reglab/statecodes huggingface dataset:
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.01 - General › Section 10.10.01.03 - 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 or Accurate.
(a) "Accuracy" or "accurate" means the degree
				  of agreement between the determination of a quantity and its true
				  value.
(b) "Accuracy" or "accurate"
				  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 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.01 - General › Section 10.10.01.04 - Incorporation by Reference

Current through Register Vol. 51, No. 14, July 12, 2024
A. In
				  this subtitle, the following documents are incorporated by reference.
B. Documents Incorporated.
(1)
											29 CFR §
												1910.1030, as amended.
(2)
											29 CFR §
												1910.1450, as amended.
(3)
											42 CFR §§
												493.801-
				  493.959, as amended.
(4)
											42 CFR §§
												493.1100-
				  493.1299, as amended.
(5)
											42 CFR §§
												493.1405-
				  493.1495, as amended.
(6)
											49 CFR §
												40.87, as amended.
(7) Forensic Chemists and Analysts Training
				  and Procedure Manual (Maryland Department of Health and Mental Hygiene,
				  1992).
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.02 - Medical Laboratories-General › Section 10.10.02.01 - Responsibilities of the Department

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  The OHCQ. The OHCQ shall conduct surveys, as set forth in this subtitle, of
				  laboratories that obtain or retain a license.
B. Surveys. The OHCQ shall:
(1) Conduct or oversee an announced or
				  unannounced survey of a laboratory at any time during its hours of operation to
				  assess compliance with applicable sections of Health-General Article, Title 17,
				  Subtitles 2 and 5, Annotated Code of Maryland, and this chapter; and
(2) Examine, as part of a survey, a
				  laboratory's facilities, equipment, quality assurance records and procedures,
				  operating procedures, personnel and personnel records, proficiency testing,
				  patient reports, and other records and files pertinent and subject to this
				  subtitle.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.02 - Medical Laboratories-General › Section 10.10.02.02 - Accredited Laboratory and Accrediting Organization

Current through Register Vol. 51, No. 14, July 12, 2024
A. Accredited Laboratory-Determination. The
				  Secretary shall accept as meeting the survey requirements of this chapter a
				  laboratory 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 laboratory's accrediting organization are equivalent to those under this
				  subtitle.
B. Accredited
				  Laboratory-Requirements. In addition to meeting the requirements for its
				  certificate of accreditation, as set forth by its accrediting organization, an
				  accredited laboratory shall:
(1) Obtain and
				  maintain a valid license issued by the Secretary; and
(2) Be subject to survey by the OHCQ for the
				  purpose of investigating complaints or validating findings of the laboratory's
				  accrediting organization.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.02 - Medical Laboratories-General › Section 10.10.02.03 - Surveys

Current through Register Vol. 51, No. 14, July 12, 2024
A. General.
(1) A licensee shall allow an on-site survey
				  by the OHCQ or, when applicable, by the laboratory's approved accrediting
				  organization, at any time during the laboratory's normal hours of operation, to
				  evaluate the laboratory's compliance with the applicable requirements,
				  conditions, and standards of this subtitle.
(2) A survey may include but is not limited
				  to:
(a) Observation and examination of
				  laboratory facilities;
(b)
				  Equipment;
(c) Quality assurance
				  and quality control program records;
(d) Operating procedures;
(e) Personnel;
(f) Personnel records;
(g) Proficiency testing;
(h) Patient reports; and
(i) Other records and files pertinent to this
				  subtitle.
(3) Laboratory
				  employees shall make data and records accessible within a reasonable time
				  during the on-site survey.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.03 - Medical Laboratories - Licenses › Section 10.10.03.01 - General

Current through Register Vol. 51, No. 14, July 12, 2024
A. Requirement.
(1) General. A person shall possess a license
				  before:
(a) Offering to perform or performing
				  a medical laboratory test or examination in this State;
(b) Offering to perform or performing a
				  medical laboratory test or examination on a specimen acquired from a health
				  care provider in this State at a laboratory located outside this State;
				  or
(c) Representing or servicing in
				  this State a laboratory regardless of the laboratory's location.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.03 - Medical Laboratories - Licenses › Section 10.10.03.02 - Letters of Exception

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  Eligibility.
(1) An individual directing a
				  POL or POCL who offers to perform or performs tests limited to one or more
				  excepted tests may obtain a letter of exception instead of a permit to offer to
				  perform or perform those tests.
(2)
				  An individual eligible for a letter of exception shall:
(a) Be qualified as a laboratory director as
				  set forth in 42 CFR §
													493.1405, including:
(i) Being a doctor of medicine or doctor of
				  osteopathy licensed in the State and having laboratory training or experience
				  appropriate for the testing performed; or
(ii) Holding an earned doctoral, master's, or
				  bachelor's degree in a chemical, physical, biological, or clinical laboratory
				  science or medical technology from an accredited institution;
(b) Provide evidence of training
				  in the performance and interpretation of excepted tests and be licensed in the
				  State as a:
(i) Nurse midwife;
(ii) Nurse practitioner;
(iii) Physician assistant;
(iv) Chiropractor;
(v) Podiatrist;
(vi) Dentist; or
(vii) Pharmacist; or
(c) Be clinical staff who:
(i) Meets the qualifications set forth in
				  COMAR 10.47.01.06D;
(ii) Is employed by a substance abuse
				  treatment program that is certified or accredited in accordance with COMAR
				  10.47.04.03D;
				  and
(iii) Is authorized to order
				  tests to detect the presence of controlled dangerous substances on patients
				  enrolled in the substance abuse treatment program.
(3) A person operating a temporary
				  medical laboratory to perform health awareness tests, regardless of testing
				  site location, is not eligible for a letter of exception.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.03 - Medical Laboratories - Licenses › Section 10.10.03.03 - Permits

Current through Register Vol. 51, No. 14, July 12, 2024
A. Requirement. A
				  person operating a medical laboratory that performs one or more tests other
				  than excepted tests shall obtain and renew a laboratory permit as required in
				  this chapter.
B. Tests Other than
				  Excepted Tests.
(1) A test other than an
				  excepted test is one not listed in Regulation .02B of this chapter.
(2) A person holding a permit may perform
				  both excepted tests and tests other than excepted tests.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.03 - Medical Laboratories - Licenses › Section 10.10.03.04 - Letter of Exception and Permit-Administrative Procedures

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  Application-Filing.
(1) Except for a
				  laboratory eligible for a multi-site license as set forth in Regulation
				  .01D(3)(b) of this chapter, a person shall apply for a license for each
				  laboratory location.
(2) A person
				  holding a license to operate a laboratory in the discipline of chemistry or
				  health awareness testing is not required to obtain a separate cholesterol
				  testing permit to conduct cholesterol testing at a temporary laboratory site if
				  the licensee complies with the requirements applicable to a temporary
				  laboratory as set forth in this subtitle.
(3) A person shall complete and file an
				  application for a license using forms provided by the OHCQ.
(4) A person shall complete on the
				  application a description of laboratory services, which includes but is not
				  limited to:
(a) Types of tests performed or
				  to be performed;
(b) Total number
				  of tests performed or to be performed annually, excluding tests for quality
				  control and proficiency testing; and
(c) Qualifications of personnel who direct,
				  supervise, and perform laboratory testing.
(5) The laboratory director shall sign the
				  application forms attesting that the information provided is accurate and that
				  the laboratory is or will be operated in accordance with the requirements and
				  standards required in this chapter.
(6) A person shall submit with the
				  application the nonrefundable partial licensing fee set forth in COMAR
				  10.10.04.02C.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.03 - Medical Laboratories - Licenses › Section 10.10.03.05 - Letter of Exception-Limited Testing for Rare Diseases

Current through Register Vol. 51, No. 14, July 12, 2024
A. The Secretary may waive the permit
				  requirements under this subtitle for a laboratory that offers to perform or
				  performs a rare disease test if the laboratory:
(1) Meets the requirements of Regulations .05
				  and .06 of this chapter; and
(2)
				  Obtains and maintains a letter of exception-limited testing for rare
				  diseases.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.03 - Medical Laboratories - Licenses › Section 10.10.03.06 - Letter of Exception-Limited Testing for Rare Diseases Standards and Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  Application Requirements and Testing Approval. A person required to obtain a
				  license to operate a laboratory that chooses to operate under a letter of
				  exception-limited testing for rare diseases shall:
(1) Submit:
(a) A completed:
(i) Application as prescribed in Regulation
				  .04 of this chapter; and
(ii)
				  Report or questionnaire as required by the Secretary to determine regulatory
				  compliance;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.04 - Medical Laboratories › Section 10.10.04.01 - General

Current through Register Vol. 51, No. 14, July 12, 2024
A. Requirement. A
				  person required to obtain and maintain a license as set forth under COMAR
				  10.10.03 shall pay the appropriate fees as set forth in this chapter.
B. A person shall submit a licensing fee in
				  the form of a check or money order made payable to the Department of Health and
				  Mental Hygiene.
C. Fees. Fees
				  include but are not limited to the following:
(1) Amend an unexpired permit-$50;
(2) Replace a lost permit-$30;
(3) Provide a copy of COMAR
				  10.10.01-.10.10.09, "Medical Laboratories"-as provided under COMAR 10.01.08;
				  and
(4) For the Department to
				  conduct out-of-State, on-site surveys of a laboratory seeking or maintaining a
				  license to test specimens of a type and in a scientific field of study for
				  which there is no national certification, for example, the subdiscipline of
				  job-related testing of hair for drugs of abuse-full cost to the
				  Department.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.04 - Medical Laboratories › Section 10.10.04.02 - Licensing - Letter of Exception

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  Letter of Exception. A person applying for a letter of exception for a POL or
				  POCL shall submit an initial application and biennially after that with each
				  renewal application.
B. Letter of
				  Exception - Limited Testing for Rare Diseases. A person applying for a letter
				  of exception-limited testing for rare diseases for a laboratory shall submit an
				  initial application and biennially after that with each renewal application.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.05 - Medical Laboratories-Proficiency Testing › Section 10.10.05.01 - Participation and Evaluation

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  Participation. A licensee operating under a permit shall ensure that the
				  laboratory:
(1) Enrolls in and participates
				  satisfactorily in a PT program that meets the criteria set forth in this
				  chapter for each of the tests that the laboratory offers to perform or
				  performs;
(2) Tests PT samples in
				  the same manner and number of times that it routinely tests patient specimens;
				  and
(3) Complies with the
				  applicable standards contained in
				  42 CFR §§
												493.801-
				  493.807.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.05 - Medical Laboratories-Proficiency Testing › Section 10.10.05.02 - Discipline, Specialty, and Subspecialty

Current through Register Vol. 51, No. 14, July 12, 2024
A. Primary Standard. A licensee operating
				  under a permit shall ensure that the laboratory participates successfully in
				  PT, when applicable, for each test or analyte in each of the following
				  disciplines, subdisciplines, and specialties:
(1) Microbiology, including the
				  subdisciplines of:
(a) Bacteriology,
(b) Mycobacteriology,
(c) Mycology,
(d) Parasitology, and
(e) Virology;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.05 - Medical Laboratories-Proficiency Testing › Section 10.10.05.03 - Program 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 PT program in this State without first obtaining program
				  approval from CMS or the OHCQ.
B.
				  Approval Granted Automatically. Except in the discipline of job-related alcohol
				  and controlled dangerous substances, or other disciplines, subdisciplines, or
				  specialties not covered by federal PT requirements, a PT program is approved
				  when it is based on written evidence issued by CMS showing the program meets
				  CMS's criteria for approval of PT programs as set forth in
				  42 CFR §§
											493.901-
				  493.959.
C. Approval Granted by the Secretary. The
				  OHCQ may approve a PT program for a laboratory discipline, subdiscipline, or
				  specialty not approved by CMS, if the program:
(1) Provides reliable, documented evidence
				  that the program is technically and administratively able to meet the
				  applicable requirements of this chapter; and
(2) Uniformly and routinely prepares and
				  submits directly to the OHCQ evaluations of all PT results from all
				  laboratories enrolled in the program and holding a Maryland permit.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.05 - Medical Laboratories-Proficiency Testing › Section 10.10.05.04 - Cytology - Departmental Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
A. The Secretary may not issue a license to
				  operate a laboratory that examines gynecologic cytology specimens if the
				  laboratory does not enroll and participate satisfactorily in a cytology PT
				  program operated or approved by the Secretary.
B. The OHCQ shall conduct annual PT for each
				  pathologist and cytotechnologist who examines gynecological cytology slides
				  acquired in the State.
C. The OHCQ
				  or an agent of the Department shall hand carry test materials for first-event
				  testing in a PT cycle to a laboratory and shall conduct and supervise all
				  testing.
D. The OHCQ shall:
(1) Conduct announced and unannounced on-site
				  testing for individuals during an annual PT cycle; and
(2) Schedule and conduct a retesting event
				  for an individual who has failed the annual PT testing event not more than 45
				  days after receipt of the notification of the PT testing event failure by the:
(a) Individual who failed the annual PT
				  testing event; and
(b) Laboratory
				  director of the individual who failed the annual PT testing event.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.05 - Medical Laboratories-Proficiency Testing › Section 10.10.05.05 - Cytology - Laboratory and Individual Standards

Current through Register Vol. 51, No. 14, July 12, 2024
A. Primary Standard. A pathologist or
				  cytotechnologist who examines gynecological cytology specimens from individuals
				  in this State shall participate satisfactorily in an annual cytology PT program
				  approved by the Secretary.
B.
				  Laboratory Standards.
(1) A licensee
				  operating under a permit to examine gynecologic cytology specimens shall ensure
				  that each pathologist and cytotechnologist who examines gynecologic cytology
				  specimens participates in a cytology PT program conducted by the Department or
				  approved by the Secretary.
(2) An
				  in-State laboratory shall participate in the Department's PT program.
(3) An out-of-State laboratory shall
				  participate in either the Department's PT program or another equivalently
				  rigorous cytology PT program approved by the Secretary.
(4) A licensee employing an individual who
				  has failed a second testing event in an annual PT cycle shall:
(a) Prohibit the individual from examining
				  gynecologic specimens and provide or secure remedial training and education in
				  gynecologic cytology for the individual, which training and education includes
				  examination by the individual of gynecologic specimens in the individual's area
				  of failure; and
(b) Document the
				  individual's completion of education and training using a form provided by the
				  OHCQ.
(5) A licensee
				  employing an individual who has failed a first or subsequent PT event and who
				  does not obtain mandated retesting or retraining, or both, shall:
(a) Immediately remove that individual from a
				  position of examining gynecologic cytology specimens for the purpose of
				  reporting diagnostic test results to a health care provider; and
(b) Provide written notice to the OHCQ within
				  30 days after being informed of the individual's last test failure that the
				  individual is no longer examining gynecologic cytology specimens for the
				  purpose of reporting diagnostic test results to a health care
				  provider.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.06 - Medical Laboratories-Quality Assurance › Section 10.10.06.01 - General

Current through Register Vol. 51, No. 14, July 12, 2024
A. Primary
				  Standards. To obtain or maintain a permit to operate a laboratory, a person or
				  licensee shall ensure that the laboratory:
(1)
				  Establishes and follows written policies and procedures for a comprehensive
				  quality assurance program designed to monitor and evaluate the ongoing and
				  overall quality and safety of the total, that is, preanalytic, analytic, and
				  postanalytic phases of the testing process;
(2) Maintains a quality assurance program
				  that:
(a) Continually evaluates the
				  effectiveness of the laboratory's policies and procedures,
(b) Routinely revises policies and procedures
				  based on the results of on-going evaluation,
(c) Identifies and corrects
				  problems,
(d) Assures accurate,
				  reliable, and prompt reporting of test results,
(e) Assures adequate and competent personnel,
				  and
(f) Documents all quality
				  assurance activities; and
(3) Establishes and maintains a laboratory
				  safety program.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.06 - Medical Laboratories-Quality Assurance › Section 10.10.06.02 - Authorization to Request Laboratory Tests

Current through Register Vol. 51, No. 14, July 12, 2024
A. Primary Standard. A laboratory may not
				  perform a laboratory test, except under a health awareness permit or
				  cholesterol permit, without obtaining written or electronic authorization from:
(1) A court of law;
(2) A doctor of medicine, osteopathy,
				  podiatric medicine, or dentistry; or
(3) Another person authorized to order
				  laboratory tests under the Annotated Code of Maryland.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.06 - Medical Laboratories-Quality Assurance › Section 10.10.06.03 - Patient Test Management

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  Primary Standard. A licensee shall ensure that the laboratory:
(1) Provides patient manipulation by
				  qualified personnel; and
(2)
				  Employs and maintains a quality assurance program that provides for:
(a) Proper patient preparation;
(b) Proper specimen:
(i) Collection,
(ii) Identification,
(iii) Preservation,
(iv) Transportation, and
(v) Processing;
(c) Record maintenance; and
(d) Accurate reporting of results.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.06 - Medical Laboratories-Quality Assurance › Section 10.10.06.04 - Reporting and Releasing Test Results

Current through Register Vol. 51, No. 14, July 12, 2024
A. Primary Standard. A laboratory shall
				  report or release test results, except results of a health awareness test, only
				  to an authorized person.
B.
				  Standards.
(1) For all test results except
				  those from a health awareness test performed at a temporary laboratory or from
				  a job-related alcohol or controlled dangerous substance test, a licensee shall
				  ensure that the laboratory:
(a) Reports
				  medical test results only to the physician, dentist, or other authorized person
				  who requested the test, or to another laboratory that requested the
				  test;
(b) Sends a copy of a test
				  result, other than a result for a health awareness or job-related alcohol or
				  controlled dangerous substances test, directly to the individual tested only
				  after the laboratory:
(i) Receives a written
				  request from the individual, and
(ii) Notifies the authorized person who
				  requested the test that the results will be released to the individual
				  tested;
(c) Meets the
				  applicable standards concerning test reports contained in
				  42 CFR §§
													493.1234 and
				  493.1291; and
(d) Reports a test result on a form that
				  identifies the name and address of the laboratory that performed the
				  test.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.06 - Medical Laboratories-Quality Assurance › Section 10.10.06.05 - Quality Control - General

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  Primary Standard. A licensee operating under a permit shall ensure that the
				  laboratory establishes and follows written quality control procedures for
				  monitoring and evaluating the quality of the analytic phase of the testing
				  process for each testing method and procedure to assure the accuracy and
				  reliability of patient test results and reports.
B. Standard. A licensee shall ensure that the
				  laboratory meets the applicable quality control standards as set forth in this
				  chapter and in 42 CFR
				  §§
											493.1200-
				  493.1299.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.06 - Medical Laboratories-Quality Assurance › Section 10.10.06.05-1 - Quality Control - Quality Control Program

Current through Register Vol. 51, No. 14, July 12, 2024
A. Primary Standard. A licensee shall
				  develop, establish, implement, maintain, and follow quality control policies,
				  procedures, and techniques that ensure accurate and reliable test results and
				  patient test reports.
B.
				  Standard-Quality Control Program. A licensee's quality control program shall:
(1) Cover all tests and related examinations
				  and procedures performed by the laboratory; and
(2) Meet the standards and requirements set
				  forth in this chapter.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.06 - Medical Laboratories-Quality Assurance › Section 10.10.06.06 - Quality Control - Single-Use Test Devices

Current through Register Vol. 51, No. 14, July 12, 2024
A. Primary Standard. This regulation applies
				  to test systems that use single-use test devices as defined in COMAR
				  10.10.01.03B.
B. Standards.
(1) General. A licensee shall ensure that the
				  test system is validated on a continuing basis and that the ongoing validation
				  includes:
(a) Calibration
				  verification;
(b) Parallel testing
				  before or, when appropriate, instead of proficiency testing; and
(c) Proficiency testing.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.06 - Medical Laboratories-Quality Assurance › Section 10.10.06.07 - Quality Control - Specialty and Subspecialty

Current through Register Vol. 51, No. 14, July 12, 2024
A. Primary Standard. A licensee operating
				  under a permit shall ensure that the laboratory establishes and follows written
				  policies and procedures for a comprehensive quality control program that
				  includes verification and assessment of accuracy, measurement of precision, and
				  detection of error for all analyses and procedures performed by the
				  laboratory.
B. Standards.
(1) General. A licensee shall ensure that the
				  laboratory meets the applicable quality control requirements for each specialty
				  and subspecialty under:
(a)
												42 CFR §§
													493.1200-
				  493.1299; and
(b) Regulations .07-.16 of this
				  chapter.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.06 - Medical Laboratories-Quality Assurance › Section 10.10.06.08 - Quality Control - Job-Related Alcohol and Drug Testing

Current through Register Vol. 51, No. 14, July 12, 2024
A. Primary
				  Standard. A licensee shall ensure that a laboratory has in place a quality
				  assurance program designed to monitor and evaluate all phases of the testing
				  process including but not limited to:
(1)
				  Laboratory certification;
(2)
				  Specimens, specimen collection, chain of custody, and transport;
(3) Security and controlled access;
(4) Storage and specimen retention;
(5) Analytical methods and
				  procedures;
(6) Accuracy,
				  precision, and reliability;
(7)
				  Single-use test devices;
(8)
				  Reporting test results; and
(9)
				  Proficiency testing.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.06 - Medical Laboratories-Quality Assurance › Section 10.10.06.10 - Quality Control - Cytology

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  Primary Standard. A licensee of a laboratory offering to perform or performing
				  tests in the subdiscipline of gynecologic cytology shall ensure that the
				  laboratory:
(1) Limits the number of slides
				  an individual may examine as set forth in
				  42 CFR §
												493.1274;
(2) Limits slide examination to the
				  laboratory premises;
(3)
				  Establishes a quality assurance program and follows written quality control
				  procedures to monitor and evaluate the quality of cytological procedures and
				  testing processes;
(4) Does not pay
				  for the examination of cytology slides on a piecework basis;
(5) Reviews not less than 10 percent of all
				  negative gynecologic slides before reporting results on those slides;
(6) Employs an individual who qualifies as a
				  supervisory cytotechnologist or a technical supervisor in gynecologic cytology
				  to review negative gynecologic slides;
(7) Does not allow the evaluation of a slide
				  that shows evidence of unsatisfactory preparation;
(8) Reports as to whether a slide is
				  satisfactory or unsatisfactory for evaluation;
(9) Maintains records for 5 years of slides
				  reported as unsatisfactory;
(10)
				  Maintains and stores for 5 years from the date of examination any slide that
				  was examined;
(11) Retains cytology
				  reports for at least 10 years;
(12)
				  Does not send gynecologic cytology slides to a laboratory not holding a State
				  license; and
(13) Requires
				  cytotechnologists and pathologists to obtain continuing education.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.06 - Medical Laboratories-Quality Assurance › Section 10.10.06.11 - Quality Control - Dermatopathology

Current through Register Vol. 51, No. 14, July 12, 2024
A. Primary Standard. In addition to meeting
				  the requirements of other applicable regulations of this subtitle, a licensee
				  of a laboratory performing tests in the subdiscipline of dermatopathology shall
				  ensure that the laboratory:
(1) Retains the
				  services of either a:
(a) Laboratory director
				  who meets the qualifications in COMAR
				  10.10.07.04B(1),
				  or
(b) Technical supervisor who
				  meets the qualifications in COMAR
				  10.10.07.05B(4);
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.06 - Medical Laboratories-Quality Assurance › Section 10.10.06.12 - Quality Control - Temporary and Mobile Laboratories: General

Current through Register Vol. 51, No. 14, July 12, 2024
A. Primary
				  Standard. The licensee shall ensure that a health awareness test or a
				  job-related screening test for alcohol or controlled dangerous substances at a
				  temporary or mobile laboratory is performed:
(1) Under effective supervision, quality
				  control, and safety procedures;
(2)
				  Using a previously evaluated analytical system; and
(3) For a job-related screening test for
				  alcohol or controlled dangerous substances, only at the request of an
				  individual authorized in COMAR
				  10.10.06.02B.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.06 - Medical Laboratories-Quality Assurance › Section 10.10.06.13 - Quality Control - Temporary and Mobile Laboratories: Personnel Training

Current through Register Vol. 51, No. 14, July 12, 2024
A. Primary
				  Standard. In addition to meeting other applicable requirements in this chapter,
				  a licensee shall ensure that all laboratory personnel performing a health
				  awareness test at a temporary or mobile laboratory are trained to perform all
				  assigned duties.
B. Standards.
(1) All Personnel. A licensee shall ensure
				  that all personnel are trained to:
(a) Keep
				  examinees' health information confidential;
(b) Deal with emergency situations such as
				  fainting and anxiety reactions;
(c)
				  Report and document information on testing services and activities;
				  and
(d) Dispose of special medical
				  waste as set forth in COMAR 10.06.06.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.06 - Medical Laboratories-Quality Assurance › Section 10.10.06.14 - Quality Control - Temporary and Mobile Laboratories: Event Registration

Current through Register Vol. 51, No. 14, July 12, 2024
A. Primary
				  Standard. In addition to meeting other applicable requirements set forth in
				  this chapter, a licensee intending to perform a health awareness test at a
				  temporary or mobile laboratory shall register the testing event with the
				  Department before the testing event may occur.
B. Standards.
(1) A licensee shall inform the OHCQ by phone
				  or in writing of the date, time, location, and on-site supervisor's name for a
				  testing event at least 14 days before the event is to take place.
(2) A licensee shall display in a public
				  place at the testing site and throughout the testing event a copy of the
				  laboratory's license.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.06 - Medical Laboratories-Quality Assurance › Section 10.10.06.15 - Quality Control - Temporary and Mobile Laboratories: Cholesterol and Health Awareness

Current through Register Vol. 51, No. 14, July 12, 2024
A. Primary
				  Standard. In addition to meeting other applicable requirements in this chapter,
				  a licensee offering to perform or performing cholesterol or health awareness
				  testing at a temporary or mobile laboratory shall ensure that the laboratory:
(1) Develops and maintains a written
				  SOPM;
(2) Validates the analyzer
				  initially and utilizes the manufacturer's reference range for the quality
				  control with each new lot of quality control;
(3) Employs and maintains an in-field quality
				  control program;
(4) Reports test
				  results as set forth in §B(5) of this regulation; and
(5) Informs examinees of test limitations
				  based on current nationally recognized standards for each test
				  performed.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.07 - Medical Laboratories-Personnel › Section 10.10.07.01 - Permitted POL and POCL - Director and Associate Director

Current through Register Vol. 51, No. 14, July 12, 2024
A. Primary
				  Standard. The licensee of a permitted POL or POCL shall employ or otherwise
				  engage the services of a qualified director or associate director and a
				  laboratory supervisor or consulting supervisor.
B. Standards.
(1) Qualifications.
(a) POL. The director of a permitted POL
				  shall be:
(i) A physician licensed by the
				  Board of Physicians to practice medicine in the State and a member or employee
				  of the practice operating the laboratory; or
(ii) An employee or contractor of the
				  practice who possesses the training and experience set forth in Regulation .05
				  of this chapter.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.07 - Medical Laboratories-Personnel › Section 10.10.07.03 - Permitted POL and POCL - Consulting Supervisor Services

Current through Register Vol. 51, No. 14, July 12, 2024
A. General.
(1) A licensee operating a permitted POL or
				  POCL who does not employ or otherwise engage technical personnel who qualify as
				  a general supervisor shall arrange with a qualified consulting supervisor to
				  provide technical and general supervisory consultation services in laboratory
				  practice.
(2) The licensee
				  operating a POL or POCL under a permit shall use a consulting supervisor who:
(a) Makes and documents on-site visits to
				  each laboratory facility at least twice each calendar year;
(b) Is available by telephone during the
				  laboratory's regular operating hours; and
(c) Completes a laboratory inspection
				  checklist, provided by the OHCQ, to be submitted to the OHCQ not more than once
				  every 2 years.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.07 - Medical Laboratories-Personnel › Section 10.10.07.04 - Permitted Laboratory Other than a POL or POCL - Director

Current through Register Vol. 51, No. 14, July 12, 2024
A. Primary
				  Standard. A licensee operating a permitted laboratory other than a POL or POCL
				  shall employ a director who meets the applicable qualifications,
				  responsibilities, and standards set forth in this chapter.
B. Standards.
(1) Qualifications. In addition to applicable
				  personnel standards set forth in this chapter, a director shall meet the
				  applicable standards set forth in
				  42 CFR §
												493.1443.
(2) Responsibilities. A director shall carry
				  out the applicable responsibilities set forth in
				  42 CFR §§
												493.1407 and
				  493.1445.
(3) Associate Director. A director shall
				  designate another individual who qualifies as a director under this chapter to
				  serve as an associate or substitute director when the director:
(a) Will be away from the laboratory for a
				  period of more than 30 days; or
(b)
				  Is unable to carry out the responsibilities set forth in §B(2) of this
				  regulation.
(4)
				  Communications. A director shall communicate with the laboratory's supervisory
				  personnel in person, in writing, or by telephone at least once a month
				  regarding the performance and operation of the laboratory.
(5) On-site Visits. A director of a
				  laboratory shall conduct an on-site visit of the laboratory at least once a
				  month.
(6) Limitation. The director
				  of a permitted laboratory may not serve as director or associate director, or
				  both, of more than five medical laboratories at the same time.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.07 - Medical Laboratories-Personnel › Section 10.10.07.05 - Permitted Laboratories - Technical Supervisors

Current through Register Vol. 51, No. 14, July 12, 2024
A. Primary Standards.
(1) A laboratory director certified, or
				  eligible for certification, in anatomic and clinical pathology by the American
				  Board of Pathology qualifies as a technical supervisor in all disciplines and
				  subdisciplines set forth in COMAR
				  10.10.01.03B,
				  except:
(a) Genetics; and
(b) Forensic toxicology.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.07 - Medical Laboratories-Personnel › Section 10.10.07.06 - Permitted Laboratory Other than a POL or POCL - Supervisors

Current through Register Vol. 51, No. 14, July 12, 2024
A. Primary
				  Standard. A licensee operating a laboratory other than a POL or POCL shall
				  employ a qualified supervisory technologist or general supervisor, who in the
				  absence of the director or technical supervisor is responsible for the proper
				  performance of laboratory procedures and reporting of laboratory test
				  results.
B. Standards: General
				  Supervisor.
(1) Personnel Qualifications. A
				  general supervisor shall be a technologist who possesses at least 4 years
				  technical experience in a licensed medical laboratory other than a laboratory
				  operating under a letter of exception.
(2) Responsibilities. A general supervisor
				  shall carry out the responsibilities set forth in
				  42 CFR §
												493.1463.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.07 - Medical Laboratories-Personnel › Section 10.10.07.07 - Permitted Laboratory Other than POL or POCL - Testing Personnel

Current through Register Vol. 51, No. 14, July 12, 2024
A. Primary
				  Standard. A permitted laboratory other than a POL or POCL shall employ or
				  engage testing personnel, sufficient in number to perform testing for the
				  volume and complexity of testing performed, who meet the qualifications and
				  carry out the responsibilities set forth in this regulation.
B. Standards-General.
(1) Personnel Qualifications. An individual
				  performing one or more laboratory tests shall meet the applicable
				  qualifications set forth in 42 CFR §
												493.1489.
(2) Responsibilities. Testing personnel shall
				  carry out the responsibilities set forth in
				  42 CFR §
												493.1495.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.08 - Medical Laboratories-Sanctions › Section 10.10.08.01 - General

Current through Register Vol. 51, No. 14, July 12, 2024
A. Authority and
				  Types.
(1) The Secretary may impose one or
				  more principal or alternative sanctions.
(2) Principal Sanctions. The Secretary may
				  impose the following principal sanctions:
(a)
				  Denial of a license;
(b) Suspension
				  of a license; and
(c) Revocation of
				  a license.
(3)
				  Alternative Sanctions. Instead of or in conjunction with lifting a principal
				  sanction, the Secretary may impose one or more of the following alternative
				  sanctions:
(a) A directed plan of
				  correction;
(b) Limitation on
				  testing; and
(c) Training and
				  technical assistance.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.08 - Medical Laboratories-Sanctions › Section 10.10.08.02 - Departmental Actions - General

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  Deficiency Posing Immediate Jeopardy.
(1) If
				  a laboratory's deficiency poses immediate jeopardy to personal or public health
				  or safety, the Secretary shall take one or more of the actions listed in
				  §A(2) and(3) of this regulation.
(2) Initial Actions. When a deficiency
				  involving immediate jeopardy is first identified, the Secretary shall:
(a) Require the laboratory to take immediate
				  action to remove the jeopardy; and
(b) Impose:
(i) A principal sanction after giving the
				  laboratory at least 24 hours notice, or
(ii) One or more alternative
				  sanctions.
(3) Follow-up Actions. If the OHCQ finds in a
				  follow-up survey of a laboratory under an alternative sanction that the
				  laboratory has not eliminated the immediate jeopardy, the Secretary shall
				  impose a principal sanction after giving the laboratory at least 24 hours
				  notice.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.08 - Medical Laboratories-Sanctions › Section 10.10.08.03 - Departmental Actions - Principal Sanctions

Current through Register Vol. 51, No. 14, July 12, 2024
A. Hearing Requirement.
(1) Except when the Secretary finds that a
				  danger to public health or safety imperatively requires that emergency action
				  be taken to correct a deficiency, the Secretary shall inform the licensee in
				  writing when a suspension or revocation of the licensee's license takes effect,
				  the reason for the suspension or revocation, and that the licensee has an
				  opportunity for a hearing on the matter before the suspension or revocation
				  takes effect, as provided in State Government Article, §
											10-226, Annotated
				  Code of Maryland.
(2) When a
				  finding is made that the public health or safety imperatively requires that
				  emergency or immediate action be taken, the Secretary shall inform the licensee
				  in writing of a suspension or revocation of the licensee's license, the reason
				  for the suspension or revocation, and that the licensee has an opportunity for
				  a hearing on the matter, as provided in State Government Article, Title 10,
				  Subtitle 2, Annotated Code of Maryland, after the suspension or
				  revocation.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.08 - Medical Laboratories-Sanctions › Section 10.10.08.04 - Enforcement Procedures - Proficiency Testing

Current through Register Vol. 51, No. 14, July 12, 2024
A. Application. If a laboratory's performance
				  in proficiency testing is unsuccessful or unsatisfactory, as set forth in COMAR
				  10.10.05, the Secretary may require the laboratory to undertake the directed
				  plan of correction of the training of its personnel or the obtaining of
				  necessary technical assistance, or both, in order to meet the proficiency
				  testing requirements of this chapter.
B. Procedures. A laboratory required to
				  undertake training of personnel or to obtain necessary technical assistance
				  shall:
(1) Document the training or
				  assistance, or both, using forms provided by the OHCQ; and
(2) Submit the completed forms to the
				  OHCQ.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.08 - Medical Laboratories-Sanctions › Section 10.10.08.05 - Departmental Action - Reporting Erroneous or Questionable Patient Test Results

Current through Register Vol. 51, No. 14, July 12, 2024
A. If the
				  Department determines that a licensee has reported an erroneous or questionable
				  patient test result that threatens the health or safety of the patient, the
				  Secretary may order the licensee, within a specified period of time, to:
(1) Give prompt notice of the erroneous or
				  questionable patient test result to the:
(a)
				  Person who requested that the test be performed; and
(b) Physician or other person to whom the
				  laboratory has previously sent a report that contained the erroneous or
				  questionable result;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.09 - Forensic Laboratories - Personnel Certification and Approval of Laboratory Procedures › Section 10.10.09.01 - Qualifications

Current through Register Vol. 51, No. 14, July 12, 2024
A. Certified
				  Chemist and Certified Chemical Analyst. An applicant for certified chemist or
				  certified chemical analyst shall:
(1) Hold a
				  bachelor's degree from an accredited college or university with a major in
				  chemistry, medical technology, biology, physics, pharmacy, pharmacology, or
				  forensic science;
(2) Have
				  completed courses in analytical and organic chemistry; and
(3) Have completed a basic training program
				  for certified chemist or certified chemical analyst as set forth in Regulation
				  .02 of this chapter.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.09 - Forensic Laboratories - Personnel Certification and Approval of Laboratory Procedures › Section 10.10.09.02 - Approved Training Programs for Chemists, Chemical Analysts, and Analysts

Current through Register Vol. 51, No. 14, July 12, 2024
A. Certified
				  Chemist.
(1) An applicant for certification
				  as a certified chemist shall have successfully completed:
(a) The basic training program for forensic
				  drug chemists offered by the United States Department of Justice, Drug
				  Enforcement Administration; or
(b)
				  A training program in the discipline of controlled dangerous substances
				  provided by a forensic laboratory licensed by the Department.