October 21,2018 Mega Rule Pharmacy Deficiencies: What’s Hot, What’s Not Erin M. Foti, PharmD, BCGP Director of Consulting Services Remedi SeniorCare William M. Vaughan RN Vice President, Education / Clinical Affairs Remedi SeniorCare

Disclosure / Contact Info Erin Remedi SeniorCare Erin.foti@remedirx.com Bill Clinical Advisory Board – ISMP LTC Newsletter william.vaughan@remedirx.com

“Welcome to the ISMP Long-Term Care Advise-ERR, a medication safety newsletter designed specifically to meet the needs of administrators, nursing directors, and nurses who transcribe medication orders, administer medications, monitor the effects of medications on residents, and/or supervise those who carry out these important tasks.” http://www.ismp.org/Newsletters/longtermcare/default.aspx

Source: ProPublica (updated June, 2018) https://projects.propublica.org/nursing-homes/

Source: ProPublica (updated June, 2018) https://projects.propublica.org/nursing-homes/

Source: ProPublica (updated June, 2018) https://projects.propublica.org/nursing-homes/

Mega Rule

Regulations F 756: Drug Regimen Review F 758: Psychotropic drugs F 881: Infection prevention / control - ABT stewardship F 552: Planning / Implementing Care

Time for low budget Remedi Jeopardy

Deficiency Data: Phase II 11/28/17  7/31/18 F 756: Drug Regimen review F758: Psychotropic drugs F881: Antibiotic stewardship F 552: Planning/implement care

Data SourceS Data portal https://data.medicare.gov/ Aggregate health deficiencies cited in federally certified nursing homes https://data.medicare.gov/Nursing-Home-Compare/Health-Deficiencies/npft-b6wt Redacted deficiencies for specific nursing homes https://www.medicare.gov/nursinghomecompare/search.html Unredacted deficiencies for specific nursing homes https://projects.propublica.org/nursing-homes/ Accessed: August 23, 2018 Caution: Delay in posting survey results / look back period/redaction

F 756 – Drug Regimen Review Mega Rule: National Total = 540 G = 1 Medical record Medical Director Policies / Procedures National Total = 540 G = 1

Definition: Drug Irregularity “ … use of medication that is inconsistent with accepted standards of practice for providing pharmaceutical services, not supported by medical evidence, and/or that impedes or interferes with achieving the intended outcomes of pharmaceutical services. An irregularity also includes, but is not limited to, use of medications without adequate indication, without adequate monitoring, in excessive doses, and/or in the presence of adverse consequences, as well as the identification of conditions that may warrant initiation of medication therapy.” - Guidance to Surveyors: F 756

Definition: Pharmaceutical services The process (including documentation, as applicable) of receiving and interpreting prescriber’s orders; acquiring, receiving, storing, controlling, reconciling, compounding (e.g., intravenous antibiotics), dispensing, packaging, labeling, distributing, administering, monitoring responses to, using and/or disposing of all medications, biologicals, chemicals (e.g., povidone iodine, hydrogen peroxide); The provision of medication-related information to health care professionals and residents; The process of identifying, evaluating and addressing medication-related issues including the prevention and reporting of medication errors; and The provision, monitoring and/or the use of medication-related devices - Guidance to Surveyors: F 755

F 756 – Drug Regimen Review Failure to report / respond / implement recommendations An interview with the Director of Nursing (DON) on 04/20/18 at 3:30 P.M. revealed she was new to the position since 03/29/18. The DON verified she was not able to find the pharmacy recommendations or the physician follow up on the recommendations.  Review of Resident # 40's Pharmacy Consultation Report for 01/01/18 to 01/18/18 revealed the resident received a sulfonylurea and Glimepiride (to treat diabetes). Please consider titrating Glimepiride and discontinuing sliding scale insulin therapy. The Certified Nurse Practitioner (CNP) checked, I accept the recommendations above, please implement as written. However, no evidence was found of an order written [survey date: 4/25/18]

F 756 – Drug Regimen Review Failure to report / respond / implement recommendations Further review of the report on 03/12/18 revealed there was no evidence the doctor responded to the report.  On 03/06/18 at 3:15 P.M., interview with the director of nursing (DON) verified if the pharmacy recommendations were for the psychiatrist they would go in his box but he did not come into the facility that often and there was no system in place to ensure the  recommendations were addressed timely. The attending physician must document in the resident’s medical record that the identified irregularity has been reviewed and what, if any, action has been taken to address it.

F 756 – Drug Regimen Review Failure to report / respond / implement recommendations On 03/07/18 at 6:05 P.M., during interview, the DON stated she received the pharmacist's  recommendations then placed them in the appropriate physicians' folders for responses. The DON verified Resident #39's recommendations which were responded to were not responded to in a timely manner. The DON verified she had no system in place to ensure recommendations were responded to in a timely manner. After the recommendations were placed in the physicians' folders, she simply waited to get the form with a response.  Medical Director ???

F 756 – Drug Regimen Review Failure to report / respond / implement recommendations On 01/18/18 at 1:44 P.M., interview with the Director of Nursing verified the pharmacy identified a potential drug interaction, the facility did not notify the resident's  physician prior to administration and did not monitor the resident for potential adverse reactions. Reported to the facility by dispensing pharmacist Administered x 2 days before physician was notified  drug discontinued

F 756 – Drug Regimen Review National Trends Failure to identify irregularity PRN psychotropic > 14 days No justification/duration in the record Failure to respond to recommendations timely “During an interview on 4-14-18 at 8:34 AM, the Administrator stated that the DON was unable to locate any pharmacy recommendations for prior months. S/he said that reports had been going to the DON who has just been setting them aside.” Failure to maintain recommendations in the record Policy 9.1 Medication Regimen Review (MRR), Procedure 12. revealed that the Facility should maintain readily available copies of MRRs on file in Facility as part of the resident's permanent health record.

Failure to report recommendations timely F 756 – Drug Regimen Review Actual harm Failure to report recommendations timely “When interviewed, the Director of Nurses stated that the numerous pharmacy recommendations “were not reviewed by facility staff and were not sent to the physician to be followed up on because they were too busy.” Multiple falls  fractured hip (attributed, in part, to medications referenced in several unanswered pharmacy recommendations)

F 756 – Drug Regimen Review Medical director and pharmacy recommendations, your experience? Recent survey: “The DON must sign the pharmacy recommendations” Recent IDR: 3/15: Glucosamine 1500 mg one tab bid 3/15: Dispensed two 750 mg tabs MAR not corrected 5/1: Survey med pass observation -- > one tab documented, two administered Deficiency: F 756 (D) – “The pharmacist failed to report the discrepancy” IDR: regulation, scope of practice, resource burden  A level The problem  broad definition of irregularity

F 758 – Psychotropic drugs Mega Rule: National Total = 1,123 J = 2 Definition Processes (indication, non-pharm, GDR) PRN limits National Total = 1,123 J = 2

What's wrong with this picture? - Actual deficiency cited June 7, 2018 F 758 – Psychotropic Drugs What's wrong with this picture? - Actual deficiency cited June 7, 2018

F 758 – Psychotropic Drugs National Themes Failure to document indication Failure to attempt GDR All 4 classes Failure to monitor individualized target behavior Failure to address via comprehensive care plan Failure to attempt non-pharm intervention

F 758 – Psychotropic Drugs Failure to attempt non-pharm intervention Interview on 01/11/18 at 9:48 A.M., with the Director of Nursing (DON) confirmed, after reviewing Resident #43's medical progress notes, there was no documented evidence of any non-pharmalogical interventions attempted prior to the staff administering the as needed  Haldol injection to Resident #43 No documentation of non pharmacological interventions being attempted prior to the staff administering as needed pain or anti anxiety medications to Resident #5. 

F 758 – Psychotropic Drugs “Staff administered an as needed (PRN) Antipsychotic Medication to Resident #101 on multiple occasions without attempting  other measures before using the drug … the Minimum Data Set (MDS) Coordinator stated the nurses had not entered information into the system correctly to activate a prompt which asks what nonpharmacological measures have been attempted prior to administering the medication”

F 758 – Psychotropic Drugs Failure to monitor behaviors /side effects “Interview with the Director of Nursing (DON) … revealed the order for antipsychotic monitoring was discontinued by the physician. The DON was unable to clarify why the order had been discontinued.”  PRN > 14 days No rationale / duration Failure to use non-pharmacological interventions PRN anti-anxiety (20x) PRN antipsychotic All of the above in one resident .PRN antipsychotic was administered “20 times over a period of 22 days without evidence of assessment to determine the underlying cause of exhibited behaviors, attempts at non-pharmacological interventions prior to administration, or physician evaluation of continued need.” 

F 758 – Psychotropic Drugs “The Assistant Director of Nursing (ADON) was interviewed and asked of  the expectation of nurses before giving PRN pain medications. ADON stated I would expect them to assess the resident first. They are also supposed to try things such as giving water, turning on music and changing position before they pop something down their throats”

F 758 – Psychotropic Drugs “The Assistant Director of Nursing (ADON) was interviewed and asked of  the expectation of nurses before giving PRN pain medications. ADON stated I would expect them to assess the resident first. They are also supposed to try things such as giving water, turning on music and changing position before they pop something down their throats”

F 758 – Psychotropic Drugs “The Assistant Director of Nursing (ADON) was interviewed and asked of  the expectation of nurses before giving PRN pain medications. ADON stated I would expect them to assess the resident first. They are also supposed to try things such as giving water, turning on music and changing position before they pop something down their throats” §483.45(c)(3) A psychotropic drug is any drug that affects brain activities associated with mental processes and behavior. These drugs include, but are not limited to, drugs in the following categories: (i) Anti-psychotic; (ii) Anti-depressant; (iii) Anti-anxiety; and (iv) Hypnotic

F 758 – Psychotropic Drugs “The Assistant Director of Nursing (ADON) was interviewed and asked of  the expectation of nurses before giving PRN pain medications. ADON stated I would expect them to assess the resident first. They are also supposed to try things such as giving water, turning on music and changing position before they pop something down their throats”

F 758 – Psychotropic Drugs Failure to attempt GDR “The pharmacist recommended Resident #1 be reviewed for a gradual dose reduction on 12/17/17. There had been no response to the recommendation when the surveyor was at the facility 1/30-1/31/18 … Review of the Doctor's Progress Notes revealed no documentation between 12/17/17 and  1/31/18 related to the pharmacist recommendations for a gradual dose reduction … there was no current documentation of clinical contraindications.”

F 758 – Psychotropic Drugs PRN > 14 days 11/2/17: Anti-anxiety medication order tid PRN (no stop date) - administered almost daily 12/22/17: Consultant pharmacist review  either d/c or consider routine dosing  MD discontinue (documented on pharmacy recommendation) 1/4/18: Surveyor review: Order remains tid PRN, administered almost daily “Interview with the director of nursing revealed that the resident was still on the medication because the facility disagreed with the physician's assessment and held the order to discontinue for the nurse practitioner to review …  the nurse manager left it to the DON to call the physician and request routine dosing, but the DON was gone that week and the matter was not handled until 1/4/18” [after surveyor intervention]

You are now the surveyor: Scope/Severity ?

You are now the surveyor: Scope/Severity ? Immediate Jeopardy - “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.” - Appendix Q

F 758 – Psychotropic Drugs Immediate jeopardy Psychiatrist prescribed Trilifan to a resident in error based on misinformation from the nursing staff  administered x 45 days  lethargy, decreased intake, decreased activities, decline ADLs  surveyor intervention

F 758 – Psychotropic Drugs Immediate jeopardy Admit from home on hospice  within 2 weeks, seen by psych, ordered Haldol .25 mg bid x 14 days (no indication in the record)  using EHR, nursing inputs Haldol 20 mg bid  dispensed  4 doses  hospitalization (ADR / overdose) Federal CMP: $ 98,455.00.

F 881: infection prevention / control abt stewardship Mega Rule: Establish program Use protocols System to monitor National Total = 259* Nothing > F Majority = F

F 881: infection prevention / control abt stewardship S/S = C Failure to implement program Interview conducted on 05/03/18 at 1:57 P.M. with Nurse #26 revealed the facility had no documentation of the antibiotic stewardship program nor any infection control log for the months of January, February, and March. She stated the infection control program was undocumented for three months because the employee responsible for collecting the data  no longer worked for the facility. 

F 881: infection prevention / control abt stewardship S/S= F Failure to implement program Review of the facility's infection control log revealed no evidence the facility implemented an Antibiotic Stewardship Program. On 05/09/18 at 10:45 A.M. interview with Registered Nurse (RN) #12 verified the facility had not implemented an antibiotic stewardship program to date. 

F 881: infection prevention / control abt stewardship Policy The facility failed to ensure residents receiving antibiotic therapy were properly assessed, evaluated and educated before the initiation of the antibiotic therapy. The Director of Nursing (DON) confirmed the facility was not appropriately evaluating antibiotics given to residents. The DON verified  the facility was not following up and assessing residents who were receiving antibiotics according to their policy. Review of the policy revealed the use of the antibiotics will be monitored in all residents with appropriate lab work. Antibiotics orders will be reviewed for appropriateness and clarification with the physicians as needed. If and when antibiotics were prescribed over the phone, the physician will assess the resident within 72 hours. 

F 881: infection prevention / control abt stewardship Failure to establish program “In an interview on 04/19/18 at 11:40 a.m. the RDO said they did not currently have an antibiotic stewardship program up and running … In an interview on 04/19/18 at 12:20 p.m., the Administrator said she was not aware that the facility had not started the antibiotic stewardship program” “Interview on 5/18/18 with the DON revealed the facility has not instituted antibiotic stewardship program. She stated the consultant pharmacy brought her a policy and procedure and the corporate nurse brought a better policy. DON stated she is not instituted the policy yet because she is acting as interim DON and will leave as soon” “On 5/23/18 at 3:00 PM, Administrative Nurse D stated he/she managed the infection control program and verified the logs were not complete. Administrative Nurse D stated there were multiple urinary tract infections, including several on one hallway, and he/she verified the facility had no antibiotic stewardship program in place.”

F 881: infection prevention / control abt stewardship Failure to follow protocols The facility failed to accurately implement the protocols using the Surveillance Data Collection Form established by the facility, to  ensure residents reviewed for infections with antibiotics were screened correctly. The form did not include the check marks to indicate if the criteria was met for the use of the antibiotic. (California) According to the Centers for Disease Control and Prevention (CDC), there are identified core elements/actions a nursing home should ensure to prevent antibiotic resistance. The nursing home should:  1. Educate their providers on the potential harm of antibiotics. 2. Document the met criterias for the use of the antibiotic and making this information accessible (e.g., verifying indication and planned duration is documented on transfer paperwork) helps ensure that antibiotics can be modified as needed based on additional laboratory and clinical data and/or discontinued in a timely manner to reduce unnecessary  antibiotic exposure and improve resident outcomes

F 881: infection prevention / control abt stewardship Does F 881 require that facilities incorporate CDC’s core elements of antibiotic stewardship into their use protocols and monitoring system?

F 881: infection prevention / control abt stewardship The facility must develop an antibiotic stewardship program which includes the development of protocols and a system to monitor antibiotic use. This development should include leadership support and accountability via the participation of the medical director, consulting pharmacist, nursing and administrative leadership, and individual with designated responsibility for the infection control program if different - Guidance to Surveyors F 881

F 881: infection prevention / control abt stewardship “ … surveyors must base all cited deficiencies on a violation of statutory and/or regulatory requirements, rather than sections of the interpretive guidelines. The deficiency citation must be written to explain how the entity fails to comply with the regulatory requirements, not how the facility fails to comply with the guidelines for the interpretation of those requirements.” -CMS memorandum S&C-08-10

F 881: infection prevention / control abt stewardship Protocols: Up to 75 percent of antibiotics prescribed in nursing homes are prescribed incorrectly. The most common prescribing problems in nursing homes are using an antibiotic when not needed, choosing the wrong antibiotic, and using the correct antibiotic but for the wrong dose or duration. - Center for Disease Control and Prevention

F 881: infection prevention / control abt stewardship Failure to assess for continued use The DON acknowledged the resident's course for the use of the antibiotic had not been assessed or monitored. The DON verified the facility lacked documented evidence of a rationale for the continued administration of the antibiotic from 02/02/18 to 05/22/18.  The Physician's Assistant (PA) acknowledged the resident had been on the antibiotic since 02/02/18. The PA indicated the infection was colonized as the resident had been on the antibiotic for an extended period of time. The PA indicated the resident was supposed to see a pulmonologist. The PA  indicated the pulmonologist would have made recommendations regarding the continued administration of the antibiotic. The PA indicated there was a lack of documented evidence a rationale for the continued use of the antibiotic. 

You are now the surveyor: Scope/Severity ? Immediate Jeopardy - “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.” - Appendix Q

F 881: infection prevention / control abt stewardship Failure to communicate laboratory results 4/21: UA findings positive for a urinary tract  infection. [indication for UA not specified]  MD call  Cipro bid x 5 days (1st dose administer 4/23) 4/23: C&S resistant to Cipro  no MD notification  Cipro administered x 5 days “The ADON said the facility was still in the process of developing an antibiotic stewardship program and did not have a policy and procedure to provide.”

F 881: infection prevention / control abt stewardship Standardized tool /criteria for diagnosis Timely administration Communication Antibiotic time out Black box warning Because the risk of these serious side effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis and uncomplicated urinary tract infections, the FDA has determined that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options.

F 881: infection prevention / control abt stewardship Bottom Line Develop a program (Streamline) Follow the program Do the basics

F 552: Planning / Implementing Care Mega Rule: In advance Qualified staff Risks / benefits / alternatives National Total = 125* C = 1 F = 2 G = 1

F 552: implementing / planning care The facility failed to ensure a resident's request for a change of time regarding medication was accommodated. Midodrine prior to dialysis The facility failed to ensure Resident Rights were maintained regarding medication administration. Medication error: roommate’s insulin Resident #166 stated I told the nurse the medications were for my roommate but she just lifted by shirt and gave the medicine in my stomach. I don't have any hard feelings toward the nurse and I feel fine. I have diabetes but don't take insulin

F 552: implementing / planning care The facility failed to ensure a resident who wore hand brace/splints was consulted in the wearing schedule. Interview on 03/29/18 at 02:17 P.M. with TPM #610 confirmed the resident was not involved in her decisions for her care related to the splints.

F 552: implementing / planning care S/S = C “The facility failed to inform residents of the need to perform extensive inspection and subsequent cleaning procedures in residents' rooms due to the identification of bed bugs in the facility … a facility employee discovered a bug on herself. All facility rooms were inspected and two live and three dead bed bugs were found on a resident’s bed … the whole facility was treated for bed bugs. This treatment required that all residents be out of their rooms and placed in either the activity room or dining room for a period of approximately two to four hours … interview with the DON indicated  that the residents' responsible parties were made aware of the bed bugs and treatment, but the facility did not tell the residents being relocated for approximately fours hours to the common areas of the actual reason for the relocation.”

F 552: implementing / planning care “The facility failed to ensure Resident 116 was allowed to participate in his treatment plan for pain medication administration and maintain acceptable pain levels.” Lower leg amputation  multiple PRN orders to treat pain (no routine meds)  “Resident 116 stated he had an amputation three days ago and still feels pain. Resident 116 further stated I'm blind but still feel pain 9/10 (On a pain scale of 0-10, 0-no pain to 10-extreme pain) to the left foot. Resident 116 stated he requested to have his pain medications administered routinely but his request was denied There no documentation that facility staff had met with Resident 116 regarding his desire to have his pain medications given routinely”

F 552: implementing / planning care The facility failed to inform residents in advance of the risks and benefits of proposed care and treatment for 1of 17 residents reviewed for resident rights in that Residents #61 did not have signed consents for pychoactive medications. This failure affected 1 resident who received psychoactive medications without informed consents and placed 67 other residents at risk of receiving treatments without informed consent … Resident #61's family member and Power of Attorney said that no one had called to get her consent for medications but said that she would give it. 

F 552: implementing / planning care Failure to contact correct health care decision-maker with change in condition  4 day delay in hospitalization 11/3/17: new onset left side weakness  NP contacted, send to hospital  alternate health care agent contacted, treat in house 11/7/17: neurological symptoms progressed  hospitalized (alternate health care agent informed) 1/2/18: surveyor interview of primary health care agent  never informed of change in condition, subsequent hospitalization or potential clinical interventions to prevent progression of stroke

F 552: implementing / planning care “Based on observation, interview and record review, the facility failed to ensure two residents (Resident 133 and Resident 339) were explained about their medications, prior to the administration. This deficient practice had the potential to result in violating the resident's right to be informed, in order to be able to accept or refuse their treatments … LVN 5 acknowledged he had not explained any of the medications to Resident 133 prior to administering the medications. LVN 5 further stated, We need to tell the residents what medications they are receiving. They have a right to know. … LVN 6 stated I do not tell the residents what medications they are taking unless there is a new medication because they (residents' medications) are all the same each time. I do not know if that is the right way to go about it.” Prior to administration of every medication, every time !

F 552: implementing / planning care What is your process? Risks/Benefits/Alternatives – How much is enough? Black box warnings? Which staff member? Documentation? Signed consent? Unavailability of surrogate? QAPI  data

F 552: implementing / planning care Themes Psychotropic drugs Antipsychotics Antidepressants Timing Admission Prior to each dose Documentation Resident versus “responsible party” Hospice