in clinical specimens, but may need to refer them for definitive identification. When permanently stained smears for intestinal protozoa are indicated, polyvinyl alcohol fixative (PVA) or other appropriate fixative is available, and such material is placed in a fixative and then referred to a reference laboratory for staining identification.”
2. Extent 3. “Definitive identification of parasites present to the extent required to establish a correct clinical diagnosis and to aid in selection of safe and effective therapy. Laboratories are expected to have a high degree of expertise and should be able to differentiate Plasmodium falciparum from other species of Plasmodium.”
Note There is no longer a College of American Pathologists listing for extent 1 (no parasitologic procedures are performed and all specimens are submitted to a reference laboratory). However, in this situation, the laboratory would not be required to subscribe to outside proficiency testing specimens in this discipline.
Based on the Extent of Services mentioned above and the requirements in the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88), all (with rare exceptions) clinical laboratories (including physician office laboratories performing other than waived tests) must participate in an approved program of interlaboratory comparison testing that is consistent with the level and complexity of the work performed. The comprehensive microbiology and/or parasitology survey programs are recommended. The state Department of Health must be consulted to confirm which proficiency testing services fulfill the requirements related to a laboratory’s particular accreditation, particularly if the laboratory accepts interstate specimens in parasitology.
There must be evidence of active review of the survey results by the laboratory director or the designated supervisor. There also must be written evidence of evaluation of the results and, if indicated, corrective action when unacceptable results have been reported. Corrective action statements should review the correct answer and specific steps that will be taken to ensure that the same, or similar, error will not occur in the future. On the basis of the regulations within CLIA ’88, HCFA or one of the HCFA-approved agencies (may include some state agencies) will be involved in the process of monitoring laboratory performance and coordinating any possible sanctions that might be involved as a result of unacceptable performance in proficiency testing programs.
Copies of the 28 February 1992 Federal Register containing the final CLIA regulations can be obtained by writing to Government Printing Office, Attn: New Order, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date of the issue requested (28 February 1992) and stock number (069-001-00042-4). A $3.50 check or money order payable to “Superintendent of Documents” or a Visa or MasterCard number and expiration date should be enclosed. Orders may be made by telephone [(202) 783-3238] or fax [(202) 512-2250].
It is recommended that all of the proficiency testing specimens be saved for future review, particularly when students are being trained or technologists, pathologists, and residents are receiving review training. It is just as important to maintain negative specimens as to maintain positive ones, since many errors are made in which artifacts are identified as parasites. Specimens should be periodically checked to make sure that the volume of fixative is sufficient to prevent the specimens from drying out. These specimens should be cataloged for easy reference.
Specific recommendations for the handling and examination of proficiency testing specimens can be found in Table 11.6. These guidelines should assist the participant in the proper approach to these specimens.
CLIA ’88 mandated universal regulation for all clinical laboratory testing sites in the United States, including previously unregulated sites in physician offices. Quality testing was to be achieved through a combination of total quality management and mandated minimum quality practices. Through both internal and external proficiency testing, performance standards were also mandated. After the implementation of CLIA ’88, the percentage of laboratories passing proficiency testing requirements has improved and almost all laboratories are currently using quality practices for a more comprehensive quality system approach (51, 52).
Survey results from the Laboratory Proficiency Testing Program, Toronto, Ontario, Canada, over the course of the program, which began in 1977, indicate a marked improvement in laboratory performance. They send four samples in each of four surveys per year consisting of specimens to be examined for gastrointestinal parasites. Improvement is thought to result from a combination of voluntary withdrawal by laboratories with poor performance and improved performance by the other laboratories. Extensive educational initiatives have also played a significant role in improved performance (53).
Supervision
The QC program should be under surveillance by the chief technologist or section supervisor and should be reviewed at least once each month by the laboratory director, QC supervisor, or other supervisor designate. There should be written evidence of active review of all records (controls for routine procedures, instrument function tests, and equipment checks [temperature, humidity, systems, maintenance]). There should also be written evidence of corrective action when controls do not fall within acceptable limits. A written checking system should be in operation to help detect clerical errors, analytical errors, and/or unusual laboratory results. This system should also provide for error correction within acceptable time frames. With the emphasis on outcome-oriented measures, it is very important to have the capability to track testing through the preanalytical, analytical, and postanalytical phases (specimen integrity, processing, testing, reporting, and consultation), with primary emphasis being placed on accurate, reliable, and timely diagnostic testing for good patient outcome. This approach to laboratory inspections is emphasized by HCFA or other HCFA-designated agencies for outside inspections and should also be emphasized in all in-house quality assurance programs.
Procedure Manuals
Although card files and wall charts are acceptable for quick review, a well-written and complete procedure manual is very important for the routine operation of the laboratory and mandatory for accreditation requirements (Tables 11.7 and 11.8). Instructions contained in manufacturers’ package inserts are helpful but do not fulfill the requirements for a procedure manual. It is highly recommended that the National Committee for Clinical Laboratory Standards (NCCLS; now the Clinical and Laboratory Standards Institute [CLSI]) format be followed for protocol preparation (54). This publication covers the design, preparation, maintenance, and use of technical procedure manuals for the clinical laboratory. The procedure manual should contain for each test: (i) the principle of the test; (ii) acceptable specimens (including rejection criteria) and instructions for proper specimen collection and processing; (iii) preparation of reagents and solutions; (iv) all supplies and equipment necessary to perform the test; (v) QC procedures, results, and interpretation (including corrective action if QC is out of control); (vi) the test method; (vii) possible results; (viii) the correct way to report results; (ix) procedure notes (tips); (x) limitations of the procedure; (xi) additional tables and charts; and (xii) references. Complete parasitology protocols (written according to the NCCLS guidelines)
