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Based on observation, interview and record review, the hospital failed to control high alert medications (Total Parental Nutrition), and identify the causes of multiple discrepancies in documented TPN infusion amounts versus prescribed hourly infusion rates for two out of two sampled patients (Patients 40 and 41) receiving TPN, and failed to account for medications returned to the pharmacy for one of two sampled patients (Patient 80). These failures indicated that a potential medication error may have occurred when an audit revealed medications for Patient 80 were missing and unaccounted for by the pharmacy and may have potentially resulted medication errors in TPN infusion for Patients 40 and 41.

Findings:

1. On 8/27/12 at 10:13 a.m., when observed with the Chief Clinical Officer (CCO), Patient 40 was receiving TPN via infusion pump at 75 ml per hour. According to Medication Administration Record (MAR), Patient 40 started to have TPN infusion at 75 ml per hour on 8/16/12 at 10:30 p.m.

On 8/28/12 at 8:58 a.m., review of flowsheets with CCO showed that there was no data to show Patient 40 's TPN intake from day shifts of 8/17/12, 8/20/12, 8/22/12, 8/23/12, 8/25/12, 8/26/12, 8/27/12, and night shifts of 8/18/12 and 8/26/12. The 24-hour TPN intake should have been 1800 ml based on prescribed 75 ml per hour. The flowsheets showed that Patient 40 had 613 ml TPN intake on 8/17/12, 800 ml TPN on 8/18/12 and 8/20/12, 900 ml TPN on 8/22/12, 825 ml TPN on 8/23/12, 600 ml TPN on 8/25/12, no TPN infused amount on 8/26/12, and 862 ml TPN on 8/27/12.

On 8/28/12 at 9:10 a.m., further review of flowsheets with CCO showed that on 8/19/12, Patient 40 received 850 ml TPN total at 6:38 a.m., 900 ml at 6:43 p.m., and 700 ml at 7:12 p.m. CCO said nurses should have documented each 12-hour shift's total TPN intake and then cleared the infusion pump data about the infused amount for oncoming shift to start a new counting of TPN infusion amount.

On 8/28/12 at 9:30 a.m., Nursing Supervisor 1 confirmed that flowsheets were the only areas for nurses to document the infused TPN amounts for Patient 40.

2. On 8/27/12 at 2:36 p.m., when observed with Chief Clinical Officer (CCO), Patient 41 was receiving TPN via infusion pump at 58 ml per hour. According to History and Physical dated 8/14/12, Patient 41 had medical history of chronic kidney disease. Physician 1 indicated to monitor Patient 41's intake and output amounts.

On 8/28/12 at 10 a.m., review of MAR showed that Patient 41 started to have TPN infusion from 8/14/12 at 10 p.m. at 58 ml per hour continuously as ordered. Patient 41 should have received 1392 ml of TPN for 24 hours. Review of flowsheets showed no data of any infused TPN amounts on the rest of the respective days except documentation on flowsheets showed 456 ml TPN on 8/15/12 at 5:32 a.m.; 1504 ml TPN on 8/16/12 at 7:34 a.m.; 696 ml TPN on 8/17/12 at 6:16 a.m.; 638 ml TPN on 8/18/12 at 6:49 a.m.; 630 ml TPN on 8/20/12 at 6:30 a.m.

In the same record review, there were missing data on TPN infusion amounts on 8/25/12 and 8/26/12. On 8/19/12, the nursing flowsheets indicated the infused TPN amount at 7:09 a.m. was 625 ml; at 6:53 p.m. was 600 ml; at 7:09 p.m. was 696 ml. On 8/24/12, the nursing flowsheets showed the infused TPN amount at 6:14 a.m. was 580 ml; at 7:56 a.m. was 684 ml. CCO stated that quality assurance staff recently started a TPN audit using a newly developed TPN audit spreadsheet because nurses were not doing appropriate monitoring and documentation of TPN infusion amounts every shift.

In a phone staff interview on 8/28/12 at 10:17 a.m., Pharmacist 1 said pharmacists only knew when the nurses started TPN in electronic medication administration record. She said pharmacists did not audit the TPN infusion amounts that were documented in the nursing flowsheets. When mentioned that the flowsheets showed Patient 41 received 456 ml TPN on 8/15/12 at 5:32 a.m. and 1504 ml TPN on 8/16/12 at 7:34 a.m. with missing infused TPN amount in day shift of 8/15/12. Pharmacist 1 said the 1504 ml TPN on 8/16/12 at 7:34 a.m. was not an expected 12-hour infusion amount when the prescribed hourly rate was 58 ml per hour. She said pharmacists did not audit the infused amounts of TPN in flowsheets on overdose or underdosage concerns.

In a staff interview on 8/28/12 at 2:20 p.m., record review of flowsheets with Interim Nurse Manager/DON and the Pharmacist in Charge (PIC) showed that Patient 41 received 174 ml TPN on 8/28/12 at 1:32 a.m., and then after almost five hours later at 6:35 a.m., Patient 41 received 690 ml TPN that was 300 ml higher than five hours' expected infusion amount. Interim Nurse Manager/Interim DON said the nurse may have forgot to clear the infusion pump data to restart a new counting of infusion amount. The PIC said the nurse could document the remaining TPN amount to be TPN infused amount instead.

In a staff interview on 8/28/12 at 3 p.m., review of Patient 41's flowsheets with Nursing Educator showed that on 8/19/12, Patient 41 received 625 ml at 7:09 a.m., 600 ml at 6:53 p.m. and 696 ml at 7:09 p.m. Nursing Educator said the nurses may have forgot to clear the infusion pump data to start a new counting of TPN infusion amount. She said she hoped the nurses would look at the TPN infusion bag to compare with infusion pump for checking any discrepancy of TPN infused amounts.

According to the List of High Alert Medications (7/2012), TPN/PPN are high alert medications. The Policy of High-Alert Medications (H-MM 70-001) (11/2010) showed that "high-alert medications are those drugs involved in a high percentage of medication errors and/or sentinel events and medications that carry a higher risk for abuse, errors or other adverse outcomes."

According to Lexicomp Online (drug reference website), the Institute for Safe Medication Practices (ISMP) includes "TPN among its list of drugs which have a heightened risk of causing significant patient harm when used in error."



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3. A review of the American Society of Health-System Pharmacists (a nationally recognized professional organization) in the entitled document Minimum Standard for Pharmacies in Hospitals indicated "The pharmacy shall be responsible for the procurement, distribution, and control of all drug products used in the hospital ..."

A review on 08/28/12 at 10:15 a.m. of the Pharmacy Technician fill/return list indicated a list of medications that were returned from the nursing stations that had not been administered to patients. The returns could be an indication of extra medications sent by the pharmacy, held/discontinued medications, or medication errors.

During an interview on 08/28/12 at 10:15 a.m. the Pharmacist in Charge (PIC) stated that the Pharmacy did not evaluate and review the returns for medication errors with the exception of Coumadin (anticoagulant) and antibiotics. The majority of the returns were not evaluated and reviewed for medication errors. She acknowledged the importance of evaluating and reviewing the returns for medication errors.

An interview on 08/28/12 at 3:45 p.m. the PIC stated from 08/01/12 to 08/10/12 there were 175 returned medications. The majority of the returns were not evaluated and reviewed for medication errors with the exception of Coumadin and antibiotics.

A sampling of 2 patients from the Pharmacy Technician fill/return list indicated one (Patient 80) of two patients had two missing doses of medications. The dispense record of Patient 80 indicated 13 total doses of acetazolamide (medication used for edema, glaucoma, alkalosis) were dispensed. The medication administration record indicated that 10 doses were administered. The Pharmacy Technician fill/return list indicated 1 dose was returned. Based on the dispense, administration, and return records for Patient 80, two doses of acetazolamide should be left (calculated as 13-10+1=2 doses left).

An observation on 08/28/12 at 11:00 a.m. of Patient 80's medication drawer revealed that Patient 80 did not have any doses left of the acetazolamide. The missing doses could have been a medication error in which additional doses of acetazolamide were administered. The PIC stated she could not account for the missing doses of acetazolamide.