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Based on interview and record review, the facility failed to fully investigate an allegation of "toxic amounts of vancomycin" administered to Patient 1 . The facility failed to analyze the processes for ordering, labeling, dispensing, administering, and monitoring vancomycin.

Patient # 1, a nine (9) month old infant, received intravenous (IV) vancomycin at the incorrect rate for for nine days.

Findings include:

TX # 00232554

Review of complaint intake TX # 00232554 read: "... Patient # 1 was receiving toxic amounts of Vancomycin being infused over 17 minutes per pharmacy instructions. This infusion went on for several weeks...Patient suffered severe complications and required to be transferred out out to organ failure...:

Interview on 03-31-16 at 10:30 A.M. with Chief Executive Officer (CEO) #1 she stated the facility's accrediting agency had been on-site in the fall to investigate the same issue. She said the accrediting agency's issue was the failure of the physician to order vancomycin trough levels. CEO #1 stated this had been discussed with the medical director. The decision had been made to build in a computer "reflux order" to remind the physician to consider ordering a vancomycin trough level every 7 days. CEO went on to say ordering the tough level was still at the physician's discretion.

CEO # 1 stated nursing in-services regarding vancomycin administration had also been conducted. She said the facility did not perform an RCA (root cause analysis) because they did not consider this a near miss or sentinel event.

Interview on 04-14-16 with facility Chief Clinical Officer (CCO ) # 2, he supplied the facility documentation of investigation. He provided the facility newsletter, dated December 2015. Review of the document revealed a section entitled "Nursing Nook" related to Vancomycin administration. CCO # 2 was unable to locate any other documentation related to the facility investigation regarding vancomycin administration to Patient # 1.

Interview on 04-14-16 at 3:25 PM with Nurse Educator # 12 she stated CEO # 1 asked her in early October 2015 to research the correct vancomycin rates for pediatric patients. Nurse educator went on to say CEO #1 " showed me a vancomycin syringe for Patient # 1 that had been mislabeled with the wrong rate of 17 milliliters (ml) per minute, which was way too fast."

Nurse Educator # 12 reported she developed nursing education related to vancomycin for the facility newsletter. She said the facility did not perform an RCA and did not review the processes related to the ordering and labeling of vancomycin.

Review of the clinical record of Patient # 1 revealed she was a 9 month old infant admitted to the facility on 09-02-15 with diagnoses of Trisomy 21, cleft palate, and sepsis with necrotizing fascitis of the left leg.

Review of physician orders for Patient # 1 revealed the following:

09-21-15: "Vancomycin HCL : 117 mg ( vial) / Vancomycin 500 mg injection: Dose= 117 mg= 29.25 cubic centimeter (cc): 29.25 ml @ 100 mls/ hr" [ total infusion time approximately 17 minutes]

10-01-15: " Vancomycin HCL : 117 mg ( vial) / Vancomycin 500 mg injection: Dose= 117 mg= 29.25 cubic centimeter (cc): 29.25 ml @ 14.625 mls/ hr" [total infusion time 2 hours]

Review of the Medication Administration Records (MAR) for Patient # 1 from 09-21-15 through 10-06-15 revealed :

*The rate of infusion for the vancomycin was incorrect for nine (9) days.

This was verified by CCO # 2.

Interview on 04-14-16 at 4;35 P.M. with Vice President Quality/Risk # 3 she stated an RCA was not performed because there was no patient death. She went on to say she was unaware the infusion rate for the vancomycin were incorrect for Patient # 1.

Review of drug manufacture's recommendations ( package insert) for Vancomycin Hydrochloride for Injection, USP, it read: " DOSAGE AND ADMINISTRATION:...Patients with Normal Renal Function...Pediatric Patients: The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every six hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients..."

Review of facility policy titled "Sentinel Event," dated 08/15, read: " Policy;...we will take the appropriate steps to prevent the occurrence of sentinel events and near misses within the organization. These steps include the education of staff and use of information..on risk reduction strategies...Sentinel Event: an unexpected occurrence involving the death or serious physical or psychological injury or risk thereof...A. "Risk thereof" ( near miss)-any process variance for which a reoccurrence would carry a significant chance of a serious adverse outcome...Any "near miss"...in the context of the Quality and Safety activities, HBH will conduct an intensive assessment on any event qualified as a "near miss." A root cause analysis (RCA) and action plan will be completed within 45 days of discovery of the event/ near miss..."

Based on interview and record review, the facility failed to document, fully investigate, and incorporate a serious medication error into its QAPI Program.

Patient # 1, a nine (9) month old infant, received intravenous (IV) vancomycin infused at the incorrect rate for for nine days.

The facility failed to include this error into the QAPI program and related processes; although medication errors had been identified by the facility as the highest risk priority for 2015.

Findings include:

TX # 00232554

Review of complaint intake TX # 00232554 read: "... Patient # 1 was receiving toxic amounts of Vancomycin being infused over 17 minutes per pharmacy instructions. This infusion went on for several weeks...Patient suffered severe complications and required to be transferred out out to organ failure...:

Interview on 03-31-16 at 10:30 A.M. with Chief Executive Officer (CEO) #1 she stated the facility's accrediting agency had been on-site in the fall to investigate the same issue. She said the accrediting agency's issue was the failure of the physician to order vancomycin trough levels. CEO #1 stated this had been discussed with the medical director. The decision had been made to build in a computer "reflux order" to remind the physician to consider ordering a vancomycin trough level every 7 days. CEO went on to say ordering the tough level was still at the physician's discretion.

CEO # 1 stated nursing in-services regarding vancomycin administration had also been conducted. She said the facility did not perform an RCA (root cause analysis) because they did not consider this a near miss or sentinel event.

Interview on 04-14-16 with facility Chief Clinical Officer (CCO ) # 2, he supplied the facility documentation of investigation. He provided the facility newsletter, dated December 2015. Review of the document revealed a section entitled "Nursing Nook" related to Vancomycin administration. CCO # 2 was unable to locate any other documentation related to the facility investigation regarding vancomycin administration to Patient # 1.

Interview on 04-14-16 at 3:25 PM with Nurse Educator # 12 she stated CEO # 1 asked her in early October 2015 to research the correct vancomycin rates for pediatric patients. Nurse educator went on to say CEO #1 "showed me a vancomycin syringe for Patient # 1 that had been mislabeled with the wrong rate of 17 milliliters (ml) per minute, which was way too fast."

Nurse Educator # 12 reported she developed nursing education related to vancomycin for the facility newsletter. She said the facility did not perform an RCA and did not review the processes related to the ordering and labeling of vancomycin.

Nurse Educator # 12 and CCO # 2 were unable to locate a medication error report or an incident report related to the vancomycin error.

Review of the clinical record of Patient # 1 revealed she was a 9 month old infant admitted to the facility on 09-02-15 with diagnoses of Trisomy 21, cleft palate, and sepsis with necrotizing fascitis of the left leg.

Review of physician orders for Patient # 1 revealed the following:

09-21-15: "Vancomycin HCL : 117 mg ( vial) / Vancomycin 500 mg injection: Dose= 117 mg= 29.25 cubic centimeter (cc): 29.25 ml @ 100 mls/ hr" [ total infusion time approximately 17 minutes]

10-01-15: " Vancomycin HCL : 117 mg ( vial) / Vancomycin 500 mg injection: Dose= 117 mg= 29.25 cubic centimeter (cc): 29.25 ml @ 14.625 mls/ hr" [total infusion time 2 hours]
Review of the Medication Administration Records (MAR) for Patient # 1 from 09-21-15 through 10-06-15 revealed :

*The rate of infusion for the vancomycin was incorrect for nine (9) days.

This was verified by CCO # 2.

Interview on 04-14-16 at 4:35 P.M. with Vice President Quality/Risk # 3 she stated an RCA was not performed because there was no patient death. She went on to say she was unaware the infusion rate for the vancomycin were incorrect for Patient # 1.

Review of drug manufacture's recommendations ( package insert) for Vancomycin Hydrochloride for Injection, USP, it read: " DOSAGE AND ADMINISTRATION:...Patients with Normal Renal Function...Pediatric Patients: The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every six hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients..."

Review of facility policy titled "Medication Administration," dated 08-2014, read: "...V. Safety Standards: A. Reporting: Errors, missed doses, expired product, medication reactions, adverse drug events.....at a minimum should occur..2. A completed Safety Event report form to notify the Quality office before the end of the shift.."

Review of facility document titled" 2015 Quality /Risk Annual Evaluation " revealed the facility had identified Medication Errors as the highest risk priority for 2015. The evaluation read: "Priorities and Goals (2015) ...[.risk priorities are listed in descending order of vulnerability ( 12 being the highest).] Medication Errors (risk level 10) : Probability of Occurrence: High....Management of Risk: : ...Involve Licensed Nurses in reviewing Medication Error Report in Nurse Practice Council ...complete RCA as needed...Follow up with staff involved in errors within 72 hours of occurrences..."