College of American Pathologists
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  Improving inspections a matter of refinement


October 2001
Originally published in CAP TODAY

The Commission on Laboratory Accreditation met in Chicago July 12 and 13. A state commissioners meeting was held July 14. Meeting highlights follow.

New policy manual

The commission approved the revised edition of the policy manual referred to in the June issue of "Laboratory Accreditation News." Most of the updates are improvements in format and arrangement of topics.

Postinspection critiques

LAP staff introduced new postinspection critiques that will become standard in late 2001. The critiques better reflect recent changes and provide more relevant data for future program improvements. Participants are encouraged to respond, as this is the best avenue for providing factual, helpful feedback to the commission regarding its on-site inspection experience. The team leader and members receive a separate CME form, and all team members will receive CME, based on their hours of active participation.

POC testing custom checklist?

During the last meeting, one breakout group reviewed the point-of-care testing inspection procedure. POC testing refers to analytical testing activities performed within the institution, but outside the physical facilities of the clinical laboratory; they do not require dedicated, permanent space. The commission conjectured that a laboratory might be motivated to mount an instrument on a dolly and wheel it into a patient's room for POC testing.

With this unlikely possibility in mind, inspectors should remain alert to the presence of high-tech instruments that may trigger the need for a specialty checklist in addition to the POC testing checklist. To address this issue more formally, an introductory paragraph will be inserted at the beginning of the POC testing checklist, stating, in part, "If a POCT laboratory has a scope of service in a particular discipline that exceeds those addressed in this checklist, a section-specific checklist may be required."

RLAP and beyond

Inspectors in the Reproductive Laboratory Accreditation Program often encounter laboratories performing other disciplines within the same laboratory. These frequently include chemistries, endocrinology, hematology, urinalysis, and immunology.

The RLAP's initial objective remains: It is a specialized program to accredit reproductive laboratories performing embryology and andrology tests. Inspectors are confronted with the question of whether to review the in vitro fertilization tests only or to inspect the whole lab. The commission reviewed and discussed several options. It is the responsibility of the RLAP laboratory director to decide who should inspect non-RLAP testing activities. If requested, CAP will provide additional inspectors to cover non-IVF sections, and the regular RLAP team will inspect IVF activities. The RLAP director may request CAP accreditation for the discipline of embryology only. Alternatives for other sections may include Centers for Medicare and Medicaid Services inspection or inspection by another accrediting agency.

New PTES form

Inspectors traditionally have reviewed the laboratory's Surveys results and noted their responses to unacceptable results as part of the routine inspection. To assist this process and to add another dimension, staff has developed a new proficiency testing exception summary form from the CAPLinks project. The purpose is to provide a tip-off to inspectors to review the laboratory's responses during their inspection.

and directors should recall that individual analytical errors on Surveys do not trigger the PTES report, nor do these single asterisk-generating mishaps require reporting to CAP. They do require the laboratory to acknowledge the error, review the source, and take appropriate corrective action. The only way to ensure this activity is during the inspector's on-site visit. Usually it is the absence of any evidence that the error has been noted and acted on that results in a checklist deficiency. The corrective action may be at the section supervisor's level, but there should also be some evidence of review by the laboratory director.

On the other hand, the PTES is generated when certain criteria of repeated errors are triggered within a discipline. These criteria vary between regulated and nonregulated analytes and on the number of challenges offered per year. The emphasis is on the summary, and the objective is to identify and correct systematic errors. These investigations and corrective actions must be reported to the CAP within 30 days and must be signed by the laboratory director. A common reason for rejection of the report has been the absence of the director's signature.

The commissioners requested that the PTES reports and explanatory information be included in the inspector's packet and also provided to the commissioners for use in making accreditation decisions.

Optimal number of inspectors, specialty inspectors

During the breakout sessions, one group discussed the problem of determining the appropriate number of inspectors for a team. Another group considered requirements and qualifications for specialty and subspecialty inspectors.

Assigning commissioners, inspection team leaders, and laboratory directors need to improve communications concerning the optimal number of inspectors to perform an on-site inspection. Although occasionally there may be too few inspectors or some less than fully qualified for certain disciplines, the opposite problem is far more frequent. Inspection team size creep has occasionally resulted in more inspectors than employees on-site. This may occur inadvertently when a team leader sees the inspector assignment form and notes that the last inspection required, e.g. four inspectors. Just to be sure the next team can handle it, the leader brings five or six members; the next leader compounds the interest again.

More likely, this is an undesired effect of increasing specialty sections. Peer review must be ensured, but team leaders should pay closer attention to the activities list to ascertain the actual extent of the subspecialty sections. If specialty section team members are required, by all means bring them, and use their extra time to cover parts of lab general, e.g. safety, computer, disaster plans, Surveys review, etc., to relieve others. Some specialty sections, e.g. cytopathology, cytogenetics, molecular pathology, and histocompatibility disciplines, may indeed require one full inspector-day. Team leaders and assigning commissioners should remain aware of the CAP's resources to locate inspectors for specialty areas or to provide staff inspectors for certain situations.

Clearly, the team leader may not be qualified to inspect all areas, no more so than a laboratory director may be qualified to practice in all subspecialties. Each role requires only that a fully qualified individual cover the area, whether as inspector or as inspectee. Similarly, directors and team leaders are held responsible for ensuring competence of the individuals in either case. The commission agreed to a pilot study under which a selected few state commissioners will develop suggested numbers and specialty qualifications of laboratory inspectors. They then will track actual numbers used and check for outliers, based on team size. Smaller teams of one to five may trigger outlier status if more than two additional inspectors are taken. Larger teams will require greater standard deviations of inspector team numbers to trigger an outlier review.

Team leaders should also consider the maturity of individual inspectors and the degree of experience they might bring as a team that has inspected together on prior visits. Also, they should take into account the expected degree of preparation of the lab to be inspected. An initial inspection may be far more time consuming than returning to a laboratory that has been accredited, with few deficiencies, over several accreditation cycles.

Regardless of the team's number and makeup, the leader should give full advance information to the director. Team members, by name and specialty, should be identified in advance so their counterparts at the lab can know whom to expect during the on-site visit. Likewise, directors should provide similar advance information to promote a collegial learning experience for both sides.

Subdisciplines and new labs

Another breakout group proposed recommendations for improving identification of subspecialty disciplines to optimize inspection team size and composition. For example, hematology may include basic or sophisticated coagulation testing; transfusion medicine may range from full transfusion services, parentage, and tissue donor testing to donor collection. Microbiology may be a full multidiscipline area or might offer only Gram stains. Including such information in the inspection packet will further aid the team leader in selections.

group also considered the question of accrediting a laboratory prior to commencement of patient testing. Although unusual, there are circumstances where this practice may be appropriate, and the commission decided not to preclude such requests. Regional and state commissioners will deal with individual applicants.

Special presentations

At both the regular meeting and the state commissioners meeting, senior CAP staff offered presentations to enhance the work of the LAP. Education Department director Collette Steward, PhD, provided new information on proposed improvements in the inspector training seminars. She emphasized the need for more interactive discussion periods and to develop new curricula that more closely follow the actual inspection sequence. Both the instructor's and the participant's manuals will be updated for current content and improved to facilitate more efficient note-taking during presentations. The new seminar programs should debut in 2002.

CAP public relations director and former TV broadcaster Sandra Grear demonstrated techniques for effective presentations and offered speaking tips. Both speakers noted the need to keep presentation slides uncluttered and to use few points per slide.

International lab inspections Commission vice chair Robert R. Rickert, MD, noted a marked expansion of international laboratories requesting accreditation. These are mainly civilian labs with a corresponding decrease in military labs. The LAP is increasing the use of CAP fellows residing abroad as well as trained inspectors overseas. Team leaders may come from the United States, with members recruited from the country of the laboratory being inspected, or from nearby.

Disaster plans

In early June, tropical storm Allison inundated large portions of Houston and Harris County, Texas. Some medical institutions fared far better than others. Unfortunately, many of those hardest hit were within the Texas Medical Center. One major teaching hospital's basement-located pathology department was essentially destroyed. Fortunately, some of the other institutions remained open and operating.

We recount this unfortunate incident to alert inspectors, not to mention laboratory directors, to evaluate their internal and external disaster plans more carefully. Inspectors should inquire about prior flooding or incidents in which disasters were narrowly averted. Are corrective action plans designed to avert future recurrences? Has the laboratory experienced fires, hailstorms, wind damage, or excess exposure to noxious fumes, either internally or externally? Were truly corrective measures taken-for example, relocating pathology services to upper floors-or did the lab simply replace equipment in the same flood-prone area?

The items within the laboratory general checklist that address disaster plans may easily be glossed over during a busy on-site visit. However, similar to the items concerning space requirements, they may become extremely important in retrospect. Inspectors are not serving directors or their institutions well if obviously hazardous conditions remain. Inspectors should bring such conditions to the attention of administrators during their conference and explain that phase I deficiencies, when left unaddressed, can be upgraded to phase II.

Unusual problem

Occasionally an almost dramatically different sort of problem surfaces during the regional commissioner's reports, prompting a strong response from the commission. In one instance a laboratory director requested that a hematology lab deficiency be removed. The checklist question asked if hematology slides with suspected malignant cells are reviewed by a pathologist before final reporting. The director objected to the deficiency on grounds that this could violate the laboratory's policy on reflex testing.

Commission chair William Hamlin, MD, strongly supported the deficiency as cited and noted this item is there "for the benefit of the patient."

State commissioners meetings

The state commissioners began their program by sharing a wide variety of techniques they use to assign inspection team leaders in their areas. Some have elaborate grid systems laid out on chart paper; others simply make phone calls. The common thread among all the presentations was the need for advance planning, from six to 18 months ahead of the inspection due date.

Handling pathologist directors who balk at being assigned is especially tricky. For such reticent pathologists, the state commissioners might threaten to call their administrator and inform him or her that the lab director refuses to fulfill a CAP obligation. Other problems may involve solo practitioners who claim they can't leave their practice, or won't leave their practice unless CAP compensates a locum tenens. (The CAP won't.) A conversation may follow regarding how the reluctant pathologist covers his vacations, illnesses, and meeting time. If this fails, the state commissioner may explain that the next reapplication will not be accepted since the requirements of standard four have not been met.

Checklist update

CAP staff reported on the current status of checklist revisions. Proposed versions of checklists have been posted on the CAP Web site, pending acceptance by the Centers for Medicare and Medicaid Services. To date, revisions of laboratory general, hematology, microbiology, and urinalysis have been approved. CAP has released laboratory general, microbiology, transfusion medicine, and anatomic pathology. Updates are available on the Web site. Please note that the language in a proposed checklist may not match the final release exactly.

Progress on the concept of customized checklists was presented, and it was noted that custom checklists must address needs of laboratories and inspectors. Customization is now at the level of specialties and subspecialties. LAP may use subdiscipline and group-based filters. Groups, e.g. electrophoresis technology, may be filtered out, based on application. The primary objective is to delete or to minimize the items that are "N.A." for the laboratory under review.

Chair change

President Paul Bachner, MD, announced that William Hamlin, MD, will step down as chair of the Commission on Laboratory Accreditation, and that Ronald Lepoff, MD, will succeed him on Jan. 1, 2002.

Next meeting

The next commission meeting is scheduled for Nov. 8-10