CLA polishes checklists, prepares Surveys for new year
Queries and comments
Terri Yablonsky Stat
The Ohio State University Medical
The Commission on Laboratory Accreditation, meeting in Short Hills, NJ, Nov. 6 through 8, approved proficiency testing providers, tweaked inspection forms, and reviewed relationships. Highlights of the meeting follow.
The CAP Point-of-Care Testing Committee has been working to streamline the point-of-care checklist. It recommends removing the alternative testing section and revising the physician-performed testing section.
In a hospital, the medical staff’s credentialing process can be used to document the competency of physicians, or the medical staff can cede this responsibility to the laboratory director, who may choose to use more conventional tools to document competency. Either method is satisfactory and meets the CLIA requirement for competency assessment.
Certain tests, such as transcutaneous bilirubin in neonates and pulse oximetry, are not considered by the Centers for Medicare and Medicaid Services to be laboratory tests covered by CLIA regulations because no samples are involved. The biomedical and nursing departments, respectively, may be responsible for such equipment testing and quality control documentation requirements.
Approved Surveys providers
The Commission on Laboratory Accreditation has approved proficiency testing offered by eight providers. The commission’s criteria differ from those used by CMS, so programs approved by CMS are not automatically approved by the commission. The criteria ensure that the College can monitor proficiency testing performance for all analytes on an ongoing basis.
The CLA grants approval on a "by-analyte" basis, rather than by provider or program. Laboratories considering an alternative provider should contact that provider directly to determine whether it has been approved by the CAP and for which analytes.
Required proficiency testing
The commission has developed a list of analytes for which proficiency testing
from an approved provider is required. The list is available on the CAP Web
site at http://www.cap.org/.
Proficiency testing is also required for analytes that do not appear on this
list. In such cases the laboratory must demonstrate proficiency every six months.
Laboratories may find it easier to subscribe to a product from an approved provider
to satisfy this requirement than to develop alternative methods.
Suggested number of inspectors
Based on the work of an expert panel of the commission and the CAP biostatistics department, the CAP has developed an algorithm to estimate the ideal number of inspectors for an inspection. This algorithm considers the number of disciplines within the laboratory, the lab’s activity menu, and its total test volume.
Programming to make this information available to inspection team leaders has been completed, user tested, and installed. In early 2004, LAP participants will receive additional information about this new feature and suggestions on how to use it.
The recommended number of inspectors will be included on the inspector assignment form to guide the assigning commissioner in making assignments and inspection team leaders in assembling a team that includes the optimal number of inspectors with the proper technical experience. It is important not to take too many inspectors, which can overwhelm laboratory personnel. Conversely, taking too few inspectors and rushing through the day can be frustrating and disappointing for well-prepared laboratory staff.
Team member check-off list
A team member check-off list will soon be available in the inspector’s packet
and on the CAP Web site. The team member check-off list will complement the
team leader check-off list included in the inspector’s packet and will be available
on the CAP Web site at www.
cap.org/ apps/cap.portal?_nfpb=true&_ page Label=lab_inspections_page.
Because the commission had observed variability in how well team leaders prepare team members prior to inspection day, the CLA developed this list to help team members identify what to read in the laboratory accreditation manual and what to review in the packet. The list also provides tips on how to conduct an inspection.
After an inspection has been completed and the College has received the results, the laboratory receives a post-inspection critique to assess the entire inspection process from completing the application materials to obtaining proper information from the CAP. The critique also addresses contact with the team leader, number of inspectors used, skill and appropriateness of the inspectors, and the educational value of the inspection.
Approximately 65 percent of inspected laboratories complete this four-page form and return it to the College. Copies of the completed post-inspection critiques are forwarded to the appropriate regional commissioners. The chair of the CLA also reviews a number of these responses and may communicate directly with the laboratory or the inspection team leader to clarify any issues that have been raised. If problems are noted, the regional commissioner may contact the laboratory director and team leader to follow up.
Data from all post-inspection critiques are also aggregated and used to identify trends and suggestions that may help improve the Laboratory Accreditation Program. And data from the inspection team leader and team member evaluations are aggregated and used to detect significant trends. These forms have been anonymous for several years, but they will now include, at a minimum, identification of the laboratory inspected in the event that followup is necessary.
Growth of the Laboratory Accreditation Program
The number of laboratories participating in the Laboratory Accreditation Program
as well as the number of laboratories using CAP accreditation to satisfy CLIA
requirements continue to increase. These data may be viewed on the CMS Web site
To support these inspection and accreditation activities, the CLA sponsored
21 live inspector training seminars throughout the United States in 2003. The
CLA also sponsored six audio conferences in 2003. Participants in these free
events can earn continuing education or continuing medical education credit.
The schedule of continuing education events for 2004 can be found on the CAP
Web site, www.cap.org. Click
"Education" on the left side of the home page and then select "Course Catalog,"
followed by "Laboratory Accreditation Program Education."
Relationship with AABB
The College and the American Association of Blood Banks continue to work together to complete a crosswalk between the accreditation requirements of the two organizations to develop an inspection tool that would serve both organizations. The goal is for a laboratory to be inspected by either program and meet the requirements of both. Thus, a laboratory that wants AABB and CAP accreditation of its blood bank would only have to be inspected once. This arrangement is expected to be implemented by early 2005.
RRelationship with New York state
The Wadsworth Public Health Laboratories of the Department of Health of the state of New York conducted several joint laboratory inspections with the CAP last year to assess the equivalence of the CAP standards with those of New York. While the College has been informed that its inspection and accreditation processes are consistent with those of New York, the state has not recognized the CAP Laboratory Accreditation Program. Further, the College has not been able to convince the state to recognize its accreditation for those out-of-state laboratories that analyze specimens from people who live in New York.
Wadsworth Public Health Laboratories has also been unwilling to seek College approval of its proficiency testing program. Such approval would provide financial relief for New York-based laboratories that elect to be accredited by the College.
CMS validation of CAP inspections
As a condition for deemed equivalency set by CMS, state survey agencies must reinspect a sample of laboratories inspected and accredited by the College to confirm that CAP inspection and accreditation continue to meet or exceed CLIA requirements. CMS recently reported that in a sample of 75 laboratories reinspected in 2002, a disparity rate of seven percent was found, a rate well below the threshold value of 20 percent.
The commission has determined that it should expand its accreditation activities to stem cell, embryo, and sperm banks. It is developing the appropriate checklist questions to implement these changes.
The commission concluded that it will not inspect and accredit tissue banks and eye banks.
Several breakout sessions were held during the planning part of the commission meeting. Reports were given at the meeting, some of which will require followup or will be discussed further at subsequent commission meetings. Details of each breakout session follow.
International accreditation issues. In some areas
of the world, Surveys materials have been delayed going through customs. Because
some Surveys materials are less stable, delayed deliveries can hinder a laboratory’s
ability to obtain correct results.
Commissioners recommended sending an e-mail to alert international laboratories when Surveys are shipped, noting that shipping dates are included in the Surveys catalog. If stability issues continue to be a problem, the laboratory could seek approval from the international commissioner to enroll in nonapproved international PT programs for a particular analyte. Results would then be submitted to the deputy commissioner for ongoing performance monitoring.
Internal controls and CLIA ’88. The current checklists
allow for use of internal controls for waived and unmodified complexity tests.
As a general rule, the Jan. 24, 2003 CLIA ’88 regulations state that on each
day of patient testing, two levels of control material must be run for quantitative
tests and a positive and negative control must be run for qualitative tests
unless overridden elsewhere in the regulations. It is not explicitly stated
that these controls must be external.
The latest version of the state operations manual, however, implies that external controls are required unless the laboratory uses a particular algorithm to reduce the frequency of external controls from daily to weekly or monthly. This new requirement would take effect Oct. 1, 2005.
Commissioners considered whether checklist questions should be revised to reflect these changes. They concluded that the appropriate CAP scientific resource committees should be asked to consider whether data support the use of such algorithms and, if not, what type of studies would be required to validate their use. The group also recommended that the College contact CMS to obtain the data used to develop such algorithms.
Unannounced inspections. The JCAHO has informed the
CAP that in 2006 it will begin performing only unannounced inspections. The
JCAHO has asked the CAP to develop a similar plan for laboratories accredited
by the College but located in a hospital accredited by the JCAHO. The CAP and
the JCAHO, per CLIA mandate, must inspect laboratories on a biennial basis,
with inspections occurring within the 24th month following the previous inspection.
To keep laboratories on this timeline, the CAP historically has instructed team
leaders to schedule the inspection in the 30-day window prior to the lab’s anniversary
Commissioners discussed the benefits and obstacles of unannounced inspections and whether to do this only in JCAHO-accredited hospital settings or for all CAP-accredited laboratories. The group recommended that the College communicate with JCAHO its perceptions of the strengths and weaknesses of such inspections. Among the strengths of the CAP accreditation program are its educational and peer review components. Unannounced inspections can reduce these benefits if key laboratory personnel are not in the laboratory when inspectors arrive.
This group will continue to meet to develop a strategy that maintains what the College considers to be the advantages of its approach to inspection and accreditation, while at the same time satisfying the forthcoming JCAHO requirements.
Accreditation to ISO 15189 and quality systems essentials.
Many international laboratories are interested in accreditation to ISO standards,
in particular to ISO 15189, Medical laboratories-particular requirements
for quality and competence. Commissioners in one group discussed whether
ISO-specific questions should be integrated into the current checklists or whether
this accreditation should be a separate program.
The group recommended that accreditation to ISO 15189 be a value-added program separate from but complementary to the regular CAP inspection, and that a separate certificate be awarded for each program if a laboratory chooses to be inspected for both programs.
Another group, which considered whether to integrate into the present accreditation program quality system essentials, or QSEs, based in part on NCCLS document HS01-A, "A Quality System Model for Health Care; Approved Guideline," recommended that QSEs be used to supplement the elements of the ISO program. Any element deemed essential to meeting the standards for laboratory accreditation obviously would be incorporated into the checklists as soon as practical.
Details of this new program will be available in the near future.
Post-inspection critique followup. This breakout
group expanded on the discussion of how commissioners and CAP central office
staff can use the feedback they receive from laboratories and inspectors. Most
of the recommendations arising from the initial review of post-inspection critiques
at previous commission meetings have already been implemented. Some issues,
however, are still being addressed, including computer programming to fine-tune
the inspector assignment process, improving the timing of communications from
team leader to laboratory, selecting the optimal number of inspectors, increasing
the consistency of and ability to interpret checklist questions, and reducing
redundancy in the checklists.
Some of the initiatives that have been implemented include improved e-mail communication from the central office to the assigning and regional commissioners when labs are not assigned on time; providing the team leader with a fill-in-the-blank letter to send to labs detailing arrival time, anticipated completion time, and team composition; providing the team leader with the recommended number of inspectors and using flags for significant deviations; including examples of appropriate compliance with checklist questions; letting laboratories know via e-mail when such documents as proficiency testing exception summary responses and responses to deficiencies cited at inspections have been received; and combining checklists or eliminating questions when there is a history of zero deficiencies in the field.
Custom checklists. Custom checklists were implemented
on March 31, 2003. The LAP uses the laboratory’s activity menu to eliminate
subdisciplines and checklist question groups that do not apply to activities
performed by the laboratory, so it is important that laboratories communicate
such changes as soon as practical.
The first major change was to consolidate four checklists-automated and general chemistry, special chemistry, toxicology, and blood gas-into one. Commissioners recommended placing certain groups of questions, such as those related to hemoglobin electrophoresis, body fluids, and malaria, in the checklists based on where the laboratory says it performs the associated tests. For example, in one laboratory, malaria questions might be in the microbiology checklist while in another they might be in the hematology checklist.
The group suggested that the commission proceed slowly since laboratory activity menus may not be accurate and because radical changes might be difficult for laboratories and inspectors to handle. Commissioners also recommended putting molecular pathology questions into the microbiology checklist for those laboratories doing molecular testing using FDA-approved kits.
LAP education. The commission has received positive
feedback from inspector training seminar participants about the new curriculum,
which includes role-playing and learning how to deal with common scenarios that
occur during the inspection.
Many of the section-specific breakout sessions have been revised; however, some are too long for the time allotted. New instructional modules are planned for safety, quality improvement, and best practices.
Commissioners have held inspector training seminars at specialty societies and during national and regional seminars. Seminars planned from the vantage point of labs that are going to be inspected are slated to begin in spring 2004. The commissioners noted that the CAP audio conferences have been well received but need to be publicized better. The group also recommended that the evening seminars for team leaders be revived, followed by an inspection the next day.
The commission will hold its next regular meeting in Boston, Mass., on March
11 and 12. A training seminar that emphasizes what laboratorians should do to
prepare for an inspection, rather than inspector training, will be held on March
Terri Yablonski Stat is a writer in Evanston, Ill.