UNFRACTIONATED HEPARIN (UFH) is a high-alert medication due to its potential for significant patient harm if used in error.1 It is recognized by the Institute for Safe Medication Practices as one of six drugs most commonly associated with serious injury and death.2 Between January 1997 and December 2007, The Joint Commission recorded 446 medication-related sentinel events, with 21 (5%) events involving UFH.3 Additionally, US pharmacopeia MedMarx reported over 17,000 medication errors related to UFH between 2003 and 2007. Half of these errors originated during administration, most commonly due to an incorrect dosage or omission.3,4
Due to significant safety concerns, UFH is included in the Joint Commission's National Patient Safety Goals (NPSG). As of 2018, the NPSG recommended following the approved protocols for the initiation and maintenance of anticoagulants, including written policies addressing baseline and continuing lab monitoring.5 Hospitals and healthcare facilities should also evaluate their safety practices, make improvements to these practices, and measure the effectiveness of any changes.5 This article discusses the effect of standardized processes on the initiation of UFH infusion protocols and dosage adjustments at a community teaching hospital.
Background: A local problem
The first UFH dosing algorithm was developed in 1991.6 Although the initial protocols were physician-led, more recent nurse- and pharmacist-driven UFH dosing protocols have been established and used in practice. The efficacy of these has been established using statistical outcomes, including the percentage of patients to reach a therapeutic activated partial thromboplastin time (aPTT), the time to therapeutic aPTT, any changes in the initial infusion rate, and dosage adjustments based on lab monitoring.7,8
Between July 1, 2015, and June 30, 2016, the teaching hospital reported 52 errors involving the initiation and dosage adjustments of I.V. UFH infusions through the facility's voluntary adverse event reporting system. Each error was reviewed by a process improvement team comprised of clinical bedside nursing staff and led by a clinical nurse specialist, who evaluated the errors collectively. UFH infusions and bolus orders, lab orders, and instructions for nurse-driven administration and titration are part of the facility protocol. To reduce UFH-related errors and better align with the NPSG, organizational policies and procedures pertaining to UFH infusions were updated, standardized processes were created for the nursing staff, and the facility nurses were educated about the changes.
Process standard work, a continuous quality improvement tool that follows best practices and details the methods and steps involved in completing a task, was implemented at the hospital on September 1, 2016. The tool contained step-by-step instructions for the initiation of UFH infusions, adjustments based on patient aPTT values, and follow-up lab monitoring of aPTT values. Because UFH is a high-alert medication, the policy, procedures, and process standard work required a second nurse to witness the initiation of UFH infusions and all administration rate changes. He or she was designated as the unit charge nurse.
Before the implementation of process standard work, a baseline error rate for UFH infusions had not been established through patient medical record review. Although process observations and assessments were conducted, an evaluation of staff protocol adherence was not completed after the process changes took effect. Given the inherent drawbacks of voluntary event reporting, this retrospective, quality improvement cohort study reviewed patient medical records to compare UFH protocol adherence before and after the implementation of process standard work.
Methods and design
The authors designed and conducted the trial. Because it was a retrospective quality improvement project and no interventions were made as part of the study, it did not require institutional review board approval. Additionally, it had no sponsors or outside funding. Statistical analysis was performed independently by a senior research specialist at the hospital.
A retrospective medical record review analyzed standard VTE or cardiac UFH anticoagulant protocols initiated in either the preintervention group in January 2016 or the postintervention group in January 2017. These timelines were selected to minimize seasonal variations in patient populations and allow for a washout period after the process standard work implementation. Protocols were included for adult patients age 18 or older. Patients were excluded if they were admitted to the ICU, if their UFH infusion was interrupted for any reason, or if no aPTT values were reported. Only the first protocol was included for each admission, and all recorded aPTT results were evaluated in every UFH protocol that was analyzed.
The study defined adherence to dosing and monitoring in the UFH anticoagulation protocols. It included evaluation for UFH dose adjustments following a reported aPTT and the appropriate timing for the next aPTT depending on the protocol. Appropriately timed aPTTs were drawn 6 hours ±1 hour from the previous aPTT lab draw or along with routine morning labs. Additionally, the study determined the total time to action and defined it as the time from a reported aPTT result until the UFH dose adjustment was completed and documented in the electronic health record (EHR).
Data on patient demographics, time of action, and reported aPTT levels and associated clinical responses were collected from the EHR. Dose adjustments were documented in the medication administration record and compared with the UFH protocol to determine the appropriateness of each action. The raw data were collected and sent to a senior research specialist at the hospital for independent statistical analysis. Nonadherence to the protocol was also tracked and documented, including omissions, incorrect actions, and doses exceeding the maximum initial allowable dosage.
Pearson's chi-squared test was used to analyze the primary outcomes of dosage adjustments following aPTT and the appropriate timing of the next aPTT. The Mann-Whitney U test analyzed the time to action from reported aPTTs. The significance level was set a priori at less than 0.05, and all analysis was conducted using statistics software (see Statistical resources).9-11
Data and results
In total, 215 protocols were reviewed for the study, 109 of which were included in the final analysis (53 in preintervention and 56 in postintervention). These accounted for 445 aPTTs (225 preintervention and 220 postintervention). Additionally, the median duration of a UFH infusion was approximately 24 hours in both groups (23.5 hours and 22.7 hours, respectively). Patient demographics from the UFH protocol were comparable with the exception of the groups' mean age (70.6 years and 63.8 years, respectively) and dosing weight (85 kg [187.4 lb] and 95.5 kg [210.5 lb], respectively).
No significant difference was demonstrated between the pre- and postintervention groups in adhering to the nurse-driven UFH protocols. The appropriate interventions were implemented in 89.3% of aPTTs in the preintervention group and 90.9% of the postintervention group for a P value of .57. The aPTT timing was also similar in both groups, with approximately half of all aPTTs in each group timed appropriately (55.6% and 50.9%, respectively, for a P value of .33) (see Adherence to the UFH protocol). The median time from a reported aPTT to completion of the appropriate action was 47 minutes in preintervention and 40 minutes postintervention for a P value of .30.
Types of nonadherence to the UFH protocol were also grouped, and the most common errors were related to an omission (23 out of 24 errors [95.8%] and 16 out of 20 errors [80%], respectively). These included missed rate adjustments, boluses, and infusion holds.
Discussion of results
In adult patients who required UFH, no difference in adherence to nurse-driven protocols was observed following the implementation of process standard work. Despite an observed adherence rate of approximately 90% in both groups, a 10% error rate was still found for this high-alert medication.
Although many UFH dosing nomograms have been developed and published, protocol adherence has not been well evaluated. In a 2001 study, researchers developed a UFH nomogram and assessed adherence to it.12 The trial included 11 patients and yielded an overall adherence rate of 88%, similar to the results of this study. Although both dosing errors and lab errors (including aPTT timing) were included, the protocol was not nurse-driven. This study is the first to examine adherence to a nurse-driven UFH protocol.
The gap in nursing process standard work related to omission errors was an important finding; these processes do not address all protocol-related aPTTs. As there are no automated reminders or notifications for new lab results currently, only aPTTs observed by the primary nurse will be acted upon and witnessed by the secondary nurse. There are also no steps or safeguards currently included in either the protocol or process standard work that account for and act on aPTTs missed by the primary nurse.
Additionally, the study showed wide variation in the timing for lab monitoring of aPTTs. While the process standard work provides guidance on appropriate timing for follow-up aPTTs, the UFH order instructions do not designate a specific time frame in the EHR. The 2010 study from Williams and colleagues included standard timing for aPTT lab draws to minimize miscommunication between the nursing staff and the phlebotomists regarding scheduled blood draws.8 Implementation of standard timing for aPTT blood draws may improve the percentage of appropriately timed lab work.
In addition to discoveries regarding UFH protocols and process standard work, the study also established a baseline adherence rate for the VTE and cardiac UFH protocols. These data are an important part of quality improvement initiatives, showing the effectiveness of different interventions.
A washout period after the implementation of nursing process standard work provided a more accurate depiction of current workflows for UFH infusion initiation and dosage adjustment. This permitted time to distribute UFH infusion process standard work documents, educate the staff, and allow staff to master the new procedure. Additionally, conducting research at similar times of year helped control certain variables between the two groups, such as hospital census and patient population.
Because of its retrospective design, the study was limited. Retrospective medical record reviews rely on documentation in the EHR and cannot account for inaccuracies or omissions in the system. Although patients whose UFH protocols had been altered in the EHR were excluded, some actions counted as errors may have been purposeful deviations from the protocol according to verbal prescriber orders.
Additionally, because of differences between the EHR documentation and infusion management software, ICU patients were excluded from the study. Therefore, ICU adherence rates are unknown, and the study results cannot be applied to ICU patients.
Finally, due to a lack of standardization regarding specific timing of aPTTs, the appropriate timing was defined to collect data in the same way for each aPTT. This may not always be the interval used by the staff involved in each instance, however, as there may be additional contributing factors. These include lab scheduling conflicts and procedures, and they may not be accounted for in the EHR.
Future implications and applications
The implications of this study depend on revisions to the nursing policies, procedures, and process standard work at individual institutions. As most errors were due to omission, relying on nurses to remember the next aPTT result is likely an inadequate solution. Consideration may be given to EHR optimization that includes alerts when new aPTT results are available for patients receiving UFH infusions. Rather than relying on human recall, an electronic reminder can be useful in capturing new lab results. Once aPTT results were recognized by a clinical nurse, the error rate was low.
Similarly, UFH protocols should be updated to standardize timing for aPTT orders by including specific directions within order sets and adopting standardized draw times. Additionally, more complete EHR data should be addressed, including documentation of when UFH infusions are started, held, and stopped.
Once process standard work and UFH protocols are updated, staff education is important. Because this study established a baseline error rate and several limitations in facility protocols and procedures, future studies may be performed for ongoing quality improvement.
Among adult patients administered I.V. UFH for VTE or cardiac disorders, there was no change in adherence to a nurse-driven UFH protocol after the implementation of process standard work. Revision of the current standards may be beneficial to reduce medication errors related to the initiation and adjustment of a nurse-driven UFH protocol.