The PACE provider shall comply with: 42 CFR 460 et seq.; This chapter; The Medicaid provider agreement and the PACE Organization Provider Agreement signed with the Department; COMAR 10.09.36; Standards in P.L. 101-330, Americans with Disabilities Act of 1990, 42 U.S.C. §12101 et seq.; Any other applicable regulations, transmittals, and guidelines issued by the Department that are in effect; and All other requirements of applicable federal and State law. The PACE provider shall have a signed PACE program agreement with the Department and CMS which establishes the terms of the relationship between the PACE provider and the Department. The PACE provider shall obtain approval by the Department before establishing additional care sites. The PACE provider shall obtain approval by the Department before expanding its service area. Professional and Administrative Standards. The PACE provider shall have the professional and administrative ability and staffing to carry out its duties and responsibilities according to the PACE Program Agreement and PACE Organization Provider Agreement, which shall include the following: A full-time administrator; Sufficient allied health, medical social work, clerical, and support staff to provide proper medical care within acceptable professional standards; A demonstrated ability to deliver health services within the service area according to standards established by the Department; A management information system, which shall: Meet the requirements of Regulations .14 and .15 of this chapter; and Maintain medical and financial records for 10 years; An acceptable PACE participant grievance and appeals procedure and system for reporting the disposition of grievances and appeals to the Department, as specified in Regulation .19 of this chapter; A procedure established to provide PACE participants an ability to participate in matters of policy and operation; and A sufficient quality assurance and performance improvement system, as specified in Regulation .13 of this chapter. Nondiscrimination. In connection with the performance of its obligations under this chapter, the PACE provider shall comply with all applicable federal and State laws, regulations, or orders which prohibit discrimination on grounds of race, age, creed, sex, color, national origin, marital status, physical or mental handicap, health status, or need for health services. Provision of Services and Health Care Delivery. A PACE provider shall provide: The services set forth in Regulation .09 of this chapter and covered under the PACE provider benefit package: Promptly and continuously, consistent with accepted medical practice and community professional standards; and Through its own employees and agents or through contractors, except for emergency services; and Written notice to PACE participants if there is a significant change in the nature, location, or provider of services provided. The PACE provider may not knowingly have as a director, officer, partner, or owner of more than 5 percent of the entity's equity, a person or an affiliate of a person who is or has been debarred, suspended, or otherwise excluded from participating in procurement activities under the Federal Acquisition Regulation or from participating in nonprocurement activities under regulations issued pursuant to federal Executive Order No. 12549 or under guidelines implementing such an order. The PACE provider may not knowingly have an employment, consulting, or other agreement with a person described in §H of this regulation, for the provision of items and services that are significant and material to the PACE provider's obligations under this chapter. The PACE provider and its agents and employees, in the performance of the services covered under this chapter, shall act in an independent capacity and may not act as officers, employees, or agents of the Department. An individual employed by the State or any department, commission, agency, or branch of the State, whose duties include matters relating to or affecting the subject matter of this chapter, may not be an employee of a PACE provider. Any obligations of the PACE provider set forth in this chapter may be waived by the Department, but the waiver extends only to the particular case, time, and manner specified by the Department and is not a waiver of any other provision of this chapter. If the PACE Program Agreement exempts the PACE provider from financial responsibility for any services available under the State Plan, the PACE provider shall be required by the PACE Organization Provider Agreement to provide for these services. Liability. The PACE provider shall be wholly at risk for all medically necessary and appropriate services covered under the PACE provider benefit package. The Department may not make additional payment for services under this section. The PACE provider may not collect any payment from a PACE participant except as specified in Regulation .05 of this chapter. The PACE provider is solely responsible for ensuring that it does not issue payments for services for which it is not liable in its PACE Organization Provider Agreement, and the Department may not accept responsibility for refunding to the PACE provider any excess payments made by the PACE provider.