Health inspection·March 5, 2021

F 0756 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Few Ensure a licensed pharmacist perform a monthly drug regimen review, including the medical chart, following irregularity reporting guidelines in developed policies and procedures. **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observations, record reviews, and interviews the facility failed to obtain a physician response and to implement orders related to pharmacy recommendations in a timely manner for one (#19) out of five residents sampled for unnecessary medications. Findings included: Resident #19 was interviewed on 3/2/21 at 12:37 p.m. while he was lying in bed after the noon meal. On 3/4/21 at 12:40 p.m., the resident was observed sitting on the front porch with supervision smoking a cigarette. Resident #19 was admitted on [DATE]. The admission Record included diagnoses not limited to unspecified Chronic Obstructive Pulmonary Disease (COPD) and unspecified Peripheral Vascular Disease. The 5-day Minimum Data Set (MDS), dated [DATE], indicated a Brief Interview of Mental Status (BIMS) score of 6 out of 15 indicative of severe cognitive impairment. A review of a Pharmacy Recommendation for Resident #19, dated 12/5/20, indicated a recommendation that read, Resident has an order for Spiriva Inhaler. The normal dose for Spiriva is 2 inhalations with one capsule daily. Recommend changing to the 2 inhalation with one capsule daily to maximize effect. The recommendation was unsigned by the physician and did not include a response that the physician either agreed or disagreed with the recommendation. A second recommendation regarding the resident's Spiriva was made on 2/7/21. The recommendation indicated that the physician agreed and signed it on 2/7/21. A review of Resident #19's December 2020, January 2021, February 2021, and March 2021's Medication Administration Records (MAR) indicated a physician order, dated 12/4/20, that instructed staff to administer Spiriva Handi-haler 18 microgram (mcg) capsule (Tiotropium Bromide Monohydrate) - 1 capsule inhale orally one time a day for COPD. The MAR revealed the Spiriva Handi-haler had been administered daily from 12/5/20 until 3/3/21 except for 1/13/21 and 2/24/21. The MAR's identified that the order was discontinued on 3/3/21 at 1704 (5:04 p.m.). At 4:08 p.m. on 3/3/21, the NHA provided the pharmacy's December 2020 list of no recommendations and clean copies of recommendations made for three of the five residents, including Resident #19. The NHA identified that the DON was printing out the orders from the recommendations to show that the facility had implemented the changes. Page 1 of 3 105714 105714 03/05/2021 Concordia Manor 321 13th Ave N Saint Petersburg, FL 33701

F 0756 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Few Upon returning to the DON's office on 3/3/21 at 4:45 p.m., she stated she was printing out the orders from the December 2020 recommendations to show that they had been followed up. When asked to review Resident #19's December 2020 and February 2021 pharmacy recommendations regarding Spiriva, the DON and Regional DON reviewed the Spiriva order and the two recommendations and confirmed that the order had not been responded to in December and not changed in February per physician response on 2/7/21. When asked what was a reasonable time for the physician to respond to a pharmacy recommendation, the DON stated 2-3 weeks. When asked what her process was for ensuring pharmacy recommendations were reviewed and that the physician had responded, the DON stated that she printed off the individual recommendations, handed them to the floor nurse responsible for the resident, and they were to call the physician regarding the recommendation and put the order (if necessary) into the computer then place the recommendation into the physician book for their signature. She stated she followed up with the recommendations throughout the month to ensure they were done. The DON stated the missed December 2020 recommendation for Resident #19 was her fault, I must have missed it. Immediately after entering the facility at 7:34 a.m. on 3/4/21, a copy was observed of Resident #19's pharmacy recommendation related to Spiriva. The copy continued to be unsigned and indicated a Telephone Order (T.O.) 3/3/21 Received new order (n.o.) from 'named physician' to change Spiriva inhale to 2 inhalation with (c) one capsule daily. Included with the note was an order written to start on 3/4/21 at 9:00 a.m. for Spiriva one capsule one time a day, scheduled for everyday with the additional direction of give 2 inhalation with 1 capsule daily. The review of the Pharmacy Recommendations for Resident #19's administered Spiriva identified that the recommendation was responded to two days shy of three months after the original recommendation was made and 24 days after the physician signed that he agreed with the pharmacy request to change Spiriva dosage. On 3/4/21 at 10:26 a.m., the DON stated the process for the pharmacy recommendation was that after the physician signed it, they would give it to the nurse and the nurse would input the order into the computer, if necessary. When asked what the procedure would be if the nurse was not available when the recommendation was signed, she stated the physician would place the signed recommendation in their binder and then Medical Records would take out the recommendation and give it the nurse to put the order in the computer. She identified that after the nurse put the order into the computer they would give it back to Medical Records for filing. The DON stated she goes to the unit and checks that the pharmacy recommendations and orders (if applicable) are in the computer, she identified that all physician orders are reviewed in the facility's morning meeting. An interview was conducted on 3/4/21 at 1:36 p.m. with the facility's Medical Director. When asked what his expectation was for the facility to respond to a pharmacy recommendation. He stated that pharmacy recommendations trickle in and the physicians are in once or twice a week so should be taken care of at that time. When asked what the expectation was for the facility to implement a recommendation that had been responded to and signed by the physician, he stated within 24 hours. In response to a request for the Pharmacy Recommendations policy, on 3/4/21, the facility provided a typewritten, undated procedure, Pharmacy Consultant Recommendation Follow Up. The procedure identified the following: 1. DON receives report from pharmacy consultant 2. DON makes copies of all recommendations 105714 Page 2 of 3 105714 03/05/2021 Concordia Manor 321 13th Ave N Saint Petersburg, FL 33701

F 0756 3. DON distributes recommendations to appropriate Unit Manager for follow up Level of Harm - Minimal harm or potential for actual harm 4. Unit Manager follows up with the physician regarding recommendations 5. Orders are written and carried out as appropriate Residents Affected - Few 6. Unit Manager files completed recommendation in chart 7. Unit Manager gives copy of completed recommendation to DON 8. DON checks off recommendation as completed on the Master Report which is kept in a Pharmacy Consultant Report binder in the DON office. At 1:57 a.m. on 3/4/21, the DON was asked who the Unit Manager was, she stated, we don't have one, I'm the Unit Manager. The Regional DON stated the procedure of Pharmacy Consultant Recommendation Follow Up was for the bigger buildings and the DON acted as the Unit Manager and in these case the Unit Manager would be the floor nurses. The Regional stated the facility does not have a policy for pharmacy recommendations so it would fall under Physician Orders. At 2:08 p.m. on 3/5/21, the Consultant Pharmacist stated her expectation would be for the recommendation to be responded to by her next visit, 30 days later, give or take. She confirmed that the recommendation for Resident #19's Spiriva was done in December then again in February. She acknowledged that she had not been in the facility yet during March. The policy titled Physician Orders, February 2020, identified that Physician orders will be dated and signed at next physician visit. The procedure portion of the policy included the following: 1. Obtain one of the following types of physician orders: - verbal - telephone order - transmitted by facsimile machine - written by the physician 11. Note physician's order (recaps/renewals, telephone/verbal, or fax orders, etc.) by writing noted dating, and signing with name and title.; 13. Physician will sign the monthly recap/renewals orders at the next visit, unless otherwise determined by state law; 16. When the physician changes an order that is currently in place, discontinue the original physician's order when the physician changes an order that is currently in place. Assure the new order reflects the change and order components required. 105714 Page 3 of 3