considered unsatisfactory if it falls within the limits established by reference laboratories.

§ 74.43 Test results.

The Secretary shall notify the laboratory director of the results of the proficiency tests. Where the laboratory reports reflect lack of proficiency, the Secretary may recommend corrective measures, consultation, or training in an appropriate laboratory; and may upon the written request of the laboratory director, furnish the laboratory with additional samples after corrective measures have been taken. Results reflecting a lack of proficiency may constitute a basis for denial, revocation, suspension, or limitation of the laboratory license or letter of exemption.

Subpart F-Accreditation-State Laws-Stringency of StandardsTermination

§ 74.46 Accredited laboratories; State laws; stringency of standards; letter of exemption.

(a) Accredited laboratories; State laws; stringency of standards; assurance of continuation of compliance with standards. In determining whether 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 submitted 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 sec. 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; termination of treatment as accredited laboratory. (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 (1) 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 (2) 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 a an agreement on forms prescribed by the Secretary signed by the owner or authorized representative of such laboratory to permit inspections as prescribed in this part for licensed laboratories.

(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.

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, ex

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, turbid).

or

(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 documentation 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 section 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.

(c) Limitation. Where it is proposed to limit a license or letter of exemption, the procedures or categories of procedures with respect to which the license or letter will no longer be applicable shall be stated in the notice.

Subpart -Hearings [Reserved]

75.3

Conditions for using name of U.S. Public Health Service in connection with smoke inspection guides.

AUTHORITY: The provisions of this Part 75 issued under sec. 215, 58 Stat. 690, as amended; 42 U.S.C. 216. Sec. 2(b), 69 Stat. 322, as amended; 42 U.S.C. 1857a(b).

SOURCE: The provisions of this Part 75 appear at 25 F.R. 1911, Mar. 4, 1960, unless otherwise noted.

§ 75.1 Design and test specifications for the smoke inspection guide.

(a) It must consist of a single piece of photographic film as described in paragraph (c) of this section which has been exposed and developed to give four adjacent rectangular areas, each a dif

ferent intensity of neutral gray and a fifth area of clear unexposed film. The neutrality of the gray shades shall be verified by equal absorption values over the visual range of light wavelengths as measured in a spectrophotometer.

(b) The guide shall be 1" wide, 4%" long, and have a total thickness of 0.009” (±0.001). The four corners of the guide shall be rounded with a " radius of curvature. The rectangular areas of gray shall be 1" wide and 13/16" high. The unexposed area shall be 1" wide and 1%" high. Tolerances on dimensions unless otherwise specified shall be ±1⁄416". The gray areas shall be arranged in an increasing order of gray intensity from top to bottom along the length of the film with the clear unexposed area at the bottom. The guide shall be provided with a protective case as a precaution against scratching and soiling when not in use.

(c) The undeveloped photograph film shall consist of blue-sensitivity, negativetype emulsion coated on clear, cellulose acetate butyrate support. It shall have a clear gel backing for curl control and a clear, unhardened gel overcoat which will give considerable protection against normal handling abrasion. The film shall have an exposure index of 6 to tungsten light, a contrast of about 2 when processed for 5 minutes at a temperature of 68° F. in Armed Forces De

veloper No. 2 (MIL-D-4825). The exposure index of 6 to tungsten light is an index suitable for use with photoelectric meters calibrated according to ASA exposure meter standards.

(d) The four intensities of gray proceeding from light to dark shall be designated in terms of percentage light transmission having the values of 80, 60, 40, and 20 percent ±5 percent. These values of percentage transmission shall be determined using a transmissometer with specifications described in paragraph (e) of this section as the primary standard of reference. A sensitive densitometer capable of measurement of differences in optical densities within ±0.005 and calibrated with reference to the primary standard shall be acceptable as a secondary standard of reference. The transmission values of 80, 60, 40, and 20 percent shall also be referred to as nominal Ringlemann Nos. 1, 2, 3, and 4, respectively.

(e) The transmissometer used for measurement of the transmission values of the gray areas shall have collimating tubes with 0.25" diameter apertures and viewing angles within 5° attached to the detector and lamp. The spectral response of the transmissometer shall be restricted to the visual range and comparable to the human eye. A schematic of a transmissometer for calibration of smoke guides is shown in Figure 1.

Lamp

§ 75.2 Instructions for the application of the smoke inspection guide.

(a) Introduction. The design and development of the smoke inspection guide is the result of an evaluation of both the transmission and the reflection type guides. The percent blackness values were chosen to correspond to the nominal Ringelmann Chart values for two reasons: First, this will permit the use of the guide without extensive revision of legislation; second, the nominal Ringelmann values have been shown to occur during certain periods of the day under specific conditions of atmospheric illumination.

(b) Reading the guide. (1) The guide is held at reading distance from the eye and positioned between thumb and forefinger such that nominal transmission values of 80, 60, 40, and 20 percent are in a vertical column in an increasing order of blackness from top to bottom corresponding to Ringelmann Nos. 1, 2, 3, and 4.

(2) The smoke under observation is sighted alongside the guide and a film shade of blackness is noted, which most closely matches the smoke. It is necessary whenever possible that the reading be made against the same type background for both the smoke and the film guide. A reading will be subject to error if, for example, the sky is the background for the smoke and a building for the guide or vice versa.

(3) At all times of reading the guide should be shaded from direct sunlight. Errors will be introduced if the chart is read with sunlight directed from other than the background of the observer. There is no preferred direction of sunlight coming from the background. Care should be taken to prevent interfering reflections on the guide.

(c) Maintenance of guide. The guide should be kept in a holder at all times except when in use. It should not be held in any manner other than as specified under reading instructions. Any dust which collects on it as a result of electrostatic charge build-up should be brushed off, using a soft brush. Fingerprints as a result of inadvertent handling should be wiped off using a lint-free lens cleaner type paper.

and the conditions of paragraph (b) of this section may be identified with the following statement:

The manufacturer certifies that this smoke inspection guide has been produced in compliance with the design and test specifications for smoke inspection guides developed by the U.S. Public Health Service (42 CFR Part 75).

In each case the name of the manufacturer must also be shown immediately following such identification.

(b) The instructions for use set out in this part must be supplied with the guide by the manufacturer in such form as to be readily available when the guide is to be used.

§ 76.1

Definitions.

As used in this part:

(a) "Executive Order" means Executive Order No. 11282.

(b) "Nonurban areas" means all areas other than urban areas.

(c) "Ringelmann Scale" means the Ringelmann Scale as published in the latest U.S. Bureau of Mines Information Circular entitled "Ringelmann Smoke Chart".

(d) "Secretary" means the Secretary of Health, Education, and Welfare.

(e) "Smoke Inspection Guide" means the U.S. Public Health Service Smoke Inspection Guide described in Part 75 of this title.

(f) "Urban areas" means those areas classified as urban in the latest available Federal census, or as Standard Metro