changes.
In the meantime, no changes will be made to CAP checklists regarding the frequency
with which control materials are run.
Accrediting part of a laboratory
The Laboratory Accreditation Program does not accredit parts of a laboratory. The College requires that all testing performed by a laboratory under one CLIA and one CAP number be inspected and accredited. A laboratory with a single CLIA number and CAP number cannot choose to have only selected analytes inspected and accredited. The laboratory’s test menu must consist substantially of tests within the College’s areas of medical expertise in order for a lab to be accredited by the CAP.
Suggested number of inspectors
The commissioners reviewed a new report prepared by Laboratory Accreditation Program staff that compares the suggested number of inspectors used with the actual number used for a large number of laboratories inspected in early 2004. The suggested number is now available on the inspector assignment form used by the assigning commissioners and in the inspection team leader’s inspection packet. To control inspection related costs and operate efficiently, it is recommended that the number of inspectors used not deviate significantly from the suggested number.
Some wording changes will be made to discipline-specific checklists. For example, person in charge will be reworded as person in charge of the technical aspects of testing. Furthermore, questions relating to comparability of instruments will be added, and phase I safety questions will be replaced with a note to refer to the questions in the laboratory general checklist. This will eliminate duplicate citations of deficiencies in the discipline-specific and laboratory general checklists.
The systems option will be reopening soon. This option, initially offered in 1998 but unavailable for several years, is an integrated and unified accreditation process for groups of laboratories that meet specific criteria. Laboratory systems that have been on the waiting list will be notified before the option is opened to other interested systems.
Two significant changes have been made to the accreditation process: each participating
system will receive CAPLinks reports for all laboratories within that system,
and each participating system will receive a pre-inspection visit from a staff
technologist several months before the inspection. This visit will be used to
assess the degree to which the system has integrated its processes—for
example, procedure manuals, safety manual, quality improvement program—and
to assist the inspection team leader in assembling the inspection team. A staff
technologist will also participate in the on-site inspection.
Commissioners reviewed the questions in the laboratory general checklist pertaining to the role and activities of the consulting pathologist. When the director of the laboratory is a nonpathologist physician or doctoral scientist who is not trained or does not have expertise in all areas of the laboratory, a consulting pathologist must be used to ensure that all disciplines offered by the laboratory have appropriate physician oversight. A pathologist must perform all anatomic pathology services.
Lists of specialty inspectors are provided in the packet for each inspection where the histocompatibility, cytogenetics, molecular pathology, and flow cytometry checklists are used. These inspectors have a general knowledge of laboratory accreditation requirements and specific technical expertise. The commission continues to monitor the use of these inspectors.
Procedure manual review
The commission emphasized the importance of the requirement that each procedure in a procedure manual be reviewed and the review documented with a signature for each individual procedure or line-by-line on a table of contents. One signature for the entire manual is not adequate, and the entire manual will not be considered one procedure.
Relationship with UNOS
In its effort to have the Laboratory Accreditation Program recognized by the United Network for Organ Sharing, the College has revised the histocompatibility checklist to comply with UNOS’ requirements. The checklist with the proposed changes was slated to be presented at the UNOS board of directors’ meeting this month.
Relationship with AABB
A group composed of members of the American Association of Blood Banks and the CAP continues to work on an assessment tool that could be used to inspect and accredit a transfusion service for both agencies in a single on-site inspection. An organization would then be able to select which agency would conduct the inspection. The group is also addressing inspector/assessor training, anniversary date synchronization, and validation of the accreditation process.
Sexual harassment is addressed in the Laboratory Accreditation Manual included
in each inspection packet, on the CAP Web site (www.cap.org),
and in inspector training seminars. To reinforce the CAP’s position of zero
tolerance, the cover letter that accompanies the inspection packets will also
address the issue.
"CAPNews" is a new newsletter for laboratory managers and supervisors. The newsletter is in a paper format but will be available online in the future. The publication will address checklist changes, commonly asked questions about the accreditation process, and other inspection-
Four breakout sessions were held during the commission meeting. Details of each session follow.
Proficiency testing. A list of analytes for which
external proficiency testing is required can be found on the CAP Web site. The
commission requires all laboratories to subscribe to proficiency testing for
each analyte and for each matrix tested for each analyte. For example, a laboratory
offering glucose testing in five matrices—serum/plasma, whole blood, body
fluid, cerebrospinal fluid, and urine—would have to subscribe to proficiency
testing for glucose for each of these matrices if such testing is available
from an approved provider. This CAP requirement is more stringent than CLIA
This breakout group reaffirmed the commission’s position that proficiency testing will be required on an analyte basis, but commissioners concluded that some exceptions may be made. The commissioners in this group also recommended that the CLA review its policies about participating in proficiency testing to develop a systematic approach for including specific analyte/matrix combinations on the CAP Web site.
Internet initiatives. The CAP is increasingly using
the Internet in its proficiency testing and laboratory accreditation efforts.
Early Web-based initiatives have focused on proficiency testing.
Each accredited laboratory should have recently received a letter from the College informing it of changes to the CAP Web site and assigning it a personal identification number, or PIN, for setting up a secure delegated administration account. Once a laboratory has signed in to delegated administration using its PIN, it will be able to review PT results that it faxed to the College. This should reduce the amount of erroneous data from scanning errors being evaluated by the College.
Starting in January, CMS/LAP proficiency testing scores will be available on the CAP Web site, and laboratories will be able to submit PT data electronically.
The commission asked this breakout group to consider which elements of the Laboratory Accreditation Program should be included in the Web initiative. The group recommended including the application, reapplication, activity menu updates, guidelines for implementing new tests and instruments, and instant messaging for help in responding to deficiencies. The group also suggested including continuous quality control monitoring with notification of problems, allowing the inspector to review such laboratory documents as the quality improvement plan and chemical hygiene plan prior to the inspection day, and increasing the use of e-mail between participants and the Laboratory Accreditation Program.
The laboratory in 2014. In response to a request
from the CAP Strategic Planning Committee, this breakout group attempted to
predict how the clinical laboratory will look 10 years from now. Noting that
change occurs slowly in laboratories despite the appearance of new technologies,
the group predicted that the laboratory would not change markedly in 10 years.
The changes it did forecast were increased use of robotics and trained laboratory staff having a greater role in managing processes rather than performing technical tasks because of staff shortages. The types of testing would change to more point of care, waived, home-procured samples, alternative tests, and direct-access testing. With clinicians becoming ever busier, the group predicted that laboratories would send results directly to them and that pathologists would help them manage the large amount of data. Furthermore, the laboratory would have to deal with more pre- and post-analytical issues.
Laboratory accreditation too might change. Inspections for laboratories that
historically had few deficiencies may become more streamlined. There could be
different types of accreditation for smaller and waived laboratories. The CAP
might partner with other organizations and expand the inspection process to
entire hospitals. All aspects of the inspection could be documented online,
eliminating paper entirely.
Higher level inspections. The Laboratory Accreditation
Program uses 16 discipline-specific checklists containing more than 3,000 questions.
It takes the average inspector, who does one inspection every other year, two
to six hours to inspect a laboratory section using one checklist.
This group considered how checklist questions could be organized to allow the
volunteer inspector to understand the regulatory requirements and adequately
inspect the laboratory section. The commissioners used as a model the example
of how four checklists—chemistry, special chemistry, toxicology, and blood
gases—were consolidated into one.
The group reported that questions could be reorganized to allow the inspector to follow a specimen from time of collection through reporting of results. Inspectors could be trained in sampling techniques so that an appropriate subset of all data generated in the 24-month period between on-site inspections could be reviewed. Simpler inspection techniques could be developed for small laboratories. All PT questions could be reviewed at the College, relieving inspectors of this duty. The commissioners also suggested having inspectors or qualified CAP staff review online, prior to the inspection day, some of the laboratory’s information, such as the quality improvement plan or chemical hygiene plan.
The last day of the commission meeting was a training seminar that emphasized how laboratories should prepare for an inspection. More than 100 people attended the seminar. Regional commissioners and CAP staff served as instructors.
The commission will hold its next meeting in Chicago on July 8 and 9. A state commissioners update will be held on July 10.