Valley Healthcare Center
1680 North Waterman Avenue, San Bernardino, CA 92404
Citation Number: 240006862
Citation Date: 02/11/2010
Violation Date: 8/31/2008
Class: AA
Penalty: $ 90,000

CLASS AA CITATION -- MEDICATION
REGULATION VIOLATION:
72313 Nursing Service - General
(a) Medications and treatments shall be administered as follows:
(2) Medications and treatments shall be administered as prescribed.

On September 24,2008 at 10:00 AM, an unannounced visit was made to the facility to investigate an entity reported incident of failing to give medication as prescribed by the physician.

Based on observation, interviews and record review, the faciiity failed to: Administer Methotrexate (a medication used to decrease pain, swelling and lessen joint damage associated with rheumatoid arthritis) in the physician-ordered oral dosage of 2.5 milligram at 12 hour intervals for 3 doses once weekly.

FINDINGS:
The Death Certificate revealed that Patient A expired on August 31, 2008 at 7:55 PM, and the cause of death was disseminated intravascular coagulation (a condition, often caused by overwhelming infection, in which blood clots form in the blood vessels, using up the clotting materials, followed by generalized bleeding). The second cause of death listed was sepsis (overwhelming infection in the blood).

Patient A's clinical record indicated that Patient A was a 54 year old woman admitted to the facility on July-27, 2006. Patient A had diagnoses that included rheumatoid arthritis, anemia and diabetes mellitus. Review of the history and physical for Patient A, dated March 1, 2008, reflected that the rehabilitation potential for Patient A was "good."

Patient A's physician order for Methotrexate was dated August 15, 2008, drafted at the facility and signed by Physician 1. A review of the order reflected, "MTX 2.5 mg. 1 tab PO q 12hrsx3qwk", (Methotrexate medication 2.5 milligram one tablet by mouth every twelve hours times three doses every week).

Medication Administration Record (MAR) was conducted on September 24, 2008 10:30 AM with the Director of Nursing (DON). In the MAR, the physician order had been transcribed as Methotrexate 2.5 milligram 1 tablet orally every 12 hours times 3 weeks to be given at 9:00 AM and 9:00 PM. The MAR documented that Patient A was administered Methotrexate 2.5 milligram tablets at 9:00 AM and 9:00 PM from August 16, 2008 through August 29, 2008, for a total of 28 tablets. This was 22 tablets more than what Physician 1 ordered for that time period. The MAR also indicated that Patient A received aspirin, a non-steroidal anti-inflammatory medication (NSAID), daily.

Physician's Desk Reference, 54th Edition, page 1426, and the online Physician's Desk Reference on February 23, 2009, recommended a starting dose of Methotrexate for rheumatoid arthritis as oral doses of 2.5 milligrams at 12 hour intervals for 3 doses given once weekly.

The Physician's Desk Reference (PDR) for the medication Methotrexate, stated the medication hada Black Box Warning that stated in part, "Severe, sometimes fatal, bone marrow suppression (decrease in production by the bones of red blood cells, infection-fighting white blood cells and parts of the blood that contribute to clotting) and GI (gastro-intestinal) toxicity reported with concomitant (at the same time) NSAIDS". The Warnings/Precautions section in the PDR read, "Monitor closely; toxicity may be related to dose and frequency of administration."

An interview with the Director of Nursing Services (DON) was conducted on September 24, 2008 at 10:30 AM. The DON stated that Physician 1 ordered Patient A to receive Methotrexate medication, a 2.5 milligram tablet orally at 12 hour intervals for 3 doses given once a week. If administered as ordered, Patient A would have received a total of 6 tablets from August 16, 2008 through August 29, 2008, not the 28 tablets that she was administered.

The pharmacy medication labels on the two blister packs had typed instructions to give Methotrexate 2.5 mg. tablet ea (each) take 1 tab (tablet) by mouth every 12 hours for 21 days (therapy to end September 5, 2008).

An interview was conducted on September 24, 2008 at 10:00 AM with Administrator 1, who stated that the pharmacy label was incorrect, that the medication was not to be administered every day.

On December 30, 2008 at 2:40 PM, Pharmacist A was interviewed. Pharmacist A stated that she told Clerk 1 to call the facility to obtain clarification of the order for Methotrexate medication for Patient A.

An interview with Clerk 1, the data entry clerk for the contracted pharmacy who dispensed the medication to the facility, was conducted on October 8, 2008 at 3:00 PM. Clerk 1 stated that she did not know what "MTX" was, so she showed the faxed physician order to Pharmacist A, who stated that it was not a standard dose for the Methotrexate. Clerk 1 then stated that she called the facility to obtain clarification of the medication order. Clerk 1 spoke with LVN 3, who stated that the physician's order was to give to Patient A Methotrexate medication, one tablet every twelve hours for three weeks.

An interview with LVN 3 was conducted on September 24,2008 at 3:30 PM. LVN 3 stated that on August 15, 2008 the pharmacy called her about folic acid and did not ask for a clarification of the Methotrexate medication order for Patient A.

Patient A's laboratory results dated July 14, 2008, before she began the Methotrexate medication indicated the following results: white blood cells (infection-fighting cells) 3.9 per cubic mm (normal 4.8-1 0.8), hemoglobin (part of the blood that carries oxygen) 10.6 grams per dl (normal 12-16), and platelets 267 per cubic ml (normal 140-440).

Laboratory results dated August 25, 2008, after she started the Methotrexate medication indicated the following results: white blood cells (infection-fighting cells) 2.2 per cubic mm (normal 4.8-10.8), hemoglobin (part of the blood that carries oxygen) 9.9 grams per dl (normal 12-16), and platelets 241 per cubic mm (normal 140-440).

Licensed Nurses Progress Notes, dated August 30,2008 at 12:00 AM. LVN 4 documented that Patient A had coffee brown emesis (vomit) and black tarry stool (a sign suggesting bleeding in the stomach or intestines). Physician 1 was notified and Patient A was transferred to the emergency department of.an acute care medical center.

Administer Methotrexate (a medication used to decrease pain, swelling and lessen joint damage associated with rheumatoid arthritis) in the physician-ordered oral dosage of 2.5 milligram at 12 hour intervals for 3 doses once weekly. The facility's failure to follow the physician's medication order placed the patient at risk for serious side effects, excessive medication that resulted in bone marrow suppression (decrease in production by the bones of red blood cells, infection-fighting white blood cells and parts of the blood that contribute to clotting), sepsis, disseminated intravascular coagulation and the subsequent death of the patient, resulting in Patient A's death on August 31, 2008.

These violations presented either an imminent danger that death or serious harm would result or a substantial probability that death or serious physical harm would result and these violations were a direct proximate cause of the death of the patient.