The purpose of this chapter is to set minimum standards for licensure of health care staff agencies providing services in Maryland. The regulations of this chapter do not preclude a health care staff agency from operating with independent contractors. In this chapter, the following terms have the meanings indicated. Terms Defined. Abuse. “Abuse” means: The nontherapeutic infliction upon a resident of physical pain or injury; or A persistent course of conduct intended to produce, or resulting in, mental or emotional distress to a resident, for example, verbal intimidation of a resident. “Abuse” does not mean the performance of an accepted medical procedure ordered by a physician or administered by another health care professional practicing within the scope of the physician's or health care professional's license. “Agency” means a health care staff agency. Allied Health Care Field. “Allied health care field” means a healthcare profession subject to licensure under Health Occupations Article, Annotated Code of Maryland. “Allied health care field” does not include the healthcare profession of physician assistant. “Board” means a health occupation licensing board authorized to license, certify, and discipline a health care practitioner in accordance with the Health Occupations Article. “Client facility” means a health care facility that contracts with a health care staff agency for the referral of health care practitioners. “Deficiency” means any failure of the health care staff agency to meet the requirements of Health-General Article, Title 19, Subtitle 20, Annotated Code of Maryland, or any rule or regulation that the Secretary adopts under that subtitle. “Department” means the Department of Health. “Health care facility” means a hospital or related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland. Health Care Practitioner. Except as provided in §B(9)(b) of this regulation, “health care practitioner” means any individual licensed or certified under Health Occupations Article, Annotated Code of Maryland, who practices in an allied health care field. “Health care practitioner” does not include: An acupuncturist; A dentist; A nurse anesthetist; A nurse midwife; A nurse practitioner; A pharmacist; A physician; or A podiatrist. “Initially providing or referring” means the first time a health care staff agency provides or refers a particular health care practitioner to a health care facility. “Licensee” means the person, association, partnership, corporation, limited-liability company, or other entity to which a license is issued. “Neglect” means failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness. Health Care Staff Agency. “Health care staff agency” means any person, firm, corporation, partnership, or other business entity engaged in the business of referring health care practitioners as employees or independent contractors to render temporary health care services at a health care facility in the State. “Health care staff agency” does not include: A health care staff agency operated by a health care facility or its affiliates solely for the purpose of procuring, furnishing, or referring temporary or permanent health care practitioners for employment at that health care facility or its affiliates; A home health agency regulated under Health-General Article, Title 19, Subtitle 4, Annotated Code of Maryland; or Any health care practitioner procuring, furnishing, or referring their own services to a health care facility without the direct or indirect assistance of a health care staff agency. “Office” means the Office of Health Care Quality in the Department. “Responsible party” means the individual at a health care staff agency who controls the day-to-day operation of the health care staff agency. “Secretary” means the Secretary of Health. A person, firm, corporation, partnership, or other business entity may not maintain or operate a health care staff agency in this State without first obtaining a license from the Secretary and complying with the regulations of this chapter. An agency shall post its license conspicuously onsite so that it is clearly visible to the general public. An out-of-State agency providing services in this State shall have a current Maryland license conspicuously posted at the: Office in this State where the agency conducts its day-to-day operations, if the agency operates an in-State office; or Agency's records repository that is located in this State, if the agency utilizes a records repository. A person operating an agency may not use the term “health care staff agency” in its advertising without first obtaining a license from the Secretary. A license is valid only in the name of the licensee to whom the license is issued and is not subject to sale, assignment, or other transfer. If the agency ceases to operate for any reason, the license is void and the licensee shall immediately return the license to the Department. Application for Licensure. A person desiring to refer a health care practitioner to a health care facility to render temporary health care services in this State shall file an application with the Secretary, on a written or electronic form provided by the Secretary. The application for licensure shall contain the agency's business name, address, telephone number, and responsible party. Along with the application, the applicant shall submit a copy of the agency’s policies and procedures as specified in Regulation .08 of this chapter. Additional Requirements. The applicant shall: Demonstrate compliance with all applicable federal, State, and local laws and regulations; and Submit all documentation requested by the Department that is relevant to the applicant's ability to operate an agency in compliance with this chapter, including documentation of any: Past or current operation of a health-related facility or an agency; Prior denial, suspension, or revocation of a license of certification to provide care to third parties; and Felony conviction of the applicant or anyone with direct or indirect ownership interest in the agency. The Secretary may require an applicant to submit information to demonstrate the applicant's financial ability to operate an agency in compliance with this chapter. Duration of License. An agency's annual license shall expire on the annual anniversary of the date the license was originally issued unless the license is renewed for a 1-year term. License Renewal. At least 1 month before the current license expires, the Office shall send to the agency, by first-class mail to the last known address of the agency, a renewal notice that states: The date on which the current license expires; The date by which the renewal application shall be received by the Office for the renewal to be issued and mailed before the license expires; and That no renewal fee is required. Before a license expires, the agency may renew its license for an additional term by submitting a renewal application on a written or electronic form provided by the Secretary, if the agency: Otherwise is entitled to be licensed; and Provides updates, if any, to the agency's policies and procedures as specified in Regulation .09 of this chapter. Failure to Renew License. When an agency fails to renew its license, the agency shall: Immediately stop referring personnel to health care facilities; and Notify health care facilities where personnel are currently referred that the agency no longer has a valid operating license. Based on information provided to the Department by the applicant and the Department's own investigation, the Secretary shall: Approve the application unconditionally; Approve the application conditionally, which may include, among other conditions, requiring the applicant to use the services of a management firm approved by the Secretary; or Deny the application. Nursing Staff Agency Licensees. Effective September 15, 2014, a person holding a nursing staff agency license who is in good standing and refers only nursing personnel shall be deemed to meet the requirements for issuance of a health care staff agency license. A person holding a nursing staff agency license who wishes to expand their referrals to other health care practitioners in addition to nursing personnel shall first obtain a new health care staff agency license. Rights of Applicant if License is Revoked or Denied. Denial of License. The Secretary shall inform the applicant of the reasons for refusal to issue a license. Revocation of License. The Secretary may, for cause shown, revoke or refuse to reissue any license. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing consistent with Regulation .17 of this chapter. A licensee shall notify the Department of any change in agency ownership, name, or address within 30 calendar days of the change. Any change in agency ownership, name, or address requires the issuance of a new license. If the sale, transfer, assignment, or lease of an agency causes a change in the person or persons who control or operate the agency, the agency shall be considered a “new agency” and the new owner shall comply with all regulations of this chapter when applying for a new license. If the licensee fails to notify the Office of the changes in §A of this regulation, the Office may impose a fine of $100. The Department or its designee may conduct announced or unannounced licensure or complaint inspection visits to the agency's office or records repository, if utilized by an out-of-State agency, to ensure compliance with the requirements of this chapter. The agency's office or records repository, if utilized by an out-of-State agency, shall be available during normal business hours for announced or unannounced inspections by the Department or its designee. An agency with offices out-of-State shall comply with the regulations of this chapter and shall reimburse the Department for reasonable travel expenses incurred in conducting out-of-State inspections. An agency shall maintain records to support compliance with the regulations of this chapter. The responsible party of the agency shall provide all records requested by the Office not later than 24 hours after the request. The agency shall develop, document, and implement policies and procedures. Policies and procedures shall include, but are not limited to: Selecting and verifying the credentials of a health care practitioner referred by the agency; Validating the experience of a health care practitioner prior to referral by the agency; Tracking and acting on serious or life-threatening complaints received by a client, facility, or the client facility's agent; Reporting of an action or condition performed by a health care practitioner as required under Regulation .09C of this chapter; Verifying the following: A health care practitioner referred by the agency is of satisfactory health status and has received the necessary testing and immunization as required or requested by the client facility; Drug screening of a health care practitioner is performed before referral by the agency, if the client facility requires drug screening for facility employees; Drug testing of a health care practitioner referred by the agency is performed, if there is probable cause to perform a drug test or if a client facility requests a drug test; Criminal background checks of a health care practitioner are performed before referral by the agency, if the client facility requires criminal background checks for facility employees; The references of a health care practitioner referred by the agency; A health care practitioner referred by the agency has I-9 status that permits them to legally work in the United States; and A health care practitioner has active licensure or certification with the Board; and Investigating a complaint or grievance presented to an agency by the client facility, an individual receiving services, a representative of the individual receiving services, or any concerned individual that includes a: Description of how and to whom to file a complaint within the agency; Description of how and to whom to file a complaint with the Office; Commitment to conduct a thorough investigation into any allegation against individuals referred by the agency; and Mechanism for making completed investigation reports available to the Department immediately upon request during inspections. An agency may not knowingly provide or refer a heath care practitioner to render temporary services who is not authorized under Health Occupations Article, Annotated Code of Maryland, to practice their profession in Maryland. An agency and client facility shall ensure that the scope of practice of the referred health care practitioner is consistent with Health Occupations Article, Annotated Code of Maryland. If an agency is aware of an action or inaction by a health care practitioner who is provided or referred by the agency that may be grounds for action under Health Occupations Article, Annotated Code of Maryland, the agency shall report the action or condition to the appropriate Board and the Office immediately when the action or condition is known by the agency. An individual shall have immunity from liability described in the Courts and Judicial Proceedings Article, §5-709, Annotated Code of Maryland, for making a report as required under §C of this regulation. Personnel Qualifications and Duties. The agency shall maintain the following from client facilities: Job descriptions for referred individuals; and A documented procedure for the agency and client facility to determine that an individual's qualifications are consistent with the assignments to which the individual is being referred. The agency shall maintain documentation indicating that individuals providing services in any health care facility within the State have been educated by the agency or the facility about: The facility's policies and procedures related to the individuals' scope of practice and responsibilities in the referred assignment; and The individuals' obligations under Maryland law to report abuse and neglect. An agency shall attest on a form developed by the Department that the agency is in compliance with the federal: Civil Rights Act of 1964; Rehabilitation Act of 1973; Americans with Disabilities Act of 1990; and Drug Free Workplace Act of 1988, if applicable. The Department may impose a civil money penalty if a deficiency exists. In determining whether a civil money penalty is to be imposed, the Department shall consider the following factors: The number, nature, and seriousness of the deficiencies; The extent to which the deficiencies are part of a pattern; The degree of risk to the health, life, or safety of the residents of the client facility caused by the deficiency or deficiencies; The efforts made by, and the ability of the agency to correct the deficiency or deficiencies; An agency's prior history of compliance in general and specifically with reference to the cited deficiencies; and Other factors as justice may require. If the Department determines that a deficiency or a pattern of deficiencies exists, the Department shall notify the agency of the deficiency or deficiencies and may: Impose a per-day civil money penalty until compliance has been achieved; Permit the agency the opportunity to correct the deficiencies by a specific date; or Impose a per-instance civil money penalty for each deficiency. If the Department permits an agency the opportunity to correct the deficiencies by a specific date and the agency fails to comply with this requirement, the Department may impose a per-day civil money penalty for each day of violation until correction of the deficiency or deficiencies has been verified and compliance has been maintained. When a civil money penalty is imposed, the Department shall issue an order that includes the: Deficiency or deficiencies on which the order was based; and Amount of civil money penalty to be imposed. A civil money penalty imposed under this chapter for a first offense may not exceed: $2,500 for each instance of violation; or $2,500 per day until correction of the deficiency or deficiencies has been verified and compliance has been maintained. A civil money penalty imposed under this chapter for a second offense may not exceed: $5,000 for each instance of violation; or $5,000 per day until correction of the deficiency or deficiencies has been verified and compliance has been maintained. A civil money penalty imposed under this chapter for a third or subsequent offense may not exceed: $10,000 for each instance of violation; or $10,000 per day until correction of the deficiency or deficiencies has been verified and compliance has been maintained. Per-Instance Civil Money Penalty. The effective date may be as early as the date that the deficiency or deficiencies on which the civil money penalty is based first occurred. Per-Day Civil Money Penalty. The daily civil money penalty starts to accrue as of the date of the inspection, survey, or interview by the Department that identifies the deficiency or deficiencies on which the civil money penalty is based. The accrual of the daily civil money penalty ceases when correction of the deficiency or deficiencies on which the civil money penalty was based has been verified. A civil money penalty payment is due 15 calendar days after: The time period for requesting a hearing has expired, if a request for a hearing has not been received; or Receipt of a written request from the agency to waive its right to a hearing and reduce the amount of the civil money penalty by 40 percent, if the written request is received by the Department within 30 calendar days of the Department's order imposing the civil money penalty. The amount of the civil money penalty, when determined, may be deducted from any sum owed by the State to the agency. A licensee aggrieved by the imposition of a civil money penalty may appeal the action by filing a request for a hearing in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. The Secretary may immediately suspend a license on finding that the public health, safety, or welfare imperatively requires emergency action pursuant to State Government Article, §10-226(c), Annotated Code of Maryland. The Department shall deliver a written notice to the agency: Informing the agency of the emergency suspension; Giving the reasons for the action and the regulation or regulations with which the licensee has failed to comply that form the basis for the emergency suspension; and Notifying the agency of its right to request a hearing and to be represented by counsel. The filing of a hearing request does not stay the emergency action. Suspended License. If a license is suspended by emergency action, the agency shall: Immediately return the license to the Department; and Cease making referrals. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .17 of this chapter. The Office of Administrative Hearings shall conduct a hearing as provided in Regulation .17 of this chapter and issue a proposed decision within 10 business days of the close of the hearing record. Exceptions may be filed by an aggrieved person pursuant to COMAR 10.01.03. The Secretary shall make a final decision pursuant to COMAR 10.01.03. If the Secretary's final decision does not uphold the emergency suspension, the agency may resume operation. Denial or Revocation of License. The Secretary, for cause shown, may notify the agency of the decision to revoke or deny the license. Except as provided in Regulation .15 of this chapter, the denial or revocation shall be stayed if a hearing is requested. Criteria for Denial or Revocation. The Department shall notify the agency in writing of the following: The effective date of the denial or revocation; The reason for the denial or revocation; The regulations with which the licensee has failed to comply that form the basis for the denial or revocation; That the agency is entitled to a hearing if requested, and to be represented by counsel; That the agency shall stop providing services on the effective date of the denial or revocation if the agency does not request a hearing; That the denial or revocation shall be stayed if a hearing is requested; and That the agency is required to surrender its license to the Department if the denial or revocation is upheld. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .17 of this chapter. An agency shall file a request for a hearing with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality of the Department, not later than 30 calendar days after receipt of notice of the Secretary's action. This request shall include a copy of the Secretary's action. A hearing requested under this chapter shall be conducted in accordance with: State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland; COMAR 28.02.01; and COMAR 10.01.03. The burden of proof is as provided in COMAR 10.01.03.28. Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01. The aggrieved person may file exceptions as provided in COMAR 10.01.03.35. A final decision by the Secretary shall be issued in accordance with COMAR 10.01.03.35. Health-General Article, §2-104 and Title 19, Subtitle 20, Annotated Code of Maryland Effective date: December 17, 2007 (34:25 Md. R. 2211) Chapter revised effective September 15, 2014 (41:18 Md. R. 1009) Regulation .05A, D amended effective December 21, 2015 (42:25 Md. R. 1542); August 29, 2016 (43:17 Md. R. 953); March 13, 2017 (44:5 Md. R. 292) Regulation .05D amended effective June 5, 2017 (44:11 Md. R. 524) Regulation .06B amended effective August 29, 2016 (43:17 Md. R. 953)