Maryland Administrative Code

.10 General Supervisor Requirement, Qualifications, and Responsibilities. 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 …

.11 Testing Personnel Requirement and Qualifications. 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 …

.12 First-Tier, Supplemental, and Second-Tier Tests. 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) Onl…

.13 Screening Test Blood-Spot Specimens — Collection and Test Requisition. 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…

.14 Screening Test Blood-Spot Specimens — Procedures, Submission, and Delivery Requirements. 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…

.15 Test Blood-Spot Specimens — Use, Research, Storage, and Retention. 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 Marylan…

.16 Test Records — Retention. 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…

.17 Testing — First-Tier. 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 I…

.18 Testing — Second-Tier and Supplemental. A. When a test request is made by an individual authorized to request a laboratory test, as set out in COMAR 10.10.06.02: (1) A permittee other than the Department's public health laboratory may perform a second-tier or supplemental tes…

.19 Proficiency and Competency Testing for Newborn Screening Tests. 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 …

.20 Quality Control. A. Quality Control Program. (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…

.21 Quality Assessment and Quality Assurance. 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 mec…

.22 Quality Assurance — Continuity of Operations and Disaster Recovery Plan. 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 …

.23 Reporting Test Results. 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, cari…

.24 Reporting Abnormal Test Results to the Follow-Up Unit. 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) Telephoni…

.25 Reporting System and Communication Software. 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…

.26 Availability of Statistical and Scientific Data. 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) Th…

.27 Sanctions. 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…

.01 Scope. These regulations affect all institutions or related facilities, as defined in Regulation .02 of this chapter, that deliver a newborn infant from its mother.

.02 Definitions. A. In this chapter, 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 extrac…

.03 Identification of Newborn Infants — Mandatory Procedure. 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. B. An individual empl…

.04 Identification of Newborn Infants — Additional Procedures Permitted. 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 …

.01 Purpose. 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-l…

.02 Scope. 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.

.03 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Alternative birthing site” means any site of birth other than a hospital. (2) “Appropriate services” mean any necessary audiological, medical, developmental, speech-langua…

.04 High Risk Factors. 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…

.05 Model System. 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 s…

.06 Early Hearing Detection and Intervention Advisory Council. 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 sta…

.07 Procedures for Birthing Hospitals and Alternative Birthing Sites. 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, e…

.08 Procedures for Audiologists and Licensed Professionals Conducting Audiological Screening or Evaluations. 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…

.09 Department Procedures. 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) Deve…

.01 Incorporation by Reference. 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. Cross References 10.14.05.02B(21)

.02 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Agency” means a legally incorporated body or governmental unit which provides services to disabled children or their families, or both. (2) “Allowable cost” means the maxi…

.03 Covered Services. A. The CMS Program shall authorize covered services when a CMP has been approved. B. The CMP shall: (1) Include: (a) All diagnoses or suspected diagnoses; (b) Service requested or provided; (c) Specific reason for the service request; (d) Evaluation or treat…

.04 Rights and Responsibilities. 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 applic…

.05 General Eligibility Criteria. 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 pur…

.06 Medical Eligibility. 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) Chro…

.07 Financial Eligibility. A. An applicant's financial eligibility is based upon the composition and income of the family unit. B. Family Unit. A family unit consists of one or more of the following members residing in the same household: (1) The applicant; (2) The natural or ado…

.08 Application Process. 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) A…

.09 Disposition of Application. 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 applic…

.10 Record Retention and Confidentiality. 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 f…

.11 General Conditions of Provider Participation. 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 provi…

.12 Conditions of Hospital Participation. 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…

.13 General Billing Procedures. 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 …

.14 Billing Procedures for Physician Office Services. 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 …

.15 Billing Procedures for Medically Necessary Dental Services. 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) …

.16 Billing Procedures for Orthodontic Services. 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 fo…