College of American Pathologists
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  Brushing up on the latest provisos, ideas


June 2002
Originally published in CAP TODAY

The Commission on Laboratory Accreditation met March 14-15 for its regular meeting; an inspector training session using the new, more interactive format was presented on March 16. This was the first meeting as chair for Ronald Lepoff, MD.

Complaints and validations

Gerald Hoeltge, MD, the special commissioner for nonroutine processes, reported the turnaround time for resolving complaints is less than 90 days in 70 percent of cases. The CAP evaluates corrective actions that laboratories take in response to deficiencies cited by the Centers for Medicare and Medicaid Services during its validation inspections; Dr. Hoeltge reported these reviews are completed within 90 days for 90 percent of the CMS validation inspections.

The College is using discrepancies between CAP and regulatory agency inspections to improve its accreditation program. For example, if certain checklist questions are commonly cited, we will use this as a teaching point in the inspector training sessions.

Slides reviewed off-site

The commissioners discussed so-called accreditation of microscopes. According to CMS regulations, any site where diagnoses are rendered must have a CLIA number. Thus, if a pathologist is reviewing slides and making diagnoses at home, that site must have a CLIA number and must be inspected. If a pathologist works in two locations, takes slides from one place to another, and makes diagnoses at the second site, that location must also be licensed and inspected for the discipline being performed. For example, a pathologist might wish to review Pap tests while waiting for a frozen section at a smaller hospital whose laboratory is not licensed or accredited for cytology. This would not comply with CLIA regulations.

New accreditation condition

In the "Technical Issues" section on its Web site, CMS recently announced the modification of the CLIA regulatory provision that allows a laboratory up to six months to notify CMS (or its designee) of any changes in the tests it performs [PHSA section 353(d)(1)(A)]. Affecting laboratories with either a certificate of compliance or a certificate of accreditation, the new interpretation reads as follows:

Performing tests outside approved specialties or subspecialties—If a laboratory wishes to begin testing outside its approved specialties or subspecialties, the laboratory must notify CMS (or its designee) prior to initiating patient testing in the new specialty or subspecialty. CMS (or its designee) must then determine compliance and establish the date the laboratory is approved to perform patient testing in the new specialty or subspecialty.

The CAP accreditation letter will be modified to require that labs notify the commission when there is an addition to their specialties/subspecialties. The College will then relay this information to CMS. The CAP regional commissioner will review the scope of the new testing and decide if a focused reinspection is required. Laboratories that report and bill for testing not on their CLIA certificate are violating federal requirements.

Complete conditions of accreditation

Laboratory accreditation by the College is valid for two years and may be maintained if certain conditions are met. One new condition is described above. The accreditation letter lists the following conditions:

  1. Provide an inspection team similar in size and composition to that required for your inspection and perform at least one inspection during the two-year accreditation cycle if asked to do so by the assigning commissioner.
  2. Submit an application for reinspection in time for it to be done before the laboratory's anniversary date. Application materials will be sent automatically; they must be completed and returned within 35 days of the date sent.
  3. Participate in the CAP Surveys or a CAP-approved alternative proficiency testing program.
  4. Notify the commission of changes in the laboratory's location, ownership, or directorship. Accreditation does not automatically survive such changes. Documentation, including a copy of the new director's curriculum vitae and an organizational chart, will be requested to evaluate accreditation status.
  5. Notify the commission, prior to beginning testing, of an addition to your laboratory's specialties/subspecialties. (New)
  6. Notify the commission whenever the laboratory is the subject of an investigation by a state or federal agency or adverse media attention related to laboratory performance.
  7. Submit a completed self-evaluation verification form in the interim year.

Specialty inspectors

Some specialty societies are interested in the level of training for inspectors in histocompatibility, molecular pathology, cytogenetics, and reproductive laboratory medicine. The LAP contends inspectors should be peers of the laboratory they are inspecting. If pathologist team leaders or team members routinely perform similar testing at their own laboratories, they should be qualified to inspect. If the team leader needs help finding a specialty inspector, the College can provide a list of qualified individuals in the area.

A breakout session was held at this meeting to discuss the best way to provide qualified inspectors. In these areas of special interests, we will follow the example of the cytopathology checklist, which reminds inspectors they should perform cytopathology in their own laboratory.

Renewal of JCAHO agreement

The Joint Commission for the Accreditation of Healthcare Organizations has announced that the LAP is the first of the JCAHO's cooperative agreement partners to meet the expanded criteria for participation. As a result, laboratories may continue to substitute accreditation by the College for inspection and accreditation by JCAHO.

Sentinel event reporting

The commission requires its accredited laboratories to be involved in sentinel event reporting. This new requirement is found in the note accompanying the question, GEN.20400, which will be modified as noted (see bold type):

GEN.20400 Is there a systematic program to identify and correct problems that may interfere with patient care services?

Note: There must be an organized method for documentation of all identified problems, irrespective of which shift or in which laboratory section they occur. There should be an emphasis on clinical, rather than business/management issues.

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.

Use of CAP checklists by vendors

Several companies have addressed CAP checklist questions in communications to laboratories purchasing their instruments, equipment, or supplies; some have asked to incorporate checklists into their software. We encourage their efforts to improve the quality of laboratory medicine.

However, the CAP checklists change over time, and it is the responsibility of the laboratory being inspected to be up-to-date. Labs cannot rely exclusively on publications or software provided by vendors. Checklists are copyrighted and require CAP approval for commercial use.

Commissioner job descriptions

Since we require laboratories to have job descriptions for all their employees, the commission has recently written more complete ones for the special commissioners of toxicology, reproductive, federal and state legislative and regulatory activity, education, systems, and nonroutine processes. This is in addition to the regional commissioners, state, deputy or division commissioners, and the regional assistants.

Injured inspectors

A hypothetical question was raised concerning inspectors who are injured as a result of conducting an inspection. Such instances will have to be handled case by case. While the College insurance policy should cover the inspector, ultimately coverage depends on the specific facts. Inspectors are reminded to comply with laboratory policies and to use personal protective equipment and clothing, as appropriate, while in the laboratory.

Special training for new laboratories

Some hospital laboratories would prefer to be accredited by the CAP, but say the amount of work required is overwhelming. The commissioners discussed possible educational programs to help laboratories prepare for an inspection. We will develop breakout sessions to address this need and will offer these at our training sessions.

RLAP program combined with LAP

Approximately 15 percent of the laboratories in the Reproductive Laboratory Accreditation Program perform only embryology testing and are not required to have a CLIA number. These laboratories must have a formal agreement with another laboratory to which they refer high-complexity testing. When the LAP inspects these laboratories, no report is sent to CMS. If any other testing is performed, a CLIA number is required. Under a new proposal, these laboratories would be incorporated into the LAP's main program, and the team leader provided with a special inspector for the RLAP portion.

New inspector training format

The education commissioner reported on the new format for training inspectors. This will be much more interactive and will include common inspection scenarios regarding interpretation of a checklist question or an approach used to address particular questions. The participants will be asked to evaluate these situations, responses to checklist questions, sample procedures, charts, and manuals, then vote on whether they would cite a deficiency, give a recommendation, or accept what the laboratory is doing. The answers will be discussed with the group.

Ideal number of inspectors

Over the years, there has been an "inspector creep," with each subsequent team leader taking more inspectors than were used on the previous inspection. The most extreme examples have involved inspection teams larger than the laboratory's employee complement. This creates huge problems for the lab during the inspection, with personnel attempting to answer questions from multiple inspectors simultaneously.

Commissioners agreed it is usually easy to determine the correct number of inspectors. Recommendations will be given to team leaders based on the experience of the regional commissioners and on information provided by the laboratory. A small group of commissioners is monitoring a sample of laboratory inspections to compare the number of inspectors recommended against the actual number taken on an inspection. This issue will be covered during the training seminars in a breakout session for team leaders.

Answering participant questions

Consistency in responding to questions asked by laboratorians was discussed. The College receives 25 to 30 letters a week and receives more than 30 e-mails per week. The questions are circulated among the technical associates to make them aware of the questions and to provide uniform answers. Responses to questions are reviewed by regional commissioners with responsibility for a given checklist. The answers are then filed electronically for use the next time the question is asked.

Customized checklists

A subcommittee continues to develop plans for customized checklists. The goal is for the inspector to take questions only for activities performed at the laboratory.

An example: The laboratory does not perform electron microscopy or do hemoglobin electrophoresis. These questions would not be printed for the anatomic pathology and hematology checklists sent to the inspector. This information would be gleaned from the laboratory's activity menu, proficiency survey subscriptions, and other information in the application packet. When in doubt, questions would be retained, as it is better to have slightly too many questions and mark them "not applicable" than to inspect the laboratory and find that the questions needed are not immediately available.

study has been done and another is planned to refine the process before it is made available for all inspections.

Systems inspections

The systems inspection program was discussed in a breakout session. This program is not currently accepting new laboratory systems. Labs in this program will have to demonstrate progressively more integration between laboratories in the same system as time goes on.

Next meeting

The commission will meet in Chicago on July 11-13. The state and division commissioners update is planned for July 13.