Medication errors are one of the most common causes

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1 OUTCOMES IN PRACTICE Development and Implementation of a Standardized Sliding Scale Insulin Protocol Margaret H. Bahlinger, MS, RPh, and Kathryn A. Adkins, RN, BSN, CPHQ Medication errors are one of the most common causes of avoidable harm to patients in health care organizations. Among the high-alert medications that have the highest risk of causing injury when misused is insulin [1 3]. In 2000, Baptist St. Anthony s Health System (BSA), a nonprofit regional referral center located in Amarillo, Texas, participated in a VHA Medication Error Reduction initiative to reduce the likelihood of medication errors at the hospital. In light of the fact that 12% of inpatients in 2000 had a diagnosis of diabetes and that insulin was the second most common medication reported in medication error reports, BSA decided to focus on reducing insulin-related medication errors and preventable adverse events. In this paper, we describe a quality improvement project to reduce errors of insulin prescribing and administration using a standardized protocol and preprinted order form. Background BSA is licensed for approximately 400 beds, employs 2900, and has 326 physicians on staff. The center serves southern Colorado and Kansas, northeastern New Mexico, and the panhandles of Oklahoma and Texas. Medicare covers 55% of BSA s patient population. The area has an increasing obese, sedentary, and aging population and a growing number of diabetics. BSA is a member of VHA, Inc., a national alliance of 2200 community-owned health care organizations. The quality improvement project was implemented by BSA s interdisciplinary Medication Error Committee, which meets weekly to review medication errors and adverse events. The committee identifies trends and problems and delegates these to subcommittees or teams for action plans. The team appointed to attend VHA s Medication Error Reduction program included 4 nurses, a pharmacist, a quality improvement (QI) reviewer, and the hospital s risk manager. A physician member of the hospital s pharmacy and therapeutics committee volunteered to serve as team advisor. Evaluation of Clinical Processes Variations in blood glucose levels in diabetic patients at BSA were often addressed with an insulin sliding scale. Although there is debate about the applicability of the traditional sliding scale in inpatient blood glucose management [4 6], sliding scale insulin is relatively common in the hospital as an adjunct diabetes management tool. To identify types and numbers of sliding scales in current use, team members retrieved and examined copies of all sliding scale insulin orders from pharmacy files between 1 and 14 November Results of this preliminary audit showed the following: 94 different sliding scale orders 44% of the orders used the abbreviation u for units, a potential cause of tenfold dosing error [1,2] Lack of consistent measures to address hypoglycemia Difficulties in order interpretation due to handwriting To obtain a more detailed clinical picture, systematic sampling was used to obtain a 5% sample of patients who had received sliding scale insulin at BSA between December 2000 and February 2001; the charts of 32 patients were reviewed. Data from this assessment are shown in the baseline column in Table 1. The team was concerned about these findings. Good management of blood glucose levels in hospitalized diabetics is important; it improves the healing process and decreases the risk of complications [7,8]. The American Diabetes Association generally suggests target blood glucose levels of 80 to 120 mg/dl before meals and 100 to 140 mg/dl at bedtime in otherwise well diabetics [9]. Although hospitalized diabetics could be expected to have blood glucose readings somewhat higher than this, the mean of mg/dl was inappropriately high. Patients averaged 27 finger sticks each, suggesting that the high readings required additional follow-up testing and care. Better blood glucose control presumably could prevent or reduce the need for this. The usual standard of nursing care at BSA is to telephone the physician when a From Baptist St. Anthony s Health System, Amarillo, TX. Vol. 8, No. 11 November 2001 JCOM 31

2 SLIDING SCALE INSULIN Table 1. Clinical and Performance Measures in Insulin Sliding Scale Project Protocol Protocol Baseline Group 1 Group 2 Measure n = 32 n = 24 n = 27 Glucose problem (< 60 or 47% 21% 15% > 400 mg/dl) Glucose 251 mg/dl 27% 5% 18% Mean blood glucose, mg/dl Median blood glucose, mg/dl Interventions to treat low blood glucose Extra blood glucose checks Extra insulin doses Calls made to physicians for either high or low blood glucose readings Finger sticks glucose level is below 60 or above 400 mg/dl. With better blood glucose control, the need for such calls would diminish. Intervention To address the problems identified in the audit, the team decided to develop and implement a standardized sliding scale insulin protocol for inpatients with type 2 diabetes, by far the most common form of diabetes [10]. Standardizing the protocol would reduce the opportunities for errors such as omissions, wrong timing, and dosing mistakes due to misunderstood handwriting and abbreviations. Safety would be enhanced through the use of a preprinted order form that clearly designates the specific increments of insulin coverage [11]. Sample insulin sliding scale orders that had been successfully used in other VHA member hospitals were downloaded from VHA s electronic database. Components of various sample orders were selected and incorporated into a new form; the form was reviewed by BSA s pharmacy and therapeutics committee, staff endocrinologists, and a family practice physician and revised based on their input. The pilot form is shown in Figure 1. The preprinted, standardized order form eliminates abbreviations and the need for handwriting that could lead to error. Four dosing regimens are identified. The form includes instructions for adjusting the dosing scale upward or downward based on specific parameters and nursing assessment data and indicates when the nurse is to contact a physician. A pilot nursing unit serving family practice and a variety of medical and surgical patients was selected, and nurses were instructed on the protocol during regularly scheduled staff meetings in late May The pharmacy manager educated pharmacists about the new order and protocol in staff meetings during the same period, and standard pharmacy computer input methods were developed to facilitate and standardize pharmacist order processing. The implementation team mailed a sample order form and letter to all staff physicians, offering but not mandating the pilot protocol. Soon after the physicians received the letter, many asked for the protocol to be made available throughout the institution, not just on 1 nursing unit, and the pilot unit concept was abandoned. Nursing directors, with the help of BSA s diabetes educator, quickly educated nurses about the protocol on other patient care units. The sliding scale insulin order sheet instructs the user to employ another protocol, the hypoglycemia protocol, when fasting blood sugar is below 60 mg/dl (Figure 1). Although the hypoglycemia protocol was a current part of nursing policy, physicians, nurses, and pharmacists asked for information and clarification on this protocol. Medication floor stock levels were found to be inadequate to support protocolbased hypoglycemia care in some nursing units. Pharmacy and nursing personnel examined each floor s automated dispensing cabinets, and each was stocked with 40% dextrose oral gel, 50% dextrose injection syringes, and glucagon injection sufficient to manage estimated need. Measurement The implementation team s nurse QI reviewer collected data from pilot protocol orders on file in the pharmacy written between 7 June (pilot start date) and 17 July. Physicians from 9 specialties had used the protocol for 24 patients, or 13% of all patients who had received sliding scale insulin during this time. Mean blood glucose level decreased from to mg/dl. Glucose problems were reduced by more than half. Other comparative measures are shown in Table 1. In August 2001, the team completed another round of data collection, reviewing the charts of the 27 patients for whom pilot protocol orders were written between 18 July and August 14. Of greatest interest was the control of the patients blood glucose. Data showed sustained improvement (Table 1). Physicians from 12 specialties had used the protocol. Improvement Needs Further education for physicians, nurses, and pharmacists is needed regarding patient selection for application of the standardized sliding scale insulin protocol. Chart review revealed that two type 1 diabetics were placed on the protocol. For 1 patient, the protocol was discontinued and new orders written before the patient received any protocolbased treatment. The second patient received sliding scale insulin on the protocol and had inadequate blood glucose 32 JCOM November 2001 Vol. 8, No. 11

3 OUTCOMES IN PRACTICE BSA AFFIX PATIENT LABEL HERE PHYSICIAN S ORDERS PILOT Standing Sliding Scale Insulin INSULIN PROTOCOL FOR TYPE II DIABETICS Not recommended for more than two (2) days as the only method of control. REGIMENS: Low Dose Regimen: Suggested as starting point for the thin and elderly. Moderate Dose Regimen: Suggested as the starting point for average weight. High Dose Regimen: Suggested as the starting point for overweight patients. Very High Dose Regimen: Suggested as the starting point for patients with infections or those receiving steroids. DATE TIME ORDER VERIFICATION 1. Start sliding scale at dose level. 2. All insulin is Humulin-R (regular) insulin given subcutaneously unless otherwise specified. 3. If potassium is low (< 3.5 meq/l), call physician. 4. Check capillary blood glucose on prescribed schedule. Q 6 H (12 MN 6 AM 12 N 6 PM) Recommended for patients who are NPO. AC & HS (30 minutes before meals and at 9 PM) Recommended for patients WHO ARE ABLE TO EAT. 5. Changes: Advance to next higher dose regimen if glucose level is > 250 two (2) times in 24 hours and all readings were > 100. Decrease to the next lower dose regimen if glucose level is between 60 and 100 twice in 24 hours. 6. If any reading is 60 or below, initiate hypoglycemia protocol and notify MD. 7. Write a new Sliding Scale Insulin Protocol order sheet with dose regimen changes and send a copy to Pharmacy. Glucose Level Medium Dose Very High Dose (mg/dl) Low Dose Regimen Regimen High Dose Regimen Regimen Other Serum FBS < 60 Hypoglycemia Hypoglycemia Hypoglycemia Hypoglycemia Protocol, and Protocol, and Protocol, and Protocol, and call MD call MD call MD call MD units 5 units 6 units units 8 units 10 units 15 units units 10 units 14 units 18 units units 12 units 17 units 21 units units 16 units 20 units 25 units > units, and 12 units, and 12 units, and 12 units, and call MD call MD call MD call MD Physician s Signature: Date: Time: Suggested conversion to daily Humulin-N requirement: Use 3 /4 of total daily Humulin-R requirement as the total daily Humulin-N requirement. Figure 1. Sliding scale insulin order form used in pilot project. Vol. 8, No. 11 November 2001 JCOM 33

4 SLIDING SCALE INSULIN control. In addition, improved consistency is needed in documenting blood glucose data in the patient chart diabetic record. At BSA, blood glucose values and sliding scale insulin doses must be documented both on the medication administration record (MAR) and in the patient diabetic chart record. Documentation on the MAR was very good. Documentation in the chart record, however, was sometimes not completed simultaneously, making patient assessment more time consuming. This has been addressed with nursing education and procedural changes. Changes to the order form also are needed. The next draft will state specificially the events that the nurse is to report to the physician, such as reporting that a patient s food intake has changed. Boxes and lines on the form were distracting and interfered with clarity and will be revised or deleted as appropriate in the next version. The name of the form will be changed to make it clear that it is only for patients with type 2 diabetes and that the protocol is for sliding scale insulin coverage, (eg, Type 2 diabetic sliding scale insulin protocol ). The protocol is not recommended for more than 2 days as the only method of control. However, there is no reference on the form to long-acting insulins or oral antidiabetic agents that may be appropriate for the patient to continue while hospitalized. This also will be addressed in the next draft of the form. Further, a cautionary statement will be added that the protocol must not be used to manage diabetic ketoacidosis. The revised form and protocol will become official in the hospital pending the pharmacy and therapeutics committee s approval. Cost-Savings Analysis BSA s project implementation team performed an analysis to estimate cost avoidance associated with the standardized sliding scale insulin protocol. The team based their costsaving analysis on the following assumptions: The number of BSA inpatients using sliding scale insulin in a year could be estimated from the proportion of sliding scale insulin patients in the baseline group, compared to total patients during the same time frame. Of 4995 inpatients in 3 months, 12%, or about 600, of these patients used sliding scale insulin. In 1 year, this totals 2400 patients. Team members who were nurses estimated nursing time needed to treat high or low blood glucose (minimum of 30 minutes per episode), extra blood glucose checks and monitoring (minimum of 10 minutes per check), and telephone calls to physicians (at least 1 hour for telephone call, instructions, and documentation). This averaged 10.4 hours of extra nursing time per patient in the pre-protocol group with out-of-control blood glucose. Out of control blood glucose was defined as less than 60 or greater than 400 mg/dl. A telephone call was required for each blood glucose reading outside this range, and often more than 1 intervention was needed. At the time of baseline data collection, the average salary and benefit cost per hour for a registered nurse was estimated conservatively at $ This equated to $ (10.4 hours x $21.75/hour) in salary and benefit time for a nurse to manage blood glucose that was too high or too low. Before pilot protocol introduction, however, BSA adjusted nursing salaries such that the average salary and benefit cost was $23.00 per hour. Therefore, the team estimated comparable excess nursing time cost in the protocol group to be $ (10.4 hours x $23.00/hour). Out-of-control blood glucose has the potential to lead to an adverse drug event (ADE), with its attendant costs and hazards. The incidence of out-of-control blood glucose readings was calculated as the percentage of all readings under 60 and over 400 mg/dl in both the baseline and protocol groups. For estimation purposes, the same percentage estimate was used to calculate the number of patients in a year who could be at risk for experiencing a sliding scale insulin-related ADE. Risk avoidance was calculated based on the dollars the hospital paid for claims associated with adverse drug events from October 1999 through March 2001, averaged over the number of reported preventable adverse drug events (medication errors) that reached patients during the same period at BSA. The average amount per event was $2097. This figure excluded cost of insurance, legal fees, personnel costs, and supply expense. Using these assumptions, the team calculated dollar estimates for supplies, nursing time, and risk avoidance for both the baseline and protocol groups of patients. They extrapolated these estimates to the total number of patients using sliding scale insulin at BSA in 1 year. Comparisons of annualized cost estimates and savings are shown in Table 2. Projected savings for risk avoidance are shown in Table 3. Annualized potential savings projections totaled $340,055. Applicability Potential savings figures do not necessarily translate into identifiable dollars in the hospital s bottom line. They are 34 JCOM November 2001 Vol. 8, No. 11

5 OUTCOMES IN PRACTICE Table 2. Cost Analysis for Sliding Scale Insulin: Projected 1-Year Cost Savings Baseline Patients (n = 32) Protocol Patients (n = 24) Annualized $ Cost Annualized $ Estimated % of (% x Cost per % of Cost(% x Cost per $ Savings Item Patients (n ) Patient x 2400*) Patients (n ) Patient x 2400*) for 1 Year Nursing salary and benefits to manage (15) 254, (5) 119, ,202 out-of-control blood per patient per patient Low blood glucose treatment: juice and 12.5 (4) (1) $2.18 per treatment Low blood glucose treatment: juice and 12.5 (4) $3.78 per treatment Low blood glucose treatment: 50% dextrose 6.25 (2) injection $3.25 per treatment High blood glucose treatment: regular human 12.5 (4) (2) recombinant $12.03 per treatment Supplies for extra blood glucose finger stick (10) (3) $0.60 per check TOTAL 260, , ,743 *Average nursing salary cost per hour changed between baseline and protocol data collection periods. Estimated number of sliding scale insulin patients at BSA in 1 year = See assumptions in text. Table 3. Risk Avoidance: Projected Savings Baseline Group Protocol Group Number of Readings (n = 868) Number of Readings (n = 327) Annualized $ Cost Annualized $ Cost Potential ADEs Potential ADEs Estimated % Potential (% x Cost per % Potential (% x Cost per $ Savings Item ADEs ADE*x 2400) ADEs ADE*x 2400) for 1 Year Blood glucose > 400 mg/dl , , ,246 Blood glucose < 60 mg/dl , , ,066 TOTAL 322, , ,312 ADE = adverse drug event. *Cost per ADE = $2097. See assumptions in text. soft dollars. These figures are useful primarily in constructing estimates to cost-justify a project and appraise anticipated benefits. It is reasonable to expect an improvement of this nature to save the hospital money by increasing staff efficiency and by reducing unnecessary use of materials. The analysis we conducted is a method of attaching a value to increased efficiency and reduced wastage. The savings estimate does not include costs associated with increased length of stay (LOS) due to lack of blood glucose control. To date, the team has not examined the LOS variable in this project. All of the patients in both the baseline or protocol groups were admitted to the hospital primarily for treatment of another condition, with diabetes as comorbidity. A patient s LOS was associated more closely with the admitting diagnosis than with blood glucose control or lack thereof. The same was true of costs associated with level of care. In the patient charts examined, the team did not find any transfers to higher levels of care due to blood glucose control problems. Like LOS, the level of care was more closely related to the patient s admitting diagnosis than to blood glucose control. Level of care cost variations were not included in cost estimates for this project. Both LOS and level of care may become important considerations as the project continues. The results of this project may not be applicable to the needs of other institutions and patient populations. It is best described as a quality improvement effort, and adjustments and continued monitoring are necessary. The observed Vol. 8, No. 11 November 2001 JCOM 35

6 SLIDING SCALE INSULIN improvements may not be due solely to the new protocol, and the baseline and protocol groups may vary with respect to traits yet to be identified. The additional staff education and the attention focused on diabetes care in general are probably responsible for some positive changes. Summary An easy-to-use preprinted order form and standardized sliding scale insulin protocol for type 2 diabetics simplified the complex process of administering and monitoring a high-alert medication. Improved blood glucose control and more efficient use of resources were observed. Further adjustment and improvement of the order form and protocol are planned, and continued quality improvement monitoring is needed. BSA team members included the authors, Terry Ammerman, RN, MSN; Marty Farris, RN, CDE; Carla Jones; Susan Jones, RN, BSN; Marilyn Mays, RN; and Lou Rogers, RN, BS. The team gratefully acknowledges the support and advice of Dr. Charles V. Wright Jr, MD, MMM, Texas Tech University Health Sciences Center Medical School at Amarillo, physician advisor for the project. Thanks also to Dr. Ken Brantley, MD, PhD, for constructive comments and suggestions for improvements, and to Dr. Robert S. Urban, MD, Chair, BSA Pharmacy and Therapeutics Committee. Corresponding author: Margaret H. Bahlinger, MS, RPh, Pharmacy Manager, Baptist St. Anthony s Health System, 1600 Wallace Blvd., Amarillo, TX References 1. Cohen MR, Kilo CM. High-alert medications: safeguarding against errors. In: Cohen MR, editor. Medication errors. Washington (DC): American Pharmaceutical Association; Joint Commission on Accreditation of Healthcare Organizations. High-alert medications and patient safety. Sentinel Event Alert 1999 Nov 19; Issue Argo AL, Cox KK, Kelly WN. The ten most common lethal medication errors in hospital patients. Hosp Pharm 2000; 35: Hirsch IB, Farkas-Hirsch R. Sliding scale or sliding scare: it s all sliding nonsense. Diabetes Spectrum 2001;14: Bergenstal RM, Fish LH, List S. The insulin sliding scale is not dead. Arch Intern Med 1998;158: Nath C, Ponte CD. Lessons learned about insulin therapy. Nursing 2000;30: American Diabetes Association. Insulin administration [position statement]. Diabetes Care 2001;24(Suppl 1):S Kendall DM, Bergenstal RM. Comprehensive management of patients with type 2 diabetes: establishing priorities of care. Am J Manag Care 2001;7(10 Suppl):S Standards of medical care for patients with diabetes mellitus. American Diabetes Association. Diabetes Care 1994;17: Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes in the United States. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention; Smetzer J, Cohen MR. Safety briefs. ISMP medication safety alert! 2001;6:2. Copyright 2001 by Turner White Communications Inc., Wayne, PA. All rights reserved. 36 JCOM November 2001 Vol. 8, No. 11