The Commission on Laboratory Accreditation met in Memphis, Tenn., March 15 and 16. An advanced inspector training seminar was held March 17.
LAP complaints commissioner Gerald Hoeltge, MD, reported that late responses from laboratory directors were the most common reason for delays in resolving complaint investigations. The allotted time of 10working days may be insufficient for some situations, but staff and regional commissioners must be diligent in following up. These time limits have been established to meet quality assurance and regulatory requirements.
Use of CAP logo
The commission approved a new policy on use of the CAP accreditation designation and logo by CAP-accredited laboratories. Accredited laboratories may state on patient reports: "This laboratory is accredited by the College of American Pathologists," and they may include their CAP accreditation number. Accredited laboratories may not use the CAP logo for any purpose.
The commission also considered whether to allow laboratories that subscribe to the CAP Surveys program but are not accredited by the Laboratory Accreditation Program to use the CAP number. The commission recommended that such laboratories should not use this number in advertising, promotional materials, or patient reports.
Team leader qualifications
Laboratory directors are entitled to inspectors who meet the requirement of a "peer with similar status, type of practice, and hospital or lab size." Nonboard-certified pathologists, doctoral scientists, and medical technologists increasingly are serving as team leaders and members. The key element is defining "peer," establishing agreement on inspection by such individuals, and obtaining the consent of the laboratory director.
Laboratory directors sometimes set up a separate operation and CLIA number for the billing of professional components, usually for outpatients. In such a situation, the inspector may be confronted with a duplicate set of checklists-one for each of the laboratories. Very few questions are applicable to the billing-only type office. Reapplication forms now ask which laboratory activities are performed in the billing lab. Most of the related activities involve anatomic pathology and laboratory general items.
The commission discussed ways to avoid confusion and to prevent inspectors from duplicating their efforts. Staff offered a variety of options and this area is being developed further. Inspectors encountering such situations may call the CAPheadquarters (800-323-4040 ext. 6065) for guidance.
State commissioners meeting
The state commissioners will meet in Chicago on July 14. They may, however, elect to come in a day early for a hands-on SCORES update. The SCORES program can help the commissioners identify appropriate peer inspectors and make the inspection assignments in a timely manner. CAP staff reported that some state commissioners are not using SCORES to make inspector assignments online. The SCORES session will offer state commissioners an excellent opportunity to improve skills and efficiency and to practice using SCORES. (These educational activities do not qualify for continuing medical education credits under the requirements of the Accreditation Council for Continuing Medical Education.)
CAPLINKS briefly took center stage at the commission meeting. R. Bruce Williams, MD, Ronald Lepoff, MD, and staff marketing representative Monica Short introduced the new service, which allows laboratories to integrate information from LAP, Surveys, and other CAP products and services. CAPLINKS (Laboratory INtegration Knowledge Source), which is primarily directed at multi-laboratory arrangements and national reference laboratories, extracts performance data from all laboratory sites. The program collects and analyzes information about CAP services, including LAP checklist deficiencies, Surveys analyte exceptions, Q-Tracks performance data, and Laboratory Management Index Program management data. By using CAPLINKS to consolidate and summarize this information, laboratory directors can monitor multiple parameters from different sites, allowing them to more effectively detect and manage systematic problems.
Targeted laboratories should have already received a CAPLINKS brochure.
Anatomic pathology checklist updates
Checklist commissioner Albert Rabinovitch, MD, PhD, provided updates on the anatomic pathology checklists. As reported in the March "LAPNews," the autopsy committee recommended, and Dr. Rabinovitch supported, changing the time limits for autopsy reports. The current language is divided into two parts:
Question (Phase I): Are the majority of autopsy final reports produced within 30 days?
Question (Phase II): For all cases, is the final autopsy report produced within 60 days? Note: Allowance may be needed if portions of a case are referred for external consultation and completion of the case is dependent upon information from such consultations (e.g., complex neuropathology).
Another new item addresses frozen sections.
Question (Phase I): Following frozen section examination, is the residual frozen tissue routinely processed and a paraffin section prepared for comparison with the intraoperative interpretation? Note: Alternatively, the lab may have a policy specifying the types of specimens for which permanent section followup may be unnecessary (e.g., face marginal sections).
Given the recent reapproval of deemed status by the Health Care Financing Administration, Dr. Rabinovitch has been submitting proposed checklists to the agency on a regular basis. Through this means, assuming the Centers for Disease Control and Prevention or HCFA does not pose significant objections, the CAPwill activate the entire menu of updated, previously "proposed" checklist items available on its Web site. (Details regarding how to access the new checklists are provided herein under the subhead "Guide to the CAP Web site.")
Inspectors and laboratory directors need to remember, however, that they need to use the checklist edition sent to the laboratory in the reapplication packet for the inspection.
Audio conference programs are attracting a growing number of participants as the list of topics expands. Only about five percent of the audiences, however, have been pathologists; the remaining 95 percent have been other laboratorians. Pathologists: You are missing a time-efficient opportunity to keep your inspection skills up-to-date at no cost, with no travel, and with no hassle! Tune in with your laboratory staff and learn what they learn. (More information about the audio conferences is available on the CAPWeb site, www.cap.org, under "Education" on the home page.)
Also worthy of attention is freelance writer Vida Foubister's article "Sidestepping common deficiencies" (CAPTODAY, May 2001, page 34). The article, which is based on interviews with West Central regional commissioner Thomas Ruhlen, MD, reviews and expands on Dr. Ruhlen's audio conference presentation last year about the most common discipline-specific deficiencies found during CAP inspections. Dr. Ruhlen offers laboratory directors suggestions for preventing and remedying deficiencies, and he offers inspectors tips for conducting on-site visits.
As a new offering, LAP commissioner Frank Rudy, MD, presented an audio conference on the summation conference on May 16.
The new edition of the Laboratory Accreditation Manual will reflect the information obtained from these presentations.
Guide to the CAP Web site
The CAPWeb site contains a plethora of useful information relevant to the LAP. Bookmark it! For the latest on CAPchecklists, go to www.cap.org/html/ftpdirectory/checklistftp.html. Click on "Comparing old and new versions of a CAP checklist" for directions on how to compare the most current version and the previously approved field version. Tackle one checklist at a time. Compare the different versions and watch for updates or changes from "proposed" to "current" as HCFA authorizes release of the more current versions.
Use the CAPWeb site to learn all you ever wanted to know about the LAP but did not know how to ask. Go to www.cap.org/laboratory_accreditation/lap.html. From here you can access a variety of information, including the schedule of audio conferences, LAP inspection education seminars, and basic self-study that may be completed online and for CME credits. Not sure how to complete a PTES form? See the instructions under "LAP Proficiency Testing Exception Summary (PTES) Response Form and Instructions." (You may want to print this page for future reference and to distribute to section supervisors and inspection coordinators.)
Also worthy of mention is the LAP e-mail address: firstname.lastname@example.org. This is an efficient means for contacting LAP staff.
HIPAA standards requirements
CAP counsel Jack Bierig briefed the commission on new requirements imposed by the privacy standard in the Health Insurance Portability and Accountability Act. These regulations address patient privacy protection and patient access to medical records.
inspectors may be affected by this regulation while performing on-site reviews of patient records. Although their exposure to such information is inadvertent and transitional and is a necessary part of reviewing a laboratory's performance, it may become necessary for the College to develop guidelines and checklist questions pertaining to the new regulations.
Bierig is investigating whether the College may be exempted as a "health oversight agency." He will provide the commission with additional information at its July meetings.
Centralized computer facilities
Directors of laboratories using a common or remote centralized computer facility must obtain and provide responses to computer-related checklist questions. Laboratory directors and inspectors must obtain the necessary information, regardless of whether the centralized computer system is available for the on-site inspection. If inspectors know about the centralized system in advance, they may use their pre-inspection letter to the director to request that the necessary information be available for the on-site visit.
One of the breakout groups discussed the changing patterns of point-of-care testing facilities. The defining element for these activities is "testing that is not performed in permanent dedicated space."
The scope of POC testing continues to expand and to present increasingly complex challenges to directors and inspectors. New issues, such as computer interfaces between POC testing areas and the central laboratory and the problems of noninvasive or in-vivo testing, require attention. Inspectors need to know who is in charge of POC testing services. This is frequently a nursing service responsibility, and inspectors should establish appropriate contact with this group's administrative personnel.
The breakout group recommended that the CAP continue to use the current operative definition for POC testing and develop guidelines for using the limited service lab and/or selected discipline-specific checklist items, which are to be moved into the POC testing checklist. This may become the ideal pilot area for developing customized checklists.
The commission will consult with CAP scientific resource committees, and possibly the NCCLS, about establishing specific guidelines for quality control and proficiency testing of noninvasive test procedures. The bleeding time stands as a time-honored example of such a challenge.
The commission has long dreamed of truly customized checklists that would be specific to a given laboratory's organization and scope of testing. The College is working on it. One of the breakout groups discussed progress to date, which has developed to the stage of preliminary pilot testing in selected laboratories.
To accomplish its objective, the College may require laboratories to provide additional information on their reapplication questionnaires. Laboratories are already providing much of this information when they complete the scope of services and activity menu sections of the application. The LAP basically will need to know specifically what the laboratory does, where the service is provided, and under whose jurisdiction the service is offered-for example, the laboratory or some other institutional directorship.
In the simplest terms, the focus likely will be at the level of section headers and subheaders within the existing checklists.
Although considerable groundwork remains, as well as further pilot testing and a great deal of computer programming, the concept is in place and implementation will follow in due time. Stay tuned.
Regional commissioners R. Bruce Williams, MD, and Desiree Carlson, MD, reviewed, condensed, and updated the extensive LAPpolicy manual. Final approval for the revised manual is expected at the July commission meeting. While most of the LAP's active participants likely will not peruse the entire manual, it is worth noting that the reviewers provided an interesting introduction that includes a historical summary.
The initial LAP policies, the summary says, were established in February 1962, following approval by the Board of Governors in 1961. Originally designated the CAP Inspection and Accreditation Program, the name was officially changed to the Laboratory Accreditation Program in 1980 under the Commission on Laboratory Accreditation.
A number of the original policies remain in place, although they are not identified as original policies in the new manual.
When the CLA came into being, it did not "grandfather" accreditation to any CAP member. The CLAestablished 10 geographic regions and the CAP president appointed a commissioner to each. Such appointments, however, were subject to those members' laboratories having first met the Standards for Laboratory Accreditation. The new commission also developed a laboratory questionnaire, which has evolved into the present system of checklists.
When Congress enacted the Clinical Laboratory Improvement Act of 1967, those laboratories accredited by the College were exempted from licensure under the CLIA regulations. In 1979, the Joint Commission of Hospitals granted similar recognition to the CAP program as evidence of its compliance with the JCAH standards.
Interviews: preliminary briefing
As part of each on-site visit, the inspection team leader should request that the laboratory director schedule brief interviews with representatives of the institution's administration and, as applicable, with a member of the medical staff, preferably the elected chief of staff. If special function laboratories are under separate administration and are also being inspected, those laboratories should also be contacted in advance. If POC testing is under the nursing service, it may be helpful to interview the individual in charge of these activities.
The interviews should not be regarded as perfunctory requirements but as substantive parts of the inspection. They can provide insight into the effectiveness of the laboratory services, as viewed by administrative and clinical personnel.
Experienced inspectors suggest holding a brief private meeting with the laboratory director early in the inspection process. Inspectors should ask the directors what they consider problems or points of excellence-this information could be helpful during the interviews. Inspectors should assure the director that they will not discuss client or contract issues, but that they may be able to provide feedback as to how the laboratory is perceived by those interviewed. Be sure to establish the director's understanding of his or her lines of authority and responsibility in order to validate these with the administrator.
Inspectors may choose to open interviews with administrators by offering a brief historical perspective on the LAP, similar to the points covered herein under the subhead "CLApolicies." They should stress the voluntary aspects of the program for inspectors and directors and the educational benefits to both, including the "free" CME credits awarded to medical and technical staff. They should inform administrators that they will not ask questions about or discuss contractual or client list issues.
Inspectors may then ask administrators about how they perceive the director's relationship with administration and how the director is perceived by others. Does the director attend and actively participate in administrative and medical staff meetings and committee work? Does the director cooperate and interact well with individuals in other service areas-for example, nursing, emergency room, and operating room personnel? Does the administrator field complaints about service? If so, are those issues addressed to the complainant's satisfaction? As appropriate, inspectors should gingerly address the administrative concerns of directors if the directors authorize such an exchange.
Inspectors can invite administrators to the summation conference and explain that the commission makes the final accreditation decision, not the inspector, and that it is the inspector's job to gather information. They should stress the ultimate goal of the LAP-the continuing improvement of laboratory services for the benefit of the patient. Inspectors should try to dissuade overly competitive administrators from seeking, or demanding, the objective of "zero deficiencies" as the only acceptable outcome of the visit. They need to help them understand the purpose of citing deficiencies, even those the laboratory is able to correct during the visit. If necessary, they should accept responsibility for being thorough, but not "picky," which is what separates the CAP program from other agencies' accreditation programs. It may be helpful for inspectors to remind administrators that the Joint Commission on Accreditation of Healthcare Organizations requires compliance with its own stringent requirements for continuing quality improvement.
Should complaints about the program's cost arise, inspectors should assure administrators that the "real" costs are in providing excellence in patient care-not the fees the CAP charges to validate their efforts. Inspectors should thank the administrator for the institution's support of the LAP and conclude by saying in a positive tone that they will see him or her at the summation conference.
Interviewing medical staff
An inspector's introductory remarks to the medical staff representative may be similar to those made to the administrator. It is important that these representatives understand that the LAP's goal is to improve laboratory services for patients and that the program is voluntary and educational. Inspectors should acknowledge that medical staff representatives have limited time for such interviews.
Inspectors need to get to the point and ask the medical staff representatives if their staff enjoys an effective and efficient working relationship with pathologists and other laboratorians. Is the scope of service appropriate for their needs and their patient population mix? Are stats and intraoperative consultations timely, and do the physicians trust the reports? Are clinical and anatomical pathology reports readily available, legible, and understandable, and are normal values and abnormal results clearly indicated? How is the service level on evening, night, and weekend/holiday shifts? The inspector should remind the representative that the inspection team is evaluating these aspects but that the true test is whether those who use the service are satisfied. The CAP requires periodic surveys of clinician and patient satisfaction and documentation of continuing improvement in aspects of laboratory services that may be identified. Is the medical staff aware of these, and have they noted improvement when indicated?
Do pathologists actively participate in medical staff committees and meetings? Is there good cooperation between the medical staff sections and those in the pathology department? For example, are infectious disease physicians welcome to stop by the microbiology laboratory to see cultures on their patients? Is there a multiheaded microscope available so clinical personnel can review with pathologists or qualified laboratorians blood and body fluids, Pap smears, or surgicals? Does the pathology department contribute to teaching conferences? Are medical staff representatives made aware of problems between pathologists and radiologists, surgeons, or anesthesiologists? Is the blood bank supply adequate and managed efficiently? Are autopsies available and reports issued within 30 to 60 days?
An inspector obviously need not ask about all these particulars unless it becomes evident that there are problems with the service.
The inspector should invite the medical staff representative to the summation conference and briefly explain its purpose. Above all, inspectors need to thank representatives for their time and make themselves available for followup feedback.
Followup to interviews
Inspectors should use judgment in briefing laboratory directors about interview findings. In most cases, all goes well, and this may be shared in complimentary fashion during the summation conference. If some topics of discussion seem more personal or confidential, another brief, private meeting with the director may be warranted. If one or both interviews reflected very poorly on the director or the department, inspectors should withhold their findings, to the extent possible, and contact their state commissioner after the inspection.
Inspectors must never discuss inspection findings with anyone outside the laboratory, other than a commission member or LAP staff, during that inspection instance. This would violate the CAP's long-standing policies regarding release of confidential information. Stringent policies guide CAP staff and commission members as to what information may be released without the director's express permission. Information that is publicly available includes the laboratory's accreditation status, date of last on-site inspection, date from which the laboratory has been continuously accredited, and the recently adopted performance assessment report of "accredited" or "accredited with distinction."
In contrast, free exchange of scientific information before, during, and following inspections is not only allowed but encouraged. One should, however, be reasonably certain that the exchange is freely given and received. In the same vein, if an inspector requests a copy of a document-for example, a sample page of a procedure manual-from laboratory staff, he or she should verify that the lab director supports the release of that documentation.