1. Nancy L. Losben Chair, ASCP Foundation
Regulatory Insights from Recent Long Term Care Surveys: A Phase 2 Update
Nancy L. Losben
Chair, ASCP Foundation

2. I have no actual or potential conflicts of interest associated with this presentation. Nancy L. Losben

3. Pre-Test Questions
What questions should I expect from a surveyor during the pharmacist’s interview for medication regime review?
How can I identify the residents likely to be included in the surveyor’s list of residents to review?
How should physicians and facility staff appropriately document a medication regimen’s indications for use in the medical chart?
What can I do to promote the documentation of a prescriber’s rationale to continue a medication that has the potential for a drug misadventure?
What are the four elements of a plan of correction for a nursing facility deficiency in a pharmacy-related issue?

4. Objectives
Prioritize Medication Regimen Review based on the new Appendix P, Surveyors Procedures for Long Term Care Facilities, effective May 6,
Evaluate pharmacy services-related deficiencies cited since the implementation of Phase Two of the Mega Rule.
Address prescribers’ resistance to discontinuing PRN antipsychotic and psychotropic medications.
Create a plan of correction for a deficiency in medication regimen review.
Identify Infection Control issues during a Medication Pass Observation

5. Key Phrases Irregularity Complete Chart
Interview, Observation, Documentation
Inadequate Monitoring
Indication for use

6. Appendix P, Effective May 6, 2018 Surveyor Off-site Activities
Certification/GuidanceforLawsAndRegulations/Nursing-Homes.html
Review the CASPER 3 report for pattern of repeat deficiencies.
Document the results of the last Standard survey.
Review complaints and Facility Reported Incidents (FRI) since the last Standard survey
you will include up to five complaint/FRI residents in the initial pool and the sample
Indicate whether the facility has a history of abuse allegations, patterns of abuse, or citations since the last survey
Contact the Ombudsman in accordance with State policy. Notify the ombudsman of the proposed day of entrance into the facility and if applicable,

7. Team reviews offsite information
MDS Indicator Facility Rate Report. Review the report to get a sense of how many residents and which MDS indicators are of potential concern at the facility. Click on the Reports icon
Offsite selected residents. Review the list of offsite selected residents and their MDS indicators.

8. Mandatory Facility Tasks
Beneficiary Protection Notification Review
Dining Observation (assign all surveyors who are assigned to a dining area or room trays but communicate that one surveyor has primary responsibility)
Infection Control (assign all surveyors but communicate that one surveyor has primary responsibility)
Kitchen
Make Kitchen observations throughout the survey
Medication Administration
Medication Storage
QAA/QAPI
Resident Council Meeting
Sufficient and Competent Nurse Staffing (assign all surveyors but communicate that one surveyor has primary responsibility)

9. Facility Entrance Discuss with the Administrator items 1 – 4
Conduct a brief Entrance Conference
Ask for a resident roster for your assigned area with an indicator for the new admissions in last 30 days
All other surveyors: Go to your assigned areas.
Briefly screen all residents in your assigned area and observe, interview, and complete a limited record review for initial pool residents
Conduct a quick head-to-toe observation of the resident.
Include any newly admitted or vulnerable resident with potential concerns
Vulnerable residents (dependent on staff such as a resident who has Alzheimer’s or is quadriplegic);
New admissions in the last 30 days; and
Identified Concern

10. Facility Matrix Date of Admission if Admitted within the Past 30 days
Alzheimer’s / Dementia
MD, ID, or RC & No PASARR Level II
Medications: Insulin (I), Anticoagulant (AC), Antibiotic (ABX), Diuretic (D), Opioid (O), Hypnotic (H), Antianxiety (AA), Antipsychotic (AP), Antidepressant (AD), Respiratory (RESP)
Facility Acquired Pressure Ulcer(s) (any stage)
Worsened Pressure Ulcer(s) (any stage)
Excessive Weight Loss w/out Prescribed Weight Loss Program
Tube Feeding
Dehydration
Physical Restraints
Fall (F), Fall with Injury (FI), or Fall w/Major Injury (FMI)
Indwelling Catheter
Dialysis: Peritoneal (P), Hemo (H), in facility (F) or offsite (O)
Hospice
End of Life Care / Comfort Care / Palliative Care
Tracheostomy
Ventilator
Transmission-based Precautions
Intravenous Therapy
Infections (M, WI, P, TB, VH, C, UTI)

11. Getting to the Pool of Selected Residents
At least one resident
who Smokes, one resident
who is receiving Dialysis,
one resident on Hospice,
one resident on a Ventilator, and one resident who is
on Transmission-Based Precautions
Conduct the full resident observation (RO) for all residents in the initial pool.
Complete at least three RRI/family interviews across the team on the first day of the survey
Conduct a limited record review (RR) after your interviews and observations are completed for all initial pool residents.
For any resident marked as non-interviewable, refused, or unavailable, review the record for the following information: pressure ulcers, dialysis, infections, nutrition (system can help calculate % weight loss), falls in the last 120 days, ADL decline in the last 120 days, low risk bladder and bowel (B&B), unplanned hospitalizations, elopement and change of condition in the last 120 days.
For any resident in the initial pool who is currently receiving insulin, an anticoagulant, an antipsychotic with a diagnosis of Alzheimer’s or dementia,

12. Getting to the Pool of Selected Residents
Dining Observation: Each surveyor will observe the first scheduled FULL meal
All surveyors complete dining observations for the first full meal.
Select the Sample
select and display the five residents for an Unnecessary Medication review who may or may not be in the sample.
Facility tasks were triggered - environment, personal funds or resident assessments.
Finalize the selection of residents for the three closed record reviews (death, hospitalization and discharge)
Infection Control
All surveyors observe for breaks in infection control throughout the survey,

13. Investigation Sufficient and Competent Nurse Staffing
Throughout the survey, all surveyors are considering whether concerns with staffing can be linked to resident complaints, or quality of life and care concerns.
Personal Funds
Complete this review when there are identified concerns with sampled residents not having access to funds or not receiving a quarterly statement. Only complete the applicable section of the pathway.
Environment

14. Investigation Two ways to view your investigations:
Investigation By Resident – you can access all of the care areas being investigated for that resident. Click on the resident’s name and you will see all the care areas (one investigative area is listed per screen) in the pull-out on the right side of the screen. This option is useful when making observations, interviewing the resident, RR or family, or reviewing the record.
Investigation By Care Area

15. Pathways Administrative Person Centered Medication Administration
Personal Funds
PASARR
Accidents
Neglect
Dining
Extended Stay
Hospitalization
Hospice/End of Life
Environment
Beneficiary Notice
Resident Council
Kitchen
Sufficient Staff and Competency
Activities
General
Discharge
Medication Administration
Medication Storage
Unnecessary Medications
Resident Assessment
Pain management
Dialysis
Nutrition
Communication/Sensory
Respiratory
Infection Control/ Immunization
Pressure Ulcer
Physical restraint
Rehab/Restorative
Dementia Care
Dental
Bowel and Bladder
Urinary Catheter/ITI
Behavior/Emotional
Activities of Daily Living
Tube Feeding
Hydration

16. Medication Administration Surveyor Pathway
Medication held and physician notified in the presence of an adverse effect, such as signs
of bleeding or abnormal lab results with anticoagulants.
Multi-dose vials which have been opened or accessed (e.g., needle-punctured) are dated
and discarded within 28 days unless the manufacturer specifies a different (shorter or longer)
date for the opened vial.
Observe for the safe use of point of care devices (e.g., blood glucose meter, International Normalized
Ratio (INR) monitor).
Finger stick devices (both lancet and lancet-holding devices) are used for one resident.
If used for more than one resident, the point-of-care testing device (e.g., blood glucose meter, INR monitor) is cleaned and disinfected after every use according to manufacturer’s instructions.
Insulin pens must be clearly labeled with the resident’s name and other identifier(s) to verify
that the correct pen is used on the correct resident
Medication held and physician notified in the presence of an adverse effect, such as signs of
bleeding or abnormal lab results with anticoagulants.
Staff did not crush and combine medications and then give medications all at once via feeding tube.

17. Department of Health and Human Services CDC Vaccine Storage Toolkit
Reading and recording storage unit temperatures a minimum of 2 times each workday
Reading and recording minimum/maximum temperatures from a digital data logger 1 time each workday, preferably each morning
Reviewing and analyzing temperature data at least weekly for any shifts in temperature trends
Rotating stock at least weekly so vaccines with the earliest expiration dates are used first
Do not store any vaccine in a dormitory-style or bar-style combined refrigerator/ freezer unit under any circumstances.
Do not store vaccines in deli, fruit, or vegetable drawers, or in the door. Temperatures in these areas are not stable and can differ from those inside the main part of the unit.
Arrange vaccines and diluents in rows, allowing space between rows to promote air circulation. This helps each vaccine and diluent maintain a consistent temperature.

19. Recent Pharmacy Services-Related Deficiencies

20. Medication Storage Surveyor Pathway
Medications and biologicals in medication rooms, carts, boxes, and refrigerators were maintained
within:
Secured (locked) locations, accessible only to designated staff;
Clean and sanitary conditions; and
Maintain temperatures in accordance with manufacturer specifications and monitor according to
national guidelines (e.g., see CDC vaccine storage and handling).
Unit or area where the medication storage task was conducted:      
Did the facility provide pharmaceutical services (including procedures that assure the
accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals)
to meet the needs of each resident? Yes No F755
Are all medications and biologicals stored and labeled properly (medication rooms,
carts, boxes, refrigerators)? Yes No F755 and/or F761
Does the facility have a system to account for the receipt, usage, disposition, and
reconciliation of all controlled medications? Yes No F755
Other Tags and Care Areas to consider: Misappropriation of Resident Property/Exploitation
Related to Drug Diversion (F602), Infection Prevention and Control (F880)

21. F755 Pharmacy Services- Controlled Substance Liquid SS=D

22. F755 Pharmacy Services

23. F755 Pharmacy Services SS=D

24. F756 Drug Regimen Review SS=D
This REQUIREMENT is not met as evidenced by: Based on the record reviewed , it was determined that the facility failed to document in the resident’s medical record that an identified pharmacy irregularity has been reviewed by the attending  physician or 1 in 5 residents investigated in standard survey sample.
The survey then states the issue, then quotes as staff nurse as saying that the prescriber does not document or sign irregularity notice. Surveyor then interviewed NP in question who (at least their stories matched) admitted that she does not (I quote) she does not document the irregularity has been reviewed, the action taken, or if no change to medication, the rationale in the resident’s medical record.   She said that to the surveyor.

25. F756 Drug Regimen Review SS=D
Based on interview, clinical record review and documentation review pharmacist failed to identify and report medication irregularity to physician.
Mirtazapine 7.5 mg HS for appetite loss. Mirtazapine is an antidepressant and is used to treat depression. The resident does not have a diagnosis of depression. Medication was used for 6 months. Pharmacist stated he was not aware of a requirement that medications must be FDA approved for the specific use it is being ordered for, and the drug was in the resident’s best interest.
Megestrol was also being used to treat loss of appetite.
F758 was also cited (SS=D)

26. F756 Medication Regimen Review
This REQUIREMENT is not met as evidenced by: Based on observation, record review, and interview, the facility's consultant pharmacy failed to notify the facility of the need to monitor the effectiveness of and for side effects of medications for 3 residents
The Quarterly MDS dated 10/9/17 documented a BIMS score of 0, which indicated severely impaired cognition. The resident did not exhibit behaviors and required extensive assistance with all ADLs. The resident received antipsychotic and antidepressant medications. Behavior monitoring records for September 2017, October 2017, and November 2017 documented target behavior and the medication linked to the behavior, but were incomplete
A physician's order dated 4/24/17 directed staff to rate and assess the resident's pain twice daily and to refer to the Medication Administration Record (MAR) and Treatment Administration Record (TAR) for non-medication interventions for pain. Pain assessments for October 2017, November , and December 2017 were incomplete.
A resident was prescribed Risperidone for behaviors. According to fda.gov, a side effect of Risperidone is constipation. The consultant pharmacy medication reviews dated 4/13/16, 5/12/16, 6/21/16, 7/26/16, 8/23/16, 9/16/16, 10/18/16, 11/10/16, 12/20/16, 1/14/17, 2/9/17, 3/21/17, 4/13/17, 5/19/17, 6/23/17, 7/20/17, 8/24/17, 9/26/17, 10/17/17, 11/22/17, and 12/28/17 (21 months) failed to identify the need for staff to complete behavior monitoring and BM records.
Inadequate Monitoring

27. F756 Drug Regimen Review SS=D
Based on interview and record review, the consulting pharmacist failed to address the lack of rationale for administering AS NEEDED prn Psychotropic medications and inconsistent documentation of effectiveness of the PRN medication. Lorazepam had been administered 14 of 15 times without documentation in December 2017 and 20 of 20 times in January, Consulting Pharmacist stated
Staff often administered lorazepam with pain medication used for leg pain.
F758 (SS=D) Unnecessary Psychotropic Drugs also cited

28. Unnecessary Drugs Surveyor Pathway The Pharmacist Interview
Do you perform a monthly MRR (or more frequently if needed)?
Do you include each resident’s medical record in this monthly review?
How do you evaluate PRN medications, specifically PRN psychotropic and antipsychotic medications?
What are you reviewing (e.g., adequate indication, dose, continued need, and adverse consequences)?
Did you identify and report to the attending physician, medical director, and DON any irregularities with this resident’s medication regimen? Did you use a separate written report?
If the pharmacist didn’t identify a specific issue, ask why the issue was not identified as an irregularity on the MRR.
What is the MRR process for short-stay residents?
What protocols to do you have in place (e.g., lab to monitor for adverse events and drug interactions related to use of antibiotics and other high-risk medications)?
Are you part of the IDT who reviews this resident’s medication?
What steps do you take when an irregularity requires immediate action? Are these steps part of facility policy .

29. F757 Unnecessary Drugs
Based on staff interview and clinical record review, Resident with C. difficile infection and diarrhea continued on diuretic in the presence of dehydration. 

30. Unnecessary Drug Surveyor Pathway
Are care planned interventions implemented for medications that pose a high risk for adverse consequences?
Does the resident have psychosocial, behavioral, mental, or physical adverse consequences that may be related to a medication

31. “Indication for use” is defined as the identified, documented clinical rationale for administering a medication that is based upon an assessment of the resident’s condition and therapeutic goals and is consistent with manufacturer’s recommendations and/or clinical practice guidelines, clinical standards of practice, medication references, clinical studies or evidence-based review articles that are published in medical and/or pharmacy journals. CMS State Operations Manual , Appendix PP - Guidance to Surveyors for Long Term Care Facilities Transmittals for Appendix PP, (Rev. 173, )

32. F757 Unnecessary Drugs Indication for Use
“I have a surveyor wanting to tag a facility for not having an appropriate diagnosis for antipsychotic.  They are saying Dementia with Behavior or BPSD or (as in this woman’s case) Dementia with psychosis is not an acceptable diagnosis.  She is going to tag the facility. Yes she has had a successful dose reduction, well within the guidelines”
“OK this surveyor is sure sticking to her guns.  She is REALLY trying to tag the facility on dementia with psychosis doesn’t count as a proper diagnosis for an antipsychotic.”
“I’ve given her the printout from page 489 of the SOM to show dose reductions.  In the meantime (unfortunately) the admin of the facility pulled up some old P&P from the med pass company from 2015.  Outdated, but it doesn’t specifically say dementia in the policy, but does address behaviors and therefore she says it doesn’t count as a diagnosis.  I have since given them our Omnicare update policy to place in the record.”
Indication for Use

33. F758 Unnecessary Psychotropic Meds/PRN Use SS=D
Based on staff interview and record review, the facility failed to ensure that the as needed orders for psychotropic drugs are limited to 14 days.
Findings- Resident number 114 had an order for lorazepam mg PO BID PRN starting 12/12/17 and ending 3/12/18. There was no evidence in the clinical record that the physician documented their rationale for extending the medication beyond 14 days as required.

34. F758 Unnecessary Psychotropic Drugs SS=D
Resident admitted with DX: HF, HTN, DM, Non-Alzheimer’s Dementia with behavioral disturbances. MDS BIMs Score of 3 meaning the resident was cognitively impaired. Resident also assessed as depressed, poor appetite, short-tempered. MDS Section E indicates No Behavioral symptoms on the MDS , But MDS indicates the use of an antipsychotic (Risperidone 0.25 mg daily) since 9/27/17.
Facility staff unable to show any documented behaviors. Interview of staff on 3/06/18 revealed no monitoring for specific behaviors on psychotropic MAR or in computer system.

35. F758 Unnecessary Psychotropic Drugs SS=D
Facility failed to ensure as needed (PRN) orders for psychotropic drugs are limited to 14days.
Lorazepam 0.5 mg PO BID started on 12/12/17 and ending 3/12/18. There was no evidence in the clinical record that the physician documented their rationale for extending the medication beyond 14 days.

36. What else can we do? Engaging Prescribers
Psychotropic stewardship program
Ban PRN Antipsychotics for patients with Dementia
Stop order policies
No verbal phone orders without non-drug intervention
Computer programming changes
Peer Review: Measure prescribing habits and report to QA/PI
What else can we do?

37. F Tag 553, Right to Participate in a Plan of Care
Facility received a deficiency when the medication was changed due to coverage of a non-formulary medication.
A review of the medical chart indicated no documentation that the resident or their representative was informed about the change in the medication order.

38. F 842 Medical Records SS=D
Facility has a resident who receives Bumetanide, but has an allergy to Furosemide and Penicillin. The alert for possible allergy came up in their Medical Records System, and the nurse notified the Nurse Practitioner, who stated to give the med.
This resident was a re-admission and came to the center on the medication from the hospital. The resident had received the medication prior to going to the hospital as well since June with no adverse effects.
They received a citation under "medical records" F842 at a D level, for failure to have documentation by the NP to explain rationale  

39. F880 Infection Control

40. Antibiotic Stewardship Program Surveyor Pathway
Determine whether the facility has an antibiotic stewardship program that includes:
Infection Prevention, Control & Immunizations
Written antibiotic use protocols on antibiotic prescribing, including the documentation of the indication, dosage, and duration of use of antibiotics;
Protocols to review clinical signs and symptoms and laboratory reports to determine if the antibiotic is indicated or if adjustments to therapy should be made and identify what infection assessment tools or management algorithms are used for one or more infections (e.g., SBAR tool for urinary tract infection (UTI) assessment, Loeb minimum criteria for initiation of antibiotics);
A process for a periodic review of antibiotic use by prescribing practitioners
Protocols to optimize the treatment of infections by ensuring that residents who require antibiotics are prescribed the appropriate antibiotic;
A system for the provision of feedback reports on antibiotic use, antibiotic resistance patterns based on laboratory data, and prescribing practices for the prescribing practitioner.

41. F881 Antibiotic Stewardship No SS
  The CMS surveyors did not like that the facility had corporate policies for Anti-infective / Antimicrobial Stewardship Program.
CMS said the policies need to be facility specific.  CMS also said that the McGeer’s is out of date and there is “something” better available.  They did not give information on what the “something” was.

42. F881 Antibiotic Stewardship No SS
Infection control – lack of evidence supporting active implementation of antibiotic stewardship program
Infection control – lack of education to staff of person- centered antibiotic stewardship

43. Complaint Investigation – 91 pages SS=J
Your facility’s non-compliance with F758 Unnecessary Drugs and F760 Significant Medication Error has been determined to constitute substandard quality of care as defined at
89 YO female. Psychiatrist ordered Haldol 2.5 mg at 2 PM and at bedtime x 14 days for major depressive disorder. The medical chart did not include documentation of depressive symptoms . The nurse entered the order in the electronic medical record system as 20 mg. Resident discharged to hospital with Acute Encephalopathy and Neuroleptic Malignant Syndrome.
F658 Comprehensive Care Plan
F755 Pharmacy Services
F758 Unnecessary Drugs
F760 Free from Significant Medication Errors
F835 Administration
F867 QAPI/QAA
6 additional state tags

44. Let’s Build a Plan of Correction
What corrective actions will be accomplished for those residents found to have been affected by the deficient practice
How will you identify other residents having the potential to be affected by the same deficient practice
What measures will be put into place or what systemic changes will you make
How will the corrective actions be monitored to assure the deficient practices will not recur, i.e., what quality measures

45. Post-Test Questions
What questions should I expect from a surveyor during the pharmacist’s interview for medication regime review?
How can I identify the residents likely to be included in the surveyor’s list of residents to review?
How should physicians and facility staff appropriately document a medication regimen’s indications for use in the medical chart?
What can I do to promote the documentation of a prescriber’s rationale to continue a medication that has the potential for a drug misadventure?
What are the four elements of a plan of correction for a nursing facility deficiency in a pharmacy-related issue?

46. Questions and Thank You