VHA Diagnostic Electron Microscopy Program
CAP Question Regarding Annual External Peer Review
Posted below is a query submitted to the National EM Program regarding a CAP accreditation checklist question which may also present itself in your local facility. The Pathology and Laboratory Medicine Service National Enforcement Officer contacted CAP and obtained a response from Ed Gruber in the accreditation division of the CAP.
It is my understanding that the CAP has recently started requiring electron microscopy labs to have external evaluations of their cases twice a year. Rigorous and excellent though your annual reviews are, they are only once a year. Will this suffice or will each lab have to get someone else to evaluate it so that it happens twice a year? It probably would be best if this were clarified at a national level. I'd be very grateful if you would discuss this with Dr. Shelburne and the CAP, then get back to me.
This question has been discussed with the CAP by Michael A. Brophy, National Enforcement Officer, Pathology and Laboratory Medicine Service (115a) after consultations with Dr. Ted Beals and Dr. John Shelburne. Specifically, Mr. Ed Gruber [mailto: email@example.com]of the CAP accreditation division provided the following guidelines, per e-mail from Michael Brophy:
E-mail from Michael Brophy:
As I indicated earlier today via phone, I have discussed the issue of proficiency testing in electron microscopy with Mr. Ed Gruber in the CAP accreditation division. Mr. Gruber suggested that we respond to the phase II questions that were cited with the suggestion that these general checklist questions were misapplied. The more appropriate question which addresses this aspect of electron microscopy is the question listed below (08.02000 or ANP.02000).
QUESTION: ANP.02000 PHASE: I
As applicable, is the laboratory enrolled in or has it attempted to enroll in a peer educational program in anatomic pathology (e.g., CAP APEX program)?
NOTE: The laboratory should consider enrollment in programs appropriate to its scope of service (e.g., CAP APEX program). Such programs provide valuable educational opportunities for peer performance comparisons in both technical and diagnostic arenas. While none of these completely emulate the precise clinical setting involving anatomic pathology preparations and rendering of anatomic or clinical diagnoses, they can be a useful benchmark of peer-based performance in a national data base.
COMMENTARY: ANP.02000 PHASE: I
THE LABORATORY SHOULD ENROLL IN OR ATTEMPT TO ENROLL IN A PEER EDUCATIONAL PROGRAM IN ANATOMIC PATHOLOGY (e.g., CAP APEX PROGRAM). SUCH PROGRAMS PROVIDE VALUABLE EDUCATIONAL OPPORTUNITIES FOR PEER PERFORMANCE COMPARISONS IN BOTH TECHNICAL AND DIAGNOSTIC ARENAS. WHILE NONE OF THESE COMPLETELY EMULATE THE PRECISE CLINICAL SETTING INVOLVING ANATOMIC PATHOLOGY PREPARATIONS AND RENDERING OF ANATOMIC OR CLINICAL DIAGNOSES, THEY CAN BE A USEFUL BENCHMARK OF PEER-BASED PERFORMANCE IN A NATIONAL DATA BASE.
In addition, Mr. Gruber suggested that we provide a description of our program, which meets the intent of 08.02000 or ANP.02000. For your convenience, I have some sections of the EM Monitoring and Quality Assessment excerpts from VHA Handbook 1106.1 below.
(1) Appropriate monitoring procedures for emission of radiation from each electron microscope will be established in keeping the existing VA safety policy (MP-3, Pt. III, App. 5M).
(2) The following procedures are used in monitoring:
(a) Analysis of the numerical data in the workload section of the VistA Lab Module.
(b) Analysis of the annual report.
(c) Quality assessment by the Ad Hoc EM Review Group, annually and on an as needed basis.
c. Sharing Resources. The shared utilization of EM resources for diagnostic, research and education purposes is encouraged to promote optimal utilization.
(1) Such arrangements which include appropriate proration of recurring costs, will be developed locally, and specified in a written Structured Joint Utilization Agreement, ensuring that first priority is given to critical diagnostic needs of VA patients.
(a) The contents of the agreements will be concurred in and the document signed by the:
1. Chief, EM Unit, in the laboratory service,
2. Chief, or Director, Laboratory Service,
3. The individual responsible for research and development at the facility,
4. The individual responsible for education at the facility, and
5. Chief of Staff or Director of Clinical Services, or Director of Medical Staff.
(b) Completed agreements will be forwarded for approval to the VISN for review and recommendation, and then to the Director, P&LMS, VHA Headquarters, or returned to the VA medical facility for revision.
(c) So that the agreements remain consonant with local needs, the medical facility director or CEO will develop a procedure to ensure that all agreements are reviewed at least annually, and, at a minimum, on each anniversary of approval by the VISN Director.
1. If no changes are indicated, the medical facility Director will notify the local concerned personnel that the agreement remains in effect.
2. If need for substantive changes is identified, a new agreement will be prepared and forwarded to the VISN Director for referral to the Director, P&LMS, VHA Headquarters.
(2) Patient specimens received from non-VA medical facilities through sharing agreements, and on which a diagnosis is rendered and a report issued, constitute a patient service and will be billed accordingly.
(a) This policy applies even though the specimens may be used also for teaching and research.
(b) The charges for the services provided must be established so that the VA medical facility recovers its full costs.
d. Quality Assessment
(*) As Diagnostic EM usually functions as an adjunct to conventional anatomic pathology techniques, the policies and procedures for continuing quality assessment and improvement outlined also apply to diagnostic EM. Certain aspects of the EM Program are unique.
(*) Assessment of the quality of EM examinations is an additional factor in monitoring performance. Quality will be assessed through review by a peer group, the Ad Hoc EM Review Group, of cases from each diagnostic EM Program. Attention will be given to:
(a) The quality of the electron micrographs,
(b) The description of the findings in the report,
(c) The accuracy of the diagnosis, and
(d) The citation of literature references, when appropriate.
(4) Determination of satisfactory performance will depend upon meeting the productivity and/or utilization standard, and in satisfying the peer group in regard to quality.
(5) These resources may be supplemented as indicated by requests for additional information and occasionally by site visits.
(a) Annually, the Director, P&LMS, will prepare letters containing an evaluation of each diagnostic EM Program and concluding with the assigned rating. The letters are prepared for the signature of the VISN Director.
(b) When a program is rated as unsatisfactory, a probationary status is assigned.
1. The probationary status normally prevails for 1 year to allow time for correction of the deficiencies.
2. Failure to correct the deficiencies within the 1-year grace period may result in orderly closure of the diagnostic EM Program. In some instances where the productivity and/or utilization criteria are not met although the quality is satisfactory a decision may be reached during, or at the conclusion, of the probationary period to reduce the program from full to half level.
NOTE: The medical facility Director during the grace period, may decide after consultation with the or Medical Staff Director, the Chief or Director, Laboratory Service, and the program chief of the EM Units, that patient care needs could be met as well by closing the EM Unit and obtaining the services from another VA or non-VA facility. In such instances, the medical facility Director will discuss the local decision with the Director, P&LMS, before any final actions for closure are taken.
The important points to emphasize are that this is a formal program and does have a periodic review requirement (annually). If you need any additional information or clarification, please let me know.
Michael A. Brophy
National Enforcement Officer
Pathology and Laboratory Medicine Service (115a)
(202) 273-8332 FAX (202) 273-7561