reglab/statecodes huggingface dataset:
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.08 - Technical Supervisor Requirement, Qualifications, and Responsibilities

Current through Register Vol. 51, No. 14, July 12, 2024
A. Technical
				  Supervisor Requirement. A permittee that offers to perform or performs a
				  first-tier, supplemental, or second-tier test shall employ a technical
				  supervisor.
B. Director as
				  Technical Supervisor. The director may function as the technical supervisor if
				  the director meets the technical supervisor qualifications specified in this
				  regulation.
C. Technical Supervisor
				  Qualifications. The technical supervisor shall meet the qualifications for a
				  technical supervisor set forth at COMAR
				  10.10.07.05A(1)
				  and B(7).
D. Technical Supervisor
				  Responsibilities. A technical supervisor shall be:
(1) Responsible for the:
(a) Technical and scientific methods used in
				  the laboratory; and
(b) Oversight
				  of the laboratory;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.09 - Clinical Consultant Requirement, Qualifications, and Responsibilities

Current through Register Vol. 51, No. 14, July 12, 2024
A. Clinical
				  Consultant Requirement. A permittee that offers to perform or performs
				  first-tier, supplemental, or second-tier tests shall employ a clinical
				  consultant.
B. Director as Clinical
				  Consultant. The director may function as the clinical consultant if the
				  director meets the qualifications set forth under §C of this
				  regulation.
C. Clinical Consultant
				  Qualifications. The clinical consultant shall be:
(1) A doctor of medicine or a doctor of
				  osteopathy licensed to practice medicine or osteopathy; and
(2) Board certified by the American Board of
				  Medical Genetics as a:
(a) Clinical
				  geneticist;
(b) Medical geneticist;
				  or
(c) Biochemical
				  geneticist.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.10 - General Supervisor Requirement, Qualifications, and Responsibilities

Current through Register Vol. 51, No. 14, July 12, 2024
A. General
				  Supervisor Requirement. A permittee that offers to perform or performs
				  first-tier, supplemental, or second-tier tests shall employ a general
				  supervisor.
B. General Supervisor
				  Qualifications. The general supervisor shall:
(1) Meet the qualifications for a general
				  supervisor set forth at COMAR
				  10.10.07.06B(1);
				  and
(2) Have at least 6 months
				  experience supervising the operation of applicable test systems, including:
(a) Tandem mass spectrophotometry
				  (MS/MS);
(b) Time-resolved
				  immunofluorometry;
(c)
				  Enzyme-linked immunosorbent assay (ELISA) systems; and
(d) Isoelectric focusing and high-performance
				  liquid chromatography.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.11 - Testing Personnel Requirement and Qualifications

Current through Register Vol. 51, No. 14, July 12, 2024
A. Requirement. A permittee that offers to
				  perform or performs first-tier, supplemental, or second-tier tests shall employ
				  sufficient laboratory testing personnel to perform testing in accordance with
				  the requirements of this chapter.
B. Qualifications. Testing personnel shall
				  meet the qualifications set forth at COMAR
				  10.10.07.07B.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.12 - First-Tier, Supplemental, and Second-Tier Tests

Current through Register Vol. 51, No. 14, July 12, 2024
A. First-Tier Tests; Requirement. The
				  Department's public health laboratory shall perform first-tier tests on all
				  screening blood-spot specimens collected from a newborn infant.
B. First-Tier Tests; Testing Limitations.
(1) Only the Department's public health
				  laboratory may screen for the disorders listed in §C of this
				  regulation.
(2) A permittee may
				  perform a supplemental or a second-tier test only when the test is requested by
				  an individual authorized to request a medical laboratory test as provided in
				  COMAR 10.10.06.02B.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.13 - Screening Test Blood-Spot Specimens - Collection and Test Requisition

Current through Register Vol. 51, No. 14, July 12, 2024
A. Blood-Spot
				  Specimen Collection.
(1) A person shall
				  collect a newborn infant's blood-spot specimen for testing under this chapter
				  by using only the special blood-spot specimen collection test requisition card
				  provided by the Department.
(2) The
				  Department shall provide the special blood-spot specimen collection test
				  requisition card to the:
(a) Individual in
				  charge of a birthing facility or the individual's designated representative;
				  or
(b) Home birth
				  attendant.
(3) The
				  individual in charge of a birthing facility or the individual's designated
				  representative, or the home birth attendant shall collect a blood-spot specimen
				  consisting of heel-stick whole blood obtained:
(a) When a newborn infant is 24 to 48 hours
				  old;
(b) On a blood-spot specimen
				  collection test requisition card provided by the Department; and
(c) As set forth in Regulation .14 of this
				  chapter.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.14 - Screening Test Blood-Spot Specimens - Procedures, Submission, and Delivery Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  Standard Operating Procedure. The individual in charge of a birthing facility
				  or the individual's designated representative, or the home birth attendant
				  shall maintain written standard operating procedures for the collection,
				  handling, storage, and transport of newborn infant blood-spot specimen
				  collection test requisition cards, including instructions for staff to:
(1) Ensure and maintain blood-spot specimen
				  integrity, quality, and acceptability;
(2) Ensure proper:
(a) Site preparation and cleaning;
(b) Performance of the heel stick puncture;
				  and
(c) Application of whole blood
				  to the collection test requisition card;
(3) Identify precautions against:
(a) Milking or squeezing the blood-spot
				  specimen collection site;
(b)
				  Layering successive drops of blood on the same circle on the blood-spot
				  specimen collection test requisition card;
(c) Filling the circles on both sides of the
				  filter paper;
(d) Touching or
				  smearing a blood-spot specimen before it is fully air-dried;
(e) Scratching or abrading the blood-spot
				  specimen;
(f) Not allowing a
				  blood-spot specimen to dry thoroughly before sending the blood-spot specimen
				  collection test requisition card to a laboratory; and
(g) Damaging, stretching, or wrinkling the
				  filter paper before, during or after blood-spot specimen collection;
(4) Recognize unsatisfactory
				  blood-spot specimens; and
(5)
				  Handle and temporarily store a blood-spot specimen collection test requisition
				  card, including the procedures and techniques for:
(a) Drying blood-spot specimens;
(b) Stacking of blood-spot specimen
				  collection test requisition cards; and
(c) Temporarily storing blood-spot specimen
				  collection test requisition cards.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.15 - Test Blood-Spot Specimens - Use, Research, Storage, and Retention

Current through Register Vol. 51, No. 14, July 12, 2024
A. Use. A permittee
				  may use a newborn infant blood-spot specimen from a newborn infant to test for
				  only the conditions listed in Regulation .12C of this chapter.
B. Research. A researcher may not use a
				  Maryland newborn infant's blood spot specimen or test results for research
				  purposes unless the:
(1) Research is approved
				  in writing by the Department's:
(a) Newborn
				  Screening Program; and
(b)
				  Institutional Review Board; and
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.16 - Test Records - Retention

Current through Register Vol. 51, No. 14, July 12, 2024
The Department's public health laboratory shall retain and
					 maintain electronically or as a hard copy for 25 years the:
A. Top copy of the requisition portion of the
				  blood-spot specimen collection test requisition card;
B. All test results and reports;
C. Electronic data bases; and
D. Supporting documents that show how a
				  reported test result was obtained and verified, including but not limited to:
(1) Quality control records;
(2) Instrument maintenance and repair
				  records;
(3) Test reagent records;
				  and
(4) Instrument and test system
				  data.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.17 - Testing - First-Tier

Current through Register Vol. 51, No. 14, July 12, 2024
A. The
				  Department's public health laboratory shall test, using first-tier tests,
				  appropriately timed and collected blood-spot specimen of a newborn infant's
				  blood for the disorders listed in Regulation .12C of this chapter.
B. Full-Term Healthy Newborn Infants.
(1) If a newborn infant is born at term and
				  is healthy, the Department's public health laboratory shall conduct a:
(a) First screening using first-tier tests to
				  detect the disorders listed in Regulation .12C of this chapter on a blood-spot
				  specimen collected when the full-term healthy newborn infant is between 24 and
				  48 hours old; and
(b) Second
				  screening using first-tier tests on a blood-spot specimen collected when the
				  full-term healthy infant is between 10 and 14 days old.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.18 - Testing - Second-Tier and Supplemental

Current through Register Vol. 51, No. 14, July 12, 2024
A. When a test request is made by an
				  individual authorized to request a laboratory test, as set out in COMAR
				  10.10.06.02B:
(1) A permittee other than the Department's
				  public health laboratory may perform a second-tier or supplemental test;
				  and
(2) The Department's public
				  health laboratory may perform a second-tier test.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.19 - Proficiency and Competency Testing for Newborn Screening Tests

Current through Register Vol. 51, No. 14, July 12, 2024
A permittee shall:
A. Meet all requirements set forth in COMAR
				  10.10.05;
B. Successfully
				  participate in one or more approved proficiency testing programs that cover all
				  first-tier, second-tier, and supplementary tests offered or
				  performed;
C. Evaluate and document
				  performance, semiannually during the first year of testing and annually
				  thereafter, of all individuals responsible for testing; and
D. In addition to the proficiency testing
				  requirement in §A of this regulation, participate in the Centers for
				  Disease Control and Prevention's Newborn Screening Quality Assurance
				  Program.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.20 - Quality Control

Current through Register Vol. 51, No. 14, July 12, 2024
A. Quality
				  Control Program. A permittee shall develop, establish, implement, maintain, and
				  follow written quality control policies, procedures, and techniques that
				  provide and ensure accurate, reliable, and valid test results and reports.
(1) A permittee shall develop, establish,
				  implement, maintain and follow written quality control policies, procedures,
				  and techniques that provide and ensure accurate, reliable, and valid test
				  results and reports.
(2) A
				  permittee's quality control program shall:
(a) Cover all tests, methods, and procedures
				  performed by the laboratory; and
(b) Meet the standards and requirements set
				  forth in this chapter and COMAR 10.10.06.
(3) A permittee's quality control procedures
				  and practices shall include, but are not limited to, the use of:
(a) Analyses of reference materials to ensure
				  the reproducibility and accuracy of test results;
(b) Systems to ensure proper functioning of
				  instruments, equipment, reagents, and performance of laboratory
				  personnel;
(c) Valid reagents,
				  equipment, calibration, and systematic procedural checks;
(d) A system that ensures timely and
				  pertinent error detection and correction for the review and reporting of test
				  results; and
(e) Quality control
				  materials from the Centers for Disease Control and Prevention's Newborn
				  Screening Quality Assurance Program.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.21 - Quality Assessment and Quality Assurance

Current through Register Vol. 51, No. 14, July 12, 2024
A. A permittee shall:
(1) Establish and follow a written quality
				  assessment plan that covers all phases of the testing process;
(2) Meet the applicable quality assurance
				  requirements of COMAR 10.10.06; and
(3) Have an accessioning mechanism or system
				  that:
(a) Tracks blood-spot specimens and
				  allows first and subsequent blood-spot specimens and test results from the same
				  newborn infant to be linked for testing and analysis; and
(b) Identifies a specific analyte that
				  requires retesting when a newborn infant's prior screening test results for
				  that analyte are abnormal or border-line abnormal.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.22 - Quality Assurance - Continuity of Operations and Disaster Recovery Plan

Current through Register Vol. 51, No. 14, July 12, 2024
A permittee shall develop, implement, and maintain written
					 continuity of operations and disaster recovery plans that ensure the continuous
					 performance of essential functions and operations:
A. During an emergency; or
B. When the laboratory temporarily can no
				  longer meet the requirements and standards set forth in this chapter.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.23 - Reporting Test Results

Current through Register Vol. 51, No. 14, July 12, 2024
A. All
				  Test Results. For a newborn infant, a permittee shall:
(1) Report all first-tier, supplemental, and
				  second-tier results to:
(a) The person who
				  requested the test; and
(b) An
				  individual who will use the test results in identifying, tracking, caring for,
				  and treating the newborn infant, including:
(i) A physician specialist; and
(ii) Personnel in the Follow-Up
				  Unit;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.24 - Reporting Abnormal Test Results to the Follow-Up Unit

Current through Register Vol. 51, No. 14, July 12, 2024
A. Reporting Requirements. A permittee shall
				  immediately report an abnormal or diagnostic test result to the Follow-Up Unit
				  by:
(1) Telephoning and personally speaking
				  to an individual in the Follow-Up Unit;
(2) Telephoning and personally speaking to a
				  back-up individual representing the Follow-Up Unit, if an attempt to make
				  in-person contact with an employee of the Follow-Up Unit fails; and
(3) Following up a telephonic report within
				  24 hours with a report by facsimile or electronic mail to the Follow-Up
				  Unit.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.25 - Reporting System and Communication Software

Current through Register Vol. 51, No. 14, July 12, 2024
A permittee shall:
A. Have available and use a reliable and
				  accurate electronic information system that is capable of collecting,
				  compiling, transferring, and communicating all normal and abnormal test results
				  to the Follow-Up Unit; and
B.
				  Provide the Follow-Up Unit, where applicable, with:
(1) The necessary information system and
				  electronic communications software or interface to be used by the Follow-Up
				  Unit to receive from the permittee the newborn screening test results and
				  reports required in this chapter; and
(2) Software programming assistance to ensure
				  that the:
(a) Permittee's data transmitted to
				  the Follow-Up Unit is accurate and timely; and
(b) The Follow-Up Unit's information system
				  maintains compatibility with the permittee's information system.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.26 - Availability of Statistical and Scientific Data

Current through Register Vol. 51, No. 14, July 12, 2024
A. Statistical Reports. The State's public
				  health laboratory, the Follow-Up Unit, or both, on request, shall provide
				  Newborn Screening Program statistical data for official State and national
				  reports to:
(1) The Council;
(2) The Department's Office of Genetics and
				  Children with Special Healthcare Needs; and
(3) State and federal agencies that use test
				  results and statistics for the care and treatment of newborn infants.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants › Section 10.10.13.27 - Sanctions

Current through Register Vol. 51, No. 14, July 12, 2024
A. Due to the
				  life-threatening nature and effect of errors in newborn screening testing, the
				  Secretary may order summarily the suspension of a permit if the Secretary finds
				  that the public health, safety, or welfare imperatively requires emergency
				  action, including but not limited to, if a permittee has:
(1) Failed to report a newborn infant's
				  abnormal test result as required in this chapter;
(2) Falsified a document submitted to the
				  Department, including but not limited to a:
(a) Newborn infant screening test report;
				  or
(b) Quality control or quality
				  assurance report; or
(3)
				  Failed to provide a corrected or amended test report if the permittee has
				  reported an erroneous or questionable test result.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.01 - Identification of Infants › Section 10.11.01.01 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
These regulations affect all institutions or related
					 facilities, as defined in Regulation .02 of this chapter, that deliver a
					 newborn infant from its mother.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.01 - Identification of Infants › Section 10.11.01.02 - Definitions

Current through Register Vol. 51, No. 14, July 12, 2024
A. In these
				  regulations, the following terms have the meanings indicated.
B. Terms Defined.
(1) "Born" means the complete expulsion or
				  extraction of a product of human conception from its mother, regardless of the
				  period of gestation, if, after the expulsion or extraction, it breathes or
				  shows any other evidence of life, such as heartbeat, pulsation of the umbilical
				  cord, or definite movement of voluntary muscle, whether or not the umbilical
				  cord is cut or the placenta is attached.
(2) "Cord blood sampling" means the taking of
				  a sample of a newborn infant's blood from the infant's umbilical
				  cord.
(3) "Footprinting" means the
				  taking of an ink or other type of impression of the skin patterns located on
				  the sole of the newborn infant's foot.
(4) "Institution" means:
(a) A hospital or related institution as
				  defined in Health-General Article, §19-301, Annotated Code of
				  Maryland;
(b) A freestanding
				  birthing center as defined in Health-General Article, § 19-1101, Annotated
				  Code of Maryland; or
(c) Any other
				  facility that delivers an infant from its mother.
(5) "Secretary" means the Secretary of Health
				  and Mental Hygiene or the Secretary's designee.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.01 - Identification of Infants › Section 10.11.01.03 - Identification of Newborn Infants - Mandatory Procedure

Current through Register Vol. 51, No. 14, July 12, 2024
A. An institution shall perform the infant
				  identification procedures described in this regulation:
(1) Immediately after the birth of the
				  infant; and
(2) Before the mother
				  and infant are separated.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.01 - Identification of Infants › Section 10.11.01.04 - Identification of Newborn Infants - Additional Procedures Permitted

Current through Register Vol. 51, No. 14, July 12, 2024
A. An institution
				  may perform additional identification procedures on an infant before the infant
				  leaves the delivery room. These methods do not link mother and infant, but may
				  be useful in establishing the identity of an infant, and include:
(1) Cord blood sampling;
(2) Footprinting;
(3) Taking a color photograph of the
				  infant;
(4) Physically assessing
				  the infant and documenting of any distinguishing features; or
(5) Another procedure proposed by the
				  institution to the Secretary for approval that provides at least equivalent
				  identification.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.02 - Early Hearing Detection and Intervention Program › Section 10.11.02.01 - Purpose

Current through Register Vol. 51, No. 14, July 12, 2024
The Early Hearing Detection and Intervention Program shall
					 provide for the universal hearing screening of newborns and early
					 identification and follow-up of newborns and infants who have, or are at risk
					 for developing, a permanent hearing status that affects speech-language skills.
					 The Program shall identify newborns and infants who have a permanent hearing
					 status that affects speech-language skills as early as
					 possible.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.02 - Early Hearing Detection and Intervention Program › Section 10.11.02.02 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
This chapter requires the screening of all newborns and
					 infants born in Maryland and follow-up for those who have, or are at risk for
					 developing, a permanent hearing status that affects speech-language
					 skills.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.02 - Early Hearing Detection and Intervention Program › Section 10.11.02.04 - High Risk Factors

Current through Register Vol. 51, No. 14, July 12, 2024
Any of the following high risk factors are considered
					 relevant in determining the possibility of a newborn or infant developing a
					 permanent hearing status that affects speech-language skills under this
					 chapter:
A. Caregiver concern
				  regarding hearing speech, language, or developmental delay;
B. Family history of a permanent hearing
				  status that affects speech-language skills occurring during
				  childhood;
C. Medical risk factors:
(1) Neonatal intensive care for more than 5
				  days;
(2) Extracorporeal membrane
				  oxygenation;
(3) Assisted
				  ventilation;
(4) Hyperbilirubinemia
				  that requires exchange transfusion of the blood;
(5) Exposure to ototoxic medications, such as
				  gentimycin and tobramycin; and
(6)
				  Exposure to loop diuretic medications, such as furosemide and lasix;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.02 - Early Hearing Detection and Intervention Program › Section 10.11.02.05 - Model System

Current through Register Vol. 51, No. 14, July 12, 2024
The Department shall establish and maintain a model system
					 to provide for the implementation of an early identification program and
					 follow-up of newborns and infants who have or are at risk for developing a
					 permanent hearing status that affects speech-language skills and includes the
					 following components:
A. Educational
				  materials;
B. Telephone resource
				  line with TTY capabilities;
C.
				  Department database to gather and maintain program data;
D. A service referral directory;
E. In-service training of hospitals, local
				  health departments, and local education agencies;
F. Referral to appropriate agency or
				  professional for services;
G.
				  Program monitoring and review;
H.
				  Confidentiality of records and information in accordance with Health-General
				  Article, §§4-101 and 4-301 - 4-309, Annotated Code of Maryland;
				  and
I. Continuum of follow-up which
				  includes:
(1) Contacting the primary care
				  provider in writing or by telephone to verify the status of the
				  infant;
(2) Contacting parents or
				  guardians in writing or by telephone to facilitate referral for diagnostic
				  audiological assessment and referral for appropriate services; and
(3) Interfacing with the single point of
				  entry for the early intervention system.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.02 - Early Hearing Detection and Intervention Program › Section 10.11.02.06 - Early Hearing Detection and Intervention Advisory Council

Current through Register Vol. 51, No. 14, July 12, 2024
The Advisory Council shall:
A. Advise the Department on:
(1) The implementation of an early
				  identification program and follow-up of newborns and infants who have, or are
				  at risk for developing, a permanent hearing status that affects speech-language
				  skills;
(2) Setting of standards
				  for the Program including procedures for hearing screening;
(3) Monitoring and reviewing of the Program;
				  and
(4) Provision of quality
				  assurance for the Program;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.02 - Early Hearing Detection and Intervention Program › Section 10.11.02.07 - Procedures for Birthing Hospitals and Alternative Birthing Sites

Current through Register Vol. 51, No. 14, July 12, 2024
For each infant delivered at the facility or site, birthing
					 hospital staff and, in the cases of alternative birthing sites, the licensed
					 professional attending the birth shall:
A. Within 48 hours of delivery, enter
				  demographic and birth event data into the Department database;
B. Within 48 hours of discharge from care in
				  the Department database:
(1) Document:
(a) The hearing screening test results;
				  and
(b) Any known risk factors;
				  and
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.02 - Early Hearing Detection and Intervention Program › Section 10.11.02.08 - Procedures for Audiologists and Licensed Professionals Conducting Audiological Screening or Evaluations

Current through Register Vol. 51, No. 14, July 12, 2024
A. An
				  audiologist or a licensed professional who performs a hearing screening or
				  audiological diagnostic evaluation on a child younger than 5 years old due to
				  the presence of a risk factor as listed in Regulation .04 of this chapter or in
				  follow-up to the birth hearing screening of a newborn or infant who did not
				  receive or did not pass the birth hearing screening shall:
(1) Within 2 business days:
(a) Report the results of the screening or
				  audiological diagnostic evaluation to the Program in the Department
				  database;
(b) Document
				  recommendations and referrals provided in the Department database;
				  and
(c) Confirm or update the
				  demographic information of the child or infant in the Department database;
				  and
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.02 - Early Hearing Detection and Intervention Program › Section 10.11.02.09 - Department Procedures

Current through Register Vol. 51, No. 14, July 12, 2024
A. The
				  Program shall:
(1) Implement the model
				  system;
(2) Perform duties and
				  responsibilities in accordance with the advice and consultation of the Advisory
				  Council;
(3) Exercise independent
				  judgment in the day-to-day operations of the Program;
(4) Develop Program processes in consultation
				  with the Advisory Council;
(5)
				  Conduct in-service training on Program procedures;
(6) Maintain a Department database to monitor
				  infants at risk for developing a hearing status that affects speech-language
				  skills;
(7) Track infants
				  identified as at risk for developing a permanent hearing status that affects
				  speech-language skills for a period of 5 years;
(8) Maintain a service directory within the
				  Department database;
(9) Assure
				  operation of the telephone resource line;
(10) Facilitate referral for diagnostic
				  audiological assessment and early intervention for infants who are at risk for
				  developing a permanent hearing status that affects speech-language
				  skills;
(11) Maintain records of
				  the audiological assessment reports for infants at risk for developing a
				  permanent hearing status that affects speech-language skills; and
(12) Interface with the single point of entry
				  of the early intervention system.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.03 - Children's Medical Services Program › Section 10.11.03.01 - Incorporation by Reference

Current through Register Vol. 51, No. 14, July 12, 2024
In this chapter, the federal poverty guidelines, as
					 amended, which are updated periodically in the Federal Register by the U.S.
					 Department of Health and Human Services, are incorporated by reference.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.03 - Children's Medical Services Program › Section 10.11.03.03 - Covered Services

Current through Register Vol. 51, No. 14, July 12, 2024
A. The CMS
				  Program shall authorize covered services when a CMP has been
				  approved.
B. CMS may request
				  further information from the provider in order to:
(1) Include:
(a) All diagnoses or suspected
				  diagnoses;
(b) Service requested or
				  provided;
(c) Specific reason for
				  the service request;
(d) Evaluation
				  or treatment findings;
(e)
				  Follow-up plans related to the service provided by the CMS Program;
(f) Source of primary health care;
				  and
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.03 - Children's Medical Services Program › Section 10.11.03.04 - Rights and Responsibilities

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  Applicant.
(1) The applicant shall furnish
				  factual information regarding the applicant's eligibility, and shall keep the
				  CMS Program informed of any change in demographic, financial, medical, or
				  insurance coverage status.
(2) An
				  eligible applicant shall use only Medical Assistance approved
				  providers.
(3) An applicant shall
				  complete a Medical Assistance application when the applicant is considered
				  potentially eligible.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.03 - Children's Medical Services Program › Section 10.11.03.05 - General Eligibility Criteria

Current through Register Vol. 51, No. 14, July 12, 2024
A. To be eligible for the CMS Program's
				  services, an applicant shall:
(1) Submit a
				  completed, signed, and dated CMS Program application;
(2) Provide documentation of:
(a) State residency, as this program is not
				  meant to cover those whose sole purpose in coming to Maryland is to obtain
				  medical care or coverage; and
(b)
				  Being younger than 22 years old;
(3) Provide a form of identification for the
				  applicant and the applicant's parents or guardians if the applicant is less
				  than 18 years old;
(4) Have income
				  that does not exceed:
(a) 200 percent of the
				  federal poverty level; or
(b) 250
				  percent of the federal poverty level, if the applicant is eligible for a
				  medical deduction under Regulation .07D of this chapter; and
(5) Have an eligible medical
				  condition as set forth in Regulation .06 of this chapter.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.03 - Children's Medical Services Program › Section 10.11.03.06 - Medical Eligibility

Current through Register Vol. 51, No. 14, July 12, 2024
A. Children
				  with special health care needs may be eligible for services covered by the CMS
				  Program.
B. Chronic medical
				  conditions which may render an applicant medically eligible include, but are
				  not limited to, the following:
(1) Chronic
				  asthma;
(2) Chronic renal
				  disease;
(3) Cystic
				  fibrosis;
(4) Diabetes and other
				  endocrine disorders;
(5)
				  Hemophilia;
(6) Immune
				  deficiencies;
(7) Juvenile
				  rheumatoid arthritis;
(8) Leukemia
				  and other childhood cancers;
(9)
				  Phenylketonuria and other inborn errors of metabolism; and
(10) Sickle cell anemia and other chronic
				  anemia.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.03 - Children's Medical Services Program › Section 10.11.03.07 - Financial Eligibility

Current through Register Vol. 51, No. 14, July 12, 2024
A. An
				  applicant's financial eligibility is based upon the composition and income of
				  the family unit.
B. Family Unit.
(1) A family unit consists of one or more of
				  the following members residing in the same household:
(a) The applicant;
(b) The natural or adoptive parents,
				  stepparents, or legal guardian if the applicant is unmarried;
(c) The unmarried natural or adoptive
				  siblings of the applicant who are younger than 22 years old;
(d) The lawful spouse of the applicant;
				  or
(e) Other individuals who are
				  not included in this regulation and who are dependents for federal income tax
				  purposes.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.03 - Children's Medical Services Program › Section 10.11.03.08 - Application Process

Current through Register Vol. 51, No. 14, July 12, 2024
A. The CMS
				  Program shall make applications available to, but which are not limited to, the
				  following agencies:
(1) Local health
				  department;
(2) Admitting, social
				  services, or business office of a participating hospital;
(3) Cooperating agencies; and
(4) An applicant, upon request.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.03 - Children's Medical Services Program › Section 10.11.03.09 - Disposition of Application

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  General.
(1) The CMS Program professional
				  staff shall:
(a) Review individual
				  applications;
(b) Determine CMS
				  Program eligibility and services to be approved for payment by the CMS Program
				  within 30 calendar days of receipt of the complete application;
(c) Verify the information provided by an
				  applicant which may include an interview:
(i)
				  With the applicant if the applicant is 18 years old or older, or with the
				  applicant's parent or guardian; and
(ii) Which is held at a mutually convenient
				  place and time for all parties.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.03 - Children's Medical Services Program › Section 10.11.03.10 - Record Retention and Confidentiality

Current through Register Vol. 51, No. 14, July 12, 2024
A. Records.
(1) A provider shall:
(a) Retain and reproduce, upon request for a
				  minimum of 6 years, records and reports required by the Department for the
				  administration of services; and
(b)
				  Be responsible for maintaining patient records for services that it provides in
				  accordance with the approved Department retention schedule.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.03 - Children's Medical Services Program › Section 10.11.03.11 - General Conditions of Provider Participation

Current through Register Vol. 51, No. 14, July 12, 2024
A. A provider of services which are covered
				  by the CMS Program shall comply with the following general requirements:
(1) For fee for service reimbursement, be
				  approved by Medical Assistance in writing as a Medical Assistance
				  provider;
(2) For copay and
				  deductible reimbursement, be a participating provider with the insurance plan
				  purchased by the CMS Program for the family;
(3) Request preauthorization on the forms
				  designated by the CMS Program;
(4)
				  Adhere to administrative procedures that are established by the CMS Program for
				  the specific treatment services; and
(5) Maintain adequate records, including
				  prescriptions, for a minimum of 6 years, and make them available upon request
				  to the Department or the Department's designee.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.03 - Children's Medical Services Program › Section 10.11.03.12 - Conditions of Hospital Participation

Current through Register Vol. 51, No. 14, July 12, 2024
A hospital shall:
A. Comply with all relevant State and federal
				  requirements related to the provision of health services and the receipt of
				  funds;
B. Be licensed by the
				  Department pursuant to the Hospital and Related Institutions subtitle,
				  Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, as a
				  hospital, and be licensed, as may be required, by other applicable State and
				  local laws;
C. Be accredited by the
				  Joint Commission for Accreditation of Hospitals; and
D. Provide the following services:
(1) A physician specialist who is qualified
				  in the area of need for which a recipient is hospitalized, and who shall
				  supervise and be involved in:
(a) The ongoing
				  care of a child; and
(b) Directing
				  the development of the CMP and other appropriate care plans;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.03 - Children's Medical Services Program › Section 10.11.03.13 - General Billing Procedures

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  A provider shall accept payment at the Medical Assistance rate as payment in
				  full.
B. A provider shall submit:
(1) Requests for payment on the form
				  designated by the CMS Program; and
(2) Completed reports and attachments as
				  requested by the CMS Program.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.03 - Children's Medical Services Program › Section 10.11.03.14 - Billing Procedures for Physician Office Services

Current through Register Vol. 51, No. 14, July 12, 2024
A. A physician shall:
(1) Comply with all procedures listed in
				  Regulation .13 of this chapter;
(2)
				  Charge the CMS Program the usual and customary charge to the general public for
				  similar services; and
(3) Bill the
				  CMS Program as specified by the CMS Program.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.03 - Children's Medical Services Program › Section 10.11.03.15 - Billing Procedures for Medically Necessary Dental Services

Current through Register Vol. 51, No. 14, July 12, 2024
A. A dentist shall
				  comply with all procedures listed in Regulation .13 of this chapter.
B. The CMS Program shall:
(1) Cover approved diagnostic, restorative,
				  and preventive treatment as described in the CMP; and
(2) Preauthorize estimates of
				  costs.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.03 - Children's Medical Services Program › Section 10.11.03.16 - Billing Procedures for Orthodontic Services

Current through Register Vol. 51, No. 14, July 12, 2024
A. An orthodontist shall comply with all
				  procedures listed in Regulation .13 of this chapter.
B. The CMS Program shall:
(1) Reimburse for correction of the full
				  permanent dentition; and
(2) Give
				  special consideration to services for children with malocclusions in the mixed
				  dentition associated with cleft palates or other craniofacial
				  deformities
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.03 - Children's Medical Services Program › Section 10.11.03.17 - Billing Procedures for Durable Goods and Equipment

Current through Register Vol. 51, No. 14, July 12, 2024
A. The durable goods and equipment providers
				  shall comply with all procedures listed in Regulation .13 of this
				  chapter.
B. A provider shall charge
				  the CMS Program the usual and customary charge to the general public for
				  similar durable goods and equipment.
C. The CMS Program shall:
(1) Pay for covered services which are the least
				  expensive, except for those described in §B of this regulation;
(2) Determine, based upon expected duration
				  of medical needs, whether durable medical equipment will be purchased or
				  rented; and
(3) Pay for repairs to
				  purchased durable medical equipment and disposable medical supplies according
				  to the Medical Assistance reimbursement rate for charges.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.03 - Children's Medical Services Program › Section 10.11.03.18 - Billing Procedures for Pharmacy Services

Current through Register Vol. 51, No. 14, July 12, 2024
A. A pharmacy provider shall comply with all
				  procedures listed in Regulation .13 of this chapter.
B. A pharmacy provider shall:
(1) Upon request, produce records to verify
				  any charge to the CMS Program; and
(2) Charge the CMS Program the usual and customary
				  charge to the general public for similar prescriptions.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 11 - MATERNAL AND CHILD HEALTH › Chapter 10.11.03 - Children's Medical Services Program › Section 10.11.03.19 - Billing Procedures for Hospitals

Current through Register Vol. 51, No. 14, July 12, 2024
A. All hospitals shall comply with the
				  following procedures:
(1) Hospitals located
				  in Maryland that participate in the CMS Program shall charge and be reimbursed
				  at the Medical Assistance rates approved by the Health Services Cost Review
				  Commission;
(2) The CMS Program
				  shall pay room and board charges for the day of admission, and may not pay room
				  and board charges for the day of discharge from the hospital;
(3) The CMS Program may not reimburse for
				  the services of a hospital's salaried or contractual physicians as a separate
				  line item;
(4). The contractual
				  physicians' salaries shall be included in the room and board rate or the
				  appropriate ancillary service;
(5)
				  When a patient is discharged from one general hospital and is admitted to
				  another general hospital and 24 hours have not elapsed between the discharge
				  and admission, the CMS Program shall pay only for those medically necessary
				  days, with the payment for the patient's hospitalization being apportioned
				  between the two hospitals;
(6) The
				  CMS Program shall be contacted regarding exceptions or extenuating
				  circumstances relating to admissions and discharges if the patient returns the
				  same day before the hospital patient count;
(7) All nonemergency inpatient hospital
				  admissions require preadmission approval by the CMS Program;
(8) Authorization is required by the CMS
				  Program or its designee for more than one preoperative inpatient day;
				  and
(9) The CMS Program may not
				  reimburse for hospital admissions where a child has been discharged due to
				  cancellation of planned surgery or treatment. The hospital may not bill the
				  family for these charges.