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CALIFORNIA CODE OF REGULATIONS
TITLE 17. PUBLIC HEALTH
DIVISION 1. STATE DEPARTMENT OF HEALTH SERVICES
CHAPTER 2. LABORATORIES
SUBCHAPTER 1. SERVICE LABORATORIES
GROUP 2. CLINICAL LABORATORY REGULATIONS
ARTICLE 5. ISSUANCE OF LICEN
Date:
08/31/2009
Document:
ยง 1050. Clinical Laboratory Standards
(a) All licensed clinical laboratories shall be conducted, maintained, and operated without injury to the public health and shall maintain records, equipment, and facilities which are adequate and appropriate for the services rendered and demonstrate satisfactory performance in a proficiency program approved by the department.
(b) Proficiency Testing.
(1) The laboratory must participate in a state approved proficiency testing program and demonstrate satisfactory performance in all of the laboratory specialties that include tests performed in the laboratory. Proficiency shall be tested in the following specialties: microbiology, serology, clinical chemistry, hematology, and immunohematology.
(2) The participating laboratory must test applicable materials each time they are distributed by the approved proficiency testing service according to a schedule approved by the department.
(3) Those procedures performed by the laboratory for which test materials are provided by the approved proficiency testing service and which have been designated by the department as a requirement for measuring test performance, must be proficiency tested by the participating laboratory each time test materials are received.
(4) The participating laboratory must authorize the approved proficiency testing service to report proficiency test results to the department.
(5) The participating laboratory must test applicable materials only in the laboratory to which the license and the proficiency testing requirement applies using personnel and equipment used in that facility in providing services.
(6) A laboratory may be required to discontinue providing a service in a procedure or category of procedures if:
(A) For three consecutive quarters the laboratory fails to report on test materials received for procedures for which the laboratory is required to be proficiency tested, or
(B) For three consecutive quarters the laboratory demonstrates unsatisfactory performance in a procedure or category of procedures. A determination of satisfactory performance for a procedure shall be based upon results being within acceptable limits established by the proficiency testing service for that procedure and approved by the department. A determination of satisfactory performance for a category of procedures shall be based upon an average of performance within the category over four consecutive quarters.
(7) A laboratory whose services have been disapproved because of unsatisfactory performance may apply to the department for reapproval to provide these services after demonstrating satisfactory performance during the two consecutive quarters or testing periods immediately prior to requesting reapproval.
(c) Direction. The person or persons directing a licensed clinical laboratory shall assume the following responsibilities:
(1) Determine what laboratory procedures will be performed, the techniques that will be followed, and the equipment and reagents that will be used.
(2) Determine the scope and nature of procedures to control the reliability of test performance and personally monitor these control programs.
(3) Regularly assess the activities of the laboratory by personal observation, evaluation, and review of reports of laboratory findings.
(4) Establish qualification criteria of laboratory personnel.
(5) Determine the format of laboratory report forms and decide what information is to be contained on these report forms.
(6) Regularly consult with supervisors and other staff members.
(7) Confer with those served by the laboratory on matters that relate to test performance and determine the nature and scope of technical and administrative information to be released by the laboratory staff.
(8) Be available daily in any laboratory performing cytology and serve as director of no more than three (3) laboratories.
(9) Cause a licensed physician or dentist, qualified in cytopathology, to personally examine and report findings on abnormal or questionable gynecologic and all non-gynecologic specimens.
(d) Facilities. The laboratory must provide for and assure that:
(1) There is adequate space including working surface to conduct and control the performance of all test procedures performed in the laboratory.
(2) There is adequate area for safe storage and use of equipment and supplies.
(3) All areas are well lighted and properly ventilated.
(4) Fume hoods and biological safety cabinets, properly installed and regulated, are used if required for safe performance of tests or for safe preparation of materials.
(5) Instructions to be followed in case of fire and other emergencies are posted in a conspicuous place.
(e) Equipment and Test Materials.
(1) The laboratory must provide for and assure that equipment, instruments, glassware, and reagents are maintained in proper working order by periodic inspection, testing, or calibration in a manner acceptable to the department.
(2) All reagents and stains shall be dated at the time of preparation and initialed by the person making the reagents or stains, or the date received and date opened if commercially prepared reagents or stains are used. All reagents and stains shall be labeled to indicate identity, and titer, strength, or concentration. Recommended storage temperature and expiration date, and other pertinent information necessary for quality control must be on the label.
(f) Records.
(1) Retention of Records: The laboratory must maintain for a period of at least two years documentation of the following:
(A) Records of specimens received and tested, including identification of the patient, name of the submitter, dates of receipt and report, type of test performed, and test results.
(B) Records of inspection, validation, calibration, repair, and replacement to insure proper maintenance and operation of equipment and proper reactivity of test materials.
(C) Manuals, card files, or flow charts for each procedure performed in the laboratory which include:
1. Name of procedure.
2. Source or reference for the test method.
3. Date the procedure was last reviewed or modified by the director or supervisor.
4. Current specific instructions for test performance.
5. The standards and controls required.
6. Instructions for collecting and handling specimens to insure test reliability.
(D) Records of quality control procedures in use in the various technical areas of the laboratory, including results on standards and reference materials and action limits when appropriate.
(E) Additional requirements for cytology. The laboratory shall retain all cytology slides and cell blocks for a minimum of five (5) years and all cytology reports for a minimum of ten (10) years.
(2) Cytology Specimen Documents. The laboratory shall maintain cytology records indicating the daily accession of specimens, each of which is numbered, and an appropriate cross-filing system according to patient's name.
(A) Requests shall contain at least the following information:
1. The laboratory accession number when assigned by the laboratory.
2. The name of the person from whom the specimen was taken.
3. The name of the licensed physician or other authorized person or clinical laboratory who submitted the specimen.
4. Minimum information provided shall include: source of specimen (anatomic site), age of patient, previous therapy (endocrine, surgical, radiation, birth control, etc.), gynecologic history on cervical-vaginal specimens, including date and normalcy of patient's last menstrual period, duration of patient's current pregnancy, if any, and patient's menopausal status or essential history on non-gynecologic specimen.
5. The date the specimen was collected.
(B) Reports shall contain at least the following information:
1. The dates the specimen was collected, received in the laboratory and reported by the laboratory; and the accession number.
2. The result of the laboratory examination.
(3) Cytology Laboratory Records.
(A) The laboratory director shall be responsible for the final laboratory report and shall sign all abnormal and all non-gynecological reports. Each report, or a laboratory copy, shall be signed or initialed by the cytopathologist and/or cytotechnologist who examined the preparation and evaluated the final report. The names of all persons who examined the specimen and their evaluation, if inconsistent with the final report, shall be indicated on the laboratory work sheet or report copy.
(B) Duplicate copies of laboratory reports are filed in a manner which permits ready identification and accessibility.
(C) Laboratories shall utilize reporting systems that are as explicit as is cytologically feasible and must include acceptable morphologic terminology.
(D) If a specimen is judged by the laboratory director or cytotechnologist to be suboptimal, an accompanying statement shall indicate the reason, e.g., samples of sparse cellularity, poor preservation, or exhibiting other factors interfering with the laboratory evaluation, such as, excessive blood, inflammatory cells, etc.
(g) Quality Control.
(1) The laboratory must conduct, maintain, and operate programs for controlling the quality of test performance in a manner acceptable to the department.
(2) Additional Cytology.
(A) Specimen Identification. All smears and other specimens shall be labelled for patient identification and appropriately prepared by the submitter.
(B) Specimen Preparation.
1. The laboratory shall use the Papanicolaou staining technique or its equivalent as determined by the laboratory director.
2. Staining quality of cytologic specimens shall be checked at least once daily, with suboptimal results corrected immediately.
3. Gynecologic specimens shall be processed totally separately from non-gynecologic specimens.
(C) Microscopy.
1. Each specimen shall be evaluated to determine whether the material is satisfactory and consistent with the patient source. For satisfactory specimens, a cytologic evaluation shall be rendered according to the reporting system, as outlined in Section 1050(f)(3)(C).
2. The laboratory shall have a sufficient number of certified cytotechnologists to handle, under general supervision, the volume and diversity of tests performed requiring the exercise of independent judgment. No cytotechnologist shall be required to examine more than 75 one-slide gynecologic cases or 50 two-slide gynecologic cases per day; not including aspiration cytology specimens, cell block specimens, and other not normally examined by a cytotechnologist. Work load ratios for cytotechnologists who also prepare and stain slides shall be based on time spent in examining cytologic preparations.
3. The director or a supervising cytotechnologist shall examine (to verify proper staining and correct interpretation) at least ten (10) percent of all gynecologic smears previously examined and classified as not abnormal or questionable, including smears initially examined by a supervising cytotechnologist.
(3) Clinical Correlation. The laboratory shall maintain records for a minimum of 10 years of histologic or clinical confirmation of cytologic findings on abnormal cases and false negative and false positive results for each category of specimens, when such results are made available to them.
(h) Clinical Laboratory Test Results. Clinical laboratory test results shall not be reported from the laboratory until these results have been critically reviewed and verified for accuracy, reliability, and validity by a licensed physician and surgeon or a person, other than a trainee, duly licensed under Chapter 3, Division 2, Business and Professions Code (commencing with Section 1200).
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