N.J. Admin. Code § 8:44-2.7

Current through Register Vol. 56, No. 21, November 4, 2024

Section 8:44-2.7 - Management

(a) The clinical laboratory shall maintain records and facilities which are adequate and appropriate for the services offered.

(b) Workrecords of quantitative tests must be maintained and these records must indicate final results together with all corresponding instrument readings and calculations. Where instrumentation produces tracings or print-outs of results, these tracings or print-outs must be retained and may serve as the workrecord.

(c) A compilation shall be kept of all automated and manual methods for tests which are performed in or offered by the laboratory. Each procedure shall be reviewed and dated by the technical supervisor at least annually. For those tests which are normally performed on automated test equipment, provision shall be made and documented for performing such tests by alternate methods, or for storing the test specimens, in the event this equipment becomes inoperable.

(d) Space and facilities shall be adequate to properly perform the services which are performed in or offered by the laboratory.

1. Workbench space shall be ample, well-lighted, and convenient to sink, water, gas, and suction and electrical outlets as necessary.

2. Work areas shall be arranged so as to minimize problems in transportation and communication.

3. The laboratory shall be properly ventilated.

4. Volatile chemicals and inflammable solvents shall be properly stored as specified by O.S.H.A.

5. Temperature and humidity shall be controlled within limits required for proper performance of tests and operation of instruments affected by these variations.

6. Voltage levels at electrical sources to which automated equipment is connected shall be monitored and recorded.

7. Adequate fire precautions and occupational safety and health laws shall be known, posted, and observed insuring that there is freedom from physical, chemical, and biological hazards.

(e) No persons other than a licensed physician, or one otherwise authorized by law, shall manipulate a patient for the collection of specimens except that qualified technical personnel of the laboratory may collect blood or remove stomach contents and collect material for smears and culture under the direction, or upon the written request of a licensed physician.

(f) Syringes, needles, lancets, or other blood-letting devices capable of transmitting infection from one person to another shall not be reused unless they are properly sterilized prior to each use and wrapped in a manner which will insure that they remain sterile until used. Appropriate sterilization and disinfection techniques shall be utilized, as required, for tests performed on potentially contaminated material and for the protection of laboratory personnel. Disposable syringes, needles, pipettes, Petri dishes, and other disposable items shall be destroyed immediately after use as stipulated in N.J.S.A. 2A:170-25.1 7. Each sterilizing cycle shall contain a device which indicates proper sterilization and a record kept of time, temperature, pressure and type of indicator. Proper operation of the autoclave shall be checked monthly with viable spores.

(g) The laboratory shall examine specimens only at the request of a licensed physician, dentist, or other person authorized by law to use the findings of laboratory examinations and shall report only to those authorized by law to receive such results.

1. If the patient is sent to the laboratory, a written request for the desired laboratory procedures must be obtained from a person authorized by law to use findings of laboratory examination.

2. If only a specimen is sent, it must be accompanied by a written request.

3. If the laboratory receives reference specimens from another laboratory, it shall report back to the laboratory submitting the specimens.

(h) The laboratory shall maintain a record indicating the daily accession of specimens, each of which is numbered or otherwise appropriately identified. Records shall contain the following information:

1. The laboratory number or other identification of the specimen.

2. The name and other identification of the person from which the specimen was taken.

3. The name of the licensed physician or other authorized person or clinical laboratory which submitted the specimen.

4. The date the specimen was collected by the physician or other authorized person.

5. The date the specimen was received in the laboratory.

6. The condition of unsatisfactory specimens when received (e.g., broken, leaked, hemolyzed, or turbid, etc.).

7. The type of test performed.

8. The date that test was performed.

9. The results of the laboratory test or cross-reference to results and the date of reporting.

10. The name and address of the laboratory to which forwarded if the procedure is not performed at this laboratory.

(i) The original or true duplicate of the laboratory report shall be sent promptly to the licensed physician or other authorized person who requested the test and all reports shall be preserved by the laboratory for a period of at least 2 years after the date of submittal of the report. Laboratory reports of fully automated, multicomponent testing must consist of, or have attached, instrument tracings or true duplicates of such tracings or computer printout of test results.

1. The laboratory director is responsible for the laboratory report.

2. True duplicate copies or a suitable record of laboratory reports shall be filed in the laboratory in a manner which permits ready identification and accessibility.

3. The results of laboratory tests or procedures or transcripts thereof shall be sent to the licensed physician, dentist or other person authorized by law to use the findings of laboratory examinations. The patient may request a copy of such reports. The laboratory may charge a reasonable fee for copying.

4. Pertinent "normal" ranges as determined by the laboratory performing the tests shall be available to the physician requesting such tests.

5. A list of analytical methods employed by the laboratory and a basis for the listed "normal" range shall be maintained in the laboratory. The list shall be made available to any physician ordering an examination upon request.

6. If the laboratory refers specimens to another laboratory, the physician ordering an examination shall receive the original reference laboratory report or a true duplicate of that report. The reference laboratory must report its findings on report forms of the reference laboratory. If the physician so requests, the referring laboratory may authorize the testing laboratory to report directly to the physician or other authorized person who requested the test, in which even the testing laboratory must send a duplicate of the report to the referring laboratory.

N.J. Admin. Code § 8:44-2.7