HospitalInspections.org

This Condition is NOT met as evidenced by:
Based on review of the clinical records, review of hospital policy, review of hospital documentation and interviews with hospital personnel for one of eleven sampled patients (Patient #1), the facility failed to ensure that multiple staff members administered prescribed medication to Patient #1 in accordance with physician orders which resulted in a significant medication error.

Cross reference with A 0405.

Based on review of clinical records, review of hospital policies and procedures, review of hospital documentation and interviews with hospital personnel for one of eleven patients (Patient #1) receiving Bupivicaine via a medication infusion device, the facility failed to ensure that nursing staff administered the medication to the patient in accordance with physician orders for over a thirty six hour period. The findings include:
1a. Patient #1 was admitted to the hospital on 4/4/13 from Acute Care Hospital #2 with diagnoses that included second and third degree burns to over sixteen percent of his/her body including the right upper chest, right upper extremity and neck. Patient #1 subsequently underwent a serial debridement of the burn wounds with grafting on 4/10/13. Review of the Operative Report dated 4/10/13 identified that an " On-Q " local anesthetic continuous infusion catheter was placed beneath the donor site and centered on the left hip. Physician orders dated 4/10/13 at 9:40 AM directed the administration of Bupivacaine (a local anesthetic) 0.5% solution via On-Q pump (Surgical: Painbuster) four hundred milliliters (400 ml) through the intracatheter at the left hip at four ml per hour.

Review of the Post Anesthesia Care Unit (PACU) record dated 4/10/13 and interview with RN #2 on 4/30/13 at 11:15 AM identified that on 4/10/13 at 11:00 AM, he/she attached the On-Q pump at four ml per hour to Patient #1's infusion catheter. RN #2 identified that although he/she observed the dial on the pump which was not familiar to her, he/she did not touch the dial. RN #2 stated that he/she checked the medication label on the pump and that it was the same as the physician order. Although physician orders directed that the Bupivacaine infusion be administered via the Painbuster pump which does not have a dial, RN #2 attached the On-Q pump prepared and sent from the pharmacy to Patient #1's intracatheter. The pump attached by RN #2 was not a Painbuster pump as ordered by the physician but actually a Select-a Flow pump with a dial. The On-Q Select-a-Flow pump has a dial for dosage delivery that can be set from zero to fourteen ml per hour whereas, the On-Q Painbuster pump is a continuous infusion of four ml per hour. RN #1 incorrectly documented the infusion in the Electronic Medication Administration Record (eMAR) as a Bupivacaine infusion infusing at four ml per hour via On-Q Painbuster pump. Patient #1 was transferred from the PACU to the Burn Unit on 4/10/13 at 12:10 PM. RN #3, RN #4 and RN #5, all Burn Unit nursing staff, provided subsequent care to Patient #1 over the following thirty six hours (4/10/13 through 4/11/13) and failed to identify that the incorrect pump was used at the incorrect dosage.

b. Interview with the Burn Unit admission nurse, RN #3, on 5/1/13 at 10:30 AM identified that although she checked the medication label with the physician order, he/she was unaware of the difference between the On-Q Painbuster pump and the On-Q Select-a-Flow pump and had not been educated on the difference. RN #3 stated that he/she did not see or touch the dial of the incorrectly placed On-Q Select-a-Flow pump during the time he/she provided care to Patient #1.

c. Interview with RN #4 on 4/30/13 at 11:40 AM identified that although he/she checked the medication label with the physician order while caring for Patient #1, he/she was unaware of the difference between the On-Q Painbuster pump and the On-Q Select-a-Flow pump and had not been educated on the difference. RN #4 stated that he/she did not see or touch the dial of the incorrectly placed On-Q Select-a-Flow pump during the time he/she provided care to Patient#1. In addition, RN #4 incorrectly documented that Patient #1's Bupivacaine infusion was running at four ml per hour via On-Q Painbuster pump in the eMAR.

d. Review of the clinical record and interview with RN #5 on 4/30/13 at 12:15 PM identified that on 4/11/13, he/she initially checked the medication label with the physician order. RN #5 stated that on 4/11/13 sometime between 7:30 AM and 8:00 AM, he/she found the On-Q pump empty and that all of the Bupivacaine had been infused. RN #5 stated that he/she realized that the On-Q Select-a-Flow pump (the pump with a dial) was attached to Patient #1's catheter, not the On-Q Painbuster pump as per physician order. RN #5 observed that the dial on the pump was set at fourteen ml per hour. RN #5 notified MD #1, MD #2, MD #3 and the Burn Unit Nurse Manager.

Interview with MD #1 on 4/30/13 at 1:30 PM identified that Patient #1 received four hundred ml (400 ml) of Bupivacaine over a twenty four hour period instead of over a four day period. Review of the clinical record and interview with MD #1 identified that the Bupivacaine was incorrectly infused via an "On-Q Select-a-Flow" pump rather than an "On-Q Painbuster" pump as directed by physician order. MD #1 identified that the Bupivacaine infusion was immediately discontinued on 4/11/13 at approximately 8:30 AM and that Patient #1 was treated with intravenous lipids in order to treat the effects of the Bupivacaine received. Review of the clinical record dated 4/11/13 at 9:00 AM identified that Patient #1 received an overdose of Bupivacaine. The progress note dated 4/12/13 at 4:10 AM identified that Patient #1 continued to deteriorate, subsequently experienced hypercapnia (elevated carbon dioxide) and changes in cardiac rhythm. Although aggressive resuscitation measures were implemented until 4:08 AM on 4/12/13, Patient #1 expired.

Hospital policy for Medication Administration directed in part, that all medication be administered using the five rights of medication administration: the right medication, the right dose, the right patient, the right time and the right route. Review of the hospital's Pharmacy and Therapeutics Committee minutes dated March 13, 2012 reflected that the On-Q Pumps with Bupivacaine were reviewed by the committee and accepted for use at the hospital. However, interviews with the Director of Pharmacy on 5/1/13 at 11:30 AM and the Vice President of Patient Care Services on 4/30/13 at 1:00 PM identified that the hospital did not have an On-Q pump and/or Bupivacaine administration policy.

This Condition is NOT met as evidenced by:
Based on review of the clinical records, review of hospital policy, review of hospital documentation and interviews with hospital personnel for one of eleven sampled patients (Patient #1), the hospital failed to ensure that a medication policy and procedure for the use of On-Q infusion pumps was developed in order to minimize drug errors.

Cross reference with A 0491 and A 0501.

Based on review of clinical records, review of hospital policies and procedures, review of hospital documentation and interviews with hospital personnel for one of eleven patients (Patient #1), who received Bupivacaine via a medication infusion pump ("On-Q pump"), the pharmacist failed to select the appropriate infusion pump and/or dispense the medication in accordance with physician order and/or the hospital failed to ensure that a policy and procedure was developed to ensure safe use of a medication infusion device. The findings include:


1a. Patient #1 was admitted to the hospital on 4/4/13 from Acute Care Hospital #2 with diagnoses that included second and third degree burns sustained in a fire to over sixteen percent of his/her body including the right upper chest, right upper extremity and neck. Patient #1 subsequently underwent a serial debridement of the burn wounds with grafting on 4/10/13. Review of the Operative Report dated 4/10/13 identified that an "On-Q" local anesthetic continuous infusion catheter was placed beneath the donor site and centered on the left hip. Physician orders dated 4/10/13 at 9:40 AM directed the administration of Bupivacaine (a local anesthetic) 0.5% solution for On-Q pump (Surgical: Painbuster) 400 milliliters (ml) through the intracatheter at the left hip at four ml per hour.

Review of the Pharmacy Intravenous (IV) log dated 4/10/13 identified that Pharmacist #1 and Pharmacy Technician #1 prepared the Bupivacaine infusion for Patient #1 with Bupivacaine 0.5% and four hundred cc (400 cc) diluent for Patient #1. Interview with Pharmacist #1 on 4/29/13 at 2:45 PM identified that he/she recalled taking Patient #1's On-Q pump from the Painbuster storage bin, not the Select-a-Flow storage bin, but did not recall seeing the name "Painbuster" on the bag. The On-Q Select-a-Flow pump has a dial for dosing that can be set from zero to fourteen ml per hour whereas, the On-Q Painbuster pump is a continuous infusion of four ml per hour. Pharmacist #1 identified that he/she visualized and checked the syringes of 0.5% Bupivacaine that would be used to fill the elastomeric On-Q pump device (a ball-like holding bag). Pharmacist #1 identified that the Pharmacy Technician was responsible to prime the line, clamp the line, and turn the dial to zero. The Pharmacist stated that the pump would then be delivered to the nursing staff, who were responsible to set the dial to the prescribed amount in accordance with physician orders.


b. Review of the medication label used to label Patient #1's On-Q pump on 4/10/13 read that the Bupivacaine was to be administered via a Painbuster pump. Interview with Pharmacy Technician #1 on 4/30/13 at 10:00 AM identified that he/she did not check the medication label that was applied to Patient #1's On-Q pump on 4/10/13. Pharmacy Technician #1 stated that he/she only recalled turning the On-Q pump dial to zero after filling the ball on the pump that holds the medication (Painbuster pumps provide continuous infusion and have no adjustable dial).

c. Review of Patient #1's Post Anesthesia Care Unit (PACU) record dated 4/10/13 and interview with RN #2 on 4/30/13 at 11:15 AM identified that on 4/10/13 at 11:00 AM, he/she attached the On-Q pump to Patient #1's intracatheter. RN #2 identified that he/she observed the dial on the pump tubing which was new to him/her but that he/she did not touch the dial. RN #2 stated that he/she checked the medication label on the pump and it was the same as the physician order. Although the physician orders directed that the Bupivacaine infusion be administered via the Painbuster pump, RN #2 attached the On-Q pump with the dial (Select-a Flow pump) sent from the pharmacy, to Patient #1's intracatheter. Another nurse, RN #, incorrectly documented in the Electronic Medication Administration Record (eMAR) that Patient #1 was receiving a Bupivacaine infusion at four ml per hour via On-Q Painbuster pump. Patient #1 was transferred from the PACU to the Burn Unit on 4/10/13 at 12:10 PM. Burn Unit Nursing staff that included RN #3, RN #4 and RN #5, all provided care to Patient #5 over the following thirty six hours (4/10/13 through 4/11/13) Interviews with RN #3 on 5/1/13 at 10:30 AM and RN #4 on 4/30/13 at 11:40 AM who provided direct care to Patient #1 on 4/10 to 4/11/13, identified that they had not seen or touched the On-Q Select-a-Flow pump dial. RN #3, RN #4, and RN #5 further identified that although they checked the medication label with the physician order, they were unaware of the difference between the On-Q Painbuster pump and the On-Q Select-a-Flow pump and had not been educated on the difference.
Review of the clinical record and interview with RN #5 on 4/30/13 at 12:15 PM identified that on 4/11/13 sometime between 7:30 AM and 8:00 AM on 4/11/13, he/she found Patient #1's On-Q pump empty and that all of the Bupivacaine had been infused. RN #5 observed that the dial of the pump was set at fourteen ml per hour and that the On-Q Select-a-Flow pump (a pump with a dial) was attached to Patient #1's catheter, not the On-Q Painbuster pump as per physician order. RN #5 notified MD #1, MD #2, MD #3 and the Burn Unit Nurse Manager.

Interviews with the Director of Pharmacy and the Pharmacy Clinical Coordinator, and Pharmacist #2 on 4/29/13 at 10:00 AM identified that the "On-Q Select-a Flow" pump was incorrectly pulled from the pharmacy and dispensed from the pharmacy with the Bupivacaine for Patient #1 on 4/10/13. Interview with the Director of Pharmacy on 5/1/13 at 11:30 AM identified he/she would expect the Pharmacist and the Pharmacy Technician to check the medication label with the physician order and to check that the correct On-Q pump was being dispensed. Documentation and interviews with hospital personnel failed to reflect that Pharmacist #1 accurately selected the appropriate medication infusion pump and dispensed the medication in accordance with physician orders.


Interview with MD #1 on 4/30/13 at 1:30 PM identified that Patient #1 received four hundred cubic centimeters (cc) of Bupivacaine over a twenty four hour period instead of over four days. Review of the clinical record, review of hospital documentation, and interview with MD #1 identified that the Bupivacaine was incorrectly infused via an "On-Q Select-a-Flow" pump rather than an "On-Q Painbuster" pump at fourteen ml (14 ml) per hour rather then the prescribed four ml (4 ml) per hour. MD #1 identified that the Bupivacaine infusion was immediately discontinued on 4/11/13 at approximately 8:30 AM and that Patient #1 was treated with intravenous lipids in order to treat the effects of the Bupivacaine received. Patient #1 experienced changes in mental status and subsequently, a change in cardiac rhythm on 4/12/13 at 1:00 AM. Patient #1's condition continued to deteriorate. Although aggressive resuscitation measures were implemented until 4:08 AM when Patient #1 expired.


Review of pharmacy education documentation dated 7/1/12 identified that staff was educated on the different types of On-Q pumps, local anesthetics, process for order entry, manufacturer and delivery processes. However, review of facility policies and interview with Pharmacist #1 on 4/29/13 at 2:45 PM lacked documentation to reflect that the pharmacy department had developed a policy/procedure to direct the procedure for safe use of the different On-Q pumps.

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Based on review of clinical records, review of hospital policies and procedures, review of hospital documentation and interviews with hospital personnel for one of eleven patients (Patient #1) receiving the medication, Bupivacaine via a medication infusion device, the pharmacy failed to ensure that compounding, packaging, and/or dispensing was performed in accordance with physician orders and/or that appropriate supervision of the Pharmacy Technician was provided before the medication was delivered to Patient #1. The findings include:

1a. Patient #1 was admitted to the hospital on 4/4/13 from Acute Care Hospital #2 with diagnoses that included second and third degree burns sustained in a fire to over sixteen percent of his/her body including the right upper chest, right upper extremity and neck. Patient #1 subsequently underwent a serial debridement of the burn wounds with grafting on 4/10/13. Review of a Physician Order dated 4/10/13 at 9:40 AM directed that the medication, Bupivacaine, (a local anesthetic) 0.5% solution for On-Q pump (Surgical: Painbuster) 400 ml intracatheter left hip at four milliters (ml) per hour. Review of the Operative Report dated 4/10/13 identified that an "On-Q" local anesthetic continuous infusion catheter was placed beneath the donor site and centered on the left hip.

Interviews with the Director of Pharmacy and the Pharmacy Clinical Coordinator, Pharmacist #2 on 4/29/13 at 10:00 AM identified that the On-Q Select-a Flow pump dispensed by the pharmacy for use to Patient #1 on 4/10/13 was not the On-Q Painbuster pump that was ordered by the physician. The On-Q Select-a-Flow pump has a dial for dosing that can be set from zero to fourteen ml per hour whereas, the On-Q Painbuster pump is a continuous infusion of four ml per hour. The Director of Pharmacy and Pharmacist #2 identified that the two different On-Q pumps were stored in two separate storage bins on shelves located outside of the Intravenous (IV) room in the pharmacy.

Interview with Pharmacist #1 on 4/29/13 at 2:45 PM identified that he/she recalled taking Patient #1's On-Q pump from the Painbuster bin, not the Select-a-Flow bin, but did not recall seeing "Painbuster" on the bag. Pharmacist #1 identified that the pump, the medication (Bupivacaine), and the medication label were placed in the production tray and passed through the bypass window to the IV Room. Pharmacist #1 identified that he/she visualized and checked the syringes containing 0.5% Bupivacaine that would be used to fill the elastomeric On-Q pump device (a ball-like holding bag) by the Pharmacy Technician.


b. Interview with Pharmacy Technician #1 on 4/30/13 at 10:00 AM identified that he/she did not check the medication label that he/she applied to Patient #1's On-Q pump on 4/10/13. Pharmacy Technician #1 stated that he/she recalled turning the On-Q pump dial to zero after filling the device with the medication. (Painbuster pumps provide continuous infusion and have no adjustable dial) Interview with the Director of Pharmacy on 5/1/13 at 11:30 AM identified he/she would expect the Pharmacist and the Pharmacy Technician to check the medication label with the physician order and to check for the correct On-Q pump.


Review of pharmacy education documentation dated 7/1/12 identified that education was provided regarding the different types of On-Q pumps, local anesthetics, the process for order entry, manufacturer and delivery information. However, interview with Pharmacist #1 on 4/29/13 at 2:45 PM identified that the pharmacy department had not developed a policy/procedure for the On-Q pumps for pharmacy staff to refer to.


Review of hospital documentation, review of a physician progress note dated 4/11/13 at 9:00 AM and subsequent interview with MD #1 on 4/30/13 at 1:30 PM identified that Patient #1 received four hundred ml (400 ml) of Bupivacaine over a twenty four hour period instead of over four days via the On-Q Select-a-Flow pump not the On-Q Painbuster pump as per physician order. Review of the clinical record and facility documentation identfied that Patient #1 experienced changes in mental status and subsequently, a change in cardiac rhythm on 4/12/13 at 1:00 AM. Patient #1's condition continued to deteriorate. Although aggressive resuscitation measures were implemented until 4:08 AM when Patient #1 expired.