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Based on record review and interviews, Hospital #2 did not meet the Condition of Nursing Services because Hospital #2 failed to ensure that the nursing care for 1 of 10 patients (Patient #1) met the standards of practice for following the plan of care and medication administration resulting in Patient #1's decline in medical condition and subsequent death.

Findings include:

Please see F-288 for background information.

The Physician Progress Note, dated 4/24/12, indicated that Patient #1's Methotrexate order was clarified and changed to three 2.5 mg tablets to equal 7.5 mg weekly.

The Medication Administration Record (MAR), dated 4/25/12, indicated that Patient #1 received Methotrexate 7.5 mg.

The Discharge Summary, dated 4/26/12, indicated that Patient #1 was discharged to Hospital #2 for rehabilitation therapy.

The Surveyor conducted a tour of the Rehabilitation Unit on 5/24/12 at 8:30 A.M. with the Chief Nursing Officer (CNO), Quality Director and the Pharmacy Director present. Observation of the medication room indicated that several medication reference manuals were available for nursing staff. The medication room contained 3 automated medication dispensers (Med Dispense) and 4 books contained printed MARs.

Observation and interviews with the CNO and the Pharmacy Director during the tour indicated that: nursing faxed medication orders to the Pharmacist who entered the orders into the Pharmacy's medication order entry system. The Pharmacy's medication order entry system interfaced with Hospital #2's medication dispensing system. Medications that, if given in error resulted in serious consequences, were considered high alert medications. High alert medications were identified as such both in the Med Dispense system and on the printed MARs.

The CNO and the Pharmacy Director said that pre-printed MARs were generated by the Pharmacy on admission and every Wednesday thereafter. The CNO said that medications taken in between were handwritten onto the existing MAR.

The CNO said that 24-hour chart checks were performed daily on the night shift to ensure that medication orders were transcribed correctly and pre-printed MARs were reviewed against the old MARs before being placed in the medication books.

The Physician's Admitting Order Sheet, dated 4/26/12 at 5:50 P.M., indicated that the admitting nurse (Nurse #1) contacted the Physician Assistant for admission orders that included Methotrexate 2.5 mg po (oral) three tabs weekly, last dose given on 4/25/12 (at Hospital #1).

The pre-printed MAR, printed on 4/26/12 at 7:03 P.M., included Methotrexate 7.5 mg po, 3 tabs x 2.5 mg/each every Wednesday, HIGH ALERT MEDICATION. The MAR indicated that the medication order was entered into the system by Pharmacist #1.

The Surveyor interviewed Pharmacist #1 on 5/29/12 at 10:45 A.M. Pharmacist #1 said that on 4/26/12, she reviewed and entered Patient #1's medications into the medication order entry system. Pharmacist #1 said she used the date Methotrexate was last given to Patient #1 to determine the next date due. Pharmacist #1 said she was familiar with Methotrexate and had no concerns because the dose ordered was reasonable. Pharmacist #1 said that if medication was time-blocked (such as weekly), then the nurse was responsible for blocking the time on the MAR.

Observation of the MAR indicated that the Methotrexate was not time-blocked to indicate the next date the medication was due (5/2/12).

The MAR, dated 4/27/12 at 6:30 A.M., indicated that Patient #1 was given Methotrexate 3 tabs x 2.5 mg to equal 7.5 mg in error.

The Physician Order Sheet, dated 4/27/12 at 1:00 P.M., included to discontinue Patient #1's Methotrexate order. The Physician Order Sheet indicated that a new order for Methotrexate order to 2.5 mg daily was entered. The Physician Order Sheet indicated that the order was noted by Nurse #2.

The Surveyor interviewed Nurse #2 on 5/29/12 at 2:00 P.M. with the CNO and Quality Director present. Nurse #2 said that Patient #1's caregiver had brought in a list of Patient #1's home medications. Nurse #2 said the list indicated that Patient #1 was taking Methotrexate 2.5 mg daily at home. Nurse #2 said the list was given to the Physician Assistant.

The Surveyor interviewed the Physician Assistant on 5/24/12 at 10:55 A.M. with the CNO and Quality Director present. The Physician Assistant said Patient #1's caregiver brought in a list and said that approximately 3 weeks prior, Patient #1's Methotrexate was increased to 2.5 mg daily. The Physician Assistant said she then changed Patient #1's Methotrexate order to accommodate his/her home regimen.

The Physician Order Sheet, dated 4/27/12 at 4:00 P.M., indicated that the Physician Assistant was contacted by Pharmacist #2 regarding the Methotrexate order. The Physician Order Sheet indicated that Patient #1's daily Methotrexate order was to start on 4/30/12.

Review of Patient #1's MAR indicated that on 4/27/12, the revised Methotrexate order was handwritten onto the existing MAR and was correctly blocked out to start 4/30/12 at 9:00 A.M.

Nurse #2 said that she transcribed the order onto the MAR as Methotrexate 2.5 mg po daily to start 4/30/12.

Observation of the dose indicated that 2.5 mg was written originally, then the number 7 was written over the 2, changing the dose from 2.5 mg to 7.5 mg.

Review of the Physician Order Sheet, dated 4/28/12, indicated that a 24-hour chart check was performed by Nurse #3.

The Surveyor interviewed Nurse #3 on 5/24/12 at 11:20 A.M. with the CNO and the Quality Director present. Nurse #3 said that when she reviewed Patient #1's Methotrexate order against the MAR, there was no Methotrexate dose discrepancy. Nurse #3 said that if she had observed the write-over, she would have corrected the MAR to match the physician order and would have notified leadership of the discrepancy.

The Surveyor interviewed the nurse who administered 9:00 A.M. medications to Patient #1 on 4/28/12 and 4/29/12 (Nurse #4) on 5/29/12 at 2:30 P.M. with the CNO and Quality Director present. Nurse #4 said she did not remember anything regarding Patient #1's Methotrexate order because it was not scheduled to be administered on 4/28/12 or 4/29/12.

The Surveyor interviewed the nurses who performed the 24-hour chart checks during the night shift on 4/29/12 and 4/30/12 (Nurse #5 and Nurse #6) on 5/29/12 respectively at 1:30 P.M. and 3:07 P.M. with the CNO and the Quality Director present. Nurse #5 and Nurse #6 said they did not remember reviewing Patient #1's Methotrexate order. Nurse #5 said that if she had observed any discrepancy between the physician order and MAR, she would have notified the physician for clarification. Nurse #6 said that is she had noted any discrepancy between the physician order and MAR, she would have notified someone in leadership.

The MAR and the Pharmacy Activity Report, dated 4/30/12 to 5/6/12, indicated that Patient #1 received Methotrexate three 2.5 mg tabs to equal 7.5 mg each day.

The Surveyor interviewed the Nurse who administered Patient #1's Methotrexate on 4/30/12, 5/1/12, 5/2/12, 5/5/12 and 5/6/12, (Nurse #7)on 5/24/12 at 11:10 A.M. with the CNO and Quality Director present. Nurse #7 said that on 4/30/12, she administered Methotrexate 7.5 mg to Patient #1 because the dose on the MAR, 7.5 mg, matched the dose on Med Dispense. Nurse #7 said that she noted that a 7 had been written over the 2 to change the Methotrexate dose from 2.5 mg to 7.5 mg, but did not question the write-over because she took that as a correction. Nurse #7 said she had no questions regarding the daily dose of 7.5 mg.

The Surveyor interviewed Pharmacist #2 on 5/29/12 at 9:00 A.M. with the CNO, Quality Director and Pharmacy Director present. Pharmacist #2 said that when she revised the Methotrexate order in the medication order entry system on 4/27/12, she was focused on ensuring that it clearly indicated not to start the medication until 4/30/12 and did not revise the dose field which was previously 7.5 mg (from the 4/26/12 order).

The MAR, dated 5/1/12 and 5/2/12, indicated that Nurse #7 administered Methotrexate 7.5 mg to Patient #1 each day.

The weekly pre-printed MAR, printed on 5/2/12, dated 5/3/12 to 5/9/12, included Methotrexate 7.5 mg po 3 tabs x 2.5 mg/each daily, cytotoxic drug, handle with care, HIGH ALERT MEDICATION.

The CNO said that a new MAR was printed out on Wednesday, 5/2/12, and was reconciled by Nurse #8 and Nurse #9.

The Surveyor interviewed Nurse #8 on 5/24/12 at 11:35 A.M. with the CNO present. Nurse #8 said that she performed the first MAR reconciliation on 5/2/12, checking the newly printed MAR against the old MAR. Nurse #8 said that she did not remember Patient #1's MAR in particular, but remembered that the old MAR matched the newly printed MAR and, therefore, she had no questions regarding the order or the dose.

The Surveyor interviewed Nurse #9 on 5/29/12 at 3:00 P.M. with the CNO and Quality Director present. Nurse #9 said she performed the second reconciliation of the old MAR against the newly printed MAR. Nurse #9 said she was familiar with Methotrexate and dosing because she had administered it to Rheumatoid Arthritis patients who received high doses and, therefore, had no questions regarding Patient #1's Methotrexate order. Nurse #9 said she noted, but did not question the write-over because there was no discrepancy between the old and new MAR.

The MAR and Pharmacy Activity Report, dated 5/3/12 and 5/4/12, indicated that Nurse #10 administered Methotrexate three 2.5 mg tablets to equal 7.5 mg to Patient #1.

The Surveyor interviewed Nurse #10 on 5/29/12 at 11:30 A.M. with the CNO and Quality Director present. Nurse #10 said she had given Methotrexate in the past and had administered high doses, so Patient #1's Methotrexate dose did not alarm her. Nurse #10 said that if she questioned the dose, she would have referred to the medication reference manual available on the Unit.

The MAR and Pharmacy Activity Report, dated 5/5/12 and 5/6/12, indicated that Nurse 310 administered Methotrexate three 2.5 mg tablets to equal 7.5 mg to Patient #1.

The Nursing Daily Assessment and Narrative, dated 5/6/12, indicated that Patient #1 had a fever ranging from 99.3 to 101.7 degrees Fahrenheit (normal range is 97.8 to 98.8 degrees Fahrenheit). The Narrative indicated that Patient #1 complained of a cough and sore throat. The Narrative indicated that the Attending Physician was notified and orders were given for cough medicine and throat lozenges. The Narrative indicated that Patient #1's buttocks were red and excoriated with areas of superficial peeling and Patient #1 developed many pink lesions on his/her chest, back and abdomen.

The Nursing Narrative (Narrative), dated 5/7/12, indicated that Patient #1 continued with a fever. The Narrative indicated that Patient #1's buttocks was very excoriated and bleeding and the rash on his/her back and abdomen was popping and draining fluid. The Narrative indicated that the medical staff made the decision to transfer Patient #1 to Hospital #1 for evaluation of possible encephalopathy. The Narrative indicated that Hospital #1 later informed Hospital #2 that Patient #1 was transferred to Hospital #3, a tertiary care center.

The MAR, dated 5/7/12, indicated that Patient #1 did receive his/her scheduled medications prior to the transfer.

Review of the Discharge Summary, dated 5/7/12, indicated that an addendum was added that identified Patient #1 was receiving Methotrexate 7.5 mg instead of 2.5 mg daily. The Discharge Summary indicated that Hospital #1 was notified if the error in case it was contributing to Patient #1's condition. The Discharge Summary indicated that Patient #1's family was notified of the error and an investigation was started.

The Discharge Summary from Hospital #3, dated 5/11/12, indicated that Patient #1 presented to Hospital #1 on 5/7/12 with a pruritic rash, pain in his/her mouth/tongue and had received an overdose of Methotrexate. Blood tests from Hospital #1 indicated that Patient #1's white blood cell count was 1.7 (normal range is 4.8 to 10.8, low range indicative of neutropenia) and his/her platelet count was 57,000 (normal range is 130-400, 000). The Discharge Summary indicated that Patient #1's rash was tested and was negative for infection or Zoster. The Discharge Summary indicated that Patient #1's Methotrexate level was undetectable at less than 0.1, however, toxicology indicated that the level was considered toxic. The Discharge Summary indicated that the hospital course included treatment of neutropenia fever, thrombocytopenia due to Methotrexate toxicity, mouth ulcerations and suspected healthcare-associated pneumonia and/or the effects of Methotrexate toxicity on the lungs. The Discharge Summary indicated that Patient #1 developed respiratory failure and was intubated, subsequently went into cardiac arrest and the decision was made to stop the resuscitation efforts due to his/her poor prognosis.

The Death Certificate Working Copy, dated 5/11/12, indicated that the cause(s) of death were: acute respiratory failure (immediate), healthcare acquired pneumonia (days), bone marrow suppression (days) and the underlying cause was Methotrexate toxicity (days).

Based on record review and interviews, Hospital #2 was not in compliance with the Condition of Participation for Pharmacy Services because the Pharmacy Department did not ensure that: 1) safety mechanisms were in place when medications were entered into the medication order entry system and 2) there was other mechanisms in place to ensure safe medication practices other than identifying Methotrexate as a high/alert/risk medication on the MAR and in the medication dispensing system.

Findings include:

Please refer to the Condition of Participation for Nursing Services for medical information related to Patient #1.

1) The Physician Order Sheet, dated 4/27/12 at 1:00 P.M., included to discontinue Patient #1's Methotrexate order. The Physician Order Sheet indicated that a new order for Methotrexate order to 2.5 mg daily was entered.

The Physician Order Sheet, dated 4/27/12 at 4:00 P.M., indicated that the Physician Assistant was contacted by Pharmacist #2 regarding the Methotrexate order. The Physician Order Sheet indicated that Patient #1's daily Methotrexate order was to start on 4/30/12.

The Surveyor interviewed Pharmacist #2 on 5/29/12 at 9:00 A.M. with the CNO, Quality Director and Pharmacy Director present. Pharmacist #2 said that when she received the new Methotrexate order, she checked to see when the last dose of Methotrexate was administered. Pharmacist #2 said she noted that Patient #1 had received Methotrexate on 4/27/12. Pharmacist #2 said she contacted the Physician Assistant who in turn ordered the medication to be started on 4/30/12. Pharmacist #2 said that the medication order entry system allowed the Pharmacist to either discontinue the existing order and enter a new order or revise the existing order. Pharmacist #2 said that when the existing order was revised, the Pharmacist entered a series of fields, the first being dose. Pharmacist #2 said that the system allowed the Pharmacist to move to the next field simply by hitting the enter key, whether changes were made or not. Pharmacist #2 said she revised the existing Methotrexate order in the system.

The weekly pre-printed MAR, printed on 5/2/12 ans dated 5/3/12 to 5/9/12, included Methotrexate 7.5 mg po 3 tabs x 2.5 mg/each daily, cytotoxic drug, handle with care, HIGH ALERT MEDICATION.

The Surveyor interviewed Pharmacist #2 regarding the 7.5 mg Methotrexate dose in the Med Dispense system. Pharmacist #2 said that when she revised the Methotrexate order in the medication order entry system on 4/27/12, she was focused on ensuring that it clearly indicated not to start the medication until 4/30/12 and did not revise the dose field which was previously 7.5 mg (from the 4/26/12 order).

Hospital #2 did not have a standard procedure for addressing changes in existing medication orders, leaving the decision to the Pharmacist as to whether to discontinue the existing order and enter the new order or to revise the existing order already in the system.

2) The Policy/Procedure titled High Alert/Risk and Hazardous Medications indicated that methotrexate was considered a high alert medication.

The Policy did not indicate any specific actions related to Methotrexate that the various departments were to take to minimize risks associated with the medication.

Based on record review and interviews, the Hospital (Hospital #2) failed to ensure that: 1) its corrective action plan, developed in response to investigation of a significant medication error, included a mechanism to monitor compliance with Hospital #2's Error Correction Policy was followed and 2) its corrective action plan was fully implemented at the time of the survey.

Findings include:

1) The History and Physical (H&P) from Hospital #1, dated 4/22/12, indicated that Patient #1 was admitted to Hospital #1 after a fall at home. The H&P indicated that after the fall, Patient #1 remained on the floor for 10 hours before being found by a home health aide. The H&P indicated that Patient #1 was diagnosed with rhabdomyolysis (breakdown of skeletal muscle tissue due to lying in one position for a prolonged period of time). The H&P indicated that Patient #1's medical history was significant for hypertension (high blood pressure), atrial fibrillation (rapid, fluttering heart beat), congestive heart failure (accumulation of fluid around the heart due to heart dysfunction) and rheumatoid arthritis. The H&P indicated that Patient #1's admission medications included Methotrexate 2.5 mg three times a week.

The Discharge Summary, dated 4/26/12, indicated that Patient #1's hospitalization was unremarkable except for low grade fevers of unknown etiology. The Discharge Summary indicated that on 4/26/12, Patient #1 was discharged to Hospital #2 for rehabilitation therapy. The Discharge Summary indicated that Patient #1's Methotrexate order remained unchanged from admission, Methotrexate 2.5 mg three times a week.

The Physician Order Sheet, dated 4/27/12, included a new order for Methotrexate 2.5 mg daily to start on 4/30/12.

Review of Patient #1's Medication Administration Record (MAR) indicated that on 4/27/12, the revised Methotrexate order was handwritten onto the existing MAR and was correctly blocked out to start 4/30/12 at 9:00 A.M.

Observation of the dose indicated that 2.5 mg was written originally, then the number 7 was written over the 2, changing the dose from 2.5 mg to 7.5 mg.

The Error Correction Policy indicated that when a record entry was incorrect, the person correcting the entry was to draw a line through the incorrect entry, sign and date the incorrect entry and document the correct information.

The MAR and the Pharmacy Activity Report, dated 4/30/12 to 5/6/12, indicated that Patient #1 received Methotrexate three 2.5 mg tabs to equal 7.5 mg each day instead of 2.5 mg as originally ordered.

The Nursing Narrative, dated 5/7/12, indicated that Patient #1 was transferred first to Hospital #1 then to Hospital #3.

The Discharge Summary from Hospital #3, dated 5/11/12, indicated that Patient #1 expired.

The Death Certificate Working Copy, dated 5/11/12, indicated that the underlying cause of Patient #1's death was Methotrexate toxicity (days).

The Chief Nursing Officer (CNO), the Quality Director and the Pharmacy Director were interviewed throughout the survey and Hospital #1's internal investigation regarding the significant medication error was reviewed. The CNO and Quality Director said and the Investigation indicated that: 1) someone (unidentified) did not follow the Error Correction Policy and wrote over the 4/27/12 Methotrexate order in the MAR to change the dose from 2.5 mg to 7.5 mg, 2) the staff did not recognize the write-over as an error verses a correction and 3) despite multiple interviews, the investigation could not determine who did the write-over because everyone interviewed denied performing the incorrect change.

Review of the Corrective Action Plan did not include a mechanism to monitor for compliance with the Error Correction Policy, such as auditing MARs for compliance.

2) The following corrective actions were not fully implemented at the time of the survey: 1) starting 5/23/12 with a completion date of 5/31/12, transcription classes were held and/or are scheduled that includes a post-test, 2) revision of the Transcription Policy (currently in draft form) and 3) a meeting was scheduled for 5/30/12 to consider implementation of additional alerts such alert stickers in the medications of high alert medications and highlighting high alert medications on the MARs and 4) starting June, 2012, a Failure Mode and Effects Analysis Team was going to be created to analyze ways to improve the safety net for catching variances more effectively.