Opioid Use in the Elderly


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A few years ago, I was reviewing the clinical record of a patient who had just been discharged from the hospital with a severe GI bleed. While he was hospitalized, a drug screen was run and it was determined that he had no opioids in his system despite the fact that he had Lortab ordered three or four times a day. Going back further, I read that while his wife was present during visits, she was often ‘napping’. I do not know how the physician knew to order the drug screen but it’s not a long leap to figure out why Adult Protective Services were called. As it was discovered, the patient’s wife was substituting two aspirin for the Lortab doses; hence the bleed.

Fast forward to a couple of months ago when I read a chart of a man who had chronic back pain. He had been taking oxycodone for years and had recently underwent surgery which mostly corrected the cause of his pain. He then fell and was admitted for pneumonia. The admitting physician said the patient asked for much more than his prescribed dose of pain medication. When he received it, he was somnolent and showed other signs of overdose.

Then there was a patient whose chart indicated that she had very severe 10/10 pain on each visit. The physician was not called. I called the agency on this during a meeting as multiple clinicians had seen the patient. They told me that what I didn’t see was the five o’clock news when the patient was arrested for selling her prescription medication.

Here are some facts.

  • Pain affects approximately 100 million American adults each year, resulting in a national cost of $635 billion annually in medical treatment and loss of productivity.
  • Medicare beneficiaries (aged and disabled) have among the highest and fastest-growing rates of diagnosed opioid use disorder at more than 6 of every 1,000 beneficiaries (CMS, January 2017).
  • In 2011, on an average day, 80 adults aged 65 and older visited the emergency department for problems with narcotic pain relievers and seven older adults’ visits (on an average day) involved heroin (Mattson et al., 2017)

Obviously, there is more information and statistics about Opioid use in the elderly. Half of the internet could be filled with the complex reasons of how the epidemic began but that is hardly useful information. The most useful intervention that a visiting clinician can employ is common sense which is exceedingly uncommon in healthcare. Consider the following:

  1. Blind adherence to CDC guidelines is causing some patients who have been on large doses of narcotics for years to have their doses abruptly dropped by a significant level. This Huffington Post Story tells the story of Jay Lawrence who had his pain medication reduced by 25%. Shortly before the next pain management visit, when he expected that his dosage would be reduced again, he committed suicide. If a visiting nurse or therapist had been in the home, they could have tried to intervene by documenting the patient’s history including prior and current abilities. Although awkward, the CDC guidelines should have been reviewed with the physician as he appeared to be following guidelines for patients new to narcotic pain relievers.
  2. Disabuse yourself of the notion that narcotics given for legitimate pain do not cause addiction. Many of you will be insulted by this tidbit of advice but this information was shared with healthcare providers for years by pharmaceutical sales people. In fact, there is no ICD-10 code for addiction – only for dependence which occurs after taking the medication for a prolonged period of time regardless of the reason.
  3. Do not hesitate to code an F11 code if you have physician documentation.
    Assess the patient completely for pain remembering that assessment is more than interview. For years, we were told by very respectable organizations that the patient’s pain was what the patient said it was. That’s not always true. A full assessment includes observation of the patient’s ability to participate in daily activities, assessing sleep patterns, appetite and nonverbal behaviors such as grimacing, inability to focus on what you are saying and guarding the area the area where the pain is. Ask family members when present during assessments if the patient shows signs of pain during the evening or in the mornings when getting out of bed.
  4. The blind adherence to CDC guidelines has physicians focusing on the amount of opioids ordered but they seem to be oblivious to the recommendation that they find treatment and/or support for patients who may have a serious problem. The physician is more likely to refer a patient for help if you have suggestions handy. Waiting for an order takes much longer than asking for an order for a referral to specific providers.
  5. If your patient has been abruptly cut off or has had a sharp reduction in pain medication, be aware that suicides increase dramatically after the cessation of opioids. Depression is part of the withdrawal process and can be intolerable for patients who have an existing diagnosis of depression.
  6. Include both long term and short term effects of opioid pain relief. This is especially valuable for patients who do not take opioids on a regular basis but are undergoing a procedure that will leave them with pain. Help them set realistic pain goals. Teach your patient that pain medications should reduce the pain to where it is tolerable but can cause falls, confusion and impaired judgement. Long term, speak to the idea of tolerance to the medication and dependence. Reassure them that problems do not occur if they take pain meds infrequently for a short period of time and return to tylenol or NSAIDs as soon as their physician allows. Teach caregivers to wait until the patient asks for the medication instead of giving it routinely.
  7. Visiting clinicians probably see diversion more than most other healthcare providers. If there is any suspicion of diversion, ask the pharmacy to dispense only a week at a time so that missing medications will become obvious sooner if that is allowed in your state. Alternatively, ask for two pill bottles and keep only seven days worth and (with the patient’s or trusted caregiver’s knowledge) hide the remainder. If you know with reasonable certainty that medications are being taken from a patient, call elderly protective services and allow them to investigate. If there is doubt about why pills are missing, call in the social worker.

The extremists on either side of the opioid crisis are costing money and in some cases, lives. Complications from opioid use have resulted in opportunities to create new laxatives specific to Opioid induced constipation that are priced upwards of 350.00 per month. The sexual performance pharmaceuticals are also benefiting as patients suffering Opioid induced sexual dysfunction need a little boost. Falls in the elderly taking opioids are common and should a hip be broken, there is a 25 percent chance that they will not be alive in six months.

And yet, there is no feeling more powerful than shooting some morphine into the veins of a patient suffering from kidney stones. Hospice patients have a better quality of life with opioids and they are very useful for fracture and burn patients. Make no mistake. Opioids have their place as do antihypertensives, diabetic medications, etc. but they need to stay in their place. Patients should be cautioned about taking opioids for chronic pain unless all other avenues of pain relief have been explored and nurses and therapists need to be honest and unreserved in their teaching of medication safety.

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Ding!


A client just received their certification report and it was good but not deficiency free as they had been in the past.  The reason?  Although the risk factors for hospitalization were pulled from the OASIS assessment, they were not identified on the Plan of Care as risk factors for hospitalization.  The interventions were similarly not tied to the risk factors even though they did address them.  The DON reported that she talked to a friend at another agency and learned that the other agency had received the very same tag.  Coincidence or survey trend?  Time will tell.  For now, smart agencies will go with ‘survey trend’ as their final answer.

The Condition of Participation is §484.60(a)(2).  It reads:

(2) The individualized plan of care must include the following:

  1. All pertinent diagnoses;
  2. The patient’s mental, psychosocial, and cognitive status;
  3. The types of services, supplies, and equipment required;
  4. The frequency and duration of visits to be made;
  5. Prognosis;
  6. Rehabilitation potential;
  7. Functional limitations;
  8. Activities permitted;
  9. Nutritional requirements;
  10. All medications and treatments;
  11. Safety measures to protect against injury;
  12. A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors.
  13. Patient and caregiver education and training to facilitate timely discharge;
  14. Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient;
  15. Information related to any advanced directives; and
  16. Any additional items the HHA or physician may choose to include.

This is a new requirement included in the 2018 Conditions of Participation.  It’s something that (hopefully) has been done by agencies in the past but risk factors haven’t always been labeled.  The requirement is consistent with the CMS goal of avoiding unnecessary admissions.

There are no instructions on how to do this.  Prior to the final regulations, the proposed regs suggested stratifying patients as high, medium or low risk.  That was omitted from the final rule.  From the 2018 CoPs:

While there may be benefits to establishing more inter-HHA consistency in the application of this requirement, we do not believe that those benefits would outweigh the cost of reducing HHA flexibility and innovation to determine the best possible way to achieve the overall goal of reducing unnecessary emergent care visits and hospital admissions.

The OASIS question that examines risk factors for hospitalization is M1033 reads:

(M1033) Risk for Hospitalization: Which of the following signs or symptoms characterize this patient as at risk for hospitalization? (Mark all that apply.)

  •  History of falls (2 or more falls – or any fall with an injury – in the past 12 months)
  •  Unintentional weight loss of a total of 10 pounds or more in the past 12 months
  •  Multiple hospitalizations (2 or more) in the past 6 months
  •  Multiple emergency department visits (2 or more) in the past 6 months
  •  Decline in mental, emotional, or behavioral status in the past 3 months
  • Reported or observed history of difficulty complying with any medical instructions (for example, medications, diet, exercise) in the past 3 months
  •  Currently taking 5 or more medications
  •  Currently reports exhaustion
  •  Other risk(s) not listed in 1–8
  •  None of the above

Additionally, M1036 looks at smoking, obesity, alcohol dependency and drug dependency.  There is a falls risk assessment which may score high in patients who have not fallen in the last 12 months such as those who had a recent hip replacement.  Depression is assessed and is known to impair recovery in most illnesses and conditions but is not included in the question specific for risk factors unless it has an onset within 3 months.

Some of the most dangerous risks to our patients are not captured by OASIS at all.

  • Elderly patients living alone in a rural area
  • Patients unable to afford or prepare food; may have frequent interruptions in utilities due to financial limitations.
  • Transportation or willing caregiver to pick up medications.
  • Functionally illiterate patients

It is possible that drawing in some information from OASIS might meet the condition, but it may not serve the patient.  On the other hand, it is highly unlikely that you would be hit with a survey deficiency if you included risk factors that were based on a full assessment even if they are not included in the OASIS assessment.

You won’t find many interventions to address isolation, depression and lower socioeconomic status in care pathways for other conditions, but they are equally as important for some patients as falls precautions which are ordered for pretty much everyone.  It may cost a little more but in the long run, lower hospitalization rates will correspond with higher margins.

The CoP’s mandate that care plans include patient risks for hospitalizations and Emergency Room visits and corresponding interventions to mitigate the risks.  Since you must do it, make it meaningful.

Contact us if you need help setting up a system for this or if you would have us review your careplans for you.

Here We Go Again


A notification of the intent to re-implement the Pre-Claim Review process is being published today in the Federal Register.  The purpose, as stated in the notice, is to develop and improve methods to investigate and prosecute fraud in the home healthcare services.  In other words, Medicare wants you to send them evidence before you are even suspected of a crime. At its onset, agencies in Illinois, Ohio, Florida, North Carolina and Texas with the option to expand.

If there was even a chance that this burdensome, intrusive and expensive process would serve its stated process, my objections might not be so strong (but maybe they would).  Assuming that this process involves collecting the same information as the 2016/2017 demonstration, it is not likely identify or help in the prosecution of fraud. For those of you unfamiliar with the process, agencies had to gather and submit eligibility information for patients and submit it prior to billing the final claim.  (Palmetto GBA’s Guide to PCR submission) What’s even more amazing is that the United States Congress agrees with me.   

Here’s what they wrote in the Final Rule for the 2015 PPS update:

Each year, the CMS’ Office of Financial Management (OFM), under the Comprehensive Error Rate Testing (CERT) program, calculates the Medicare Fee-for-Service (FFS) improper payment rate. For the FY 2013 report period (reflecting claims processed between July 2011 and June 2012), the national Medicare FFS improper payment rate was calculated to be 10.1 percent.  For that same report period, the improper payment rate for home health services was 17.3 percent, representing a projected improper payment amount of approximately $3 billion.  The improper payments identified by the CERT program represent instances in which a health care provider fails to comply with the Medicare coverage and billing requirements and are not necessarily a result of fraudulent activity.

Worse than being ineffective, the proposed PCR project does not state goals of prevention of fraud, improvement of patient outcomes, or identification of opportunities for innovative approaches to home healthcare.   The process focuses on Face-to-Face information, documentation of homebound status, signatures and dates, and care plans. Nothing written here is meant to dismiss the importance of these statutory requirements but agencies who are fraudulently bent are coached by the CMS in how to get paid whether or not visits are being made or if the ordered care is given. Numerous checklists and examples could serve as a Fraud 101 primer.    It befuddles me that an undated signature may result in a denial or delay in payment but Medicare doesn’t understand that a fraudulent agency may document homebound status perfectly even when the details are contrary to reality.

But you do have a choice.  You can opt out of the PCR process.  It’s a condescending choice like when a toddler is told he can eat his vegetables or be sent to bed early with no dessert. Most kids will hold their nose and get the Broccoli down.  

Similarly, Medicare is giving agencies a choice to participate in PCR or suffer a 25 percent reduction in payment IF they are paid after a mandatory request for additional records (ADR).  So agencies will hold their nose and participate in PCR.

Agencies can also opt for a post payment review. In this scenario, you would submit information after being paid which means any errors found occurred prior to billing.  Undated signature? Denied. Then you will have an overpayment which will be recouped. There are few things worse than having money you already earned taken back. But agencies have a choice.

Agencies will be removed from PCR after they reach an unannounced target goal. If the purpose of PCR is accurately stated, how could the goal be less than 100 percent?  If a 90 percent target is set, that means that 10 percent of claims meet the categories of fraud, abuse or waste.  

What has never happened to the best of my knowledge is anyone being notified by the person reviewing a patient in the pre-claim review process of errors that might cost Medicare money. Just once I would like to see advice to an agency to include therapy because even though it was received in a prior admission, it’s worth another shot because the patient is having pain difficult to manage without opiates increasing the risk of falls and subsequent injury.  

Luckily, you don’t have to sit back and wait for the curtain to fall.  You have been invited to comment on the PCR process. Before you do, take a look at the document which was to have been included in today’s Federal Register.  As of now, it does not appear to be there.

Note that there are multiple ways to submit your comments.  Use them all. Tell your co-workers, bosses, employees and mother to read the memo and draw their own conclusions.  There is an ethical dilemma if you tell them how to feel about a political matter but providing a stamp won’t draw the attention of anyone.

Also note the title of the gentleman who signed the memo; Director, Paperwork Reduction Staff.  I couldn’t make that up if I tried.

The Coders will prepare comments for submission and share them with you. Please feel free to share your comments for or against the reimplementation of the Pre-Claims Review Demonstration.  And remember, you have options.

 

Conditions of Participation… Professional Requirements


This week’s Condition of Participation involves Professional Services.  These are common practice and similar to what is in place in your agency anyway.   There are new requirements for the Administrator and a new position called ‘Clinical Manager’.  The requirements are linked in the post.  Adjust your job descriptions and a review of the Medicare Benefit Policy Manual, chapter 7 would be a good idea.

The Condition is pasted below followed by the standards that will be surveyed to verify compliance.

484.75 Condition of Participation: Skilled professional services.

Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician and medical social work services as specified in §409.45 of this chapter.

Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care.

This Condition is written as though you know all about subsections 409.44 and 409.45 but in case you do not, you can click the links.

Not to be confused with official guidance from Medicare, here’s an abbreviated summary of what you already know:

Skilled nursing services are those skills which can only be performed by a nurse.  Coverage is determined by the complexity of the skill as well as the condition of the patient.  If the skill could be performed by the average Joe, it would not be considered skilled.  The Medicare Benefit Policy Manual is our favorite source for researching skilled nursing services.

Physical Therapy skills must be of a nature that they can only be performed safely by a skilled therapist.  In determining if therapy is skilled, determine if the Jimmo ruling of 2013 applies.

Medical Social Workers provide services ordered by the physician to address emotional and social needs that may interfere with the patient’s ability to respond to the plan of care or the agency’s ability to carry out the plan of care.  According to the Interpretative Guidelines, they are furnished ‘on a short-term basis and it can be demonstrated that the service is necessary to resolve a clear and direct impediment to the effective treatment of the beneficiary’s medical condition or to his or her rate of recovery’.

The standards that demonstrate compliance should be familiar to you even if you did not know they were a part of the Conditions of Participations.

The first standard reads:

484.75(a) Standard: Provision of services by skilled professionals.

Skilled professional services are authorized, delivered, and supervised only by health care professionals who meet the appropriate qualifications specified under §484.115 and who practice according to the HHA’s policies and procedures.

The appropriate qualifications are in another section, so we made a quick cheat sheet.  The information is straight forward except for physical and occupational therapists.  Each of these therapists have provisions for states that do not have licensing laws.  A quick search of the web revealed that all states require licensing so if you stick with licensed therapists in your state, you should be okay.

There is also a provision in this condition that professional services are provided according to the agency’s policies and procedures.  This includes contracted therapists so be sure to share relevant policies with contractors and include them in compliance training.

484.75(b) Standard: Responsibilities of skilled professionals.

Skilled professionals must assume responsibility for, but not be restricted to, the following:

  1. Ongoing interdisciplinary assessment of the patient;

The interpretative guidelines define ‘interdisciplinary’ as an approach to healthcare that includes a range of health service workers, both professionals and non-professionals, with the majority being from professional groups. Ongoing interdisciplinary assessment is the continual involvement of all skilled professional staff involved in the plan of care from the initial assessment through discharge and periodic interactive, discussions regarding the status and recommendations for the plan of care. The interdisciplinary approach recognizes the contributions of the disciplines (MDs, RNs, LPN/LVN, PT, OT, SLP, MSW, HH aides) and their interactions with each other to meet the patient’s needs.

The Coders recommend weekly or bi-weekly case conferences where patients approaching the end of their episodes are discussed in a meaningful way by all involved disciplines.  Any patients who have significant changes in their condition or treatment plans can be added to the list.  It also means documentation of any casual discussions you may have with other agency employees or physicians.

  1. Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); 
  1. Providing services that are ordered by the physician as indicated in the plan of care; 
  1. Patient, caregiver, and family counseling; 
  1. Patient and caregiver education; 
  1. Preparing clinical notes;
  1. Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; 
  1. Participation in the HHA’s QAPI program; 
  1. Participation in HHA-sponsored in-service training 

Some of these criteria will be discussed in subsequent parts of the Conditions of Participation so don’t worry if one or more confuses you.

Supervision

Supervision is the focus of the next standard supporting the condition involving Skilled Services.  There are numerous references made to §484.115; our little cheat sheet referenced above with personnel qualifications. 

484.75(c) Standard: Supervision of skilled professional assistants

This is a generic supervision standard that applies to therapy assistants, LPN, etc.  As such, it does not include a time frame or the criteria for supervision.  Oversight is usually guided by the practice standards for each discipline.  Additionally, there must be written instructions for these assistants and you can expect that they will be surveyed.

484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k).

484.75(c)(2) Rehabilitative therapy services are provided under the supervision of an occupational therapist or physical therapist that meets the requirements of §484.115(e, f) or (g, h), respectively. 

Please note that therapists can only supervise assistants within their disciplines.  Occupational Therapy must supervise Occupational Therapy assistants, etc.

484.75(c)(3) Medical social services are provided under the supervision of a social worker that meets the requirements of §484.115(m).

Home Health Aide services, training and competency are soon to follow.  Meanwhile if you have any problems with the Professional Services information, feel free to drop us a line.

CoP’s Continued…. Infection Control


Clean Hands Count

Historically, there have been very few studies concerning infection control and home Visits.  The work environment is the patient’s home and there is only so much we can do to control it.   We don’t have a housekeeping department to mop up our messes with industrial strength cleaning agents like hospital nurses.  We cannot fire other family members if they don’t wash their hands and what about those pets who jump on the bed after being outside?

One idea is to simply give up.  A better idea is to recognize that without a clean-up crew and a controlled environment, Infection Control is more important than ever.  And, since the new Conditions of Participation you must implement a program by mid January 2018,  the latter option might be best.

The condition is straight forward.  Here it is for reference.

The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases.

The reason Infection Control is getting an entire blog post to itself even though technically it is part of the QA Condition is because the Interpretive Guidelines list specific components that your surveyors will be assessing.  They include six components identified by the CDC as being relevant in the home.

  1. Hand Hygiene;
  2. Environmental Cleaning and Disinfection;
  3. Injection and Medication Safety;
  4. Appropriate Use of Personal Protective Equipment;
  5. Minimizing Potential Exposures; and
  6. Reprocessing of reusable medical equipment between each patient and when soiled.

Not only should your plan address all six of these issues, but they should be evident in practice.

Hand Hygiene

The Interpretive guidelines advise agencies that handwashing should occur:

  1. Before contact with a patient;
  2. Before performing an aseptic task (e.g., insertion of IV, preparing an injection, performing wound care);
  3. After contact with the patient or objects in the immediate vicinity of the patient;
  4. After contact with blood, body fluids or contaminated surfaces;
  5. Moving from a contaminated-body site to a clean body site during patient care; and
  6. After removal of personal protective equipment (PPE);

Alcohol based hand sanitizers are the most effective products for reducing the number of germs on the hands of healthcare providers most of the time. Antiseptic soaps and detergents are the next most effective and non-antimicrobial soaps are the least effective.  Bars of soap are so retro that they really don’t deserve much attention except that you might still find them in patient homes.

When hands are not visibly dirty, alcohol based hand sanitizers are the preferred method for hand hygiene. The agency must ensure that supplies necessary for adherence to hand hygiene are provided.  However, be careful if you have a patient diagnosed with Clostridium Difficile as hand sanitizers are not effective.  Gloves must be worn.

Environmental Cleaning and Disinfecting

The interpretive guidelines recognize that you have little control over the tidiness and disinfection in another person’s home.  However, they do state that the home health personnel ‘must maintain their equipment and supplies clean, during the home visit, during transport of reusable patient care items in a carrying case in the staff vehicle and for use of the items in multiple patients’ homes.’  Thus, your primary focus is on your supplies and equipment.

Safe Injection Practices

Safe injection practices include:

  1. Use aseptic technique when preparing and administering medications;
  2. Do not reuse needles, lancets, or syringes for more than one use on one patient; Use single-dose vials for parenteral medications whenever possible;
  3. Do not administer medications from a single-dose vial or ampule to multiple patients;
  4. Use fluid infusion and administration sets (i.e intravenous bags, tubing and connectors) for one patient only and dispose appropriately after use;
  5. Consider a syringe or needle/cannula contaminated once it has been used to enter or connect to patient’s intravenous infusion bag or administration set;
  6. Enter medication containers with a new needle and a new syringe even when obtaining additional doses for the same patient;
  7. Insulin pens must be dedicated for a single patient and never shared even if the needle is changed;
  8. Sharps disposal should be in compliance with applicable state and local laws and regulations.

Since none of you would dream of reusing or sharing equipment, your attention is needed at number 8.  Know your state and local laws and regulations about disposal of sharps.  Frankly, it is a little insulting that someone thought they had to tell home health nurses that they shouldn’t use insulin pens or IV sets on more than one patient.

Appropriate Use of PPE

This refers to the gear used as a barrier against infection.  The idea is that any contaminants thrown your way will hit your PPE and be disposed of as you leave the patient room.  Examples include gloves, gowns, masks, and eye protection depending on the nature of the potential threat.

Although it is not clearly spelled out, it is in inherent in any regulation about PPE that the staff understand how to use it.  It is not as easy as it looks and taking it off is even more difficult.  Do you remember the nurse, Nina Pham who contracted Ebola in a Dallas Hospital?   She might tell you to take every advantage to learn about PPE.

Minimizing Potential Exposures

This focuses on the protection of the family members, other caregivers and visitors and the transmission of pathogens while transporting specimens and medical waste such as sharps.  There isn’t much written on it in the interpretive guidelines or Conditions of Participation probably because each patient and family are in a different situation.  Nobody catches arthritis by breathing the same air as a patient but patients with contagious diseases need to be assessed and plan put into place that is specific to the nature of the patient’s contagious condition.

Reprocessing (cleaning and disinfecting) of Reusable Medical Equipment is essential.

Reusable medical equipment (e.g., glucose meters, INR machines and other devices such as, blood pressure cuffs, oximeter probes) must be cleaned/disinfected prior to use on another patient and when soiled. The HHA must ensure that staff are trained to:

  • Maintain separation between clean and soiled equipment to prevent cross contamination; and
  • To follow the manufacturer’s instructions for use and current standards of practice for patient care equipment transport, storage, and cleaning/disinfecting.

There must be documentation that the staff has been trained.  To minimize the resources spent on training, an agency might limit the purchase of machines such as INRs and blood glucose machines to one or two brands so the instructions don’t change.  If, like many agencies, you opt to use the patient’s equipment whenever possible, be sure that patients know how to use and maintain their equipment.

The next standard is:

The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA’s quality assessment and performance improvement (QAPI) program. The infection control program must include:

Surveillance

According the Interpretative guidelines, The HHA infection control program should ‘use observation and evaluation of services from all disciplines to identify sources or causative factors of infection, track patterns and trends of infections, establish a corrective plan, and monitor effectiveness of the corrective plan.’

In other words, you should task all disciplines with looking for infections, their underlying cause and any trends.  A plan should be established to address any trends or patterns and the agency will monitor effectiveness.

The Interpretative Guidelines suggest the following activities be used in your surveillance:

  • Clinical record review;
  • Staff reporting procedures;
  • Review of laboratory results;
  • Data analysis for physician and emergency room visits for symptoms of infection; and
  • Identification of root cause of infection through evaluation of HHA personnel technique and selfcare technique by patients or caregivers.

More specifically, we suggest:

  • New orders for antibiotics
  • Hospitalizations for suspected infection
  • Deteriorating wounds
  • Fever – most computer systems have a trendline for temperature over time. Look for spikes.

If you have any other suggestions, please share them.

Now that you know who has been infected, an analysis should occur.  The easiest way to do this is to enter your numbers on a spreadsheet and then make a graph out of them.  If you are not friends with MS Excel, you can do the same thing manually.  Depending on the type of graph, you may see spikes, clusters or other indicators that ‘one of these things is not like the other’.

Put a plan into place that will address any variations in data or infections that might have arisen from your care or have been prevented by your care.  Instead of asking what your agency did wrong, consider what could have been done better.

Write down the steps that are needed to address any areas that could be approved.  Assign them to appropriate staff.  The agency does not have to break new ground in the science of infection control.  The tools and knowledge are there.  Use them.

Monitoring results is the missing step in many infection control programs.  When you write your plan that includes specific activities, include the frequency and method of monitoring results.  This will allow the agency to rapidly respond to any increase in infections that occur despite your well executed plan.  This is not failure, by the way.  Recognizing that a plan isn’t working and calling an impromptu meeting to make changes before your regular meetings is how good Infection Control Programs are managed.

When positive results are noted, they should be shared.  You have asked your nurses to participate in your Infection Control Program.  Let them know when their hard work has netted results.

The last standard in Infection Control concerns training and education.

The HHA must provide infection control education to staff, patients, and caregiver(s).

The interpretive guidelines are clear on what is expected:

HHA staff education should include as a minimum:

  • Appropriate use, transport, storage, and cleaning methods of patient care equipment according to manufacturer’s guidelines and receive the following provide the following for staff education:
  • Job-specific, infection prevention education and training to all healthcare personnel for all of their respective tasks;
  • Processes to ensure that all healthcare personnel understand and are competent to adhere to infection prevention requirements as they perform their roles and responsibilities;
  • Written infection prevention policies and procedures that are widely available, current, and based on current standards of practice;
  • Training before individuals are allowed to perform their duties and periodic refresher training as designated by HHA policy;
  • Additional training in response to recognized lapses in adherence and to address newly recognized infection transmission threats (e.g., introduction of new equipment or procedures);
  • Provide in-service infection control education for staff at periodic intervals (minimally annually) consistent with accepted standards of practice, such as: at orientation, annually, and as needed to meet the staffs learning needs to provide adequate care, identify infection signs and symptoms, identify routes of infection transmission, appropriately disinfect/sanitize/transport equipment and devices used for the patient’s care, medical waste disposal, including instructions on how to implement current infection prevention/treatment practices in the home setting.

It might be that Medicare is serious about Infection Control.  What do you think?

There is a plethora of tools on the internet to help with Infection Control.  As time allows, we will post links to some of them.  Many agencies have Infection Control programs that are outdated or not implemented and some of them are frankly too confusing to follow.   Simplify instead of complicate what is in place.  Put your real efforts into preventing and monitoring infections and let your computer do the data collection.

One approach that has a 100 percent chance of failure is writing or buying a pretty binder and keeping on the shelf between surveys.  The plan should be available and have clear instructions for anyone with a question.  The number of pages your plan has irrelevant.  The effectiveness of the program is where you should focus your efforts.

If you need any help designing and implementing an infection control program or any or all of the Conditions of Participation, you know who to contact.  We’re ready and willing to help.

Conditions of Participation – Quality Improvement


Maybe the most frustrating element of Quality Improvement for us has always been that there is not a clear definition.  One agency may ‘QA’ notes as they come in but never go any further.  Another may collect data on countless areas of concern but never put into place a plan for improving those areas.  There are those agencies with a program that is great but so complex and time consuming that it never gets done.

All of that is changing.  Effective January 18, 2018, agencies must meet specific criteria in their Quality Assurance as written into the new Conditions of Participation.  The Condition reads as follows:

(484.65) The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data driven QAPI program.  The HHA’s governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA’s performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS.

The short version:

  1. Your agency must have a QA program that is based on data
  2. It must reflect the complexity of the agency and include all services provided.
  3. Focus on indicators related to improved outcomes including:
    1. Adverse Events
    2. Use of emergent care services
    3. Hospital admissions and readmissions
  4. Takes action to address performance across the spectrum of the agency
  5. The agency must document its program and be able to show compliance to CMS.

This is not hard.  It does require time and buy in from employees in every department of the agency.  Agencies who invest the resources to make this happen will find themselves at the top of the list for star ratings and be every referral source’s darling.  But, it will not happen unless and until senior leadership in the agency buys into the process. With Gusto.

The standards that will be surveyed to determine compliance are similarly easy, but they are comprehensive.  Here they are  (paraphrased):

The agency must be capable of showing improvement in indicators for which there is evidence that health outcomes, care and patient safety will improve when action is taken to address those indicators  In other words, the indicators chosen by your agency must be useful.

And agencies must measure, analyze and track indicators, including adverse events and other aspects of performance that enable the agency to assess processes of care, services and operations.  Simply put, agencies will review data related to their chosen indicators to determine if their plans are working and the plan must include the frequency at which data is collected.  The governing body must approve the frequency of data collection.

Standard – Program Data

The agency must use data from OASIS when applicable as well as other relevant data in the design of its program to:

  1. Monitor effectiveness of service and quality of care
  2. Identify opportunities for improvement

The governing body is the person or group of persons who assume full legal authority and responsibility for the agency’s overall operations.  Ultimately, the buck stops at the governing body.  They write checks and approve budgets.  They can veto decisions.  It may be the owner of a small agency or a group of executives appointed by the boards of publicly traded companies.  Think CEOs, CFO’s and any other person with a job title beginning with a capital C.

So, the Governing body approves the data that will be collected as well as the frequency.  That means that if the data is not collected or is useless or does not result in improvement; ignorance on the part of the governing body will not be an acceptable excuse.  Truly, it never was acceptable but now it is in writing.

Medicare has already given agencies three indicators they expect to see written into the Quality Assurance plan; hospitalizations, emergent care and adverse events.  You’re halfway there but to be effective means determining why patients are visiting the hospital and receiving emergent care.  You already have much of that information in your transfer assessments.  You should know what percentage of your patients are hospitalized because of falls, wounds, medication errors, etc.  If more than a quarter of your patients are going to the hospital for unknown reasons, it could be that the clinicians completing the assessment aren’t taking the time to find out.  Now is the time to instill the importance of taking the effort to get the information required to complete a transfer assessment.

Potentially Adverse Events must be investigated, and action must be taken to prevent future occurrences.  This is not new but is overlooked with an alarming frequency.  Adverse Events retrieved in OASIS reports often have diminished value due to of the age of the data, but you can investigate Adverse Events as they happen while all staff involved with care are still employed and memories are still fresh.  The names of the Potentially Avoidable Events are self-explanatory, and a list provided to staff who complete discharge assessments or billing audits may be useful for identification prior to generating an outdated report.

Monitored Measures to Demonstrate and Track Sustained Improvement

For all activities undertaken to improve quality of care by the agency, there must be measures that are monitored to demonstrate improvement and track sustained improvements. It is a common occurrence for education to yield immediate results for a brief period of time with a return to baseline after a few weeks.

Performance Improvement Projects

Agencies must conduct performance improvement projects. The number and scope of distinct projects must reflect the scope, complexity and past performance of the agency.  Documentation will include a description of the project, the underlying reason for undertaking the project and measurable achievement.  The nature of the project is up to the agency but it must be related to data that has been and will be collected.

Governing Body Responsibilities

Finally, the governing body is responsible for ensuring that:

  • An ongoing program is defined, implemented and maintained
  • The Quality Assurance activities address priorities for improved care and patient safety and that all actions are evaluated for effectiveness.
  • Clear expectations for patient safety are established, implemented and maintained
  • That any findings of fraud or waste are appropriately addressed.

Regarding fraud and waste, the interpretive guidelines go on to say:

In the event that the HHA identifies a possibly illegal action by its employees, contractors or responsible/relevant physicians, it is the responsibility of the HHA to report the actions to the appropriate authorities according to the individual State laws and the nature of the action(s).

I have taken liberties with the actual language.  The full text of the new Conditions of Participation can be found here.  Ultimately it is the responsibility of each agency to understand the CoP’s and we hope we are able to help you.  But we are not now and never will be a substitute for any regulatory body or document.

Next up in the new Conditions of Participation is Infection Control which will be discussed in detail next week.  For now, agencies will do well to pull all relevant OASIS reports and outcomes so that a plan can be put in place.

As always, if you need help implementing the new Conditions of Participation, you know who to contact.

Two More New Conditions of Participation


Assessment and Plan of Care

The current Conditions of Participation are not specific about the scope of the assessment or the plan of care, but most agencies are already meeting the CoP’s due out in January.  In the current CoP’s, the scope of practice for each discipline is defined, followed by a section on clinical records.  It reads:

A clinical record containing pertinent past and current findings in accordance with accepted professional standards is maintained for every patient receiving home health services. In addition to the plan of care, the record contains appropriate identifying information; name of physician; drug, dietary, treatment, and activity orders; signed and dated clinical and progress notes; copies of summary reports sent to the attending physician; and a discharge summary. The HHA must inform the attending physician of the availability of a discharge summary. The discharge summary must be sent to the attending physician upon request and must include the patient’s medical and health status at discharge.

The new Conditions of Participation have details about what is expected to be in your assessment and plan of care.

Assessment:

The condition reads: Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient’s eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment

The standards that fall under this condition are as follows as I understand them.  They are not verbatim.

  1. The RN must conduct an initial assessment to determine the immediate care and support needs of the patient and for Medicare patients, determine eligibility, including homebound status. This visit must occur within 48 hours of referral or return to the home or on the specific date ordered by the MD.
  2. When nursing isn’t ordered, Physical Therapy, Speech Therapy or Occupational Therapy can perform the initial assessment. This is later clarified to read that Occupational Therapy can perform the assessment if the need for OT services establishes the need for services.
  3. The initial assessment must be completed in a manner consistent with the immediate needs of the patient but no later than five days after the start of care.
  4. Content of the plan of care is expected to include:
    1. Patient strengths, goals and care preferences – including information that may be used to demonstrate patient progress to the patient’s goals and measurable outcomes identified by the agency.
    2. The patient’s continuing need for home care
    3. Medical, nursing, rehab, social and discharge planning needs
    4. Medication review of all drugs the patient is using to include
      1. Potentially adverse effects
      2. Drug reactions
  • Ineffective drug therapy
  1. Significant side effects
  2. Significant drug interactions
  3. Duplicate drug therapy
  4. Non-compliance with therapy
  1. The patient’s primary caregiver(s) and other support including their willingness and ability to provide care, their availability and schedules and the patient’s representatives, if any.
  2. Incorporation of the OASIS dataset into the comprehensive assessment.
  1. The assessment must be updated at least every 60 days and also at the time of a significant change in condition, beneficiary elected transfer, transfer and discharge to the same agency within the same 60-day period, within 48 hours of return to home after a hospitalization and discharge.

Surely you have realized by now that most of these criteria are already written into the OASIS regulations, prior Conditions of Participation and sound clinical principles.   Now they are Conditions of Participation and while similar to what we already do, note that Occupational Therapy can now perform OASIS assessments.  Also, it’s worth noting that whenever the comprehensive assessment is mentioned, it is followed by the assessment of Medicare eligibility for Medicare patients including homebound status.

Careplanning, Coordination of Care and Quality of Care

 This is a new condition and while many agencies already do most of this, there are some standards that some agency’s haven’t done in the past.

The actual condition is:

Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient’s medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice.

The standards that agency’s will follow to ensure and demonstrate compliance are as follows:

  1. Each patient must receive services that are written in a patient specific plan of care identifying patient goals and outcomes, established and reviewed periodically and signed by a doctor of medicine, osteopathy or podiatry acting within his or her scope of practice.
  2. If the physician refers a patient and the plan of care cannot be completed until after an evaluation visit, the physician is consulted to approve additional orders.

Contents of the Plan of Care

  1. The individualized plan of care must include the following:
  • All pertinent diagnoses;
  • (mental, psychosocial, and cognitive status;
  • The types of services, supplies, and equipment required;
  • The frequency and duration of visits to be made;
  • Prognosis;
  • Rehabilitation potential;
  • Functional limitations;
  • Activities permitted;
  • Nutritional requirements;
  • All medications and treatments;
  • Safety measures to protect against injury;
  • Risk assessment for emergency room visits and rehospitalizations and all necessary interventions to address the risk factors.
  • Patient and caregiver education and training to facilitate timely discharge;
  • Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient;
  • Information related to any advanced directives; and
  • Orders, including verbal orders
  1. Drugs, services and treatments are administered only as ordered by a physician
  2. Flu and pneumonia vaccines may be administered per agency policy developed in consultation with a physician and after the assessment of a patient to determine contraindications.
  3. Verbal orders must be accepted only in accordance with state laws pertaining to verbal orders. When a verbal order is obtained, services are to be carried out as ordered without waiting on the signed order. Verbal orders must include the signature, date and time that the order was received and be placed in the clinical record.  They are to be authenticated and dated by the physician who gave the orders in accordance with state laws and regulations as well as agency policies.

Review and Revision of the Plan of Care

  1. The plan of care is reviewed and revised by the physician who is responsible for the for the home health plan of care as often as indicated by the patient’s condition but at least every 60 days. The agency  must promptly alert the relevant physician(s) to any changes in the patient’s condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered.
  2. The revised plan of care must reflect current information from the patient’s updated comprehensive assessment and contain information concerning progress towards goals identified by the agency and patient in the plan of care.
  3. Any revisions to the pan of care due to a change in health status must be communicated to the patient, representative (if any) and all physicians writing orders for the patient.
  4. Any revisions to discharge plans must be communicated to the patient, representative (if any) and all physicians ordering care, the patient’s primary care practitioner or other health care professional who will provide care to the patient after discharge from the agency.

Ensuring Care Coordination involves:

  1. Communication with all physicians involved in the plan of care.
  2. Integration of orders from all physicians involved in the plan of care to assure the coordination of all services and interventions provided to the patient.
  3. Integration of services provided by the agency or under arrangement to assure the identification of patient needs and factors that affect patient safety and treatment and coordination of care.
  4. Involvement of the patient, representative (if any), and caregivers as appropriate in coordination of care activities.
  5. Ensure that education is provided by the agency to the patient and caregivers regarding care and services in the Plan of Care and to ensure a timely discharge.

The agency must provide written information to the patient that includes:

  1. Visit schedule of all agency and contracted personnel
  2. Patient Medications and instructions on how to take meds including medication name, dosage and frequency and which meds will be administered by the agency or contracted personnel.
  3. Al pertinent instructions related to the patient’s care and treatments that the agency will provide specific to the patient needs.
  4. The name and contact information of the agency’s clinical manager.

So that’s a lot.  Agencies who choose to wait will be working weekends and holidays to be in compliance by mid-January.  The first thing I might do is call my software vendor.  The plan of care requirements haven’t changed but the information that is required to be given to the patient has.  Could a patient friendly medication sheet containing frequency as well as the name and strength of the med be generated?  Depending on your patient population, there may be questions about whether or not you want to leave the entire plan of care in the home.  Will the computer generate a separate form?

Notice that teaching must be specific to the patient.  This may seem self-evident but I have seen nurses teach that Neurontin is for seizures when the patient never had a seizure in their life but was taking Neurontin for neuropathy.  Still, the patient verbalized understanding.

Care coordination and communication is an ongoing Condition and an ongoing problem.  I thought that software messaging would reduce the problem but sadly it has not.  The software accounts I have for clients have so many emails in the inboxes and the vast majority of them do not concern me. One of you has a better idea.  Care to share?

Look for more next week.  Meanwhile, get through these Conditions before moving on to the next.