Feature Story

CLA probes problems, reacts to new rules and regs

Queries and comments

The Commission 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.

Investigating 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 PT results.

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.

Handling complaints
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.

Proposed 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.

Relationship 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.

Relationship with California
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.

Relationship with JCAHO
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.

New 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.

CAP-accredited 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.

Accreditation 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.

Inpatient self-testing
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.

Sharing PT information
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 areas.

All laboratories 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.

Monitoring formaldehyde levels
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.

Laboratories 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.

Central office report
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.

Receipt 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 by laboratories.

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.

Labs should make sure they provide the CAP with correct e-mail addresses. Forms for updating e-mail addresses are available on the CAP Web site.

Limited service checklist
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.

Staff 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 a pathologist.

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.

Accreditation brochure
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.

Marketing is also planning to develop a quarterly newsletter to keep laboratory directors and managers current on changes in the accreditation process.

Consolidation 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 inspection.

Nonpathologist 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.

Accreditation-focused educational endeavors
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.

Systems inspection option
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.

Annual competency assessment
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 requirement.

Proficiency testing orders
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.

Lab 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 process.

Breakout sessions
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.

Regional 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 team leaders.

As laboratories 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.

Checklist questions 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 packet.

International 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.

Team member 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 team members.

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.

State commissioner 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.

Pathologists 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.

Next meeting
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.