Protecting, Maintaining and Improving the Health of Minnesotans

Certified Mail # 7003-2260-0000-9987-6944

January 9,2013

Subject: - IDR Provider # 245596 Project # S5596022

This is in response to your letter of November 2,2012, in regard to your request of an informal dispute resolution (IDR) for the federal deficiencies at tag F329 and F428 issued pursuant to the survey event 009Nll, completed on September 28,2012.

The information presented with your letter, the CMS 2567 dated September 28, 2012 and corresponding Plan of Correction, as well as survey documents and discussion with representatives of L&C staff have been carefully considered and the following determination has been made:

F329 (D) 42 CFR §483.25 (I): Unnecessary Drugs-each resident's drug regimen must be free from unnecessary drugs.

Summary of the facility's reason for IDR of this tag: The facility identified R46 had a diagnosis of arthritis, and had received meloxicam since December 2008. The quarterly pain assessments done by the facility indicated R46 had little or no pain and was well controlled. Lab work including complete blood count (CBC) , platelets, and complete metabolic panel (CMP), had been monitored every 6 months and findings were within normal limits consistently. The facility also pointed out there is no specific language in the State Operations Manual (SOM) that requires non-steroidal anti-inflammatory (NSAID) drugs to be evaluated for reduction at least every 6 hlonths. ,.,

Summary of facts: The clinical record for R46 identified the resident had diagnoses that included: a history (hx) of multiple pulmonary emboli, hx of deep vein thrombosis (DVT) and arthritis. The clinical record also identified R46 had received meloxicam since September 2010 for left shoulder pain. On 2116112, the Consultation Report from the consulting pharmacist indicated R46 was receiving both warfarin and meloxicam, and identified the combination therapy could lead to gastrointestinal (GI) adverse events.

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January 9, 2013

The consulting pharmacist had recommended a possible trial discontinuation of the meloxicam, and monitoring of the use of any as needed (PRN) Tylenol use to assess pain control. On 3/21112, the p-hysician had responded to the recommendation with an order to try to decrease the meloxicam from 7.5 mg (milligrams) daily to 7.5 mg every other day. On 9/27112, the facility staff posed a question to the physician about whether R46's elevated PT/INR (protime/international normalized ratio) could be related to the continued use of the meloxicam 7.5 mg every other day. The physician had responded by writing an order to "continue present dose of mel oxic am," and had documented that the medication was beneficial for R46. Lab tests conducted on 1111111,511112 and 10116112, revealed hemoglobin (Hgb), platelets were within normal limits. Lab test results from 5/29112 and 10116112, revealed the resident's creatinine levels (kidney function) were within normal limits. The PT/INR levels were monitored consistently and adjustments to the dosage done as indicated. Pain assessments completed on 3127112 and 6/26112, identified R46 had scored a 0 on each (indicating no pain) and which were all done after the reduction of the meloxicam. The resident's care plan, revised 8114112, identified potential problems to include: complications from chronic anticoagulant use, and listed various interventions that included monitoring the resident's stools for frank red blood, black or tarry stools, bleeding of gums, any noted bruising and to report to nursing if noted. Interview with consulting pharmacist on 9/27112 indicated a GI bleed was the main concern with the combination therapy of warfarin and meloxicam, however the pharmacist had also stated R46's Hbg had been stable.

Summary of findings: R46 had diagnoses ofhx of pulmonary emboli, DVT and arthritis and received combination therapy of warfarin and meloxicam. On 2116112, the consulting pharmacist had identified a concern of potential GI adverse events and had recommended a trial discontinuation of the meloxicam. On 3/21112, the physician had responded with an order to try to decrease the dose of mel oxic am from 7.5 mg daily to 7.5 mg every other day. R46 remained on warfarin and meloxicam 7.5 mg every other day with laboratory values including CBC, platelets and creatinine remaining within normal limits. The facility had monitored the PT/INR levels consistently and adjustments done to the routine dosing as indicated. The facility had identified the potential for adverse events, decreased the dosage of the meloxicam in response to the identified potential consequences. In addition, the facility had conducted consistent lab monitoring, and had monitored for symtpoms of adverse consequences.

This in not a valid example of a deficient practice under this regulation and will be removed from the 2567 Statement of Deficiencies.

F428 (D) 42 CFR §483.60 Drug Regimen Review-the drug regimen of each resident must be reviewed monthly and the pharmacist must report any irregularities to the attending physician, director of nursing and these reports must be acted upon.

Summary of the facility's reason for IDR of this tag: The facility had identified the potential for adverse events, decreased the dosage of the NSAID rpedication in response to pharmacist's recommendations, and conducted consistent monitoring of lab results for R46, therefore meeting regulation language for F428.

January 9, 2013

Summary of facts: On 2/16/12, the Consultation Report from the consulting pharmacist indicated R46 was receiving both warfarin and meloxicam, and identified the combination therapy could lead to GI adverse events. The consulting pharmacist had recommended a possible trial discontinuation of the meloxicam, and monitoring of the use of any PRN Tylenol use to assess pain control. On 3/21112, the physician had [~sponded to the recommendation with an order to try to decrease the meloxicam from 7.5 mg daily to f{5 mg every other day. Interview with consulting pharmacist on 9/27/12 indicated a GI bleed was the iUain concern with the combination therapy of warfarin and meloxicam, however the pharmacist had also stated R46's Hbg had been stable.

Summary of findings: The pharmacist had identified the potential for adverse events, the physician had responded to the irregularity by decreasing the dosage of the meloxicam. In addition, R46 remained stable, with no demonstrated adverse effects as evidenced by within normal lab tests done consistently by the facility and no documented symptoms of unusual bleeding.

This in not a valid example of a deficient practice under this regulation and will be removed from the 2567 Statement of Deficiencies.

the revised Statement of Deficiencies is attached.

This concludes the Minnesota Department of Health informal dispute resolution process.

~lease note it is your responsibility to share the information contained in this letter and the results of this review with the President of your facility's Governing Body.

Sincerely,

Gail Anderson, Unit Supervisor Licensing and Certification Program Division of Compliance Monitoring Telephone: 218-332-5140 Fax: 218-332-5196

cc: Office of Ombudsman for Long-Term Care Pam Kerssen, Assistant Program Manager Licensing and Certification File Gary Nederhoff, Rochester District Office Unit Supervisor

S5596022