F279 483.20 Develop Comprehensive Care Plan (d) A facility must use the results of the assessment to develop, review and revise the resident's comprehensive plan of care.
The facility must develop a comprehensive care plan for each resident that includes measurable objectives and timetables to meet a resident's medical, nursing, and mental and psychosocial needs that are identified in the comprehensive assessment.
The care plan must describe the services that are to be furnished to attain or maintain the resident's highest practicable physical, mental, and psychosocial well-being as required under section 483.25; and any services that would otherwise be required under section 483.25 but are not provided due to the resident's exercise of rights under section 483.10, including the right to refuse treatment under section 483.10(b)(4).
F329 483.25 Drug Regimen is Free from Unnecessary Drugs
(I) 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.
An unannounced visit was made on 7/11/11 to initiate an investigation of Complaint #CA00274673 concerning quality of care and treatment. The reports identified allegations Resident 1 had fallen, sustained a head injury and died. As a result of the investigation, it was determined that the facility failed to:
1. Ensure the resident was free from unnecessary drugs when Coumadin/warfarin was ordered and administered for 17 days without monitoring which contributed to his death from bleeding in the brain and coagulopathy (bleeding disorder).
2. Revise a care plan for anticoagulant treatment when Coumadin was ordered.
Resident 1 was originally admitted to the facility on 12/12/06 with diagnoses which included a prior stroke with paralysis of his right arm and leg, atrial fibrillation (irregular heart rhythm), hematuria (presence of blood in the urine) and recurrent urinary tract infection. Resident 1's most recent readmission was 5/7/11, following treatment of recurring urinary tract infections. In the event of a cardio-pulmonary arrest (loss of heart and/or lung function), Resident 1 was to be fully resuscitated (Full Code).
The last full MDS (minimum data set, an assessment tool) dated 10/6/10, described Resident 1 as being non-English speaking, but he used signs and gestures to enable staff to understand his needs. Resident 1 was described as having short term memory problems and modified cognitive skills. The resident was not able to walk, but used a wheelchair to move himself around the facility.
Review of the clinical record initiated on 7/11/11 for Resident 1 revealed the following:
Readmission physician's orders dated 5/7/11 included "PT/INR (bleeding time studies. PT stands for Prothrombin Time. INR stands for International Normalized Ratio, a test which measures blood clotting time) monitor for Coumadin." (Coumadin is a medication to prevent clot formation), "Coumadin, start when bleeding stops- review by PCP" (primary care physician).
A laboratory report dated 5/12/11 at 1:30 p.m. documented INR level of 1.2 and indicated the level was normal for someone not receiving anti-coagulation therapy. The INR lab report dated 5/12/11 contained a hand written note "Resident currently not on any dosage of Coumadin, please decide dosage." To the right of this note, in different handwriting was "D/C [discontinue) I&R (INR) if not on Coumadin 5/12/11 per [MD name] at 1345 (1:45 p.m.)." A third written note was below the first and it documented: "Resident new admit from hospital. Came with order for Coumadin but no dosage. PT/INR done to set parameter. Please advice (sic)!!"
A physician's order dated 5/13/11 for "Verbal order from NP (nurse practitioner) to start Coumadin 3 mg. (milligrams, a unit of measure for medications) orally every evening for prophylaxis (prevention measure)." The order was written at 4 p.m.
The Medication Administration Record (MAR) for May 2011 included an entry for Coumadin 3 mg orally, at bed time each day. The medication was documented as given daily starting 5/13/11 . The MAR also had an entry for PT/INR every Monday and Thursday. There were no signatures on any dates indicating a lab test result was available or checked. The clinical record contained no other laboratory reports documenting PT/INR values after 5/12/11 .
Review of LexiComp.com, an on-line drug information source revealed the following information (in part) about warfarin, the generic name for Coumadin:
"Warfarin is used for chronic oral anticoagulation in a variety of clinical settings. Monitoring warfarin therapy by adjusting the INR to lie within the recommended range for the disorder treated (e.g., 2.0-3.0) is recommended. Dosing warfarin is more complex than with many drugs.
High alert medication: The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs which have a heightened risk of causing significant resident harm when used in error.
Geriatric Considerations: Before committing an elderly resident to long-term anticoagulation therapy, the risk for bleeding complications secondary to falls, drug interactions, living situation, and cognitive status should be considered. A risk of bleeding complications has been associated with increased age.
Adverse Reactions - Bleeding is the major adverse effect of warfarin. Hemorrhage may occur at virtually any site. Risk is dependent on multiple variables, including the intensity of anticoagulation and resident susceptibility.
Warnings/Precautions Hemorrhage: Possible massive hemorrhage involving the Gl (gastrointestinal) tract, spinal cord, GU (genitourinary tract), cerebral, pericardia!, pulmonary, adrenal, or hepatic (liver) sites. Hemorrhagic (bleeding) complications may be manifested by signs or symptoms that do not indicate obvious bleeding, such as paralysis; headache; pain in the chest, abdomen, joints, muscles, or other areas; dizziness; shortness of breath; difficulty breathing or swallowing; unexplained swelling; weakness; hypotension (low blood pressure); or unexplained shock. Results principally from overdosage. Careful clinical management, including frequent PT or INR determinations, is required."
The Coumadin product information provided by the manufacturer with the medication
validated the above reference. In the section titled, Highlights of Prescribing Information,
(in part) stated:
"WARNING: BLEEDING RISK. Coumadin can cause major or fatal bleeding. Perform regular monitoring of INR in all treated patients ... Monitoring: Obtain daily INR determinations until stable in the therapeutic range ... Most common adverse reactions to COUMADIN are fatal and nonfatal hemorrhage from any tissue or organ ... An INR of greater than 4 appears to provide no additional therapeutic benefit in most patients and is associated with a higher risk of bleeding ...Patients 60 years or older appear to exhibit greater than expected INR response to the anticoagulant effects of warfarin ...Therefore, as patient age increases, a lower dose is usually required to produce a therapeutic level of anticoagulation ..." The product insert also included specific guidelines for monitoring.
On 5/19/11 (Day #7 of his anticoagulation therapy), Resident 1 fell from his wheelchair without apparent injury. Neurological assessments were done but there was no documented evidence that a bleeding risk was considered or anticoagulation monitoring ordered.
A Fax Notification Form dated 5/26/11 at 3:30 p.m. (Day #14 of his anticoagulation therapy) documented, "Resident had an unwitnessed and unassisted fall at 1530 (military time for 3:30 p.m.). Resident was sitting in w/c (wheelchair) and fell to floor. Bleeding to upper right forehead and to right cheek bone due to rug burn, no S/T (skin tear) observed. Right eye swollen and purple discoloration. Observed VS (vital signs) 126/72, 82 (pulse), 18 (respirations), 102.0 (temperature in Fahrenheit). [Complains] to right leg. No swelling or discoloration noted to legs/knees. Will continue to observe." The physician documented "noted" and signed the form and returned it to the facility on 5/27/11 . There was no acknowledgement of an elevated temperature, and no orders were given. This note was signed by a Licensed Vocational Nurse (LVN). There was no documented evidence that anticoagulation monitoring was considered or ordered.
A Nurse's Note dated 5/26/11 at 9:30 p.m. included, "DON (Director of Nursing) notified and will do an assessment tomorrow." A Nurse's Note dated 5/27/11 at 2:53a.m. documented the resident had a temperature of 100.9 Fahrenheit. "Skin excoriations to right side of face, right eye blackened." The note was not signed. A Nurse's Note dated 5/27/11 at 1:58 a.m. included "Right is purple and swollen. Right side of face has two abrasions upper and lower." The note was not signed. On that same day at 6 p.m. the notes indicated "forehead bleeding, refused to get out of bed, swollen bruised eye, generalized pain."
There was no documentation in the record that Resident 1 was assessed by a Registered Nurse (RN) following his fall. During an interview with the DON on 7/13/11 at 3:30p.m. she stated "I came in on the night shift and assessed [Resident 1]...1 have no note ... l was concerned his cheek bone was fractured." The DON stated there was not an x-ray done of the resident's facial bones. The DON was not able to locate an RN assessment of Resident 1 following the fall.
On 5/29/11 at 1:35 p.m., there was an indication that the family member "wanted to speak to Hospice to decide if that is the next step ..." An untimed and unsigned order for a Hospice Consult was in the clinical record.
On 5/30/11 Resident 1 was transferred to the emergency room of a General Acute Care Hospital (GACH) following a change in condition. The resident's condition was described in a 5/30/11 Nurse's Note at 5:56 p.m. as "Alert and responsive ... rapid respirations and low BP (blood pressure)." The resident's blood pressure was "50/36" (normal range was 100/60 to 140/90) and his respiratory rate was "36" per minute (normal range was 16-20 per minute).
Review of the GACH clinical record for Resident 1's admission on 5/30/11 revealed: A History and Physical report dated 5/30/11 which included: "Assessment (1) septic (infection) shock with multiorgan failure ... (2) Intracranial (inside the skull) hemorrhage with subarachnoid bleed. This is probably secondary to his fall and his coagulopathy. (3) "Iatrogenic coagulopathy (clotting disorder due to medical treatment). The resident probably is on Coumadin, and his INR is more than 18...1 do not think the resident is going to survive this episode." A laboratory report dated 5/30/11 included an INR result of"18.2" (18 times normal).
On 06/03/11, Resident 1 was transferred from the GACH to another skilled nursing facility for comfort care. He died there on 06/04/11 at 5:10 a.m.
The Death Certificate for Resident 1 listed the following diagnoses: 1. Cardiopulmonary arrest (heart beat and breathing stopped); 2. Subdural hematoma (blood accumulation between the brain and the dura covering); 3. Probably secondary to Coumadin."
Review of undated facility policy titled "INR Coumadin Protocol" included (in part) "Notify the attending physician of PT/INR results of 3.0 or greater... 3. If INR is greater than 3.0 a. hold Coumadin ..."
During an interview with LN 4 on 9/16/11 at 3:25 p.m. LN 4 stated "Before giving Coumadin I want to know the INR results. Monday and Thursday INRs are routine for our residents. All Coumadin is given on PM shift; PM nurses know to get the INR every Monday and Thursday."
During an interview with the Director of Nursing (DON) on 7/13/11 at 3:30 p.m. she stated they had reviewed the record and were unable to locate the lab tests following the 5/12/11 test. The DON stated "We're following up with the lab, they didn't come and draw blood, they received the order but never came out." The DON stated "The evening shift nurse is responsible for ensuring the INR is done when they give the medication." The DON verified the PT/INR tests ordered twice weekly on Mondays and Thursdays after Coumadin was started were not done for Resident 1 on the following scheduled days: 5/16/11, 5/19/11, 5/23/11, 5/26/11 and 5/30/11.
Resident 1 had received Coumadin 3 mg. daily for 17 days without any laboratory monitoring. An INR of 18.2 was six times the therapeutic range for prevention of blood clots.
Further review of the clinical record revealed for Resident 1 revealed:
A 9/23/10 Care Plan for Risk for bruising and/or abnormal bleeding referenced the use of Plavix, a blood thinner which was no longer administered to the resident after his discharge on 5/3/11. The care plan included a goal of "will have therapeutic levels of medications [without signs and symptoms] of abnormal bleeding and excessive bruising daily [through] 7/6/11." No other blood thinner care plan was in the record and no revision was documented when the Coumadin was ordered.
In an interview with the DON on 10/18/11 starting at 1:15 p.m. she stated the anticoagulant care plan "should have been changed when he went on Coumadin."
As a result of the investigation, it was determined that the facility failed to:
1. Ensure the resident was free from unnecessary drugs when Coumadin/warfarin was
ordered and administered for 17 days without monitoring which contributed to his death
from bleeding in the brain.
2. Revise a care plan for anticoagulant treatment when Coumadin was ordered.
These violations presented either (1) imminent danger that death or serious harm to the patients or residents of the long-term health care facility would result therefrom, or (2) substantial probability that death or serious physical harm to patients or residents of the long-term health care facility would result therefrom and were a direct proximate cause of death of the patient or resident.