Cannabis, LTC and CA
Several months ago, SAVVY on the SOM published two blogs on the use of medical marijuana. We did this, not as a moral or political issue but because a) the largest population of new users are seniors, and b) as a reminder that federal law prevails over state law – which prohibits the use of a schedule 1 drug where prohibited by the Controlled Substances Act.
This AFL is the newest information on the use of CBD for a very specific diagnosis. Additionally, CBD of no more than 0.1 percent THC has been moved from a schedule I to a schedule V drug – meaning it can lawfully be prescribed under federal and California law.If your facility is not in California, please check with your state office.
February 14, 2019
TO: All Facilities
SUBJECT: Transfer of Epidiolex ® (Cannabidiol or CBD) from Schedule I to Schedule V of the Controlled Substances Act
AUTHORITY: Health and Safety Code section 11150.2 Title 21 Code of Federal Regulations section 1308.15
All Facilities Letter (AFL) Summary
• This AFL notifies health facilities that the Drug Enforcement Administration (DEA) has moved the cannabidiol (CBD) drug Epidiolex ® from federal Schedule I to Schedule V.
• Only drugs approved by the Food and Drug Administration (FDA) that contain CBD derived from cannabis and no more than 0.1 percent residual tetrahydrocannabinols (THC) have been moved to Schedule V.
• Epidiolex ®, and any subsequent CBD drug that meets the criteria of FDA approval and THC content, may be lawfully prescribed and dispensed under federal and California law.
On September 28, 2018, the Federal Register issued the final rule Schedules of Controlled Substances: Placement in Schedule V of Certain FDA-Approved Drugs Containing Cannabidiol; Corresponding Change to Permit Requirements. The final rule places FDA-approved drugs containing CBD with no more than 0.1 percent THC in Schedule V of the Controlled Substances Act.
Epidiolex ®, an oral solution that contains CBD extracted from the cannabis plant, is the only drug currently included in Schedule V. The FDA approved Epidiolex ® on June 25, 2018, for treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older.
With the enactment of Assembly Bill 710 (Chapter 62, Statutes of 2018), Epidiolex ® and any subsequent CBD drug that meets the criteria of FDA approval and THC content, may be lawfully prescribed and dispensed under federal and California law.
The FDA has not yet approved any other CBD products or products that contain CBD; therefore, the vast majority of cannabis and/or CBD products remain as Schedule I under federal and California law. Drugs containing cannabis/marijuana, or any of its component parts or derivatives, that do not meet criteria of FDA approval and THC content may not be prescribed or dispensed. Health facilities must continue to comply with state and federal law for pharmaceutical services.
If you have questions about this AFL, please contact the L&C Pharmaceutical Consultants Unit at at [email protected]
Nursing Services in LTC
I was asked to speak at the Wisconsin SNF DON conference held at Lake Geneva in February.
One of the other speakers was a nurse from CMS who spoke about F725 – Nursing Services.
F725 reads: The facility must have sufficient nursing staff with appropriate competencies and skill sets to provide nursing and related services to assure resident safety and attain or maintain the highest practicable physical, mental and psycho social well-being of each resident, as determined by resident assessments and individual plans of care and considering the number, acuity and diagnoses of the facility resident population in accordance with the facility assessment.
What struck me as extraordinary in this presentation was staffing data collection from SNF sub-acute units.
Respiratory Therapists are not counted in the staffing hours for sub-acute units. This is not an oversight – this is deliberate on the part of CMS.
Why would CMS choose not to count RTs in the staffing mix for a sub-acute? Management of a ventilator, ventilator rounds, ventilator setting adjustments, suctioning and responding to alarms are vital to the care of residents on such a unit. RNs and LVNs in these units simply do not have the ventilator knowledge or the time to handle the complexities of ventilator management. But when these areas of concern were raised, the CMS nurse said RTs might be added in the future!
PBJ is submitted electronically. Staffing reports are electronically sent to providers. This is a simple line item addition which would take an IT person 10 minutes of time.
Perhaps CMS is unaware of the Scope of Practice for RTs.
We would encourage Sub-Acute Administrators and DONs to write to CMS and to the AHCA to express their concerns and ask for assistance in correcting this deficient practice on the part of CMS.
We also encourage writing to the American Association of Respiratory Care attn.: Anne Marie Hummel, Associate Director for Government Affairs and ask for AARC support to correct this deficiency on the part of CMS.
For CMS to ignore this issue leaves SNF Sub-Acute units with the very real possibility of earning a one star for staffing without any recourse.
We know we have written a newsletter and blogged extensively on the Activity Program but with the number of questions and observations we have made lately – this information bears repeating.
We continue to see Activity Assessment forms which have not been updated in the last 5 to 10 years; forms which may ask about interests such as music but are not completed with specifics such as types of music or artists, or worse yet, forms which contain a list of various nonspecific interest categories and the documentation is just the word “yes.” These answers are not resident specific and do not meet the intent of Resident Focused Care or provide for meaningful life activities.
We recently reviewed such a form which showed the resident loved classical music without a mention of any specifics (Big Band? Baroque? Mozart? Opera?). The care plan had no notation related to any type of music. The documented activities showed that music was provided four times in three months. This is a deficiency waiting to happen!
These examples do not meet the requirements at F-656 for a Resident Focused Comprehensive Care Plan OR the requirements at F-675 for Quality of Life OR F-679 Activities Meet the Interests and Needs of Each Resident.
If one reviews F-656, under the heading “Potential Tags for Additional Investigation,” one finds “If the surveyor identifies concerns about the resident’s care plan being individualized and person-centered, the surveyor should also review requirements at:
The verbiage at F-675 references the 1986 Institute of Medicine report which identified “that a sense of well-being, self-esteem, and self-worth was enhanced by personal control over choices, such as mealtimes, activities, clothing…”
F-679 clearly states “The facility must provide…an ongoing program to support residents in their choice of activities…”
This regulation also provides some wonderful activity approaches to residents with Dementia and references non-CMS websites which the facility may find useful in developing a meaningful activity program for residents with Dementia.
Don’t give surveyors a reason to use a non-resident focused activity tool, the activity care plan, or documentation of activities provided as a reason for a deeper look at your facilities ability to provide Resident Focused Care.
Privacy in LTC
F-583 addresses Privacy and Confidentiality in EVERY way possible. Let’s take a look at some of the types of privacy covered by this regulation.
Any written communication to or from the resident must be safeguarded by the facility. The facility must not leave notices to the resident taped to the resident’s door or lying on the bedside table. Examples would include ABNs or Trust Account summaries.
There are many situations within the facility setting when a resident is asked to divulge deeply personal information. Does the admission assessment take place in a shared bedroom with a roommate present? Is the resident’s medical history discussed in this setting? Are medications reviewed in a shared bedroom?
Electronic communication includes privacy when making or receiving phone calls and safeguarding information on a shared computer. If asked by a surveyor, do residents know they can make private phone calls? If asked, does the staff know how personal information is safeguarded on a shared computer?
This includes all aspects of care given to a resident and requires more than pulling the curtains. Who is present when personal care is given to a resident? Does a second person need to be present when catheter care is given or a diaper is checked or changed?
All types of records are covered by HIPPA such as medical, social, financial, etc. Any records showing a resident’s name and personal information would also come under HIPPA – such as the dietary listing of residents, diagnoses and their diets, a listing of daily lab draws which includes resident names, DOB and lab tests, a clipboard of residents with surgery or diagnoses requiring PT treatments, or a MAR left open on a med cart. Any of these incidents would be a HIPPA violation.
When requested, is there a space where private meetings can take place? Do residents know they can request a private space for a meeting? Do staff know where this private space is located?
Other examples of failure to provide privacy might include:
- Posting a resident’s weight on a public whiteboard next to the bed.
- Asking personal questions in the presence or hearing of another person (think admission assessment).
- Allowing a physician to examine or discuss medical care in a public setting (dining room).
- An unattended nurses station which contains any resident information.
- A staff member having a telephone discussion of personal resident information which can be overheard by other residents or visitors.
The bottom line is it is the facility’s and the facility’s staff responsibility to safeguard the resident’s privacy IN EVERY POSSIBLE WAY.
Data Elements for Post Acute
So here is some information that apparently not a lot of providers know about.
There has been a collaboration between CMS and RAND Corporation to develop standardized data elements for Post Acute Care. The goal is to develop, implement and maintain standardized PAC patient assessment data.
This might be quite useful as you develop your own assessment data.
Are you preparing for a survey in the near future?
You know what paperwork will be requested immediately during the Entrance Conference. Will you find yourself scrambling to assemble it? What’s due in that first hour, four hours, and 24 hours?
No sweat! We can help!
Let’s go back to school and get a large 3 ring binder. Fill it with 28 tabbed dividers. Make divider labels that correspond to the number on the Entrance Conference Worksheet that require hard copy data. Are we having fun yet? Just like your high school Trapper Keeper.
Behind door (tab) #1 is your current actual census number. No hard copy data is needed, but keep it updated.
Entrance conference item #2 is a completed matrix on admissions in the last 30 days. This goes behind tab #2. Keep it updated. And so on and so forth.
Why would you do this?
CMS wants more surveys to start during off hours or on weekends. If the survey team shows up on Saturday or at 6 am, how will your staff give the team coordinator the paperwork required immediately?
A survey binder with all of the required paperwork will save someone a lot of unnecessary stress! Make sure your staff knows what the Survey Binder is and where it is kept.
Words of Wisdom
Items #2 and #18 – Completion of the Matrix (CMS 802) was updated 1/2018. Make sure you have the latest copy. The matrix forms should be updated weekly. It may need a tweak or two when the survey starts but nothing major. The latest matrix can be found at:
We advise giving the matrix from item #18 (or at least offering it) to the survey coordinator during the Entrance Conference. The survey team will be grateful. We hope by having an up to date survey binder you and your staff will be ready for the first hour of your next survey.
Critical Element Pathways Part 1
During the new survey process, the survey team will utilize questions from several Critical Element Pathways when interviewing residents. The Critical Element Pathways were developed to assist surveyors in gathering information about the facility from the residents perspective and to standardize the questions asked of both residents and families.
The structure of the Critical Element Pathways encourages the use of multiple pathways and will form a network of linkages to potential deficiencies.
The staff at SAVVY on the SOM is recommending that the questions on these Critical Element Pathways be reviewed by the Administrative and clinical staff. Perhaps more importantly, these questions should be used to solicit input from residents and families prior to your next survey.
If residents or families have voiced dissatisfaction with aspects of care or the services at the facility, these should be resolved before your survey.
Care Planning Pathway
Ask your residents –
How did the facility involve you in your care plan and goals?
What are your goals for care? Is the facility helping you to meet your goals? How?
Ask your new admits – Did you receive a copy of your baseline care plan? Did you understand it?
For Pain Management Pathway
Ask your residents –
How were you involved in developing pain management strategies?
What treatment options (pharmacological and non-pharmacological) have been discussed with you? Were possible outcomes of different options discussed with you?
Sufficient and Competent Staff Pathway
Ask your residents –
Do you feel there is enough staff to care for you and answer your call light promptly? Are there any problems at shift change or on the weekends?
Are you able to wake, rise, eat at times you prefer?
Do you think the nursing staff are knowledgeable when caring for you?
Have you had to return to the hospital for any reason?
Behavioral Emotional Status Pathway
How are the resident’s needs being met through a person centered care approach? Can you give examples?
Urinary Catheter Pathway
Why is a urinary catheter being used? How long has the urinary catheter been in place?
Ask your resident –
Were the risks and benefits of the catheter discussed with you?
Do you have any pain or discomfort from the catheter?
Hearing and or Vision Pathway
Ask your resident –
Do you need or have you requested device(s) to assist with hearing or communication? How has the facility helped you?
If you have refused devices, what alternatives have been discussed with you??
Ask your residents –
Do you have any dental concerns which have not been addressed by the facility staff?
Are you experiencing any pain or difficulty eating because of a dental problem?
Have you had any missing or damaged partials or dentures? If so, did the facility make a referral within 3 business days?
How did the facility ensure you would be able to continue to eat and drink while waiting for dental services?
Ask your residents –
If you refuse a fluid and or dietary restriction, has the staff attempted to find alternatives and explained the potential consequences?
Ask your residents –
How does the staff involve you in decisions about your diet, food preferences, and where to eat?
Does the staff give you the correct diet, snacks, and supplements, and honor your preferences?
Ask your residents –
How were you informed about your need for therapy? Were alternatives discussed with you?
Did anyone talk to you about possible consequences if you refused therapy?
Are the services helping you to improve? How?
If you have assistive devices, were you shown how to use the device correctly?
This is just a sampling of the types of questions contained in the Critical Element Pathways. Perhaps you’ve gathered that you should ASK YOUR RESIDENTS. All the Critical Element Pathways were updated 8/3/18, and are available at:
According to the Agency for Healthcare Research & Quality (AHRQ), pressure ulcers cost the US healthcare system an estimated $9.1-$11.6 billion annually.
According to the National Database of Nursing Quality Indicators, the average cost of a pressure injury is $38,700.00!
Much of the following information was received by subscribers of SAVVY on the SOM in Volumes 3 and 4. It bears repeating because of recent survey deficiencies for the development and worsening of pressure injuries.
Remember that prior to a facility survey, the survey team will review the facility’s history including the deficiencies from the last survey, the facility’s CASPER report, and any complaints with deficiencies. The Resident Level Report will identify any residents with a new or worsening pressure injury. These residents will be targeted for interview and review during the initial tour rounds.
Since pressure injury is such a high cost item and will always be a focus area during surveys, Administration and the QAA committee must make an ongoing commitment to monitor and analyze pressure injury outcome measures.
Do you have a problem? Analyze what you’ve got!
The Quality Assurance Committee can begin by reviewing the Facility Characteristic Report and the Facility Quality Measure/Indicator Report to understand how your facility compares to other facilities in your state. Do you have a higher incidence of pressure injuries? How many of these pressure injuries were present on admit vs pressure injuries which developed after admission? If a pressure injury developed after admission, did the facility do a root cause analysis to determine why the pressure ulcer developed? Was the root cause analysis completed by a multidisciplinary team? How did the care plan change after the development of the facility acquired pressure injury? Can you prove that the care changed? If the facility received a deficiency at F 686 during your last survey, was your Plan of Correction (POC) implemented? Was your Plan of Correction effective? How do you know your POC was effective?
Note: During the Quality Assurance interview, the facility Administrator will be asked for proof that the POC was implemented and was effective.
Chart reviews may or may not tell you if the POC was implemented but direct observation of care may give you the information you need. Correlate the observations with the actions found in the resident care plan and assess the care plan. Is it specific to this resident and the identified risk factors or is the care plan canned text?
From a surveyor’s perspective, facilities receive deficiencies at F686 due to a lack of staff knowledge about preventing pressure injuries, understanding severity/staging of pressure injuries, lack of ongoing assessments, care plans which are not resident specific, care plans which do not address risk factors, care plans which are not consistently implemented, lack of root cause analysis of pressure injuries, and lack of a multidisciplinary input into care planning.
These are process problems and process problems belong to the Administrative team and the Quality Assurance Committee.
A word of caution
While implementation of the facility QAPI plan is not required until Phase 3 – November 28, 2019 – the facility must be prepared to present its QAPI Plan to the State Survey Agency beginning November 28, 2018 (see F865).
The initial assessment for the newly admitted resident with a diagnosis of dementia will contain many of the same elements as any other assessment but for the care plan to be an effective tool, the nurse will need additional time and assessment skills.
The data gathered will be a more personal history of who this person was in the past, who this person is now and what happened in between.
The goal of any care plan is to assist caregivers at all levels to understand who this resident is and how to approach and provide care to this person. If the resident is non-verbal then information may be obtained from a family member or previous caregivers.
The care plan for the resident with Dementia should include as much information as possible about the following areas:
High risk/safety issues
As each discipline gathers data, the goals for this resident should focus on ways to help this person find meaning, comfort, pleasure, security and self worth. Interventions should focus on meaningful activities which are specific to this resident.
This is where involvement of the family may be vital. Knowing what activities gave this resident pleasure in the past may be the key to meaningful activities now. Most activities can be adapted to the resident’s current abilities from listening to concerts, watching a ballet or listening to talking books. Finding ways to keep a resident engaged in meaningful activities prevents social isolation and may prevent behavioral problems. Volume 15 of SAVVY on the SOM covers person centered care in depth for more information.
Cultural competence can be defined as the willingness, knowledge and the ability to meet the cultural, social and language needs of residents and their families.
Cultural competence is an understanding of human behavior shaped by race, socioeconomic factors, ability (physical, mental, emotional), ethnicity, language, gender, sexual orientation, values, and beliefs. A culturally competent provider must have the ability to understand and integrate these factors into the facility culture and the daily delivery of health care.
How do we begin to change our facility culture?
Review the Annual Facility Assessment AND the Community Health Needs Assessment done for your county or nearest geographic area. What do these documents tell you about the cultural make up of your community and service area? What ethnic groups or nationalities are present? What religions,churches,temples, or mosques are present? What are the demographics of your service area? What are the needs of your current population now and anticipated in the future?
If the community is changing, how will you embrace the change and prepare your staff? Some strategy suggestions:
- Visit different ethnic cultural centers in your community. Speak to the leaders of these centers and ask for their help in training your staff on the important aspects of their culture.
- Visit the non-traditional churches, temples, and mosques in your community. Again, ask for their help in teaching your staff about their religious beliefs and practices. Be open to offering more diverse religious services. Include traditional healers.
- Welcome visitors from both different cultural centers and religious organizations.
- Include cultural norms and values when developing a resident centered care plan.
- Locate other health providers and clinics within your community which provide care to specific ethnic groups. These may be the places which will be providing care to your residents after discharge. If so, open communication and good working relationships can ensure a smooth discharge plan and may possibly prevent hospital re-admissions.
- Provide training to all staff from receptionists to clinical and dietary staff. Incorporate cultural attitudes and values into job description and annual evaluations.
- Provide interpreter services or a language line. Use language cards to enhance communication with non-English speaking residents.
- Recruit minority staff.
- Include family and extended family members in decision making and discharge planning.
Cultural competence is not an isolated aspect of health care delivery but it can be a huge factor in resident and family satisfaction.
Appendix Q standardizes the definition of Immediate Jeopardy and gives providers insights into how and when surveyors will make a determination of Immediate Jeopardy as follows:
“A situation in which the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”
- Only ONE individual needs to be at risk.
- Serious harm, injury, or impairment does not have to have occurred.
- High risk for serious harm, injury, or impairment in the future is enough to make a finding of immediate jeopardy.
- Because serious physical or psychological harm can result from abuse and/or neglect, residents must not be subjected to abuse/neglect by anyone – staff, visitors, family or another resident.
- Any determination of abuse or neglect is always immediate jeopardy.
The risk may have occurred in the past, may be occurring now, or may most likely occur in the future if a given situation is not immediately corrected.
The investigation will focus on:
- Did the facility create or know that a situation was occurring which had the potential to cause serious injury, harm, impairment or death?
- Did the facility have the means to implement preventive or corrective measures?
Some examples of surveyor observations which will initiate further investigation and a possible finding of Immediate Jeopardy are as follows:
- Unexplained serious injuries which have not been investigated. All fractures or dislocations – even if witnessed – should be investigated as possible abuse or neglect. Multiple episodes of falls with injuries are suspicious.
- Bruises around the breast or genital area, injuries such as black eyes, rope marks, cigarette burns, or any unexplained bruising should raise questions about abuse. Injuries such as these must be investigated by the facility. Prudent judgment would indicate these injuries should be reported to the surveying office as possible abuse.
- Failure to monitor physical or psychological aggressive behaviors by any person including other residents, staff, visitors or family. The facilities obligation is to protect residents in their care. Aggressive behavior from another resident or a family member is a form of abuse and cannot be tolerated.
- Unsafe dietary practices with the potential for food borne illnesses. Isolated observations of the dietary staff not using appropriate infection control practices may not rise to the level of Immediate Jeopardy but ongoing or widespread inappropriate actions have the potential to rise to the level of Immediate Jeopardy.
- Widespread lack of knowledge/competency by staff. Surveyor observations of actions or behaviors which do not meet the professional standards of practice accompanied by a bad clinical outcome may lead to a citation of Immediate Jeopardy.
These are a few of the “triggers” which will cause a survey team to begin investigating for possible Immediate Jeopardy. It is important to remember that the survey team will thoroughly investigate any situation with the potential for immediate jeopardy. Before a final determination of Immediate Jeopardy, the surveyor agency office will be consulted and the team’s findings reviewed.
As a provider, it is important to understand Appendix Q to avoid an Immediate Jeopardy situation.
The CMS site for Appendix Q has many more “triggers” for your review.
10.29.2018 – Value Based Purchasing
10.23.2018 – Tips for the Medication Pass
10.09.2018 – Animals in SNF
10.02.2018 – Person Centered Care
09.25.2018 – Baseline Care Plan
09.18.2018 – Hospice and the SNF – Deficiencies
09.11.2018 – Hospice and the SNF
08.28.2018 – Staff Competency & the Patient Driven Payment Model
08.21.2018 – Food and Nutrition in LTC – Part II
08.14.2018 – The SNF Readmission Reduction Program
08.07.2018 – Sexual Harassment in LTC
07.31.2018 – Death with Dignity Laws and LTC
07.24.2018 – The New Pharmacy F-Tags
07.17.2018 – Summer Sizzle
07.12.2018 – Food and Nutrition in LTC
07.05.2018 – Abuse in LTC – Part 2
06.26.2018 – Where in the world shall we live?
06.19.2018 – Abuse in LTC– Part 1
06.12.2018 – On Smoking in LTC
06.05.2018 – Let’s Talk About Teeth
05.29.2018 – Leadership
05.22.2018 – Are Baseline Care Plans a Big Deal?
05.15.2018 – LGBTQ Rights and Long Term Care
05.08.2018 – Cannabis in LTC – Part 2
05.01-2018 – Cannabis
04.24.18 – Cultural Competence
04.17.18 – Active Shooter
04.10.18 – LTC Water Requirements in a Disaster
04.03.18 – Resident Trust Accounts – Part 4
03.27.18 – New Five Star Quality Rating System
03.20.18 – On Falls – Again
02.27.18 – A Word About Money – Resident Trust Accounts
02.20.18 – Quality Improvement Culture
02.13.18 – Are You 5 Star Quality?
02.06.18 – Phase 2 Implementation
01.30.18 – F 838 SNF Administrative Roles
01.23.18 – Flu Season Prep
01.16.18 – LTC Lacks Geriatric Training
01.09.18 – QA + PI
01.02.18 – Revised CMS Survey Requirements
12.19.17 – Epic Tool for LTC Survey Preparation
12.12.17 – Smoking Regulations and LTC
12.05.17 – LTC – the elephant in the room?
11.28.17 – Abuse reporting in LTC
11.21.17 – Emergency Preparedness and LTC
11.14.17 – Abuse Reporting in LTC
11.07.17 – Finding the Base of Baseline Care Plans
10.31.17 – Fight the Flu in LTC
10.24.17 – LTC needs a new image – Part II
10.17.17 – Restraint with Restraints – Alternatives
10.10.17 – Show Restraint with (Chemical) Restraints
10.03.17 – Show Restraint with Restraints
09.26.17 – LTC needs a new image…
09.19.17 – SNF’s, Surveys and Pressure Injury
09.12.17 – F tag changes – Infection Control
09.05.17 – Well-Being and the SNF
08.29.17 – Infection Protection in SNFs
08.22.17 – Don’t Panic – Be Savvy
08.15.17 – Newest Tool for Medicare Compliance
08.08.17- Tools for Cultural Competence in SNFs
08.01.17 – Never Non-Compliant
07.25.17 – New Regs from CMS – Phase 2
07.18.17 – Phase II & the SNF DON
07.11.17 – What is Clinical Competency?
06.27.17 – Are you SAVVY on the SOM?
06.13.17 – Phase II – Facility Annual Assessment
06.06.17 – Restraint or Enabler?
05.30.17 – Quality of Life Interviews and YOU
05.16.17 – Let’s Talk about Eggs
05.09.17 – Don’t Slip on Fall Prevention
05.02.17 – Hospice in Skilled Nursing
04.25.17 – Let’s Talk About McGeer’s
04.18.17 – Survey Ready – Initial Tour Rounds
04.11.17 – “Person Centered Care”
04.04.17 – On Antibiotic Stewardship
03.28.17 – Kitchen Catastrophe?
03.21.17 – Suffer from Survey Anxiety?
03.14.17 – Activities Program 2.0
03.07.17 – Worried about Functional Outcomes?
02.28.17 – on referrals
02.16.17 – Care Plan Woes?
01.17.17 – Brand New Day