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Based on interviews and document reviews, the facility failed to ensure nursing staff administered Heparin intravenous (IV) flush solutions according to hospital policy or per physician order. Additionally, once the incident was identified, the facility failed to ensure a process was in place to prevent further recurrences.

This failure created the potential for patients to receive a larger concentration and volume of Heparin IV flush solution, which could lead to possible increase risk of the medication's side effects, including bleeding.

FINDINGS:

POLICY

According to policy, Central Venous Catheter (CVC) Flush Regimens, Heparin Flush General Information; if too much heparin is used, potential bleeding problems can occur.

Broviac SL catheters should be flushed with 1 milliliters (ml) Heparin flush solution (10units/ml concentration) for patients weighing less than or equal to 10 kilograms (kg).

1. Registered Nursing (RN) staff flushed a Broviac SL catheter with an incorrect volume and concentration of a Heparin flush solution.

a) Review of Patient #4's medical record revealed a 3ml Heparin flush of 100 units of Heparin to 1 ml of saline was administered via Patient #4's Broviac central line by RN #1 on 11/17/15 at 11:00 A.M. On 11/16/15 Patient #4 weighed 4.5 kg. Furthermore, Patient #4's medical record showed no evidence of a physician order for the volume or concentration of the Heparin flush administered.

This was in contrast to the policy.

b) On 01/18/16 at 4:04 p.m., an interview was conducted with RN #1 who confirmed s/he was the nurse who administered the heparin flush via Patient #4's Broviac central line on 11/17/15. RN #1 stated s/he did not think the dose administered was a high dose.

After review of the facility's policy for CVC flush regimens, RN #1 confirmed the dose administered via Patient #4's Broviac central line was outside of the facility's policy range. RN #1 stated since the dose administered was outside of facility policy range, a physician's order should have been obtained.

RN# 1 stated s/he remembered a patient who had a sticker that stated 100:1 on the patient's central line dressing. RN #1 stated s/he believed this indicated the concentration of heparin to be used when flushing the central line. RN #1 further stated s/he was unfamiliar with flushing Broviac central lines.

c) On 01/20/16 at 9:36 a.m., an interview was conducted with the Medication Safety and Improvement Manager (Employee #5) who stated a physician order was required to flush a CVC with a larger volume or higher concentration outside of the range specified in the policy.

d) On 01/20/16 at 12:02 p.m., an interview was conducted with the Executive Director of Perioperative Services (Employee #3) who stated radiology nursing staff were expected to follow the central line flush regimen policy. S/he further stated an exception to the policy could only occur with a physician's order.

e) On 01/20/16 at 1:54 p.m. an interview was conducted with the Accreditation & Regulatory Manger (Employee #6) and the Director of Corporate Compliance (Employee #7). Employee #7 stated the facility did not provide education to radiology nursing staff after the facility identified the 11/17/15 heparin flush incident. Employee # 7 stated s/he was unaware if the incident was brought to the attention of RN #1 and if follow-up occurred.

f) Review of an email dated 11/25/15, provided by Employee #7, revealed the facility identified the heparin flush incident on 11/25/15. The facility was unable to provide evidence that an action plan was created to prevent the incident from reoccurring in the future.

Based on observations, interviews, and document review the facility failed to ensure duties performed in the surgical department were consistent with established facility policies.

This failure resulted in staff members outside of the surgical department misinterpreting labels on central lines. Further, this failure created the potential for patients to receive warmed, intravenous (IV) fluids past the expiration date; potentially exposing them to microbial growth in the fluid and increasing the risk of hospital acquired infections.

FINDINGS:

POLICY

Table 1 of the policy Central Venous Catheter (CVC): Flush Regimens shows that for Broviac tunneled central venous catheters the flushing volume (for a patient) less than or equal to 10 kilograms is 1 milliliter (ml) of heparin flush solution (with a concentration of) 10 units to 1 ml. The policy stated if too much heparin is used, potential bleeding problems can occur.

According to the policy, Central Venous Catheter (CVC): Assist with Insertion, (providers are to) apply sterile dressing and label with date and initials. The policy does not state to label with additional pre-printed heparin concentration labels.

According to the policy, IV Solutions and Irrigation Fluids, Warming of Large Volume, place a sticker on IV bag(s) noting the date the IV bag was placed in warmer and the date it is to be removed (14 days later). Fourteen days is the maximum amount of time that parenteral solutions can be kept in the warming cabinet. If not used, remove IV bags from warmer when the IV solution sticker date indicates it needs to be removed. The sticker must remain on the IV bag as an indicator that bag has previously been warmed.

REFERENCE

According to the Association of Operating Room Nurses (AORN), Guidelines for Perioperative Practice, 2015: Recommendation II.b.1 (page 530), Fluids kept in a warming cabinet should be labeled with an expiration date based on the manufacturer's recommendation for storage above room temperature.

1. Central lines placed in the surgical department were labeled in a way that was not uniformly practiced or approved by the facility. In addition, staff caring for patients after central lines were placed were not informed of the change in practice regarding the labeling of central lines.

a) Review of the Central Venous Catheter policy lacked evidence instructing the application of a label onto the central line dressing which stated the concentration of heparin flush used.

b) A review of Patient #4's medical record revealed that a 3 ml heparin flush of 100 units of heparin to 1 ml of saline was administered via patient #4's Broviac central line per Registered Nurse (RN) #1 on 11/17/15 at 11:00 a.m. On 11/16/15 Patient #4 weighed 4.5 kg. Further investigation of Patient #4's chart showed there was no physician order obtained to give the increased concentration of heparin flush.

An interview with RN #1 on 01/18/16 at 4:04 p.m. revealed s/he remembered a patient who had a sticker that stated 100:1 on the patient's central line dressing. RN #1 stated s/he believed this indicated the concentration of heparin to be used when flushing the central line. RN #1 further stated s/he was unfamiliar with flushing Broviac central lines.

c) On 01/19/16 at 10:31 a.m., an interview with RN #2 was conducted. RN #2 stated s/he labeled central line dressings with a pre-printed label of 100:1 and s/he had been doing this for approximately 6 months. This was not consistent with the facility's policy. RN #2 stated s/he was not aware of how staff from other departments were educated about the practice of labeling central lines with heparin concentrations. S/he assumed the sticker would prompt RNs to be aware of the concentration of heparin instilled in a central line and draw back a waste of 5 mls before instilling medications into the central line.

d) On 1/19/16 beginning at 1:48 p.m., interviews were conducted with RNs #8, #9, #10, #11, and #12 in the Pediatric Intensive Care Unit (PICU), the Neonatal Intensive Care Unit (NICU), and Medical/Surgical Units. Five of five RNs reported they were unaware of the practice regarding a sticker with a heparin concentration placed on a central line and would not know what the sticker represented. Further, four of five RNs (RN #8, #9, #10, and #11) stated they would not draw back a waste on Broviac central lines, which was consistent with the facility policy.

e) On 01/20/16, 12:02 p.m., an interview with the Executive Director of Perioperative Services (Employee #3) was conducted. S/he stated there was no policy regarding placing stickers with a heparin concentration on new central lines in the Operating Room (OR). This was not a common practice as staff were not trained on the meaning of the stickers. S/he further stated medications instilled in a central line were expected to be documented in the Medication Administration Record (MAR). Employee #3 was aware that some staff were putting stickers on central line dressings with heparin concentrations. S/he stated the expectation was to not use the sticker as it was not in accordance with the policy.

2. The facility failed to properly label IV fluid bags kept in fluid warming cabinets and label bags removed from their protective overwrap with a discard date.

a) During a tour of the surgical department's north and south core rooms, on 01/19/16 at 10:49 a.m., the fluid warming cabinets were inspected. The inspection revealed all fluids in both warmers were absent of a sticker stating the date the fluids had been placed in the warmer. This was in contrast to facility policy which stated to place a sticker on IV bag(s) noting the date the IV bag was placed in warmer and the date it was to be removed (14 days later). Furthermore, it was noted, one bag of 500 ml Normal Saline (NS) and one liter NS bag had no expiration dates noted. In addition, one bag of 500 ml NS had an expiration date of "1/18" noted with a marker, which was the day prior to the tour.

The OR Charge Nurse (RN #4) was present during the inspection of the fluid warming cabinets on 01/19/16 at 10:49 a.m. S/he stated the date written with marker on the IV fluid bags in the warmer were the dates the fluids were to be removed. S/he then removed the bag marked "1/18" and the bags that had no markings.

b) During the same tour of the surgical department on 01/19/16 at 10:49 a.m., an OR suite was inspected which revealed a 3000 ml IV fluid bag of sterile saline unmarked with no overwrap.

RN #4 stated the IV fluid bag "must not have been taken out" after a spine surgery case done 01/18/16. S/he proceeded to remove the bag from the OR suite.

c) On 01/20/16 at 12:02 p.m., an interview with Executive Director of Perioperative Services (Employee #3) revealed the facility's expectation for the surgical department was to follow facility policies as well as AORN guidelines. Employee #3 stated IV fluids in the fluid warming cabinets were expected to be discarded after 14 days.