College of American Pathologists
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  Winds of change-training, checklists, pricing


February 2002
Originally published in CAP TODAY

Dr. Desiree Carlson

The Commission on Laboratory Accreditation met Nov. 8-10, 2001 for its annual planning meeting. This was the last meeting for William Hamlin, MD, as chair. In January, Ronald Lepoff, MD, became chair. Dr. Hamlin served the Laboratory Accreditation Program as chair from 1993 through 2001. Dr. Lepoff has served as a regional commissioner; as special commissioner for complaints investigations, PTES oversight, and equivalency determinations; and as liaison for the Board of Governors.

Highlights of the meeting follow. This edition of "Laboratory Accreditation News" also includes an article by CAP general counsel Jack R. Bierig, Sidley & Austin, Chicago.

Inspector training seminars format change - The Laboratory Accreditation Program holds approximately 25 free, one-day training seminars in major U.S. cities each year. These are led by the regional commissioners in each area. The goal is to prepare team leaders and team members to inspect their peer laboratories. The current format is a traditional didactic style with lectures in the morning covering the inspection process, checklist items common to all sections, and laboratory general. This is followed by smaller group breakout sessions in the afternoon to cover checklist-specific topics.

For 2002, the Education Department has developed a new curriculum, which will be much more interactive. We realize that many of our participants are already familiar with the checklists based on their own experience of being inspected. What the participants really want to know is: "What is behind the checklist questions? What would indicate noncompliance? How should the inspector handle certain situations?"

The new format will include more scenarios and role-playing exercises. Discussion will be a key part of these exercises. Participants are expected to gain practical insights into a variety of ways of meeting the checklist requirements.

Complaints or adverse publicity - The commission investigates all complaints and events with adverse media attention involving accredited laboratories. The special commissioner for complaint investigations, PTES oversight, and equivalency determinations works closely with a technical analyst at CAP headquarters. Whenever a complaint is received, the laboratory is contacted and asked to provide information about the allegation. Many complaints are anonymous, but in no case is the identity of the person reporting the complaint released to the laboratory without the consent of the complainant. After sufficient information has been obtained, the executive committee of the commission holds a conference call to determine what additional steps, if any, are necessary. Resolutions may range from determining that the complaint is not valid and closing the file to deciding that a reinspection of the laboratory is needed.

Bioterrorism - After the appearance of anthrax contamination in the U.S. mail, members of the commission's executive committee participated in a CAP review of activities related to managing bioterrorist threats. The commission believes that a laboratory that successfully participates in the LAP will have procedures in place for properly collecting, transporting, handling, testing, and shipping specimens collected from possibly exposed patients. The laboratory should guide the physicians it serves in handling these laboratory specimens.

JCAHO extends cooperative accreditation agreement - The commission was notified in November 2001 that the Joint Commission on Accreditation of Healthcare Organizations had extended its cooperative accreditation agreement with the College. This means if a hospital laboratory is accredited by the CAP, the JCAHO will accept the results and not perform a second inspection with its own surveyors when it surveys the institution. One change to the LAP laboratory general checklist was required by the JCAHO. The question number is Gen.20400: Is there a systematic program to identify and correct problems that may interfere with patient care services? The explanatory text was modified to read: "Laboratories must be involved in the root cause analysis of any unexpected event involving death or serious physical or psychological injury (or risk thereof) involving the laboratory; laboratories must be able to demonstrate appropriate risk-reduction activities based on such root cause analyses. Resolution of the problems must be documented."

Alternative proficiency testing providers - The commission has established criteria for evaluating alternative proficiency testing providers to ensure that peer groups are of adequate size, that the number of unknown challenges is sufficient for evaluation, and that the data generated can be electronically sent to the CAP for evaluation in a manner similar to the College's own proficiency materials. Accredited laboratories may use any approved proficiency testing provider to meet accreditation requirements. One of the key points in the LAP is the ongoing evaluation of a laboratory's performance based on proficiency testing between on-site inspections. The CLA has a special commissioner who reviews, evaluates, and presents applications from candidate alternative proficiency testing programs to the entire commission for approval. For a complete listing of all approved programs, call 800-323-4040 ext. 6055.

Newly revised checklists - The new checklists are now being sent to laboratories applying for accreditation. From July 1998 through February 2001 only the 1998 versions of the checklists were being used. The Centers for Medicare and Medicaid Services had been reviewing the College's reapplication for approval as an accrediting agency. During that time, no changes could be made to our existing checklists. We felt we could not remain stagnant, so changes were made and posted on our Web site as proposed versions by checklist commissioner Albert Rabinovitch, MD, PhD. This gave laboratories a head start on the changes once the new versions were approved.

On the Web site, the versions of the checklist with the alpha characters preceding the question number are the new ones. Using letters makes it easier for participants to know which checklist belongs to which section of the laboratory. With the exception of checklist 90 (used in the Reproductive Laboratory Accreditation Program), new versions of all checklists have been released.

Simultaneous validation inspections - The Centers for Medicare and Medicaid Services will from time to time perform validation inspections of laboratories that are already inspected and accredited by the CAP. This is done to ensure compliance with CLIA '88 requirements and to spot-check our inspection process. CMS selects the laboratories either at random or in response to a substantial allegation of noncompliance. In the past, CMS inspectors have appeared within 60 days of a CAP inspection. That time frame will now be lengthened to within 90 days.

Occasionally, CMS has conducted inspections simultaneously with the CAP inspection. The closer the date of the validation inspection to the CAP inspection date, the more likely that both organizations will see the same snapshot of the laboratory's operation. It is important for the CAP inspector to accurately cite laboratories for deficiencies during our inspection so a subsequent validation inspection does not uncover problems overlooked by the CAP inspector.

Laboratory accreditation growth - More than 170,000 laboratories are registered with CMS. Of these, 16,296 are accredited by one or more of the six approved accrediting organizations: CAP, JCAHO, AABB, COLA, ASHI, and AOA. The CAP now accredits more than 6,300 laboratories, 4,500 of which use CAP accreditation in lieu of inspection by CMS or another accrediting agency. The CAP currently has three accreditation programs: LAP for general laboratory testing, the Reproductive Laboratory Accreditation Program for fertility laboratories, and the Forensic Urine Drug Testing Program.

Staff inspectors - Several years ago, the commission explored ways to serve smaller laboratories better. At many small laboratories, it was difficult for the director to gather a team to inspect a peer laboratory. Medical technologists, specially trained at CAP headquarters, were hired to perform inspections of these small laboratories.

Response to these inspectors has been positive. They provide a resource to the inspected laboratories because they have seen how other small laboratories solve the same problems. These MT inspectors inspect more than 400 laboratories each year.

Recently, they participated in a pilot program to inspect small hospital laboratories where no anatomic pathology, except frozen sections, is performed. Their inspections are clustered geographically to reduce expenses. There are four inspectors and an administrative coordinator. They are also occasionally called on to supplement teams led by a pathologist.

New pricing structure - The LAP has implemented a new pricing structure, based on the time and effort required to inspect the various areas of the laboratory. In the new system, each occurrence of each discipline or subdiscipline within a laboratory contributes to the total fee, with more-complex disciplines contributing more than less-complex disciplines. There is also a base fee based on the total annual test volume. You will find more information about the new structure in the materials you receive with your re-application.

Next meeting

The commission will meet in New Orleans on March 14-16. An inspector training seminar is scheduled for March 16 to introduce the commissioners to the new educational materials for inspector training seminars.