reglab/statecodes huggingface dataset:
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 48 - CHILD ABUSE AND NEGLECT MEDICAL REIMBURSEMENT PROGRAM › Chapter 10.48.01 - Services › Section 10.48.01.07 - Payment Procedures

Current through Register Vol. 51, No. 14, July 12, 2024
A. The
				  provider shall submit the request for payment on the appropriate Medical
				  Assistance Program invoice form.
B.
				  The Department reserves the right to return to the provider, before payment,
				  all invoices not properly signed, completed, and accompanied by properly
				  completed forms required by the Department.
C. Providers shall charge the Program their
				  usual and customary charge to the general public for similar
				  services.
D. The fee schedule for
				  covered services except hospital services shall be the same as is contained in
				  the Maryland Medical Assistance Program's Professional Services Provider Manual
				  and Fee Schedule which is incorporated by reference in COMAR 10.09.02.0
				  7D.
E. The reimbursement rates for
				  all covered hospital services shall be the Health Services Cost Review
				  Commission approved rates less the discount allowed the Medical Assistance
				  Program.
F. For covered services,
				  the Program shall pay the lower of:
(1) The
				  provider's usual and customary charge to the general public for similar
				  services; or
(2) The applicable
				  rate described in §D or E of this regulation.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 48 - CHILD ABUSE AND NEGLECT MEDICAL REIMBURSEMENT PROGRAM › Chapter 10.48.01 - Services › Section 10.48.01.08 - Recovery and Reimbursement

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  The child's parent or guardian is liable to the Department of Health and Mental
				  Hygiene for all payments made on behalf of the child by this Program.
B. The child's parent or guardian shall take
				  any steps necessary to secure health benefits available for the child from a
				  public or private benefit program.
C. Upon notification to the provider that the
				  child has insurance or other coverage for services covered by this chapter, the
				  provider shall seek payment from that source.
D. If payment is made to a provider by both
				  the Program and other insurance or other source, the provider shall refund the
				  Program, within 60 days of receipt, the amount paid by the Program or the
				  insurance or other source, whichever is less.
E. The provider shall reimburse the Program
				  for any overpayments.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 48 - CHILD ABUSE AND NEGLECT MEDICAL REIMBURSEMENT PROGRAM › Chapter 10.48.01 - Services › Section 10.48.01.09 - Appeal Procedures

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  Providers filing appeals from administrative decisions made in connection with
				  these regulations shall do so according to State Government Article, Title 10,
				  Subtitle 2, and Health-General Article, 2-201-----2-207, Annotated Code of
				  Maryland.
B. Appeals shall be filed
				  within 30 days of receipt of notice of administrative decisions.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 48 - CHILD ABUSE AND NEGLECT MEDICAL REIMBURSEMENT PROGRAM › Chapter 10.48.01 - Services › Section 10.48.01.10 - Funding Availability

Current through Register Vol. 51, No. 14, July 12, 2024
Payment under this chapter is contingent on the
					 availability of funds in accordance with State Finance and Procurement Article,
					 7-234 and 7-235, Annotated Code of Maryland.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 49 - STATE ANATOMY BOARD › Chapter 10.49.01 - Fees › Section 10.49.01.01 - Definitions

Current through Register Vol. 51, No. 14, July 12, 2024
A. In this chapter,
				  the following terms have the meanings indicated.
B. Terms Defined.
(1) "Board" means the State Anatomy
				  Board.
(2) "Cadaveric specimens"
				  means requested body parts, organs, or tissues taken from a cadaver.
(3) "In-State commercial programs" means uses
				  of cadaveric specimens at in-State institutions for teaching, training or
				  research using a company's medical products such as an instrument, implant, or
				  other device.
(4) "In-State
				  programs" means institutional or government funded, or continuing medical
				  education accredited courses.
(5)
				  "In-State study programs" means Maryland medical-dental study programs that use
				  cadavers and cadaveric specimens to conduct:
(a) Anatomical disciplinary
				  instruction;
(b) Resident surgical,
				  clinical, or allied health training;
(c) Physician continuing education training
				  courses and advanced study;
(d)
				  Allied health, paramedic, and emergency medical training courses;
(e) Research study requiring cadavers or
				  human cadaveric specimens; or
(f)
				  Other educational, training, or research programs approved by the
				  Board.
(6) "Member
				  school programs" means departments of anatomy of medical-dental schools located
				  in Maryland that use cadavers and cadaveric specimens to support teaching and
				  research studies.
(7) "Member
				  schools" means from the Departments of Anatomy of the medical schools in
				  Maryland and the University of Maryland Dental College.
(8) "Out-of-State commercial" means uses of
				  cadaveric specimens at out-of-State institutions for teaching, training, or
				  research using a company's medical products such as an instrument, implant, or
				  other device.
(9) "Out-of-State
				  study programs" means out-of-State medical-dental study institutions that:
(a) Use cadavers and cadaveric specimens to
				  conduct anatomy courses as specified in §B(5) of this regulation;
				  and
(b) Are institutional or
				  government funded, or continuing medical education accredited
				  courses.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 49 - STATE ANATOMY BOARD › Chapter 10.49.01 - Fees › Section 10.49.01.02 - Reimbursement Claim Fees

Current through Register Vol. 51, No. 14, July 12, 2024
A. The
				  Board shall:
(1) Release an unclaimed body
				  under its control to a relative or friend; and
(2) Be reimbursed for expenses incurred for
				  transportation, storage, preparation, cremation, and supplies and materials
				  used.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 49 - STATE ANATOMY BOARD › Chapter 10.49.01 - Fees › Section 10.49.01.03 - Cadaver and Cadaveric Specimen Fees

Current through Register Vol. 51, No. 14, July 12, 2024
A. The Board shall review costs of services
				  provided to the State's medical-dental member school programs every 2
				  years.
B. Cost Analysis. The Board
				  shall:
(1) Perform a cost analysis of
				  expenditures and experienced program services based on activities related to
				  transportation, preparation, and disposition of bodies under its control;
				  and
(2) Determine the total average
				  cost per cadaver and cadaveric specimen, based on the cost analysis.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 50 - TISSUE BANKS › Chapter 10.50.01 - Tissue Banks › Section 10.50.01.01 - Purpose

Current through Register Vol. 51, No. 14, July 12, 2024
The intent of this chapter is to protect the public and
					 individual health by requiring that all tissue banks operating or providing
					 services in Maryland operate under qualified supervision, reliable procedures,
					 and appropriate quality assurance.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 50 - TISSUE BANKS › Chapter 10.50.01 - Tissue Banks › Section 10.50.01.02 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
This chapter does not apply to a tissue bank
					 operated:
A. By the federal
				  government; or
B. Solely for
				  research and teaching purposes, if human tissue and tissue products from the
				  research or teaching are not transplanted, transfused, or used within or upon a
				  human.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 50 - TISSUE BANKS › Chapter 10.50.01 - Tissue Banks › Section 10.50.01.04 - Incorporation by Reference

Current through Register Vol. 51, No. 14, July 12, 2024
A. In
				  this chapter, the following documents are incorporated by reference.
B. Documents Incorporated.
(1) Standards for Tissue Banking (American
				  Association of Tissue Banks, 13th Edition), Sections C, D, E, F, G, H, J, K, L,
				  and Ml-8 only;
(2) Standards for
				  Blood Banks and Transfusion Services (American Association of Blood Banks, 29th
				  Edition);
(3)
											42 U.S.C. §§
												1320d et seq., as amended;
(4)
											42 U.S.C. §§
												17921 et seq., as amended; and
(5)45 CFR Parts 160, 162, and 164, as
				  amended.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 50 - TISSUE BANKS › Chapter 10.50.01 - Tissue Banks › Section 10.50.01.05 - Responsibilities of the OHCQ

Current through Register Vol. 51, No. 14, July 12, 2024
The OHCQ, acting as the Secretary's designee, shall:
A. Inspect or have an inspection conducted
				  for each tissue bank:
(1) When an initial
				  Maryland permit to operate is sought; and
(2) Annually after a Maryland permit has been
				  issued;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 50 - TISSUE BANKS › Chapter 10.50.01 - Tissue Banks › Section 10.50.01.06 - Permits

Current through Register Vol. 51, No. 14, July 12, 2024
A. General.
(1) Permit Requirement. A person shall hold a
				  permit issued by the Secretary before the person may:
(a) Operate a tissue bank in this State;
				  or
(b) Represent or service in this
				  State a tissue bank that is:
(i) In this
				  State; or
(ii) Outside this
				  State.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 50 - TISSUE BANKS › Chapter 10.50.01 - Tissue Banks › Section 10.50.01.07 - Accredited Tissue Bank and Accrediting Organization

Current through Register Vol. 51, No. 14, July 12, 2024
A. Accredited Tissue Bank-Determination. The
				  Secretary may accept as compliance with the inspection requirements of this
				  chapter a tissue bank accredited by an organization approved by the Secretary,
				  as set forth in §C of this regulation, if the OHCQ determines that the
				  standards of the tissue bank accrediting organization are equivalent to those
				  under this chapter.
B. Accredited
				  Tissue Bank-Requirements. In addition to meeting the requirements for
				  accreditation, as set forth by a tissue bank's accrediting organization, an
				  accredited tissue bank shall:
(1) Obtain and
				  maintain a valid permit issued by the Secretary; and
(2) Be subject to inspection by the OHCQ to:
(a) Determine if the tissue bank is operating
				  in a manner that does not constitute an imminent and serious risk to public
				  health;
(b) Investigate
				  complaints;
(c) Determine whether a
				  permittee is operating a tissue bank beyond the scope of the permit;
				  and
(d) Validate findings of a
				  tissue bank's accrediting organization.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 50 - TISSUE BANKS › Chapter 10.50.01 - Tissue Banks › Section 10.50.01.08 - Tissue Bank Standards - General

Current through Register Vol. 51, No. 14, July 12, 2024
A. Applicable Laws. A tissue bank shall
				  comply with all requirements and standards in this chapter as well as with
				  other applicable federal, State, and local laws, regulations, and
				  rules.
B. Governing Body. Unless
				  provided by the institution of which it is a part, a tissue bank shall have a
				  governing body consisting of individuals from various professions, that
				  determines the scope of activities to be pursued by the tissue bank and is
				  responsible for issues of:
(1)
				  Liability;
(2) Ethical
				  considerations;
(3) Fiduciary
				  responsibility; and
(4) Compliance
				  with the standards and requirements of this chapter and those of the tissue
				  bank's standard operating procedure manual.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 50 - TISSUE BANKS › Chapter 10.50.01 - Tissue Banks › Section 10.50.01.09 - Tissue Bank Standards - Inspection

Current through Register Vol. 51, No. 14, July 12, 2024
A. General.
(1) A permittee shall allow an on-site
				  inspection by the OHCQ, at any time during the tissue bank's regular hours of
				  operation, to evaluate the tissue bank's compliance with the applicable
				  requirements, conditions, and standards of this chapter.
(2) An inspection may include, but is not
				  limited to, observation and examination of:
(a) Tissue bank facilities and physical
				  security;
(b) Equipment;
(c) Quality assurance and quality control
				  policies and records;
(d) Operating
				  procedures, policies, and records;
(e) Personnel and personnel
				  records;
(f) Donor documentation
				  and records; and
(g) Other records
				  and files pertinent to this chapter.
(3) Tissue bank employees shall make data and
				  records accessible within a reasonable time during an on-site
				  inspection.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 50 - TISSUE BANKS › Chapter 10.50.01 - Tissue Banks › Section 10.50.01.10 - Tissue Bank Standards - Personnel

Current through Register Vol. 51, No. 14, July 12, 2024
A. General Requirements. A tissue bank shall
				  employ a technical director, medical director, and sufficient staff to:
(1) Provide accurate and reliable
				  services;
(2) Meet all operational
				  needs; and
(3) Meet all statutory
				  and regulatory requirements and standards.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 50 - TISSUE BANKS › Chapter 10.50.01 - Tissue Banks › Section 10.50.01.11 - Tissue Bank Standards - Testing to Minimize Disease Transmission

Current through Register Vol. 51, No. 14, July 12, 2024
A. Required
				  Testing.
(1) General-All Donors. A permittee
				  shall ensure that a prospective donor of tissue, including both leukocyte-rich
				  and leukocyte-poor cell and tissue, intended to be used as an allograft is
				  tested for biochemical, immunological, or serological evidence of:
(a) Hepatitis B virus (HBV);
(b) Hepatitis C virus (HCV);
(c) Human immunodeficiency virus type 1
				  (HIV-1);
(d) Human immunodeficiency
				  virus type 2 (HIV-2); and
(e)
				  Treponema pallidum (syphilis).
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 50 - TISSUE BANKS › Chapter 10.50.01 - Tissue Banks › Section 10.50.01.12 - Tissue Bank Standards - Technical

Current through Register Vol. 51, No. 14, July 12, 2024
In addition to the requirements and standards in this
					 chapter, a tissue bank shall meet and comply, where applicable, with the
					 following technical requirements and standards:
A. Records management, in the manner
				  prescribed in Section C of Standards for Tissue Banking;
B. Tissue acquisition, in the manner
				  prescribed in Section D of Standards for Tissue Banking;
C. Processing, preservation, quarantine, and
				  storage, in the manner prescribed in Section E of Standards for Tissue
				  Banking;
D. Release and transfer of
				  tissue, in the manner prescribed in Section F of Standards for Tissue
				  Banking;
E. Labeling, in the manner
				  prescribed in Section G of Standards for Tissue Banking;
F. Distribution and dispensing, in the manner
				  prescribed in Section H of Standards for Tissue Banking;
G. General operations, in the manner
				  prescribed in Section J of Standards for Tissue Banking;
H. Quality assurance, in the manner
				  prescribed in Section K of Standards for Tissue Banking;
I. Tissue dispensing services, in the manner
				  prescribed in Section L of Standards for Tissue Banking;
J. Tissue distribution intermediaries, in the
				  manner prescribed in subsections M1-8 of Standards for Tissue Banking;
				  and
K. Standards for Blood Banks
				  and Transfusion Services.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.01 - General › Section 10.51.01.01 - Purpose

Current through Register Vol. 51, No. 14, July 12, 2024
The intent of this subtitle is to require a forensic
					 laboratory to:
A. Employ qualified
				  employees; and
B. Operate and
				  perform forensic analyses under:
(1) Reliable
				  procedures;
(2) Effective quality
				  control and quality assurance programs; and
(3) Qualified supervision.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.01 - General › Section 10.51.01.02 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
A. This subtitle
				  contains the standards and requirements that a forensic laboratory shall meet
				  to obtain and retain a license to perform or offer to perform forensic
				  analyses.
B. This subtitle does not
				  apply to a:
(1) Forensic laboratory operated
				  by the federal government; or
(2)
				  Laboratory licensed or certified by the Maryland Department of
				  Agriculture.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.01 - General › Section 10.51.01.03 - Definitions

Current through Register Vol. 51, No. 14, July 12, 2024
A. In this
				  subtitle, the following terms have the meanings indicated.
B. Terms Defined.
(1) Accuracy.
(a) "Accuracy" means the degree of agreement
				  between the determination of a quantity and the quantity's true
				  value.
(b) "Accuracy" includes the
				  quality of a test result as it relates to the analytic phase of the testing
				  process when the test result:
(i) Conforms
				  exactly to a standard; or
(ii)
				  Deviates only within established limits from a standard.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.01 - General › Section 10.51.01.04 - Incorporation by Reference

Current through Register Vol. 51, No. 14, July 12, 2024
In this subtitle, the following documents are incorporated
					 by reference:
A.
										42 U.S.C. §
											14131, as amended; and
B. Quality Assurance Standards for DNA
				  Testing Laboratories, September 2011, Federal Bureau of
				  Investigation.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.02 - Responsibilities, Accreditations, and Audits › Section 10.51.02.01 - Responsibilities of the Department

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  The Department shall conduct audits, as set forth in this chapter, of forensic
				  laboratories that obtain or retain a license.
B. Audits. The Department shall:
(1) Conduct or oversee an announced or
				  unannounced audit of a forensic laboratory, at any time during a forensic
				  laboratory's hours of operation, to assess compliance with applicable sections
				  of Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland,
				  and this subtitle; and
(2) Examine,
				  as part of an audit, a forensic laboratory's facilities, equipment, quality
				  assurance records and procedures, operating procedures, employees, employee
				  records, proficiency testing, results and reports of forensic analyses, and
				  other records and files pertinent and subject to this subtitle.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.02 - Responsibilities, Accreditations, and Audits › Section 10.51.02.02 - Accredited Forensic Laboratory and Accrediting Organization

Current through Register Vol. 51, No. 14, July 12, 2024
A. Accredited
				  Forensic Laboratory - Determination. The Secretary shall accept as meeting the
				  audit requirements of this subtitle a forensic laboratory accredited by an
				  organization approved by the Secretary, as set forth in §C of this
				  regulation, if the Department determines that the standards of the forensic
				  laboratory's accreditation organization are equivalent to those under this
				  subtitle.
B. Accredited Forensic
				  Laboratory - Requirements. In addition to meeting the requirements for
				  obtaining and maintaining a certificate of accreditation, as set forth by the
				  forensic laboratory's accrediting organization, an accredited forensic
				  laboratory shall:
(1) Obtain and maintain a
				  valid license issued by the Department; and
(2) Be subject to audit by the Department as
				  set forth in COMAR
				  10.51.02.03C.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.02 - Responsibilities, Accreditations, and Audits › Section 10.51.02.03 - Audits

Current through Register Vol. 51, No. 14, July 12, 2024
A. General.
(1) A licensee shall allow an on-site audit
				  by the Department and, when applicable, by the forensic laboratory's
				  accreditation organization, at any time during the forensic laboratory's normal
				  hours of operation, to evaluate the forensic laboratory's compliance with the
				  applicable requirements, conditions, and standards of this subtitle.
(2) An audit may include but is not limited
				  to observation and examination of:
(a)
				  Laboratory facilities;
(b)
				  Equipment;
(c) Quality assurance
				  and quality control program records;
(d) Operating procedures;
(e) Employees;
(f) Employee records;
(g) Proficiency testing;
(h) Forensic analysis reports; and
(i) Other records and files pertinent to this
				  subtitle.
(3) Forensic
				  laboratory employees shall make data and records accessible during an on-site
				  audit.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.03 - Licenses › Section 10.51.03.02 - License - Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  Requirements. A person operating a forensic laboratory that performs one or
				  more forensic analyses shall:
(1) Obtain,
				  complete, and submit written or electronic permit applications as prescribed in
				  this subtitle;
(2) Obtain a
				  forensic laboratory license as required in this subtitle; and
(3) Renew a forensic laboratory license as
				  required in this subtitle.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.03 - Licenses › Section 10.51.03.03 - License - Administrative Procedures

Current through Register Vol. 51, No. 14, July 12, 2024
A. Application - Filing.
(1) A person shall:
(a) Apply for a license for each forensic
				  laboratory location;
(b) File an
				  application for a license using written or electronic forms provided by the
				  Department; and
(c) Include in the
				  application a description of forensic laboratory services, which includes but
				  is not limited to:
(i) Types of forensic
				  analyses performed or to be performed;
(ii) Total number of individuals who perform
				  forensic analyses for each forensic science discipline; and
(iii) Qualifications of employees who direct,
				  supervise, and perform forensic analyses.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.04 - Proficiency Testing › Section 10.51.04.01 - Proficiency Testing - General

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  Proficiency Testing. Each year a licensee shall participate in an external
				  proficiency testing program for each forensic science discipline in which the
				  laboratory performs forensic tests and examinations, including but not limited
				  to:
(1) Firearms and toolmarks;
(2) Questioned documents;
(3) Latent prints;
(4) Trace evidence;
(5) Biology;
(6) Controlled dangerous substances;
				  and
(7) Toxicology.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.04 - Proficiency Testing › Section 10.51.04.02 - Proficiency Testing - Forensic DNA Analysis

Current through Register Vol. 51, No. 14, July 12, 2024
Regardless of whether the individual provides results or
					 conclusions, an individual who provides technical support for DNA analysis,
					 performs DNA analysis, or is designated by the technical leader as a
					 participant in DNA casework, shall meet the proficiency testing requirements
					 set forth in 42 U.S.C.
					 §
											14131, which is incorporated by
					 reference.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.04 - Proficiency Testing › Section 10.51.04.03 - Proficiency Testing Provider Approval

Current through Register Vol. 51, No. 14, July 12, 2024
A. Approval Required. A private, nonprofit,
				  or commercial organization or government agency may not provide a proficiency
				  test in this State for use by a forensic laboratory without first obtaining
				  proficiency testing approval from the Department.
B. Approval Granted by the Secretary. The
				  Department may approve a proficiency testing provider for a forensic science
				  discipline or subdiscipline, if the proficiency testing provider:
(1) Provides reliable, documented evidence to
				  the Department that the proficiency test is technically and administratively
				  able to meet the applicable requirements of this chapter; and
(2) Submits directly to the Department
				  evaluations of all proficiency test results from each laboratory that holds a
				  Maryland forensic laboratory permit.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.05 - Quality Assurance › Section 10.51.05.01 - Quality Assurance - General

Current through Register Vol. 51, No. 14, July 12, 2024
To obtain or maintain a permit to operate a forensic
					 laboratory, a person or licensee shall ensure that the forensic laboratory:
A. Establishes and follows policies
				  and procedures for a comprehensive quality assurance program designed to
				  monitor and evaluate the ongoing and overall quality and safety of the total
				  examination and forensic analysis process;
B. Maintains a quality assurance program
				  that:
(1) Continually evaluates the
				  effectiveness of the laboratory's policies and procedures;
(2) Routinely revises policies and procedures
				  based on the results of ongoing evaluation;
(3) Identifies and corrects
				  problems;
(4) Assures:
(a) Accurate, complete, and reliable
				  reporting of results of examinations and analyses;
(b) Technical procedures are validated and
				  are accepted practice in the forensic discipline; and
(c) Adequate and competent
				  employees;
(5) Requires
				  documentation of all quality assurance and quality control activities;
				  and
(6) Includes policies and
				  procedures for:
(a) Handling and preservation
				  of evidence;
(b) Calibration and
				  maintenance of equipment;
(c)
				  Handling, maintaining, and securing laboratory records including case records
				  and reports;
(d) Evaluation and
				  approval of employees;
(e)
				  Laboratory security;
(f)
				  Identifying and implementing corrective actions;
(g) Documenting and investigating
				  complaints;
(h) The operation of
				  individual characteristic databases, where appropriate; and
(i) Data integrity and ethics;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.05 - Quality Assurance › Section 10.51.05.02 - Quality Assurance - Specific

Current through Register Vol. 51, No. 14, July 12, 2024
A. Policies and Procedure.
(1) A licensee shall develop, establish,
				  maintain, implement, and follow quality assurance policies and procedures that
				  ensure that the laboratory's quality system is maintained.
(2) A
				  licensee shall ensure that the laboratory has a clear procedure describing the
				  process to uniquely identify evidence;
(3) (text
				  unchanged)
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.05 - Quality Assurance › Section 10.51.05.03 - Quality Assurance - Specific for Postmortem Forensic Toxicology

Current through Register Vol. 51, No. 14, July 12, 2024
A. In addition to
				  any applicable requirement in this chapter, a forensic laboratory performing
				  postmortem forensic toxicology shall establish a:
(1) Procedure for responding to requests for
				  the laboratory's information and documentation; and
(2) Policy for:
(a) Retention and release of laboratory
				  information;
(b) Addressing the
				  confidentiality of laboratory data; and
(c) Identifying:
(i) The extent to which interpretations may
				  be provided with test results; and
(ii) Who is authorized to provide
				  interpretations.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.05 - Quality Assurance › Section 10.51.05.04 - Quality Control Program

Current through Register Vol. 51, No. 14, July 12, 2024
A. A
				  licensee shall:
(1) Develop, establish,
				  maintain, implement, and follow quality control policies and procedures that
				  ensure accurate and reliable:
(a) Forensic
				  analysis results; and
(b) Case
				  reports;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.05 - Quality Assurance › Section 10.51.05.05 - Standard Operating Procedures Manual (SOPM)

Current through Register Vol. 51, No. 14, July 12, 2024
A. Policies and Procedures. A licensee shall
				  ensure that all policies and procedures affecting the scope of activities
				  performed in the laboratory are:
(1)
				  Documented; and
(2) Communicated
				  to, understood by, available to, and implemented by employees performing the
				  activities.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.05 - Quality Assurance › Section 10.51.05.06 - Calibration - General

Current through Register Vol. 51, No. 14, July 12, 2024
A. A
				  licensee shall develop, establish, implement, maintain, and follow calibration
				  procedures.
(1) If computers or automated
				  equipment are used for the processing, recording, reporting, storage, or
				  retrieval of calibration data, the licensee shall ensure that:
(a) Computer software is performance checked
				  after updates occur or validated;
(b) Procedures are established, maintained,
				  and followed to protect and secure the data; and
(c) Computers and automated equipment are
				  maintained to ensure proper functioning.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.05 - Quality Assurance › Section 10.51.05.07 - Validation and Performance Checks

Current through Register Vol. 51, No. 14, July 12, 2024
A. The licensee shall:
(1) Separately perform a validation or
				  conduct a performance check on standard methods before use;
(2) Validate non-standard methods, laboratory
				  designed methods, laboratory designed tests, and modifications of standard
				  methods before use; and
(3)
				  Maintain documentation of all method validation and performance check
				  activities.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.05 - Quality Assurance › Section 10.51.05.08 - Examination and Analysis

Current through Register Vol. 51, No. 14, July 12, 2024
A. A
				  licensee shall develop, establish, maintain, implement, and follow examination
				  and analysis procedures.
B. A
				  licensee shall:
(1) Ensure that all evidence
				  is given a unique identifier;
(2)
				  Ensure that, when computers or automated equipment are used for the processing,
				  recording, reporting, storage, or retrieval of examination or analysis data:
(a) Computer software is validated;
(b) Procedures are established and maintained
				  to protect and secure the data; and
(c) Computers and automated equipment are
				  maintained to ensure proper functioning;
(3) Have a policy for securing short-term and
				  long-term storage of documents, evidence, and reports, which includes:
(a) Limited access; and
(b) Environmental controls;
(4) Ensure each individual
				  sub-sample has a unique identifier, when evidentiary samples are
				  subdivided;
(5) Ensure that all
				  positive comparative analyses are verified by a second independent qualified
				  examiner or analyst who has documented expertise in the examination that was
				  performed, and the verification is documented; and
(6) Have a policy for securing evidence that
				  is in the process of being examined or analyzed.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.05 - Quality Assurance › Section 10.51.05.09 - Test Reports - General

Current through Register Vol. 51, No. 14, July 12, 2024
A. A
				  licensee shall ensure that a test report includes but is not limited to the
				  following:
(1) Name and physical address of
				  the laboratory;
(2) A unique
				  identifier on each page of the report;
(3) Identification of the forensic analysis
				  method used;
(4) A clear
				  identification of each item tested including a description of the item's
				  condition;
(5) The date each
				  forensic analysis was completed;
(6) Units of measurement, if
				  applicable;
(7) The name and
				  written or electronic signature of the examiner or analyst responsible for:
(a) Performance of the forensic
				  analysis;
(b) Interpretations of
				  forensic analysis results; and
(c)
				  Opinions;
(8) Opinions
				  and interpretations;
(9) When
				  applicable, a statement of uncertainty of measurement if the uncertainty of
				  measurement may affect the interpretation of the results of the forensic
				  analysis;
(10) The date report was
				  generated;
(11) The indication of
				  the end of the report on the report's last page; and
(12) If applicable, a statement that the
				  analysis was performed by another laboratory and identifies the facility that
				  actually performed the analysis.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.05 - Quality Assurance › Section 10.51.05.10 - Training and Competency

Current through Register Vol. 51, No. 14, July 12, 2024
A. A
				  licensee shall develop, establish, maintain, implement, and follow a written
				  training program for all technical skills in each discipline and subdiscipline
				  for each new or untrained employee and employees who need remedial
				  training.
B. AA licensee shall
				  ensure that available to all technical employees is a discipline-specific
				  training program that includes:
(1) All
				  aspects of the work being performed by the laboratory for each discipline and
				  subdiscipline in which the laboratory performs case work;
(2) Ethics and data integrity;
(3) Criminal and civil law
				  procedures;
(4) Criteria or
				  requirements to demonstrate competence;
(5) Moot court training if court testimony
				  may be required; and
(6) Expert
				  witness training if expert witness testimony may be required.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.05 - Quality Assurance › Section 10.51.05.11 - Equipment Maintenance

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  General. The laboratory shall develop, establish, maintain, implement, and
				  follow an equipment calibration and maintenance procedure and policy.
B. A licensee shall ensure that equipment,
				  before being placed into use, is calibrated or checked to establish that the
				  equipment meets either the laboratory's or manufacturer's specifications, or
				  both, as determined by the director.
C. A licensee shall ensure that records are
				  maintained on all items of equipment including at a minimum:
(1) Identity of the item of equipment and the
				  equipment's ancillary parts;
(2)
				  Manufacturer's name and serial number or other unique identifier;
(3) Performance checks ensuring the equipment
				  complies with the manufacturer's specifications;
(4) Current location, if
				  applicable;
(5) Manufacturer's
				  instructions or operating manual;
(6) Dates and results of calibrations,
				  adjustments, and service and date of next calibration;
(7) Documentation of all maintenance
				  performed, including date and signature of the individual performing the
				  maintenance; and
(8) Documentation
				  of any damage, malfunction, modification, or repair to the equipment.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.05 - Quality Assurance › Section 10.51.05.12 - Case Records

Current through Register Vol. 51, No. 14, July 12, 2024
A. A licensee
				  shall create and maintain a unique identifier system for all administrative and
				  examination documents originating from or received by the laboratory for each
				  case by:
(1) Writing all documents in
				  permanent ink and defining exceptions in the laboratory SOPM;
(2) Using electronic signatures only if a
				  security protocol is in place;
(3)
				  Having a tracking policy and system for electronic record changes, when the
				  electronic document is complete; and
(4) Identifying all administrative documents
				  with a unique identifier and signing or initialing by the individual who
				  prepared or received the document.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.05 - Quality Assurance › Section 10.51.05.13 - Complaints

Current through Register Vol. 51, No. 14, July 12, 2024
A. A licensee shall
				  retain all complaint records and documentation of the investigations and
				  corrective actions taken by the laboratory.
B. A licensee shall ensure that complaint
				  documents include at least the:
(1) Name and
				  organization of complainant, if applicable;
(2) Date of complaint;
(3) Details of complaint;
(4) Corrective action and resolution;
				  and
(5) Notification of the
				  complainant as to the resolution of the complaint.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.05 - Quality Assurance › Section 10.51.05.14 - Subcontractors

Current through Register Vol. 51, No. 14, July 12, 2024
A licensee shall:
A. Maintain a list of all subcontractors to
				  which forensic analyses are referred;
B. Be responsible for the subcontractor's
				  forensic analysis or examination;
C. Ensure that forensic analysis results from
				  the subcontractor are written or in a secured electronic form;
D. Ensure that if alternative methods are
				  used, the customer is notified before performing the examination or
				  analysis;
E. Establish and use
				  appropriate review procedures to ensure the integrity of:
(1) Outsourced samples; and
(2) Data received from the subcontractor;
				  and
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.05 - Quality Assurance › Section 10.51.05.15 - Facilities

Current through Register Vol. 51, No. 14, July 12, 2024
A. Facility
				  Administration. A licensee shall ensure that a laboratory:
(1) Is adequate for the testing services
				  offered;
(2) Has lighting,
				  plumbing, wiring, ventilation, heat, air conditioning, and humidity to meet the
				  laboratory's requirements; and
(3)
				  Has the required safety equipment as defined by the laboratory SOPM.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.05 - Quality Assurance › Section 10.51.05.16 - Ethics and Data Integrity Policy - Requirement

Current through Register Vol. 51, No. 14, July 12, 2024
A. A licensee shall:
(1) Establish and maintain a written ethics
				  and data integrity policy to be followed by all forensic laboratory employees,
				  which includes the items set forth in §B of this regulation;
(2) Provide access to the information,
				  training, and resources needed by all forensic laboratory employees to comply
				  with applicable federal and State laws, including ethics laws and regulations
				  and the ethics and data integrity policy required in §A(1) of this
				  regulation;
(3) Provide formal
				  ethics and data integrity training:
(a) As
				  part of new employee orientation; and
(b) On an annual basis for all current
				  employees;
(4) Develop
				  and utilize an employee ethics and data integrity agreement, for each employee
				  to sign annually after training, acknowledging, and certifying that the
				  employee has read, understands, and will follow the forensic laboratory ethics
				  and data integrity policy; and
(5)
				  Provide a working environment in the forensic laboratory that:
(a) Prevents employees from being subject to
				  inappropriate pressures, coercion, intimidation, unethical laboratory dilemmas,
				  or bribery from internal or external sources; and
(b) Promotes and maintains effective
				  bilateral communication through the chain-of-command, regarding concerns,
				  inquiries, and allegations pertaining to:
(i)
				  Suspected or actual unethical conduct;
(ii) Data integrity issues;
(iii) Questionable practices; or
(iv) Questions concerning forensic analysis
				  procedures or results.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.05 - Quality Assurance › Section 10.51.05.17 - Nonretaliation

Current through Register Vol. 51, No. 14, July 12, 2024
A. A licensee shall
				  establish, maintain, and follow a nonretaliation policy that ensures that an
				  employee who in good faith reports to the Secretary or the Department an issue
				  related to data integrity or unethical or fraudulent conduct will not be
				  subject to any form of discrimination or retaliation.
B. An employee who works in a forensic
				  laboratory may disclose information to the Secretary that the employee believes
				  evidences a violation or possible violation of a standard or requirement set
				  forth in this subtitle or Health-General Article, Title 17, Subtitle 2A,
				  Annotated Code of Maryland, including a standard or requirement related to data
				  integrity or unethical or fraudulent conduct.
C. A licensee shall post the document
				  developed by the Secretary and approved by the Department informing employees
				  of a forensic laboratory of the procedures to report instances of noncompliance
				  or other violations of the standards and requirements set forth in this
				  subtitle or Health-General Article, Title 17, Subtitle 2A, Annotated Code of
				  Maryland.
D. The Department shall
				  develop a forensic laboratory noncompliance document that:
(1) Has contact information for reporting
				  violations of standards and requirements for forensic laboratories, including
				  address, phone numbers, fax number, and website;
(2) Has a statement about nonretaliation and
				  nondiscrimination against anyone reporting noncompliance or other violations
				  for forensic laboratories; and
(3)
				  Is signed by the director of the Office of Health Care Quality.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.06 - Employees › Section 10.51.06.01 - Employees - Required

Current through Register Vol. 51, No. 14, July 12, 2024
A. A
				  licensee operating a forensic laboratory shall employ or otherwise engage the
				  services of qualified employees, including:
(1) A director;
(2) A technical leader;
(3) A quality assurance manager;
				  and
(4) Forensic analysts and
				  examiners.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.06 - Employees › Section 10.51.06.02 - Employees - Character and Education Verification

Current through Register Vol. 51, No. 14, July 12, 2024
A. A licensee shall establish and follow
				  written procedures for verifying the background and education of forensic
				  laboratory employees.
B. A licensee
				  shall verify the background and education of an individual by a:
(1) Background investigation;
(2) Review of the individual's grade
				  transcript from the college or university that the individual attended, that
				  is:
(a) The original record or transcript
				  document; or
(b) An official
				  certified copy of the transcript;
(3) Test for abuse of controlled dangerous
				  substances; and
(4) Polygraph
				  examination, if available.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.06 - Employees › Section 10.51.06.03 - Employees - Qualification Effective Dates

Current through Register Vol. 51, No. 14, July 12, 2024
A. Regardless of how an individual's role,
				  position, or title is identified by a licensee, on or after January 1, 2012, an
				  individual who begins employment with a licensee in a forensic laboratory shall
				  meet the appropriate employee qualifications and requirements as set forth in
				  this subtitle for a:
(1) Director;
(2) Technical leader;
(3) Quality assurance manager;
(4) Forensic analyst or examiner;
				  and
(5) Person in the chain of
				  casework who could affect the forensic analysis results, including
				  technicians.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.06 - Employees › Section 10.51.06.04 - Director - Requirement

Current through Register Vol. 51, No. 14, July 12, 2024
A licensee shall employ a forensic laboratory director
					 who:
A. Meets the qualifications set
				  forth in this chapter; and
B. Is
				  responsible for the overall operation and administration of the
				  laboratory.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 51 - FORENSIC LABORATORIES › Chapter 10.51.06 - Employees › Section 10.51.06.05 - Director - Qualifications

Current through Register Vol. 51, No. 14, July 12, 2024
A director of a forensic laboratory shall:
A. Hold an earned master's or doctoral degree
				  from an accredited institution in:
(1)
				  Forensic science;
(2) A natural
				  science such as chemistry, physics, or biology; or
(3) A subspecialty of a natural science such
				  as organic chemistry, biochemistry, or molecular biology; and