CLINICAL LABORATORIES

M.G.L. pt. Part I, tit. Title XVI, ch. c. 111D

in effect

M.G.L. c. 111D, § 1 Definitions

c. 111D, § 1. Definitions Section 1. As used in this chapter, the following words shall, unless the context clearly requires otherwise, have the following meanings: ''CLIA-waived test'', a test that the federal Centers for Medicare and Medicaid Services has determined qualifies for a Certificate of Waiver under the federal Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. § 263a. ''Clinical laboratory'', a facility or place, however named, the purpose of which is to make biological, serological, chemical, immuno-hematological, cytological, pathological or other examinations of materials derived from a human body. ''Commissioner'', the commissioner of public health. ''Company'', a corporation, partnership, limited liability company, limited liability partnership, an association, a trust or an organized group of persons, whether incorporated or not. ''Complex laboratory test'', a test which requires sophisticated technique, interpretation of multiple signals or proven technical skill. Such test shall require, but not be limited to, 1 or more of the following steps: (a) highly skilled physical manipulation; (b) technique-dependent steps in the testing, sampling or reading of results; (c) user programming of the device or devices; (d) detailed calculation of the results; (e) dilution of samples with chemically reactive substances; or (f) preparation of reagents. ''Department'', the department of public health in the executive office of health and human services. ''Exempt test'', a test which is generally noninstrumental in nature and the results of which are determined by observation of a visual signal. ''Ownership interest'', interests, including, but not limited to, any membership, proprietary interest, shares of stock in a corporation, units or other interest in a partnership, bonds, debentures, notes or other equity interest or debt instrument or co-ownership in any form. ''Person'', corporations, societies, associations, partnerships, limited liability companies, limited liability partnerships, trusts, organized group of persons, whether incorporated or not, an individual or the individual's estate upon death, any other entity, including, but not limited to, medical practice, medical office, clinic, counseling center, substance use disorder treatment program or sober house or a political subdivision of the commonwealth. ''Simple laboratory test'', a test which may require a series of steps, reagent additions or instrumentation and the results of which are generally determined by a visual signal, but which is not a complex laboratory test.

M.G.L. c. 111D, § 2 Regulatory authority of public health department

c. 111D, § 2. Regulatory authority of public health department Section 2. The department shall have authority: (1) to establish, with the advice of the advisory committee on clinical laboratories, and to enforce, requirements in addition to any prescribed in this chapter for the construction, maintenance, and utilization of clinical laboratories, including standards of performance in the examination of specimens; (2) to require evidence of successful participation by clinical laboratories licensed under section five in proficiency testing programs, and by laboratory personnel in training programs, covering all or specific laboratory specialties and approved by the department after consultation with the advisory committee on clinical laboratories; (3) to establish appropriate fees for the issuance and renewal of licenses; (4) to make such reasonable classification of clinical laboratories, by category of laboratory procedures performed or nature and scope of services provided, as the department may find necessary or appropriate in the public interest; (5) to inspect at any time any clinical laboratory and any records maintained in connection with such laboratory; provided, that a license has been issued or an application for a license has been filed under section five; (6) to conduct investigations and adjudicatory proceedings; (7) to conduct research and studies, to sponsor or hold educational programs, to make informational materials available to the public, and to engage in such other activities as may be necessary or appropriate for the administration or enforcement of this chapter; (8) to make such rules, regulations, as may be necessary or appropriate for the administration or enforcement of this chapter; and (9) to classify, with the advice of the advisory committee on clinical laboratories, laboratory tests as exempt, simple or complex, for purposes of licensing physician clinical laboratories.

M.G.L. c. 111D, § 3 Advisory committee

c. 111D, § 3. Advisory committee Section 3. There shall be within the department an advisory committee on clinical laboratories, to advise the department, as provided in section two, on the administration of this chapter. Such committee shall consist of twelve members, to be appointed by the commissioner, as follows: four persons, two physicians and two nonphysicians, who meet the requirements for confirmation as a clinical laboratory director; one other physician not a clinical laboratory director; one medical laboratory technologist; one chief executive officer of a hospital licensed by the department; and five non-providers of health services, one of whom shall be a member of the Massachusetts Bar and one a representative of manufacturers of clinical laboratory technology. Each member of the committee shall serve without compensation for a term of three years, or until his successor is appointed; provided, that no member shall serve more than two consecutive terms. A chairman of the committee shall be elected annually from the membership.

M.G.L. c. 111D, § 4 Licensing requirements; exemptions

c. 111D, § 4. Licensing requirements; exemptions Section 4. No person shall maintain a clinical laboratory in the commonwealth apart from a hospital or clinic licensed under section 51 of chapter 111, unless the person holds, and there is in effect, a license issued under section 5; provided, however, that the licensing requirement of this section shall not apply to: (a) a clinical laboratory maintained by not more than 2 licensed physicians exclusively in connection with the diagnosis and treatment of the physician's own patients; provided, that: (i) the physician or the physician's assistant under the direct supervision of such physician performs all testing; and (ii) the clinical laboratory performs only laboratory tests which the commissioner, with the advice of the advisory committee on clinical laboratories, has determined to be exempt from licensure; (b) a clinical laboratory maintained by 3 or more licensed physicians exclusively in connection with the diagnosis and treatment of the physician's own patients; provided, that: (i) the physician or the physician's assistant under the direct supervision of such physician performs all testing; and (ii) the clinical laboratory performs only laboratory tests which the commissioner, with the advice of the advisory committee on clinical laboratories, has determined to be exempt from licensure; (c) a clinical laboratory performing only CLIA-waived tests; provided, that clinical laboratories performing non-CLIA waived tests in addition to CLIA-waived tests must obtain a clinical laboratory license; (d) a clinical laboratory maintained exclusively for research and teaching purposes and not providing reports for diagnosis and treatment of patients or for a public health purpose; (e) any laboratory with respect to tests or other procedures made by it for any person engaged in the business of insurance if made for purposes of determining whether to write an insurance contract or determining eligibility or continued eligibility thereunder, or for the examination of its employees or officers; or (f) any laboratory maintained exclusively for a health promotion screening program, as defined in regulations of the department, which does not provide reports for diagnosis or treatment of patients and which meets standards for such program established by the department. No provision of this chapter other than section 6 shall apply to any agency of the commonwealth, nor shall any provision of this chapter relative to licensing apply to any hospital or clinic licensed under section 51 of chapter 111.

M.G.L. c. 111D, § 5 License; application; filing; issuance; renewal; form

c. 111D, § 5. License; application; filing; issuance; renewal; form Section 5. Any person seeking a license to maintain a clinical laboratory apart from a hospital or clinic licensed under section fifty-one of chapter one hundred and eleven shall file with the department a license application containing such information as the department may reasonably require, including but not limited to the identity of the applicant and any parent or associated company, the identity and qualifications of the proposed laboratory director, and the procedures or categories of procedures for which the license is sought. Upon receipt and review of an application for license and upon payment of the appropriate fee, the department shall issue a license if it finds that the applicant is responsible and suitable to maintain a clinical laboratory and meets such requirements as the department has established by regulation for a license. In the case of renewal application, the department may, subject to such regulations as it shall make, issue a provisional license to an applicant who does not meet every requirement for a license; provided, that the applicant has demonstrated to the department's satisfaction a good faith intention to correct deficiencies, and provided further, that the department finds that the licensee provides reliable reports of examinations of specimens and presents satisfactory evidence that the requirements for full licensure can and will be met within a period of time not to exceed six months. The department shall in no case issue a person more than two consecutive provisional licenses for the same clinical laboratory. The department shall set forth in every license issued under this section the name and address of the licensee; the name by which the clinical laboratory shall be known; the address of the licensed premises; the period which such license is issued; the classification, if any, for which such license is issued; the conditions as to transfer and assignment prescribed by law; and such other terms of issuance as the department may reasonably prescribe. The period of a full license shall be not more than two years and the period of a provisional license shall be for not more than six months. No licensee shall transfer the license issued him, or assign any authority granted thereunder, in any manner voluntarily or involuntarily, directly or indirectly, or by transfer or control of any person, without first obtaining the department's written permission, upon application to the department. Every application therefor shall contain such information as the department may require, and shall be approved or denied within sixty days of filing with the department. The department shall grant written permission if the department finds that the transferee or assignee is responsible and suitable to maintain a clinical laboratory and meets such requirements as the department has established by regulation for a license. Every denial order shall include a statement of the reasons for denial and the provisions of law relied upon, and shall be subject to judicial review.

M.G.L. c. 111D, § 6 Infectious disease reports; confidential information

c. 111D, § 6. Infectious disease reports; confidential information Section 6. The department may require the reporting of any infectious disease found in the examination of specimens at clinical laboratories if, in its opinion, reporting of such disease is necessary to protect or promote the public health. Every person who and every agency which maintains a clinical laboratory shall report evidence of any infectious disease found in the course of the examination of specimens, if so required by the department, in such form, manner, and detail and within such time as the department shall prescribe. Reports made under this section shall not be considered as constituting a diagnosis nor shall any person making a report pursuant to this section be held liable in a civil proceeding for having violated a trust or confidential relationship. Notwithstanding section ten of chapter sixty-six, every such report shall be kept confidential by the department and its employees and agents and shall not be subject to the inspection, examination, or copying by any other agency of government or by any other person.

M.G.L. c. 111D, § 7 Clinical laboratory director

c. 111D, § 7. Clinical laboratory director Section 7. Every person licensed to maintain a clinical laboratory under this chapter shall appoint an individual, who shall bear the title ''clinical laboratory director'', with responsibility for the direction of the technical and scientific operation of such laboratory, including the examination of specimens and the making of reports thereon; provided, that no individual so appointed shall serve as clinical laboratory director for more than three months unless the department within such period shall certify that such person (1) is a physician who is certified in anatomical or clinical pathology by the American Board of Pathology or in at least one laboratory speciality by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, or other national accrediting board acceptable to the department, or who possesses qualifications which the department considers equivalent to any such certification; or (2) holds an earned doctoral degree, with a chemical, physical, or biological science as his major subject, from an accredited educational institution, and he is certified in at least one laboratory speciality by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, or other national accrediting board acceptable to the department, or he possesses qualifications which the department considers equivalent to any such certification; or (3) has been responsible for direction of the technical and scientific operation of a clinical laboratory for at least twelve consecutive months at any time during the calendar years of nineteen hundred and seventy-one through nineteen hundred and seventy-five, and he meets one of the following requirements: (i) he holds an earned master's degree, with a chemical, physical, or biological science as his major subject, from an accredited educational institution and has had at least four years experience since graduation in a clinical laboratory, or (ii) he holds an earned bachelor's degree, with a chemical, physical, or biological science as his major subject, from an accredited educational institution and has had at least six years experience since graduation in a clinical laboratory, or (iii) he has passed an examination conducted by or under the sponsorship of the United States Public Health Service, and approved by the department as evidence of competence to direct the technical and scientific operation of a clinical laboratory; provided, however, that when a clinical laboratory is maintained by more than two physicians exclusively in connection with the diagnosis and treatment of patients, and the director is one of the physicians who maintains the laboratory, and the laboratory performs only procedures approved by the commissioner, the department, by regulation, may limit such educational requirements by providing that, as a minimum, said director holds a bachelor's degree with a chemical, physical or biological science as his major subject and has had since graduation at least one year of related experience in a clinical laboratory. The department may, in regulations, set conditions as to the employment of individuals as clinical laboratory directors, including a minimum number of hours per week required in such position; provided, that in no event shall any individual accept employment as a clinical laboratory director at more than 5 clinical laboratories during the same period. The department may revoke its confirmation of an appointment for cause shown but not otherwise.

M.G.L. c. 111D, § 8 Prohibited activities

c. 111D, § 8. Prohibited activities Section 8. A clinical laboratory shall not: (1) misrepresent, by false statement, by omission of a material fact, or by scheme, trick, or device, the category or categories of procedures performed at, or the service or services available at, a clinical laboratory; (2) obstruct, bar, or otherwise interfere with an inspection undertaken under the authority of section two; (3) make any false statement in or to omit a material fact from an application or other paper filed with the department; (4) offer or give a commission, rebate, or other fee, directly or indirectly to any person as consideration for the referral of a specimen derived from a human body to a clinical laboratory for examination by such laboratory; (5) solicit or accept a commission, rebate, or other fee, directly or indirectly, from any person as consideration for the referral of a specimen derived from a human body to a clinical laboratory for examination by such laboratory; (6) lend the use of the name of a licensed clinical laboratory or of a licensed hospital or clinic, or of any employee of any such laboratory or institution, to an unlicensed clinical laboratory; (7) to examine any specimen derived from a human body except upon the written request of a licensed physician, licensed dentist, licensed chiropractor, licensed surgeon, licensed podiatrist, licensed osteopath or, for the sole purpose of requesting urine drug screening, department of public health-licensed substance abuse programs, state agencies or those vendors that contract with state agencies and are designated by the contracting agency to request such screenings, or other person authorized to use the report of such examination by provision of chapter one hundred twelve, unless such examination is for the sole purpose of testing the accuracy or sufficiency of the procedures or equipment of a clinical laboratory and is by instruction of the director of such laboratory, or unless such examination is for the purpose of providing a health promotion screening program and is not used for diagnosis or treatment of patients; (8) report an examination of any specimen derived from a human body except to or as directed by the licensed physician, licensed chiropractor, licensed surgeon, licensed podiatrist, licensed osteopath or, for the sole purpose of requesting urine drug screening, department of public health-licensed substance abuse programs, state agencies or those vendors that contract with state agencies and are designated by the contracting agency to request such screenings, or other authorized person who requested such examination in writing, unless such examination was made for the sole purpose of testing the accuracy or sufficiency of the procedures or equipment of a clinical laboratory and by instruction of the director of such laboratory, or unless such examination is for the purpose of providing a health promotion screening program and is not used for diagnosis or treatment of patients; (9) make a report of an examination of any specimen derived from the human body without designating the name and address, and the name of the director, of the clinical laboratory in which such examination was actually performed; (10) represent, or to maintain a specimen collection station on behalf of, any clinical laboratory, unless such laboratory, if in the commonwealth, is licensed under section five, or unless such laboratory, if not in the commonwealth, has been accredited or is licensed in accordance with federal law; (11) employ a person as a director of a clinical laboratory, or to serve as a director of a clinical laboratory, except as provided in section seven; (12) fail to report evidence of infectious disease in violation of section six or of any rule, regulation, or order made to implement section six; (13) violate or fail to observe any requirement of this chapter or of a rule, regulation, or order made pursuant to this chapter, which the department has made subject to this section by regulation; (14) knowingly and willfully make fraudulent representations regarding the results of any laboratory test or service. Any laboratory employee, clinical laboratory director, or owner of a clinical laboratory as defined in this chapter who knowingly and willfully makes fraudulent representation regarding the results of any laboratory test or service or who should have known of the fraudulent representation of laboratory test results shall be subject to the penalties set forth in this chapter; (15) engage in any misrepresentation or false advertising of the nature, quality or cost of such services or of the terms and conditions on which such services are provided; (16) enter into any agreement or act in concert with any purchaser of or third party payor for laboratory services to commit any act which would be deemed to be a violation of section three of chapter one hundred and seventy-six D; provided further that for purposes of this subsection, all purchasers and third party payors entering into arrangements with clinical laboratories shall be deemed to be engaged in the business of insurance. (17) knowingly solicit, accept or test any specimen derived from the human body that is received from, ordered, requested or referred by: (a) any person or company in which the clinical laboratory or its directors, owners, partners, employees or family members thereof have any direct or indirect ownership interest; or (b) any person or company or its directors, owners, partners, employees or family members thereof having any direct or indirect ownership interest in the clinical laboratory; provided, however, that this clause shall not apply to: (i) a clinical laboratory owned by a licensed physician or group of licensed physicians used exclusively in connection with the diagnosis and treatment of the physician's or group of physicians' own patients and where all testing is performed by or under the direct supervision of the physician or group of physicians; (ii) a hospital or clinic licensed under section 51 of chapter 111 used exclusively in connection with the diagnosis or treatment of the hospital's or clinic's own patients; or (iii) any case exempted under subsection (b) to (d), inclusive, of 42 U.S.C. section 1395nn, or specifically permitted by regulations or rules of the United States Secretary of Health and Human Services, the federal Centers for Medicare or Medicaid Services, the executive office of health and human services or the executive office for administration and finance.

M.G.L. c. 111D, § 8A Examination of specimen derived from human body prohibited by clinical laboratory in which person or company, or any of its owners, directors, partners, employees or family members have direct or indirect ownership interest

c. 111D, § 8A. Examination of specimen derived from human body prohibited by clinical laboratory in which person or company, or any of its owners, directors, partners, employees or family members have direct or indirect ownership interest Section 8A. No person or company shall knowingly refer, request, order or send any specimen derived from the human body for examination to a clinical laboratory in which the person or company, or any of its owners, directors, partners, employees or family members thereof have a direct or indirect ownership interest. This section shall not apply to: (i) a clinical laboratory owned by a licensed physician or group of licensed physicians and used exclusively in connection with the diagnosis and treatment of the physician's or group of physicians' own patients and where all testing is performed by or under the direct supervision of said physician or group of physicians; (ii) a hospital or clinic licensed under section 51 of chapter 111 used exclusively in connection with the diagnosis or treatment of the hospital's or clinic's own patients; or (iii) any case exempted under subsections (b) to (d), inclusive, of 42 U.S.C. section 1395nn or specifically permitted by regulations or rules of the United States Secretary of Health and Human Services, the federal Centers for Medicare or Medicaid Services, the executive office of health and human services or the executive office for administration and finance.

M.G.L. c. 111D, § 9 Correction of deficiencies; orders

c. 111D, § 9. Correction of deficiencies; orders Section 9. Whenever the department finds upon inspection, or through information in its possession, that a clinical laboratory licensed under this chapter is not in compliance with a requirement prescribed in or established under this chapter, it may by order require the licensee to correct such deficiency. Every correction order shall include a statement of the deficiencies found, the provisions of law relied upon, and the period prescribed for correction, which shall be reasonable and, except in an emergency declared by the commissioner, not less than thirty days after receipt of such order. Within ten days of receipt, the affected licensee may file a written request with the department for administrative reconsideration of the order or any portion thereof. Failure by the department to grant, deny, or otherwise act upon a written request within ten days after filing shall be deemed a denial.

M.G.L. c. 111D, § 10 Unreliable reports of examinations; license modification

c. 111D, § 10. Unreliable reports of examinations; license modification Section 10. Whenever the department finds upon inspection, or through information in its possession, that a clinical laboratory, licensed under this chapter is not able to provide or is not providing reliable reports of examinations pursuant to the terms of such license, it may by order modify any term of such license as it deems necessary to enable the laboratory to provide reliable reports of examinations. Every license modification order shall include a statement of the reasons for modification, the provisions of law relied upon, and the date fixed for compliance, which date shall be reasonable and, except in an emergency declared by the commissioner, not less than thirty days after receipt of such order. Except in the case of a license modification imposed as a sanction after hearing under section eleven, a licensee in receipt of an order shall have the opportunity for a hearing under the provisions of chapter thirty A. If after hearing the licensee establishes that the order, or any portion thereof, is not warranted, the department shall rescind or qualify such order, as appropriate. The filing of a request for a hearing shall not operate as a stay of the compliance date of a license modification order, but the department shall stay the compliance date upon written request, except to the extent that a stay would jeopardize the public health or public safety.

M.G.L. c. 111D, § 11 Revocation of or administrative sanctions upon license

c. 111D, § 11. Revocation of or administrative sanctions upon license Section 11. The department may revoke the license issued under section five or impose other appropriate administrative sanction upon a license, or both, for conduct by or chargeable to him as follows: (1) failure to observe any term of such license; (2) failure to meet any requirement for such license established under section five; (3) failure to observe any order made under authority of this chapter or under other statutory authority vested in the department; (4) engaging in, or aiding, abetting, causing, or permitting, any action prohibited under section eight; or (5) other proper cause set forth in regulations made under this chapter. Before sanctioning a licensee, the department shall give such licensee notice of the charges against him, the provisions of law relied upon, and the proposed sanction, and shall afford him the opportunity for a hearing under the provisions of chapter thirty A. Where, after hearing, the department finds that cause exists for imposition of a sanction, it need not impose the sanction proposed but may instead impose a lesser sanction if, in its judgment, a lesser sanction is appropriate in the circumstances. In the event revocation is imposed, the licensee shall be permitted a reasonable period in which to cease operation, but in no case less than thirty days after notice of the decision of the department. Notwithstanding any other provision of this section, the commissioner may, at any time upon notice to the licensee, whether a hearing has been first commenced or not, suspend his licensee or issue such other preliminary order as the commissioner considers appropriate for the protection of the health or safety of the public if he should find that either is in jeopardy; provided, that a hearing shall be commenced within five days after such notice in any case of suspension without a prior hearing unless the licensee shall request a postponement. The finding of the commissioner shall be included in such notice.

M.G.L. c. 111D, § 12 Complaints by department; jurisdiction

c. 111D, § 12. Complaints by department; jurisdiction Section 12. The department, in its own name, may bring a complaint in the superior court or supreme judicial court to enforce compliance with this chapter or any rule, regulation, or order made under this chapter, whenever it shall appear that any person has engaged in, is engaging in, or is about to engage in an act or practice in violation of this chapter or of any rule, regulation, or order made under this chapter, or whenever it shall appear that any person has aided, abetted, caused or permitted, is aiding, abetting, causing or permitting, or is about to aid, abet, cause or permit such an act or practice.

M.G.L. c. 111D, § 13 Violations; penalties

c. 111D, § 13. Violations; penalties Section 13. (a) No individual shall: (i) maintain a clinical laboratory in the commonwealth without a license in violation of section 4; (ii) maintain a clinical laboratory in violation of the terms of a license issued under section 5; (iii) engage in, aid, abet, cause or permit any act prohibited under section 8; or (iv) refer, request, order or send any specimen derived from the human body in violation of section 8A. A violation of this subsection, shall be punished by imprisonment for not more than 5 years in state prison, or by imprisonment in a jail or house of correction for not more than 21/2 years, or by a fine of not more than $10,000 or by both such fine and imprisonment. The commissioner shall transmit to the attorney general evidence of an offense, which is in the department's possession. (b) If a person or company violates clause (17) of section 8 or section 8A, the attorney general may bring a civil action, either in lieu of or in addition to a criminal prosecution, and may recover a civil penalty of not less than $5,000 and not more than $10,000 per violation, plus 3 times the amount of damages sustained, including consequential damages. A person violating clause (17) of section 8 or section 8A shall be liable to the commonwealth for the expenses of the civil action brought to recover any such penalty or damages, including, but not limited to, reasonable attorney's fees, reasonable expert's fees and the costs of investigation. No action shall be brought under this section more than 6 years after it accrues. The commissioner shall transmit to the attorney general such evidence of an offense as the department may have in its possession. (c) A person or company that solicits, offers or enters into a referral arrangement or scheme with a clinical laboratory which the person or company knows or should know has a principal purpose of assuring referrals by the person or company to a particular clinical laboratory which, if the person or company directly made referrals to such clinical laboratory, would be in violation of clause (17) of section 8 or section 8A, shall be liable to the commonwealth for a civil penalty of not more than $100,000 for each referral arrangement or scheme plus 3 times the amount of damages sustained, including consequential damages. No action shall be brought under this section more than 6 years after it accrues. The commissioner shall transmit to the attorney general such evidence of an offense as the department may have in its possession.

M.G.L. c. 111D, § 14 Disclosure of ownership interests; penalty for violation

c. 111D, § 14. Disclosure of ownership interests; penalty for violation Section 14. The department shall require all clinical laboratories to disclose any ownership interests in writing to the department every 2 years. The disclosure shall contain the name and ownership interest of the disclosing person or company, as well as the names and all ownership interests of all other parties with an ownership interest in the clinical laboratory. A copy of the disclosure shall be provided by the clinical laboratory to the attorney general. Any person who fails to provide such disclosure shall be subject to a fine not exceeding $5,000 by the department.

Source: Massachusetts General Court (malegislature.gov)URL: https://malegislature.gov/Laws/GeneralLaws/PartI/TitleXVI/Chapter111DFetched: 10/20/2026