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California Association of Health Facilities RAP Session San Bernardino/Riverside District Offices Presenters: Presenters: Debra Brown, PharmD, Pharmaceutical.

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Presentation on theme: "California Association of Health Facilities RAP Session San Bernardino/Riverside District Offices Presenters: Presenters: Debra Brown, PharmD, Pharmaceutical."— Presentation transcript:

1 California Association of Health Facilities RAP Session San Bernardino/Riverside District Offices Presenters: Presenters: Debra Brown, PharmD, Pharmaceutical Consultant Debra Brown, PharmD, Pharmaceutical Consultant Edwin Hoffmark, RN, Chief of RN Unit Edwin Hoffmark, RN, Chief of RN Unit State of California State of California Department of Public Health Department of Public Health Licensing and Certification Program Licensing and Certification Program

2 Welcome ! Please keep in mind that this presentation will not be all inclusive regarding CDPH Regulations Please keep in mind that this presentation will not be all inclusive regarding CDPH Regulations Relevant questions are encouraged after the presentation. Relevant 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. 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.

3 Goals and Objectives Identify Federal and State regulatory websites Identify Federal and State regulatory websites Summarize SNF pharmaceutical services Summarize SNF pharmaceutical services Discuss statistical patterns of federal survey deficiencies related to SNF pharmaceutical services for 2010 and January – June 2011 Discuss statistical patterns of federal survey deficiencies related to SNF pharmaceutical services for 2010 and January – June 2011 Discuss Health and Safety Code related to use of Automated Drug Cabinets in SNFs Discuss Health and Safety Code related to use of Automated Drug Cabinets in SNFs Discuss elements of SNF Informed Consent for psychotherapeutic medications Discuss elements of SNF Informed Consent for psychotherapeutic medications

4 Helpful Federal SNF Regulatory Websites Federal Government Code of Federal Regulations (50) & U.S.C. Code of Federal Regulations (50) & U.S.C. Use retrieve by CFR Title 42§§ General Consumer Info. - General Consumer Info.www.cms.hhs.gov Skilled Nursing Regulations with Interpretive Guidelines & Appendix P Skilled Nursing Regulations with Interpretive Guidelines & Appendix P Regulations/12_NHs.asp Regulations/12_NHs.asp

5 Helpful California State Regulatory Websites California CDPH Licensing and Certification Homepage California CDPH Licensing and Certification Homepagehttp://www.dhs.ca.gov/lnc/default.htm Californias 29 Statutes: Health and Safety Code Californias 29 Statutes: Health and Safety Codehttp://www.leginfo.ca.gov/calaw.html Californias 28 Regulations: Title 22 Californias 28 Regulations: Title 22http://ccr.oal.ca.gov/

6 Pharmaceutical Services Dispensing, labeling, storage, administration and disposition of medications Dispensing, labeling, storage, administration and disposition of medications Timeliness of medication services Timeliness of medication services Stop orders Stop orders Monitoring of the medication distribution system (ordering, dispensing, storage and administering) Monitoring of the medication distribution system (ordering, dispensing, storage and administering) Medication ordering process and record keeping Medication ordering process and record keeping Controlled substances accountability Controlled substances accountability Provision of pharmaceutical consultant services Provision of pharmaceutical consultant services

7 Pharmaceutical Consultant Services Assist in the development, coordination, supervision and review of pharmaceutical services Assist in the development, coordination, supervision and review of pharmaceutical services Devote sufficient hours during visit for the purpose of coordinating, supervising and reviewing pharmaceutical services Devote sufficient hours during visit for the purpose of coordinating, supervising and reviewing pharmaceutical services Provide consultation on all aspects of pharmaceutical services Provide consultation on all aspects of pharmaceutical services Serve on the following committees: Pharmaceutical Services, Patient Care Policy and Infection Control Serve on the following committees: Pharmaceutical Services, Patient Care Policy and Infection Control Committee minutes must be maintained in the facility and indicate members present, date, length of meeting, subjects discussed and action taken Committee minutes must be maintained in the facility and indicate members present, date, length of meeting, subjects discussed and action taken

8 Pharmaceutical Consultant Services DRR Requirement At least monthly At least monthly Review of all drugs currently ordered Review of all drugs currently ordered Information concerning the residents condition as related to drug therapy Information concerning the residents condition as related to drug therapy Medication administration records Medication administration records Physician progress notes Physician progress notes Nurses notes Nurses notes Laboratory test results Laboratory test results Report, in writing, to Administrator and DON Report, in writing, to Administrator and DON

9 Deficiency Patterns For California Skilled Nursing Facilities 2010 F329 Drug regimen is free from unnecessary drugs (69/283 Rx deficiencies = 24.3%) 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 %) 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%) F333 Residents free from significant medication errors (31/283 Rx deficiencies = 11%) F425 Facility provides drugs and biologicals (65/283 Rx deficiencies = 23%) F425 Facility provides drugs and biologicals (65/283 Rx deficiencies = 23%) F428 Residents drug regimen reviewed monthly by the pharmacist (31/283 Rx deficiencies = 11%) F428 Residents 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%) F431 Proper labeling of drugs and biologicals (64/283 Rx deficiencies = 22.6%)

10 F329 Drug regimen is free from unnecessary drugs (38/140 Rx deficiencies = 27.1%) 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 %) 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%) F333 Residents free from significant medication errors (8/140 Rx deficiencies = 5.7%) F425 Facility provides drugs and biologicals (35/140 Rx deficiencies = 25%) F425 Facility provides drugs and biologicals (35/140 Rx deficiencies = 25%) F428 Residents drug regimen reviewed monthly by the pharmacist (25/140 Rx deficiencies = 17.9%) F428 Residents 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%) F431 Proper labeling of drugs and biologicals (31/140 Rx deficiencies = 22.1%) Deficiency Patterns for California Skilled Nursing Facilities January – June 2011

11 Automated Drug Cabinets (ADCs) in Skilled Nursing Facilities Health and Safety Code Section Health and Safety Code Section Allows for 48 medications/16 doses of each in emergency supplies (amended 1/2010) Allows 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 medications Does not apply to an automated drug delivery system when the pharmacist controls access to the medications Health and Safety Code Section Health and Safety Code Section ADC = mechanical system that stores/dispenses/distributes medication ADC = mechanical system that stores/dispenses/distributes medication ADC also collects, controls and maintains transaction information (for security/accuracy/accountability) ADC also collects, controls and maintains transaction information (for security/accuracy/accountability) Written transaction information must be readily available for review/inspection Written transaction information must be readily available for review/inspection ADC access limited to facility/contracted personnel authorized to administer medications ADC access limited to facility/contracted personnel authorized to administer medications

12 Automated Drug Cabinets (ADCs) in Skilled Nursing Facilities (contd) Health and Safety Code Section Health and Safety Code Section Written P/P must be developed/implemented by the pharmacy and facility Written P/P must be developed/implemented by the pharmacy and facility Ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of quality/potency/purity of stored medications Ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of quality/potency/purity of stored medications P/P must be maintained at the pharmacy and the facility where ADC in use P/P must be maintained at the pharmacy and the facility where ADC in use ADC also collects, controls and maintains transaction information (for security/accuracy/accountability) ADC also collects, controls and maintains transaction information (for security/accuracy/accountability)

13 Automated Drug Cabinets (ADCs) in Skilled Nursing Facilities (contd) Health and Safety Code Section Health and Safety Code Section When used as an emergency medication supply container, drugs removed shall be limited to: When 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 less A new drug order prescribed to a facility patient prior to the next delivery, or 72 hours, whichever is less Medications will be retrieved after authorization of the pharmacist (pursuant to review of the order) Medications 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 review Medications ordered on as needed basis, if utilization and retrieval subject to ongoing pharmacist review Medications that patient care policy/pharmaceutical service committee agrees are emergency/acute onset drugs Medications that patient care policy/pharmaceutical service committee agrees are emergency/acute onset drugs Pharmacist must review the order within 48 hours of retrieval Pharmacist must review the order within 48 hours of retrieval

14 Automated Drug Cabinets (ADCs) in Skilled Nursing Facilities (contd) Health and Safety Code Section Health and Safety Code Section When used to provide routine pharmacy services: When used to provide routine pharmacy services: ADC medications must be in labeled units of packaging ADC medications must be in labeled units of packaging Medications will be retrieved after review and approval of the pharmacist (pursuant to review of the order) Medications will be retrieved after review and approval of the pharmacist (pursuant to review of the order) Pharmacy providing services controls ADC access Pharmacy providing services controls ADC access Access controlled using identification/password system/biosensor Access controlled using identification/password system/biosensor ADC shall make complete/accurate record of transactions that includes all users and medications added/removed ADC shall make complete/accurate record of transactions that includes all users and medications added/removed After pharmacist reviews order, licensed staff only has access to patient-specific medications ordered by MD After pharmacist reviews order, licensed staff only has access to patient-specific medications ordered by MD

15 Automated Drug Cabinets (ADCs) in Skilled Nursing Facilities (contd) Health and Safety Code Section Health and Safety Code Section ADC systems that allow licensed staff to have access to multiple medications/not patient specific in their design are allowed if: ADC 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 patient ADC has electronic/mechanical safeguards to ensure retrieved medications are specific to that patient Facility notifies the department in writing prior to utilizing the system Facility notifies the department in writing prior to utilizing the system Notification shall include (not limited to) info re: ADC design, personnel access, P/P covering staff training, storage/security and administration issues Notification shall include (not limited to) info re: ADC design, personnel access, P/P covering staff training, storage/security and administration issues Department will review above and ensure adequate safeguards in place to ensure medications delivered appropriate to patient Department will review above and ensure adequate safeguards in place to ensure medications delivered appropriate to patient If facility not in compliance, department may revoke authorization If facility not in compliance, department may revoke authorization

16 Automated Drug Cabinets (ADCs) in Skilled Nursing Facilities (contd) Health and Safety Code Section Health and Safety Code Section Stocking of ADC shall be done by a pharmacist Stocking of ADC shall be done by a pharmacist If ADC utilizes removable pockets, cards, drawers, etc., the stocking system may be done outside the facility and delivered if: If 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 pharmacist The task of placing removable pockets, cards, etc. is performed by pharmacist/pharmacy intern/tech working under pharmacist Removable pockets, cards, etc. are transported between the pharmacy and facility in a secure tamper-evident container Removable pockets, cards, etc. are transported between the pharmacy and facility in a secure tamper-evident container Facility/pharmacy have developed P/P to ensure that pockets, cards, etc. are properly placed into ADC Facility/pharmacy have developed P/P to ensure that pockets, cards, etc. are properly placed into ADC

17 SNF Informed Consent Presented By: Edwin Hoffmark, RN, Chief of RN Unit

18 Brief History of Informed Consent 1992 to – Title 22 Section Promulgated 1992 – Title 22 Section Promulgated 1993 – Release of Pharmacy Training Bulletin PTB – Release of Pharmacy Training Bulletin PTB nd Qtr- Promulgation of revision nd Qtr- Promulgation of revision rd Qtr – Review of past training rd Qtr – Review of past training 2011 – AFL – AFL 11-08

19 Definitions 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.

20 What is Informed Consent Informed consent is first and foremost a Patient Right. Informed consent is first and foremost a Patient Right. Informed consent is granted by a Patient or a person who may act as a Patients Representative (Responsible Party.) Informed consent is granted by a Patient or a person who may act as a Patients Representative (Responsible Party.) Informed consent may be withdrawn at any time by the Patient or the RP (if applicable). 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. Informed consent is a process that does not end with a signature or the start of therapy.

21 Informed Consent is NOT Informed consent is not automatic. Informed consent is not automatic. Informed consent is not a form. Informed consent is not a form. Informed consent is not finished when consent is obtained. Informed consent is not finished when consent is obtained.

22 PERTINENT STATE REGULATIONS CCR Title 22, Division 5 CCR Title 22, Division : Definition of Consent : Definition of Consent 72052: Definition of Informed Consent 72052: Definition of Informed Consent 72082: Definition of Physical Restraint 72082: Definition of Physical Restraint 72092: Definition of Psychotherapeutic Drug 72092: Definition of Psychotherapeutic Drug 72527: Patient Rights (includes consent) 72527: Patient Rights (includes consent) 72528: Informed Consent Requirements 72528: Informed Consent Requirements

23 OTHER PERTINENT STATE LAWS and DOCUMENTS Health and Safety Code Health and Safety Code HSC (Eppel Act) HSC (Eppel Act) HSC HSC Other related references: Other related references: Schloendorff v. Society of New York Hospital (NY Supreme Court, 1914) Schloendorff v. Society of New York Hospital (NY Supreme Court, 1914) Cobbs v. Grant, (Calif. Supreme Court, 1972) Cobbs v. Grant, (Calif. Supreme Court, 1972) AFL (Reiterates provisions of H&S ) AFL (Reiterates provisions of H&S ) AFL ( Informed Consent) AFL ( Informed Consent) AFL (Q & A Regarding Informed Consent) AFL (Q & A Regarding Informed Consent)

24 Q&As 1. Agents 2. Psychotherapeutic Medications 3. Antipsychotics 4. Exceptions 5. Devices 6. Material Circumstances… 7. Verification 8. Miscellaneous

25 Agents Not Allowed Title 22 Section 72528(b) and HSC

26 Agents (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.

27 Agents (cont.) HSC If the attending physician and surgeon of a resident in a skilled 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.

28 Psychotherapeutic 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) (*except antipsychotics)

29 Psychotherapeutic Medications Includes: Medications not normally thought of as psychotherapeutic medications. Medications not normally thought of as psychotherapeutic medications. Beta blockers used to control aggressive behavior. Beta blockers used to control aggressive behavior. Sleeping medications used to control behavior e.g.; climbing out of bed, wandering… Sleeping medications used to control behavior e.g.; climbing out of bed, wandering… Any antipsychotic medication Any antipsychotic medication

30 Psychotherapeutic Medications Does NOT Include: Does NOT Include: Sleeping medications used for sleep. Diazepam used for muscle spasms

31 Antipsychotics Defined in HSC (c)(3) "Antipsychotic medication" means a medication approved by the United States Food and Drug Administration for the treatment of psychosis.

32 Exceptions to Informed Consent Title 22 Section 72528(e)&(f) Emergencies Emergencies Documentation that the patient doesnt want to be informed of the risk v. benefits. Documentation that the patient doesnt want to be informed of the risk v. benefits. Informing patient would cause harm. Informing patient would cause harm.

33 Devices 1. Physical Restraints – Title 22 § 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.

34 Material 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.

35 Verification Verification 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 … 1. Licensed Healthcare Practitioners 2. Patient or Family

36 Miscellaneous 1. Admission issues 2. Documentation 3. Acute Care Hospitals 4. Policies and Procedures

37 Informed 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… …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

38 Questions??? Please ask questions as directed by the facilitator of this session so that we can ensure an accurate and thorough response.

39 Contact Information Contact Information If you have further questions about Informed Consent please contact Edwin Hoffmark, Chief of RN Unit at: If you have further questions about Informed Consent please contact Edwin Hoffmark, Chief of RN Unit at: California Department of Public Health California Department of Public Health Licensing & Certification Program Licensing & Certification Program Fax: (916) Fax: (916) Phone: Phone:


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