1California Association of Health Facilities RAP Session San Bernardino/Riverside District Offices Presenters:Debra Brown, PharmD, Pharmaceutical ConsultantEdwin Hoffmark, RN, Chief of RN UnitState of CaliforniaDepartment of Public HealthLicensing and Certification Program
2Welcome !Please keep in mind that this presentation will not be all inclusive regarding CDPH RegulationsRelevant questions are encouraged after the presentation.It is very important for everyone to remember that survey regulations (State and Federal) are the minimum standards and the facility should always strive for levels above this minimum.
3Goals and Objectives Identify Federal and State regulatory websites Summarize SNF pharmaceutical servicesDiscuss statistical patterns of federal survey deficiencies related to SNF pharmaceutical services for 2010 and January – June 2011Discuss Health and Safety Code related to use of Automated Drug Cabinets in SNFsDiscuss elements of SNF Informed Consent for psychotherapeutic medications
4Helpful Federal SNF Regulatory Websites Federal GovernmentCode of Federal Regulations (50) & U.S.C.Use retrieve by CFR Title 42§§483- General Consumer Info.Skilled Nursing Regulations with Interpretive Guidelines & Appendix P
5Helpful California State Regulatory Websites California CDPH Licensing and Certification HomepageCalifornia’s 29 Statutes: Health and Safety CodeCalifornia’s 28 Regulations: Title 22
6Pharmaceutical Services Dispensing, labeling, storage, administration and disposition of medicationsTimeliness of medication servicesStop ordersMonitoring of the medication distribution system (ordering, dispensing, storage and administering)Medication ordering process and record keepingControlled substances accountabilityProvision of pharmaceutical consultant services
7Pharmaceutical Consultant Services Assist in the development, coordination, supervision and review of pharmaceutical servicesDevote sufficient hours during visit for the purpose of coordinating, supervising and reviewing pharmaceutical servicesProvide consultation on all aspects of pharmaceutical servicesServe on the following committees: Pharmaceutical Services, Patient Care Policy and Infection ControlCommittee minutes must be maintained in the facility and indicate members present, date, length of meeting, subjects discussed and action taken
8Pharmaceutical Consultant Services DRR Requirement At least monthlyReview of all drugs currently orderedInformation concerning the resident’s condition as related to drug therapyMedication administration recordsPhysician progress notesNurses notesLaboratory test resultsReport, in writing, to Administrator and DON
9Deficiency Patterns For California Skilled Nursing Facilities 2010 F329 Drug regimen is free from unnecessary drugs (69/283 Rx deficiencies = 24.3%)F332 Medication error rates of 5% or more (23/283 Rx deficiencies = 8.1 %)F333 Residents free from significant medication errors (31/283 Rx deficiencies = 11%)F425 Facility provides drugs and biologicals (65/283 Rx deficiencies = 23%)F428 Resident’s drug regimen reviewed monthly by the pharmacist (31/283 Rx deficiencies = 11%)F431 Proper labeling of drugs and biologicals (64/283 Rx deficiencies = 22.6%)
10Deficiency Patterns for California Skilled Nursing Facilities January – June 2011 F329 Drug regimen is free from unnecessary drugs (38/140 Rx deficiencies = 27.1%)F332 Medication error rates of 5% or more (3/140 Rx deficiencies = 2.1 %)F333 Residents free from significant medication errors (8/140 Rx deficiencies = 5.7%)F425 Facility provides drugs and biologicals (35/140 Rx deficiencies = 25%)F428 Resident’s drug regimen reviewed monthly by the pharmacist (25/140 Rx deficiencies = 17.9%)F431 Proper labeling of drugs and biologicals (31/140 Rx deficiencies = 22.1%)
11Automated Drug Cabinets (ADCs) in Skilled Nursing Facilities Health and Safety Code SectionAllows for 48 medications/16 doses of each in emergency supplies (amended 1/2010)Does not apply to an automated drug delivery system when the pharmacist controls access to the medicationsHealth and Safety Code SectionADC = mechanical system that stores/dispenses/distributes medicationADC also collects, controls and maintains transaction information (for security/accuracy/accountability)Written transaction information must be readily available for review/inspectionADC access limited to facility/contracted personnel authorized to administer medications
12Automated Drug Cabinets (ADCs) in Skilled Nursing Facilities (cont’d) Health and Safety Code SectionWritten P/P must be developed/implemented by the pharmacy and facilityEnsure safety, accuracy, accountability, security, patient confidentiality, and maintenance of quality/potency/purity of stored medicationsP/P must be maintained at the pharmacy and the facility where ADC in useADC also collects, controls and maintains transaction information (for security/accuracy/accountability)
13Automated Drug Cabinets (ADCs) in Skilled Nursing Facilities (cont’d) Health and Safety Code SectionWhen used as an emergency medication supply container, drugs removed shall be limited to:A new drug order prescribed to a facility patient prior to the next delivery, or 72 hours, whichever is lessMedications will be retrieved after authorization of the pharmacist (pursuant to review of the order)Medications ordered on “as needed” basis, if utilization and retrieval subject to ongoing pharmacist reviewMedications that patient care policy/pharmaceutical service committee agrees are emergency/acute onset drugsPharmacist must review the order within 48 hours of retrieval
14Automated Drug Cabinets (ADCs) in Skilled Nursing Facilities (cont’d) Health and Safety Code SectionWhen used to provide routine pharmacy services:ADC medications must be in labeled units of packagingMedications will be retrieved after review and approval of the pharmacist (pursuant to review of the order)Pharmacy providing services controls ADC accessAccess controlled using identification/password system/biosensorADC shall make complete/accurate record of transactions that includes all users and medications added/removedAfter pharmacist reviews order, licensed staff only has access to patient-specific medications ordered by MD
15Automated Drug Cabinets (ADCs) in Skilled Nursing Facilities (cont’d) Health and Safety Code SectionADC systems that allow licensed staff to have access to multiple medications/not patient specific in their design are allowed if:ADC has electronic/mechanical safeguards to ensure retrieved medications are specific to that patientFacility notifies the department in writing prior to utilizing the systemNotification shall include (not limited to) info re: ADC design, personnel access, P/P covering staff training, storage/security and administration issuesDepartment will review above and ensure adequate safeguards in place to ensure medications delivered appropriate to patientIf facility not in compliance, department may revoke authorization
16Automated Drug Cabinets (ADCs) in Skilled Nursing Facilities (cont’d) Health and Safety Code SectionStocking of ADC shall be done by a pharmacistIf ADC utilizes removable pockets, cards, drawers, etc., the stocking system may be done outside the facility and delivered if:The task of placing removable pockets, cards, etc. is performed by pharmacist/pharmacy intern/tech working under pharmacistRemovable pockets, cards, etc. are transported between the pharmacy and facility in a secure tamper-evident containerFacility/pharmacy have developed P/P to ensure that pockets, cards, etc. are properly placed into ADC
17Presented By: Edwin Hoffmark, RN, Chief of RN Unit SNF Informed ConsentPresented By: Edwin Hoffmark, RN, Chief of RN Unit
18Brief History of Informed Consent 1992 to 2011 1992 – Title 22 Section Promulgated1993 – Release of Pharmacy Training Bulletin PTB-93-42010 2nd Qtr- Promulgation of revisionrd Qtr – Review of past training2011 – AFL 11-08
19Definitions and Meanings For the purposes of this presentation: The only facility that is covered by Title 22 Section is the Skilled Nursing Facility. Patient = Resident Whenever Patient is mentioned, it will include Responsible Party if applicable.
20What is Informed Consent Informed consent is first and foremost a Patient Right.Informed consent is granted by a Patient or a person who may act as a Patient’s Representative (Responsible Party.)Informed consent may be withdrawn at any time by the Patient or the RP (if applicable).Informed consent is a process that does not end with a signature or the start of therapy.
21Informed Consent is NOT Informed consent is not automatic.Informed consent is not a form.Informed consent is not finished when consent is obtained.
22PERTINENT STATE REGULATIONS CCR Title 22, Division 5: Definition of Consent72052: Definition of Informed Consent72082: Definition of Physical Restraint72092: Definition of Psychotherapeutic Drug72527: Patient Rights (includes consent)72528: Informed Consent Requirements
23OTHER PERTINENT STATE LAWS and DOCUMENTS Health and Safety CodeHSC (Eppel Act)HSCOther related references:Schloendorff v. Society of New York Hospital (NY Supreme Court, 1914)Cobbs v. Grant, (Calif. Supreme Court, 1972)AFL (Reiterates provisions of H&S )AFL ( Informed Consent)AFL (Q & A Regarding Informed Consent)
25Title 22 Section 72528(b) and HSC 1418.9 AgentsNot AllowedTitle 22 Section 72528(b) and HSC
26Agents (cont.)Title 22 Section 72528(b) (b) The information material to a decision concerning the administration of a psychotherapeutic drug or physical restraint, or the prolonged use of a device that may lead to the inability of the patient to regain use of a normal bodily function shall include at least the following: (1) The reason for the treatment and the nature and seriousness of the patient's illness. (2) The nature of the procedures to be used in the proposed treatment including their probable frequency and duration. (3) The probable degree and duration (temporary or permanent) of improvement or remission, expected with or without such treatment. (4) The nature, degree, duration and probability of the side effects and significant risks, commonly known by the health professions. (5) The reasonable alternative treatments and risks, and why the health professional is recommending this particular treatment. (6) That the patient has the right to accept or refuse the proposed treatment, and if he or she consents, has the right to revoke his or her consent for any reason at any time.
27Agents (cont.)HSCIf the attending physician and surgeon of a resident in askilled nursing facility prescribes, orders, or increases an order for an antipsychotic medication for the resident, the physician and surgeon shall do both of the following:(1) Obtain the informed consent of the resident for purposes of prescribing, ordering, or increasing an order for the medication.
28Psychotherapeutic Medications What is a psychotherapeutic medication? Any medication used to control behavior or to treat thought disorder processes. It is the use of the medication and not the classification* (*except antipsychotics)
29Psychotherapeutic Medications Includes:Medications not normally thought of as psychotherapeutic medications.Beta blockers used to control aggressive behavior.Sleeping medications used to control behavior e.g.; climbing out of bed, wandering…Any antipsychotic medication
30Psychotherapeutic Medications Does NOT Include: Sleeping medications used for sleep. Diazepam used for muscle spasms
31AntipsychoticsDefined in HSC (c)(3) "Antipsychotic medication" means a medication approved by the United States Food and Drug Administration for the treatment of psychosis.
32Exceptions to Informed Consent Title 22 Section 72528(e)&(f)EmergenciesDocumentation that the patient doesn’t want to be informed of the risk v. benefits.Informing patient would cause harm.
33Devices 1. Physical Restraints – Title 22 § 72082 2. The prolonged use of a device that may lead to the inability to regain use of a normal bodily function.The Department has not specified any specific device or device category that would meet the informed consent requirements.
34Material Circumstances… The phrase is found in 72528(d) … unless material circumstances or risks change.A "change in material circumstances" usually means a change in the patient's medical or psychosocial condition which indicates that a different treatment plan should be considered. "Material circumstances" in this context are determined by licensed healthcare practitioners who are responsible for initiating a new informed consent discussion about any proposed changes to treatment. Healthcare practitioners are required to provide sufficient material information for the patient to make an informed decision to agree to the new treatment plan, to choose an alternative treatment or to refuse treatment altogether.
35Verification required by Title 22 Section 72528(c) …facility staff shall verify that the patient's health record contains documentation that the patient has given informed consent …Licensed Healthcare PractitionersPatient or Family
36Miscellaneous Admission issues Documentation Acute Care Hospitals Policies and Procedures
37Informed Consent“…In the communications process, you, as the physician providing or performing the treatment and/or procedure (not a delegated representative), should disclose and discuss with your patient:…This communications process, or a variation thereof, is both an ethical obligation and a legal requirement spelled out in statutes and case law in all 50 states… “Copyright American Medical Association
38Questions???Please ask questions as directed by the facilitator of this session so that we can ensure an accurate and thorough response.
39Contact InformationIf you have further questions about Informed Consent please contact Edwin Hoffmark, Chief of RN Unit at:California Department of Public HealthLicensing & Certification ProgramFax: (916)Phone: