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  Commission Forges Ahead
  on Many Fronts

 

May 2005
Originally published in CAP TODAY

Desiree A. Carlson, MD, Editor, Laboratory Accreditation News

Cytology PT requirement
Appealing denial or revocation of accreditation
Unannounced inspections
Scope of testing
Patient safety goals
Nonroutine inspections
Team leader checklist
Posters in the laboratory
Abbreviations on computer-generated reports
Reporting laboratory results
Ideal number of inspectors
Post-inspection review of deficiencies
Team leader training
Checklist commissioner report
ISO accreditation

Cytology PT requirement

The Centers for Medicare and Medicaid Services has confirmed that all labs subject to CLIA '88 must ensure that all required individuals are enrolled in a CMS-approved gynecologic cytology PT program by June 30. CMS is also requiring all individuals to be tested by Dec. 31. Individuals can postpone their testing in extenuating circumstances, but it must be completed by April 2, 2006. Each person must achieve a passing score by Dec. 31, 2006.

The College has submitted a Pap proficiency testing program to CMS. However, this program will not meet the 2005 compliance requirement, even if it is approved before June 30.

Those pathologists and cytotechnologists who work in Veterans Administration or Department of Defense facilities or international facilities are not required to participate in a CMS-approved PT program. To monitor their performance, the Commission on Laboratory Accreditation voted to add a checklist question to the cytopathology checklist requiring labs that are not subject to CLIA regulations to participate in a CAP-approved educational program in cytopathology.

Appealing denial or revocation of accreditation

The CLA upheld the CAP executive committee's recommendation to retain the one-year time period from when a laboratory's accreditation is denied or revoked until it is permitted to reapply for inspection and accreditation. The College determined that these laboratories need adequate time to correct deficiencies and demonstrate compliance.

Unannounced inspections

A CLA task force is developing a plan to move to unannounced domestic inspections in 2006 in response to the Joint Commission on Accreditation of Healthcare Organizations' stated requirement for continued reciprocal recognition.

The commission will review the plan at next month's meeting. Once it is approved, the CAP will share the plan with its accredited laboratories.

Scope of testing

LAP commissioners recently discussed how using different matrices, such as hair or saliva versus blood and urine, can affect the College's ability to inspect and accredit laboratories. In many cases, no proficiency testing material is available for these matrices and publications offer insufficient information on reference ranges. Yet if qualitative results are not confirmed for a laboratory, it does not qualify for the CAP's forensic urine drug testing program.

The College is looking into how to better serve laboratories using different matrices. The College reviews all applications for inspection to ensure that a laboratory is doing the majority of its testing in areas where the CLA and its inspectors have expertise.

Patient safety goals

Richard Friedberg, MD, PhD, chair of the CAP Patient Safety and Performance Measures Committee, recently gave a presentation to the commission on patient safety.

Laboratorians have used quality control and quality improvement to label what they do in the laboratory, he says, while other health care workers and the public are more in tune with the concept of safety.

The College's four main safety goals are to improve patient and sample identification; improve verification and communication of life-threatening or life-altering information; improve identification, communication, and correction of errors; and improve integration and coordination of the laboratory patient safety role within health care organizations. While many checklist questions address these goals, the checklist commissioner will be working additional safety questions into the checklists.

Nonroutine inspections

The College has conducted a greater number of nonroutine inspections during the past 12 months than in the past. When the College determines that a laboratory may be a potential problem lab, it notifies the JCAHO, CMS, and the state where the laboratory is located.

Team leader checklist

The CLA is developing a checklist for pathologist team leaders to use during laboratory inspections. The new checklist will contain the questions in the laboratory general checklist pertaining to the laboratory director's responsibilities, as well as questions about the overall quality of the laboratory and its quality management plan. It will address for the director and team leader the requirements of the director.

Posters in the laboratory

The CAP has, since October, required laboratories to hang posters listing a toll-free phone number that employees or patients can use to report problems that are not being resolved using the laboratory's standard procedures. A new checklist question has been added so inspectors can document that the posters are in place.

The posters have generated an increased number of calls to the College. However, many of the complaints have focused on nonaccreditation issues rather than laboratory testing practice or quality issues. The College has not received any negative feedback on the posters from laboratory directors.

Abbreviations on computer-generated reports

The JCAHO originally exempted computer-generated laboratory reports from a requirement for accredited organizations to develop a standardized list of abbreviations that should not be used throughout an organization. The "do not use abbreviations" policy is based on concern about the potential increased risk of medical errors from misinterpreting certain abbreviations.

Last year, the JCAHO considered removing the exemption. During a special JCAHO summit meeting addressing this issue, the CAP provided information discouraging such a move. The consensus reached at the meeting was that computer-generated reports of laboratory values should remain exempt. Subsequently, the JCAHO requested that respondents indicate whether they agree or disagree with this conclusion. Those responses were being reviewed by the JCAHO at CAP TODAY press time.

Reporting laboratory results

The JCAHO has stated that all hospitals must designate which personnel are eligible to receive verbal reports of critical laboratory results. Each laboratory should review its state requirements pertaining to this and write a policy.

Ideal number of inspectors

The commission continues to refine its algorithm for estimating the number of inspectors required to perform inspections, based on the number and complexity of the checklists required. While the algorithm has worked well in most cases, additional adjustments may be needed for large laboratories that require more than 19 inspector days.

Because it is important to train future team leaders, pathology residents can be included on inspection teams, but they should be used judiciously.

When making travel arrangements, the CAP travel desk will ask for justification if the team leader plans to take a significantly greater number of team members than indicated.

Post-inspection review of deficiencies

The new goal for post-inspection review set by the CAP central office and reviewing commissioners is 75 days after the inspection is completed, down from 120 days. Laboratories are reminded on the day of inspection that they have 30 days to send back corrections for deficiencies cited.

This documentation is now being scanned into the CAP computer system, speeding up the review process, as many labs have requested.

Team leader training

The evening team leader symposium has been reinstated by Frank Sharkey, MD, the new LAP education commissioner, and the CAP's division of education. The symposiums will start in the second half of the year. In some cases, a laboratory inspection will be held the next day.

Some potential team leaders will be able to watch experienced inspectors perform that inspection. Others will be offered an opportunity to attend inspections in their region in subsequent months.

Nine audioconferences are scheduled for 2005 to help laboratorians and inspectors understand the requirements for good laboratory practice. Nine regular inspector training seminars were scheduled for the first half of the year. A video about the inspection practice is also being developed.

Checklist commissioner report

LAP checklist commissioner Stephen Sarewitz, MD, recently reported on four new phase II checklist questions. They pertain to the CAP whistleblower poster in labs, communication of patient concerns or employee safety issues in the lab, the reporting of laboratory instrument problems and safety issues to the FDA, and the requirement that labs periodically summarize and appraise errors.

Wording in the checklists has been changed from "quality improvement" to "quality management." Additional questions about the laboratory director's responsibilities and patient safety will be added. Dr. Sarewitz will also create a question relating to how the laboratory gives feedback on quality to processing-only laboratories.

ISO accreditation

LAP inter-regional commissioner William Castellani, MD, and a working group of commissioners continue to focus on the ISO checklist and inspector education required to perform this new type of laboratory inspection. Laboratories, particularly those in other countries, have shown a great deal of interest in the CAP offering ISO accreditation.