Relationship building, reimbursement, and regulatory requirements were just a few of the topics at the Commission on Laboratory Accreditation meeting held in Chicago on July 11 and 12. Following are highlights of the commission meeting and the accompanying state commissioners meeting held on July 13.
Confidentiality for whistleblowers
The Commission on Laboratory Accreditation occasionally receives complaints or learns of potential problems through dissatisfied patients or clients or via whistleblowers, governmental agencies, or the media. All accusations and complaints are investigated in accord with policy requirements. The commissioner for non-routine processes, and if necessary, the executive committee of the commission, reviews the results of investigations.
CAP policy requires that reasonable efforts be made to maintain the confidentiality of the investigation and the identity of the complainant. This is done to protect the complainant and to reassure laboratories that their responses will be maintained with reasonable confidentiality.
Regulatory agencies or accrediting organizations with whom the College has a formal agreement, such as state agencies, the Centers for Medicare and Medicaid Services, and the Joint Commission for the Accreditation of Healthcare Organizations, perform validation inspections on a small percentage of CAP-accredited laboratories. The commission reviews the results of these validation inspections to determine how to improve the inspection process and increase consistency between inspections. The commission also uses the information in developing inspector training sessions.
Working with international labs
The College and the Singapore Accreditation Council entered into a relationship in August to develop a jointly sponsored inspection and accreditation program in Singapore. The College continues to field inquiries from other countries with an interest in improving laboratories. This interest in accreditation is sparked by a number of factors: the national government may recognize how accreditation positively affects the quality of laboratory medicine; accreditation by the College allows laboratories to participate in clinical drug trials sponsored by major international pharmaceutical companies; and laboratory directors trained in the United States recognize the value of CAP accreditation.
Relationships with AABB and UNOS
Laboratory Accreditation Program staff continue to work closely with staff of the American Association of Blood Banks to develop a mechanism of mutual recognition. These discussions have been underway for several years. The CAP and AABB once had similar checklists, but the AABB's inspection process has changed significantly, making coordinated inspections more difficult. Laboratories, however, can still request a coordinated inspection in which a single inspector, or inspection team, conducts a single inspection of the donor/transfusion service using both organizations' inspection tools.
The College is also in discussion with the United Network for Organs Sharing about recognizing that any lab accredited by the LAP for histocompatibility satisfies UNOS' histocompatibility laboratory standards.
An article in the June 10 issue of Modern Healthcare noted that the president of the American Hospital Association, Richard Davidson, had asked the JCAHO to consider using teams of volunteer non-JCAHO surveyors drawn from hospitals. JCAHO President Dennis O'Leary, MD, stated in the article that it is worth pilot testing some form of this proposal. Because this is the model the College has long employed, we will be watching this with considerable interest.
The LAP requires labs to perform an interim self-inspection on alternate years, between the on-site inspections performed by an outside team. The LAP has developed a procedure whereby the LAP computer will automatically send a certified reminder letter after a self-inspection document is due if the College has not received that document. If the laboratory does not respond, it will be notified that the executive committee of the CLA will review the situation and may revoke the laboratory's accreditation.
This new procedure is directed at laboratories that have no intention of completing their self-inspection and that plan to drop out of the program by their next anniversary date. It is not intended to punish laboratories that plan to do the inspection but have encountered extenuating circumstances. An appeals process will help determine why labs are noncompliant.
The College occasionally receives requests for reimbursement for locum
tenens for inspection team leaders. These requests are denied. Under standard IV of the CAP Standards for Laboratory Accreditation, each laboratory is required to provide a team every two years comparable to the team that is needed for its own inspection.
Reimbursement for inspection expenses
The College reimburses for usual expenses associated with performing an inspection. The dollar amounts allowed for meals are printed on the reimbursement form. Hotel accommodations should be reasonable for the geographic location. The College does not reimburse for nonroutine items, such as speeding tickets.
The CAP travel desk (800-323-4040, ext. 7800) can help make air travel arrangements for inspection-related work. Chartered travel arrangements must be approved in advance, and final arrangements must by made through the CAP travel office and purchasing department.
Annual review of procedure manuals
An LAP participant has asked the commission to reconsider the requirement in each discipline-specific checklist that procedure manuals be reviewed and signed by the director or designee annually. The commission discussed the request and overwhelmingly voted to retain the requirement for annual procedure manual review. The medical director can delegate this review; however, many commissioners felt that this is the one time the director can critically assess each procedure and determine if it reflects laboratory practice or should be revised to do so. It is especially critical to review new and existing procedures when a change is made and to document when procedures are retired.
Releasing specimens to patients
Laboratories should develop policies and procedures to handle requests from patients and physicians who would like explanted specimens, such as orthopedic hardware, teeth, and gallstones. Laboratories should, however, follow the CAP's recommended specimen-retention guidelines, which are available on the CAP Web site, www.cap.org.
Laboratories must retain all surgical pathology specimens for two weeks after issuing the final report, according to the guidelines. Patients, therefore, cannot pick up their specimens on their way home in most cases.
Several states have specific requirements governing the licensure of medical technologists and the practice of laboratory medicine. While the checklists may not address these requirements individually, the medical director must sign a statement attesting that the laboratory is in compliance with all applicable state and local requirements.
Inter-regional inspection program
The largest laboratories accredited by the College are usually part of region 15, termed the inter-region. These laboratories, which are often associated with academic institutions, are assigned to the inter-region to ensure that their inspections are conducted by teams from laboratories that are true peers. Due to the number of inspectors required to inspect such labs in a reasonable amount of time, the average lab cannot be expected to perform this function. Once assigned to the inter-region, laboratories are no longer obligated to provide inspection teams for the region in which they are geographically located, although they are encouraged to provide additional inspection teams if possible. The College plans to reassess labs in the inter-region to ensure that each one still belongs in this category.
Marketing department report
In recent surveys of inspected laboratories, team leaders, and team members, more than 97 percent of laboratories rated the inspection process an average of 4.5 out of a possible 5. Some opportunities for improvement were noted, such as assigning the team leader earlier, improving communication between the team leader and the inspected laboratory about setting the inspection date, sending the correct number of team members, reducing redundancy of checklist questions, and having more consistent interpretation of checklist questions. These items will be incorporated into future training seminars.
The American College of Surgeons Commission on Cancer will soon require the labs associated with the cancer programs they accredit to use CAP cancer reporting protocols (synoptic reports). Since these protocols were not developed with this requirement in mind, the CAP Cancer Committee is revising the protocols and will be marking required fields. The protocols will be available on the CAP Web site, www.cap.org.
This ASC requirement is scheduled to take effect Jan. 1. At this time, the LAP does not mandate use of the cancer protocols.
Alternative PT providers
The College has approved elements of proficiency testing programs from seven providers. The CAP grants such approval after the providers have demonstrated that they comply with criteria published several years ago by the CLA. Approval is granted on an analyte-by-analyte basis. Once a program's analyte is approved, laboratories may use proficiency testing results for that analyte to satisfy the LAP requirement for PT coverage.
Providers with approved analytes include AccuTest, California Thoracic Society, South Eastern Organ Procurement Foundation, and Wisconsin State Laboratory of Hygiene. Approved providers for cervicovaginal cytopathology include the American Society for Clinical Pathology (ASCPStar), the state of Maryland, and Midwest Institute for Medical Education.
The Department of Health and Human Services released in August the final modifications to the Health Insurance Portability and Accountability Act privacy rule. The rule requires that private nonprofit accrediting agencies approved by HHS (business associates) establish agreements between each accredited entity and the accrediting agency to protect the privacy and security of individuals' health care information.
HHS rejected the College's argument that it should be considered a health oversight agency, and as such, would be exempt from this agreement. HHS, however, attempted to mitigate the burden of complying with business associate agreements by providing a clause permitting a covered entity to disclose a limited data set of protected health information, not including direct identifiers, for accreditation and other health care operations purposes subject to a data use agreement. Because HHS rejected the College's arguments, any laboratory inspected by the CAP or any other accrediting agency will be required to have an agreement between it and the accrediting agency protecting the privacy and security of individuals' health information.
The College is developing for its accredited labs a standardized model agreement to be used to meet the HIPAA requirement, which it will post on the CAP Web site at a later date.
Education committee report
The CLA Education Committee, under the leadership of Thomas Merrick, MD, is pursuing ways to more effectively train laboratory participants preparing for an inspection. The committee plans a three-pronged approach, including the current live instructor-led seminars, audio conferences, and new online programs. This new programming will be added to current efforts to train team leaders and team members to inspect.
The commission approved the new approach, and the CLA will develop and test a few modules before rolling out the program in its entirety.
The CLA subcommittee working on custom checklists continues to develop ways to reduce the number of unnecessary questions posed to the laboratory by the inspector while not omitting questions related to laboratory activities.
The activity menu in the inspection application identifies those tests the laboratory performs and may serve as a guide to the customization process. In several trials, laboratories have used a slightly modified table of contents to check off what they do and thus identify applicable questions. The laboratories' responses have been compared to what the inspectors found during the inspections. Although the CLA is still fine-tuning this process, it has decided to move ahead with checklist customization at the discipline/subdiscipline level. Under this approach, checklist questions associated with disciplines not relevant to the laboratory will not be included in the checklists for that laboratory.
FUDT and LAP merger
The CAP Forensic Urine Drug Testing Program will be merged into the main Laboratory Accreditation Program. The FUDT assigning commissioner will work with the LAP assigning commissioner to ensure the combined team has the appropriate number of members with the necessary expertise. The FUDT assigning commissioner will assign inspectors for laboratories that perform only forensic urine drug testing. The FUDT commissioner will review responses to the forensic urine drug testing checklist deficiencies. The LAP commissioner will review responses to all other deficiencies.
RLAP and LAP merger
CAP headquarters staff are working to integrate the Reproductive Laboratory Accreditation Program into the Laboratory Accreditation Program. This merger will not change either program but will simplify their administration.
Inspection team check-off list
One of the breakout groups at the commission meeting focused on developing a check-off list that inspection team leaders can use in preparing for and conducting inspections. A draft was approved by the commission. The final list will be included in materials sent to the inspection team leader in advance of the inspection and will be available on the CAP Web site at a later date.
State commissioners meeting
Several of the regional and special commissioners presented new information to the state commissioners during the update on July 13. They discussed the use of specialty inspectors in more esoteric areas of laboratory testing, such as histocompatibility, molecular pathology, and cytogenetics; how to determine the correct number of inspectors for an inspection; the requirement that all accredited laboratories provide an inspection team if asked; the new job descriptions for commissioners; the new, more interactive training format; the progress being made on customizing checklists; and the new pricing structure, which was implemented since the last state commissioners meeting.
Changes to the LAP
Changes to LAP policies and procedures will be communicated to participants three times per year via "Laboratory Accreditation News" in cap today. "Laboratory Accreditation News" can be downloaded from the CAP Web site at http://www.cap.org/
The commission will hold its next regular meeting in San Antonio on Oct. 31 and Nov. 1. An inspector training seminar will be held on Nov. 2.