He-P 808.14 - Duties and Responsibilities of all Licensees

He-P 808.14. Duties and Responsibilities of all Licensees

(a) The licensee shall have a written policy and procedure setting forth the rights and responsibilities of clients admitted to the laboratory in accordance with RSA 151:20.

(b) The licensee shall define, in writing, the scope and type of services to be provided at the laboratory, including mobile laboratory vans.

(c) The licensee shall not falsify or omit any information contained in:

(1) The application in He-P 808.04(a)(1) or any other documents required for the licensing of a laboratory; or

(2) The records maintained for the clients and personnel of the laboratory.

(d) The licensees shall have responsibility and authority for:

(1) Managing, controlling and operating the laboratory;

(2) Developing and implementing written policies and procedures governing all of the operations and services provided, and for reviewing said policies and procedures annually and revising as needed;

(3) Initiating action to maintain the laboratory in full compliance at all times with all relevant health and safety requirements contained in applicable federal, state and local laws, rules, regulations, and ordinances;

(4) Establishing, in writing, a chain of command that sets forth the line of authority for the operational responsibilities of the laboratory;

(5) Appointing a laboratory/medical director who shall meet the qualification requirements as stated in:

a. 42 CFR § 493.1405 for laboratories performing moderate complexity testing or waived testing; or

b. 42 CFR § 493.1443 for laboratories performing high complexity testing;

(6) Employing a clinical consultant in accordance with 42 CFR § 493.1417 or 42 CFR § 493.1455 as appropriate;

(7) Employing a technical consultant if the laboratory is performing moderately complex tests as defined in 42 CFR § 493.1411;

(8) Employing a general supervisor and a technical supervisor if the laboratory is performing highly complex tests as defined in 42 CFR § 493.1461, 1449 and 1468 if the laboratory is performing cytology;

(9) Providing sufficient numbers of personnel who are present in the laboratory and are qualified as testing personnel according to 42 CFR 493 to perform the laboratory tests stated in the laboratory's scope of services;

(10) Providing sufficient supplies, equipment and lighting to ensure all services are provided in a safe and timely manner; and

(11) Implementing any POC that has been accepted or issued by the department.

(e) The licensee shall post the following documents in an area of the licensed premises that is conspicuous and open to clients and the general public:

(1) The current license issued in accordance with RSA 151:2;

(2) All inspection and investigation reports issued in accordance with He-P 808.09(c) and He-P 808.11(d)(2)a. for the previous 12 months;

(3) Any notice of a pending hearing or order as required by RSA 151:29, II, pertaining to the licensee issued by the department or a court during the previous 24 months;

(4) A notice as required by RSA 151:29 stating complaints may be submitted to:

Department of Health and Human Services

Health Facilities Administration

129 Pleasant Street

Concord, NH 03301

(5) A copy of the licensee's complaint procedure as required by RSA 151:29, I; and

(6) The licensee's evacuation floor plan identifying the location of, and access to all fire exits, except that mobile laboratory vans shall be exempt from this requirement.

(f) The licensee shall admit and allow any department representative to inspect the licensed premises and laboratory services for the purpose of determining compliance with RSA 151 and He-P 808 as authorized by RSA 151:6 and RSA 151:6-a.

(g) All records required for licensing shall be:

(1) Available to the department during an inspection or investigation conducted in accordance with RSA 151:6 and RSA 151:6-a; and

(2) Legible, current and accurate.

(h) Any licensee maintaining electronic records shall develop a system with written policies and procedures to protect the privacy of clients and staff that, at a minimum, include:

(1) Procedures for backing up files to prevent deletion;

(2) Safeguards to ensure the confidentiality of the information on clients and staff; and

(3) Systems to prevent the tampering of information on clients and staff.

(i) The licensee shall provide a client or their legal representative with a copy of his or her client record, pursuant to the provisions of RSA 151:21, X, upon request.

(j) The licensee shall develop a facility system with written policies and procedures that will ensure that only the client and the ordering licensed practitioner are allowed to receive a copy of the laboratory tests results unless the laboratory has written consent from the client to release the test results to others.

(k) The building or structure or mobile laboratory van that houses the laboratory shall comply with the following:

(1) All applicable local health requirements;

(2) All applicable state and local building ordinances;

(3) All applicable local zoning ordinances; and

(4) All applicable state and local fire ordinances.

(l) The licensee shall maintain a log in each mobile laboratory van to document that all on-board water is from a verifiable potable source.

(m) Licensees that perform the functions of a collection station under this rule shall also be in compliance with He-P 817 rules for collection stations.

#2192, eff 11-25-82; ss by #3193, eff 1-28-86; ss by #5317, EMERGENCY, eff 1-29-92, EXPIRED: 5-28-92

New. #5758, eff 12-20-93, EXPIRED: 12-20-99

New. #8409, eff 8-19-05; ss 8852, eff 3-24-07; ss by #10267, eff 2-2-13

The following state regulations pages link to this page.