CLASS A CITATION-- MEDICATION
483.25(1) DRUG REGIMEN IS FREE FROM UNNECESSARY DRUGS
Each resident's drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used in excessive dose (including duplicate therapy); or for excessive duration; or without adequate monitoring; or without adequate indications for its use; or in the presence of adverse consequences which indicate the dose should be reduced or discontinued; or any combinations of the reasons above. Based on a comprehensive assessment of a resident, the facility must ensure that residents who have not used antipsychotic drugs are not given these drugs unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record; and residents who use antipsychotic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs.
On 10/5/12 at 11 a.m., an unannounced visit was made to the facility to investigate an entity reported incident regarding an incident of alleged brain hemorrhage due to failure to monitor the clotting time of the resident (Resident 1).
The facility violated the aforementioned regulation when it failed to monitor the necessary blood testing for Resident 1, who received a daily dose of Coumadin, a blood thinning medication that slows the clotting time so that the blood cannot clot as easily. Resident 1 had two antibiotics which when taken with Coumadin would increase the risk of bleeding.
Prothrombin time and INR are two blood testings necessary to be monitored when a person takes Coumadin to determine the clotting time status and adjust or discontinue the dose of Coumadin according to the blood results. Prothrombin time (PT) is a blood test that measures how long it takes the blood to clot in patients receiving oral anticoagulation. The normal range is 11.1 - 13.1 seconds.
International Normalized Ration (INR) is a calculation made to standardize prothombin time. INR is based on the ratio of the person's prothrombin and normal mean prothrombin time. A normaiiNR for a person who takes Coumadin is 2.0 to 3.0 times the normal PT.
The staff interviews and records reviews showed that there were at least 14 different licensed nurses and a pharmacist over a six-week period of time who failed to ensure that Resident 1 had the necessary blood testing while on Coumadin. The failure to monitor the clotting time resulted in Resident 1 having an exaggerated effect from the Coumadin and an unrecognized delay in blood clotting resulting in brain hemorrhage and death after the removal of the breathing tube.
A medical record review, on 10/5/12 at 11:00 a.m., showed that the facility admitted Resident 1 on 8/15/12 from a rehabilitation center, for failure to wean from the breathing machine. Resident 1's diagnoses included atrial fibrillation, (abnormal heart rhythm) and history of pulmonary embolism (blood clots in the lungs) that required the use of Coumadin, a drug to prevent blood clots.
The Pulmonary Consultation Report, dated 8/15/12, indicated that Coumadin must be continued on admission and to monitor INR. The Pulmonary Consultation Report showed that on admission to the facility, Resident 1 had a tracheostomy tube or breathing tube through the throat and able to speak with the use of a special valve or, "talk leak." Resident 1 had a history of cardiopulmonary arrest (the heart and breathing stopped).
During an interview on 11/7/12 at 4:05 p.m., RNA said that Resident 1 was alert, "a very nice lady," who communicated by talking and typing on the computer. Resident 1 communicated with a son by emails.
The nurses notes, dated 9/26/12 at 12:15 p.m. to 12:46 p.m., showed that Resident 1 was discovered unresponsive with dilated pupils (sign of pressure on the brain) and had seizures. Emergency procedures were initiated. A lab report dated 9/26/12 at 12:25 p.m. showed a PT was >63.2 with an INR of >6.17. (PT, clotting time and INR were greater than six times the normal and no longer in therapeutic range for anticoagulation.) Resident 1 was transferred to the intensive care unit (ICU) of the acute care hospital at 12:46 p.m.
Review of the Neurology Consult in the ICU, dated 9/26/12, 2 p.m. to 5:30 p.m., showed that Resident 1 remained unresponsive with no voluntary movements of her extremities. The neurologist wrote that the Cat Scan (CT scan is an x-ray from many angles) showed a large intracranial hemorrhage. On 9/27/12 the neurologist wrote that Resident 1 met criteria for brain death at 11:35 a.m. The hospital Discharge Summary Death Summary dated, 10/1/12, showed that Resident 1 was pronounced dead on 9/27/12 at 3:30 p.m., with a final diagnosis of " ... Intracerebral hemorrhage secondary to over anticoagulation, felt to be adverse drug reaction secondary to fluconazole."
Further review of the medical records showed that on 8/15/12 the admission orders included Warfarin (Coumadin) 10 mg daily. On 9/17/12 at 10 a.m., the physician ordered Fluconazole (an antibiotic to treat a fungal infection) 150 mg twice a day for seven days and Levaquin (an antibiotic to treat urinary tract infection 500 mg once a day for five days. According to Lexi-Comp ONLINE, a nationally recognized drug information source, both drugs multiply the effect of Coumadin that increase the risk of bleeding. Resident 1's MAR (Medication Administration Record) showed that Resident 1 received Flucanozole (antibiotic) for the full seven days and Levaquin (antibiotic) for three days while on Coumadin.
The summary laboratory results of the blood drawn on 8/15/12 ( the day of admission), showed that Resident 1's PT was 22.1 seconds (normal range 9.6-12 seconds) with an INR of 2.09. The facility's INR goal for the treatment of pulmonary embolism and prevention of systemic embolism was 2.0 to 3.0. Resident 1's INR and PT results were within therapeutic range on admission. There was no written order for subsequent INR and PT after 8/15/12. Review of Resident 1's Anticoagulation Sheet from 8/15/12 to 9/25/12 where the licensed nurses would document the INR results and the Coumadin given showed that 14 different licensed nurses initialed that Coumadin was given. There was no INR documented on the Anticoagulation Sheet. There was no documentation to show that a licensed nurse called the physician to request an order to check Patient 1's INR and PT.
Review of the facility's policy and procedure for Anticoagulation Management Program (No. 85, Reviewed 7/09) showed, Ill Medication Specific Therapeutic Procedures: A. Warfarin: 3. "Patients on warfarin will have a PT/INR drawn daily."
Interviews of 11 facility staff that included the administrator, pharmacist, licensed nurses and physicians regarding Resident 1 showed that the facility failed to coordinate and follow the written guidelines on monitoring the INR and PT while Resident 1 was on Coumadin.
During an interview, on 10/5/12 at 1:30 p.m., Administrator 1 stated that Patient 1's warfarin was dispensed by the acute care inpatient pharmacy.
In an interview, on 10/11/12 at 9:25 a.m., the hospital's Director of Pharmacy (DOP) stated the pharmacist was to check the INR weekly for stable patients on Coumadin. The DOP stated that the facility did not have documentation that the pharmacist checked the INR from 8/15/12 to 9/26/12.
During an interview on 11/8/12 at 3:30 p.m., Physician A could not remember whether he wrote or gave a verbal order for continued INR monitoring. He said he relied partly on the practice at the facility for routine monthly PT and INR monitoring. Physician A agreed that the Order Set was not used consistently in the subacute unit or the skilled nursing facility.
During an interview and concurrent review of the Anticoagulation Flow Sheet for Resident 1, on 11/7/12 at 4:05 p.m., RN A said she administered the Coumadin on 9/18/12 and 9/19/12. RN G said the first time Coumadin was ordered there should be a special pre-printed order sheet used but since Resident 1 was on Coumadin already then the Order Set would not be used. RN A said that the practice at the facility was that once the baseline PT and INR were obtained the day shift nurse would call or fax the results to the physician and write a verbal order for future repeat lab work on the lab result record. The original lab record was missing from the chart. RNA said getting an ongoing order for PT and INR was overlooked for Resident 1.
At 4:55 p.m., RN B said she administered Coumadin to Resident 1 on 9/7/12 through 9/9/12. She said that the policy in effect during that time period was that every second Wednesday of the month was the day for the subacute unit to have the PT/INR lab draws for all residents on Coumadin. RN B said she would automatically place any patient on Coumadin in her care on monthly lab work in the computer. RN B said nurses didn't need to have a doctor's order-"just automatically do it." She said that towards the end of every month an RN was assigned to go into the computer and update the physician order sheet. That would have been the time to catch that Resident 1 was on Coumadin without a lab order. The order sheet was then printed and placed in the chart for the physician to review and sign. RN B said the reason she didn't order the lab work when she administered Coumadin was that a month hadn't passed yet; she thought Resident 1 was due for the lab on 9/12/12 per the facility's practice. RN B said there was no written policy describing practice of obtaining monthly lab work.
At 5:25 p.m., LVN C said she administered Coumadin eight times during 8/12 and none in 9/12. LVN C said that the day shift nurse caring for the Resident would call the doctor with lab results and get an order for further lab tests. LVN C said if there was no lab order she would continue to administer the Coumadin.
At 5:45 p.m., RN D administered the Coumadin on 9/11/12 and 9/24/12. RN D said she wouldn't automatically enter an order in the computer; that there had to be a Doctor's order to check the lab work. RN D said there was a pre-printed order set for Residents on Coumadin which alerts staff to do lab orders every Monday. She said it was part of the admission packet and the nurse admitting the patient should initiate it.
On 11/13/12 at 12:10 p.m., during a phone interview, RN E, who admitted the Resident 1 said that the Order Set was not in use at the time that Resident 1 was admitted. RN E said: "If I'm the one giving the medication then it's my responsibility to check the lab work," before administering the Coumadin.
On 11/13/12 at 3:10 p.m., during a phone interview, RN F said she gave Coumadin to Resident 1 on 9/24/12 and 9/25/12. RN F said that on 9/25/12 Resident 1 had blood from the trachea upon suctioning. Review of the nurses notes dated 9/25/12 at 9:20 p.m. showed that Physician B was notified. RN F said that Physician B said to watch Resident 1 for further signs of bleeding and did not order aPT or INR. RN F said that the protocol on the unit was that there must be a Doctor's order for PT and INR, that nurses don't automatically order lab work.
On 11/14/12 at 9:45 a.m., Physician B said he was on-call for Resident 1 on the evening of 9/25/12. Physician B said he knew that Resident 1 was on Coumadin and thought that the nurse said the last PT and INR was in a therapeutic range. Physician B said that many residents who have tracheostomies have blood tinged secretions. Physician B said: "In retrospect I wish I had done more."
On 11/13/12 at 3:30 p.m. during a phone interview, LVN G said she gave Coumadin to Resident 1 on 9/20/12. LVN G said during 8/15/12- 9/26/12, PT and INR lab work was done every month for residents on Coumadin. LVN G didn't know it was more than month since Resident 1 had lab work. L VN G said that she didn't notify Physician A that Resident 1 was due for follow-up lab work because Resident 1 had no side effect of bleeding from the Coumadin.
The Neurology Consultation Notes dated 9/26/12 from 2 p.m. to 5:30 p.m. showed that the resident was not a candidate for neurological intervention because no surgery will change her clinical outcome. The neurologist recommended a DNR or do not resuscitate code status.
On 9/27/12, the neurologist documented that the examination done on 9/27/12 at 11:35 a.m. showed that the resident met all the clinical criteria for brain death. The brain death was due to cerebral or brain hemorrhage secondary to Coumadin.
This failure presented an imminent danger to the resident and had a direct relationship to the cause of the death of the resident.