College of American Pathologists
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  CAP adds council, readies new
  inspection processes


December 2005
Originally published in CAP TODAY

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

The CAP Commission on Laboratory Accreditation has been focusing on the following areas in recent months.

Council on Laboratory Accreditation

The College has changed the structure of the Commission on Laboratory Accreditation by adding a new council, called the Council on Laboratory Accreditation. The CAP created the council to help the commission balance its educational and regulatory responsibilities, enhance the consistency, objectivity, and effectiveness of the inspection process, and, in general, facilitate changes to the CAP Laboratory Accreditation Program.

CAP Board member Stephen Bauer, MD, was installed as chair of the council in September. Concurrently, R. Bruce Williams, MD, took over as chair of the Commission on Laboratory Accreditation, replacing Ronald B. Lepoff, MD, who was appointed CAP secretary/treasurer.

Unannounced inspections

The CAP is moving to unannounced inspections in 2006, in part to reassure the public about the objectivity and integrity of the inspection process, and also to verify that laboratories comply with CAP standards at all times. Unannounced inspections will take place within the six months prior to a lab's anniversary date. Laboratories with anniversary dates of June 1, 2006 and later will be the first to be affected by the change.

As part of the unannounced inspection process, laboratories will not know the date of their accreditation inspection, nor will they be told in advance the name of their inspection team leader or team members. Consequently, the application process will gather more detailed information about the lab, including 10 blackout days during which no inspection will take place. This new process will not initially apply to international laboratories, reproductive or forensic urine drug testing laboratories, or labs undergoing their initial inspection.

Continuous monitoring for sustained compliance

The CAP will strengthen its process for monitoring laboratories that exhibit quality indicators of concern, such as recurring or substantial deficiencies, that place them at risk of noncompliance. These labs will be monitored through unannounced, nonroutine inspections and periodic requests for documentation between inspections.

The College will communicate the names of these labs to the Centers for Medicare and Medicaid Services, state authorities, and other appropriate accrediting organizations for their potential review. Beginning in 2006, the College will also intensify its scrutiny of laboratories' proficiency testing results to identify trending patterns.

Altering recommendations after inspections

Regional commissioners have always been allowed to act on a recommendation after an inspection if it was thought that the recommendation would improve the quality of testing in a laboratory or if it was inadvertently not cited as a deficiency. The commission approved a policy at its September meeting that would allow regional commissioners to officially escalate the recommendation to a deficiency in such cases and add it to the final report.

The College believes this policy will codify practice and bring more consistency to the CAP's accreditation processes, as well as strengthen a laboratory's quality improvement efforts.

Team leader checklist

The CAP has heightened its focus on the role of the laboratory director in ensuring laboratory quality and compliance with established program standards. In October, the College implemented the Team Leader Assessment of Lab Director and Quality checklist to help team leaders assess the qualifications and effectiveness of the laboratory director.

Team leaders will focus on the lab director's authority, involvement, and oversight in implementing and maintaining CAP accreditation standards.

Training requirements

The College will strengthen the qualification requirements for inspectors by requiring them to complete CAP training. The training will promote consistency in inspectors' understanding of program standards and ensure that techniques are applied uniformly to achieve more consistent and effective inspections.

All team leaders assigned after July 2006 will be required to undergo mandatory training. Mandatory training eventually will be required for team members as well. Team leaders, and eventually team members, will have to complete training every two years.

Team leader evening workshops are planned for each region of the country in 2006. In addition, full-day and half-day training seminars will be held in conjunction with CAP national meetings and specialty society meetings. The CAP will also provide online training beginning in late spring 2006. The College believes that most inspectors will complete their training requirements online.

Role of the regional commissioner

The Council on Laboratory Accreditation and the commission are considering updating the role of the regional commissioner to take advantage of the professional skills and expertise of these pathologists by having smaller groups of regional commissioners work on defined areas, such as education and training, checklist development, and nonroutine processes, to assist CAP special commissioners.

Special commissioners are already in place for checklists, systems inspections, education, and nonroutine processes, such as complaints and proficiency testing.

Inspection techniques in checklists

The CAP is restructuring its onsite inspection tool to provide specific direction to inspectors on conducting effective inspections, including more thoroughly documenting inspection findings. The College began including in the first part of all checklists, in October, inspection techniques that can be used to gather information about the laboratory. Such techniques include communication with bench-level personnel and direct observation of testing to ensure that written policies and procedures reflect laboratory practice.

Team assignments

The CAP has begun to centralize the team assignment process to ensure that inspection teams are selected objectively and matched to the size and complexity of the laboratory being inspected. The CAP headquarters will do the initial team leader matches. The CAP will seek approval from the state commissioner, who is knowledgeable about local situations and can confirm that the most appropriate person has been selected.

Referral of PT samples

CLIA and CAP checklists explicitly point out that a laboratory should not refer proficiency testing samples to another laboratory nor should it communicate with another laboratory prior to its PT evaluation date. Laboratories that do not adhere to these rules may be severely penalized by CMS and have their CAP accreditation revoked or denied.

A laboratory could, for example, lose its CLIA license for up to one year or the laboratory director could be prevented from operating a laboratory for up to two years for such a violation. These penalties could be imposed on both the sending and receiving laboratory. The sanctions would apply even if the laboratory director had a policy in place forbidding such actions and had no knowledge of the specific event.

While these rules are widely known, a laboratory may inadvertently refer a PT specimen to another laboratory. This can easily occur in networks with multiple CLIA laboratories or with laboratories that are associated with each other by physical location or through common management.

A good rule of thumb is for laboratories to avoid testing, checking, or reviewing PT samples or slides obtained from another CLIA laboratory. This rule also applies to a secondary review of a slide or sample by a pathologist who is not on the premises at the time of a review. In this case, the pathologist should not conduct the review from another location but should wait until he or she is at the lab where the PT sample has been tested. The laboratory also has the option of reporting "test not performed" on the PT result form.

PT "reinstatement" materials

If a laboratory's proficiency testing performance is such that the CAP has requested that it cease testing for a particular analyte or discipline, the laboratory can use special "reinstatement" PT materials to demonstrate that it has corrected the problem. The CAP is reviewing the availability of these materials to ensure that an adequate supply is available when needed.

Laboratory video

The CAP is reinforcing with laboratory personnel the pivotal role they play in the accreditation process and in the quality of testing performed in their institution. Consequently, the College will, through an educational DVD, encourage laboratory personnel to participate in the inspection process. This video, which explains the accreditation cycle, will be distributed in reapplication packets beginning next month.

  Laboratory Accreditation