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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

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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. Most Frequently Cited Deficiencies for Acute Care Hospitals and ASCs: HFAP Standards and Medicare CoPs. OBJECTIVES. - PowerPoint PPT Presentation

TRANSCRIPT

Page 1: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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

Page 2: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

Most Frequently Cited Deficiencies for Acute Care

Hospitals and ASCs:HFAP Standards and

Medicare CoPs

Page 3: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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.

Page 4: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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

Page 5: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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

Page 6: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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).

Page 7: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

15.01.09 Exercise of Patient Rights

Page 8: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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

Page 9: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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

Page 10: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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.

Page 11: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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

Page 12: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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)

Page 13: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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

Page 14: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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

Page 15: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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

Page 16: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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).

Page 17: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

25.01.01 Medication Control & Distribution(continued)

High-risk drugs may include:

Investigational drugs- missing policy and proceduresControlled 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 policyMedications – narrow therapeutic range medsPsychotherapeutic 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

Page 18: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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

Page 19: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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

Page 20: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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.

Page 21: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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,

Page 22: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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

Page 23: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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.

Page 24: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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

Page 25: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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.

(i) 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).

Page 26: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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)

Page 27: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

HFAP TOP-SCORED

CoPs

Acute Care Hospital

Page 28: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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.

Page 29: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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.

Page 30: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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.

Page 31: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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.

Page 32: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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.

Page 33: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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

Page 34: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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

Page 35: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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.

Page 36: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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.

Page 37: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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.

Page 38: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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.

Page 39: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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.

Page 40: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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

Page 41: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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.

Page 42: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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 wideQAPI not developed or implementedMaintenance not included in QAPINot effectiveness or ongoingNot data-driven Contract services not included in QAPI Improved outcomes not documentedReduction of medical errors not addressed, no plan of action

includedMissing reporting mechanisms

Page 43: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

20.00.01 Condition of Participation:

Emergency Services.

The hospital must meet the emergency needs of patients in accordance with acceptable standards of practice.

Page 44: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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.

Page 45: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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.

Page 46: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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.

Page 47: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

ASC

HFAP

TOP-SCORED

HFAP STANDARDS

Page 48: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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)

Page 49: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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.

Page 50: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

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.

Page 51: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

04.00.09 Preventive Strategies

Once an ASC has identified opportunities for improvement, the ASC must develop specific changes in its policies, procedures, equipment, etc., as applicable, to accomplish improvements in the their identified areas of weakness.

The ASC must implement preventive strategies designed to reduce the likelihood of adverse events throughout the ASC.

Page 52: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

04.00.09 Preventive Strategies

ASCs found not to be tracking medication error’s, missed medication error’s, wrong site surgery, time out not conducted, or not inclusive of entire surgical team, “missed” wrong site surgery, adverse events, or hospital transfers.

Must have processes in place to reduce or eliminate errors.

Page 53: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

04.00.10 Performance ImprovementProjects.

The number and scope of distinct improvement projects conducted annually must reflect the scope and complexity of the ASC’s services and Operations.

Each ASC must undertake one or more specific quality improvement projects each year

ASCs do not identify quality improvements projects, may identify too many projects that are not possible to implement

Not reflective of service provided

Page 54: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

04.00.11 Documentation of Projects.

The ASC must document the projects that are being conducted. The documentation at a minimum must include the reason(s) for:

a) implementing the project – type/service

b) description of the projects results- analysis and outcomes/action plans to correct

Page 55: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

05.00.02 Physical Environment.The ASC must provide a functional and sanitary environment for the provision of surgical services some examples include:

Improper lighting equipment, dirty lighting equipment

Insufficient space to provide care, treatment and serves, space does not allow for staff to respond to a patient life threating emergency situation properly

Exit doors in OR suite

Open decontamination room connected to OR suite that allows for steam to enter OR suite

Page 56: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

05.01.07 Emergency Equipment.The ASC medical staff and governing body of the ASC coordinates, develops, and revises ASC policies and procedures to specify the types of emergency equipment required for use in the ASC’s operating room.

The equipment must meet the following requirements:

a) Be immediately available for use during emergency situations (equipment is out for repair, no without backup equipment available, batteries not available)

b) Be appropriate for the facility’s patient population ( either do not have the needed equipment or equipment is something that has not been use or ever used)

c) Be maintained by appropriate personnel (missing biomedical or other services evaluation of equipment, equipment not evaluated be fore use on patients, missing patient equipment inventory list

Page 57: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

12.00.03 Infection Control Program.

The ASC must maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases.

In addition, the infection control and prevention program must include documentation that the ASC has considered, selected, and implemented nationally recognized infection control guidelines.

Page 58: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

12.00.03 Infection Control Program.The program must be:

Must be under the direction of a designated and qualified professional who has

training in infection control. §416.51(b)(1) (ASCs fail to designate an ICO, committee, or IC consultant to provide direction and oversight of IC program).

Must be part of an integral part of the ASC’s Quality Assessment Performance Improvement program (QAPI) §416.51(b)(2)-(ASCs failure to provide data to the QAPI program, no designated person to oversee QAPI performance measures).

Must be responsible for providing a plan of action for preventing, identifying and managing infections and communicable diseases and for immediately implementing corrective and preventive measures that result in improvement.

(ASCs failure to develop action plan for improvements or to identify and report to the state).

Page 59: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

HFAP

TOP SCORED

ASC CoPs

Page 60: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

01.00.02 Governing Body & Management.

Must have a Governing Body that assumes full legal responsibility for determining, implementing, and monitoring policies governing the ASC total operation.

The governing body has oversight and accountability for the quality assessment and performance improvement program, ensures that facility policies and programs are administered so as to provide quality health care in a safe environment, and develops and maintains a disaster preparedness plan.

Page 61: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

01.00.02 Governing Body & Management.

The regulation particularly stresses the responsibility of the governing body for:

Direct oversight of the ASC’s Quality Assessment Performance Improvement (QAPI) program (see 72 FR 50472, August 31, 2007 and 73 FR 68714, November 18, 2008).

The quality of the ASC’s healthcare services.

The safety of the ASC’s environment. Development and maintenance of a disaster preparedness plan.

Page 62: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

03.00.02 Surgical ProceduresPerformed Safely.

Surgical procedures must be performed in a safe manner by qualified physicians who have been granted privileges by the Governing Body of the ASC in accordance with approved policies and procedures of the ASC.

Page 63: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

03.00.02 Surgical ProceduresPerformed Safely.

The ASC’s governing body is responsible for reviewing the qualifications of all physicians who have been recommended by qualified medical personnel and granting surgical privileges as the governing body determines appropriate

Page 64: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

03.00.02 Surgical ProceduresPerformed Safely.

For all cases, the physician must be licensed in the State in which the ASC is located and practicing. (ASCs fail to PSV license, license is expired)

Must function within the scope of his/her license (physician operate outside approve privileges granted, or not part of medical training)

Regulation requires that each physician who performs surgery in the ASC has been determined qualified and granted privileges for the specific surgical procedures he/she performs in the ASC (ASCs fail to document approved privileges for initial, reappointments, approve all “hospital” privileges, etc.)

Page 65: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

04.00.01 Quality Assessment

Performance Improvement.

The ASC must develop, implement and maintain an ongoing, data-driven Quality Assessment Performance Improvement (QAPI) program.

Page 66: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

04.00.01 Quality AssessmentPerformance Improvement.

Ongoing: Performance Improvement Program for ASC such as quality data at regular intervals; analysis of the updated data at regular intervals; and updated records of actions taken to address quality problems identified in the analyses, as well as new data collection to determine if the corrective actions were effective.

Data-driven: ASCs must identify in a systematic manner what data is collected, measurement of various aspects of quality of care, the frequency of data collection, how the data is analyzed and evidence that the program used the data collected to assess quality and stimulate performance improvement.

Page 67: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

06.00.01 Medical Staff Membership &

Clinical Privileges.The Medical Staff of the ASC must be accountable to the

Governing Body.

Governing body must approve bylaws (no documentation of bylaw requirements).

A physician owner must nevertheless implement a formal process for complying with all medical staff regulatory requirements. (findings are that ASCs have no process in place or incomplete).

Page 68: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

07.00.01 Nursing Services.

The nursing services of the ASC must be directed and staffed to assure that the nursing needs of all patients are met

The ASC must ensure that the nursing service is directed under the leadership of an RN and must have documentation that it has designated an RN to direct nursing services (findings show no RN designated to over see ASCs services)

There must be sufficient nursing staff with the appropriate qualifications to assure the nursing needs of all ASC patients are met (issues with RN qualifications, training, etc.)

Page 69: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

12.00.01 Infection Control.

The Ambulatory Surgery Center (ASC) must maintain an infection control program that seeks to minimize infections and communicable diseases.

Your Infection Control plan must consider your geographic location and patient population.

Page 70: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

12.00.01 Infection Control. Provide a functional and sanitary environment for surgical services, to avoid

sources and transmission of infections and communicable diseases

Based on nationally recognized infection control guidelines

Be directed by a designated health care professional with training in infection control

Be integrated into the ASC’s QAPI program

Be ongoing

Must Include actions to prevent, identify and manage infections and communicable diseases

Must Include a mechanism to immediately implement corrective actions and preventive measures that improve the control of infection within the ASC

Page 71: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

12.00.01 Infection Control.

ASCs found not in compliance due to the following:

Faculties not cleaned or maintained

Designated staff not qualified or trained to over see IC program

Missing national recognized guidelines/or outdated

Missing or no corrective action plans development to address ASC IC issues identified

IC plan not included into QAPI

Page 72: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

QUESTIONS ????

Page 73: Donna Tiberi Blaszczyk, RN,BS,MHA Karen Y. Beem, MS, RN

QUESTIONS?

Please submit questions to:

Donna Tiberi Blaszczyk RN

312-202-8073

Karen Beem RN

312-202-8069