Title 42—Public Health--Volume 1
PART 485—CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS
§ 485.635   Condition of participation: Provision of services.
(a) Standard: Patient care policies. (1) The CAH's health care services are furnished in accordance with appropriate written policies that are consistent with applicable State law.
(2) The policies are developed with the advice of members of the CAH's professional healthcare staff, including one or more doctors of medicine or osteopathy and one or more physician assistants, nurse practitioners, or clinical nurse specialists, if they are on staff under the provisions of § 485.631(a)(1).
(3) The policies include the following:
(i) A description of the services the CAH furnishes, including those furnished through agreement or arrangement.
(ii) Policies and procedures for emergency medical services.
(iii) Guidelines for the medical management of health problems that include the conditions requiring medical consultation and/or patient referral, the maintenance of health care records, and procedures for the periodic review and evaluation of the services furnished by the CAH.
(iv) Rules for the storage, handling, dispensation, and administration of drugs and biologicals. These rules must provide that there is a drug storage area that is administered in accordance with accepted professional principles, that current and accurate records are kept of the receipt and disposition of all scheduled drugs, and that outdated, mislabeled, or otherwise unusable drugs are not available for patient use.
(v) Procedures for reporting adverse drug reactions and errors in the administration of drugs.
(vi) Procedures that ensure that the nutritional needs of inpatients are met in accordance with recognized dietary practices. All patient diets, including therapeutic diets, must be ordered by the practitioner responsible for the care of the patients or by a qualified dietitian or qualified nutrition professional as authorized by the medical staff in accordance with State law governing dietitians and nutrition professionals and that the requirement of § 483.25(i) of this chapter is met with respect to inpatients receiving post CAH SNF care.
(vii) [Reserved]
(viii) Policies and procedures that address the post-acute care needs of patients receiving CAH services.
(4) These policies are reviewed at least biennially by the group of professional personnel required under paragraph (a)(2) of this section and updated as necessary by the CAH.
(b) Standard: Patient services —(1) General: (i) The CAH provides those diagnostic and therapeutic services and supplies that are commonly furnished in a physician's office or at another entry point into the health care delivery system, such as a low intensity hospital outpatient department or emergency department. These CAH services include medical history, physical examination, specimen collection, assessment of health status, and treatment for a variety of medical conditions.
(ii) The CAH furnishes acute care inpatient services.
(2) Laboratory services. The CAH provides basic laboratory services essential to the immediate diagnosis and treatment of the patient that meet the standards imposed under section 353 of the Public Health Service Act (42 U.S.C. 263a). (See the laboratory requirements specified in part 493 of this chapter.) The services provided include the following:
(i) Chemical examination of urine by stick or tablet method or both (including urine ketones).
(ii) Hemoglobin or hematocrit.
(iii) Blood glucose.
(iv) Examination of stool specimens for occult blood.
(v) Pregnancy tests.
(vi) Primary culturing for transmittal to a certified laboratory.
(3) Radiology services. Radiology services furnished by the CAH are provided by personnel qualified under State law, and do not expose CAH patients or personnel to radiation hazards.
(4) Emergency procedures. In accordance with requirements of § 485.618, the CAH provides medical services as a first response to common life-threatening injuries and acute illness.
(c) Standard: Services provided through agreements or arrangements. (1) The CAH has agreements or arrangements (as appropriate) with one or more providers or suppliers participating under Medicare to furnish other services to its patients, including—
(i) Services of doctors of medicine or osteopathy;
(ii) Additional or specialized diagnostic and clinical laboratory services that are not available at the CAH; and
(iii) Food and other services to meet inpatients' nutritional needs to the extent these services are not provided directly by the CAH.
(2) If the agreements or arrangements are not in writing, the CAH is able to present evidence that patients referred by the CAH are being accepted and treated.
(3) The CAH maintains a list of all services furnished under arrangements or agreements. The list describes the nature and scope of the services provided.
(4) The person principally responsible for the operation of the CAH under § 485.627(b)(2) of this chapter is also responsible for the following:
(i) Services furnished in the CAH whether or not they are furnished under arrangements or agreements.
(ii) Ensuring that a contractor of services (including one for shared services and joint ventures) furnishes services that enable the CAH to comply with all applicable conditions of participation and standards for the contracted services.
(5) In the case of distant-site physicians and practitioners providing telemedicine services to the CAH's patients under a written agreement between the CAH and a distant-site telemedicine entity, the distant-site telemedicine entity is not required to be a Medicare-participating provider or supplier.
(d) Standard: Nursing services. Nursing services must meet the needs of patients.
(1) A registered nurse must provide (or assign to other personnel) the nursing care of each patient, including patients at a SNF level of care in a swing-bed CAH. The care must be provided in accordance with the patient's needs and the specialized qualifications and competence of the staff available.
(2) A registered nurse or, where permitted by State law, a physician assistant, must supervise and evaluate the nursing care for each patient, including patients at a SNF level of care in a swing-bed CAH.
(3) All drugs, biologicals, and intravenous medications must be administered by or under the supervision of a registered nurse, a doctor of medicine or osteopathy, or, where permitted by State law, a physician assistant, in accordance with written and signed orders, accepted standards of practice, and Federal and State laws.
(4) A nursing care plan must be developed and kept current for each inpatient.
(e) Standard: Rehabilitation Therapy Services. Physical therapy, occupational therapy, and speech-language pathology services furnished at the CAH, if provided, are provided by staff qualified under State law, and consistent with the requirements for therapy services in § 409.17 of this subpart.
§ 485.638   Conditions of participation: Clinical records.
(a) Standard: Records system —(1) The CAH maintains a clinical records system in accordance with written policies and procedures.
(2) The records are legible, complete, accurately documented, readily accessible, and systematically organized.
(3) A designated member of the professional staff is responsible for maintaining the records and for ensuring that they are completely and accurately documented, readily accessible, and systematically organized.
(4) For each patient receiving health care services, the CAH maintains a record that includes, as applicable—
(i) Identification and social data, evidence of properly executed informed consent forms, pertinent medical history, assessment of the health status and health care needs of the patient, and a brief summary of the episode, disposition, and instructions to the patient;
(ii) Reports of physical examinations, diagnostic and laboratory test results, including clinical laboratory services, and consultative findings;
(iii) All orders of doctors of medicine or osteopathy or other practitioners, reports of treatments and medications, nursing notes and documentation of complications, and other pertinent information necessary to monitor the patient's progress, such as temperature graphics, progress notes describing the patient's response to treatment; and
(iv) Dated signatures of the doctor of medicine or osteopathy or other health care professional.
(b) Standard: Protection of record information. (1) The CAH maintains the confidentiality of record information and provides safeguards against loss, destruction, or unauthorized use.
(2) Written policies and procedures govern the use and removal of records from the CAH and the conditions for the release of information.
(3) The patient's written consent is required for release of information not required by law.
(c) Standard: Retention of records. The records are retained for at least 6 years from date of last entry, and longer if required by State statute, or if the records may be needed in any pending proceeding.
(d) Standard: Electronic notifications. If the CAH utilizes an electronic medical records system or other electronic administrative system, which is conformant with the content exchange standard at 45 CFR 170.205(d)(2), then the CAH must demonstrate that—
(1) The system's notification capacity is fully operational and the CAH uses it in accordance with all State and Federal statutes and regulations applicable to the CAH's exchange of patient health information.
(2) The system sends notifications that must include at least patient name, treating practitioner name, and sending institution name.
(3) To the extent permissible under applicable federal and state law and regulations, and not inconsistent with the patient's expressed privacy preferences, the system sends notifications directly, or through an intermediary that facilitates exchange of health information, at the time of:
(i) The patient's registration in the CAH's emergency department (if applicable).
(ii) The patient's admission to the CAH's inpatient services (if applicable).
(4) To the extent permissible under applicable federal and state law and regulations, and not inconsistent with the patient's expressed privacy preferences, the system sends notifications directly, or through an intermediary that facilitates exchange of health information, either immediately prior to, or at the time of:
(i) The patient's discharge or transfer from the CAH's emergency department (if applicable).
(ii) The patient's discharge or transfer from the CAH's inpatient services (if applicable).
(5) The CAH has made a reasonable effort to ensure that the system sends the notifications to all applicable post-acute care services providers and suppliers, as well as to any of the following practitioners and entities, which need to receive notification of the patient's status for treatment, care coordination, or quality improvement purposes:
(i) The patient's established primary care practitioner;
(ii) The patient's established primary care practice group or entity; or
(iii) Other practitioner, or other practice group or entity, identified by the patient as the practitioner, or practice group or entity, primarily responsible for his or her care.
§ 485.639   Condition of participation: Surgical services.
If a CAH provides surgical services, surgical procedures must be performed in a safe manner by qualified practitioners who have been granted clinical privileges by the governing body, or responsible individual, of the CAH in accordance with the designation requirements under paragraph (a) of this section.
(a) Designation of qualified practitioners. The CAH designates the practitioners who are allowed to perform surgery for CAH patients, in accordance with its approved policies and procedures, and with State scope of practice laws. Surgery is performed only by—
(1) A doctor of medicine or osteopathy, including an osteopathic practitioner recognized under section 1101(a)(7) of the Act;
(2) A doctor of dental surgery or dental medicine; or
(3) A doctor of podiatric medicine.
(b) Anesthetic risk and evaluation. (1) A qualified practitioner, as specified in paragraph (a) of this section, must examine the patient immediately before surgery to evaluate the risk of the procedure to be performed.
(2) A qualified practitioner, as specified in paragraph (c) of this section, must examine each patient before surgery to evaluate the risk of anesthesia.
(3) Before discharge from the CAH, each patient must be evaluated for proper anesthesia recovery by a qualified practitioner, as specified in paragraph (c) of this section.
(c) Administration of anesthesia. The CAH designates the person who is allowed to administer anesthesia to CAH patients in accordance with its approved policies and procedures and with State scope-of-practice laws.
(1) Anesthesia must be administered by only—
(i) A qualified anesthesiologist;
(ii) A doctor of medicine or osteopathy other than an anesthesiologist; including an osteopathic practitioner recognized under section 1101(a)(7) of the Act;
(iii) A doctor of dental surgery or dental medicine;
(iv) A doctor of podiatric medicine;
(v) A certified registered nurse anesthetist (CRNA), as defined in § 410.69(b) of this chapter;
(vi) An anesthesiologist's assistant, as defined in § 410.69(b) of this chapter; or
(vii) A supervised trainee in an approved educational program, as described in § 413.85 or §§ 413.76 through 413.83 of this chapter.
(2) In those cases in which a CRNA administers the anesthesia, the anesthetist must be under the supervision of the operating practitioner except as provided in paragraph (e) of this section. An anesthesiologist's assistant who administers anesthesia must be under the supervision of an anesthesiologist.
(d) Discharge. All patients are discharged in the company of a responsible adult, except those exempted by the practitioner who performed the surgical procedure.
(e) Standard: State exemption. (1) A CAH may be exempted from the requirement for physician supervision of CRNAs as described in paragraph (c)(2) of this section, if the State in which the CAH is located submits a letter to CMS signed by the Governor, following consultation with the State's Boards of Medicine and Nursing, requesting exemption from physician supervision for CRNAs. The letter from the Governor must attest that he or she has consulted with the State Boards of Medicine and Nursing about issues related to access to and the quality of anesthesia services in the State and has concluded that it is in the best interests of the State's citizens to opt-out of the current physician supervision requirement, and that the opt-out is consistent with State law.
(2) The request for exemption and recognition of State laws and the withdrawal of the request may be submitted at any time, and are effective upon submission.
§ 485.640   Condition of participation: Infection prevention and control and antibiotic stewardship programs.
The CAH must have active facility-wide programs, for the surveillance, prevention, and control of HAIs and other infectious diseases and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic-resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in coordination with the facility-wide quality assessment and performance improvement (QAPI) program.
(a) Standard: Infection prevention and control program organization and policies. The CAH must demonstrate that:
(1) An individual (or individuals), who is qualified through education, training, experience, or certification in infection prevention and control, is appointed by the governing body, or responsible individual, as the infection preventionist(s)/infection control professional(s) responsible for the infection prevention and control program and that the appointment is based on the recommendations of medical staff leadership and nursing leadership;
(2) The infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the CAH and between the CAH and other healthcare settings;
(3) The infection prevention and control includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and that the program also addresses any infection control issues identified by public health authorities; and
(4) The infection prevention and control program reflects the scope and complexity of the CAH services provided.
(b) Standard: Antibiotic stewardship program organization and policies. The CAH must demonstrate that:
(1) An individual (or individuals), who is qualified through education, training, or experience in infectious diseases and/or antibiotic stewardship, is appointed by the governing body, or responsible individual, as the leader(s) of the antibiotic stewardship program and that the appointment is based on the recommendations of medical staff leadership and pharmacy leadership;
(2) The facility-wide antibiotic stewardship program:
(i) Demonstrates coordination among all components of the CAH responsible for antibiotic use and resistance, including, but not limited to, the infection prevention and control program, the QAPI program, the medical staff, nursing services, and pharmacy services;
(ii) Documents the evidence-based use of antibiotics in all departments and services of the CAH; and
(iii) Documents any improvements, including sustained improvements, in proper antibiotic use;
(3) The antibiotic stewardship program adheres to nationally recognized guidelines, as well as best practices, for improving antibiotic use; and
(4) The antibiotic stewardship program reflects the scope and complexity of the CAH services provided.
(c) Standard: Leadership responsibilities. (1) The governing body, or responsible individual, must ensure all of the following:
(i) Systems are in place and operational for the tracking of all infection surveillance, prevention and control, and antibiotic use activities, in order to demonstrate the implementation, success, and sustainability of such activities.
(ii) All HAIs and other infectious diseases identified by the infection prevention and control program as well as antibiotic use issues identified by the antibiotic stewardship program are addressed in collaboration with the CAH's QAPI leadership.
(2) The infection prevention and control professional(s) is responsible for:
(i) The development and implementation of facility-wide infection surveillance, prevention, and control policies and procedures that adhere to nationally recognized guidelines.
(ii) All documentation, written or electronic, of the infection prevention and control program and its surveillance, prevention, and control activities.
(iii) Communication and collaboration with the CAH's QAPI program on infection prevention and control issues.
(iv) Competency-based training and education of CAH personnel and staff, including medical staff, and, as applicable, personnel providing contracted services in the CAH, on the practical applications of infection prevention and control guidelines, policies and procedures.
(v) The prevention and control of HAIs, including auditing of adherence to infection prevention and control policies and procedures by CAH personnel.
(vi) Communication and collaboration with the antibiotic stewardship program.
(3) The leader(s) of the antibiotic stewardship program is responsible for:
(i) The development and implementation of a facility-wide antibiotic stewardship program, based on nationally recognized guidelines, to monitor and improve the use of antibiotics.
(ii) All documentation, written or electronic, of antibiotic stewardship program activities.
(iii) Communication and collaboration with medical staff, nursing, and pharmacy leadership, as well as the CAH's infection prevention and control and QAPI programs, on antibiotic use issues.
(iv) Competency-based training and education of CAH personnel and staff, including medical staff, and, as applicable, personnel providing contracted services in the CAHs, on the practical applications of antibiotic stewardship guidelines, policies, and procedures.
(d) Respiratory illness reporting —(1) Ongoing reporting. The CAH must electronically report information on acute respiratory illnesses, including influenza, SARS-CoV-2/COVID-19, and RSV.
(i) The report must be in a standardized format and frequency specified by the Secretary.
(ii) To the extent as required by the Secretary, the report must include the following data elements:
(A) Confirmed infections for a limited set of respiratory illnesses, including but not limited to influenza, SARS-CoV-2/COVID-19, and RSV, among newly admitted and hospitalized patients.
(B) Total bed census and capacity, including for critical hospital units and age groups.
(C) Limited patient demographic information, including but not limited to age.
(2) Public health emergency (PHE) reporting. In the event that the Secretary has declared a national, State, or local PHE for an acute infectious illness, the CAH must also electronically report the following data elements in a standardized format and frequency specified by the Secretary:
(i) Supply inventory shortages.
(ii) Staffing shortages.
(iii) Relevant medical countermeasures and therapeutic inventories, usage, or both.
(iv) Facility structure and operating status, including CAH/ED diversion status.
(e)-(f) [Reserved]
(g) Standard: Unified and integrated infection prevention and control and antibiotic stewardship programs for a CAH in a multi-facility system. If a CAH is part of a system consisting of multiple separately certified hospitals, CAHs, and/or REHs using a system governing body that is legally responsible for the conduct of two or more hospitals, CAHs, and/or REHs, the system governing body can elect to have unified and integrated infection prevention and control and antibiotic stewardship programs for all of its member facilities after determining that such a decision is in accordance with all applicable state and local laws. The system governing body is responsible and accountable for ensuring that each of its separately certified CAHs meets all of the requirements of this section. Each separately certified CAH subject to the system governing body must demonstrate that:
(1) The unified and integrated infection prevention and control and antibiotic stewardship programs are established in a manner that takes into account each member CAH's unique circumstances and any significant differences in patient populations and services offered in each CAH;
(2) The unified and integrated infection prevention and control and antibiotic stewardship programs establish and implement policies and procedures to ensure that the needs and concerns of each of its separately certified CAHs, regardless of practice or location, are given due consideration;
(3) The unified and integrated infection prevention and control and antibiotic stewardship programs have mechanisms in place to ensure that issues localized to particular CAHs are duly considered and addressed; and
(4) A qualified individual (or individuals) with expertise in infection prevention and control and in antibiotic stewardship has been designated at the CAH as responsible for communicating with the unified infection prevention and control and antibiotic stewardship programs, for implementing and maintaining the policies and procedures governing infection prevention and control and antibiotic stewardship as directed by the unified infection prevention and control and antibiotic stewardship programs, and for providing education and training on the practical applications of infection prevention and control and antibiotic stewardship to CAH staff.
§ 485.641   Condition of participation: Quality assessment and performance improvement program.
The CAH must develop, implement, and maintain an effective, ongoing, CAH-wide, data-driven quality assessment and performance improvement (QAPI) program. The CAH must maintain and demonstrate evidence of the effectiveness of its QAPI program.
(a) Definitions. For the purposes of this section—
Adverse event means an untoward, undesirable, and usually unanticipated event that causes death or serious injury or the risk thereof.
Error means the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. Errors can include problems in practice, products, procedures, and systems; and
Medical error means an error that occurs in the delivery of healthcare services.
(b) Standard: QAPI Program Design and scope. The CAH's QAPI program must:
(1) Be appropriate for the complexity of the CAH's organization and services provided.
(2) Be ongoing and comprehensive.
(3) Involve all departments of the CAH and services (including those services furnished under contract or arrangement).
(4) Use objective measures to evaluate its organizational processes, functions and services.
(5) Address outcome indicators related to improved health outcomes and the prevention and reduction of medical errors, adverse events, CAH-acquired conditions, and transitions of care, including readmissions.
(c) Standard: Governance and leadership. The CAH's governing body or responsible individual is ultimately responsible for the CAH's QAPI program and is responsible and accountable for ensuring that the QAPI program meets the requirements of paragraph (b) of this section.
(d) Standard: Program activities. For each of the areas listed in paragraph (b) of this section, the CAH must:
(1) Focus on measures related to improved health outcomes that are shown to be predictive of desired patient outcomes.
(2) Use the measures to analyze and track its performance.
(3) Set priorities for performance improvement, considering either high-volume, high-risk services, or problem-prone areas.
(4) Effective January 1, 2027, for CAHs that offer obstetrical services, the following additional QAPI requirements apply:
(i) Obstetrical services leadership must engage in QAPI as specified in this section for obstetrical services, including but not limited to participating in data collection and monitoring as specified in this paragraph (d) and paragraph (e) of this section.
(ii) If a maternal mortality review committee (MMRC) is available at the State, Tribal, or local jurisdiction in which the CAH is located, the facility leadership, obstetrical services leadership, or their designate(s) must further have a process for incorporating publicly available MMRC(s) data and recommendations into the CAH QAPI program as specified in this section.
(e) Standard: Program data collection and analysis. (1) The program must incorporate quality indicator data including patient care data, in order to achieve the goals of the QAPI program.
(2) Effective January 1, 2027, CAHs that offer obstetrical services, the CAH must utilize its QAPI program to assess and improve health outcomes and disparities among obstetrical patients on an ongoing basis. At a minimum, the CAH must:
(i) Analyze data and quality indicators collected for the QAPI program by diverse subpopulations as identified by the CAH among obstetrical patients.
(ii) Measure, analyze, and track health equity data, measures, and quality indicators on patient outcomes and disparities in processes of care, services and operations, and outcomes among obstetrical patients.
(iii) Analyze and prioritize identified patient health outcomes and disparities, develop and implement actions to improve patient health outcomes and disparities, measure results, and track performance to ensure improvements are sustained when disparities exist among obstetrical patients.
(iv) Conduct at least one measurable performance improvement project focused on improving health outcomes and disparities among the CAH's population(s) of obstetrical patients annually.
(f) Standard: Unified and integrated QAPI program for a CAH in a multi-facility system. If a CAH is part of a system consisting of multiple separately certified hospitals, CAHs, and/or REHs using a system governing body that is legally responsible for the conduct of two or more hospitals, CAHs, and/or REHs, the system governing body can elect to have a unified and integrated QAPI program for all of its member facilities after determining that such a decision is in accordance with all applicable state and local laws. The system governing body is responsible and accountable for ensuring that each of its separately certified CAHs meets all of the requirements of this section. Each separately certified CAH subject to the system governing body must demonstrate that:
(1) The unified and integrated QAPI program is established in a manner that takes into account each member CAH's unique circumstances and any significant differences in patient populations and services offered in each CAH; and
(2) The unified and integrated QAPI program establishes and implements policies and procedures to ensure that the needs and concerns of each of its separately certified CAHs, regardless of practice or location, are given due consideration, and that the unified and integrated QAPI program has mechanisms in place to ensure that issues localized to particular CAHs are duly considered and addressed.
§ 485.642   Condition of participation: Discharge planning.
A Critical Access Hospital (CAH) must have an effective discharge planning process that focuses on the patient's goals and treatment preferences and includes the patient and his or her caregivers/support person(s) as active partners in the discharge planning for post-discharge care. The discharge planning process and the discharge plan must be consistent with the patient's goals for care and his or her treatment preferences, ensure an effective transition of the patient from the CAH to post-discharge care, and reduce the factors leading to preventable CAH and hospital readmissions.
(a) Standard: Discharge planning process. The CAH's discharge planning process must identify, at an early stage of hospitalization, those patients who are likely to suffer adverse health consequences upon discharge in the absence of adequate discharge planning and must provide a discharge planning evaluation for those patients so identified as well as for other patients upon the request of the patient, patient's representative, or patient's physician.
(1) Any discharge planning evaluation must be made on a timely basis to ensure that appropriate arrangements for post-CAH care will be made before discharge and to avoid unnecessary delays in discharge.
(2) A discharge planning evaluation must include an evaluation of a patient's likely need for appropriate post-CAH services, including, but not limited to, hospice care services, post-CAH extended care services, home health services, and non-health care services and community based care providers, and must also include a determination of the availability of the appropriate services as well as of the patient's access to those services.
(3) The discharge planning evaluation must be included in the patient's medical record for use in establishing an appropriate discharge plan and the results of the evaluation must be discussed with the patient (or the patient's representative).
(4) Upon the request of a patient's physician, the CAH must arrange for the development and initial implementation of a discharge plan for the patient.
(5) Any discharge planning evaluation or discharge plan required under this paragraph must be developed by, or under the supervision of, a registered nurse, social worker, or other appropriately qualified personnel.
(6) The CAH's discharge planning process must require regular re-evaluation of the patient's condition to identify changes that require modification of the discharge plan. The discharge plan must be updated, as needed, to reflect these changes.
(7) The CAH must assess its discharge planning process on a regular basis. The assessment must include ongoing, periodic review of a representative sample of discharge plans, including those patients who were readmitted within 30 days of a previous admission, to ensure that the plans are responsive to patient post-discharge needs.
(8) The CAH must assist patients, their families, or the patient's representative in selecting a post-acute care provider by using and sharing data that includes, but is not limited to, HHA, SNF, IRF, or LTCH data on quality measures and data on resource use measures. The CAH must ensure that the post-acute care data on quality measures and data on resource use measures is relevant and applicable to the patient's goals of care and treatment preferences.
(b) Standard: Discharge of the patient and provision and transmission of the patient's necessary medical information. The CAH must discharge the patient, and also transfer or refer the patient where applicable, along with all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, at the time of discharge, to the appropriate post-acute care service providers and suppliers, facilities, agencies, and other outpatient service providers and practitioners responsible for the patient's follow-up or ancillary care.
§ 485.643   Condition of participation: Organ, tissue, and eye procurement.
The CAH must have and implement written protocols that:
(a) Incorporate an agreement with an OPO designated under part 486 of this chapter, under which it must notify, in a timely manner, the OPO or a third party designated by the OPO of individuals whose death is imminent or who have died in the CAH. The OPO determines medical suitability for organ donation and, in the absence of alternative arrangements by the CAH, the OPO determines medical suitability for tissue and eye donation, using the definition of potential tissue and eye donor and the notification protocol developed in consultation with the tissue and eye banks identified by the CAH for this purpose;
(b) Incorporate an agreement with at least one tissue bank and at least one eye bank to cooperate in the retrieval, processing, preservation, storage and distribution of tissues and eyes, as may be appropriate to assure that all usable tissues and eyes are obtained from potential donors, insofar as such an agreement does not interfere with organ procurement;
(c) Ensure, in collaboration with the designated OPO, that the family of each potential donor is informed of its option to either donate or not donate organs, tissues, or eyes. The individual designated by the CAH to initiate the request to the family must be a designated requestor. A designated requestor is an individual who has completed a course offered or approved by the OPO and designed in conjunction with the tissue and eye bank community in the methodology for approaching potential donor families and requesting organ or tissue donation;
(d) Encourage discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential donors;
(e) Ensure that the CAH works cooperatively with the designated OPO, tissue bank and eye bank in educating staff on donation issues, reviewing death records to improve identification of potential donors, and maintaining potential donors while necessary testing and placement of potential donated organs, tissues, and eyes take place.
(f) For purposes of these standards, the term “organ” means a human kidney, liver, heart, lung, pancreas, or intestines (or multivisceral organs).
§ 485.645   Special requirements for CAH providers of long-term care services (“swing-beds”)
A CAH must meet the following requirements in order to be granted an approval from CMS to provide post-CAH SNF care, as specified in § 409.30 of this chapter, and to be paid for SNF-level services, in accordance with paragraph (c) of this section.
(a) Eligibility. A CAH must meet the following eligibility requirements:
(1) The facility has been certified as a CAH by CMS under § 485.606(b) of this subpart; and
(2) The facility provides not more than 25 inpatient beds. Any bed of a unit of the facility that is licensed as a distinct-part SNF at the time the facility applies to the State for designation as a CAH is not counted under paragraph (a) of this section.
(b) Facilities participating as rural primary care hospitals (RPCHs) on September 30, 1997. These facilities must meet the following requirements:
(1) Notwithstanding paragraph (a) of this section, a CAH that participated in Medicare as a RPCH on September 30, 1997, and on that date had in effect an approval from CMS to use its inpatient facilities to provide post-hospital SNF care may continue in that status under the same terms, conditions and limitations that were applicable at the time those approvals were granted.
(2) A CAH that was granted swing-bed approval under paragraph (b)(1) of this section may request that its application to be a CAH and swing-bed provider be reevaluated under paragraph (a) of this section. If this request is approved, the approval is effective not earlier than October 1, 1997. As of the date of approval, the CAH no longer has any status under paragraph (b)(1) of this section and may not request reinstatement under paragraph (b)(1) of this section.
(c) Payment. Payment for inpatient RPCH services to a CAH that has qualified as a CAH under the provisions in paragraph (a) of this section is made in accordance with § 413.70 of this chapter. Payment for post-hospital SNF-level of care services is made in accordance with the payment provisions in § 413.114 of this chapter.
(d) SNF services. The CAH is substantially in compliance with the following SNF requirements contained in subpart B of part 483 of this chapter:
(1) Resident rights (§ 483.10(b)(7), (c)(1), (c)(2)(iii), (c)(6), (d), (e)(2) and (4), (f)(4)(ii) and (iii), (g)(8) and (17), (g)(18) introductory text, and (h) of this chapter).
(2) Admission, transfer, and discharge rights (§ 483.5 definition of transfer & discharge, § 483.15(c)(1), (c)(2), (c)(3), (c)(4), (c)(5), (c)(7), (c)(8), and (c)(9) of this chapter).
(3) Freedom from abuse, neglect and exploitation (§ 483.12(a)(1), (a)(2), (a)(3)(i), (a)(3)(ii), (a)(4), (b)(1), (b)(2), (c)(1), (c)(2), (c)(3), and (c)(4) of this chapter).
(4) Social services (§ 483.40(d) of this chapter).
(5) Comprehensive assessment, comprehensive care plan, and discharge planning (§ 483.20(b), and § 483.21(b) and (c)(2) of this chapter), except that the CAH is not required to use the resident assessment instrument (RAI) specified by the State that is required under § 483.20(b), or to comply with the requirements for frequency, scope, and number of assessments prescribed in § 413.343(b) of this chapter).
(6) Specialized rehabilitative services (§ 483.65 of this chapter).
(7) Dental services (§ 483.55(a)(2), (3), (4), and (5) and (b) of this chapter).
(8) Nutrition (§ 483.25(g)(1) and (g)(2) of this chapter).
§ 485.647   Condition of participation: psychiatric and rehabilitation distinct part units.
(a) Conditions. (1) If a CAH provides inpatient psychiatric services in a distinct part unit, the services furnished by the distinct part unit must comply with the hospital requirements specified in subparts A, B, C, and D of part 482 of this subchapter, the common requirements of § 412.25(a)(2) through (f) of part 412 of this chapter for hospital units excluded from the prospective payment systems, and the additional requirements of § 412.27 of part 412 of this chapter for excluded psychiatric units.
(2) If a CAH provides inpatient rehabilitation services in a distinct part unit, the services furnished by the distinct part unit must comply with the hospital requirements specified in subparts A, B, C, and D of part 482 of this subchapter, the common requirements of § 412.25(a)(2) through (f) of part 412 of this chapter for hospital units excluded from the prospective payments systems, and the additional requirements of §§ 412.29 and § 412.30 of part 412 of this chapter related specifically to rehabilitation units.
(b) Eligibility requirements. (1) To be eligible to receive Medicare payments for psychiatric or rehabilitation services as a distinct part unit, the facility provides no more than 10 beds in the distinct part unit.
(2) The beds in the distinct part are excluded from the 25 inpatient-bed count limit specified in § 485.620(a).
(3) The average annual 96-hour length of stay requirement specified under § 485.620(b) does not apply to the 10 beds in the distinct part units specified in paragraph (b)(1) of this section, and admissions and days of inpatient care in the distinct part units are not taken into account in determining the CAH's compliance with the limits on the number of beds and length of stay in § 485.620.
§ 485.649   Condition of participation: Obstetrical services.
If the CAH offers obstetrical services, the services must be well organized and provided in accordance with nationally recognized acceptable standards of practice for the health care (including physical and behavioral health) of pregnant, birthing, postpartum patients. If outpatient obstetrical services are offered, the services must be consistent in quality with inpatient care in accordance with the complexity of services offered.
(a) Standard: Organization and staffing. Effective January 1, 2026, the organization of the obstetrical services must be appropriate to the scope of the services offered. As applicable, the services must be integrated with other departments of the CAH.
(1) Labor and delivery rooms/suites (including labor rooms, delivery rooms (including rooms for operative delivery), and post-partum/recovery rooms whether combined or separate) must be supervised by an experienced registered nurse, certified nurse midwife, nurse practitioner, physician assistant, or a Doctor of Medicine or a Doctor of Osteopathy (MD/DO).
(2) Obstetrical privileges must be delineated for all practitioners providing obstetrical care in accordance with the competencies of each practitioner, and consistent with credentialing agreements established under § 485.616(b).
(b) Standard: Delivery of service. Effective January 1, 2026, obstetrical services must be consistent with needs and resources of the CAH. Policies governing obstetrical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care and safety.
(1) The following equipment must be kept at the CAH and be readily available for treating obstetrical cases to meet the needs of patients in accordance with the scope, volume, and complexity of services offered: call-in-system, cardiac monitor, and fetal doppler or monitor.
(2) There must be adequate provisions and protocols, consistent with nationally recognized and evidence-based guidelines, for obstetrical emergencies, complications, immediate post-delivery care, and other patient health and safety events as identified as part of the QAPI program (§ 485.641). Provisions include equipment (in addition to the equipment required under paragraph (b)(1) of this section), supplies, and medication used in treating emergency cases. Such provisions must be kept in the CAH and be readily available for treating emergency cases.
(c) Standard: Staff training. Effective January 1, 2027, the CAH must develop policies and procedures to ensure that relevant staff are trained on select topics for improving the delivery of maternal care.
(1) Training concepts must reflect the scope and complexity of services offered within the facility, including but not limited to:
(i) Facility-identified evidence-based best practices and protocols to improve the delivery of maternal care within the facility; and
(ii) The CAH must use findings from its quality assessment and performance improvement (QAPI) program, as required at § 485.641, to inform staff training needs and any additions, revisions, or updates to training topics on an ongoing basis.
(2) The CAH must provide relevant new staff with initial training.
(3) The governing body must identify and document which staff must complete initial training and subsequent biennial training on the topics identified at paragraph (c)(1) of this section.
(4) The CAH must document in the staff personnel records that the training was successfully completed.
(5) The CAH must be able to demonstrate staff knowledge on the topics identified at paragraph (c)(1) of this section.
§ 485.701   Basis and scope.
This subpart implements section 1861(p)(4) of the Act, which—
(a) Defines outpatient physical therapy and speech pathology services;
(b) Imposes requirements with respect to adequate program, facilities, policies, staffing, and clinical records; and
(c) Authorizes the Secretary to establish by regulation other health and safety requirements.
§ 485.703   Definitions.
Clinic. A facility that is established primarily to furnish outpatient physician services and that meets the following tests of physician involvement:
(1) The medical services are furnished by a group of three or more physicians practicing medicine together.
(2) A physician is present during all hours of operation of the clinic to furnish medical services, as distinguished from purely administrative services.
Extension location. A location or site from which a rehabilitation agency provides services within a portion of the total geographic area served by the primary site. The extension location is part of the rehabilitation agency. The extension location should be located sufficiently close to share administration, supervision, and services in a manner that renders it unnecessary for the extension location to independently meet the conditions of participation as a rehabilitation agency.
Organization. A clinic, rehabilitation agency, or public health agency.
Public health agency. An official agency established by a State or local government, the primary function of which is to maintain the health of the population served by performing environmental health services, preventive medical services, and in certain cases, therapeutic services.
Rehabilitation agency. An agency that—
(1) Provides an integrated interdisciplinary rehabilitation program designed to upgrade the physical functioning of handicapped disabled individuals by bringing specialized rehabilitation staff together to perform as a team; and
(2) Provides at least physical therapy or speech-language pathology services.
Supervision. Authoritative procedural guidance that is for the accomplishment of a function or activity and that—
(1) Includes initial direction and periodic observation of the actual performance of the function or activity; and
(2) Is furnished by a qualified person—
(i) Whose sphere of competence encompasses the particular function or activity; and
(ii) Who (unless otherwise provided in this subpart) is on the premises if the person performing the function or activity does not meet the assistant-level practitioner qualifications specified in § 485.705.
§ 485.705   Personnel qualifications.
(a) General qualification requirements. Except as specified in paragraphs (b) and (c) of this section, all personnel who are involved in the furnishing of outpatient physical therapy, occupational therapy, and speech-language pathology services directly by or under arrangements with an organization must be legally authorized (licensed or, if applicable, certified or registered) to practice by the State in which they perform the functions or actions, and must act only within the scope of their State license or State certification or registration.
(b) Exception for Federally defined qualifications. The following Federally defined qualifications must be met:
(1) For a physician, the qualifications and conditions as defined in section 1861(r) of the Act and the requirements in part 484 of this chapter.
(2) For a speech-language pathologist, the qualifications specified in section 1861(11)(1) of the Act and the requirements in part 484 of this chapter.
(c) Exceptions when no State Licensing laws or State certification or registration requirements exist. If no State licensing laws or State certification or registration requirements exist for the profession, the following requirements must be met—
(1) An administrator is a person who has a bachelor's degree and:
(i) Has experience or specialized training in the administration of health institutions or agencies; or
(ii) Is qualified and has experience in one of the professional health disciplines.
(2) An occupational therapist must meet the requirements in part 484 of this chapter.
(3) An occupational therapy assistant must meet the requirements in part 484 of this chapter.
(4) A physical therapist must meet the requirements in part 484 of this chapter.
(5) A physical therapist assistant must meet the requirements in part 484 of this chapter.
(6) A social worker must meet the requirements in part 484 of this chapter.
(7) A vocational specialist is a person who has a baccalaureate degree and—
(i) Two years experience in vocational counseling in a rehabilitation setting such as a sheltered workshop, State employment service agency, etc.; or
(ii) At least 18 semester hours in vocational rehabilitation, educational or vocational guidance, psychology, social work, special education or personnel administration, and 1 year of experience in vocational counseling in a rehabilitation setting; or
(iii) A master's degree in vocational counseling.
(8) A nurse practitioner is a person who must:
(i) Be a registered professional nurse who is authorized by the State in which the services are furnished to practice as a nurse practitioner in accordance with State law; and
(ii) Be certified as a nurse practitioner by a recognized national certifying body that has established standards for nurse practitioners; or
(iii) Be a registered professional nurse who is authorized by the State in which the services are furnished to practice as a nurse practitioner in accordance with State law and have been granted a Medicare billing number as a nurse practitioner by December 31, 2000; or
(iv) Be a nurse practitioner who on or after January 1, 2001, applies for a Medicare billing number for the first time and meets the standards for nurse practitioners in paragraphs (c)(8)(i) and (c)(8)(ii) of this section; or
(v) Be a nurse practitioner who on or after January 1, 2003, applies for a Medicare billing number for the first time and possesses a master's degree in nursing and meets the standards for nurse practitioners in paragraphs (b)(1)(i) and (b)(1)(ii) of this section.
(9) A clinical nurse specialist is a person who must:
(i) Be a registered nurse who is currently licensed to practice in the State where he or she practices and be authorized to perform the services of a clinical nurse specialist in accordance with State law;
(ii) Have a master's degree in a defined clinical area of nursing from an accredited educational institution; and,
(iii) Be certified as a clinical nurse specialist by the American Nurses Credentialing Center.
(10) A physician assistant is a person who:
(i) Has graduated from a physician assistant educational program that is accredited by the Commission on Accreditation of Allied Health Education Programs; or
(ii) Has passed the national certification examination that is administered by the National Commission on Certification of Physician Assistants; and
(iii) Is licensed by the State to practice as a physician assistant.
§ 485.707   Condition of participation: Compliance with Federal, State, and local laws.
The organization and its staff are in compliance with all applicable Federal, State, and local laws and regulations.
(a) Standard: Licensure of organization. In any State in which State or applicable local law provides for the licensing of organizations, a clinic, rehabilitation agency, or public health agency is licensed in accordance with applicable laws.
(b) Standard: Licensure or registration of personnel. Staff of the organization are licensed or registered in accordance with applicable laws.
§ 485.709   Condition of participation: Administrative management.
The clinic or rehabilitation agency has an effective governing body that is legally responsible for the conduct of the clinic or rehabilitation agency. The governing body designates an administrator, and establishes administrative policies.
(a) Standard: Governing body. There is a governing body (or designated person(s) so functioning) which assumes full legal responsibility for the overall conduct of the clinic or rehabilitation agency and for compliance with applicable laws and regulations. The name of the owner(s) of the clinic or rehabilitation agency is fully disclosed to the State agency. In the case of corporations, the names of the corporate officers are made known.
(b) Standard: Administrator. The governing body—
(1) Appoints a qualified full-time administrator;
(2) Delegates to the administrator the internal operation of the clinic or rehabilitation agency in accordance with written policies;
(3) Defines clearly the administrator's responsibilities for procurement and direction of personnel; and
(4) Designates a competent individual to act during temporary absence of the administrator.
(c) Standard: Personnel policies. Personnel practices are supported by appropriate written personnel policies that are kept current. Personnel records include the qualifications of all professional and assistant level personnel, as well as evidence of State licensure if applicable.
(d) Standard: Patient care policies. Patient care practices and procedures are supported by written policies established by a group of professional personnel including one or more physicians associated with the clinic or rehabilitation agency, one or more qualified physical therapists (if physical therapy services are provided), and one or more qualified speech pathologists (if speech pathology services are provided). The policies govern the outpatient physical therapy and/or speech pathology services and related services that are provided. These policies are evaluated at least annually by the group of professional personnel, and revised as necessary based upon this evaluation.
§ 485.711   Condition of participation: Plan of care and physician involvement.
For each patient in need of outpatient physical therapy or speech pathology services, there is a written plan of care established and periodically reviewed by a physician, or by a physical therapist or speech pathologist respectively.
(a) Standard: Medical history and prior treatment. The following are obtained by the organization before or at the time of initiation of treatment:
(1) The patient's significant past history.
(2) Current medical findings, if any.
(3) Diagnosis(es), if established.
(4) Physician's orders, if any.
(5) Rehabilitation goals, if determined.
(6) Contraindications, if any.
(7) The extent to which the patient is aware of the diagnosis(es) and prognosis.
(8) If appropriate, the summary of treatment furnished and results achieved during previous periods of rehabilitation services or institutionalization.
(b) Standard: Plan of care. (1) For each patient there is a written plan of care established by the physician or by the physical therapist or speech-language pathologist who furnishes the services.
(2) The plan of care for physical therapy or speech pathology services indicates anticipated goals and specifies for those services the—
(i) Type;
(ii) Amount;
(iii) Frequency; and
(iv) Duration.
(3) The plan of care and results of treatment are reviewed by the physician or by the individual who established the plan at least as often as the patient's condition requires, and the indicated action is taken.
(4) Changes in the plan of care are noted in the clinical record. If the patient has an attending physician, the therapist or speech-language pathologist who furnishes the services promptly notifies him or her of any change in the patient's condition or in the plan of care.
(c) Standard: Emergency care. The rehabilitation agency must establish procedures to be followed by personnel in an emergency, which cover immediate care of the patient, persons to be notified, and reports to be prepared.
§ 485.713   Condition of participation: Physical therapy services.
If the organization offers physical therapy services, it provides an adequate program of physical therapy and has an adequate number of qualified personnel and the equipment necessary to carry out its program and to fulfill its objectives.
(a) Standard: Adequate program. (1) The organization is considered to have an adequate outpatient physical therapy program if it can:
(i) Provide services using therapeutic exercise and the modalities of heat, cold, water, and electricity;
(ii) Conduct patient evaluations; and
(iii) Administer tests and measurements of strength, balance, endurance, range of motion, and activities of daily living.
(2) A qualified physical therapist is present or readily available to offer supervision when a physical therapist assistant furnishes services.
(i) If a qualified physical therapist is not on the premises during all hours of operation, patients are scheduled so as to ensure that the therapist is present when special skills are needed, for example, for evaluation and reevaluation.
(ii) When a physical therapist assistant furnishes services off the organization's premises, those services are supervised by a qualified physical therapist who makes an onsite supervisory visit at least once every 30 days.
(b) Standard: Facilities and equipment. The organization has the equipment and facilities required to provide the range of services necessary in the treatment of the types of disabilities it accepts for service.
(c) Standard: Personnel qualified to provide physical therapy services. Physical therapy services are provided by, or under the supervision of, a qualified physical therapist. The number of qualified physical therapists and qualified physical therapist assistants is adequate for the volume and diversity of physical therapy services offered. A qualified physical therapist is on the premises or readily available during the operating hours of the organization.
(d) Standard: Supportive personnel. If personnel are available to assist qualified physical therapists by performing services incident to physical therapy that do not require professional knowledge and skill, these personnel are instructed in appropriate patient care services by qualified physical therapists who retain responsibility for the treatment prescribed by the attending physician.
§ 485.715   Condition of participation: Speech pathology services.
If speech pathology services are offered, the organization provides an adequate program of speech pathology and has an adequate number of qualified personnel and the equipment necessary to carry out its program and to fulfill its objectives.
(a) Standard: Adequate program. The organization is considered to have an adequate outpatient speech pathology program if it can provide the diagnostic and treatment services to effectively treat speech disorders.
(b) Standard: Facilities and equipment. The organization has the equipment and facilities required to provide the range of services necessary in the treatment of the types of speech disorders it accepts for service.
(c) Standard: Personnel qualified to provide speech pathology services. Speech pathology services are given or supervised by a qualified speech pathologist and the number of qualified speech pathologists is adequate for the volume and diversity of speech pathology services offered. At least one qualified speech pathologist is present at all times when speech pathology services are furnished.
§ 485.717   Condition of participation: Rehabilitation program.
This condition and standards apply only to a rehabilitation agency's own patients, not to patients of hospitals, skilled nursing facilities (SNFs), or Medicaid nursing facilities (NFs) to which the agency furnishes services. The hospital, SNF, or NF is responsible for ensuring that qualified staff furnish services for which they arrange or contract for their patients. The rehabilitation agency provides physical therapy and speech-language pathology services to all of its patients who need them.
(a) Standard: Qualification of staff. The agency's therapy services are furnished by qualified individuals as direct services and/or services provided under contract.
(b) Standard: Arrangements for services. If services are provided under contract, the contract must specify the term of the contract, the manner of termination or renewal and provide that the agency retains responsibility for the control and supervision of the services.
§ 485.719   Condition of participation: Arrangements for physical therapy and speech pathology services to be performed by other than salaried organization personnel.
(a) Conditions. If an organization provides outpatient physical therapy or speech pathology services under an arrangement with others, the services are to be furnished in accordance with the terms of a written contract, which provides that the organization retains of professional and administrative responsibility for, and control and supervision of, the services.
(b) Standard: Contract provisions. The contract—
(1) Specifies the term of the contract and the manner of termination or renewal;
(2) Requires that personnel who furnish the services meet the requirements that are set forth in this subpart for salaried personnel; and
(3) Provides that the contracting outside resource may not bill the patient or Medicare for the services. This limitation is based on section 1861(w)(1) of the Act, which provides that—
(i) Only the provider may bill the beneficiary for covered services furnished under arrangements; and
(ii) Receipt of Medicare payment by the provider, on behalf of an entitled individual, discharges the liability of the individual or any other person to pay for those services.
§ 485.721   Condition of participation: Clinical records.
The organization maintains clinical records on all patients in accordance with accepted professional standards, and practices. The clinical records are completely and accurately documented, readily accessible, and systematically organized to facilitate retrieving and compiling information.
(a) Standard: Protection of clinical record information. The organization recognizes the confidentiality of clinical record information and provides safeguards against loss, destruction, or unauthorized use. Written procedures govern the use and removal of records and the conditions for release of information. The patient's written consent is required for release of information not authorized by law.
(b) Standard: Content. The clinical record contains sufficient information to identify the patient clearly, to justify the diagnosis(es) and treatment, and to document the results accurately. All clinical records contain the following general categories of data:
(1) Documented evidence of the assessment of the needs of the patient, of an appropriate plan of care, and of the care and services furnished.
(2) Identification data and consent forms.
(3) Medical history.
(4) Report of physical examinations, if any.
(5) Observations and progress notes.
(6) Reports of treatments and clinical findings.
(7) Discharge summary including final diagnosis(es) and prognosis.
(c) Standard: Completion of records and centralization of reports. Current clinical records and those of discharged patients are completed promptly. All clinical information pertaining to a patient is centralized in the patient's clinical record. Each physician signs the entries that he or she makes in the clinical record.
(d) Standard: Retention and preservation. Clinical records are retained for at least:
(1) The period determined by the respective State statute, or the statute of limitations in the State; or
(2) In the absence of a State statute—
(i) Five years after the date of discharge; or
(ii) In the case of a minor, 3 years after the patient becomes of age under State law or 5 years after the date of discharge, whichever is longer.
(e) Standard: Indexes. Clinical records are indexed at least according to name of patient to facilitate acquisition of statistical medical information and retrieval of records for research or administrative action.
(f) Standard: Location and facilities. The organization maintains adequate facilities and equipment, conveniently located, to provide efficient processing of clinical records (reviewing, indexing, filing, and prompt retrieval).
§ 485.723   Condition of participation: Physical environment.
The building housing the organization is constructed, equipped, and maintained to protect the health and safety of patients, personnel, and the public and provides a functional, sanitary, and comfortable environment.
(a) Standard: Safety of patients. The organization satisfies the following requirements:
(1) It complies with all applicable State and local building, fire, and safety codes.
(2) Permanently attached automatic fire-extinguishing systems of adequate capacity are installed in all areas of the premises considered to have special fire hazards. Fire extinguishers are conveniently located on each floor of the premises. Fire regulations are prominently posted.
(3) Doorways, passageways and stairwells negotiated by patients are:
(i) Of adequate width to allow for easy movement of all patients (including those on stretchers or in wheelchairs), (ii) free from obstruction at all times, and (iii) in the case of stairwells, equipped with firmly attached handrails on at least one side.
(4) Lights are placed at exits and in corridors used by patients and are supported by an emergency power source.
(5) A fire alarm system with local alarm capability and, where applicable, an emergency power source, is functional.
(6) At least two persons are on duty on the premises of the organization whenever a patient is being treated.
(7) No occupancies or activities undesirable or injurious to the health and safety of patients are located in the building.
(b) Standard: Maintenance of equipment, building, and grounds. The organization establishes a written preventive-maintenance program to ensure that—
(1) The equipment is operative, and is properly calibrated; and
(2) The interior and exterior of the building are clean and orderly and maintained free of any defects that are a potential hazard to patients, personnel, and the public.
(c) Standard: Other environmental considerations. The organization provides a functional, sanitary, and comfortable environment for patients, personnel, and the public.
(1) Provision is made for adequate and comfortable lighting levels in all areas; limitation of sounds at comfort levels; a comfortable room temperature; and adequate ventilation through windows, mechanical means, or a combination of both.
(2) Toilet rooms, toilet stalls, and lavatories are accessible and constructed so as to allow use by nonambulatory and semiambulatory individuals.
(3) Whatever the size of the building, there is an adequate amount of space for the services provided and disabilities treated, including reception area, staff space, examining room, treatment areas, and storage.
§ 485.725   Condition of participation: Infection control.
The organization that provides outpatient physical therapy services establishes an infection-control committee of representative professional staff with responsibility for overall infection control. All necessary housekeeping and maintenance services are provided to maintain a sanitary and comfortable environment and to help prevent the development and transmission of infection.
(a) Standard: Infection-control committee. The infection-control committee establishes policies and procedures for investigating, controlling, and preventing infections in the organization and monitors staff performance to ensure that the policies and procedures are executed.
(b) All personnel follow written procedures for effective aseptic techniques. The procedures are reviewed annually and revised if necessary to improve them.
(c) Standard: Housekeeping. (1) The organization employs sufficient housekeeping personnel and provides all necessary equipment to maintain a safe, clean, and orderly interior. A full-time employee is designated as the one responsible for the housekeeping services and for supervision and training of housekeeping personnel.
(2) An organization that has a contract with an outside resource for housekeeping services may be found to be in compliance with this standard provided the organization or outside resource or both meet the requirements of the standard.
(d) Standard: Linen. The organization has available at all times a quantity of linen essential for proper care and comfort of patients. Linens are handled, stored, processed, and transported in such a manner as to prevent the spread of infection.
(e) Standard: Pest control. The organization's premises are maintained free from insects and rodents through operation of a pest-control program.
§ 485.727   Condition of participation: Emergency preparedness.
The Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services (“Organizations”) must comply with all applicable Federal, State, and local emergency preparedness requirements. The Organizations must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:
(a) Emergency plan. The Organizations must develop and maintain an emergency preparedness plan that must be reviewed and updated at least every 2 years. The plan must do all of the following:
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by the risk assessment.
(3) Address patient population, including, but not limited to, the type of services the Organizations have the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
(4) Address the location and use of alarm systems and signals; and methods of containing fire.
(5) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation.
(6) Be developed and maintained with assistance from fire, safety, and other appropriate experts.
(b) Policies and procedures. The Organizations must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:
(1) Safe evacuation from the Organizations, which includes staff responsibilities, and needs of the patients.
(2) A means to shelter in place for patients, staff, and volunteers who remain in the facility.
(3) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains the availability of records.
(4) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency.
(c) Communication plan. The Organizations must develop and maintain an emergency preparedness communication plan that complies with Federal, State, and local laws and must be reviewed and updated at least every 2 years. The communication plan must include all of the following:
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Patients' physicians.
(iv) Other Organizations.
(v) Volunteers.
(2) Contact information for the following:
(i) Federal, state, tribal, regional and local emergency preparedness staff.
(ii) Other sources of assistance.
(3) Primary and alternate means for communicating with the following:
(i) Organizations' staff.
(ii) Federal, state, tribal, regional, and local emergency management agencies.
(4) A method for sharing information and medical documentation for patients under the Organizations' care, as necessary, with other health care providers to maintain the continuity of care.
(5) A means of providing information about the Organizations' needs, and their ability to provide assistance, to the authority having jurisdiction or the Incident Command Center, or designee.
(d) Training and testing. The Organizations must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years.
(1) Training program. The Organizations must do all of the following:
(i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least every 2 years.
(iii) Maintain documentation of the training.
(iv) Demonstrate staff knowledge of emergency procedures.
(v) If the emergency preparedness policies and procedures are significantly updated, the Organizations must conduct training on the updated policies and procedures.
(2) Testing. The Organizations must conduct exercises to test the emergency plan at least annually. The Organizations must do the following:
(i) Participate in a full-scale exercise that is community-based every 2 years; or
(A) When a community-based exercise is not accessible, an individual, facility-based functional exercise every 2 years; or.
(B) If the Organizations experience an actual natural or man-made emergency that requires activation of the emergency plan, the organization is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the Organization's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise their emergency plan, as needed.
(e) Integrated healthcare systems. If the Organizations are part of a healthcare system consisting of multiple separately certified healthcare facilities that elects to have a unified and integrated emergency preparedness program, the Organizations may choose to participate in the healthcare system's coordinated emergency preparedness program. If elected, the unified and integrated emergency preparedness program must do all of the following:
(1) Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered.
(3) Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance.
(4) Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include all of the following:
(i) A documented community-based risk assessment, utilizing an all-hazards approach.
(ii) A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach.
(5) Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively.
§ 485.729   Condition of participation: Program evaluation.
The organization has procedures that provide for a systematic evaluation of its total program to ensure appropriate utilization of services and to determine whether the organization's policies are followed in providing services to patients through employees or under arrangements with others.
(a) Standard: Clinical-record review. A sample of active and closed clinical records is reviewed quarterly by the appropriate health professionals to ensure that established policies are followed in providing services.
(b) Standard: Annual statistical evaluation. An evaluation is conducted annually of statistical data such as number of different patients treated, number of patient visits, condition on admission and discharge, number of new patients, number of patients by diagnosis(es), sources of referral, number and cost of units of service by treatment given, and total staff days or work hours by discipline.
§ 485.900   Basis and scope.
(a) Basis. This subpart is based on the following sections of the Social Security Act:
(1) Section 1832(a)(2)(J) of the Act specifies that payments may be made under Medicare Part B for partial hospitalization services and intensive outpatient services furnished by a community mental health center (CMHC) as described in section 1861(ff)(3)(B) of the Act.
(2) Section 1861(ff) of the Act describes the items and services that are covered under Medicare Part B as “partial hospitalization services” and “intensive outpatient services” and the conditions under which the items and services must be provided. In addition, section 1861(ff) of the Act specifies that the entities authorized to provide partial hospitalization services and intensive outpatient services under Medicare Part B include CMHCs and defines that term.
(3) Section 1866(e)(2) of the Act specifies that a provider of services for purposes of provider agreement requirements includes a CMHC as defined in section 1861(ff)(3)(B) of the Act, but only with respect to providing partial hospitalization services and intensive outpatient services.
(b) Scope. The provisions of this subpart serve as the basis of survey activities for the purpose of determining whether a CMHC meets the specified requirements that are considered necessary to ensure the health and safety of clients; and for the purpose of determining whether a CMHC qualifies for a provider agreement under Medicare.
§ 485.902   Definitions.
As used in this subpart, unless the context indicates otherwise—
Active treatment plan means an individualized client plan that focuses on the provision of care and treatment services that address the client's physical, psychological, psychosocial, emotional, and therapeutic needs and goals as identified in the comprehensive assessment.
Community mental health center (CMHC) means an entity as defined in § 410.2 of this chapter.
Comprehensive assessment means a thorough evaluation of the client's physical, psychological, psychosocial, emotional, and therapeutic needs related to the diagnosis under which care is being furnished by the CMHC.
Employee of a CMHC means an individual—
(1) Who works for the CMHC and for whom the CMHC is required to issue a W-2 form on his or her behalf; or
(2) For whom an agency or organization issues a W-2 form, and who is assigned to such CMHC if the CMHC is a subdivision of an agency or organization.
Initial evaluation means an immediate care and support assessment of the client's physical, psychosocial (including a screen for harm to self or others), and therapeutic needs related to the psychiatric illness and related conditions for which care is being furnished by the CMHC.
Representative means an individual who has the authority under State law to authorize or terminate medical care on behalf of a client who is mentally or physically incapacitated. This includes a legal guardian.
Restraint means—
(1) Any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a client to move his or her arms, legs, body, or head freely, not including devices, such as orthopedically prescribed devices, surgical dressings or bandages, protective helmets, or other methods that involve the physical holding of a client for the purpose of conducting routine physical examinations or tests, or to protect the client from falling out of bed, or to permit the client to participate in activities without the risk of physical harm (this does not include a client being physically escorted); or
(2) A drug or medication when it is used as a restriction to manage the client's behavior or restrict the client's freedom of movement, and which is not a standard treatment or dosage for the client's condition.
Seclusion means the involuntary confinement of a client alone in a room or an area from which the client is physically prevented from leaving.
Volunteer means an individual who is an unpaid worker of the CMHC; or if the CMHC is a subdivision of an agency or organization, is an unpaid worker of the agency or organization and is assigned to the CMHC. All volunteers must meet the standard training requirements under § 485.918(d).
§ 485.904   Condition of participation: Personnel qualifications.
(a) Standard: General qualification requirements. All professionals who furnish services directly, under an individual contract, or under arrangements with a CMHC, must be legally authorized (licensed, certified or registered) in accordance with applicable Federal, State and local laws, and must act only within the scope of their State licenses, certifications, or registrations. All personnel qualifications must be kept current at all times.
(b) Standard: Personnel qualifications for certain disciplines. The following qualifications must be met:
(1) Administrator of a CMHC. A CMHC employee who meets the education and experience requirements established by the CMHC's governing body for that position and who is responsible for the day-to-day operation of the CMHC.
(2) Clinical psychologist. An individual who meets the qualifications at § 410.71(d) of this chapter.
(3) Clinical Social worker. An individual who meets the qualifications at § 410.73 of this chapter.
(4) Social worker. An individual who—
(i) Has a baccalaureate degree in social work from an institution accredited by the Council on Social Work Education, or a baccalaureate degree in psychology or sociology, and is supervised by a clinical social worker, as described in paragraph (b)(3) of this section; and
(ii) Has 1 year of social work experience in a psychiatric healthcare setting.
(5) Mental health counselor. An individual who meets the applicable education, training, and other requirements of § 410.54 of this chapter.
(6) Occupational therapist. A person who meets the requirements for the definition of “occupational therapist” at § 484.4 of this chapter.
(7) Physician. An individual who meets the qualifications and conditions as defined in section 1861(r) of the Act, and provides the services at § 410.20 of this chapter, and has experience providing mental health services to clients.
(8) Physician assistant. An individual who meets the qualifications and conditions as defined in section 1861(s)(2)(K)(i) of the Act and provides the services, in accordance with State law, at § 410.74 of this chapter.
(9) Advanced practice nurse. An individual who meets the following qualifications:
(i) Is a nurse practitioner who meets the qualifications at § 410.75 of this chapter; or
(ii) Is a clinical nurse specialist who meets the qualifications at § 410.76 of this chapter.
(10) Psychiatric registered nurse. A registered nurse, who is a graduate of an approved school of professional nursing, is licensed as a registered nurse by the State in which he or she is practicing, and has at least 1 year of education and/or training in psychiatric nursing.
(11) Psychiatrist. An individual who specializes in assessing and treating persons having psychiatric disorders; is board certified, or is eligible to be board certified by the American Board of Psychiatry and Neurology, or has documented equivalent education, training or experience, and is fully licensed to practice medicine in the State in which he or she practices.
(12) Marriage and family therapist. An individual who meets the applicable education, training, and other requirements of § 410.53 of this chapter.
§ 485.910   Condition of participation: Client rights.
The client has the right to be informed of his or her rights. The CMHC must protect and promote the exercise of these client rights.
(a) Standard: Notice of rights and responsibilities. (1) During the initial evaluation, the CMHC must provide the client, the client's representative (if appropriate) or surrogate with verbal and written notice of the client's rights and responsibilities. The verbal notice must be in a language and manner that the client or client's representative or surrogate understands. Written notice must be understandable to persons who have limited English proficiency.
(2) During the initial evaluation, the CMHC must inform and distribute written information to the client concerning its policies on filing a grievance.
(3) The CMHC must obtain the client's and/or the client representative's signature confirming that he or she has received a copy of the notice of rights and responsibilities.
(b) Standard: Exercise of rights and respect for property and person. (1) The client has the right to—
(i) Exercise his or her rights as a client of the CMHC.
(ii) Have his or her property and person treated with respect.
(iii) Voice grievances and understand the CMHC grievance process; including but not limited to grievances regarding mistreatment and treatment or care that is (or fails to be) furnished.
(iv) Not be subjected to discrimination or reprisal for exercising his or her rights.
(2) If a client has been adjudged incompetent under State law by a court of proper jurisdiction, the rights of the client are exercised by the person appointed in accordance with State law to act on the client's behalf.
(3) If a State court has not adjudged a client incompetent, any legal representative designated by the client in accordance with State law may exercise the client's rights to the extent allowed under State law.
(c) Standard: Rights of the client. The client has a right to—
(1) Be involved in developing his or her active treatment plan.
(2) Refuse care or treatment.
(3) Have a confidential clinical record. Access to or release of client information and the clinical record client information is permitted only in accordance with 45 CFR parts 160 and 164.
(4) Be free from mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and misappropriation of client property.
(5) Receive information about specific limitations on services that he or she will be furnished.
(6) Not be compelled to perform services for the CMHC, and to be compensated by the CMHC for any work performed for the CMHC at prevailing wages and commensurate with the client's abilities.
(d) Standard: Addressing violations of client rights. The CMHC must adhere to the following requirements:
(1) Ensure that all alleged violations involving mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and misappropriation of client property by anyone, including those furnishing services on behalf of the CMHC, are reported immediately to the CMHC's administrator by CMHC employees, volunteers and contracted staff.
(2) Immediately investigate all alleged violations involving anyone furnishing services on behalf of the CMHC and immediately take action to prevent further potential violations while the alleged violation is being verified. Investigations and documentation of all alleged violations must be conducted in accordance with procedures established by the CMHC.
(3) Take appropriate corrective action in accordance with State law if the alleged violation is investigated by the CMHC's administration or verified by an outside entity having jurisdiction, such as the State survey and certification agency or the local law enforcement agency; and
(4) Ensure that, within 5 working days of becoming aware of the violation, all violations are reported to the State survey and certification agency, and verified violations are reported to State and local entities having jurisdiction.
(e) Standard: Restraint and seclusion. (1) All clients have the right to be free from physical or mental abuse, and corporal punishment. All clients have the right to be free from restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. Restraint or seclusion, defined in § 485.902, may only be imposed to ensure the immediate physical safety of the client, staff, or other individuals.
(2) The use of restraint or seclusion must be in accordance with the written order of a physician or other licensed independent practitioner who is authorized to order restraint or seclusion in accordance with State law and must not exceed one 1-hour duration per order.
(3) The CMHC must obtain a corresponding order for the client's immediate transfer to a hospital when restraint or seclusion is ordered.
(4) Orders for the use of restraint or seclusion must never be written as a standing order or on an as-needed basis.
(5) When a client becomes an immediate threat to the physical safety of himself or herself, staff or other individuals, the CMHC must adhere to the following requirements:
(i) Restraint or seclusion may only be used when less restrictive interventions have been determined to be ineffective to protect the client or other individuals from harm.
(ii) The type or technique of restraint or seclusion used must be the least restrictive intervention that will be effective to protect the client or other individuals from harm.
(iii) The use of restraint or seclusion must be implemented in accordance with safe and appropriate restraint and seclusion techniques as determined by State law.
(iv) The condition of the client who is restrained or secluded must be continuously monitored by a physician or by trained staff who have completed the training criteria specified in paragraph (f) of this section.
(v) When restraint or seclusion is used, there must be documentation in the client's clinical record of the following:
(A) A description of the client's behavior and the intervention used.
(B) Alternatives or other less restrictive interventions attempted (as applicable).
(C) The client's condition or symptom(s) that warranted the use of the restraint or seclusion.
(D) The client's response to the intervention(s) used, including the rationale for continued use of the intervention.
(E) The name of the hospital to which the client was transferred.
(f) Standard: Restraint or seclusion: Staff training requirements. The client has the right to safe implementation of restraint or seclusion by trained staff. Application of restraint or seclusion in a CMHC must only be imposed when a client becomes an immediate physical threat to himself or herself, staff or other individuals and only in facilities where restraint and seclusion are permitted.
(1) Training intervals. In facilities where restraint and seclusion are permitted, all appropriate client care staff working in the CMHC must be trained and able to demonstrate competency in the application of restraints, implementation of seclusion, monitoring, assessment, and providing care for a client in restraint or seclusion and use of alternative methods to restraint and seclusion. In facilities where restraint and seclusion are not permitted, appropriate client care staff working in CMHC must be trained in the use of alternative methods to restraint and seclusion. Training will occur as follows:
(i) Before performing any of the actions specified in this paragraph (f).
(ii) As part of orientation.
(iii) Subsequently on a periodic basis, consistent with the CMHC's policy.
(2) Training content. The CMHC must require all appropriate staff caring for clients to have appropriate education, training, and demonstrated knowledge based on the specific needs of the client population in at least the following:
(i) Techniques to identify staff and client behaviors, events, and environmental factors that may trigger circumstances that could require the use of restraint or seclusion.
(ii) The use of nonphysical intervention skills.
(iii) In facilities where restraint and seclusion are permitted, choosing the least restrictive intervention based on an individualized assessment of the client's medical and behavioral status or condition.
(iv) The safe application and use of all types of restraint or seclusion that are permitted in the CMHC, including training in how to recognize and respond to signs of physical and psychological distress.
(v) In facilities where restraint and seclusion are permitted, clinical identification of specific behavioral changes that indicate that restraint or seclusion is no longer necessary.
(vi) In facilities where restraint and seclusion are permitted, monitoring the physical and psychological well-being of the client who is restrained or secluded, including, but not limited to, respiratory and circulatory status, skin integrity, vital signs, and any special requirements specified by the CMHC's policy.
(3) Trainer requirements. Individuals providing staff training must be qualified as evidenced by education, training, and experience in techniques used to address clients' behaviors.
(4) Training documentation. The CMHC must document in the staff personnel records that the training and demonstration of competency were successfully completed.
(g) Standard: Death reporting requirements. The CMHC must report deaths associated with the use of seclusion or restraint.
(1) The CMHC must report to CMS each death that occurs while a client is in restraint or seclusion awaiting transfer to a hospital.
(2) Each death referenced in paragraph (g)(1) of this section must be reported to the CMS Regional Office by telephone no later than the close of business the next business day following knowledge of the client's death.
(3) Staff must document in the client's clinical record the date and time the death was reported to CMS.
§ 485.914   Condition of participation: Admission, initial evaluation, comprehensive assessment, and discharge or transfer of the client.
The CMHC must ensure that all clients admitted into its program are appropriate for the services the CMHC furnishes in its facility.
(a) Standard: Admission. (1) The CMHC must determine that each client is appropriate for the services it provides as specified in § 410.2 of this chapter.
(2) For clients assessed and admitted to receive partial hospitalization services and intensive outpatient services, the CMHC must also meet separate requirements as specified in § 485.918(f) and (g), as applicable.
(b) Standard: Initial evaluation. (1) A licensed mental health professional employed by the CMHC and acting within his or her state scope of practice requirements must complete the initial evaluation within 24 hours of the client's admission to the CMHC.
(2) The initial evaluation, at a minimum, must include the following:
(i) The admitting diagnosis as well as other diagnoses.
(ii) The source of referral.
(iii) The reason for admission as stated by the client or other individuals who are significantly involved.
(iv) Identification of the client's immediate clinical care needs related to the psychiatric diagnosis.
(v) A list of current prescriptions and over-the-counter medications, as well as other substances that the client may be taking.
(vi) For partial hospitalization services only, include an explanation as to why the client would be at risk for hospitalization if the partial hospitalization services were not provided.
(3) Based on the findings of the initial evaluation, the CMHC must determine the appropriate members of each client's interdisciplinary treatment team.
(c) Standard: Comprehensive assessment. (1) The comprehensive assessment must be completed by licensed mental health professionals who are members of the interdisciplinary treatment team, performing within their State's scope of practice.
(2) The comprehensive assessment must be completed in a timely manner, consistent with the client's immediate needs, but no later than 4 working days after admission to the CMHC.
(3) The comprehensive assessment must identify the physical, psychological, psychosocial, emotional, therapeutic, and other needs related to the client's psychiatric illness. The CMHC's interdisciplinary treatment team must ensure that the active treatment plan is consistent with the findings of the comprehensive assessment.
(4) The comprehensive assessment, at a minimum, must include the following:
(i) The reasons for the admission.
(ii) A psychiatric evaluation, completed by a psychiatrist, non-physician practitioner or psychologist practicing within the scope of State licensure that includes the medical history and severity of symptoms. Information may be gathered from the client's primary health care provider (if any), contingent upon the client's consent.
(iii) Information concerning previous and current mental status, including but not limited to, previous therapeutic interventions and hospitalizations.
(iv) Information regarding the onset of symptoms of the illness and circumstances leading to the admission.
(v) A description of attitudes and behaviors, including cultural and environmental factors that may affect the client's treatment plan.
(vi) An assessment of intellectual functioning, memory functioning, and orientation.
(vii) Complications and risk factors that may affect the care planning.
(viii) Functional status, including the client's ability to understand and participate in his or her own care, and the client's strengths and goals.
(ix) Factors affecting client safety or the safety of others, including behavioral and physical factors, as well as suicide risk factors.
(x) A drug profile that includes a review of all of the client's prescription and over-the-counter medications; herbal remedies; and other alternative treatments or substances that could affect drug therapy.
(xi) The need for referrals and further evaluation by appropriate health care professionals, including the client's primary health care provider (if any), when warranted.
(xii) Factors to be considered in discharge planning.
(xiii) Identification of the client's current social and health care support systems.
(xiv) For pediatric clients, the CMHC must assess the social service needs of the client, and make referrals to social services and child welfare agencies as appropriate.
(d) Standard: Update of the comprehensive assessment. (1) The CMHC must update each client's comprehensive assessment via the CMHC interdisciplinary treatment team, in consultation with the client's primary health care provider (if any), when changes in the client's status, responses to treatment, or goal achievement have occurred and in accordance with current standards of practice.
(2) For clients that receive partial hospitalization program (PHP) or intensive outpatient (IOP) services, the assessment must be updated no less frequently than every 30 days.
(3) The update must include information on the client's progress toward desired outcomes, a reassessment of the client's response to care and therapies, and the client's goals.
(e) Standard: Discharge or transfer of the client. (1) If the client is transferred to another entity, the CMHC must, within 2 working days, forward to the entity, a copy of—
(i) The CMHC discharge summary.
(ii) The client's clinical record, if requested.
(2) If a client refuses the services of a CMHC, or is discharged from a CMHC due to noncompliance with the treatment plan, the CMHC must forward to the primary health care provider (if any) a copy of—
(i) The CMHC discharge summary.
(ii) The client's clinical record, if requested.
(3) The CMHC discharge summary must include—
(i) A summary of the services provided, including the client's symptoms, treatment and recovery goals and preferences, treatments, and therapies.
(ii) The client's current active treatment plan at time of discharge.
(iii) The client's most recent physician orders.
(iv) Any other documentation that will assist in post-discharge continuity of care.
(4) The CMHC must adhere to all Federal and State-related requirements pertaining to the medical privacy and the release of client information.
§ 485.916   Condition of participation: Treatment team, person-centered active treatment plan, and coordination of services.
The CMHC must designate an interdisciplinary treatment team that is responsible, with the client, for directing, coordinating, and managing the care and services furnished for each client. The interdisciplinary treatment team is composed of individuals who work together to meet the physical, medical, psychosocial, emotional, and therapeutic needs of CMHC clients.
(a) Standard: Delivery of services. (1) An interdisciplinary treatment team, led by a physician, nurse practitioner (NP), physician assistant (PA), clinical nurse specialist (CNS), clinical psychologist, clinical social worker, marriage and family therapist (MFT), or mental health counselor (MHC), must provide the care and services offered by the CMHC.
(2) Based on the findings of the comprehensive assessment, the CMHC must determine the appropriate licensed mental health professional, who is a member of the client's interdisciplinary treatment team, to coordinate care and treatment decisions with each client, to ensure that each client's needs are assessed, and to ensure that the active treatment plan is implemented as indicated.
(3) The interdisciplinary treatment team may include:
(i) A doctor of medicine, osteopathy or psychiatry (who is an employee of or under contract with the CMHC).
(ii) A psychiatric registered nurse.
(iii) A clinical social worker.
(iv) A clinical psychologist.
(v) An occupational therapist.
(vi) Other licensed mental health professionals, as necessary.
(vii) Other CMHC staff or volunteers, as necessary.
(4) If the CMHC has more than one interdisciplinary team, it must designate the treatment team responsible for establishing policies and procedures governing the coordination of services and the day-to-day provision of CMHC care and services.
(b) Standard: Person-centered active treatment plan. All CMHC care and services furnished to clients must be consistent with an individualized, written, active treatment plan that is established by the CMHC interdisciplinary treatment team, the client, and the client's primary caregiver(s), in accordance with the client's recovery goals and preferences, within 7 working days of admission to the CMHC. The CMHC must ensure that each client and the client's primary caregiver(s), as applicable, receive education and training provided by the CMHC that are consistent with the client's and caregiver's responsibilities as identified in the active treatment plan.
(c) Standard: Content of the person-centered active treatment plan. The CMHC must develop a person-centered individualized active treatment plan for each client. The active treatment plan must take into consideration client recovery goals and the issues identified in the comprehensive assessment. The active treatment plan must include all services necessary to assist the client in meeting his or her recovery goals, including the following:
(1) Client diagnoses.
(2) Treatment goals.
(3) Interventions.
(4) A detailed statement of the type, duration, and frequency of services, including social work, psychiatric nursing, counseling, and therapy services, necessary to meet the client's specific needs.
(5) Drugs, treatments, and individual and/or group therapies.
(6) Family psychotherapy with the primary focus on treatment of the client's conditions.
(7) The interdisciplinary treatment team's documentation of the client's or representative's and primary caregiver's (if any) understanding, involvement, and agreement with the plan of care, in accordance with the CMHC's policies.
(d) Standard: Review of the person-centered active treatment plan. The CMHC interdisciplinary treatment team must review, revise, and document the individualized active treatment plan as frequently as the client's condition requires, but no less frequently than every 30-calendar day. A revised active treatment plan must include information from the client's initial evaluation and comprehensive assessments, the client's progress toward outcomes and goals specified in the active treatment plan, and changes in the client's goals. The CMHC must also meet partial hospitalization program requirements specified under § 424.24(e) of this chapter or intensive outpatient service requirements as specified under § 424.24(d) of this chapter, as applicable, if such services are included in the active treatment plan.
(e) Standard: Coordination of services. The CMHC must develop and maintain a system of communication that assures the integration of services in accordance with its policies and procedures and, at a minimum, would do the following:
(1) Ensure that the interdisciplinary treatment team maintains responsibility for directing, coordinating, and supervising the care and services provided.
(2) Ensure that care and services are provided in accordance with the active treatment plan.
(3) Ensure that the care and services provided are based on all assessments of the client.
(4) Provide for and ensure the ongoing sharing of information among all disciplines providing care and services, whether the care and services are provided by employees or those under contract with the CMHC.
(5) Provide for ongoing sharing of information with other health care and non-medical providers, including the primary health care provider, furnishing services to a client for conditions unrelated to the psychiatric condition for which the client has been admitted, and non-medical supports addressing environmental factors such as housing and employment.
§ 485.917   Condition of participation: Quality assessment and performance improvement.
The CMHC must develop, implement, and maintain an effective, ongoing, CMHC-wide data-driven quality assessment and performance improvement program (QAPI). The CMHC's governing body must ensure that the program reflects the complexity of its organization and services, involves all CMHC services (including those services furnished under contract or arrangement), focuses on indicators related to improved behavioral health or other healthcare outcomes, and takes actions to demonstrate improvement in CMHC performance. The CMHC must maintain documentary evidence of its quality assessment and performance improvement program and be able to demonstrate its operation to CMS.
(a) Standard: Program scope. (1) The CMHC program must be able to demonstrate measurable improvement in indicators related to improving behavioral health outcomes and CMHC services.
(2) The CMHC must measure, analyze, and track quality indicators; adverse client events, including the use of restraint and seclusion; and other aspects of performance that enable the CMHC to assess processes of care, CMHC services, and operations.
(b) Standard: Program data. (1) The program must use quality indicator data, including client care, and other relevant data, in the design of its program.
(2) The CMHC must use the data collected to do the following:
(i) Monitor the effectiveness and safety of services and quality of care.
(ii) Identify opportunities and priorities for improvement.
(3) The frequency and detail of the data collection must be approved by the CMHC's governing body.
(c) Standard: Program activities. (1) The CMHC's performance improvement activities must:
(i) Focus on high risk, high volume, or problem-prone areas.
(ii) Consider incidence, prevalence, and severity of problems.
(iii) Give priority to improvements that affect behavioral outcomes, client safety, and person-centered quality of care.
(2) Performance improvement activities must track adverse client events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the CMHC.
(3) The CMHC must take actions aimed at performance improvement and, after implementing those actions, the CMHC must measure its success and track performance to ensure that improvements are sustained.
(d) Standard: Performance improvement projects. CMHCs must develop, implement and evaluate performance improvement projects.
(1) The number and scope of distinct performance improvement projects conducted annually, based on the needs of the CMHC's population and internal organizational needs, must reflect the scope, complexity, and past performance of the CMHC's services and operations.
(2) The CMHC must document what performance improvement projects are being conducted, the reasons for conducting these projects, and the measurable progress achieved on these projects.
(e) Standard: Executive responsibilities. The CMHC's governing body is responsible for ensuring the following:
(1) That an ongoing QAPI program for quality improvement and client safety is defined, implemented, maintained, and evaluated annually.
(2) That the CMHC-wide quality assessment and performance improvement efforts address priorities for improved quality of care and client safety, and that all improvement actions are evaluated for effectiveness.
(3) That one or more individual(s) who are responsible for operating the QAPI program are designated.
§ 485.918   Condition of participation: Organization, governance, administration of services, partial hospitalization services, and intensive outpatient services.
The CMHC must organize, manage, and administer its resources to provide CMHC services, including specialized services for children, elderly individuals, individuals with serious mental illness, and residents of its mental health service area who have been discharged from an inpatient mental health facility.
(a) Standard: Governing body and administrator. (1) A CMHC must have a designated governing body made up of two or more designated persons, one of which may be the administrator, that assumes full legal authority and responsibility for the management of the CMHC, the services it furnishes, its fiscal operations, and continuous quality improvement. One member of the governing body must possess knowledge and experience as a mental health clinician.
(2) The CMHC's governing body must appoint an administrator who reports to the governing body and is responsible for the day-to-day operation of the CMHC. The administrator must be a CMHC employee and meet the education and experience requirements established by the CMHC's governing body.
(b) Standard: Provision of services. (1) A CMHC must be primarily engaged in providing the following care and services to all clients served by the CMHC regardless of payer type, and must do so in a manner that is consistent with the following accepted standards of practice:
(i) Provides outpatient services, including specialized outpatient services for children, elderly individuals, individuals with serious mental illness, and residents of its mental health service area who have been discharged from inpatient mental health facilities.
(ii) Provides 24-hour-a-day emergency care services.
(iii) Provides day treatment, partial hospitalization services, or intensive outpatient services, other than in an individual's home or in an inpatient or residential setting, or psychosocial rehabilitation services.
(iv) Provides screening for clients being considered for admission to State mental health facilities to determine the appropriateness of such services, unless otherwise directed by State law.
(v) Provides at least 40 percent of its items and services to individuals who are not eligible for benefits under title XVIII of the Act, as measured by the total number of CMHC clients treated by the CMHC for whom services are not paid for by Medicare, divided by the total number of clients treated by the CMHC for each 12-month period of enrollment.
(A) A CMHC is required to submit to CMS a certification statement provided by an independent entity that certifies that the CMHC's client population meets the 40 percent requirement specified at this paragraph (b)(1)(v).
(B) The certification statement described in paragraph (b)(1)(v)(A) of this section is required upon initial application to enroll in Medicare, and as a part of revalidation, including any off cycle revalidation, thereafter carried out pursuant to § 424.530 of this chapter. Medicare enrollment will be denied or revoked in instances where the CMHC fails to provide the certification statement as required. Medicare enrollment will also be denied or revoked if the 40 percent requirement as specified in this paragraph (b)(1)(v) is not met.
(vi) Provides individual and group psychotherapy utilizing a psychiatrist, psychologist, or other licensed mental health counselor, to the extent authorized under State law.
(vii) Provides physician services.
(viii) Provides psychiatric nursing services.
(ix) Provides clinical social work services.
(x) Provides family counseling services, with the primary purpose of treating the individual's condition.
(xi) Provides occupational therapy services.
(xii) Provides services of other staff trained to work with psychiatric clients.
(xiii) Provides drugs and biologicals furnished for therapeutic purposes that cannot be self-administered.
(xiv) Provides client training and education as related to the individual's care and active treatment.
(xv) Provides individualized therapeutic activity services that are not primarily recreational or diversionary.
(xvi) Provides diagnostic services.
(2) The CMHC and individuals furnishing services on its behalf must meet applicable State licensing and certification requirements.
(c) Standard: Professional management responsibility. A CMHC that has a written agreement with another agency, individual, or organization to furnish any services under arrangement must retain administrative and financial management and oversight of staff and services for all arranged services. As part of retaining financial management responsibility, the CMHC must retain all payment responsibility for services furnished under arrangement on its behalf. Arranged services must be supported by a written agreement which requires that all services be as follows:
(1) Authorized by the CMHC.
(2) Furnished in a safe and effective manner.
(3) Delivered in accordance with established professional standards, the policies of the CMHC, and the client's active treatment plan.
(d) Standard: Staff training. (1) A CMHC must provide education about CMHC care and services, and person-centered care to all employees, volunteers, and staff under contract who have contact with clients and their families.
(2) A CMHC must provide an initial orientation for each individual furnishing services that addresses the specific duties of his or her job.
(3) A CMHC must assess the skills and competence of all individuals furnishing care and, as necessary, provide in-service training and education programs where indicated. The CMHC must have written policies and procedures describing its method(s) of assessing competency and must maintain a written description of the in-service training provided during the previous 12 months.
(e) Standard: Physical environment —(1) Environmental conditions. The CMHC must provide a safe, functional, sanitary, and comfortable environment for clients and staff that is conducive to the provision of services that are identified in paragraph (b) of this section.
(2) Building. The CMHC services must be provided in a location that meets Federal, State, and local health and safety standards and State health care occupancy regulations.
(3) Infection control. There must be policies, procedures, and monitoring for the prevention, control, and investigation of infection and communicable diseases with the goal of avoiding sources and transmission of infection.
(4) Therapy sessions. The CMHC must ensure that individual or group therapy sessions are conducted in a manner that maintains client privacy and ensures client dignity.
(f) Standard: Partial hospitalization services. A CMHC providing partial hospitalization services must—
(1) Provide services as defined in § 410.2 of this chapter.
(2) Provide the services and meet the requirements specified in § 410.43 of this chapter.
(3) Meet the requirements for coverage as described in § 410.110 of this chapter.
(4) Meet the content of certification and plan of treatment requirements as described in § 424.24(e) of this chapter.
(g) Standard: Intensive outpatient services. A CMHC providing intensive outpatient services must—
(1) Provide services as defined in § 410.2 of this chapter.
(2) Provide the services and meet the requirements specified in § 410.44 of this chapter.
(3) Meet the requirements for coverage as described in § 410.111 of this chapter.
(4) Meet the content of certification and plan of treatment requirements as described in § 424.24(d) of this chapter.
(h) Standard: Compliance with Federal, State, and local laws and regulations related to the health and safety of clients. The CMHC and its staff must operate and furnish services in compliance with all applicable Federal, State, and local laws and regulations related to the health and safety of clients. If State or local law provides for licensing of CMHCs, the CMHC must be licensed. The CMHC staff must follow the CMHC's policies and procedures.
§ 485.920   Condition of participation: Emergency preparedness.
The Community Mental Health Center (CMHC) must comply with all applicable Federal, State, and local emergency preparedness requirements. The CMHC must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:
(a) Emergency plan. The CMHC must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do all of the following:
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by the risk assessment.
(3) Address client population, including, but not limited to, the type of services the CMHC has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation.
(b) Policies and procedures. The CMHC must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:
(1) A system to track the location of on-duty staff and sheltered clients in the CMHC's care during and after an emergency. If on-duty staff and sheltered clients are relocated during the emergency, the CMHC must document the specific name and location of the receiving facility or other location.
(2) Safe evacuation from the CMHC, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance.
(3) A means to shelter in place for clients, staff, and volunteers who remain in the facility.
(4) A system of medical documentation that preserves client information, protects confidentiality of client information, and secures and maintains the availability of records.
(5) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of state or Federally designated health care professionals to address surge needs during an emergency.
(6) The development of arrangements with other CMHCs or other providers to receive clients in the event of limitations or cessation of operations to maintain the continuity of services to CMHC clients.
(7) The role of the CMHC under a waiver declared by the Secretary of Health and Human Services, in accordance with section 1135 of the Social Security Act, in the provision of care and treatment at an alternate care site identified by emergency management officials.
(c) Communication plan. The CMHC must develop and maintain an emergency preparedness communication plan that complies with Federal, State, and local laws and must be reviewed and updated at least every 2 years. The communication plan must include all of the following:
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Clients' physicians.
(iv) Other CMHCs.
(v) Volunteers.
(2) Contact information for the following:
(i) Federal, State, tribal, regional, and local emergency preparedness staff.
(ii) Other sources of assistance.
(3) Primary and alternate means for communicating with the following:
(i) CMHC's staff.
(ii) Federal, State, tribal, regional, and local emergency management agencies.
(4) A method for sharing information and medical documentation for clients under the CMHC's care, as necessary, with other health care providers to maintain the continuity of care.
(5) A means, in the event of an evacuation, to release client information as permitted under 45 CFR 164.510(b)(1)(ii).
(6) A means of providing information about the general condition and location of clients under the facility's care as permitted under 45 CFR 164.510(b)(4).
(7) A means of providing information about the CMHC's needs, and its ability to provide assistance, to the authority having jurisdiction or the Incident Command Center, or designee.
(d) Training and testing. The CMHC must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. If the emergency preparedness policies and procedures are significantly updated, the CMHC must conduct training on the updated policies and procedures.
(1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years.
(2) Testing. The CMHC must conduct exercises to test the emergency plan at least annually. The CMHC must:
(i) Participate in a full-scale exercise that is community-based every 2 years; or
(A) When a community-based exercise is not accessible, conduct an individual, facility-based every 2 years; or.
(B) If the CMHC experiences an actual natural or man-made emergency that requires activation of the emergency plan, the CMHC is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the CMHC's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the CMHC's emergency plan, as needed.
(e) Integrated healthcare systems. If a CMHC is part of a healthcare system consisting of multiple separately certified healthcare facilities that elects to have a unified and integrated emergency preparedness program, the CMHC may choose to participate in the healthcare system's coordinated emergency preparedness program. If elected, the unified and integrated emergency preparedness program must do all of the following:
(1) Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered.
(3) Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance.
(4) Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include all of the following:
(i) A documented community-based risk assessment, utilizing an all-hazards approach.
(ii) A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach.
(5) Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively.