Current through Register No. 40, October 3, 2024
(a) The licensee
shall comply with all applicable federal, state, and local laws, rules, codes,
and ordinances.
(b) The licensee
shall have a written policy and procedure setting forth the rights of patients
in accordance with RSA 151:21.
(c) The licensee shall define, in writing,
the scope and type of services to be provided at the laboratory, including
mobile laboratory vans.
(d) 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 patients
and personnel of the laboratory.
(e) 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 director who
shall meet the qualification requirements as stated in:
a.
42 CFR §
493.1405 for laboratories performing moderate
complexity testing;
b.
42 CFR §
493.1443 for laboratories performing high
complexity testing; or
c. For labs
performing only waived testing the director shall meet the following
qualifications:
1. A bachelor's degree in
health sciences with a minimum of 3 years' experience in a laboratory;
or
2. An associate's degree in
health sciences with a minimum of 5 years' experience in a
laboratory;
(6) Appointing an administrator who shall
meet the following qualifications:
a. A
bachelor's degree in health sciences with a minimum of 3 years' experience in a
laboratory; or
b. An associate's
degree in health sciences with a minimum of 5 years' experience in a
laboratory;
(7)
Employing a clinical consultant in accordance with
42 CFR §
493.1417 or
42 CFR §
493.1455 as appropriate;
(8) Employing a technical consultant if the
laboratory is performing moderately complex tests as defined in
42 CFR §
493.1411;
(9) Employing a general supervisor and a
technical supervisor if the laboratory is performing highly complex tests as
defined in 42 CFR §
493.1449, 1461, and 1469 if the laboratory is
performing cytology;
(10) 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;
(11) Providing sufficient supplies,
equipment, and lighting to ensure all services are provided in a safe and
timely manner; and
(12)
Implementing any POC that has been accepted or issued by the
department.
(f) The
licensee shall post the following documents in an area of the licensed premises
that is conspicuous and open to patients and the general public:
(1) The current license issued in accordance
with RSA
151:2;
(2) All inspection reports issued 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) A copy of the patients' bill of rights,
in accordance with RSA 151:21.
(g) 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.
(h) 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.
(i) Any licensee maintaining
electronic records shall develop a system with written policies and procedures
to protect the privacy of patients and personnel that, at a minimum, include:
(1) Procedures for backing up files to
prevent deletion;
(2) Safeguards to
ensure the confidentiality of the information on patients and personnel;
and
(3) Systems to prevent the
tampering of information on patients and personnel.
(j) The licensee shall provide a patient or
their legal representative with a copy of his or her patient record, pursuant
to the provisions of RSA 151:21, X,
upon request.
(k) The licensee
shall develop a facility system with written policies and procedures that will
ensure that only the patient and the ordering licensed practitioner are allowed
to receive a copy of the laboratory tests results unless the laboratory has
written consent from the patient to release the test results to
others.
(l) 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.
(m) The licensee shall maintain a log in each
mobile laboratory van to document that all on-board water is from a verifiable
potable source.
(n) 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
