DHHS REGULATORY DIALOGUE Prepared for the Nebraska Hospital Association Annual Meeting October 13, 2016
CAHs: Top Cited Deficiencies in NE in the Past 5 years 0241 Governing Body 0302 Records System 0322 Anesthetic Risk 0337 Quality Assurance 0276 Patient Care Policies
HOSPITALS: Top Cited Deficiencies in NE in thepast 5 years 0176 Patient Rights: Restraint or Seclusion 0263 QAPI 0286 Patient Safety 0396 Nursing Care Plan 0115 Patient Rights
CRITICAL ACCESS HOSPITALS
0241 GOVERNING BODY The CAH has a governing body or an individual that assumes full legal responsibility for determining, implementing and monitoring policies governing the CAH S total operation and for ensuring that those policies are administered so as to provide quality health care in a safe environment. This means: CAHs must have an organized governing body (or individual) responsible for the conduct of the CAH operations who: Makes a determination of practitioners eligibility for appointment to the medical staff Ensures the CAH has operating policies that reflect it s responsibilities as a CAH Verifies the medical staff are operating under current approved by-laws Ensures the CAH has written criteria for staff appointment (at a minimum including character, competence, training, experience and judgement.)
SURVEYORS WILL REVIEW: policies and procedures medical staff by-laws credentialing files interview staff, and review any other documents that might show compliance/non-compliance.
WHAT HAVE WE CITED CAHs FOR: The CAH failed to ensure that physicians were reappointed in accordance with the Medical Staff Bylaws which required that reappointments be based on the provider's competence, compliance with bylaws, rules and regulations and record completion. The CAH failed to ensure that physicians were granted privileges based on qualifications as specified in the Medical Staff Bylaws. The CAH failed to ensure that physicians were only practicing those clinical privileges granted to them by the governing body as identified in the Medical Staff bylaws.
0302 RECORDS SYSTEM 485.638(a)(2) The records are legible, complete, accurately documented, readily accessible, and systematically organized. This means: CAHS need to ensure that medical records accurately and completely document ALL orders, test results, evaluations, treatments, interventions, care provided AND the patient response to those treatments, interventions and care.
SURVEYORS WILL REVIEW: policies and procedures patient records for current patients, outpatients and discharged patients interview staff
WHAT HAVE WE CITED CAHs FOR: The CAH failed to ensure that the patient medical records contained diet orders. The CAH failed to ensure that discharged patients had a discharge order in their medical record. The CAH failed to ensure that completed test results were in the patient medical record.
485.639(b) Standard: Anesthetic Risk and Evaluation 0322 ANESTHETIC RISK (1) A qualified practitioner, as specified in paragraph (a) of this section, must examine the patient immediately before surgery to evaluate the risk of the procedure to be performed. (2) A qualified practitioner, as specified in paragraph (c) of this section, must examine each patient before surgery to evaluate the risk of anesthesia. (3) Before discharge from the CAH, each patient must be evaluated for proper anesthesia recovery by a qualified practitioner, as specified in paragraph (c) of this section.
DISTINCT PARTS TO THIS REGULATION: 1. Patient examined BY A QUALIFIED PRACTITIONER IMMEDIATELY BEFORE SURGERY to evaluate RISK of procedure 2. Patient examined BY A QUALIFIED PRACTITIONER BEFORE SURGERY to evaluate RISK of anesthesia 3. Patient evaluated BY A QUALIFIED PRACTITIONER BEFORE DISCHARGE for proper anesthesia recovery
The #1 question we get asked is WHO is a QUALIFIED PRACTITIONER? (Hint: the CMS regulatory language identifies who these are)
FOR the EXAMINATION IMMEDIATELY BEFORE SURGERY: The QUALIFIED PRACTITIONER is the practitioner who will be performing the surgery. A doctor of medicine or osteopathy A doctor of dental surgery or dental medicine A doctor of podiatric medicine
For the EXAMINATION BEFORE SURGERY FOR THE RISK OF ANESTHESIA: The QUALIFIED PRACTITIONER is the person who is allowed to administer anesthesia A qualified anesthesiologist A doctor of medicine or osteopathy other than an anesthesiologist A doctor of dental surgery or medicine A doctor of podiatric medicine A certified registered nurse anesthetist An anesthesiologist assistant A supervised trainee in an approved educational program
FOR the EXAMINATION BEFORE DISCHARGE FOR ANESTHESIA RECOVERY: A QUALIFIED PRACTITIONER is the person who is allowed to administer anesthesia A qualified anesthesiologist A doctor of medicine or osteopathy other than an anesthesiologist A doctor of dental surgery or medicine A doctor of podiatric medicine A certified registered nurse anesthetist An anesthesiologist assistant A supervised trainee in an approved educational program
SURVEYORS WILL: Review patient surgical records to see when the examinations were performed, who they were performed by, and if they contain the required elements. Review practitioner qualifications, including current licensure and certification. Review CAH policies and procedures for patient discharges. Review the surgical privileges of practitioners, the current surgical roster, and review the roster of suspended surgeons and/surgeons who have restricted surgical privileges.
WHAT HAVE WE CITED CAHs FOR: The CAH failed to ensure that surgical patient records contained evidence of an examination by a qualified practitioner immediately before surgery to evaluate the risk of the procedure to be performed.
0337 QUALITY ASSURANCE 485.641(b)(1) All patient care services and other services affecting patient health and safety, are evaluated. This means the CAH has an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes the program requires that all patient care services and other services affecting patient health be evaluated
SURVEYORS WILL: Review facility policies and procedures Review Quality Assurance meeting minutes Review performance improvement plans Interview staff Review patient medical records.
WHAT HAVE WE CITED CAHs FOR: The CAH failed to ensure that all of the facility departments and services were involved in the quality assurance process, including contracted services.
0276 PATIENT CARE POLICIES 485.635(a)(3) [The policies include the following:] (iv) Rules for the storage, handling, dispensation, and administration of drugs and biologicals. These rules must provide that there is a drug storage area that is administered in accordance with accepted professional principles, that current and accurate records are kept of the receipt and disposition of all scheduled drugs, and that outdated, mislabeled, or otherwise unusable drugs are not available for patient use.
SURVEYORS WILL: Review facility policies and procedures Conduct observations of medication storage, pharmacy areas, medication distribution and medication administration Review patient orders/medical records Review documentation of scheduled medications Interview staff.
WHAT HAVE WE CITED CAHs FOR: The CAH failed to ensure that no medications were available for patient use after the BUD (beyond use date). The CAH failed to have evidence of tracking of scheduled medications in and out of the facility.
ACUTE CARE HOSPITALS
0176 PATIENT RIGHTS 482.13(e)(11) - Physician and other licensed independent practitioner training requirements must be specified in hospital policy. At a minimum, physicians and other licensed independent practitioners authorized to order restraint or seclusion by hospital policy in accordance with State law must have a working knowledge of hospital policy regarding the use of restraint or seclusion.
Hospitals must have policies and procedures that address restraint and seclusion training requirements. AT A MINIMUM: Physicians have a working knowledge of hospital policy regarding the use of restraint and seclusion AND Additional training requirements to ensure competency based on the model of care, level of physician competency and needs of patient population.
SURVEYORS WILL: Review facility policies and procedures Review credential files of practitioners who are privileged to authorize restraints Review training record documentation Review patient orders/medical records Interview staff.
WHAT HAVE WE CITED HOSPITALs FOR: The hospital failed to ensure that practitioners who were authorized to order restraints had evidence of training in their credential file. The hospital failed to have evidence that physicians authorized to order restraints were aware of the facility policies and procedures on restraints.
0263 QAPI 482.21 Condition of Participation: Quality Assessment and Performance Improvement Program 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.
SURVEYORS WILL: Review facility policies and procedures Review Quality Assurance meeting minutes Review Implementation Plans Interview staff.
WHAT HAVE WE CITED HOSPITALs FOR: The hospital failed to ensure that all services/departments were involved in the collection of quality data. The hospital failed to have evidence that recommended quality interventions were implemented and/or revised to ensure ongoing compliance.
0286 PATIENT SAFETY 482.21(a)(1), 482.21(a)(2), 482.21(c)(2), & 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.
SURVEYORS WILL: Review facility policies and procedures Review quality meeting minutes Review patient orders/medical records Interview staff Review information about grievances/medication errors.
WHAT HAVE WE CITED HOSPITALs FOR: The hospital failed to ensure that recommended interventions were implemented in a manner to prevent ongoing deficient practice.
0396 NURSING CARE PLAN 482.23(b)(4) - The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient. The nursing care plan may be part of an interdisciplinary care plan.
The plan must: Be based on patient overall needs from admission through discharge Be kept current Be part of the patient s medical record
Surveyors will: Review plans of care for a select group of patients Review what the plan encompasses and whether it was revised as needed Review when the plan was initiated and implemented Review policies and procedures Interview staff
WHAT HAVE WE CITED HOSPITALs FOR: The hospital failed to ensure that patient care plans were revised when changes occurred with the patients care needs.
0115 PATIENT RIGHTS 482.13 Condition of Participation: Patient's Rights A hospital must protect and promote each patient s rights.
This includes: Providing notice of rights Having a process for prompt resolution of patient grievances (7 days average) Informing each patient whom to contact to file a grievance
SURVEYORS WILL: review patient medical records interview staff, patients and/or families review policies and procedures
WHAT HAVE WE CITED HOSPITALs FOR: The hospital failed to provide a copy of the Notice of Patient Rights to patients The hospital failed to ensure that patient grievances were acted upon in a timely manner
OTHER STUFF.
EMERGENCY PREPAREDNESS CMS published the final rule of the Emergency Preparedness Regulations. implementation date of 11-2016. Surveying on the new requirements will start 11-2017. All medicare certified facilities are expected to be in compliance by that date. CMS is anticipating having one new Appendix to the State Operations Manual that will be for all 17 provider types affected by the new rule and is preparing training for survey staff.
HOSPITAL PHARMACY CHANGES Hospital Pharmacy Quality Assurance Report (HPQAR) was initiated by Nebraska DHHS in Spring 2016. Initially based on the same report that pharmacies with a commercial license have to complete annually for the Department. Changes were made based on comments and reviews, the form revised AND will soon be interactive and can be filled out and completed online. Facilities need to submit plan with HPQAR for areas they are not in compliance with and will receive feedback on their reported information.
INSPECTION CHANGES - HOSPITAL PHARMACIES Expectation is facility is compliant with LB37, including USP 797 and 800. Pharmacist inspectors may accompany the health surveyors, or may inspect the hospital pharmacies independently. Survey staff received training by CMS on expectations. Pharmacy inspectors are also providing guidance. We are still in the learning process. Once we complete an inspection, the survey reports are sent to the Pharmacy inspectors for review. They could potentially identify additional issues or concerns.
QUESTIONS QUESTION: SHOULD PRIVILEGING BE BASED ON THE EXPERIENCE OF THE PROVIDER AND THE CAPABILITY OF THE HOSPITAL STAFF? ANSWER: Yes.please refer to previous slides and regulations.
QUESTION: IN REGARD TO CAH REGULATION C-0207, A PARCTITIONER WITH TRAINING OR EXPERIENCE IN EMERGENCY CARE ON CALL NEEDS TO BE IMMEDIATELY AVAILABLE VIA TELEPHONE/RADIO AND ONSITE IF NEEDED WITHIN 30 MINUTES/24 HOURS A DAY. DOES THIS APPLY TO BACK UP PHYSICIANS? ANSWER: Yes. A back up is expected to provide the same service in the same timeframe.
QUESTION: WHAT DO WE DO WHEN DECREASING LICENSED BEDS IN A FACILITY? ANSWER: Notify my office. We need a letter on facility letterhead along with a new Bed Count Form. You can email those documents.
QUESTION: DEFINE ELOPEMENT. ANSWER: According to the Nebraska APS Act, elopement is considered neglect due to the lack of proper supervision. We currently do not have a specific definition of elopement in the hospital licensure regulations.
QUESTION: DEFINE ELOPEMENT. ANSWER: According to the Nebraska APS Act, elopement is considered neglect due to the lack of proper supervision. We currently do not have a specific definition of elopement in the hospital licensure regulations.
ELOPEMENT CONTINUED Typically we view elopement as a situation where a patient is not where they are expected to be and cannot be located this could also mean they are off of their usual unit (especially in the case of a behavioral health unit for example) OR it could mean they are outside the building and across the street. We expect the facility to follow their policies and procedures and we would evaluate each case. Reporting is required to meet the hospital licensure regulation requirements at 175 NAC 9-004.07 and 175 NAC 9-006.01B.
QUESTION: WHAT ARE THE REQUIREMENTS FOR PRIVILEGING IN A FACILITY. ANSWER: Refer to the previous slides and regulations.
QUESTION: WHAT IS THE UP-TO-DATE INFORMATION ON THE MEDICARE OUTPATIENT OBSERVATION NOTICE (moon)? ANSWER: At this time it is still not out
QUESTION: REGARDING DANTROLENE SODIUM, HOW MANY VIALS DOES A FACILITY NEED? WHAT ARE THE REQUIREMENTS FOR A MALIGNANT HYPERTHERMIA DRILL? WHERE SHOULD THE VIALS BE LOCATED?
ANSWER: The facility needs to do a Risk Assessment to determine how many vials they should have on hand based on the patient population of the facility, the average weight of surgical patients, and the location needs of a facility (typically anywhere there are MH triggering anesthetics administered).
ANSWERS continued Malignant Hyperthermia Drills should meet the standards of practice set forth by http://www.mhaus.org. Expired Dantrolene should be used for the practice drills.
QUESTION: OUR PHYSICIANS WANT TO TEXT ORDERS, WHAT DO THEY NEED TO DO TO BE IN COMPLIANCE. ANSWER: At this time CMS has not approved the texting of orders. They are currently working with The Joint Commission on possibly coming out with some guidance
QUESTION: WHERE CAN WE FIND THE LATEST REVISION OF THE CONDITIONS OF PARTICIPATION AND LIFE SAFETY CODE (FIRE) REGULATIONS? ANSWER: www.ecfr.gov is the most up to date source. You can also go to www.cms.gov but they aren t always as timely with regulation changes. I try to send them out to the Hospital Association when we get them from CMS.
QUESTION: WHAT DO FACILITIES NEED TO NOTIFY DHHS ABOUT? ANSWER: Notifications need to be made in accordance with 175 NAC 9 (Nebraska Hospital Licensure Regulations) the CPS/APS Act, and the Healthcare Facility Licensure Act.
QUESTION: WHAT IS REQUIRED FOR A PLAN OF CORRECTION/STATEMENT OF COMPLIANCE? ANSWER: Per CMS, an acceptable Plan of Correction must contain the following elements: 1. The plan for correcting each specific deficiency cited; 2. The plan for improving the processes that led to the deficiency that was cited, including how the hospital is addressing improvements in systems to prevent the likelihood of recurrence of the deficient practice; 3. The procedure for implementing the POC for each deficiency cited; 4. A completion date for correction of each deficiency cited; 5. The monitoring and tracking procedures that will be implemented to ensure that the PoC is effective and that the specific deficiency(ies) cited remain corrected and in compliance with the regulatory requirements; and 6. The title of the person(s) responsible for implementing the acceptable PoC.
THINGS THAT ARE NEW AT DHHS. 2 of our surveyors retired so we are in the process of training 2 new surveyors Nancy Hauschild (LMNT) and Sue Griepenstroh (RN) so you will see them out and about. We have a new staff assistant who will be working with Facility Construction, the Hospital PQARs, and license renewals, her name is Karen McGann. We changed the letter that we send out with Hospital Licensure Renewal packets. We added a Guidance Document and a Checklist. We hope this helps with this renewal process, please send me your feedback.
QUESTIONS? Diana Meyer, RN, BSN Program Manager DHHS Nebraska Public Health Licensure Acute Care Facilities/CLIA/Facility Construction diana.meyer@nebraska.gov