College of American Pathologists
Printable Version

  Commission raises bar
  for inspectors, inspections




September 2005
PAP/NGC Programs Review

Desiree A. Carolson, MD

Unannounced Inspections | Team leader checklist | Forms for new lab directors | Inspector training time frame | Notifying CAP of legal problems | Addressing patient safety | High-complexity testing | Accreditation timeline | Qualified inspectors | Labs with poor PT scores | Inspection tools | Use of staff inspectors | CLA improvement projects | New training modules | Validating the CAP inspection process | Equivalent quality control

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

Unannounced inspections

Unannounced inspections will start next year. The College has always maintained that laboratories should be ready to be inspected at any time. With unannounced inspections, some inspection details will not be able to be arranged in advance, such as the location of the summation conference, lunch arrangements, and scheduling appointments with the team leader and members of the medical staff and hospital administration. These arrangements will need to be made the day the inspector arrives.

Inspections will take place within a 90-day window around the accreditation anniversary date. Laboratories will be allowed to select 10 black-out dates during this time.

Laboratories will receive more information about unannounced inspections this fall.

Team leader checklist

The purpose of the new team leader checklist is to give additional guidance to team leaders and to ensure that they are asking the appropriate questions during the inspection. Some of the questions in the checklist come from the laboratory general checklist and others are new.

The checklist includes explanatory and instructional information about interviews with the laboratory director, hospital administrator, and representative of the medical staff. The laboratory director's responsibilities, which are detailed in the "Standards for Laboratory Accreditation," are covered in the checklist questions so the inspector will be able to understand how the laboratory director ensures that these responsibilities are performed. The team leader will also be evaluating the quality management plan, with input from each of the team members who has reviewed each laboratory section in detail.

Forms for new lab directors

The College will soon be sending out revised forms that must be completed by an accredited laboratory when that laboratory names a new director. The new director will be required to attest on the form that he or she personally performs each of the 14 responsibilities from LAP standard I or delegates some of those responsibilities, and if so, to whom, and monitors these functions. This form will also be used when a new laboratory applies for inspection. In addition to supplying a curriculum vitae, the laboratory director will be asked how he or she meets the laboratory experience requirements of CLIA '88.

Inspector training time frame

Beginning next year, all team leaders and team members will be required to successfully complete inspector training, as specified by the CLA, within two years prior to conducting an inspection. In the past, such training was encouraged, and the recommended time frame was three years prior to an inspection.

Laboratories and CAP inspectors will be receiving more information about these requirements this fall.

Notifying CAP of legal problems

The CLA revised its policy that laboratories notify the College when they receive adverse media attention or they are being investigated by another agency. The commission added the requirement that a laboratory notify the CAP when it discovers that an employee is violating a federal, state, or local law that regulates laboratories.

Addressing patient safety

Laboratories will soon see new checklist questions that address the CAP's national laboratory patient safety goals. A question about patient safety goals will be added to the quality management plan section of the laboratory general checklist to ensure that patient safety within the laboratory is coordinated with other hospital services and that safety problems are identified and corrected. The question will specifically state:

Does the laboratory address the current CAP national laboratory patient safety goals?

Note: The current CAP national laboratory patient safety goals are: 1. improve patient and sample identification at specimen collection, analysis, and resulting; 2. improve verification and communication of life-threatening or life-altering information regarding malignancies, HIV (and other serious infectious diseases), cytogenetic abnormalities, and critical values; 3. improve identification, communication, and correction of errors in a timely manner; 4. improve the coordination of the laboratory's patient safety role within health care organizations. The laboratory must document that these goals have been addressed by evaluation and/or monitoring of the processes involved.

The last sentence of the checklist question notes that there is no expectation that the lab necessarily monitor a key indicator for each of the CAP patient safety goals. The lab should, however, conduct a "mini-audit" to determine if its policies, processes, and procedures are adequate in each of the four areas and to make any necessary modifications and, if appropriate, monitor key indicators to assess its performance.

High-complexity testing

A question has been added to the April 28, 2005 edition of the anatomic pathology checklist to clarify that specimen dissection is considered high-complexity testing under the CLIA regulations and that all individuals performing this function must meet the CLIA qualifications for high-complexity testing personnel. The phase II question (ANP.11610) reads:

If specimens are dissected by individuals other than a pathologist or pathology resident, do such individuals qualify as high-complexity testing personnel under CLIA '88 regulations?

Note: The laboratory director may delegate the dissection of specimens to non-pathologist individuals; these individuals must be qualified as high-complexity testing personnel under CLIA '88 regulations. The minimum training/experience required of such personnel is: 1. an earned associate degree in a laboratory science or medical laboratory technology obtained from an accredited institution, or 2. education/training equivalent to the above that includes at least 60 semester hours or equivalent from an accredited institution. This education must include 24 semester hours of medical laboratory technology courses or 24 semester hours of science courses that includes six semester hours of chemistry, six semester hours of biology, and 12 semester hours of chemistry, biology, or medical laboratory technology in any combination. In addition, the individual must have laboratory training including either completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS (note that this training may be included in the 60 semester hours listed above), or at least three months documented laboratory training in each specialty in which the individual performs high-complexity testing.

In addition, the CLIA '88 regulations include exceptions for grandfathered individuals; these regulations (42CFR493.1489 and 1491) may be found at

This checklist question applies only to laboratories subject to CLIA '88.

Accreditation timeline

Increased use of online data collection and review in lieu of an entirely manual, paper-based system has allowed the commission to shorten the timeline from inspection to accreditation. The goal is for the College to make accreditation decisions no later than 75 days after a laboratory is inspected, down from 120 days.

Qualified inspectors

The team leader for inspections, including histocompatibility, cytogenetics, and molecular pathology section inspections, receives a list of qualified inspectors who have been approved based on training, credentials, and experience. The CAP central office has been contacting team leaders before inspections to ensure that a qualified team member will be inspecting these areas. If the team leader wants to take a member of his or her department who has not been approved by the appropriate CAP scientific resource committee, the College must approve that person prior to the inspection. This is another way to increase the number of qualified inspectors for each area.

Team leaders are encouraged to introduce pathology residents and fellows to the inspection process since they are potential team leaders. The residents and fellows should inspect areas consistent with their level of expertise and generally should not inspect anatomic pathology, cytopathology, flow cytometry, cytogenetics, and histocompatibility since special qualifications are required to inspect these areas. Suggested areas for them to inspect include small hematology laboratories, coagulation, urinalysis, and blood gas laboratories.

Labs with poor PT scores

If a laboratory has unsatisfactory performance, meaning it scored less than 80 percent on a Survey with five challenges (less than 100 percent in transfusion medicine), it is required to investigate and document its corrective action. The laboratory must retain this documentation so it can be reviewed during the next CAP on-site inspector visit. If the laboratory is unsuccessful, meaning it scored less than 80 percent on two out of three proficiency testing events, it must send documentation of its investigation of the problem and corrective action to the College. All tests, whether or not regulated by CMS, are managed the same way.

If a laboratory has a critical proficiency testing failure, meaning that three of four consecutive PT events have a score of less than 80 percent, the laboratory will be required to cease testing for this analyte and demonstrate acceptable performance on two reinstatement modules.

Inspection tools

Additional explanatory material, with helpful hints on how to conduct an inspection, will be added to each checklist starting with the October edition.

Use of staff inspectors

Staff inspectors are helping with many more inspections to provide consistency and additional information to team leaders for nonroutine inspections, systems inspections, and certain routine inspections where their expertise is helpful. They are also inspecting small laboratories, especially if there is no pathologist director and no anatomic pathology service.

CLA improvement projects

Laboratory Accreditation Program staff are working on key projects to improve inspection and accreditation processes. Among them are a video for laboratory personnel to view prior to an inspection so they understand the inspection process, projects for enhancing educational opportunities for inspection team leaders and team members, and upgraded computer capabilities for tracking laboratory performance. Additional information about these projects will be sent to laboratories later this year.

New training modules

The College has introduced new inspector training modules, including "Managing a Successful Inspection" and "Best Inspection Techniques." Both modules emphasize the type of interaction and communication that should occur during the inspection.

The CAP's education and communication services divisions are preparing a video for laboratories involved in the inspection process to explain what is expected during the inspection and how the inspection process benefits the laboratory and patients.

Validating the CAP inspection process

Commissioners recently recommended that the College set up its own quality management system for the Laboratory Accreditation Program so the CAP can validate its own inspection processes. Such a system might include spot checking certain areas by conducting focused on-site validation inspections, having a staff member accompany a team, or having the laboratory submit documentation for certain checklist questions, even if it was not cited with a deficiency, to evaluate its compliance.

Equivalent quality control

The Centers for Medicare and Medicaid Services has decided not to implement proposed alternative quality control requirements at this time. CMS has solicited more input from manufacturers and accrediting organizations on the scientific basis of quality control as it applies to single-use testing devices.

A conference to further review these issues will be held in March 2006 under the aegis of the Clinical and Laboratory Standards Institute, or CLSI.