Originally published in CAP TODAY
The CAP's relationships with regulatory agencies and other accrediting organizations and new tools for inspection team leaders were two key topics at the Commission on Laboratory Accreditation meeting held in San Antonio Oct. 31 and Nov. 1, 2002. Highlights of the meeting follow.
First CAP annual meeting
Mary Kass, MD, CAP president-elect, announced that the first CAP annual meeting, CAP '03—The Pathologists' Meeting, will be held in San Diego Sept. 10-14. To register, call 800-323-4040 and select option one.
Relationships with regulatory bodies
Centers for Medicare and Medicaid Services. In October, CAP representatives met with Tom Scully, CMS administrator. They discussed efforts to streamline and improve the federal government's enforcement of the Clinical Laboratory Improvement Amendments of 1988.
State of New York. CAP representatives met in August with representatives from the state of New York to continue discussing how to reduce duplicate College and state inspections. They concluded that New York would observe several CAP inspections in late 2002 and early 2003 to assess the College's standards against its own requirements. The representatives also focused on efforts to eliminate the requirement for New York laboratories to subscribe to proficiency testing programs from the state and the College.
State of California. The College and the state of California are working to ensure that directors of California laboratories are made aware of state requirements that are more stringent than, or otherwise differ from, those of the College and CLIA '88. To address specific state requirements, the commission will consider adding a new checklist or reapplication question asking if the laboratory has a documented system or procedure in place to ensure that the laboratory is aware of current federal, state, county, and city laws as they pertain to laboratory practice and operations.
Relationships with other accrediting organizations
United Network for Organ Sharing. The College continues to hold discussions with UNOS about that organization recognizing the Laboratory Accreditation Program as meeting UNOS' requirements. To that end, the histocompatibility checklist has undergone significant changes. UNOS' recognition of the LAP would eliminate duplicate inspections and accreditation.
National Marrow Donor Program. The commission continues to seek recognition of the LAP from the National Marrow Donor Program. As part of this effort, the commission is trying to reduce the number of duplicate inspections by the College and the NMDP.
American Association of Blood Banks. The commission and the American Association of Blood Banks are exploring mutual recognition of their accreditation programs.
Health Insurance Portability and Accountability Act
Important deadlines are nearing for entities covered under HIPAA. All covered entities, except small health plans, must comply with the privacy-related requirements of HIPAA by April 14. Small health plans have until April 14, 2004 to meet these requirements. More information on HIPAA can be found on the CMS Web site, http://www.cms.hhs.gov/hipaa/hipaa2/default.asp.
To help laboratories comply with the privacy requirements, the College sent a sample business associate agreement to all accredited laboratories in December. This document will be the preferred agreement between laboratories and the CAP, which is considered a business associate of each laboratory, or its parent organization, under HIPAA.
Inspector training seminars will provide information about the responsibilities of inspectors regarding protected health information, or PHI. During each inspection, inspectors will be asked to sign a statement on the inspector's summation report acknowledging that PHI seen during the inspection will be kept confidential. Commissioners, regional assistants, and staff will be educated about the HIPAA regulations and will also be required to keep PHI confidential.
Ideal number of inspectors
A task group led by regional health commissioner Greg Gagnon, MD, has, with the assistance of CAP biostatistics staff, developed an algorithm to determine the ideal number of inspectors for each inspection. The algorithm produced results consistent with the recommendations of a panel of experts. Staff will implement programming to provide this information to inspection team leaders. Each inspection team leader will receive in the inspection packet an estimate of the number of people required to complete the inspection in one day. Nonetheless, inspection team leaders are still encouraged to contact laboratory directors before inspections to discuss the appropriate number of inspectors.
In its ongoing effort to provide qualified peer inspectors, the LAP collects information about each potential inspector from the personnel qualification form, which is included in every application and reapplication packet. The form has been modified to capture more comprehensive information about inspectors' qualifications. Details such as areas of expertise, credentials, certifications, and language fluencies can be provided to future inspection team leaders to ensure that the inspectors are appropriately qualified. The new form was implemented in November. It will also be used to update specialty inspector information in the inspector database.
New tool for inspection team leaders
The commission, based on work from a breakout group at a previous meeting, designed a checklist to help inspection team leaders manage inspection logistics. Implemented in December, this list will be mailed to inspection team leaders when they are assigned to inspections by the state commissioner. The information will be entered into the College's computer system.
To help manage the size of the inspection teams, an item on this list encourages inspection team leaders to contact laboratory directors before each inspection to discuss the appropriate number of inspectors. In the future, a report of demographic information on the laboratories to be inspected will accompany the list. This new report will also include the calculated ideal number of inspectors.
While CMS requires that test volumes in anatomic pathology be reported in terms of slides and blocks, this information is not useful to an inspection team leader when determining the effort required to complete an inspection. To supplement the CMS-mandated information, the LAP will soon start collecting test volumes in anatomic pathology based on the number of specimens accessioned and provide this information to inspection team leaders.
Notification of change of commissioner
When a new regional or state commissioner is appointed, the College now notifies by letter all directors of laboratories affected by the change. Directors thus have current contact information should they have questions about inspections or other accreditation issues.
In response to a question from a pathology group, the commission reviewed and clarified its position on electronic signatures. The pathologist who reviews slides and makes diagnoses must be the person who signs out cases using his or her electronic signature. No one else may use the diagnosing pathologist's electronic signature.
Stephen Sarewitz, MD, of Seattle, replaced Albert Rabinovitch, MD, as checklist commissioner in January. Dr. Rabinovitch, who served as checklist commissioner for 10 years, volunteered an immense number of hours to bring the checklists into the computer age. Dr. Sarewitz has served as an LAP regional commissioner and as complaints commissioner. We welcome him to his new post.
Question HEM.25000 of the hematology-coagulation checklist requires that the temperature of various devices be checked appropriately. Dr. Rabinovitch received correspondence from a participant who uses an alarmed minimum/maximum thermometer system and who asked if daily recording of temperature for such a device is still required. The commissioner agreed that such new technologies are acceptable, provided the alarm function is monitored periodically. Such systems may be the only way a laboratory can accurately monitor the temperature of equipment when the lab is not staffed. It is important to remember that if, for example, temperature-dependent samples or reagents are stored in a refrigerator over a weekend, staff cannot assume that the appropriate temperature was maintained without such an alarm system.
The College is exploring the possibility of becoming an ISO registrar. The most recent version of ISO 15189, Quality Management in the Medical Laboratory, focuses, as its title implies, on the medical laboratory environment, and thus it may be a useful assessment tool in that environment. A cross-walk between ISO 15189 and the checklists has been completed. The commission is considering mechanisms to ensure that accreditation by the College prepares a laboratory for ISO certification.
To help control costs related to on-site inspections, the commission urges inspection team leaders to use the CAP travel desk, an extension of Bannockburn Travel Management, to make flight and hotel arrangements. To obtain the best airfares, make reservations at least 21 days before departure. The CAP travel desk can be reached at 800-323-4040 ext. 7800.
Homeopathic or naturopathic laboratories
The College occasionally receives applications from laboratories that provide homeopathic or naturopathic laboratory services. The strength of the College's laboratory accreditation program, however, lies, in part, in pathologists' expertise in allopathic laboratory medicine. Gerald Hoeltge, MD, commissioner for non-routine processes, led a breakout group at the meeting in a discussion of homeopathic and naturopathic testing. The breakout group will reconvene at the next CLA meeting to develop policies focusing on these laboratories and report its findings to the commission.
Custom checklists and more
A long-standing CLA task force recommended to the commission an approach for customizing checklists. In turn, the commission has divided several disciplines into subdisciplines for customization purposes. The commission assigned staff to implement this plan by the end of the first quarter of 2003.
The task force will also consider combining multiple checklists used in a single section unit and customizing checklists for systems inspections. The group will consider more extensive customization in the future.
chemistry and toxicology checklists have recently been integrated into a single document, recognizing that many laboratories perform these disciplines in a single section. Because special chemistry is often performed with chemistry and toxicology as well, the special chemistry checklist will be integrated into the combined chemistry checklist. These changes will reduce the number of redundant questions.
Upon receiving inspector summation reports from inspection team leaders, the LAP sends a four-page questionnaire, known as the post-inspection critique, to the director of each inspected laboratory. Revised and expanded about a year ago, this questionnaire assesses the quality of the inspection itself and solicits further information by providing space for additional responses.
College enters the responses from each questionnaire into a database for analysis by client relations and marketing staff. Each questionnaire is then distributed to the appropriate regional and state commissioners for review and followup.
The questionnaire has a response rate of more than 60 percent and has been the source of several commission initiatives to improve the inspection and accreditation process.
Proficiency testing exceptions
The Laboratory Accreditation Program monitors proficiency testing scores from all CAP or CAP-approved PT programs for laboratories accredited by the College. The monitoring process takes place about seven to 10 days after the results of a PT analyte group are evaluated by the PT provider. The LAP monitors PT scores for acceptable performance by comparing them against the performance criteria set by the LAP.
If the performance for an analyte or subspecialty fails to meet specific criteria, the LAP sends a packet of information including the proficiency testing exception summary report, or PTES, to the participant. This report includes a PTES response form containing specific information about the unsatisfactory or unsuccessful result. PTES reports are typically issued if the laboratory's result is not acceptable after grading or if the laboratory's proficiency testing provider failed to report a score to LAP when the laboratory's activity (test) menu included the subject analyte. In both instances, the laboratory must respond within approximately three weeks of receiving the PTES packet.
The proper response to these two types of unacceptable results differs dramatically. A successful response to a proficiency testing result found unacceptable on grading includes a report of the investigation to determine the cause of the unacceptable result; a description of the cause, if identified; a description of the corrective action taken to prevent recurrence of the unacceptable result; evidence that the corrective action was successful; and the signature of the laboratory's medical director. The instructions accompanying the PTES report identify these elements and provide a list of some common causes of unacceptable results. On the other hand, a successful response to a PTES report caused by failure to report an expected result includes an explanation of why results were not received for the analyte and a plan to prevent recurrence.
In both cases, all responses are reviewed by technical staff, who evaluate them against the elements identified above for appropriateness and effectiveness. In some instances, further documentation may be required before the case is closed. On rare occasions, responses are forwarded to the commissioner for non-routine processes for final review and adjudication.
Recent review of several responses to PTES reports reveals that one common cause for further communication from the College is that the laboratory fails to provide a description of the corrective action taken to prevent recurrence. Laboratories may avoid extra work by initially providing a clear description of the corrective action.
The commission will hold its next regular meeting in Washington, DC, on March 13 and 14. An inspector training seminar will take place March 15.