reglab/statecodes huggingface dataset:
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 173.000 - Mobile Integrated Health Care and Community Ems Programs › Section 173.060 - Community EMS Program Approval

Current through Register 1525, July 5, 2024
(A) Any
			 Community EMS Applicant seeking a valid Certificate of Approval for public
			 health service(s) as defined in Department guidelines issued pursuant to 105
			 CMR 173.060(B) shall be required to provide notification, in the form and
			 manner as determined by the Department, at least 30 calendar days prior to
			 anticipated commencement of Community EMS Program operations.
(B) The Department shall not issue a
			 Certificate of Approval to authorize a Community EMS Program to provide any
			 services other than those evidence-based illness and injury prevention
			 services, such as falls prevention, concussion training, certain vaccinations
			 under local public health authority direction, blood pressure screenings and
			 health promotion screening programs, pursuant to 105 CMR 180.000:
The
			 Operation, Approval and Licensing of Clinical Laboratories
, that are
			 deemed high-value public health services with low-risk potential to patients as
			 defined by the Department in guidelines and are consistent with identified
			 community health needs. Persons may submit to the Commissioner for
			 consideration by the Department a written request with appropriate supplemental
			 evidence supporting the future inclusion in, or exclusion from, said guidelines
			 of certain evidence-based illness and injury prevention service(s).
(C) All EMS Personnel training and activities
			 related to the Community EMS Program must be approved by the local public
			 health agency and the primary ambulance service's affiliate hospital medical
			 director.
(D) The designated
			 primary ambulance service's affiliate hospital medical director shall:
(1) Ensure all EMS Personnel providing
			 services in a Community EMS Program successfully complete additional training
			 tailored to meet the specific needs of the particular Community EMS
			 Program;
(2) Review the quality of
			 the EMS Personnel's delivery of services; and
(3) Ensure EMS Personnel provide services
			 only within their scope of practice.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 173.000 - Mobile Integrated Health Care and Community Ems Programs › Section 173.070 - Certificate of Approval

Current through Register 1525, July 5, 2024
(A) Following
			 Department determination that the proposed MIH or Community EMS Program has met
			 the minimum requirements of 105 CMR 173.000, the Department shall issue a
			 Certificate of Approval to the applicant, subject to any terms and conditions
			 specified by the Department.
(B)
			 Unless otherwise expressly denied by the Department in writing, notification,
			 as set forth in 105 CMR 173.060(A), shall constitute a valid Certificate of
			 Approval for the purposes of a Community EMS Program pursuant to 105 CMR
			 173.060 and 173.070.
(C) A
			 Certificate of Approval shall be valid for two years from the date of issue
			 unless otherwise specified in the Certificate of Approval.
(D) The Department may deny an application
			 for a Certificate of Approval for any of the reasons set forth in 105 CMR
			 173.080.
(E) A Certificate of
			 Approval may not be transferred or assigned to another service, program,
			 agency, entity, or location.
(F)
			 After receipt of a Certificate of Approval, an MIH or Community EMS Program may
			 seek approval of modifications in accordance with processes and criteria
			 established in Department guidance.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 173.000 - Mobile Integrated Health Care and Community Ems Programs › Section 173.080 - Grounds for Denial, Revocation, or Non-renewal of Approval

Current through Register 1525, July 5, 2024
Each of the following, in and of itself, shall constitute full
				and adequate ground on which the Department may deny an application for a
				Certificate of Approval, provide the applicant with the option to resubmit,
				revoke or refuse to renew a Certificate of Approval to operate an MIH or
				Community EMS Program:
(A) Failure to
			 meet applicable requirements for approval as specified in 105 CMR
			 173.000;
(B) Failure to meet the
			 requirements of applicable federal or state law or regulations;
(C) Failure to provide information as
			 required within 105 CMR 173.000;
(D) Any action or condition that endangers
			 public health and safety, as determined by the Department;
(E) Obtaining or attempting to obtain a
			 Certificate of Approval or renewal thereof by fraud, misrepresentation, or
			 knowing omission(s) of material information, or by submission of incorrect,
			 false or misleading information;
(F) Fraud, deceit or knowing omission(s) of
			 material information or providing false or misleading statements, orally or in
			 writing, to the Department;
(G)
			 Conviction of an applicant, approved entity or person with significant
			 financial or management interest in the MIH or Community EMS Program, whether
			 proposed or in operation, of Medicare or Medicaid fraud, or other criminal
			 offense related to the operation of the program or indicating that operation of
			 the program may endanger public health or safety;
(H) Reasonable basis for the Department to
			 conclude that a discrepancy exists between the representations by the applicant
			 as to the MIH or Community EMS Program services to be afforded patients and the
			 services actually rendered or to be rendered;
(I) Failure to meet the duties and
			 responsibilities for MIH or Community EMS Programs as required by 105 CMR
			 173.000;
(J) Failure to comply with
			 any term or condition prescribed by the Department within a Certificate of
			 Approval;
(K) Failure to submit an
			 acceptable plan of correction as required under 105 CMR 173.120;
(L) Failure to comply with a
			 Department-approved plan of correction or correction order in accordance with
			 105 CMR 173.120;
(M) Denial of
			 entry to Department agents to conduct site visits or inspections, or an attempt
			 to impede the work of Department agents; or
(N) Any other violation of M.G.L. c. 111O,
			 105 CMR 173.000, or related Department guidelines.
Nothing in 105 CMR 173.080 shall limit the Department from
				adopting additional grounds through adjudication.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 173.000 - Mobile Integrated Health Care and Community Ems Programs › Section 173.090 - Process for Denial, Revocation or Refusal of a Certificate of Approval for an MIH or Community EMS Program

Current through Register 1525, July 5, 2024
(A) If the
			 Department initiates an action to deny, revoke, or refuse to renew a
			 Certificate of Approval, the Department shall provide the MIH or Community EMS
			 Program with written notice of the reasons and grounds for the Department's
			 action, the provisions of law relied upon, and an opportunity to resubmit the
			 application within 30 calendar days of receipt of the notice of agency action.
			 If the Department denies the resubmitted application, the MIH or Community EMS
			 Program may request an adjudicatory hearing within 14 calendar days of receipt
			 of the notice of agency action.
(B)
			 Upon receipt of a request for hearing within the time period prescribed by 105
			 CMR 173.090(A), the Department shall afford the aggrieved party an opportunity
			 for an adjudicatory hearing to be conducted by a designated hearing
			 officer.
(C) If a hearing is not
			 requested within the time period prescribed by 105 CMR 173.090(A), the right to
			 a hearing shall be waived and a final agency decision shall be
			 issued.
(D) All adjudicatory
			 proceedings shall be conducted in accordance with M.G.L. c. 30A and
			 801 CMR 1.01:
Formal Rules
.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 173.000 - Mobile Integrated Health Care and Community Ems Programs › Section 173.110 - Complaints

Current through Register 1525, July 5, 2024
(A) Upon receipt of any complaint or serious
			 incident report, the Department shall take appropriate steps to investigate, as
			 appropriate, whether the reported or alleged act or practice violates M.G.L. c.
			 111O, any provision of 105 CMR 173.000, any guidelines, or any condition
			 imposed by the Department in its Certificate of Approval. The Department may
			 also refer the complaint or serious incident report to the appropriate
			 governmental authority responsible for licensure, certification, registration,
			 approval, or oversight as deemed necessary.
(B) If, after investigation, the Department
			 finds that the act or practice violates M.G.L. c. 111O, any provision of 105
			 CMR 173.000, Department guideline, or any condition imposed by the Department
			 in its Certificate of Approval, the Department may issue a correction order in
			 accordance with 105 CMR 173.120 or an agency action in accordance with 105 CMR
			 173.090.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 173.000 - Mobile Integrated Health Care and Community Ems Programs › Section 173.120 - Inspections, Statement of Deficiency, Order to Correct

Current through Register 1525, July 5, 2024
(A) The Department, either announced or
			 unannounced, may inspect any MIH or Community EMS Program for compliance with
			 105 CMR 173.000, Department guidelines, or conditions imposed by the Department
			 in its Certificate of Approval.
(B)
			 Whenever the Department finds upon inspection or through information in its
			 possession that an MIH or Community EMS Program is not in compliance, it may
			 issue an order to correct the deficiency. The correction order shall include a
			 statement of the deficiencies found, the provision of law relied upon, and a
			 reasonable prescribed period for correction.
(C) Within ten business days, an MIH or
			 Community EMS Program shall submit to the Department a written plan of
			 correction for each violation cited in the deficiency statement.
(D) Every plan of correction shall set forth,
			 with respect to each deficiency, the specific corrective step(s) to be taken, a
			 timetable for such steps, and the date by which compliance will be achieved.
			 The timetable and the compliance dates shall be consistent with achievement of
			 compliance in the most expeditious manner possible.
(E) The Department shall review the plan of
			 correction for compliance and will notify the MIH or Community EMS Program
			 whether the plan is accepted or rejected.
(F) Upon expiration of the time specified for
			 correction, the Department may re-inspect the MIH or Community EMS Program in
			 order to determine whether it is in compliance with the correction
			 order.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 173.000 - Mobile Integrated Health Care and Community Ems Programs › Section 173.130 - Summary Suspension of Certificate of Approval

Current through Register 1525, July 5, 2024
(A) In accordance with 105 CMR 173.090, the
			 Commissioner may summarily suspend an MIH or Community EMS Program Certificate
			 of Approval, pending further proceedings for revocation of or refusal to renew
			 a Certificate of Approval, whenever the Commissioner finds that the continued
			 operation of such program poses an imminent threat to public health and
			 safety.
(B) The Department shall
			 issue written notice of the suspension action which shall contain the reasons
			 and grounds for immediate suspension, the provisions of law relied on, and an
			 opportunity to request an adjudicatory hearing within 14 calendar days of
			 receipt of the notice of the suspension action.
(C) Upon receipt of a request for hearing
			 within the time period prescribed by 105 CMR 173.090, the Department shall
			 promptly afford the aggrieved party an opportunity for an adjudicatory hearing
			 to be conducted by a designated hearing officer. If a hearing is not requested
			 within the required time period, the right to a hearing shall be waived and a
			 final agency decision shall issue.
(D) Until the suspension is lifted or final
			 agency determination is made, the MIH or Community EMS Program may not
			 operate.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 173.000 - Mobile Integrated Health Care and Community Ems Programs › Section 173.140 - Waiver of Requirements

Current through Register 1525, July 5, 2024
(A) The Commissioner
			 may waive the applicability of one or more of the requirements imposed on a
			 particular MIH or Community EMS program by 105 CMR 173.000 if the Commissioner
			 finds that:
(1) Compliance would cause undue
			 hardship;
(2) The MIH or Community
			 EMS Program's non-compliance would not adversely affect the quality of patient
			 care or patient safety;
(3) The MIH
			 or Community EMS Program has instituted compensating features that are
			 acceptable to the Department.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 173.000 - Mobile Integrated Health Care and Community Ems Programs › Section 173.150 - Severability

Current through Register 1525, July 5, 2024
The provisions of 105 CMR 173.000 are severable. If a court of
				competent jurisdiction declares any section, subsection, paragraph, or
				provision unconstitutional or invalid, the validity of the remaining provisions
				shall not be affected.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.001 - Purpose

Current through Register 1525, July 5, 2024
The purpose of
				105 CMR 180.000 is to
				establish the rules and regulations which clinical laboratories must follow in
				order to be operating and, if applicable, licensed in co mpliance with M.G.L.
				c. 111D.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.002 - Citation

Current through Register 1525, July 5, 2024
105 CMR 180.000 shall be
				known as
				105 CMR 180.000:
The Operation, Approval and Licensing of Clinical
				Laboratories
.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.003 - Scope and Application

Current through Register 1525, July 5, 2024
105 CMR 180.000 establishes
				the minimum standards which all clinical laboratories including those which are
				part of a clinic or hospital licensed under M.G.L. c. 111 § 51, must meet
				in order to be operating in compliance with M.G.L. c. 111D.
				105 CMR 180.000 further
				establishes pursuant to M.G.L. c. 111D the licensing requirements and
				enforcement procedures for all clinical laboratories which are not subject to
				licensure under M.G.L. c. 111 § 51.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.004 - Waiver of Requirements Imposed on Laboratories

Current through Register 1525, July 5, 2024
(A) The Commissioner may waive the
			 applicability to a particular laboratory of one or more of the requirements
			 imposed on that laboratory by
			 105 CMR 180.000 if the
			 Commissioner finds that:
(1) compliance would
			 cause undue hardship to the laboratory; and
(2) the laboratory is in substantial
			 compliance with the spirit of the requirement; and
(3) the laboratory's non-compliance does not
			 adversely affect the quality of the laboratory's test results.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.030 - Licensure and Approval

Current through Register 1525, July 5, 2024
(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.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.031 - Special Projects

Current through Register 1525, July 5, 2024
The Department will consider proposals for special projects for
				the innovative delivery of clinical laboratory services. No such plan shall be
				implemented without prior written approval of the Department. Such plans shall
				be implemented only on an experimental basis and subject to renewal of the
				approval by the Department at such periods as the Department shall
				fix.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.035 - Enforcement Procedures

Current through Register 1525, July 5, 2024
(A)
Correction Orders and Administrative Reconsideration
(1) Whenever the Department finds upon
			 inspection or through information in its possession that a clinical laboratory
			 licensed or approved pursuant to c. 111D is not incompliance with a provision
			 of M.G.L. c. 111D or a regulation promulgated thereunder, it may order the
			 licensee or approved entity to correct such deficiency. The 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 30 days after receipt of such order.
(2) The Department shall notify the licensee
			 or approved entity of his right to administrative reconsideration of the
			 correction order. The licensee or approved entity may within ten days of
			 receipt of the order, file a written request with the Department for
			 administrative reconsideration. The request shall clearly identify the licensee
			 or approved entity, state the date and nature of the order, state the reason
			 why the order should be rescinded or modified and shall be signed by either the
			 licensee or approved entity or the director employed by the licensee or
			 approved entity.
(3) The Department
			 shall have ten days after receipt of the reconsideration request to act upon
			 the request. Failure of the Department to grant, deny or otherwise act upon a
			 reconsideration request within ten days after filing shall be deemed a
			 denial.
(4) Upon expiration of a
			 correction order, the Department may reinspect the clinical laboratory in order
			 to determine compliance by the laboratory with the correction order. If the
			 Department makes a determination of substantial non-compliance with the
			 correction order, the Department may issue a Notice of Sanctions to the
			 clinical laboratory. The Notice of Sanctions shall be subject to the procedures
			 set forth in 105 CMR 180.035(C).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.040 - Condition: General Requirements

Current through Register 1525, July 5, 2024
Each laboratory licensed or approved by the Department shall
				meet the standards set forth in
				105 CMR
				180.041 through
				180.044.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.041 - Standard - Responsibility of Owners

Current through Register 1525, July 5, 2024
(A)
			 The owner shall be responsible for the proper maintenance and ethical operation
			 of the clinical laboratory and for any violations of
			 105 CMR 180.000 and other
			 regulations. The Department shall be notified in writing within a 30-day period
			 of changes in Director, General Supervisor, and Technical Supervisor.
			 Significant changes in the physical facilities shall be reported to the
			 Department within 30 days after initiation of such changes.
(B) The owner shall notify the Department 15
			 days in advance of any change in the location or ownership of a
			 laboratory.
(C) The owner shall be
			 responsible that the clinical laboratory is at all times under the direction of
			 a Director acceptable to the Department. In the case where the Director is to
			 be absent for more to the approval of the Department, and shall so notify the
			 Department in advance.
(D) The
			 owner shall notify the Department in advance whenever the designated Director
			 is expected to terminate his employment. Permission may be granted to continue
			 operation of the laboratory for a time period not to exceed six calendar weeks
			 after the termination of the Director and prior to the appointment of a new
			 Director.
(E) The owner and
			 director shall, if different persons, be jointly and severally responsible for
			 the operation of the laboratory in compliance with the provisions set forth in
			 105 CMR 180.000 and with
			 other pertinent regulatory and statutory requirements.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.043 - Standard - Advertising

Current through Register 1525, July 5, 2024
(A) Advertising is
			 permissible in professional media if it is of an ethical nature and does not
			 contain misleading statements or unsubstantiated claims. Advertising to
			 individuals in the general public is permitted so long as such advertising:
(1) does not misrepresent, by false
			 statement, by omission of a material fact, or scheme, trick, or device, the
			 category or categories of procedure performed at, or the service or services
			 available at, the clinical laboratory;
(2) informs the public that Massachusetts law
			 prohibits laboratories from performing tests without a written request from a
			 licensed physician, dentist, or other authorized person; and
(3) conforms to all other Massachusetts laws
			 and regulations.
Personal solicitation by an owner or his agent shall be
				considered advertising within the meaning of 105 CMR 180.043.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.044 - Standard - Reporting of Infectious Diseases

Current through Register 1525, July 5, 2024
Clinical laboratories shall be responsible for reporting to the
				Department any result on a specimen that yields evidence significant from a
				public health standpoint of the presence or for the prevention, diagnosis, or
				control of any of those infectious diseases identified by the Department in
				conjunction with the Advisory Committee on Clinical Labs.
(A) These reports shall be submitted on forms
			 provided by the Department at intervals specified by the Department.
(B) The Department shall supply each
			 responsible laboratory with guidelines indicating the specific laboratory
			 evidences of the diseases which are required to be reported.
(C) Clinical laboratories making such reports
			 shall not be held liable for having violated a trust or confidential
			 relationship. The reports should be deemed confidential and not a public record
			 within the meaning of M.G.L. c. 4, § 7(26).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.045 - Condition - Compliance with Federal, State and Local Laws

Current through Register 1525, July 5, 2024
Each laboratory shall comply with all applicable federal, state
				and local laws. Such compliance shall include , at a minimum, the
				following:
(A)
Licensure
			 or Certification
. All laboratories subject to regulation shall
(1) be licensed, approved or certified
			 according to applicable laws, and
(2) have current approval by the federal,
			 state or local agency responsible for licensing, approving or certifying the
			 laboratory.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.050 - Condition - Laboratory Director

Current through Register 1525, July 5, 2024
Every person licensed or approved to maintain a clinical
				laboratory under
				105 CMR 180.000 shall
				appoint an individual, who shall bear the title "Clinical Laboratory
				Director".
No individual so appointed shall serve as clinical laboratory
				director for more than three months unless the Department within that period
				shall certify that such person is qualified pursuant to
				105 CMR
				180.060.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.060 - Standard - Laboratory Director: Qualifications

Current through Register 1525, July 5, 2024
The minimum qualifications for a Clinical Laboratory Director
				shall be as follows:
(A) A physician
			 who is certified in anatomical or clinical pathology by the American Board of
			 Pathology or in at least one laboratory specialty by the American Board of
			 Medical Microbiology, the American Board of Clinical Chemistry, the American
			 Board of Dermatology, or other national accrediting board acceptable to the
			 department, or who possesses qualifications which the department considers
			 equivalent to any such certification except that physicians certified by the
			 American Board of Dermatology are restricted to director of a dermatology
			 laboratory; or
(B) An individual
			 who 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 atleast one laboratory specialty 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
(C) An individual
			 who has been responsible for direction of the technical and scientific
			 operation of a clinical laboratory for at least 12 consecutive months at any
			 time during the calendar years of 1971 through 1975, and who meets one of the
			 following requirements:
(1) 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; or
(2) 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
(3) 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; or
(4) A physician who meets the following
			 requirements:
(a) is a member of the group
			 practice which is maintaining the laboratory exclusively in connection with the
			 diagnosis and treatment of its own patients and the laboratory is performing
			 only those test procedures which are included on the approved limited license
			 test list;
(b) holds an earned
			 bachelor's degree with a chemical, physical, or biological science as his/her
			 major subject; and
(c) has at least
			 one year of pertinent experience subsequent to graduation in a clinical
			 laboratory with the range of testing at least as broad as the testing in the
			 current laboratory.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.070 - Standard - Laboratory Director: Duties and Responsibilities

Current through Register 1525, July 5, 2024
Each laboratory shall employ a director who administers the
				technical and scientific operation of the laboratory including the reporting of
				findings of laboratory tests. Such administration shall include, at a minimum,
				the following:
(A) In no event shall
			 any individual accept employment as a clinical laboratory Director at more than
			 three clinical laboratories during the same period. The director may be
			 employed on a full-time, or regular part-time basis.
(B) The director shall, commensurate with the
			 laboratory workload, spend an adequate amount of time in the laboratory to
			 direct and supervise the technical performance of the staff and be readily
			 available for personal or telephone consultation.
(C) The director shall be responsible for
			 ensuring the quality operation of the laboratory and the accuracy of test
			 results.
(D) The director shall be
			 responsible for the employment of qualified laboratory personnel and their
			 in-service training.
(E) If the
			 director is continuously absent for more than six weeks the laboratory shall
			 temporarily employ a qualified substitute director who shall assume
			 responsibility for the functions of the laboratory.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.100 - Condition - Laboratory Supervision

Current through Register 1525, July 5, 2024
The clinical laboratory shall be supervised by qualified
				personnel. There shall be two categories of required supervisors: General
				Supervisors and Technical Supervisors.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.105 - Standard - General Supervision

Current through Register 1525, July 5, 2024
(A) A qualified
			 general supervisor shall be on the laboratory premises and immediately
			 available to the bench area during all hours in which tests are being
			 performed.
(B) A qualified general
			 supervisor shall not be required to be on the premises during shifts or working
			 periods when only emergency (or STAT) work is being performed. When such
			 emergency (or STAT) testing is performed, it shall be performed by a
			 technologist qualified to perform such tests, and the next regularly scheduled
			 supervisor who is responsible for the results of the work shall review them. A
			 written record of the actual review shall be maintained.
(C) With respect to the specialty of
			 diagnostic cytology, cytotechnologists shall not examine slide preparations
			 unless a supervisor who qualifies pursuant to the provisions of
			 105 CMR
			 180.115(H)  or
			 180.125(B)(1)
			 or (B)(3)  is on the premises at all
			 times.
(D) A general supervisor may
			 also be a technical supervisor in those specialties in which the general
			 supervisor qualifies.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.110 - Standard - Technical Supervision

Current through Register 1525, July 5, 2024
The laboratory shall perform only those laboratory procedures
				and tests that are within the specialties and subspecialties in which the
				laboratory is licensed and for which the laboratory has a qualified
				supervisor.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.120 - Standard - General Supervisor: Duties and Responsibilities

Current through Register 1525, July 5, 2024
The qualified general supervisor shall, under the general
				directions of the laboratory director:
(A) Supervise technical personnel and
			 reporting of findings;
(B) Perform
			 tests requiring special scientific skills; and
(C) Assume such other administrative
			 responsibilities as are delegated by the director.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.125 - Standard - Technical Supervisor: Qualifications

Current through Register 1525, July 5, 2024
A clinical laboratory shall have one or more individuals who
				qualify as a Technical Supervisor for each specialty area in which the
				laboratory is licensed to perform tests. The Director and/or the General
				Supervisor may qualify as the Technical Supervisor in one or more of the
				specialties, provided he meets the following criteria:
(A) For all specialties except pathology:
(1) Qualifies as a laboratory Director or
			 General Supervisor under
			 105 CMR
			 180.060(A),
			 180.060(B),
			 180.060(C)(1),
			 180.115(B),
			 or
			 180.115(C),
			 and has two years of full-time experience subsequent to graduation in the
			 specialty for which is to be qualified; or
(2) Qualifies as a Director or General
			 Supervisor under
			 105 CMR
			 180.060(C)(2),
			 180.115(D),
			 180.115(E),
			 or
			 180.115(F)
			  and has four years of pertinent full-time
			 experience subsequent to graduation in the specialty for which is to be
			 qualified; or
(3) Qualifies as a
			 laboratory Director or General Supervisor under
			 105 CMR
			 180.060(C)(3),
			 180.115(G),
			 180.115(I),
			 or
			 180.115(J),
			 and has six years of pertinent full-time experience in an approved clinical
			 laboratory in the specialty for which he wishes to be qualified.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.130 - Standard - Technical Supervisor: Duties and Responsibilities

Current through Register 1525, July 5, 2024
The technical supervisor for each specialty shall spend an
				adequate amount of time in the laboratory to supervise the technical
				performance of the staff in the specialty and be readily available for personal
				or telephone consultation.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.155 - Standard - Technologist: Qualifications

Current through Register 1525, July 5, 2024
Each clinical laboratory technologist shall meet one of the
				following criteria:
(A) Have earned a
			 bachelor's degree in medical laboratory science from an accredited college or
			 university; the degree program shall have included a one year structured
			 clinical laboratory experience in e it he r
(1) the general areas of a clinical
			 laboratory, or
(2) in a specialty
			 area; or
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.160 - Standard - Technologist: Duties and Responsibilities

Current through Register 1525, July 5, 2024
The laboratory shall employ a sufficient number of clinical
				laboratory technologists and/or cytotechnologists to proficiently perform under
				general supervision the clinical laboratory tests which require the exercise of
				independent judgment.
(A) The clinical
			 laboratory technologists shall perform tests requiring the exercise of
			 independent judgment and responsibility with minimal supervision by the
			 director or supervisors only in those specialties or subspecialties in which
			 the laboratory technologists are qualified by education, training, and
			 experience.
(B) Specialties in
			 which the clinical laboratory technologist is not qualified by education,
			 training, or experience shall be performed only under the direct supervision of
			 the laboratory supervisor or qualified technologist.
(C) Clinical laboratory technologists shall
			 be present in sufficient number to adequately supervise the work of technicians
			 and trainees.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.165 - Standard - Cytotechnologist: Qualifications

Current through Register 1525, July 5, 2024
Each cytotechnologist shall meet one of the following
				requirements:
(A) Have successfully
			 completed two years in an accredited college or university with at least 12
			 semester hours in science, eight hours of which were in biology, and
(1) have had 12 months of training in a
			 school of cytotechnology accredited by an accrediting agency approved by the
			 Department, or
(2) have received
			 six months of formal training in a school of cytotechnology accredited by an
			 accrediting agency approved by the Department and six months of full-time
			 experience in cytotechnology in a laboratory acceptable to the pathologist who
			 directed such formal six months of training, or
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.170 - Standard - Cytotechnologist: Duties and Responsibilities

Current through Register 1525, July 5, 2024
A cytotechnologist shall be qualified by education, training
				and experience, to perform tests requiring the exercise of independent judgment
				and responsibility with minimal supervision by the director or supervisors. The
				cytotechnologist shall perform tests only in those specialities or
				subspecialties in which he is qualified.
(A) Tests inspecialties in which the clinical
			 laboratory cytotechnologist is not qualified by education, training, or
			 experience shall be performed only under the direct supervision of the
			 laboratory supervisor or a qualified technologist.
(B) An individual qualified as a
			 cytotechnologist solely under
			 105 CMR
			 180.165 of this section may supervise
			 technicians and trainees only in the specialty of cytology.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.180 - Standard - Technician: Duties and Responsibilities

Current through Register 1525, July 5, 2024
Clinical laboratory technicians shall be employed in sufficient
				numbers to meet the workload demands of the laboratory and shall function only
				under direct supervision of a clinical laboratory technologist.
(A) Each technician shall perform only those
			 clinical laboratory procedures which require a degree of skill and judgment
			 commensurate with the education, training, and technical abilities of the
			 technician.
(B) Clinical laboratory
			 technicians shall perform procedures under the supervision of a qualified
			 laboratory technologist, supervisor, or director.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.190 - Standard - Technologist Trainee: Duties and Responsibilities

Current through Register 1525, July 5, 2024
Technologist trainees may perform procedures for which they
				have received specific technical training under the personal and direct
				supervision of a qualified supervisor or technologist.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.200 - Standard - Training Programs

Current through Register 1525, July 5, 2024
Training programs required for trainee-level personnel shall be
				structured so as to insure that they will produce individuals who can
				adequately perform duties at the technologist level. The director and
				supervisors shall actively provide for the development of trainees by
				formulating a structured program for the training. The laboratory shall have a
				means for examining the proficiency of the trainee and for providing records of
				the trainee's progress. Any laboratory employing trainees shall submit a
				written plan for the training of the Department for approval. The laboratory
				should consider the following factors when designing the training program: size
				of the laboratory, type of tests performed, number and qualifications of all
				personnel and the individual trainee's ability and needs.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.255 - Standard - Laboratory Procedure Manual

Current through Register 1525, July 5, 2024
(A)
			 There shall be available at all times, in the immediate bench area, to
			 personnel engaged in examining specimens and performing related procedures
			 within a category (
e.g.
, clinical chemistry, hematology,
			 pathology, etc.), current laboratory manuals or other complete written
			 descriptions and instructions for all automated and manual test procedures
			 which are performed by the laboratory. Procedures shall include:
(1) The analytical methods used by those
			 personnel, properly designated and dated to reflect the most recent supervisory
			 review;
(2) Reagents;
(3) Control and calibration
			 procedures;
(4) Pertinent
			 literature references. Textbooks may be used as supplements to such written
			 descriptions but shall not be used in lieu thereof.
Each procedure shall be reviewed and dated by the technical
				supervisor at least annually. Written approval shall be given by the director
				or supervisor of all changes in laboratory procedures.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.260 - Standard - Facility Management

Current through Register 1525, July 5, 2024
Space and facilities shall be adequate to properly perform the
				services which are performed inor offered by the laboratory. Such space and
				facilities shall include, at a minimum, the following:
(A) Workbench space shall be ample,
			 well-lighted, and convenient to sink, water, gas, suction and electrical
			 outlets as necessary.
(B) Work
			 areas shall be arranged so as to minimize problems in transportation and
			 communication.
(C) The laboratory
			 shall be properly vented.
(D)
			 Volatile chemicals and inflammable solvents shall be properly stored in areas
			 where ignition is unlikely and restricted from open flame or heat.
(E) Temperature and humidity shall be
			 controlled within those limits which are necessary for proper performance of
			 tests and proper operation of laboratory instruments.
(F) Appropriate enclosures, such as fume
			 hoods and biological safety cabinets, shall be utilized when handling hazardous
			 materials.
(G) Adequate fire
			 precautions and occupational safety and health laws shall be posted in areas
			 frequented by and visible to employees. The precautions and laws shall be known
			 and observed by laboratory employees to insure that there is freedom from
			 unnecessary physical, chemical, biological and electrical hazards.
(H) The laboratory shall maintain a sanitary
			 environment.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.265 - Standard - Collection of Specimens

Current through Register 1525, July 5, 2024
No person other than a licensed physician or an individual
				authorized by a qualified laboratory director or individual otherwise
				authorized by state law or regulation may collect blood or other specimens from
				a patient.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.270 - Standard - Sterilization

Current through Register 1525, July 5, 2024
Syringes, needles, lancets, or other blood-letting devices
				capable of transmitting infection from one person to another shall not be
				reused unless they are properly sterilized prior to each use and wrapped in a
				manner which will insure that they remain sterile until used.
(A) Appropriate sterilization and
			 disinfection techniques shall be utilized, as required, for tests performed on
			 potentially contaminated material and for the protection of laboratory
			 personnel.
(B) Disposable syringes,
			 needles, pipettes, petri dishes, and other disposable items shall be
			 appropriately discarded immediately after use.
(C) Records shall be kept which indicate that
			 each sterilizing cycle contains a device which indicates proper sterilization
			 was carried out.
(D) Proper
			 operation of the autoclave shall be checked monthly with viable spores or
			 appropriate indicators.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.275 - Standard - Disposal of Medical Waste

Current through Register 1525, July 5, 2024
Licensing regulations governing the disposal of infectious or
				physically dangerous medical or biological waste are set forth in
				105 CMR 480.000:
Storage and Disposal of Infectious or Physically Dangerous Medical or
				Biological Waste: State Sanitary Code Chapter VIII
which is
				incorporated herein by reference.