Feature Story

Averting skirmishes—complaint, conflicts rules revised

March 2001

The Commission on Laboratory Accreditation met in Toronto Nov. 9 and 10, 2000. An advanced inspector training seminar was held Nov. 11.

Complaint investigation policy

A complaint is defined as any allegation or apparent discovery that an accredited laboratory does not meet the Standards for Laboratory Accreditation. Such complaints are investigated by the special commissioner for complaint investigations, PTES oversight and equivalency. The so-called complaints commissioner reviews each case and, when appropriate, convenes a conference call with the executive committee of the Commission on Laboratory Accreditation. The commission reviewed and approved language modifications for the policy on complaint investigations.

Staff conducts an initial investigation in conjunction with the complaints commissioner, who may conclude, based on the evidence assembled during the initial investigation, that the complaint is not substantiated and choose to close the case. If the complaints commissioner does not close the case, the laboratory is given an opportunity to respond. If the laboratory's response is inadequate, the complaints commissioner may call a meeting of the CLA executive committee to determine further action, which may include a focused or comprehensive reinspection.

If the reinspection fails to substantiate the allegations, the complainant will be notified of this, and the case will be closed. If substantial evidence is found to support the complaint, the laboratory will have an opportunity to resolve the identified issues. If the laboratory fails to correct the problem to the satisfaction of the complaints commissioner and the executive committee, accreditation may be revoked. In such a case the laboratory director may proceed with an appeal process, first to the commission, then to the Board of Governors. Final reports of investigation of sustained complaints are sent to the laboratory director. Actions of revocation are reported immediately to the laboratory director and appropriate oversight agencies. Information about substantiated complaints is provided to the inspection team leader for the next on-site inspection.

The complaints commissioner, Gerald A. Hoeltge, MD, discussed several recent examples referred to the LAP for resolution. He pointed out that some complaints are accreditation issues that the commission must address, whereas other complaints are problems of customer service that may be outside CAP jurisdiction. Although sympathetic to customer service problems, the College can intervene on behalf of individual patients only when there are indications that the Standards for Laboratory Accreditation may have been violated.

Use of CAP logo
As reported in the November "LAP News," staff, with counsel, is developing a policy regarding use of the CAP logo and the CAP accreditation number by accredited laboratories. Their use could be construed as indicating the College guarantees the precision and accuracy of every individual test result. By College policy, use of the CAP logo is restricted to the College. The commission requested further revisions to clarify the designation of the CAP accreditation number and its approved use and will review the final version at its March meeting.

Staff inspections of small rural hospital labs
Edgar H. Pierce Jr., MD, reported on the ongoing use of staff inspections of small rural hospital laboratories in Tennessee. This has been well received by labs in this region, following a pilot study. The criteria used in the pilot study to identify candidate laboratories included:

• Size did not exceed 100 beds.
• Scope of testing did not include specialty areas, cytopathology, or anatomic pathology, unless the anatomic pathology was limited to frozen sections.
• Inspection could be completed by one or two inspectors in two days or less.

The pilot project was directed to these specific laboratories to provide more expertise in covering these labs and to provide relief for the voluntary inspection force. The program supplements the ongoing staff inspections of office laboratories and other small labs.

The commission considered several options for expanding the present program, including a review of an existing policy that allows regional and state commissioners to assign nonpathologist inspectors to small labs not performing anatomic pathology. Loyd Wagner, MD, offered a motion to extend this policy further: "At the discretion of the assigning commissioner, inspection teams for small hospitals may be led by staff or well-qualified nonpathologist inspectors who will select team members from the region." The assigning commissioner must secure permission from the laboratory director before assigning a nonpathologist as the team leader.

Staff will modify the current policy. These changes will provide options in addition to CAP staff inspectors for appropriate peer review of smaller and remotely located laboratories.

Staff inspection scheduling
As a related issue, laboratories undergoing on-site inspections by CAP staff inspectors have sometimes objected to the scheduled inspection date. To minimize travel expenses, staff inspectors will be scheduled to inspect groups of laboratories that are clustered geographically. Well in advance of their anniversary date, staff-inspected laboratories will be notified of the week when their inspection will be scheduled. If a laboratory does not agree to be inspected during this week, it may be charged an additional fee to cover the inspector's travel expenses. Although somewhat sympathetic to the problems with staffing that small laboratories may have, the commission concluded this policy permitted the most effective use of staff inspectors.

Military laboratory directors
CLA vice chair Robert Rickert, MD, discussed the problems associated with correspondence addressed to directors of military laboratories. In many cases, correspondence directed by agreement with the Department of Defense to the "chief, laboratory services" fails to reach the appropriate person. To alleviate this problem, future correspondence will be directed to the "chief, laboratory services," with copies sent to the base or the hospital commanding officer, the laboratory medical director, the consulting pathologist, if available, and the clinical laboratory improvement program office.

Performance assessment report update
To date, just over 400 laboratories have received performance assessment reports. There have been no complaints and few inquiries related to the program.

The commission discussed whether to include the Forensic Urine Drug Testing program. The program will not be expanded for now, but staff will begin to develop the support systems.

Discontinuance of the athletic drug testing program
The commission voted to discontinue the athletic drug testing program. Enrollment decreased from seven to four laboratories in the last two years; two of the laboratories currently accredited indicate they will drop accreditation within the next two years.

Phlebotomy sites
The commission decided to include remote phlebotomy sites in the inspection process for accredited laboratories. If the inspector determines that test procedures such as bleeding time or waived testing are being performed at a phlebotomy site and have not been declared on the laboratory's application, the site should be treated as a "by the way" laboratory or a laboratory unprepared for inspection and not be included in the current inspection.

Inspectors should use the phlebotomy-related questions from the Lab General checklist. Applicable safety and preanalytical checklist questions are appropriate to use during the inspection. Procedural deficiencies should be entered on the Lab General section of the inspector's summary report.

Overseas versus international laboratories
Dr. Rickert requested and the commission agreed to change the nomenclature of the presently designated overseas labs to "international laboratories." Inspectors assigned to international laboratories should arrange all travel through the CAP travel office. Dr. Rickert also proposed the appointment of additional deputy commissioners to positions representing the Laboratory Accreditation Program in their countries. These appointees are CAP fellows who have long experience and familiarity with the program. Dr. Rickert anticipates these deputy commissioners will promote the program and supplement inspection teams coming from the United States with qualified members drawn from the area.

Aaron Lupovitch, MD, reported on his visit to Taiwan, on which he was accompanied by Peter Howanitz, MD. There are about 400 laboratories in Taiwan, ranging from huge governmental facilities to small labs. The Taiwanese pathologists, many of whom trained in the United States, are extremely enthusiastic about the College program. They seek accreditation and regard the LAP as the gold standard, Dr. Lupovitch reported.

Hans Peters, MD, expanded the list of countries in which laboratories have expressed interest in accreditation to include India, Pakistan, Taiwan, China, Dubai, and Greece. He and Dr. Rickert also plan to develop lists of potential inspectors in these countries to assist with the inspection workload and to decrease travel and other costs of sending U.S.-based team members.

The commission directed staff to investigate alternative methods for shipping Surveys to international laboratories to avoid delays that might compromise the quality of Surveys materials.

Update on audioconferences
The new Laboratory Accreditation Program audioconferences have been well received. Participants have signed on and taken part in live question-and-answer sessions following the lecture. Topics have included the inspection process, checklist updates, meeting QC/QI requirements, and solutions to most common deficiencies. Those who miss the live presentations can find them on the CAP Web site under online education, where they can download the handout, listen to the audio, and receive CME/CLME for completing the exercise. LAP staff and members of the commission or scientific resource committees will update each audioconference as it comes up for repeat presentation.

Uniformity of results reported by system labs
John Harbour, MD, suggested a new requirement for system laboratories. The issue was, Should different laboratories within a system be required to have a defined mechanism for test correlation that would verify comparability of results throughout the system, similar to the expectation to perform correlation of tests performed on different equipment/by different methods within an institution? Following discussion, the commission decided to encourage, but not require, laboratories to ensure comparability of results among laboratories within a system, for the present time.

Awards
During the CAP business meeting at the House of Delegates last fall, CAP president Paul Bachner, MD, presented awards to several commissioners and staff. Robert Baisden, MD, received the Blumberg award, and commissioners Albert Rabinovitch, MD, PhD, and Dr. Peters received awards for long and distinguished service. LAP staff Peter Mockridge, Roxanne Schwoch, and Denise Driscoll received awards for their excellent work on the SCORES project, in which the new client server-based computer software support accreditation activities was designed and implemented.

Conflicts of interest
The commission's policy on conflicts of interest primarily addresses commercial business-related conflicts to avoid improprieties in personal profit from CAP-related activities. One of the breakout groups addressed additional potential conflict issues that may arise related to the assignment of inspection teams. Several safeguards prevent conflicts of interest in the assignment of inspectors.

• Commissioners do not assign inspection team leaders for their own laboratories; instead, team leaders for these laboratories are assigned by other commissioners.
• The accreditation decision is made by the regional commissioner, not by the inspection team leader; this may temper the actions of individual inspectors and teams.
• Checklist items deal only with scientific/technical items, not business arrangements. Inspectors are specifically constrained from discussing contract issues during an inspection or in interviews with administrators or others.
• The inspection team leader and members are identified prior to the inspection, and assignments are made to avoid consecutive cycle assignments to the same team or cross-assignments within a year's time frame.

The breakout group recommended further instructions to inspectors to help avoid public perceptions of an unfair inspection and accreditation process. The group defined an unfair inspection as a situation in which an otherwise neutral inspection becomes predictably biased toward permissiveness or harshness in the inspection report. Upon recommendations by the group and with the commission's approval, certain changes will be included in the next update of the Laboratory Accreditation Manual:

• Commissioners should be sensitive to client satisfaction issues when assigning inspectors.
• Commissioners must avoid assigning business partners to inspect one another. Affiliated hospitals may provide teams to inspect affiliates, depending on the affiliation and nature of the relationship between the pathologists and the institutions.
• State and regional commissioners should evaluate and judge the reasonableness of assignments.

The group also reviewed the role of paid or informal consultants and made further recommendations as follows:

• Any receipt of money for consultation should lead commissioners to excuse themselves from decisions or actions involving that laboratory.
• When commissioners offer informal or paid consultation, they must state that their opinions are personal and disclaim that they have been endorsed by the CAP.
• Members of inspection teams should avoid solicitations for consultation services before, during, and up to one year following an on-site inspection visit.

The commission can do only so much in terms of safeguards. As with any regulation or attempt to control human activities, there may always be exceptions to the rule as well as exceptional persons who may strive to bend the rule one way or another.

Assigning commissioners should bear in mind this program is voluntary, but that peer review is a key element. The commission will continue to monitor and to revisit the issue of conflicts of interest.

Cytopathology checklist language
During the meeting and via e-mail the CLA engaged in a dialogue with members of the Cytopathology Committee. The principal point of interest was use of the term "diagnosis" within the checklist, with members of the Cytopathology Committee preferring the less explicit term "interpretation." Both groups have exercised considerable thought and communication on the subject and wound up in a compromise. The checklist commissioner, Dr. Rabinovitch, will adjudicate the final language, in which either "diagnosis" or "interpretation" will appear in the next iteration of proposed checklist changes. Since the Health Care Financing Administration recently renewed its approval of the College as a deemed organization, these revisions can now be submitted for approval by HCFA and released for field use.

Laboratory directors should understand that checklist terminology should not direct their preferences in reporting their own cases. The commissioners generally favored the premise that a positive Pap test constitutes a diagnosis, as validly as a positive biopsy. The committee members said even a positive finding constitutes only an interpretation, the purpose of which is to direct the clinician to perform more definitive studies, i.e. a biopsy, recognizing the possibility of false negative biopsy results due to sampling errors. Both groups agree that accurate communication to the clinician, not only describing the findings but also suggesting appropriate followup, is imperative.

Waived testing
CAP's position on waived testing appeared in the Oct. 25, 2000, issue of "Statline" and remains available on the CAP Web site under www.cap.org/advocacy/comments/waivlett.html. The commission reaffirmed support for the principle that all patient care testing should be subject to QC and PT procedures. While challenging the basis of HCFA's test classification system, the commission strongly urges that manufacturers of waived test devices be held accountable for their proper use. Manufacturers are urged to build in appropriate measures to ensure accurate and precise test results.

Record retention guidelines
Participants at inspector training seminars frequently ask for guidelines regarding retention of various records and materials. The recommendations at left are from the College—not just the Commission on Laboratory Accreditation. As with all such documents regarding the practice of pathology, neither CAP nor the commission mandates adherence to the letter of the recommendations. Directors may set their own time limits as well as method for retaining various records and materials. Inspectors should use good judgment in determining if the stated retention periods are enforced and if they meet the needs for patient care within the inspected facility. Directors whose retention policies differ markedly from the CAP's consensus guidelines are advised to document their reasons for such variances, as well as any circumstances that might compromise adherence to the commonly accepted periods of retention.