Nick-Maximillien/medgate-compiler-data huggingface dataset:
Guideline text:
(Rev. 37, Issued:  10-17-08; Effective/Implementation Date:  10-17-08)

§482.23(b)(2) - The nursing service must have a procedure to ensure that hospital nursing personnel for whom licensure is required have valid and current licensure.

## Interpretive Guidelines §482.23(b)(2)

The hospital's procedure must ensure that all nursing personnel have valid and current licensure that complies with State licensure laws.  Furthermore, the Condition of Participation (CoP) Compliance with Federal, State and local laws (42 CFR 482.11) requires the hospital to assure that personnel meet applicable standards (such as continuing education, certification or training) required by State or local law.

## Survey Procedures §482.23(b)(2)

- Review hospital personnel records or records kept by the nursing service to determine that RNs, LPNs, and other nursing personnel for whom licensure is required have current valid licenses.
- Review the nursing service licensure verification policies and procedures.  Is licensure verified for each individual nursing services staff person for whom licensure is required?

A-0395

(Rev. 37, Issued:  10-17-08; Effective/Implementation Date:  10-17-08)

## §482.23(b)(3) - A registered nurse must supervise and evaluate the nursing care for each patient.

## Interpretive Guidelines §482.23(b)(3)

A RN must supervise the nursing care for each patient.  A RN must evaluate the care for each patient upon admission and when appropriate on an ongoing basis in accordance with accepted standards of nursing practice and hospital policy.  Evaluation would include assessing the patient's care needs, patient's health status/conditioning, as well as the patient's response to interventions.

## Survey Procedures §482.23(b)(3)

- Review staffing schedules and assignments.
- Determine that a RN is assigned to supervise and evaluate the nursing care furnished to each patient.

Structured rule (JSON):
{"intent_tags": ["safety", "quality", "compliance"], "logic_config": {"required_artifact": "valid and current licensure for nursing personnel"}, "rule_type": "existence", "scope_tags": ["facility", "legal"]}
Guideline text:
Limit consultation to 7 units per session.

Structured rule (JSON):
{"intent_tags": ["safety"], "logic_config": {"event_type": "consultation", "max_count": 7}, "rule_type": "count_sanity", "scope_tags": ["clinical"]}
Guideline text:
(Rev. 151, Issued: 11-20-15, Effective: 11-20-15, Implementation: 11-20-15)

§482.25(b)(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.

## Interpretive Guidelines §482.25(b)(5)

In accordance with accepted standards of practice, the medical staff, in coordination and consultation with the pharmacy service, determines and establishes the reasonable time to automatically stop orders for drugs and biologicals not specifically prescribed as to time or number of doses.  The hospital must implement, monitor, and enforce this automatic stop system.

It is important to note that hospitals with an electronic health record (EHR) system may have time and dose parameters automatically built into computerized provider order entry (CPOE) screens.  These may be part of the hospital's plan for addressing automatic stop orders.

## Survey Procedures §482.25(b)(5)

- Review policies and procedures to determine that there is a protocol established by the medical staff to discontinue and review patients' medical records to determine compliance with stop-order policy;
- Ask unit staff what happens in the case of drugs with no stop date or prescribed number of doses.  Are they aware of the automatic stop policy?  Can they describe how it is enforced?

Structured rule (JSON):
{"intent_tags": ["safety", "quality", "compliance"], "logic_config": {"required_artifact": "automatic drug discontinuation after a reasonable time predetermined by medical staff", "trigger_assertion": "drug order lacks specific time or number of doses"}, "rule_type": "conditional_existence", "scope_tags": ["clinical", "facility", "legal"]}
Guideline text:
It is recommended that all hospitals participating in the care of high-risk patients have an ICCU/CCU equipped to provide all required aspects of care, including treatment of ischaemia, severe heart failure, arrhythmias, and common comorbidities.

Structured rule (JSON):
{"intent_tags": ["safety", "quality"], "logic_config": {"required_artifact": "ICCU/CCU equipped to provide all required aspects of care for high-risk patients"}, "rule_type": "existence", "scope_tags": ["facility"]}
Guideline text:
If the LDL-C goal is not achieved despite maximally tolerated statin therapy and ezetimibe after 4–6 weeks, the addition of a PCSK9 inhibitor is recommended. 785 , 786 , 795 , 796

Structured rule (JSON):
{"intent_tags": ["safety", "quality"], "logic_config": {"required_artifact": "addition of a PCSK9 inhibitor", "trigger_assertion": "LDL-C goal is not achieved despite maximally tolerated statin therapy and ezetimibe after 4\u20136 weeks"}, "rule_type": "conditional_existence", "scope_tags": ["clinical"]}
Guideline text:
(Rev. 200, Issued: 02-21-20; Effective: 02-21-20, Implementation: 02-21-20)

§482.42(d)(3)  The unified and integrated infection prevention and control and antibiotic stewardship programs have mechanisms in place to ensure that issues localized to particular hospitals are duly considered and addressed; and

## Interpretive Guidelines §482.42(d)(3)

Guidance is pending and will be updated in future release.

Structured rule (JSON):
{"intent_tags": ["safety", "quality", "compliance"], "logic_config": {"required_artifact": "unified and integrated infection prevention and control and antibiotic stewardship programs with mechanisms to address localized issues"}, "rule_type": "existence", "scope_tags": ["clinical", "facility", "legal"]}
Guideline text:
Heart Rate must be above 66.

Structured rule (JSON):
{"intent_tags": ["safety"], "logic_config": {"min_value": 66, "target_vital": "Heart Rate"}, "rule_type": "threshold", "scope_tags": ["clinical"]}
Guideline text:
The committee met in 2024 to review the guidelines. [Ref: 977]

Structured rule (JSON):
{"intent_tags": [], "logic_config": {}, "rule_type": "unsupported", "scope_tags": [], "summary": "Non-executable narrative text"}
Guideline text:
In P2Y 12 receptor inhibitor-naïve patients undergoing PCI, cangrelor may be considered. 251 – 254

Structured rule (JSON):
{"intent_tags": ["safety", "quality"], "logic_config": {"required_artifact": "cangrelor consideration", "trigger_assertion": "P2Y 12 receptor inhibitor-na\u00efve patients undergoing PCI"}, "rule_type": "conditional_existence", "scope_tags": ["clinical"]}
Guideline text:
Transfer to a PCI-capable centre is recommended in all patients immediately after fibrinolysis. 184 – 186 , 212 , 213 , 222 – 224

Structured rule (JSON):
{"intent_tags": ["safety", "quality"], "logic_config": {"anchor": "fibrinolysis", "max_delay_minutes": 0, "target": "transfer to a PCI-capable centre"}, "rule_type": "temporal", "scope_tags": ["clinical"]}
Guideline text:
If the LDL-C goal is not achieved despite maximally tolerated statin therapy and ezetimibe after 4–6 weeks, the addition of a PCSK9 inhibitor is recommended

Structured rule (JSON):
{"intent_tags": ["safety", "quality"], "logic_config": {"required_artifact": "addition of a PCSK9 inhibitor", "trigger_assertion": "LDL-C goal not achieved despite maximally tolerated statin therapy and ezetimibe after 4\u20136 weeks"}, "rule_type": "conditional_existence", "scope_tags": ["clinical"]}
Guideline text:
(Rev. 37, Issued:  10-17-08; Effective/Implementation Date:  10-17-08)

[the patient must be seen face-to-face within 1 hour after the initiation of the intervention -- ]

§482.13(e)(12 ) (ii)To evaluate -

- (A) The patient's immediate situation;
- (B) The patient's reaction to the intervention;
- (C) The patient's medical and behavioral condition; and
- (D) The need to continue or terminate the restraint or seclusion.

## Interpretive Guidelines §482.13(e)(12)(ii)

The 1-hour face-to-face evaluation includes both a physical and behavioral assessment of the patient that must be conducted by a qualified practitioner within the scope of their practice.  An evaluation of the patient's medical condition would include a complete review of systems assessment, behavioral assessment, as well as review and assessment of the patient's history, drugs and medications, most recent lab results, etc.  The purpose is to complete a comprehensive review of the patient's condition to determine if other factors, such as drug or medication interactions, electrolyte imbalances, hypoxia, sepsis, etc., are contributing to the patient's violent or self-destructive behavior.

Training for an RN or PA to conduct the 1-hour face-to-face evaluation would include all of the training requirements at §482.13(f) as well as content to evaluate the patient's immediate situation, the patient's reaction to the intervention, the patient's medical and behavioral condition (documented training in conducting physical and behavioral assessment); and the need to continue or terminate the restraint or seclusion.

## Survey Procedures §482.13(e)(12)(ii):

- Was the 1-hour face-to-face evaluation conducted by a practitioner authorized by hospital policy in accordance with State law to conduct this evaluation?
- If the 1-hour face-to-face evaluations are conducted by RNs who are not advanced practice nurses (APN), verify that those RNs have documented training that demonstrates they are qualified to conduct a physical and behavioral assessment of the patient that addresses:  the patient's immediate situation, the patient's reaction to the intervention, the patient's medical and behavioral condition, and the need to continue or terminate the restraint or seclusion.
- Does documentation of the 1-hour face-to-face evaluation in the patient's medical record include all the listed elements of this requirement?
- Did the evaluation indicate whether changes in the patient's care were required, and, if so, were the changes made?
- Is practice consistent with hospital policy and State law?

Structured rule (JSON):
{"intent_tags": ["safety", "quality", "compliance"], "logic_config": {"anchor": "initiation of intervention (restraint/seclusion)", "max_delay_minutes": 60, "target": "face-to-face evaluation"}, "rule_type": "temporal", "scope_tags": ["clinical", "facility", "legal"]}
Guideline text:
(Rev. 37, Issued:  10-17-08; Effective/Implementation Date:  10-17-08)

## §482.23  Condition of Participation:  Nursing Services

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.

## Interpretive Guidelines §482.23

The hospital must have an organized nursing service and must provide on premise nursing services 24 hours a day, 7 days a week with at least 1 registered nurse (RN) furnishing or supervising the service 24 hours a day, 7 days a week (Exception:  small rural hospitals operating under a waiver as discussed in §482.23(b)(1)).

The Social Security Act (SSA) at §1861(b) states that nursing services must be furnished to inpatients and furnished by the hospital .  The SSA at §1861(e) further requires that the hospital have a RN on duty at all times (except small rural hospitals operating under a nursing waiver).

The nursing service must be a well-organized service of the hospital and under the direction of a registered nurse.

The nursing service must be integrated into the hospital-wide QAPI program.

## Survey Procedures §482.23

- Determine if the nursing service is integrated into the hospital-wide QAPI program.
- Interview the director of the service.  Request the following items:
- Organizational chart(s) for nursing services for all locations where the hospital provides nursing services;
- Job or position descriptions for all nursing personnel including the director's position description.
- Select at least one patient from every inpatient care unit.  Observe the nursing care in progress to determine the adequacy of staffing and to assess the delivery of care. Other sources of information to use in the evaluation of the nursing services are: nursing care plans, medical records, patients, family members, accident and investigative reports, staffing schedules, nursing policies and procedures, and QAPI activities and reports.  Interview patients for information relative to the delivery of nursing services.

Structured rule (JSON):
{"intent_tags": ["safety", "quality", "compliance"], "logic_config": {"required_artifact": "24/7 nursing services furnished or supervised by a Registered Nurse"}, "rule_type": "existence", "scope_tags": ["clinical", "facility", "legal"]}
Guideline text:
Future research is needed to establish optimal thresholds. [Ref: 575]

Structured rule (JSON):
{"intent_tags": [], "logic_config": {}, "rule_type": "unsupported", "scope_tags": [], "summary": "Non-executable narrative text"}
Guideline text:
(Rev. 200, Issued: 02-21-20; Effective: 02-21-20, Implementation: 02-21-20)

§482.43(a)(7) Standard: Discharge Planning Process

(7) The hospital 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 admitted within 30 days of a previous admission, to ensure that the plans are responsive to the patient postdischarge needs.

## Interpretive Guidelines §482.43(a)(7)

Guidance is pending and will be updated in future release.

Structured rule (JSON):
{"intent_tags": ["safety", "quality", "compliance"], "logic_config": {"required_artifact": "regular assessment of discharge planning process, including periodic review of discharge plans and readmissions within 30 days"}, "rule_type": "existence", "scope_tags": ["facility", "legal"]}
Guideline text:
(Rev. 37, Issued:  10-17-08; Effective/Implementation Date:  10-17-08)

§482.25(b)(9) - A formulary system must be established by the medical staff to assure quality pharmaceuticals at reasonable costs.

## Interpretive Guidelines §482.25(b)(9)

The medical staff must establish a formulary system.  The formulary lists medications for dispensing or administration that the hospital maintains or that are readily available.  In accordance with accepted standards of practice, the medical staff, in consultation with the pharmacy service, should develop written criteria for determining what medications are available for dispensing or administration.  At a minimum, the criteria include the indication for use, effectiveness, risks (including propensity for medication errors, abuse potential, and sentinel events), and costs.

Processes and mechanisms should be established to monitor patient responses to a newly added medication before the medication is made available for dispensing or administration within the hospital.

Medications designated as available for dispensing or administration are reviewed periodically based on emerging safety and efficacy information.

The hospital should have processes to approve and procure medications that are not on the hospital's medication list.

The hospital should have processes to address medication shortages and outages, including the following:

- Communicating with appropriate prescribers and staff;
- Developing approved substitution protocols;
- Educating appropriate LIPs, appropriate health care professionals, and staff about these protocols; and
- Obtaining medications in the event of a disaster.

## Survey Procedures §482.25(b)(9)

- Interview the pharmacist to determine that the medical staff has established a formulary that lists drugs that actually are available in the hospital.
- Interview the Pharmacy Director to determine that there is a process for creation and periodic review of a formulary system.
- Determine that the formulary lists drugs that are available.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Structured rule (JSON):
{"intent_tags": ["safety", "quality", "compliance"], "logic_config": {"required_artifact": "medical staff established formulary system"}, "rule_type": "existence", "scope_tags": ["clinical", "facility", "legal"]}
Guideline text:
(Rev. 105, Issued: 03-21-14, Effective: 03-21-14, Implementation: 03-21-14)

## Patient Safety, Medical Errors &amp; Adverse Events

## §§482.21(a)(1), 482.21(a)(2), 482.21(c)(2), &amp; 482.21(e)(3)

§482.21(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 … identify and reduce medical errors.

(2) The hospital must measure, analyze, and track…adverse patient events….

§482.21(c) Standard:  Program Activities…

(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. §482.21(e) 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:…

(3)  That clear expectations for safety are established.

Structured rule (JSON):
{"intent_tags": ["safety", "quality", "compliance"], "logic_config": {"required_artifact": "ongoing patient safety and quality improvement program, including medical error reduction, adverse event tracking, and preventive actions"}, "rule_type": "existence", "scope_tags": ["clinical", "facility", "legal"]}
Guideline text:
See Appendix A for a list of contributing authors. [Ref: 405]

Structured rule (JSON):
{"intent_tags": [], "logic_config": {}, "rule_type": "unsupported", "scope_tags": [], "summary": "Non-executable narrative text"}
Guideline text:
The level of evidence for this section is based on expert consensus. [Ref: 810]

Structured rule (JSON):
{"intent_tags": [], "logic_config": {}, "rule_type": "unsupported", "scope_tags": [], "summary": "Non-executable narrative text"}
Guideline text:
The committee met in 2024 to review the guidelines. [Ref: 670]

Structured rule (JSON):
{"intent_tags": [], "logic_config": {}, "rule_type": "unsupported", "scope_tags": [], "summary": "Non-executable narrative text"}
Guideline text:
Management of MINOCA according to the final established underlying diagnosis is recommended, consistent with the appropriate disease-specific guidelines.

Structured rule (JSON):
{"intent_tags": ["quality", "safety"], "logic_config": {"required_artifact": "Management plan consistent with underlying diagnosis and disease-specific guidelines", "trigger_assertion": "MINOCA diagnosis established"}, "rule_type": "conditional_existence", "scope_tags": ["clinical"]}
Guideline text:
Immediate coronary angiography and PCI of the IRA (if indicated) is recommended in patients with CS complicating ACS. 394 , 396 , 404

Structured rule (JSON):
{"intent_tags": ["safety", "quality"], "logic_config": {"anchor": "diagnosis of CS complicating ACS", "max_delay_minutes": 15, "target": "coronary angiography and PCI of the IRA"}, "rule_type": "temporal", "scope_tags": ["clinical"]}
Guideline text:
(Rev. 200, Issued: 02-21-20; Effective: 02-21-20, Implementation: 02-21-20)

§482.43(c)(2) The hospital , as part of the discharge planning process, must inform the patient or the patient's representative of their freedom to choose among participating Medicare providers and suppliers of the post-discharge services and must, when possible, respect the patient's or the patient's representative goals of care and treatment preferences, as well as other preferences they express. The hospital must not specify or otherwise limit the qualified providers or suppliers that are available to the patients.

## Interpretive Guidelines §482.43(c)(2)

Guidance is pending and will be updated in future release.

(Rev. 200, Issued: 02-21-20; Effective: 02-21-20, Implementation: 02-21-20)

§482.43(c)(3) The discharge plan must identify any HHA or SNF to which the patient is referred in which the hospital has a disclosable financial interest, as specified by the Secretary, and any HHA or SNF that has a disclosable financial interest in a hospital under Medicare. Financial interests that are disclosable under Medicare are determined in accordance with the provisions of part 420, subpart C, of this chapter.

## Interpretive Guidelines §482.43(c)(3)

Guidance is pending and will be updated in future release.

Structured rule (JSON):
{"intent_tags": ["safety", "quality", "compliance", "integrity"], "logic_config": {"required_artifact": "patient informed of freedom to choose post-discharge providers and suppliers, hospital has not limited choices, and discharge plan identifies disclosable financial interests in HHA/SNF referrals", "trigger_assertion": "discharge planning process initiated"}, "rule_type": "conditional_existence", "scope_tags": ["clinical", "facility", "legal"]}
Guideline text:
Ticagrelor is recommended irrespective of the treatment strategy (invasive or conservative) (180 mg LD, 90 mg b.i.d. MD). 238

Structured rule (JSON):
{"intent_tags": ["safety", "quality"], "logic_config": {"required_artifact": "Ticagrelor administration (180 mg LD, 90 mg b.i.d. MD)"}, "rule_type": "existence", "scope_tags": ["clinical"]}
Guideline text:
In HBR patients, aspirin or P2Y12 receptor inhibitor monotherapy after 1 month of DAPT may be considered.

Structured rule (JSON):
{"intent_tags": ["safety", "quality"], "logic_config": {"required_artifact": "consideration of aspirin or P2Y12 receptor inhibitor monotherapy", "trigger_assertion": "patient is High Bleeding Risk (HBR) AND has completed 1 month of Dual Antiplatelet Therapy (DAPT)"}, "rule_type": "conditional_existence", "scope_tags": ["clinical"]}
Guideline text:
Prasugrel should be considered in preference to ticagrelor for ACS patients who proceed to PCI. 244 , 290

Structured rule (JSON):
{"intent_tags": ["safety", "quality"], "logic_config": {"required_artifact": "documentation of Prasugrel preference over Ticagrelor", "trigger_assertion": "patient has Acute Coronary Syndrome (ACS) and proceeds to Percutaneous Coronary Intervention (PCI)"}, "rule_type": "conditional_existence", "scope_tags": ["clinical"]}
Guideline text:
Intravascular imaging (preferably optical coherence tomography) may be considered in patients with ambiguous culprit lesions.

Structured rule (JSON):
{"intent_tags": ["safety", "quality"], "logic_config": {"required_artifact": "intravascular imaging", "trigger_assertion": "ambiguous culprit lesions"}, "rule_type": "conditional_existence", "scope_tags": ["clinical"]}
Guideline text:
Intravenous opioids should be considered to relieve pain.

Structured rule (JSON):
{"intent_tags": ["safety", "quality"], "logic_config": {"required_artifact": "consideration of intravenous opioids for pain relief"}, "rule_type": "existence", "scope_tags": ["clinical"]}