216 R.I. Code R. 216-RICR-60-05-4.8

Current through December 26, 2024

Section 216-RICR-60-05-4.8 - Organization and Management

4.8.1Governing Body and Management

A. Each clinical laboratory and/or station shall have a governing body or equivalent legal authority ultimately responsible for:

1. The management and control of the operation;

2. The assurance of the quality of services;

3. The compliance with all federal, state and local laws and regulations; and

4. Compliance with other relevant health and safety requirements, including the rules and regulations of this Part.

4.8.2Director of Laboratory

A. Each clinical laboratory shall have a laboratory director who shall be responsible for the day to day management and operation of the laboratory and to ensure the achievement and maintenance of quality standards of practice. The director shall meet the following minimum qualifications:

1. Be a person of good moral character;

2. Has earned from an accredited college or university a doctorate of philosophy, science, public health or medicine after successful completion of a curriculum that has been accredited by a national or regional certifying authority and has a minimum of one (1) year experience in supervising laboratory procedures, or has earned a master's degree in chemistry, bacteriology, biology or allied sciences and has at least two (2) years experience in laboratory procedures that includes one year of supervision; or has earned a bachelor's degree in bacteriology, biology, chemistry or allied sciences and has a minimum of at least four (4) years experience in laboratory procedures, including two (2) years of supervision.

B. The director of each clinical laboratory or his/her designee who meets the qualifications of §4.8.2(A)(2) of this Part shall furthermore be responsible for no less than the following:

1. Be present on the premises of the laboratory during the hours of operation for a sufficient period of time to ensure adequate and appropriate supervision of laboratory activities;

2. The accurate performance of all tests in the laboratory including the submission of appropriate reports on all tests pursuant to §4.8.4 of this Part;

3. The work of all personnel in the laboratory and for hiring adequately trained personnel commensurate with the workload;

4. Be available at all times during the hours of operation for personal or telephone consultation with personnel;

5. Notify the licensing agency within ten (10) days of any change in laboratory services or supervisory personnel;

6. Establish and maintain an effective quality assurance program; and

7. Other such activity(ies) as may be deemed appropriate.

C. In the event the director of the laboratory is absent for a continuous period of time longer than one (1) month duration, the laboratory shall not operate unless a person who meets the qualifications of §4.8.2(A)(2) of this Part is in attendance.

4.8.3Personnel

A. Each clinical laboratory and station shall employ a sufficient number of qualified personnel who are licensed and/or certified pursuant to provisions of R.I. Gen. Laws § 23-16.2-6 commensurate with the workload to ensure that services are provided effectively and safely and in accordance with current laboratory standards of practice.

1. A job description for each position shall be established, clearly delineating qualifications, duties, and responsibilities for each position.

2. Personnel records shall be maintained for each employee that shall contain no less than:

a. Current background information pertaining to qualifications, to justify initial and continued employment;

b. Evidence of periodic evaluation of technical work performance;

c. Such other data as may be deemed appropriate.

B. Stations

1. Personnel in blood collection stations shall be proficient in venipuncture, specimen processing and shall have training in patient management and emergency situations.

4.8.4Records and Reports

A. Each clinical laboratory shall maintain appropriate records and reports, that shall be available for inspection by authorized representatives of the licensing agency. Such records and reports shall include:

1. Records of the operation and maintenance of all laboratory equipment;

2. Records of all specimen examinations in accordance with §4.8.4(D) of this Part;

3. Records of control values, standard values, calibration curves and calculations of standard deviations; and

4. Reports of proficiency testing program results as well as copies of forms used by the laboratory to report results to the proficiency testing company;

5. Policies and procedures that describe a comprehensive quality assurance program designed to monitor and evaluate the ongoing and overall quality of the total testing process; and

6. Such other reports as may be deemed necessary.

B. Clinical laboratory reports shall be based upon and confined to the findings of the laboratory examinations. Test results shall be submitted promptly to the licensed physician or other authorized medical personnel who requested the test(s).

1. No reports shall be worded to convey or simulate a diagnosis or prognosis or to specify or suggest specific medication, surgical manipulation or other form of treatment unless signed by a physician or other authorized medical personnel.

2. Reports to physicians or other authorized medical personnel on specimens submitted by a licensed laboratory to a reference laboratory shall specify the name and address of the reference laboratory that shall be licensed in accordance with §4.9.3(C) of this Part.

3. Each clinical laboratory shall report communicable diseases in accordance with the rules and regulations pertaining to Reporting and Testing of Infectious, Environmental and Occupational Diseases (Part 30-05-1 of this Title).

C. Each station shall maintain a record(s) in chronological sequence indicating the daily collection of specimens.

D. Each clinical laboratory and station shall maintain a record indicating the processing of specimens, each of which shall be uniquely identified. The records of specimens shall contain no less than:

1. The unique laboratory identifier;

2. The name and other identification of the person from whom the specimen was obtained;

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

4. Date of the collection and source of the specimen;

5. Condition of specimen upon receipt (e.g., broken, turbid, etc.);

6. The date and time of specimen receipt;

7. The type of test requested and performed;

8. The results of laboratory tests or cross reference to results;

9. The date of reporting;

10. The identity of the testing personnel; and

11. The name and address of laboratory to which specimen(s) are referred if procedure(s) are not performed on the premises.

E. Reports and records shall be retained for no less than five (5) years, except for histopathology reports that shall be retained for ten (10) years from the date the reports were issued.

F. Laboratories shall retain all cytology slide preparations for five years from the date of examination and all histologic slide preparations for ten (10) years from the date of examination.

216 R.I. Code R. 216-RICR-60-05-4.8