Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

1. Most Frequently Cited Deficiencies for Acute Care Hospitals and ASCs: HFAP Standards and Medicare CoPs Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

2. Most Frequently Cited Deficiencies for Acute Care Hospitals and ASCs:HFAP Standards andMedicare CoPs

3. OBJECTIVES • Knowledge and Understanding of the top scored HFAP Hospital standards and Condition of Participation (CoP’s). • Understanding standard and Condition of Participation requirement compliance issues.

4. 01.00.08 Categories Eligible for Appointment. The governing body must determine, in accordance with state law, which categories of practitioners are eligible candidates for appointment to the medical staff. §482.12(a) §482.12(a)(1) • The medical staff must, at a minimum, be composed of physicians who are doctors of medicine or doctors of osteopathic medicine. • Healthcare professionals must be legally authorized to practice within the state where the hospital is located and providing services within their authorized scope of practice (issues noted during survey is that facilities failed to conduct PSV for license, expired license, no license, functioning outside scope of practice, practitioners were not eligible candidates for appointment to medical staff or medical staff privileges) • The medial staff may include other types of health care professionals such as: • Doctor of medicine or osteopathic medicine • Doctor of dental surgery or of dental medicine • Doctor of podiatric medicine • Doctor of optometry • A Chiropractor

5. 10.01.04 Dating & Timing of Orders. The hospital must ensure that all orders, including verbal orders, are dated, timed, and authenticated promptly. The Merriam-Webster online dictionary defines “prompt” as performed readily or immediately. • All verbal orders must dated, timed, and signed promptly- immediately • Verbal orders must include a read-back and verification process per hospital policy • Authentication of a verbal orders may be written, electronic, or faxed • The prescribing practitioner must verify, sign, date and time verbal orders as soon as possible after issuing the order, in accordance with hospital policy, and State and Federal requirements • Verbal orders whether “telephone” or given “on site” must be authenticated within state law or hospital policy

6. 11.08.01 Adequate Facilities The hospital shall maintain adequate facilities for its services • Designed and maintained in accordance with federal, state, and local laws, regulations and guidelines(facility layout, toilets, sinks, drinking water supply, irrigation system’s, etc.). • Designed and maintained to reflect the scope and complexity of the services it offers in accordance with accepted standards of practice (sufficient space to provide care, treatment and services; proper sterilization & disinfection areas, ASC’s deemed status -separate waiting areas).

7. 15.01.09 Exercise of Patient Rights

8. Exercise of Patient Rights(15.01.09 continued) • The right to the confidentiality of his/her clinical records • The right to access his/her clinical records information within a reasonable time frame • The right to be free from restraints of any form that are not medically necessary, or used for the purpose of coercion, discipline, convenience, or retaliation by staff • The right to be fully informed of and to consent or refuse to participate in any unusual, experimental or research project without compromising his/her access to services • The right to know the professional status of any person providing his/her care / services

9. Exercise of Patient Rights(continued) • The right to know the reasons for any proposed change in the Professional Staff responsible for his/her care- staff not wearing ID badges • The right to know the reasons for his/her transfer either within or outside the hospital- transfer forms incomplete, patients/families not informed • The right to know the hospital, other persons, other organizations relationship(s) of participating in the provision of his/her care(physician ownership, hospital ownership, etc.) • The right of access to the cost of care treatment and services, itemized when possible- • The right to be informed of the hospital's reimbursement source for his/her services provided and if any limitations which may be placed upon his/her care

10. Exercise of Patient Rights(15.01.09 continued) • Informed of the right to have pain treated as effectively as possible • Hospital must have written policies and procedures regarding the visitation rights of patients including those to set forth clinically necessary or reasonable restrictions/limitations: • Must be informed of any visitation restrictions or limitations and why • Must be informed to receive visitors- spouse, domestic partners (including same sex),family member of friend and the right to deny consent at any time • Cannot restrict, limit or otherwise deny visitation privileges based on race, color, national origin, religion, sex, gender identity, sexual orientation, or disability • Ensure all visitors enjoy full and equal visitation privileges consistent with patient preferences. • The patient's family has the right of informed consent for donation of organs and tissues.

11. 15.01.10 Participation in the Plan of Care The patient has the right to participate in the development and implementation of his or her plan of care. Hospital are required to plan the patient’s care, with patient participation, to meet the patient’s psychological and medical needs. • Hospitals are missing policies and procedures to address patient and family participation, or fail to develop and implement policies to address patient or family participation in care • Patients/family not informed, advance directives not explained or provided to patients/family • Patient/family not kept up to date regarding status of care, treatment or services

12. 15.01.12 Advance Directives The patient has the right to formulate advance directives and to have hospital staff and practitioners who provide care in the hospital comply with these directives, in accordance with 482.13(b)(3). (hospitals do not track a patients advance directive in the medical records, staff unaware of patients advance directives, or simply do not ask patients about advance directives)

13. 15.01.17 Privacy & Safety: Safe Setting The patient has the right to receive care in a safe setting. • Hospital staff should follow current standards of practice for patient environmental safety, infection control, and security • Hospitals are missing or do not consistently implement policy and procedures regarding security access to facility • Construction sites not secured or protected from patients/staff/visitors • Hospitals missing infection control plan, have incomplete infection control plans or the plan is not hospital wide program • Hospitals have no designated Infection Control Officer or the Infection Control Officer is not trained, educated or qualified to oversee the IC program

14. 25.01.01 Medication Control & Distribution 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. • Procedures must be established to prevent unauthorized usage and distribution • Provide for an accounting of the receipt and disposition in accordance with state and Federal law and regulations

15. 25.01.01 Medication Control & Distribution(continued) • Pharmacist actively involved and participates with appropriate hospital staff and committees, to develop and implement guidelines, protocols, policies and procedures for the provision of pharmaceutical services to ensure patient safety. • High-Risk Medications/Patients • Hospitals should have systems in place to minimize adverse drug events such as: • checklists – not available or not used • dose limits- medication dose limits not identified or established • pre-printed orders- are out dated, not approved through medical staff, no national references noted • special packaging- missing new expiration dates, no identification noted • special labeling- not implemented • double-checks- not implemented, or are inconsistent • guidelines- ISMP or other nationally recognized references used

16. 25.01.01 Medication Control & Distribution(continued) “High risk medications” are those medications involved in a high percentage of medication errors and or critical events and medications that carry a higher risk for abuse, errors, or other adverse outcomes. • High risk mediations may vary from hospital to hospital • Hospitals must review and identify medication inventory to define their high risk medications High-risk or high-alert drugs are available from such organizations as the Institute for Safe Medication Practices (ISMP) and the United States Pharmacopoeia (USP).

17. 25.01.01 Medication Control & Distribution(continued) High-risk drugs may include: • Investigational drugs- missing policy and procedures • Controlled medications- not stored correctly, missing sign-out signatures, poor receipt and storage processes, missing med counts, etc. • Medications not on the approved FDA list- no policy • Medications – narrow therapeutic range meds • Psychotherapeutic medications and look-alike/ sound-alike medications- no mechanism to identify these meds to avoid errors such as, special labels red/orange/special lettering, etc. • Medications that are new to the market or new to the hospital- staff education

18. 25.01.01 Medication Control & Distribution(continued) • Review of Orders-pharmacist reviews before order is dispensed, except in emergencies: • Appropriateness • Therapeutic duplication • Appropriateness of drug, dose, frequency, route,& administration method • Potential interactions • Real or potential allergies or sensitivities • Variation from criteria for use and • Other contraindications • Monitor Medication Effects • Sterile Preparation- not followed • Emergency Medication Kits- not available, missing meds or expired meds • Automated Drug Dispensing Machines- issues with inventory levels • Report Adverse Reactions- not reporting medication adverse events • Medications from Home- missing policy, no process to accept or store home meds • Investigational Medications- no policy or approval, IRB protocol

19. 30.00.09 Standards of Practice Surgical Service: • Must be consistent with needs and resources • Must have policies governing surgical care • Must be designed to assure the achievement and maintenance of high standards of medical practice and patient care • There is a policy manual governing activities in all operative/invasive procedure locations

20. 30.00.09 Standards of Practice(continued) These standards address, at a minimum to: • Aseptic and sterile surveillance and practice, including scrub techniques- not followed, failure to follow hand hygiene • Identification of infected and non-infected cases- missing or incomplete tracking mechanism, no f/up and reporting • Housekeeping requirements/procedures- missing OR cleaning policies and procedures, P & P not followed- use of wrong cleaning products, etc. • Patient care requirements (preoperative work-up, patient consents/releases, clinical procedures, safety practices, patient identification procedures- no informed consent process, consents not written in language patient can understand, missing consents, incorrect consents, missing lab results, poor two patient identification process, vague surgical site marking, etc.

21. 30.00.09 Standards of Practice(continued) • Duties of scrub and circulating nurse- circulating RN performing other duties, not always available, scrub nurse competencies missing or incomplete , first assist RN missing list of approved privileges/procedures allowed • DNR status- not addressed , missing or no policy • Safety practices, including patient identification, site identification, procedure verification, and surgical counts- poor site marking procedure, time out not documented/not all staff involved in time- out, surgical count not consistently performed, medication labeling, using single vial medication on multiple patients, etc. • The requirement to conduct surgical counts in accordance with accepted standards of practice- not following policy- also may wish to consider counting number of staples used in closure • Scheduling of patients for surgery- over scheduling, delays, cancellations,

22. 30.00.09 Standards of Practice (continued) • Outpatient surgery postoperative care planning and coordination, and provisions for follow-up care- poor processes, f/up not consistently implemented • Personnel policies unique to the OR- missing policies, PPE not used or used inconsistently, partially compliant/IC – nails, etc. • Resuscitative techniques- qualified, trained staff equipment, expired emergency medications, etc. • Handling infectious, biomedical, and medical waste- not followed, bagged/stored improperly, not sealed, sharps containers full/not locked

23. 30.00.09 Standards of Practice(continued) • Care of surgical specimens, including collection, labeling, handling, and processing methods: missing policy for specimen collections and processing • Malignant hyperthermia: not following the MH recommended protocols, insufficient Dantrolene vials (36 vials is noted to stabilize the patient), no process to screen for MH patient’s or family history, etc. With new standard should run drill to determine if mediation is retrievable within 10 minutes • Appropriate protocols for all surgical procedures performed. These may be procedure-specific or general in nature, includes required list of equipment, materials, and supplies necessary to properly proceed with surgical procedure: missing or expired supplies, not all equipment available, no biomed equipment checks, expired meds, insufficient surgical trays, etc.

24. 30.00.09 Standards of Practice(continued) • Sterilization and disinfection procedures: policy/procedure manual not available for staff on sterilization/disinfection process, failure to follow manufactures recommendation for high level disinfections solutions, high volume “Flash sterilization”, dirty/clean utility rooms flow allows for cross contamination, steam sterilizing equipment missing biomed tags, staff competency missing or incomplete, log data incomplete, spore testing log results missing or inconsistently documented, policies fail to note national recommended practices such as the CDC, AORN, etc. • Acceptable operating room attire: failure to follow OR policy, not wearing clean OR shoes, surgical caps improperly worn, gel nails, jewelry, masks, etc. • Alcohol-based skin preparations in anesthetizing locations must have appropriate policies and procedures to reduce the associated risk of fire: missing or no policy, staff education not available

25. 30.00.10 History & Physical • Prior to surgery or any procedure requiring anesthesia services; only except in emergency cases. • Any history and physical conducted more than 30 days prior to admission is not acceptable and must be repeated. The only exception is for emergency situations. • A medical history and physical examination must be completed and documented no more than 30 days before or 24 hours after admission or registration(common finding, H & P exceeds 30 day time frame).

26. 30.00.10 History & Physical(continued) • (ii) An updated examination of the patient, including any changes in the patient’s condition, must be completed and documented within 24 hours after admission or registration when the medical history and physical examination are completed within 30 days before admission or registration. (common findings are the H & P update is missing, incomplete, must state patient examined, no changes noted, approve for surgery, reviewed changes to H& P & patient approved for surgery- must be dated, timed and signed by the physician)

27. HFAP TOP-SCORED CoPs Acute Care Hospital

28. 01.00.05 Condition of Participation:Governing Body • The hospital must have an effective governing body legally responsible for the conduct of the hospital as an institution. • If a hospital does not have an organized governing body, the person(s) legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body.

29. 01.00.05 Condition of Participation:Governing Body • The hospital must have only one governing body and this governing body is responsible for the conduct of the hospital as an institution. • In the absence of an organized governing body, there must be written documentation that identifies the individual or individuals that are responsible for the conduct of the hospital operations.

30. 03.04.01 Condition of Participation:Utilization Review The hospital must have in effect a utilization review (UR) plan that provides for review of services furnished by the institution and by members of the Medical Staff to patients entitled to benefits under the Medicare and Medicaid program.

31. 03.04.01 Condition of Participation:Utilization Review Common Findings related to UR: • Facility does not have a UR plan, the plan is incomplete or is not consistently implemented. • UR plan does not delineate the responsibilities/authority for those involved in the performance of UR activities. • Procedures for review of such as, the medical necessity of admissions, appropriateness of the setting, medical necessity of extended stays, and medical necessity of professional services are missing, incomplete or not performed consistently. • UR committee minutes are incomplete, missing, do not note members attendance documentation, missing dates, discussions, missing names/titles or meetings not convened as stated.

32. 07.00.00 Condition of Participation:Infection Control • The hospital must provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. • There must be an active program for the prevention, control, and investigation of infections and communicable diseases.

33. 07.00.00 Condition of Participation:Infection Control The hospital infection control program must be: • hospital-wide • include all locations • all campuses • all departments • all services

34. 07.00.00 Condition of Participation:Infection Control Examples: • There is no hospital – wide infection control plan developed • IC Program lacks all required components • No designated infection control officer (ICO) • ICO lacks the necessary required training for IC position in order to implement an effective infection control program • There is no infection control annual report given to the Board • IC activities are not included in the QAPI program • Hand washing surveillance and environmental rounds are not completed consistently and are not documented

35. 07.00.00 Condition of Participation: Infection Control Examples of areas to monitor: • food storage, preparation areas, serving and dish rooms • refrigerators, ice machines • air handlers, autoclave room • venting systems • inpatient rooms, treatment areas, labs • waste handling in surgical areas, supply, storage, equipment cleaning, etc.

36. 10.00.01 Condition of Participation:Medical Record Services. • 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.

37. 10.00.01 Condition of Participation:Medical Record Services. • The Hospital must have one unified medical record service that has administrative responsibility for all medical records, both inpatient and outpatient records. • The hospital must create and maintain a medical record for every individual, both inpatient and outpatient, evaluated or treated in the hospital.

38. 10.00.01 Condition of Participation:Medical Record Services. The term “medical records” includes at least: • written documents • computerized electronic information • radiology film and scans • laboratory reports and pathology slides • videos, audio recordings • Other forms of information regarding the condition of a patient.

39. 11.00.01 Environment. The hospital must be constructed, arranged, and maintained to ensure the safety of the patient, and to provide facilities for diagnosis and treatment, and for special hospital services appropriate to the needs of the community.

40. 11.00.01 Environment. The hospital’s “Hospital Maintenance” and hospital departments or services are responsible for the hospital’s buildings and equipment (both hospital equipment and patient care equipment) must be incorporated into the hospital’s QAPI program and be in compliance with QAPI requirements. Environmental findings include: • Missing documentation for patient or other equipment biomedical checks • Off site locations are not included • Environmental tours not conducted • Issues reported or observed are not resolved • Environmental issues not reported to the QAPI committee or other leadership

41. 12.00.01 Condition of Participation:Quality Assessment Performance Improvement. • 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.

42. 12.00.01 Condition of Participation:Quality Assessment Performance Improvement. The quality assessment performance improvement program is found non compliant due to: • QAPI is Hospital wide • QAPI not developed or implemented • Maintenance not included in QAPI • Not effectiveness or ongoing • Not data-driven • Contract services not included in QAPI • Improved outcomes not documented • Reduction of medical errors not addressed, no plan of action included • Missing reporting mechanisms

43. 20.00.01 Condition of Participation:Emergency Services. The hospital must meet the emergency needs of patients in accordance with acceptable standards of practice.

44. 20.00.01 Condition of Participation:Emergency Services. • The facility Written Plan for the provision of care and services identifies the level of emergency services provided. • This usually is patterned after Federal or State guidelines for "trauma" designations. Facilities which offer specialty services only, and very small - isolated facilities may opt to list their level of emergency service as "triage, stabilize and transport“ providing only very basic levels of emergency care.

45. 25.00.00 Condition of Participation:Pharmaceutical Services. • 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.

46. 30.00.00 Condition of Participation:Surgical Services • If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable Standards of Practice. • If outpatient surgical services are offered, the services must be consistent in quality with inpatient care in accordance with the complexity of services offered.

47. ASC HFAP TOP-SCORED HFAP STANDARDS

48. 04.00.06 Program Activities. The ASC must set priorities for its performance improvement activities that: • Focus on high-risk, high-volume and problem-prone areas. §416.43(c)(1)(i). • Consider incidence, prevalence and severity of problems in those areas. §416.43(c)(1)(ii) • Affect health outcomes, patient safety and quality of care.§416.43(c)(1)(iii)

49. 04.00.06 Program Activities. • ASCs not consistently tracking incidences rates or frequency at which problems occur in the ASC related to indicators • ASCs not tracking their severity of problems such as patient transfers of patients to a hospital, other adverse or unplanned outcomes fro surgical procedures • ASCs not conducting evaluations of surgical cases, even when procedures are low volume cases/incidents. • ASCs not collecting, analyzing and aggregating data based on their indicators.

50. 04.00.09 Preventive Strategies. The ASC must implement preventive strategies throughout the facility targeting adverse patient events and ensure that all staff is familiar with these strategies.