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42 C.F.R. §§ 482.21–482.27

7 sections in range

§482.21. Condition of participation: Quality assessment and performance improvement program.

42 C.F.R. § 482.21

The hospital must develop, implement, and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital's governing body must ensure that the program reflects the complexity of the hospital's organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS.
(a)
Standard: Program scope.
(1)
The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will improve health outcomes and identify and reduce medical errors.
(2)
The hospital must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that assess processes of care, hospital service and operations.
(b)
Standard: Program data.
(1)
The program must incorporate quality indicator data including patient care data, and other relevant data such as data submitted to or received from Medicare quality reporting and quality performance programs, including but not limited to data related to hospital readmissions and hospital-acquired conditions.
(2)
The hospital must use the data collected to—
(i)
Monitor the effectiveness and safety of services and quality of care; and
(ii)
Identify opportunities for improvement and changes that will lead to improvement.
(3)
The frequency and detail of data collection must be specified by the hospital's governing body.
(4)
Effective January 1, 2027, for hospitals that offer obstetrical services, the hospital must utilize its quality assessment and performance improvement (QAPI) program to assess and improve health outcomes and disparities among obstetrical patients on an ongoing basis. At a minimum, the hospital must:
(i)
Analyze data and quality indicators collected for the QAPI program by diverse subpopulations as identified by the hospital among obstetrical patients.
(ii)
Measure, analyze, and track data, measures, and quality indicators on patient outcomes and disparities in processes of care, services and operations among obstetrical patients.
(iii)
Analyze and prioritize 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 among obstetrical patients.
(iv)
Conduct at least one measurable performance improvement project focused on improving health outcomes and disparities among the hospital's population(s) of obstetrical patients annually.
(c)
Standard: Program activities.
(1)
The hospital must set priorities for its performance improvement activities that—
(i)
Focus on high-risk, high-volume, or problem-prone areas;
(ii)
Consider the incidence, prevalence, and severity of problems in those areas; and
(iii)
Affect health outcomes, patient safety, and quality of care.
(2)
Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital.
(3)
The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained.
(d)
Standard: Performance improvement projects. As part of its quality assessment and performance improvement program, the hospital must conduct performance improvement projects.
(1)
The number and scope of distinct improvement projects conducted annually must be proportional to the scope and complexity of the hospital's services and operations.
(2)
A hospital may, as one of its projects, develop and implement an information technology system explicitly designed to improve patient safety and quality of care. This project, in its initial stage of development, does not need to demonstrate measurable improvement in indicators related to health outcomes.
(3)
The hospital must document what quality improvement projects are being conducted, the reasons for conducting these projects, and the measurable progress achieved on these projects.
(4)
A hospital is not required to participate in a QIO cooperative project, but its own projects are required to be of comparable effort.
(e)
Standard: Maternal health QAPI activities. Effective January 1, 2027, for hospitals that offer obstetrical services, the following additional QAPI requirements apply:
(1)
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 paragraph (b) of this section.
(2)
If a maternal mortality review committee (MMRC) is available at the State, Tribal, or local jurisdiction in which the hospital 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 hospital QAPI program as specified in paragraph (b) of this section.
(f)
Standard: Executive responsibilities. The hospital's governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following:
(1)
That an ongoing program for quality improvement and patient safety, including the reduction of medical errors, is defined, implemented, and maintained.
(2)
That the hospital-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety; and that all improvement actions are evaluated.
(3)
That clear expectations for safety are established.
(4)
That adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital's performance and reducing risk to patients.
(5)
That the determination of the number of distinct improvement projects is conducted annually.
(g)
Standard: Unified and integrated QAPI program for multi-hospital systems. If a hospital is part of a hospital system consisting of multiple separately certified hospitals using a system governing body that is legally responsible for the conduct of two or more hospitals, the system governing body can elect to have a unified and integrated QAPI program for all of its member hospitals 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 hospitals meets all of the requirements of this section. Each separately certified hospital 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 hospital's unique circumstances and any significant differences in patient populations and services offered in each hospital; 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 hospitals, 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 hospitals are duly considered and addressed.
Notes, amendments, and revision history

Amendments

[68 FR 3454, Jan. 24, 2003, as amended at 84 FR 51818, Sept. 30, 2019; 89 FR 94591, Nov. 27, 2024]

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

[68 FR 3454, Jan. 24, 2003, as amended at 84 FR 51818, Sept. 30, 2019; 89 FR 94591, Nov. 27, 2024]

§482.22. Condition of participation: Medical staff.

42 C.F.R. § 482.22

The hospital must have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital.
(a)
Standard: Eligibility and process for appointment to medical staff. The medical staff must be composed of doctors of medicine or osteopathy. In accordance with State law, including scope-of-practice laws, the medical staff may also include other categories of physicians (as listed at § 482.12(c)(1)) and non-physician practitioners who are determined to be eligible for appointment by the governing body.
(1)
The medical staff must periodically conduct appraisals of its members.
(2)
The medical staff must examine the credentials of all eligible candidates for medical staff membership and make recommendations to the governing body on the appointment of these candidates in accordance with State law, including scope-of-practice laws, and the medical staff bylaws, rules, and regulations. A candidate who has been recommended by the medical staff and who has been appointed by the governing body is subject to all medical staff bylaws, rules, and regulations, in addition to the requirements contained in this section.
(3)
When telemedicine services are furnished to the hospital's patients through an agreement with a distant-site hospital, the governing body of the hospital whose patients are receiving the telemedicine services may choose, in lieu of the requirements in paragraphs (a)(1) and (a)(2) of this section, to have its medical staff rely upon the credentialing and privileging decisions made by the distant-site hospital when making recommendations on privileges for the individual distant-site physicians and practitioners providing such services, if the hospital's governing body ensures, through its written agreement with the distant-site hospital, that all of the following provisions are met:
(i)
The distant-site hospital providing the telemedicine services is a Medicare-participating hospital.
(ii)
The individual distant-site physician or practitioner is privileged at the distant-site hospital providing the telemedicine services, which provides a current list of the distant-site physician's or practitioner's privileges at the distant-site hospital.
(iii)
The individual distant-site physician or practitioner holds a license issued or recognized by the State in which the hospital whose patients are receiving the telemedicine services is located.
(iv)
With respect to a distant-site physician or practitioner, who holds current privileges at the hospital whose patients are receiving the telemedicine services, the hospital has evidence of an internal review of the distant-site physician's or practitioner's performance of these privileges and sends the distant-site hospital such performance information for use in the periodic appraisal of the distant-site physician or practitioner. At a minimum, this information must include all adverse events that result from the telemedicine services provided by the distant-site physician or practitioner to the hospital's patients and all complaints the hospital has received about the distant-site physician or practitioner.
(4)
When telemedicine services are furnished to the hospital's patients through an agreement with a distant-site telemedicine entity, the governing body of the hospital whose patients are receiving the telemedicine services may choose, in lieu of the requirements in paragraphs (a)(1) and (a)(2) of this section, to have its medical staff rely upon the credentialing and privileging decisions made by the distant-site telemedicine entity when making recommendations on privileges for the individual distant-site physicians and practitioners providing such services, if the hospital's governing body ensures, through its written agreement with the distant-site telemedicine entity, that the distant-site telemedicine entity furnishes services that, in accordance with § 482.12(e), permit the hospital to comply with all applicable conditions of participation for the contracted services. The hospital's governing body must also ensure, through its written agreement with the distant-site telemedicine entity, that all of the following provisions are met:
(i)
The distant-site telemedicine entity's medical staff credentialing and privileging process and standards at least meet the standards at § 482.12(a)(1) through (a)(7) and § 482.22(a)(1) through (a)(2).
(ii)
The individual distant-site physician or practitioner is privileged at the distant-site telemedicine entity providing the telemedicine services, which provides the hospital with a current list of the distant-site physician's or practitioner's privileges at the distant-site telemedicine entity.
(iii)
The individual distant-site physician or practitioner holds a license issued or recognized by the State in which the hospital whose patients are receiving such telemedicine services is located.
(iv)
With respect to a distant-site physician or practitioner, who holds current privileges at the hospital whose patients are receiving the telemedicine services, the hospital has evidence of an internal review of the distant-site physician's or practitioner's performance of these privileges and sends the distant-site telemedicine entity such performance information for use in the periodic appraisal of the distant-site physician or practitioner. At a minimum, this information must include all adverse events that result from the telemedicine services provided by the distant-site physician or practitioner to the hospital's patients, and all complaints the hospital has received about the distant-site physician or practitioner.
(b)
Standard: Medical staff organization and accountability. The medical staff must be well organized and accountable to the governing body for the quality of the medical care provided to patients.
(1)
The medical staff must be organized in a manner approved by the governing body.
(2)
If the medical staff has an executive committee, a majority of the members of the committee must be doctors of medicine or osteopathy.
(3)
The responsibility for organization and conduct of the medical staff must be assigned only to one of the following:
(i)
An individual doctor of medicine or osteopathy.
(ii)
A doctor of dental surgery or dental medicine, when permitted by State law of the State in which the hospital is located.
(iii)
A doctor of podiatric medicine, when permitted by State law of the State in which the hospital is located.
(4)
If a hospital is part of a hospital system consisting of multiple separately certified hospitals and the system elects to have a unified and integrated medical staff for its member hospitals, after determining that such a decision is in accordance with all applicable State and local laws, each separately certified hospital must demonstrate that:
(i)
The medical staff members of each separately certified hospital in the system (that is, all medical staff members who hold specific privileges to practice at that hospital) have voted by majority, in accordance with medical staff bylaws, either to accept a unified and integrated medical staff structure or to opt out of such a structure and to maintain a separate and distinct medical staff for their respective hospital;
(ii)
The unified and integrated medical staff has bylaws, rules, and requirements that describe its processes for self-governance, appointment, credentialing, privileging, and oversight, as well as its peer review policies and due process rights guarantees, and which include a process for the members of the medical staff of each separately certified hospital (that is, all medical staff members who hold specific privileges to practice at that hospital) to be advised of their rights to opt out of the unified and integrated medical staff structure after a majority vote by the members to maintain a separate and distinct medical staff for their hospital;
(iii)
The unified and integrated medical staff is established in a manner that takes into account each member hospital's unique circumstances and any significant differences in patient populations and services offered in each hospital; and
(iv)
The unified and integrated medical staff establishes and implements policies and procedures to ensure that the needs and concerns expressed by members of the medical staff, at each of its separately certified hospitals, regardless of practice or location, are given due consideration, and that the unified and integrated medical staff has mechanisms in place to ensure that issues localized to particular hospitals are duly considered and addressed.
(c)
Standard: Medical staff bylaws. The medical staff must adopt and enforce bylaws to carry out its responsibilities. The bylaws must:
(1)
Be approved by the governing body.
(2)
Include a statement of the duties and privileges of each category of medical staff (e.g., active, courtesy, etc.)
(3)
Describe the organization of the medical staff.
(4)
Describe the qualifications to be met by a candidate in order for the medical staff to recommend that the candidate be appointed by the governing body.
(5)
Include a requirement that—
(i)
A medical history and physical examination be completed and documented for each patient no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, and except as provided under paragraph (c)(5)(iii) of this section. The medical history and physical examination must be completed and documented by a physician (as defined in section 1861(r) of the Act), an oral and maxillofacial surgeon, or other qualified licensed individual in accordance with State law and hospital policy.
(ii)
An updated examination of the patient, including any changes in the patient's condition, be completed and documented within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, when the medical history and physical examination are completed within 30 days before admission or registration, and except as provided under paragraph (c)(5)(iii) of this section. The updated examination of the patient, including any changes in the patient's condition, must be completed and documented by a physician (as defined in section 1861(r) of the Act), an oral and maxillofacial surgeon, or other qualified licensed individual in accordance with State law and hospital policy.
(iii)
An assessment of the patient (in lieu of the requirements of paragraphs (c)(5)(i) and (ii) of this section) be completed and documented after registration, but prior to surgery or a procedure requiring anesthesia services, when the patient is receiving specific outpatient surgical or procedural services and when the medical staff has chosen to develop and maintain a policy that identifies, in accordance with the requirements at paragraph (c)(5)(v) of this section, specific patients as not requiring a comprehensive medical history and physical examination, or any update to it, prior to specific outpatient surgical or procedural services. The assessment must be completed and documented by a physician (as defined in section 1861(r) of the Act), an oral and maxillofacial surgeon, or other qualified licensed individual in accordance with State law and hospital policy.
(iv)
The medical staff develop and maintain a policy that identifies those patients for whom the assessment requirements of paragraph (c)(5)(iii) of this section would apply. The provisions of paragraphs (c)(5)(iii), (iv), and (v) of this section do not apply to a medical staff that chooses to maintain a policy that adheres to the requirements of paragraphs of (c)(5)(i) and (ii) of this section for all patients.
(v)
The medical staff, if it chooses to develop and maintain a policy for the identification of specific patients to whom the assessment requirements in paragraph (c)(5)(iii) of this section would apply, must demonstrate evidence that the policy applies only to those patients receiving specific outpatient surgical or procedural services as well as evidence that the policy is based on:
(A)
Patient age, diagnoses, the type and number of surgeries and procedures scheduled to be performed, comorbidities, and the level of anesthesia required for the surgery or procedure.
(B)
Nationally recognized guidelines and standards of practice for assessment of specific types of patients prior to specific outpatient surgeries and procedures.
(C)
Applicable state and local health and safety laws.
(6)
Include criteria for determining the privileges to be granted to individual practitioners and a procedure for applying the criteria to individuals requesting privileges. For distant-site physicians and practitioners requesting privileges to furnish telemedicine services under an agreement with the hospital, the criteria for determining privileges and the procedure for applying the criteria are also subject to the requirements in § 482.12(a)(8) and (a)(9), and § 482.22(a)(3) and (a)(4).
Notes, amendments, and revision history

Amendments

[51 FR 22042, June 17, 1986, as amended at 59 FR 64152, Dec. 13, 1994; 71 FR 68694, Nov. 27, 2006; 72 FR 66933, Nov. 27, 2007; 76 FR 25563, May 5, 2011; 77 FR 29074, May 16, 2012; 79 FR 27154, May 12, 2014; 84 FR 51818, Sept. 30, 2019]

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

[51 FR 22042, June 17, 1986, as amended at 59 FR 64152, Dec. 13, 1994; 71 FR 68694, Nov. 27, 2006; 72 FR 66933, Nov. 27, 2007; 76 FR 25563, May 5, 2011; 77 FR 29074, May 16, 2012; 79 FR 27154, May 12, 2014; 84 FR 51818, Sept. 30, 2019]

§482.23. Condition of participation: Nursing services.

42 C.F.R. § 482.23

The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse.
(a)
Standard: Organization. The hospital must have a well-organized service with a plan of administrative authority and delineation of responsibilities for patient care. The director of the nursing service must be a licensed registered nurse. He or she is responsible for the operation of the service, including determining the types and numbers of nursing personnel and staff necessary to provide nursing care for all areas of the hospital.
(b)
Standard: Staffing and delivery of care. The nursing service must have adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed. There must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for the care of any patient.
(1)
The hospital must provide 24-hour nursing services furnished or supervised by a registered nurse, and have a licensed practical nurse or registered nurse on duty at all times, except for rural hospitals that have in effect a 24-hour nursing waiver granted under § 488.54(c) of this chapter.
(2)
The nursing service must have a procedure to ensure that hospital nursing personnel for whom licensure is required have valid and current licensure.
(3)
A registered nurse must supervise and evaluate the nursing care for each patient.
(4)
The hospital must ensure that the nursing staff develops and keeps current a nursing care plan for each patient that reflects the patient's goals and the nursing care to be provided to meet the patient's needs. The nursing care plan may be part of an interdisciplinary care plan.
(5)
A registered nurse must assign the nursing care of each patient to other nursing personnel in accordance with the patient's needs and the specialized qualifications and competence of the nursing staff available.
(6)
All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of the clinical activities of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer).
(7)
The hospital must have policies and procedures in place establishing which outpatient departments, if any, are not required under hospital policy to have a registered nurse present. The policies and procedures must:
(i)
Establish the criteria such outpatient departments must meet, taking into account the types of services delivered, the general level of acuity of patients served by the department, and the established standards of practice for the services delivered;
(ii)
Establish alternative staffing plans;
(iii)
Be approved by the director of nursing;
(iv)
Be reviewed at least once every 3 years.
(c)
Standard: Preparation and administration of drugs.
(1)
Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient's care, and accepted standards of practice.
(i)
Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under § 482.12(c) only if such practitioners are acting in accordance with State law, including scope-of-practice laws, hospital policies, and medical staff bylaws, rules, and regulations.
(ii)
Drugs and biologicals may be prepared and administered on the orders contained within pre-printed and electronic standing orders, order sets, and protocols for patient orders only if such orders meet the requirements of § 482.24(c)(3).
(2)
All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures.
(3)
With the exception of influenza and pneumococcal vaccines, which may be administered per physician-approved hospital policy after an assessment of contraindications, orders for drugs and biologicals must be documented and signed by a practitioner who is authorized to write orders in accordance with State law and hospital policy, and who is responsible for the care of the patient.
(i)
If verbal orders are used, they are to be used infrequently.
(ii)
When verbal orders are used, they must only be accepted by persons who are authorized to do so by hospital policy and procedures consistent with Federal and State law.
(iii)
Orders for drugs and biologicals may be documented and signed by other practitioners only if such practitioners are acting in accordance with State law, including scope-of-practice laws, hospital policies, and medical staff bylaws, rules, and regulations.
(4)
Blood transfusions and intravenous medications must be administered in accordance with State law and approved medical staff policies and procedures.
(5)
There must be a hospital procedure for reporting transfusion reactions, adverse drug reactions, and errors in administration of drugs.
(6)
The hospital may allow a patient (or his or her caregiver/support person where appropriate) to self-administer both hospital-issued medications and the patient's own medications brought into the hospital, as defined and specified in the hospital's policies and procedures.
(i)
If the hospital allows a patient to self-administer specific hospital-issued medications, then the hospital must have policies and procedures in place to:
(A)
Ensure that a practitioner responsible for the care of the patient has issued an order, consistent with hospital policy, permitting self-administration.
(B)
Assess the capacity of the patient (or the patient's caregiver/support person where appropriate) to self-administer the specified medication(s).
(C)
Instruct the patient (or the patient's caregiver/support person where appropriate) in the safe and accurate administration of the specified medication(s).
(D)
Address the security of the medication(s) for each patient.
(E)
Document the administration of each medication, as reported by the patient (or the patient's caregiver/support person where appropriate), in the patient's medical record.
(ii)
If the hospital allows a patient to self-administer his or her own specific medications brought into the hospital, then the hospital must have policies and procedures in place to:
(A)
Ensure that a practitioner responsible for the care of the patient has issued an order, consistent with hospital policy, permitting self-administration of medications the patient brought into the hospital.
(B)
Assess the capacity of the patient (or the patient's caregiver/support person where appropriate) to self-administer the specified medication(s), and also determine if the patient (or the patient's caregiver/support person where appropriate) needs instruction in the safe and accurate administration of the specified medication(s).
(C)
Identify the specified medication(s) and visually evaluate the medication(s) for integrity.
(D)
Address the security of the medication(s) for each patient.
(E)
Document the administration of each medication, as reported by the patient (or the patient's caregiver/support person where appropriate), in the patient's medical record.
Notes, amendments, and revision history

Amendments

[51 FR 22042, June 17, 1986, as amended at 67 FR 61814, Oct. 2, 2002; 71 FR 68694, Nov. 27, 2006; 72 FR 66933, Nov. 27, 2007; 77 FR 29074, May 16, 2012; 78 FR 50970, Aug. 19, 2013; 79 FR 44129, July 30, 2014; 84 FR 51819, Sept. 30, 2019]

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

[51 FR 22042, June 17, 1986, as amended at 67 FR 61814, Oct. 2, 2002; 71 FR 68694, Nov. 27, 2006; 72 FR 66933, Nov. 27, 2007; 77 FR 29074, May 16, 2012; 78 FR 50970, Aug. 19, 2013; 79 FR 44129, July 30, 2014; 84 FR 51819, Sept. 30, 2019]

§482.24. Condition of participation: Medical record services.

42 C.F.R. § 482.24

The hospital must have a medical record service that has administrative responsibility for medical records. A medical record must be maintained for every individual evaluated or treated in the hospital.
(a)
Standard: Organization and staffing. The organization of the medical record service must be appropriate to the scope and complexity of the services performed. The hospital must employ adequate personnel to ensure prompt completion, filing, and retrieval of records.
(b)
Standard: Form and retention of record. The hospital must maintain a medical record for each inpatient and outpatient. Medical records must be accurately written, promptly completed, properly filed and retained, and accessible. The hospital must use a system of author identification and record maintenance that ensures the integrity of the authentification and protects the security of all record entries.
(1)
Medical records must be retained in their original or legally reproduced form for a period of at least 5 years.
(2)
The hospital must have a system of coding and indexing medical records. The system must allow for timely retrieval by diagnosis and procedure, in order to support medical care evaluation studies.
(3)
The hospital must have a procedure for ensuring the confidentiality of patient records. In-formation from or copies of records may be released only to authorized individuals, and the hospital must ensure that unauthorized individuals cannot gain access to or alter patient records. Original medical records must be released by the hospital only in accordance with Federal or State laws, court orders, or subpoenas.
(c)
Standard: Content of record. The medical record must contain information to justify admission and continued hospitalization, support the diagnosis, and describe the patient's progress and response to medications and services.
(1)
All patient medical record entries must be legible, complete, dated, timed, and authenticated in written or electronic form by the person responsible for providing or evaluating the service provided, consistent with hospital policies and procedures.
(2)
All orders, including verbal orders, must be dated, timed, and authenticated promptly by the ordering practitioner or by another practitioner who is responsible for the care of the patient only if such a practitioner is acting in accordance with State law, including scope-of-practice laws, hospital policies, and medical staff bylaws, rules, and regulations.
(3)
Hospitals may use pre-printed and electronic standing orders, order sets, and protocols for patient orders only if the hospital:
(i)
Establishes that such orders and protocols have been reviewed and approved by the medical staff and the hospital's nursing and pharmacy leadership;
(ii)
Demonstrates that such orders and protocols are consistent with nationally recognized and evidence-based guidelines;
(iii)
Ensures that the periodic and regular review of such orders and protocols is conducted by the medical staff and the hospital's nursing and pharmacy leadership to determine the continuing usefulness and safety of the orders and protocols; and
(iv)
Ensures that such orders and protocols are dated, timed, and authenticated promptly in the patient's medical record by the ordering practitioner or by another practitioner responsible for the care of the patient only if such a practitioner is acting in accordance with State law, including scope-of-practice laws, hospital policies, and medical staff bylaws, rules, and regulations.
(4)
All records must document the following, as appropriate:
(i)
Evidence of—
(A)
A medical history and physical examination completed and documented no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, and except as provided under paragraph (c)(4)(i)(C) of this section. The medical history and physical examination must be placed in the patient's medical record within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services.
(B)
An updated examination of the patient, including any changes in the patient's condition, when the medical history and physical examination are completed within 30 days before admission or registration, and except as provided under paragraph (c)(4)(i)(C) of this section. Documentation of the updated examination must be placed in the patient's medical record within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services.
(C)
An assessment of the patient (in lieu of the requirements of paragraphs (c)(4)(i)(A) and (B) of this section) completed and documented after registration, but prior to surgery or a procedure requiring anesthesia services, when the patient is receiving specific outpatient surgical or procedural services and when the medical staff has chosen to develop and maintain a policy that identifies, in accordance with the requirements at § 482.22(c)(5)(v), specific patients as not requiring a comprehensive medical history and physical examination, or any update to it, prior to specific outpatient surgical or procedural services.
(ii)
Admitting diagnosis.
(iii)
Results of all consultative evaluations of the patient and appropriate findings by clinical and other staff involved in the care of the patient.
(iv)
Documentation of complications, hospital acquired infections, and unfavorable reactions to drugs and anesthesia.
(v)
Properly executed informed consent forms for procedures and treatments specified by the medical staff, or by Federal or State law if applicable, to require written patient consent.
(vi)
All practitioners' orders, nursing notes, reports of treatment, medication records, radiology, and laboratory reports, and vital signs and other information necessary to monitor the patient's condition.
(vii)
Discharge summary with outcome of hospitalization, disposition of case, and provisions for follow-up care.
(viii)
Final diagnosis with completion of medical records within 30 days following discharge.
(d)
Standard: Electronic notifications. If the hospital 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 hospital must demonstrate that—
(1)
The system's notification capacity is fully operational and the hospital uses it in accordance with all State and Federal statutes and regulations applicable to the hospital'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 hospital's emergency department (if applicable).
(ii)
The patient's admission to the hospital'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 hospital's emergency department (if applicable).
(ii)
The patient's discharge or transfer from the hospital's inpatient services (if applicable).
(5)
The hospital 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.
Notes, amendments, and revision history

Amendments

[51 FR 22042, June 17, 1986, as amended at 71 FR 68694, Nov. 27, 2006; 72 FR 66933, Nov. 27, 2007; 77 FR 29074, May 16, 2012; 84 FR 51819, Sept. 30, 2019; 85 FR 25637, May 1, 2020]

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

[51 FR 22042, June 17, 1986, as amended at 71 FR 68694, Nov. 27, 2006; 72 FR 66933, Nov. 27, 2007; 77 FR 29074, May 16, 2012; 84 FR 51819, Sept. 30, 2019; 85 FR 25637, May 1, 2020]

§482.25. Condition of participation: Pharmaceutical services.

42 C.F.R. § 482.25

The hospital must have pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital's organized pharmaceutical service.
(a)
Standard: Pharmacy management and administration. The pharmacy or drug storage area must be administered in accordance with accepted professional principles.
(1)
A full-time, part-time, or consulting pharmacist must be responsible for developing, supervising, and coordinating all the activities of the pharmacy services.
(2)
The pharmaceutical service must have an adequate number of personnel to ensure quality pharmaceutical services, including emergency services.
(3)
Current and accurate records must be kept of the receipt and disposition of all scheduled drugs.
(b)
Standard: Delivery of services. In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law.
(1)
All compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist and performed consistent with State and Federal laws.
(2)
(i)
All drugs and biologicals must be kept in a secure area, and locked when appropriate.
(ii)
Drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of 1970 must be kept locked within a secure area.
(iii)
Only authorized personnel may have access to locked areas.
(3)
Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use.
(4)
When a pharmacist is not available, drugs and biologicals must be removed from the pharmacy or storage area only by personnel designated in the policies of the medical staff and pharmaceutical service, in accordance with Federal and State law.
(5)
Drugs and biologicals not specifically prescribed as to time or number of doses must automatically be stopped after a reasonable time that is predetermined by the medical staff.
(6)
Drug administration errors, adverse drug reactions, and incompatibilities must be immediately reported to the attending physician and, if appropriate, to the hospital's quality assessment and performance improvement program.
(7)
Abuses and losses of controlled substances must be reported, in accordance with applicable Federal and State laws, to the individual responsible for the pharmaceutical service, and to the chief executive officer, as appropriate.
(8)
Information relating to drug interactions and information of drug therapy, side effects, toxicology, dosage, indications for use, and routes of administration must be available to the professional staff.
(9)
A formulary system must be established by the medical staff to assure quality pharmaceuticals at reasonable costs.
Notes, amendments, and revision history

Amendments

[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986; 71 FR 68694, Nov. 27, 2006; 77 FR 29075, May 16, 2012]

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986; 71 FR 68694, Nov. 27, 2006; 77 FR 29075, May 16, 2012]

§482.26. Condition of participation: Radiologic services.

42 C.F.R. § 482.26

The hospital must maintain, or have available, diagnostic radiologic services. If therapeutic services are also provided, they, as well as the diagnostic services, must meet professionally approved standards for safety and personnel qualifications.
(a)
Standard: Radiologic services. The hospital must maintain, or have available, radiologic services according to needs of the patients.
(b)
Standard: Safety for patients and personnel. The radiologic services, particularly ionizing radiology procedures, must be free from hazards for patients and personnel.
(1)
Proper safety precutions must be maintained against radiation hazards. This includes adequate shielding for patients, personnel, and facilities, as well as appropriate storage, use, and disposal of radioactive materials.
(2)
Periodic inspection of equipment must be made and hazards identified must be promptly corrected.
(3)
Radiation workers must be checked periodically, by the use of exposure meters or badge tests, for amount of radiation exposure.
(4)
Radiologic services must be provided only on the order of practitioners with clinical privileges or, consistent with State law, of other practitioners authorized by the medical staff and the governing body to order the services.
(c)
Standard: Personnel.
(1)
A qualified full-time, part-time, or consulting radiologist must supervise the ionizing radiology services and must interpret only those radiologic tests that are determined by the medical staff to require a radiologist's specialized knowledge. For purposes of this section, a radiologist is a doctor of medicine or osteopathy who is qualified by education and experience in radiology.
(2)
Only personnel designated as qualified by the medical staff may use the radiologic equipment and administer procedures.
(d)
Standard: Records. Records of radiologic services must be maintained.
(1)
The radiologist or other practitioner who performs radiology services must sign reports of his or her interpretations.
(2)
The hospital must maintain the following for at least 5 years:
(i)
Copies of reports and printouts.
(ii)
Films, scans, and other image records, as appropriate.
Notes, amendments, and revision history

Amendments

[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986]

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986]

§482.27. Condition of participation: Laboratory services.

42 C.F.R. § 482.27

The hospital must maintain, or have available, adequate laboratory services to meet the needs of its patients. The hospital must ensure that all laboratory services provided to its patients are performed in a facility certified in accordance with part 493 of this chapter.
(a)
Standard: Adequacy of laboratory services. The hospital must have laboratory services available, either directly or through a contractual agreement with a certified laboratory that meets requirements of part 493 of this chapter.
(1)
Emergency laboratory services must be available 24 hours a day.
(2)
A written description of services provided must be available to the medical staff.
(3)
The laboratory must make provision for proper receipt and reporting of tissue specimens.
(4)
The medical staff and a pathologist must determine which tissue specimens require a macroscopic (gross) examination and which require both macroscopic and microscopic examinations.
(b)
Standard: Potentially infectious blood and blood components—
(1)
Potentially human immunodeficiency virus (HIV) infectious blood and blood components. Potentially HIV infectious blood and blood components are prior collections from a donor—
(i)
Who tested negative at the time of donation but tests reactive for evidence of HIV infection on a later donation;
(ii)
Who tests positive on the supplemental (additional, more specific) test or other follow-up testing required by FDA; and
(iii)
For whom the timing of seroconversion cannot be precisely estimated.
(2)
Potentially hepatitis C virus (HCV) infectious blood and blood components. Potentially HCV infectious blood and blood components are the blood and blood components identified in 21 CFR 610.47.
(3)
Services furnished by an outside blood collecting establishment. If a hospital regularly uses the services of an outside blood collecting establishment, it must have an agreement with the blood collecting establishment that governs the procurement, transfer, and availability of blood and blood components. The agreement must require that the blood collecting establishment notify the hospital—
(i)
Within 3 calendar days if the blood collecting establishment supplied blood and blood components collected from a donor who tested negative at the time of donation but tests reactive for evidence of HIV or HCV infection on a later donation or who is determined to be at increased risk for transmitting HIV or HCV infection;
(ii)
Within 45 days of the test, of the results of the supplemental (additional, more specific) test for HIV or HCV, as relevant, or other follow-up testing required by FDA; and
(iii)
Within 3 calendar days after the blood collecting establishment supplied blood and blood components collected from an infectious donor, whenever records are available.
(4)
Quarantine and disposition of blood and blood components pending completion of testing. If the blood collecting establishment (either internal or under an agreement) notifies the hospital of the reactive HIV or HCV screening test results, the hospital must determine the disposition of the blood or blood product and quarantine all blood and blood components from previous donations in inventory.
(i)
If the blood collecting establishment notifies the hospital that the result of the supplemental (additional, more specific) test or other follow-up testing required by FDA is negative, absent other informative test results, the hospital may release the blood and blood components from quarantine.
(ii)
If the blood collecting establishment notifies the hospital that the result of the supplemental, (additional, more specific) test or other follow-up testing required by FDA is positive, the hospital must—
(A)
Dispose of the blood and blood components; and
(B)
Notify the transfusion beneficiaries as set forth in paragraph (b)(6) of this section.
(iii)
If the blood collecting establishment notifies the hospital that the result of the supplemental, (additional, more specific) test or other follow-up testing required by FDA is indeterminate, the hospital must destroy or label prior collections of blood or blood components held in quarantine as set forth at 21 CFR 610.46(b)(2) and 610.47(b)(2).
(5)
Recordkeeping by the hospital. The hospital must maintain—
(i)
Records of the source and disposition of all units of blood and blood components for at least 10 years from the date of disposition in a manner that permits prompt retrieval; and
(ii)
A fully funded plan to transfer these records to another hospital or other entity if such hospital ceases operation for any reason.
(6)
Patient notification. If the hospital has administered potentially HIV or HCV infectious blood or blood components (either directly through its own blood collecting establishment or under an agreement) or released such blood or blood components to another entity or individual, the hospital must take the following actions:
(i)
Make reasonable attempts to notify the patient, or to notify the attending physician or the physician who ordered the blood or blood component and ask the physician to notify the patient, or other individual as permitted under paragraph (b)(10) of this section, that potentially HIV or HCV infectious blood or blood components were transfused to the patient and that there may be a need for HIV or HCV testing and counseling.
(ii)
If the physician is unavailable or declines to make the notification, make reasonable attempts to give this notification to the patient, legal guardian, or relative.
(iii)
Document in the patient's medical record the notification or attempts to give the required notification.
(7)
Timeframe for notification— For donors tested on or after February 20, 2008. For notifications resulting from donors tested on or after February 20, 2008 as set forth at 21 CFR 610.46 and 610.47 the notification effort begins when the blood collecting establishment notifies the hospital that it received potentially HIV or HCV infectious blood and blood components. The hospital must make reasonable attempts to give notification over a period of 12 weeks unless—
(i)
The patient is located and notified; or
(ii)
The hospital is unable to locate the patient and documents in the patient's medical record the extenuating circumstances beyond the hospital's control that caused the notification timeframe to exceed 12 weeks.
(8)
Content of notification. The notification must include the following information:
(i)
A basic explanation of the need for HIV or HCV testing and counseling;
(ii)
Enough oral or written information so that an informed decision can be made about whether to obtain HIV or HCV testing and counseling; and
(iii)
A list of programs or places where the person can obtain HIV or HCV testing and counseling, including any requirements or restrictions the program may impose.
(9)
Policies and procedures. The hospital must establish policies and procedures for notification and documentation that conform to Federal, State, and local laws, including requirements for the confidentiality of medical records and other patient information.
(10)
Notification to legal representative or relative. If the patient has been adjudged incompetent by a State court, the physician or hospital must notify a legal representative designated in accordance with State law. If the patient is competent, but State law permits a legal representative or relative to receive the information on the patient's behalf, the physician or hospital must notify the patient or his or her legal representative or relative. For possible HIV infectious transfusion beneficiaries that are deceased, the physician or hospital must inform the deceased patient's legal representative or relative. If the patient is a minor, the parents or legal guardian must be notified.
(c)
General blood safety issues. For lookback activities only related to new blood safety issues that are identified after August 24, 2007, hospitals must comply with FDA regulations as they pertain to blood safety issues in the following areas:
(1)
Appropriate testing and quarantining of infectious blood and blood components.
(2)
Notification and counseling of beneficiaries that may have received infectious blood and blood components.
Notes, amendments, and revision history

Amendments

[57 FR 7136, Feb. 28, 1992, as amended at 61 FR 47433, Sept. 9, 1996; 72 FR 48573, Aug. 24, 2007; 84 FR 51819, Sept. 30, 2019; 85 FR 72909, Nov. 16, 2020]

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

[57 FR 7136, Feb. 28, 1992, as amended at 61 FR 47433, Sept. 9, 1996; 72 FR 48573, Aug. 24, 2007; 84 FR 51819, Sept. 30, 2019; 85 FR 72909, Nov. 16, 2020]