tories for analysis pursuant to the same time schedule and under conditions similar to those to which the laboratories being tested will be subjected.

(b) Samples identical to those submitted to laboratories for proficiency testing in categories of procedures which require semiquantitative or qualitative results, shall be submitted to three or more reference laboratories which shall examine the material contained in the sample in detail and report identification and content or titer to the Secretary. Samples identical to those submitted to laboratories for proficiency testing shall also be submitted to 10 or more referee laboratories for examination pursuant to the same time schedule and under conditions similar to those to which the laboratories being tested will be subjected.

§ 74.42 Satisfactory participation; particular procedures and categories.

(a) Clinical chemistry; hematology. (1) The limits for acceptability of results for each analysis shall be obtained by superimposing, on one scale, three subsets of limits obtained as provided in paragraph (a)(2) of this section.

(2) (i) Subset-Applicant and licensee laboratories. The subset of limits for applicant and licensee laboratories shall encompass the central 95 percent tile calculated from the results of all applicant and licensee laboratories. A reported result which is obviously deviant from the other results will not be used in determining the limits. However, for any sample, no more than 5 percent of the results will be discarded on the basis of being "obivously deviant."

(ii) Subset-Reference laboratories. The subset of limits determined from reference laboratory results shall encompass all reference laboratory results and shall consist of the lowest and highest result. A result which is obviously deviant from the other results will not be used in establishing the limits. However, for any sample, no more than 5 percent of the results will be discarded on the basis of being "obviously deviant."

(iii) Subset-Clinical requirements. The subset of limits for clinical requirements shall be centered on the median reference laboratory result on each sample and shall encompass 0.5 (one-half) the normal population range, in the case of a sample the value of which is in the normal range, or shall encompass 0.5 (one-half) the appropriate range in the case of a sample the value of which is outside the normal range. The normal population range or other appropriate range shall be determined by the Secretary.

(3) Results for applicant and licensee laboratories must fall between the lowest lower limit and highest upper limit of the three subsets of limits.

(b) Microbiology. The results obtained by applicant, licensee, and referee laboratories from tests on samples shall be graded by comparison with the results obtained by reference laboratories. The grade of an applicant or licensee laboratory may not be more than 10 percentage points lower than the minimal grade obtained by the referee laboratories. A grade obtained by a referee laboratory which is obviously deviant from those obtained by other referee laboratories will not be used in establishing acceptable achievement. However, for any shipment of samples the grades of not more than ten percent of the referee laboratories will be discarded on the basis of being "obviously deviant."

(c) Serology. (1) The results obtained by applicant and licensee and reference laboratories from qualitative and quantitative tests on samples shall be graded by, (i) comparing them with results obtained by reference laboratories, and (ii) comparing results of duplicate samples.

(2) Agreement with reference laboratories:

(i) The grade for the qualitative test shall be the percentage of results in agreement with the results obtained by the reference laboratories.

(ii) The grade for the quantitative test shall be the percentage of results in agreement: Provided, That results shall be deemed to be in agreement where each result (titer) does not deviate more than one twofold dilution

from the range of results obtained by the reference laboratories.

(iii) Grades must fall, and deviant results shall be treated, as provided in paragraph (b) of this section for microbiology.

(3) Reproducibility on duplicate specimens:

(i) The grade for the qualitative tests shall be the percentage of results on duplicate specimens that are in agreement.

(ii) The grade for the quantitative test shall be the percentage of results on duplicate specimens that are in exact agreement or that reflect a deviation of not more than one fourfold dilution for nonsyphilis serological tests; or one twofold dilution for syphilis serological tests.

(iii) Grades must fall, and deviant results will be treated, as provided in paragraph (b) of this section for microbiology.

(d) Immunohematology. For ABO grouping, Rh-typing, and cross-matching, there must be agreement with the results of the tests made by reference laboratories. For irregular antibody identification, the criteria contained in paragraph (c) of this section, relating to proficiency testing in serology, shall be applicable.

(e) Exfoliative cytology; histopathology; oral pathology. The results obtained by applicant and licensee laboratories and referee laboratories from examination

of histopathological sample specimens shall be graded by comparison with the results obtained by reference laboratories which are directed by a Board Certified pathologist. The lowest acceptable grade of an applicant and licensee laboratory must fall within 10 percentage points of the minimal grade obtained by the referee laboratories. The results obtained by applicant and licensee laboratories and referee laboratories from examination of cytological specimens shall be graded by comparison with the results obtained by reference laboratories which are directed by a Board certified pathologist or certified cytopathologist. The lowest acceptable cancer detection performance of applicant and licensee laboratories must fall within 10 percentage points of the

minimum grade obtained by the referee laboratories. A result obtained by a referee laboratory which is obviously deviant from those obtained by reference and other referee laboratories will not be used in establishing acceptable achievement. However, for any shipment of samples, no more than 10 percent of the referee laboratories' grades will be discarded on the basis of being "obviously deviant."

(f) Radiobioassay. The limits for acceptability of results for each analysis shall be determined by the central 95 percentile calculated from the results of all laboratories. A reported result which is obviously deviant from the other results will not be used in determining the limits. However, for any sample, no more than 5 percent of the results will be discarded on the basis of being obviously deviant: Provided, That no result may be considered unsatisfactory if it falls within the limits established by reference laboratories.

er the standards applied by an approved accreditation body in inspecting and accrediting any hospital or any laboratory pursuant to the provisions of section 353(d)(2) of the Act or provided for by State law under section 353(1), are equal to or more stringent than the provisions of the Act and the rules and regulations issued pursuant thereto, the Secretary may consider inter alia whether the standards applied or provided for are equal to or more stringent than those applicable or issued hereunder relating to maintenance of a quality control program, records, equipment, and facilities, qualifications of personnel, quality and extent of proficiency testing, renewal of accreditation and frequency and comprehensiveness of on-site inspections. The standards for accreditation of laboratories shall be sumitted in writing to, and reviewed by, the Secretary at least annually and from time to time as the Secretary may deem necessary: Provided, That neither the number of tests, nor the number of inspections required or provided for by the standards of such body or the law of a State shall be conclusive in determining whether such standards are equal to or more stringent than those required by section 353 of the Act and the standards prescribed thereunder or whether there is adequate provision for assuring that such standards continue to be met.

(b) Accreditation; notices; submittal. An approved accreditation body shall submit to the Director written notice of

(1) Accreditation of each hospital or laboratory accredited by it (unless the laboratory is a laboratory to which the regulations contained herein are not applicable under the provisions of § 74.2(b)), containing the name of such hospital or laboratory, the date or dates of such accreditation, and the procedures to which such accreditation is applicable, within 10 days after (i) receipt of notice from the Secretary that the standards applied by such body have been determined to be equal to or more stringent than the provisions of section 353 of the Act and the rules and regulations issued

under such section 353, or (ii) the date of accreditation, whichever is later.

(2) Termination of accreditation of a hospital or laboratory within 5 days after such termination.

(3) Results of proficiency tests conducted by the approved accreditation body as soon as they become available and in no event, except upon written authorization from the Secretary, later than 60 days after the date designated for submittal of results to the accrediting body.

(c) Letter of exemption; issuance. The Secretary may issue a letter of exemption to a laboratory upon application by such laboratory, certifying to or providing on a form prescribed by the Secretary—

(1) Its accreditation by an approved accreditation body; the procedures to which such accreditation is applicable; and the date or dates of such accreditation.

(2) Its agreement to permit inspection by the Secretary, make records available and submit reports as may be required by the Secretary.

(3) Such other relevant information as the Secretary may require.

§ 74.47 Accreditation; stringency of standards; failure to demonstrate; applicability of licensing requirements.

(a) Standards of accrediting body; equivalence or greater stringency; failure to demonstrate: If the Secretary at any time, on the basis of (1) a review of the standards applied by an accrediting body, (2) evidence of violations of such standards, (3) inspections, or (4) other relevant factors, determines that the standards applied by an accrediting body are not equal to or more stringent than the provisions of section 353 of the Act and the rules and regulations issued thereunder or that the provision of any such body for requirements, practices, and procedures for assuring that such standards continue to be met by accredited hospitals and laboratories is inadequate, the Secretary shall give notice thereof to such accrediting body and shall provide a reasonable period for revision of standards, requirements, practices, and procedures and for submittal to the Director of satisfactory evidence

(i) that it has adopted and effectively applied equivalent or more stringent standards to hospitals and laboratories in determining whether to accredit such hospitals and laboratories and (ii) that there is adequate provision for assuring that such standards continue to be met by the accredited hospitals or laboratories. Upon expiration of such period and notice to such body of the determination that it has not submitted satisfactory evidence, which notice shall contain a specification of the basis for the determination, the provisions of section 353 of the Act requiring licensing shall apply effective 30 days after the date of receipt of such notice by such accreditation body.

(b) Accreditation: Inspection. No exemption shall be granted unless the Secretary has received an agreement on forms prescribed by the Secretary signed by the owner or authorized representative of such laboratory permit inspections as prescribed in this part for licensed laboratories.

to

(c) Accredited laboratories shall be subject to such provisions of the regulations in this part, including but not limited to those relating to proficiency testing and availability of records, as the Secretary may direct: Other than the provisions relating to licensing.

[33 FR 20043, Dec. 31, 1968, as amended at 38 FR 10722, May 1, 1973]

Subpart G-General Provisions

§ 74.50 Records: Maintenance, availability,

retention.

Records of observations shall be made, concurrently with the performance, of each step in the examination of specimens. Records shall reflect the actual results of all control procedures. All pertinent laboratory records shall be made available for such inspection, examination, and copying as the Secretary may direct. All records shall be retained for a period of at least 2 years after the date of submittal of report except as otherwise prescribed in this part or authorized by the Secretary.

§ 74.51 Reports to the Secretary.

Laboratories shall submit to the Secretary such reports of operations as the Secretary, from time to time, may require.

§ 74.52 Personnel records.

Personnel records shall be maintained on a current basis. They shall include a complete resume of each employee's training, experience, duties, and date or dates of employment.

§ 74.53 Specimen records.

Daily accession records shall contain the following information:

(a) The laboratory number or other identification.

(b) The name and other identification of the person from whom the specimen was taken, if available.

(c) The name of the licensed physician or other person or laboratory who or which submitted the specimen.

(d) The date the specimen was collected by the physician, or other authorized person if available.

(e) The date the specimen was received in the laboratory.

(f) The condition of unsatisfactory specimens and packages when received (e.g., broken, leaked, hemolyzed, or turbid).

(g) The type of test performed.

(h) The result of the laboratory test and the date the test was completed. § 74.54 Laboratory report and record.

(a) The laboratory report shall be sent promptly to the physician or other person who requested the test and a suitable record of each report shall be preserved by the laboratory for not less than 2 years. The name of the laboratory actually performing the examination shall be indicated in the report to the person submitting the specimen.

(b) Tissue pathology and cytology reports shall utilize an established nomenclature.

(c) Reports of quantitative analyses shall include the units of concentration or activity and, where requested or indicated, the usual range of values for good health.

(d) A list of analytical methods employed by the laboratory and docu

mentation of usual range of values for good health shall be made available to the person or laboratory submitting the specimen.

§ 74.55 Equipment and facilities.

The laboratory equipment maintenance program shall assure satisfactory operation of all equipment. Space, facilities, and equipment shall be adequate to properly perform the services offered by the laboratory. Workbench space shall be ample for the type and volume of work being done, and well lighted to facilitate accuracy and precision. There shall be freedom from unnecessary chemical, radiological, biological, and other hazards which may contaminate or otherwise adversely affect examination of specimens and, where applicable, provision shall be made for sterilization of contaminated material.

§ 74.56 Inspection.

The Secretary may conduct an inspection of every licensed laboratory at least annually and may conduct other inspections from time to time. Inspections shall be made at any time during the performance of procedures and services and may include observation of complete examinations of specimens by personnel and methods ordinarily and routinely employed by the laboratory, examination of personnel files, procedural manuals, and records of tests including quality control and calibration. Inspections may be made with or without notice.

§ 74.57 Change in ownership.

The Director shall be notified of any change in the ownership of a licensed laboratory, other than a transfer of stock, within 10 days of any such change.

§ 74.58 Change in director or supervisor.

Changes in directors and in supervisors for any reason shall be reported to the Director within 30 days of the effective date of change.

Subpart H-Revocation, Suspension, and Limitation of Licenses and Letters of Exemption; Notice

§ 74.60 Revocation, suspension, and limitation of licenses and letters of exemption.

A laboratory license or letter of exemption may be revoked, suspended, or limited, whenever the Secretary, after reasonable notice and opportunity for hearing to the owner or operator of the laboratory as provided herein finds, in the case of a license, that such owner, or operator, or any employee of the laboratory has committed any of the actions specified in section 353(e) of the Act, or in the case of a letter of exemption, that the laboratory is no longer eligible for such letter of exemption.

§ 74.61 Contents of notice.

(a) General. A notice issued pursuant to § 74.60 shall contain a statement of the proposed action and of the grounds upon which the action is proposed to be taken.

(b) Suspension. Where it is proposed to suspend a license or letter of exemption, (1) the period of such proposed suspension or the action which will be required to end the suspension shall be stated in the notice, and (2) the notice shall provide that if the appropriate remedial action is not taken within the period of suspension prescribed, the license or letter will be revoked.