Arizona Department of Health Services Licensing and CMS Deficient Practices

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1 Arizona Department of Health Services Licensing and CMS Deficient Practices Connie Belden, RN., Bureau of Medical Facility Licensing August 8, 2013

2 General Comments Deficient Practices per visit Trend 13 /visit in /visit in /visit in /visit in /visit in /visit in 2013 (5 months January-May)

3 Survey Timelines Centers of Medicare and Medicaid Average of every 3 Years unless Directed by CMS as a Targeted facility ADHS Compliance Survey Annually If Deficient Free then one licensing period is skipped Complaint Investigation Ad Hoc

4 Survey Types State: - Allows you to operate a Healthcare Institution in Arizona Initial Licensing Compliance Surveys CMS: - Purpose is for Reimbursement Certification for Payment Processes

5 Deficient Practice Trends Most Frequent CMS COP Deficiencies CMS Life Safety Code Building & Fire Code Standards Patient Care Polices Patient Activities Quality Assurance Nursing Services Governing Body Most Frequent State Rule Deficiencies State Nursing Services Quality Management Medical Staff Pharmaceutical Services Administration Environmental Services Infection Control

6 CMS Deficiencies Patient Care Policies Condition of Participation: Provision of Services The CAH S health care services are furnished in accordance with appropriate written policies that are consistent with applicable State law. The policies are developed with the advice of a group of professional personnel that includes one or more doctors of medicine or osteopathy and one or more physician assistants, nurse practitioners, or clinical nurse specialists, if they are on staff under the provisions of (a)(1); at least one member is not a member of the CAH staff.

7 CMS Deficiency Patient Care Policies The policies include the following: A description of the services the CAH furnishes, including those furnished through agreement or arrangement. The CAH s written patient care policies must describe the types of health care services that are available at the CAH, including whether those services are furnished by CAH staff or through agreements or arrangements. The types of health services described must include services provided both on-site and off-site. Healthcare services provided through agreement or under arrangement include those provided through formal contracts, informal agreements, or lease arrangements. Services furnished under arrangement or by agreement may include both healthcare services provided on-site at the CAH by a contractor, as well as healthcare services provided to the CAH s patients outside the CAH. For example, the CAH may contract

8 CMS Deficiency Patient Care Policies Policies and procedures for emergency medical services. Guidelines for the medical management of health problems that include the conditions requiring medical consultation and/or patient referral, the maintenance of health care records, and procedures for the periodic review and evaluation of the services furnished by the CAH. Comprehensive enough to cover most health problems that patients usually refer to a MD/DO; Describe the medical procedures available to the PA, NP and/or CNS; Describe the medical conditions, signs, or developments that require consultation or referral; and Compatible with State laws.

9 CMS Deficiency Patient Care Policies 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.

10 CMS Deficiency Patient Care Policies Administration of drugs and biologicals Policies and Procedure Drugs and biologicals are stored in accordance with manufacturer s directions and State and Federal requirements; Employees provide pharmaceutical services within their scope of license and education; Pharmacy records have sufficient detail to follow the flow of pharmaceuticals from their entry into the CAH through dispensation/administration; The pharmacy maintains controls over drugs and medications in all CAH locations, including floor stock; Maintaining pharmacy and accounting records pertaining to the requisitioning and dispensing of drugs and pharmaceutical supplies; Ensuring that drugs are being dispensed only by a licensed pharmacist; and Only pharmacists or pharmacy-supervised personnel compound, label and dispense drugs or biologicals.

11 Record System Administration of drugs and biologicals Policies and Procedure Accountability procedures to ensure control of the distribution, use, and disposition of all scheduled drugs. Records of the receipt and disposition of all scheduled drugs must be current and must be accurate. Records trace the movement of scheduled drugs throughout the service.

12 Administration of drugs and biologicals Policies and Procedure Receipt and Distribution of Drugs Therapeutic appropriateness of a patient s medication regimen; Therapeutic duplication in the patient s medication regimen; Appropriateness of the route and method of administration; Medication-medication, medication-food, medication-laboratory test and medication-disease interactions; Clinical and laboratory data to evaluate the efficacy of medication therapy to anticipate or evaluate toxicity and adverse effects; and Physical signs and clinical symptoms relevant to the patient s medication therapy.

13 Administration of drugs and biologicals Policies and Procedure Dispensation of Drugs Only the pharmacy compounds or admixes all sterile medications, intravenous admixtures, or other drugs except in emergencies or when not feasible (for example, when the product s stability is short). Whenever medications are prepared,: staff uses safety materials and equipment while preparing hazardous medications. staff uses techniques to ensure accuracy in medication preparation. staff uses appropriate techniques to avoid contamination during medication preparation: Using clean or sterile technique as appropriate; Maintaining clean, uncluttered, and functionally separate areas for product preparation to minimize the possibility of contamination; Using a laminar airflow hood or other appropriate environment while preparing any intravenous (IV) admixture in the pharmacy, any sterile product made from non-sterile ingredients, or any sterile product that will not be used with 24 hours; and Visually inspecting the integrity of the medications.

14 Administration of drugs and biologicals Policies and Procedure Drug Storage All drugs and biologicals must be kept in a locked room or container. If the container is mobile or readily portable, when not in use, it must be stored in a locked room, monitored location, or secured location that will ensure the security of the drugs or biologicals. All drugs and biologicals must be stored in a manner to prevent access by unauthorized individuals. Persons without legal access to drugs and biologicals cannot have unmonitored access to drugs or biologicals. Persons without legal access to drugs or biologicals cannot have keys to medication storage rooms, carts, cabinets, or containers.

15 Administration of drugs and biologicals Policies and Procedure System for Labeling and Management of Outdated Drugs The CAH must have a pharmacy labeling, inspection, and inventory management system that ensures that outdated, mislabeled, or otherwise unusable drugs and biologicals are not available for patient use.

16 Policies and Procedures Procedures for reporting adverse drug reactions and errors in the administration of drugs.

17 Policies and Procedures A system for identifying, reporting, investigating and controlling infections and communicable diseases of patients and personnel. Designated Infection Control Officer

18 Policies and Procedures Procedures that ensure that the nutritional needs of inpatients are met in accordance with recognized dietary practices and the orders of the practitioner responsible for the care of the patients Qualified Dietitian A qualified dietitian must supervise the nutritional aspects of patient care. The dietitian can be part of the CAH staff or work under contract (may be full or part time) and is responsible for all inpatient nutrition including swing bed services.

19 Patient Activities Special Requirements for CAH Providers of Long-Term Care Services ( Swing-Beds ) Patient activities Directed by an individual on the facility staff who is designated as the activities director and who serves in consultation with a therapeutic recreation specialist, occupational therapist, or other professional with experience or education in recreational therapy. Comprehensive assessment, comprehensive care plan, and discharge planning Specialized rehabilitative services ( of this chapter). Dental services

20 Quality Assurance Condition of Participation: Periodic Evaluation and Quality Assurance Review The CAH carries out or arranges for a periodic evaluation of its total program at least once a year and includes review of the: Utilization of CAH services Quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes Patient care services and other services affecting patient health and safety, are evaluated Nosocomial infections and medication therapy are evaluated Quality and appropriateness of the diagnosis and treatment furnished by nurse practitioners, clinical nurse specialists, and physician assistants at the CAH are evaluated by a member of the CAH staff who is a doctor of medicine or osteopathy or by another doctor of medicine or osteopathy under contract with the CAH;

21 Quality Assurance Quality and appropriateness of the diagnosis and treatment furnished by doctors of medicine or osteopathy at the CAH are evaluated by-- One hospital that is a member of the network, when applicable; One QIO or equivalent entity Takes corrective action when there are identified findings

22 Nursing Services Nursing services must meet the needs of patients. In order to meet the needs of patients, nursing services must be a wellorganized service of the CAH and under the direction of a registered nurse. The CAH and the director of the nursing service are responsible for: the clinical activities of all nursing to include the clinical activities of all non- CAH nursing personnel (contract, agency, or volunteer) The CAH and the director of nursing service ensure that all CAH nursing staff and each non-cah nursing staff person is adequately: trained and oriented Supervised clinical activities are evaluated and all nursing personnel know the CAH policies and procedures An appropriately qualified CAH-employed RN should conduct the supervision and evaluation of the clinical activities of each non-cah nursing staff.

23 Nursing Services A registered nurse must provide (or assign to other personnel) the nursing care of each patient, including patients at a SNF level of care in a swing-bed CAH. The care must be provided in accordance with the patient's needs and the specialized qualifications and competence of the staff available. Delegation must be within the Scope of Practice Patient needs are met by ongoing assessments of patients needs and provides nursing staff to meet those needs. An RN must make all patient care assignments

24 Nursing Services A nursing care plan must be developed and kept current for each inpatient.

25 Condition of Participation: Organizational Structure 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.

26 State Rules Effective October 1, 2013 Training Schedule ADHS Rules for All Healthcare Institutions s/health-care-institutions

27 Nursing Services Rule Identifier Change R Current Arizona Administrative Code October 1, 2013 New Integrated Rules R Nursing Services

28 Nursing Services An administrator shall ensure that: 1. Nursing services are provided 24 hours a day, and 2. A nurse executive is appointed who is qualified according to the requirements in policies and procedures. B. A nurse executive shall designate a registered nurse who is present in the hospital to be accountable for managing the nursing services when the nurse executive is not present in the hospital. C. A nurse executive shall ensure that: 1. Policies and procedures for nursing services are established, documented, and implemented; 2. An acuity plan is established, documented, and implemented

29 Nursing Services A rural general hospital with more than one patient has one registered nurse and at least one other nursing personnel member on duty. If there is only one registered nurse in the hospital, an additional registered nurse is on-call who is able to be present in the hospital within 15 minutes after being called; 10. If a hospital has a patient in a unit, there is a minimum of one registered nurse in the unit; 11. If a hospital has more than one patient in a unit, there is a minimum of one registered nurse and one additional nursing personnel member in the unit;

30 Quality Management An administrator shall ensure that: 1. A plan is established, documented, and implemented for an ongoing quality management program that, at a minimum, includes: a. A method to identify, document, and evaluate incidents; b. A method to collect data to evaluate hospital services and environmental services related to patient care; c. A method to evaluate the data collected to identify a concern about the delivery of hospital services or environmental services related to patient care; d. A method to make changes or take action as a result of the identification of a concern about the delivery of hospital services or environmental services related to patient care; e. A method to identify and document each occurrence of exceeding licensed

31 Quality Management A documented report is submitted to the governing authority that includes: a. An identification of each concern about the delivery of hospital services or environmental services related to patient care, and b. Any changes made or actions taken as a result of the identification of a concern about the delivery of hospital services or environmental services related to patient care;

32 Medical Staff A. A governing authority shall ensure that: 1. The organized medical staff is directly accountable to the governing authority for the quality of care provided by a medical staff member to a patient in a hospital; 2. The medical staff bylaws and medical staff regulations are approved according to the medical staff bylaws and governing authority requirements; 3. A medical staff member complies with medical staff bylaws and medical staff regulations;

33 Pharmaceutical Services A committee, composed of at least one physician, one pharmacist, and other personnel members as determined by policies and procedures is established to: a. Develop a drug formulary, b. Update the drug formulary at least every 12 months, c. Develop medication usage and medication substitution policies and procedures, and d. Specify which medication and medication classifications are required to be automatically stopped after a specified time period unless the ordering medical staff member specifically orders otherwise; An expired, mislabeled, or unusable medication is disposed of according to policies

34 Pharmacy Services A medication administration error or an adverse reaction is reported to the ordering medical staff member or the medical staff member's designee A pharmacy medication dispensing error is reported to the pharmacist In a pharmacist's absence, personnel members designated by policies and procedures have access to a locked area containing a medication; A medication is administered in compliance with an order

35 Governing Authority Administration Adopt a quality management program Review and evaluate the effectiveness of the quality management program at least once every 12 months Administrator Policies and Procedures Cover quality management, including incident report and supporting documentation; Cover contracted services Cover infection control

36 Environmental Services The hospital premises and equipment are: a. Cleaned and disinfected according to policies and procedures or manufacturer's instructions to prevent, minimize, and control infection or illness; and b. Free from a condition or situation that may cause a patient or other individual to suffer physical injury; A pest control program is implemented and documented; Biohazardous medical waste is identified, stored, and disposed of according to 18 A.A.C. 13, Article 14 and policies and procedures; Equipment used to provide hospital services is: a. Maintained in working order; b. Tested and calibrated according to the manufacturer's recommendations or, if there are no manufacturer's recommendations, as specified in policies and procedures; and c. Used according to the manufacturer's recommendations; and Documentation of equipment testing, calibration, and repair is maintained for at least 12 months after the date of the testing, calibration, or repair.

37 Infection Control An administrator shall ensure that: 1. An infection control program that meets the requirements of this Section is established under the direction of an individual qualified according to policies and procedures; 2. An infection control program has a procedure for documenting: a. The collection and analysis of infection control data, b. The actions taken relating to infections and communicable diseases, and c. Reports of communicable diseases to the governing authority and state and county health departments; 3. Infection control documents are maintained for at least two years after the date of the document; 4. Policies and procedures are established, documented, and implemented:

38 Infection Control Policies and procedures are established, documented, and implemented: a. To prevent or minimize, identify, report, and investigate infections and communicable diseases that include: i. Isolating a patient; ii. Sterilizing equipment and supplies; iii. Maintaining and storing sterile equipment and supplies; iv. Use of personal protective equipment such as gowns, masks, or face protection; v. Disposing of biohazardous medical waste; and vi. Transporting and processing soiled linens and clothing;

39 Infection Control An infection control committee is established according to policies and procedures and consists of: a. At least one medical staff member, b. The individual directing the infection control program, and c. Other personnel identified in policies and procedures; and The infection control committee: a. Develops a plan for preventing, tracking, and controlling infections; b. Reviews the type and frequency of infections and develops recommendations for improvement; c. Meets and provides a quarterly written report for inclusion by the quality management program; and d. Maintains a record of actions taken and minutes of meetings.

40 Thank You Questions Comments