Licensure and Approval

(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 ofapprovalinaccordance with 105 CMR 180.030(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 Testing), 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 ofthe 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 proceduresand 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 specifyingthe nature ofalltesting 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. Afacilitymayenter 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 healthpromotion 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 witha 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 controloneachday 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 maintainrecords 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 at 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 issuedbythe 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 Microbiology Bacteriology Mycology Parasitology Virology Other Microbiology Immunology Syphilis Non-Syphilis Viral Serology (HIV Testing) Clinical Chemistry Routine Chemistry Endocrinology Toxicology Urinalysis Radioassay (In-Vitro) Immunochemistry Other Chemistry Immunohematology Blood Group and Rh Typing Rh Titers Cross-Matching (Non-transfusion purposes) Cross-Matching (Transfusion purposes - See 105 CMR 180.410(C)(5)) Other Immunohematology Hematology Routine Hematology Cellular Studies Coagulation Other Hematology Pathology Diagnostic Cytology Histopathology Oral Pathology Radiobioassay Cytogenetics 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) Notwithstandinganyof 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 requirementfora 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 ofexaminationsofspecimensand 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 forthin105 CMR180.030(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.