(A)
Application. Clinical Laboratories functioning under
the control of a hospital or clinic licensed pursuant to M.G.L. c. 111 §
51 shall apply for a certificate of approval. Any person or entity who operates
a health promotion screening program shall apply for a letter of approval in
accordance with 105 C MR 1 8 0.030(D). All other clinical laboratories shall
apply for a license issued pursuant to M.G.L. c. 111D. Any laboratory which is
accredited, certified or licensed by a program which is deemed equivalent to
these regulatory standards by the Department will be considered to meet the
requirements of 105 CMR 108.000. Any laboratory services not inspected and
accredited, certified, or licensed by a deemed equivalent program shall comply
with all requirements for licensure or approval.
All laboratories, including those which are inspected and
accredited, certified or licensed by a deemed equivalent program, must comply
with requirements set forth in
105 CMR
180.450, et seq. Proficiency
Evaluation, and
105 CMR
180.044 Reporting of Infectious Diseases. All
laboratories, including those which are inspected and accredited, certified or
licensed by a deemed equivalent program, must comply with requirements set
forth in
105
CMR 180.300: Special Requirements
-Viral Serology (HIV Test ing), Facilities requesting licensure or
approval under
105 CMR 180.000 shall
submit an application on a form approved by the Department.
(B)
Licenses. The
Department shall issue two classes of licenses to laboratories which are not
otherwise subject to licensure pursuant to the laws of the Commonwealth. The
classes of licensure shall be known as "Limited" and "Full".
(1) Limited License:
(a) A limited laboratory license shall be
issued to any qualified person who maintains a clinical laboratory and who
meets one of the following requirements:
1. In
the case of an independent clinical laboratory performs only those limited
laboratory examinations approved by the Department.
2. In the case of a physician office
laboratory performs only those simple laboratory tests approved by the
Department.
(b) A list
of the approved laboratory examinations shall be available from the Department.
The Limited Test List for independent laboratories and the Simple Test List for
physician office laboratories approved by the Commissioner in consultation with
the Department's Advisory Committee on Clinical Laboratories may be reviewed
annually.
Notwithstanding the list of approved laboratory examinations
for a limited license, persons qualifying for a limited license shall perform
only those examinations which are within the training and experience of the
individual who will be performing the test.
(c) Applicants who are determined to meet the
requirements for a limited license shall in addition to the requirements of
M.G.L. c. 111D, meet all of the following requirements:
1. Make available for review by the
Department written policies and procedures for the collection and examination
of specimens as well as detailed written procedures for the collection,
transport and handling of those specimens which are referred to an outside
laboratory.
2. Perform appropriate
quality control and preventive maintenance, approved by the Department, for all
test procedures and equipment. Documentation demonstrating that the expected
control reactions were obtained shall be maintained by the facility.
3. Participate satisfactorily in an approved
proficiency testing program covering all laboratory specialties in which the
laboratory is approved to perform tests. Criteria for participation and
satisfactory performance shall be as stated below in
105 CMR
180.450.
4. Make available a permanent, identifiable
area for the handling of specimens and safe storage of supplies and
equipment.
5. Properly date and
enter all laboratory results into the patient's medical record.
6. Keep all records of laboratory testing and
quality control for a minimum of 4 years.
7. Maintain records documenting the initial
training of any individual who performs testing. Ongoing continuing education
and training shall be provided to such individuals and evidence of successful
completion of such education and training shall be maintained.
8. File an annual affidavit with the
Department specifying the nature of all testing services, the individuals
performing the tests, the individuals responsible for the accuracy of the
tests, the methods of testing employed, the quality control practices employed
and any other information required by the Department.
9. A facility may enter into a written
contract for the provision of all or part of the clinical laboratory services
with a laboratory which is either licensed, approved or certified by the
appropriate state or federal agencies. The facility must have detailed written
procedures for the collection, transport and handling of all specimens being
referred to such outside laboratory. The procedures shall be available for
review by the Department.
(2)
Full License:
(a) A full laboratory license shall be
required of any person who maintains a clinical laboratory which performs test
procedures in addition to those approved by the Commissioner pursuant to 105
CMR 180.030(B)(1)(a).
(b) A
laboratory with a full license shall comply with these regulations, M.G.L. c.
111D, and any other applicable statutes or regulations.
(c) Full licenses shall state the specialty
areas in which a laboratory is qualified to deliver services.
(3)
Renewal
Laboratories licensed pursuant to M.G.L. c. 111D shall be
required to have their licenses, whether limited or full, renewed every two
years.
(4)
Fees(a) The fee for
a limited license shall be $100.00 for initial or renewal licensure.
(b) The fee for a full license shall be
$100.00 for each specialty area for which a license is issued.
(C)
Certificate of Approval. The Department shall issue
two classes of certificates of approval to laboratories which are operating as
part of a clinic or hospital licensed pursuant to M.G.L. c. 111, § 51. The
classes of certificates of approval shall be known as "Limited" and "Full." The
requirements for a limited certificate of approval shall be exactly the same as
the requirements for a limited license as set forth in 105 CMR 180.030(B)(1).
The requirements for a full certificate of approval shall be exactly the same
as the requirements for a full license as set forth in 105 CMR 180.030(B)(2).
Certificates of approval shall be renewable every two years. There shall be no
fee for certificates of approval. The enforcement procedures set forth in
105 CMR
180.035 shall not apply to laboratories which
receive certificates of approval.
(D)
Letter of
Approval
The Department shall issue a letter of approval to qualified
health promotion screening programs that perform only those health promotion
screening tests approved by the Department in consultation with the
Department's Advisory Committee on Clinical Laboratories. A list of the
approved health promotion screening tests shall be available from the
Department. Letters of approval shall be renewable every two years. The
requirements for a letter of approval shall be as follows.
(1) The entity must establish and follow an
appropriate procedure for performing the test. This procedure must include at a
minimum the following information:
(a)
specimen collection and preparation;
(b) materials and equipment
required;
(c) steps to follow to
perform the test;
(d) limitations
of the procedure;
(e) cautions to
be observed which may affect the test results;
(f) safety precautions to protect patients
and testing personnel;
(g) normal
range of results;
(h) results which
require follow up with a physician;
(i) quality control procedures to be followed
using appropriate reference materials;
(j) calibration and maintenance protocols;
and
(k) a plan for remedial or
corrective action to be followed in the event that quality control results do
not fall within acceptable limits.
(2) All analytical equipment used for the
performance of tests (i.e., timers, detectors or meters) must be calibrated or
checked as appropriate for the device.
(3) All test reagents must be properly stored
and may not be used beyond their expiration dates.
(4) Each method must be tested with
appropriate reference materials to assure accuracy and precision:
(a) Each qualitative method must be tested
with a positive and negative control on each day of testing.
(b) Each quantitative method must be tested
with a normal and abnormal or high and low controlon each day of testing. In
the event that only one control level is available, the control material must
be tested after every 20 patient tests during the course of the day.
(c) The accuracy of the screening procedure
must be verified by sending at least one previously tested specimen to a
licensed laboratory on a semi-annual basis.
(d) All quality control tests must be
performed at the location of (and prior to) each public screening.
(e) Remedial or corrective action must be
taken in the event that quality control results do not fall within acceptable
limits.
(5) Quality
control and calibration measures shall be recorded and documentation shall be
maintained for one year.
(6) All
persons tested must be provided with a confidential written test result that
includes pertinent educational materials including, but not limited to, the
following information:
(a) the limitations of
the test;
(b) the interpretation of
the test result(s);
(c) associated
risk factors;
(d) the need for
physician follow-up; and
(e) a
telephone number for additional information (if additional information is
available).
(7) All
infectious or physically dangerous medical waste including blood saturated
materials and sharps must be stored and disposed of in accordance with the
requirements set forth in
105 CMR 480.000:
Storage and Disposal of Infectious or Physically Dangerous Medical or
Biological Waste: State Sanitary Code Chapter VIII.
(8) The entity must maintain records
documenting the initial training of any individual who performs testing.
Training programs should be established on a schedule that is specified by the
Department. Ongoing continuing education and retraining shall be provided to
such individuals if applicable or as needed. The training program must be
taught by health professionals with experience in clinical detection,
measurement and analysis appropriate for the screening services offered.
Training programs should reference appropriate national standards as available.
The program must include a t a minimum:
(a) a
thorough training on proper specimen collection;
(b) a thorough training in the content and
application of the pertinent test protocols;
(c) a means for testing employee technique
and proficiency in performing the test including retesting known samples;
and
(d) a thorough training on test
limitations and potential errors, interpretation of results, associated risk
factors, and appropriate need for physician referral.
(9) All persons involved with the collection,
handling and/or testing of specimens must conform with the "Guidelines for
Prevention of Transmission of Human Immunodeficiency Virus and Hepatitis B
Virus to Health-Care and Public-Safety Workers" as issued by the Centers for
Disease Control of the Department of Health and Human Services publication
dated February, 1989 or as most recently updated. These guidelines require new
gloves for the collection and processing of each specimen.
(10) All puncture wounds resulting from
specimen collection must be covered with a sterile gauze adhesive strip
(bandage) following sample collection.
(11) An application for approval shall
include a list of health promotion screening sites, dates and period of time
(if known). The Department must be notified prior to each health promotion
screening event which is to take place in a location other than the location
indicated when initial approval is sought. Such notification must be made at
least five days prior to each event and must include the expected date,
location and period of time.
(12)
At every public screening event the letter of approval issued by the Department
must be conspicuously displayed.
(E)
Classification of
Specialties
(1) Laboratories with
a full license or certificate of approval may be licensed or approved to
perform tests in the following specialty and sub-specialty areas:
|
Specialty
|
Sub-Specialty
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|
Microbiology
|
Bacteriology
|
|
Mycology Parasitology Virology
|
|
Other Microbiology
|
|
Immunology
|
Syphilis
|
|
Non-Syphilis
|
|
Viral Serology (HIV Testing)
|
|
Clinical Chemistry
|
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Routine Chemistry
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|
Endocrinology
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Toxicology
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Urinalysis
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Radioassay (In-Vitro)
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Immunochemistry
|
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Other Chemistry
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Immunohematology
|
Blood Group and Rh Typing
|
|
Rh Titers
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Cross-Matching (Non-transfusion
|
|
purposes)
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Cross-Matching (Transfusion
|
|
purposes - See
105 CMR
180.410(C)(5) )
|
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Other Immunohematology
|
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Hematology
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Routine Hematology
|
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Cellular Studies
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Coagulation
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Other Hematology
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Pathology
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Diagnostic Cytology
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Histopathology
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Oral Pathology
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Radiobioassay
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Cytogenetics
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Histocompatability Testing
|
(F) A specialty or sub-specialty area shall
be included in the laboratory license or certificate provided that the
laboratory supplies sufficient evidence to the Department that the laboratory
functions actively in that specialty or sub-specialty and performs a reasonable
number of tests to maintain its proficiency.
(G)
Provisional Licenses and
Certificates
(1) Notwithstanding
any of the 105 CMR 180.030(A) through (F), the Department may issue a
provisional license or certificate if it determines that the laboratory
applicant does not meet every requirement for a full or limited license or
certificate; provided that the laboratory has demonstrated to the Department's
satisfaction a good faith intention to correct deficiencies; provided further
that the Department finds that the laboratory provides reliable reports of
examinations of specimens and presents satisfactory evidence that the
requirements for full licensure or certification can and will be met within a
six month period.
(2) A provisional
license or certificate shall be for such a term as the Department deems
appropriate, but in no event shall the term exceed six months.
(3) No laboratory shall be issued more than
two consecutive provisional licenses or certificates.
(4) The fee for a provisional license,
limited or full, shall be exactly the same as for a limited or full license as
set forth in 105 CMR 180.030(B)(4). There shall be no fee for provisional
certificates.
(H) The
Department or its agents may make regular on-site visits to inspect the
laboratory for licensure pursuant to M.G.L. c. 111D, § 2. or approval
pursuant to M.G.L. c. 111 §§ 51 through 53.
