California Association of Health
Facilities RAP Session
San Bernardino/Riverside District
Offices
 Presenters:
Debra Brown, PharmD, Pharmaceutical Consultant
 Edwin Hoffmark, RN, Chief of RN Unit
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State of California
Department of Public Health
Licensing and Certification Program
Debra.Brown@cdph.ca.gov
 RNUnit@cdph.ca.gov
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Welcome !
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Please keep in mind that this presentation will
not be all inclusive regarding CDPH Regulations
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.
Goals and Objectives
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Identify Federal and State regulatory websites
Summarize SNF pharmaceutical services
Discuss statistical patterns of federal survey deficiencies
related to SNF pharmaceutical services for 2010 and
January – June 2011
Discuss Health and Safety Code 1261.6 related to use
of Automated Drug Cabinets in SNFs
Discuss elements of SNF Informed Consent for
psychotherapeutic medications
Helpful Federal SNF Regulatory
Websites
Federal Government
 Code of Federal Regulations (50) & U.S.C.
http://www.gpoaccess.gov/cfr/
Use retrieve by CFR Title 42§§483
www.cms.hhs.gov - General Consumer Info.
 Skilled Nursing Regulations with Interpretive
Guidelines & Appendix P
http://www4.cms.hhs.gov/GuidanceforLawsAnd
Regulations/12_NHs.asp
Helpful California State
Regulatory Websites
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California CDPH Licensing and
Certification Homepage
http://www.dhs.ca.gov/lnc/default.htm
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California’s 29 Statutes: Health and Safety
Code
http://www.leginfo.ca.gov/calaw.html
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California’s 28 Regulations: Title 22
http://ccr.oal.ca.gov/
Pharmaceutical Services
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Dispensing, labeling, storage, administration and
disposition of medications
Timeliness of medication services
Stop orders
Monitoring of the medication distribution system
(ordering, dispensing, storage and administering)
Medication ordering process and record keeping
Controlled substances accountability
Provision of pharmaceutical consultant services
Pharmaceutical Consultant
Services
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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
Provide consultation on all aspects of pharmaceutical
services
Serve on the following committees: Pharmaceutical
Services, Patient Care Policy and Infection Control
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Committee minutes must be maintained in the facility and
indicate members present, date, length of meeting, subjects
discussed and action taken
Pharmaceutical Consultant Services
DRR Requirement
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At least monthly
Review of all drugs currently ordered
Information concerning the resident’s condition as
related to drug therapy
Medication administration records
Physician progress notes
Nurses notes
Laboratory test results
Report, in writing, to Administrator and DON
Deficiency Patterns For California
Skilled Nursing Facilities 2010
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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%)
Deficiency Patterns for California Skilled
Nursing Facilities January – June 2011
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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%)
Automated Drug Cabinets (ADCs) in
Skilled Nursing Facilities
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Health and Safety Code Section 1261.5
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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
Health and Safety Code Section 1261.6
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ADC = mechanical system that stores/dispenses/distributes
medication
ADC also collects, controls and maintains transaction
information (for security/accuracy/accountability)
Written transaction information must be readily available for
review/inspection
ADC access limited to facility/contracted personnel
authorized to administer medications
Automated Drug Cabinets (ADCs) in
Skilled Nursing Facilities (cont’d)
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Health and Safety Code Section 1261.6
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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
 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)
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Automated Drug Cabinets (ADCs) in
Skilled Nursing Facilities (cont’d)
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Health and Safety Code Section 1261.6
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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
 Medications will be retrieved after authorization of the
pharmacist (pursuant to review of the order)
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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
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Pharmacist must review the order within 48 hours of retrieval
Automated Drug Cabinets (ADCs) in
Skilled Nursing Facilities (cont’d)
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Health and Safety Code Section 1261.6
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When used to provide routine pharmacy services:
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)
 Pharmacy providing services controls ADC access
 Access controlled using identification/password
system/biosensor
 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
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Automated Drug Cabinets (ADCs) in
Skilled Nursing Facilities (cont’d)
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Health and Safety Code Section 1261.6
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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
 Facility notifies the department in writing prior to utilizing
the system
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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
If facility not in compliance, department may revoke
authorization
Automated Drug Cabinets (ADCs) in
Skilled Nursing Facilities (cont’d)
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Health and Safety Code Section 1261.6
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Stocking of ADC shall be done by a pharmacist
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If ADC utilizes removable pockets, cards, drawers, etc.,
the stocking system may be done outside the facility and
delivered if:
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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
Facility/pharmacy have developed P/P to ensure that pockets,
cards, etc. are properly placed into ADC
SNF Informed Consent
Presented By:
Edwin Hoffmark, RN, Chief of RN Unit
Brief History of Informed Consent
1992 to 2011
1992 – Title 22 Section 72528 Promulgated
 1993 – Release of Pharmacy Training
Bulletin PTB-93-4
 2010 2nd Qtr- Promulgation of 72528
revision
 2010 3rd Qtr – Review of past training
 2011 – AFL 11-08
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Definitions and Meanings
For the purposes of this presentation:
The only facility that is covered by Title 22 Section
72528 is the Skilled Nursing Facility.
Patient = Resident
Whenever Patient is mentioned, it will include
Responsible Party if applicable.
What is Informed Consent
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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.
Informed Consent is NOT
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Informed consent is not automatic.
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Informed consent is not a form.
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Informed consent is not finished when consent
is obtained.
PERTINENT STATE
REGULATIONS
CCR Title 22, Division 5
 72018.1: Definition of Consent
 72052: Definition of Informed Consent
 72082: Definition of Physical Restraint
 72092: Definition of Psychotherapeutic
Drug
 72527: Patient Rights (includes consent)
 72528: Informed Consent Requirements
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OTHER PERTINENT STATE
LAWS and DOCUMENTS
Health and Safety Code
HSC 1418.8 (Eppel Act)
HSC 1418.9
Other related references:
Schloendorff v. Society of New York Hospital (NY
Supreme Court, 1914)
Cobbs v. Grant, (Calif. Supreme Court, 1972)
AFL 09-12 (Reiterates provisions of H&S 1418.8)
AFL 11-08 ( Informed Consent)
AFL 11-31 (Q & A Regarding Informed Consent)
Q&A’s
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6.
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8.
Agents
Psychotherapeutic Medications
Antipsychotics
Exceptions
Devices
Material Circumstances…
Verification
Miscellaneous
Agents
Not Allowed
Title 22 Section 72528(b) and HSC 1418.9
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.
Agents (cont.)
HSC 1418.9
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.
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)
Psychotherapeutic 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
Psychotherapeutic Medications
Does NOT Include:
Sleeping medications used for sleep.
Diazepam used for muscle spasms
Antipsychotics
Defined in HSC 1418.9(c)(3)
"Antipsychotic medication" means a
medication approved by the United States
Food and Drug Administration for the
treatment of psychosis.
Exceptions to Informed Consent
Title 22 Section 72528(e)&(f)
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Emergencies
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Documentation that the patient doesn’t
want to be informed of the risk v. benefits.
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Informing patient would cause harm.
Devices
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.
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.
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 …
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2.
Licensed Healthcare Practitioners
Patient or Family
Miscellaneous
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Admission issues
Documentation
Acute Care Hospitals
Policies and Procedures
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… “
Copyright 1995-2011 American Medical Association
Questions???
Please ask questions as directed by the
facilitator of this session so that we can
ensure an accurate and thorough response.
Contact Information
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If you have further questions about Informed
Consent please contact Edwin Hoffmark,
Chief of RN Unit at:
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California Department of Public Health
Licensing & Certification Program
Fax: (916) 324-4820
 Email:
RNUnit@cdph.ca.gov
 Phone: 1-800-236-9747