Massachusetts 2025-2026 Regular Session

Massachusetts House Bill H2395 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	1 of 1
2	2	HOUSE DOCKET, NO. 2079 FILED ON: 1/15/2025
3	3	HOUSE . . . . . . . . . . . . . . . No. 2395
4	4	The Commonwealth of Massachusetts
5	5	_________________
6	6	PRESENTED BY:
7	7	Marjorie C. Decker
8	8	_________________
9	9	To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General
10	10	Court assembled:
11	11	The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill:
12	12	An Act relative to clinical laboratories.
13	13	_______________
14	14	PETITION OF:
15	15	NAME:DISTRICT/ADDRESS :DATE ADDED:Marjorie C. Decker25th Middlesex1/15/2025 1 of 12
16	16	HOUSE DOCKET, NO. 2079 FILED ON: 1/15/2025
17	17	HOUSE . . . . . . . . . . . . . . . No. 2395
18	18	By Representative Decker of Cambridge, a petition (accompanied by bill, House, No. 2395) of
19	19	Marjorie C. Decker relative to clinical laboratories. Public Health.
20	20	The Commonwealth of Massachusetts
21	21	_______________
22	22	In the One Hundred and Ninety-Fourth General Court
23	23	(2025-2026)
24	24	_______________
25	25	An Act relative to clinical laboratories.
26	26	Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority
27	27	of the same, as follows:
28	28	1 SECTION 1. Section 2 of chapter 111D of the General Laws, as appearing in the 2022
29	29	2Official Edition, is hereby amended by striking out subsections (1) and (2) and inserting in place
30	30	3thereof the following subsections:-
31	31	4 (1) to establish and to enforce, requirements in addition to any prescribed in this chapter
32	32	5for the construction, maintenance, and utilization of clinical laboratories, including standards of
33	33	6performance in the examination of specimens;
34	34	7 (2) to require evidence of successful participation by clinical laboratories licensed by the
35	35	8department in proficiency testing programs, and by laboratory personnel in training programs,
36	36	9covering all or specific laboratory specialties and approved by the department;
37	37	10 SECTION 2. Said section 2 of said chapter 111D, as so appearing, is hereby further
38	38	11amended by striking out subsection (5) and inserting in place thereof the following subsection:- 2 of 12
39	39	12 (5) to inspect at any time any clinical laboratory and any records maintained in
40	40	13connection with such laboratory; provided, that a license has been issued or an application for a
41	41	14license has been filed pursuant to section 5;
42	42	15 SECTION 3. Said section 2 of said chapter 111D, as so appearing, is hereby further
43	43	16amended by striking out subsections (8), (9), and (10) and inserting in place thereof the
44	44	17following subsections:
45	45	18 (8) to make such rules, regulations, as may be necessary or appropriate for the
46	46	19administration or enforcement of this chapter;
47	47	20 (9) to classify, laboratory tests as exempt; and
48	48	21 (10) to establish minimum qualifications of laboratory personnel.
49	49	22 SECTION 4. Said chapter 111D is hereby further amended by striking out section 3, as
50	50	23appearing in the 2022 Official Edition, and inserting in place thereof the following section:-
51	51	24 Section 3. The department may from time to time convene an advisory committee on
52	52	25clinical laboratories, to advise the department on the administration of this chapter. The Advisory
53	53	26Committee shall serve solely in an advisory capacity and shall not have authority to make
54	54	27binding decisions. Such committee shall consist of 13 members, to be appointed by the
55	55	28commissioner, as follows: 5 persons, 3 physicians and 2 nonphysicians, who meet the
56	56	29requirements for a clinical laboratory director as defined in regulation by the department; 1 other
57	57	30physician not a clinical laboratory director; 1 medical laboratory technologist; 1 chief executive
58	58	31officer of a hospital licensed by the department; and 5 non-providers of health services, 1 of
59	59	32whom shall be a member of the Massachusetts Bar and 1 a representative of manufacturers of 3 of 12
60	60	33clinical laboratory technology. Each member of the committee shall serve without compensation
61	61	34for a term of 3 years, or until a successor is appointed; provided, that no member shall serve
62	62	35more than 2 consecutive terms.
63	63	36 SECTION 5. Said chapter 111D is hereby further amended by striking out section 5, as
64	64	37appearing in the 2022 Official Edition, and inserting in place thereof the following section:-
65	65	38 Section 5. Any person seeking a license to maintain a clinical laboratory apart from a
66	66	39hospital or clinic licensed under section 51 of chapter 111 shall file with the department a license
67	67	40application containing such information as the department may reasonably require, including but
68	68	41not limited to: the identity of the applicant and any parent or associated company, including
69	69	42respective ownership interests, the identity and qualifications of the proposed laboratory director;
70	70	43and the procedures or categories of procedures for which the license is sought.
71	71	44 Upon receipt and review of an application for license and upon payment of the
72	72	45appropriate fee, the department shall issue a license if it finds that the applicant is responsible
73	73	46and suitable to maintain a clinical laboratory and meets such requirements as the department has
74	74	47established by regulation for a license. In the case of renewal application, the department may,
75	75	48subject to such regulations as it shall make, issue a provisional license to an applicant who does
76	76	49not meet every requirement for a license; provided, that the applicant has demonstrated to the
77	77	50department's satisfaction a good faith intention to correct deficiencies, and provided further, that
78	78	51the department finds that the licensee provides reliable reports of examinations of specimens and
79	79	52presents satisfactory evidence that the requirements for full licensure can and will be met within
80	80	53a period of time not to exceed 6 months. The department shall in no case issue a person more
81	81	54than 2 consecutive provisional licenses for the same clinical laboratory. 4 of 12
82	82	55 The department shall set forth in every license issued under this section the name and
83	83	56address of the licensee; the name by which the clinical laboratory shall be known; the address of
84	84	57the licensed premises; the period which such license is issued; the classification, if any, for
85	85	58which such license is issued; the conditions as to transfer and assignment prescribed by law; and
86	86	59such other terms of issuance as the department may reasonably prescribe. The period of a license
87	87	60shall be not more than 2 years and the period of a provisional license shall be for not more than 6
88	88	61months.
89	89	62 No licensee shall transfer the license issued to the licensee, or assign any authority
90	90	63granted thereunder, in any manner voluntarily or involuntarily, directly or indirectly, or by
91	91	64transfer or control of any person, without first obtaining the department's written permission,
92	92	65upon application to the department. Every application therefor shall contain such information as
93	93	66the department may require, and shall be approved or denied within 60 days of filing with the
94	94	67department. The department shall grant written permission if the department finds that the
95	95	68transferee or assignee is responsible and suitable to maintain a clinical laboratory and meets such
96	96	69requirements as the department has established by regulation for a license. Every denial order
97	97	70shall include a statement of the reasons for denial and the provisions of law relied upon, and shall
98	98	71be subject to judicial review.
99	99	72 SECTION 6. Said chapter 111D is hereby further amended by striking out section 7, as
100	100	73appearing in the 2022 Official Edition, and inserting in place thereof the following section:-
101	101	74 Section 7. Every clinical laboratory licensed by the department shall have an individual
102	102	75appointed, who shall bear the title ''clinical laboratory director'', with responsibility for the
103	103	76direction of the technical and scientific operation of such laboratory, including the examination 5 of 12
104	104	77of specimens and the making of reports thereon. The department shall, in regulations, set the
105	105	78qualifications and conditions as to the employment of individuals as clinical laboratory directors,
106	106	79which may include the following: educational and clinical experience needed to hold the position
107	107	80of clinical laboratory director and certifications needed.
108	108	81 SECTION 7. Said chapter 111D is hereby further amended by striking out section 8, as
109	109	82appearing in the 2022 Official Edition, and inserting in place thereof the following section:-
110	110	83 Section 8. A clinical laboratory shall not:
111	111	84 (1) misrepresent, by false statement, by omission of a material fact, or by scheme, trick,
112	112	85or device, the category or categories of procedures performed at, or the service or services
113	113	86available at, a clinical laboratory;
114	114	87 (2) obstruct, bar, or otherwise interfere with an inspection undertaken under the authority
115	115	88of section 2;
116	116	89 (3) make any false statement in or to omit a material fact from an application or other
117	117	90paper filed with the department;
118	118	91 (4) offer or give a commission, rebate, or other fee, directly or indirectly to any person as
119	119	92consideration for the referral of a specimen derived from a human body to a clinical laboratory
120	120	93for examination by such laboratory;
121	121	94 (5) solicit or accept a commission, rebate, or other fee, directly or indirectly, from any
122	122	95person as consideration for the referral of a specimen derived from a human body to a clinical
123	123	96laboratory for examination by such laboratory; 6 of 12
124	124	97 (6) lend the use of the name of a licensed clinical laboratory or of a licensed hospital or
125	125	98clinic, or of any employee of any such laboratory or institution, to an unlicensed clinical
126	126	99laboratory;
127	127	100 (7) to examine any specimen derived from a human body except upon the written request
128	128	101of a licensed physician, licensed dentist, licensed chiropractor, licensed surgeon, licensed
129	129	102podiatrist, licensed osteopath or other licensed health care practitioner acting within their scope
130	130	103of practice to make such a written request or, for the sole purpose of requesting urine drug
131	131	104screening, department of public health-licensed substance use disorder programs, state agencies
132	132	105or those vendors that contract with state agencies and are designated by the contracting agency to
133	133	106request such screenings, or other person authorized to use the report of such examination by
134	134	107provision of chapter 112, unless such examination is for the sole purpose of testing the accuracy
135	135	108or sufficiency of the procedures or equipment of a clinical laboratory and is by instruction of the
136	136	109director of such laboratory, or unless such examination is for the purpose of providing a health
137	137	110promotion screening program and is not used for diagnosis or treatment of patients;
138	138	111 (8) report an examination of any specimen derived from a human body except to or as
139	139	112directed by the licensed physician, licensed chiropractor, licensed surgeon, licensed podiatrist,
140	140	113licensed osteopath or other licensed health care practitioner acting within their scope of practice
141	141	114to make such a written request, or, for the sole purpose of requesting urine drug screening,
142	142	115department of public health-licensed substance use disorder programs, state agencies or those
143	143	116vendors that contract with state agencies and are designated by the contracting agency to request
144	144	117such screenings, or the patient who requested, in writing, the report of the patient’s own
145	145	118examination, or other authorized person who requested such examination in writing, unless such
146	146	119examination was made for the sole purpose of testing the accuracy or sufficiency of the 7 of 12
147	147	120procedures or equipment of a clinical laboratory and by instruction of the director of such
148	148	121laboratory, or unless such examination is for the purpose of providing a health promotion
149	149	122screening program and is not used for diagnosis or treatment of patients;
150	150	123 (9) make a report of an examination of any specimen derived from the human body
151	151	124without designating the name and address, of the clinical laboratory in which such examination
152	152	125was actually performed;
153	153	126 (10) represent, or to maintain a specimen collection station on behalf of, any clinical
154	154	127laboratory, unless such laboratory, if in the commonwealth, is licensed by the department, or
155	155	128unless such laboratory, if not in the commonwealth, has been accredited or is licensed in
156	156	129accordance with federal law;
157	157	130 (11) employ a person as a director of a clinical laboratory, or to serve as a director of a
158	158	131clinical laboratory, except as provided in section 7;
159	159	132 (12) fail to report evidence of infectious disease in violation of section 6 or of any rule,
160	160	133regulation, or order made to implement section 6;
161	161	134 (13) violate or fail to observe any requirement of this chapter or of a rule, regulation, or
162	162	135order made pursuant to this chapter, which the department has made subject to this section by
163	163	136regulation;
164	164	137 (14) knowingly and willfully make fraudulent representations regarding the results of any
165	165	138laboratory test or service. Any laboratory employee, clinical laboratory director, or owner of a
166	166	139clinical laboratory as defined in this chapter who knowingly and willfully makes fraudulent
167	167	140representation regarding the results of any laboratory test or service or who should have known 8 of 12
168	168	141of the fraudulent representation of laboratory test results shall be subject to the penalties set forth
169	169	142in this chapter;
170	170	143 (15) engage in any misrepresentation or false advertising of the nature, quality or cost of
171	171	144such services or of the terms and conditions on which such services are provided;
172	172	145 (16) enter into any agreement or act in concert with any purchaser of or third party payor
173	173	146for laboratory services to commit any act which would be deemed to be a violation of section 3
174	174	147of chapter 176D; provided further that for purposes of this subsection, all purchasers and third
175	175	148party payors entering into arrangements with clinical laboratories shall be deemed to be engaged
176	176	149in the business of insurance.
177	177	150 (17) knowingly solicit, accept or test any specimen derived from the human body that is
178	178	151received from, ordered, requested or referred by: (a) any person or company in which the clinical
179	179	152laboratory or its directors, owners, partners, employees or family members thereof have any
180	180	153direct or indirect ownership interest; or (b) any person or company or its directors, owners,
181	181	154partners, employees or family members thereof having any direct or indirect ownership interest
182	182	155in the clinical laboratory; provided, however, that this clause shall not apply to: (i) a clinical
183	183	156laboratory owned by a licensed physician or group of licensed physicians used exclusively in
184	184	157connection with the diagnosis and treatment of the physician's or group of physicians' own
185	185	158patients and where all testing is performed by or under the direct supervision of the physician or
186	186	159group of physicians; (ii) a hospital or clinic licensed under section 51 of chapter 111 used
187	187	160exclusively in connection with the diagnosis or treatment of the hospital's or clinic's own
188	188	161patients; (iii) a clinical laboratory operated by a college or university exclusively in connection
189	189	162with the diagnosis and treatment of the college or university’s own students, staff, and faculty 9 of 12
190	190	163and that meets the requirements in section 7 and department regulations for clinical laboratory
191	191	164director and where all tests are performed under the direct supervision of the clinical laboratory
192	192	165director; or (iv) any case exempted under subsection (b) to (d), inclusive, of 42 U.S.C. section
193	193	1661395nn, or specifically permitted by regulations or rules of the United States Secretary of Health
194	194	167and Human Services, the federal Centers for Medicare or Medicaid Services, the executive office
195	195	168of health and human services or the executive office for administration and finance.
196	196	169 SECTION 8. Said chapter 111D is hereby further amended by striking out section 8A, as
197	197	170appearing in the 2022 Official Edition, and inserting in place thereof the following section:-
198	198	171 Section 8A. No person or company shall knowingly refer, request, order or send any
199	199	172specimen derived from the human body for examination to a clinical laboratory in which the
200	200	173person or company, or any of its owners, directors, partners, employees or family members
201	201	174thereof have a direct or indirect ownership interest. This section shall not apply to: (i) a clinical
202	202	175laboratory owned by a licensed physician or group of licensed physicians and used exclusively in
203	203	176connection with the diagnosis and treatment of the physician's or group of physicians' own
204	204	177patients and where all testing is performed by or under the direct supervision of said physician or
205	205	178group of physicians; (ii) a hospital or clinic licensed under section 51 of chapter 111 used
206	206	179exclusively in connection with the diagnosis or treatment of the hospital's or clinic's own
207	207	180patients; (iii) a clinical laboratory operated by a college or university exclusively in connection
208	208	181with the diagnosis and treatment of the college or university’s own students, staff, and faculty
209	209	182and that meets the requirements in section 7 and department regulations for clinical laboratory
210	210	183director and where all tests are performed under the direct supervision of the clinical laboratory
211	211	184director; or (iv) any case exempted under subsections (b) to (d), inclusive, of 42 U.S.C. section
212	212	1851395nn or specifically permitted by regulations or rules of the United States Secretary of Health 10 of 12
213	213	186and Human Services, the federal Centers for Medicare or Medicaid Services, the executive office
214	214	187of health and human services or the executive office for administration and finance.
215	215	188 SECTION 9. Said chapter 111D is hereby further amended by striking out section 9, as
216	216	189appearing in the 2022 Official Edition, and inserting in place thereof the following section:-
217	217	190 Section 9. Whenever the department finds upon inspection, or through information in its
218	218	191possession, that a clinical laboratory licensed by the department is not in compliance with a
219	219	192requirement prescribed in or established under this chapter, it may by order require the licensee
220	220	193to correct such deficiency. Every correction order shall include a statement of the deficiencies
221	221	194found, the provisions of law relied upon, and the period prescribed for correction, which shall be
222	222	195reasonable and, except in an emergency declared by the commissioner, not less than 30 days
223	223	196after receipt of such order. Within 10 days of receipt, the affected licensee may file a written
224	224	197request with the department for administrative reconsideration of the order or any portion
225	225	198thereof. Failure by the department to grant, deny, or otherwise act upon a written request within
226	226	19910 days after filing shall be deemed a denial.
227	227	200 SECTION 10. Said chapter 111D is hereby further amended by striking out section 10, as
228	228	201appearing in the 2020 Official Edition, and inserting in place thereof the following section:-
229	229	202 Section 10. Whenever the department finds upon inspection, or through information in its
230	230	203possession, that a clinical laboratory, licensed by the department is not able to provide or is not
231	231	204providing reliable reports of examinations pursuant to the terms of such license, it may by order
232	232	205modify any term of such license as it deems necessary to enable the laboratory to provide reliable
233	233	206reports of examinations. Every license modification order shall include a statement of the reasons
234	234	207for modification, the provisions of law relied upon, and the date fixed for compliance, which date 11 of 12
235	235	208shall be reasonable and, except in an emergency declared by the commissioner, not less than 30
236	236	209days after receipt of such order.
237	237	210 Except in the case of a license modification imposed as a sanction after hearing under
238	238	211section 11, a licensee in receipt of an order shall have the opportunity for a hearing under the
239	239	212provisions of chapter 30A. If after hearing the licensee establishes that the order, or any portion
240	240	213thereof, is not warranted, the department shall rescind or qualify such order, as appropriate. The
241	241	214filing of a request for a hearing shall not operate as a stay of the compliance date of a license
242	242	215modification order, but the department shall stay the compliance date upon written request,
243	243	216except to the extent that a stay would jeopardize the public health or public safety.
244	244	217 SECTION 11. Said chapter 111D is hereby further amended by striking out section 11, as
245	245	218appearing in the 2022 Official Edition, and inserting in place thereof the following section:-
246	246	219 Section 11. The department may revoke the license issued pursuant to section 5 or
247	247	220impose other appropriate administrative sanction upon a license, or both, for conduct by or
248	248	221chargeable to the licensee as follows:
249	249	222 (1) failure to observe any term of such license;
250	250	223 (2) failure to meet any requirement for such license established under section 5;
251	251	224 (3) failure to observe any order made under authority of this chapter or under other
252	252	225statutory authority vested in the department;
253	253	226 (4) engaging in, or aiding, abetting, causing, or permitting, any action prohibited under
254	254	227section 8; or
255	255	228 (5) other proper cause set forth in regulations made under this chapter. 12 of 12
256	256	229 Before sanctioning a licensee, the department shall give such licensee notice of the
257	257	230charges against such licensee, the provisions of law relied upon, and the proposed sanction, and
258	258	231shall afford the licensee the opportunity for a hearing under the provisions of chapter 30A.
259	259	232Where, after hearing, the department finds that cause exists for imposition of a sanction, it need
260	260	233not impose the sanction proposed but may instead impose a lesser sanction if, in its judgment, a
261	261	234lesser sanction is appropriate in the circumstances. In the event revocation is imposed, the
262	262	235licensee shall be permitted a reasonable period in which to cease operation, but in no case less
263	263	236than 30 days after notice of the decision of the department.
264	264	237 Notwithstanding any other provision of this section, the commissioner may, at any time
265	265	238upon notice to the licensee, whether a hearing has been first commenced or not, suspend such
266	266	239licensee’s license or issue such other preliminary order as the commissioner considers
267	267	240appropriate for the protection of the health or safety of the public if the commissioner should find
268	268	241that either is in jeopardy; provided, that a hearing shall be commenced within 5 days after such
269	269	242notice in any case of suspension without a prior hearing unless the licensee shall request a
270	270	243postponement. The finding of the commissioner shall be included in such notice.
271	271	244 SECTION 12. Said chapter 111D is hereby further amended by striking out section 14, as
272	272	245appearing in the 2022 Official Edition, and inserting in place thereof the following section:-
273	273	246 Section 14. All clinical laboratories shall disclose ownership interests in writing to the
274	274	247Attorney General’s office upon initial licensure and thereafter every 2 years. The disclosure shall
275	275	248contain the name and ownership interest of the disclosing person or company, as well as the
276	276	249names and ownership interests of all other parties with an ownership interest in the clinical
277	277	250laboratory.