Implementation Plan

MISSION STATEMENT














The threefold mission of the perioperative dept at our facility is to first strive to achieve safe, successful surgical intervention, second to promote an uneventful phase 1 post operative recovery with the minimal discomfort possible, and third to enable the client and his caregivers to provide a continued effective recovery upon admission to post operative phase II. For the diabetic population this is particularly challenging. External evaluation of evidence based research clearly demonstrates a direct correlation between elevated glucose levels and postoperative complications, manifested by delayed wound healing and increased incidence of infections (Allen 2008, Maser 1996, Mathias 2007, Moghissi 2009, Wellard 2007). Research further suggests the standardized practice of monitoring blood glucose levels every 1 to 2 hours intraoperatively, as stress induced hyperglycemia is the body’s expected response (Furnary 1999, Maser, Moghissi). The ADA recommended range is 140 to 180 mg dL under physiologically stressed conditions and 100 to 140 under normal inpatient stress conditions (Moghissi).

Product Selection
A continuous glucose monitoring device (CGMD) should provide early detection of undesirable hypoglycemic events and ultimately avert postoperative complications secondary to hyperglycemia (Allen, George 2009, Magee 2007, Mathias,). CGMD’s are a recent innovation. Of the 3 FDA approved devices we investigated, we have selected the Seven Plus from DexCom, who offers an excellent product and superior vendor service in addition to being the only major medical manufacturer company solely dedicated to diabetic management (dexCom.com).

Planning Phase of Implementation Plan
The planning phase will be under the direction of a multidisciplinary team of perioperative and diabetic nurse educators with input from clinical II and III staff RN’s, in addition to selected anesthesiologists, endocrinologists, and pharmacists. Materials management and the DexCom vendors will be also utilized. Step one will be preparation. The current policies and procedures for point of care accuchecks will be revised to temporarily coincide with the Seven Plus CGM. A policy and procedure will be created specifically for patients receiving CGM, including the insertion, maintenance and interpretation of the receiver monitor read outs according to manufacture guidelines. Patient selection criteria for the initial phase will be defined utilizing the ranges of the Body Mass Index (BMI) of Diabetic Type II patients, proposed length of surgery, and type of anesthesia.

Go Live Step 1
Nursing preparation will include education and instruction. Education will include a review class about diabetes management, the postoperative complications associated with hyperglycemia, and the signs and symptoms of hypoglycemia. A review of the current policy and procedure for point of care testing and insulin administration will be followed with the additional CGM policy. An instruction video will demonstrate proper technique for probe insertion, receiver calibration, trend reading, and wave form interpretation of a malfunctioning probe with trouble shooting techniques, along with concise documentation for all of the above. An on-line written test via the education web site covering these topics will be given. After passing the test, simulated hands-on training with return demonstrations of proficiency will commence with the superusers being trained prior to their peers.

Go live Step II
The initial go live phase will be implemented by parallel conversion on a limited number of patients who meet selection criteria. On site vendor support will be ongoing during the first three days. Staffing of the affected units will be increased by 20% and super users will not be given regular patient assignments for the first 2 weeks.
During the first 2 weeks, in addition to following CGM policy and procedure guidelines, glucose levels will be monitored by point of care accuchecks every 2 hours from the start of the surgical procedure for a total of 8 hours, and then every 4 hours according to current policy. Any hypoglycemia or hyperglycemia trending, or suspect clinical manifestations, will be verified with an accuheck and treated according to diabetic algorithm protocol as prescribed by the involved endocrinologists.
Internal evaluation will first be made at the end the 2 weeks, including a comparison of CGM and simultaneous accucheck readings. If the discrepancies of the interstitial glucose levels are consistently within the expected 20 percentile range of error, the patient selection criteria will be expanded to include all Type II diabetics undergoing general anesthesia with an expected 23 hour observation stay. The bihourly accuchecks will revert to the prior practice of pre and post surgical and every 4 hours thereafter for the next 45 days, again comparing and recording readings between devices. This will allow time for careful scrutiny of the Seven Plus CGMD and promote maximum nurse proficiency with the product. Any suspect reading or symptoms from the patient will still warrant a point of care accucheck at any time between scheduled readings. Another internal evaluation of the product including the nursing staff will be made at the end of 45 days. If the goal of achieving tighter glucose control is overall effective, then the policy will be updated to the manufacture recommendation of accuchecks only being checked every 12 hours.

Case Study
A study was done in 2007 to assess the reliability and accuracy of CGM compared to blood glucose levels during surgery. 29 patients undergoing major scheduled surgeries were participants. An arterial line was inserted and frequent blood glucose monitoring occurred throughout the surgery. 100 samples were compared and the lower and upper limits of blood glucose coincided to interstitial CGM at 21% and 18% respectively” (Yamashita 2008). This evidence based study confirms the manufacture’s claim of CGM device reliability during the perioperative experience, in addition to the benefit afforded to diabetic patients by the value of constant observance of glucose trends and ultimately a decrease in uncomfortable finger sticks (dexCom.com).




Reference List:

Allen, G (2008). Evidence for practice. Continuous blood glucose monitoring during surgery. AORN Journal, 87(5), 1016-1017.

Maser, R., Ellers, J., & DeCherney, G. (1996). Glucose monitoring of patients with diabetes mellitus receiving general anesthesia: a study of the practices of anesthesia providers in a large community hospital. AANA Journal, 64(4), 357-361.

Mathias, J. (2007). Aiming for tighter glucose control…this article originally appeared in the September 2006 OR Manager. OR Manager, 10-12.

Moghissi, E.S. MD, Korytkowski, M.T. MD, DiNardo, M. MSN, Hirsch, Irl B. MD, Inzuchi S.E. MD, Ismail-Beigi, F. MD (MayJune 2009). American Association of Clinical Endocrinologists and American Diabetes Association Consensus Statement of an inpatient glycemic control. Endocrine Practice, Vol 15 (4), 1-10

Wellard, Sally J. RN PHD, Cox, Helen RN PhD, Bhujoharry, Claire BN (2007). Issues in the provision of nursing care to people undergoing cardiac surgery who also have type 2 diabetes. International Journal of Nursing Practice 2007; 13: 222-

Furnary, A.P., Zer, K.J., Grunkemeier, GL (1999). Landmark studies on glucose control: risk of hyperglycemia. Annual of Thoracic Surgery 1999; 67:352-362
George, Christa M. (2009) Future Trends in Diabetes Management. American Nephrology Nurses’ Association, 36(5), 477-483

Magee, M. (2007). Hospital protocols for targeted glycemic control: development, I mplementation, and models for cost justification. American Journal of Health-System Pharmacy, 64S, 15-23

DexCom, http://www.dexcom.com/

Yamashita K., Okabayashi T. (2008). The accuracy of a continuous blood glucose monitor during surgery. Anesthesia Analogue 2008; 106 (1), 160-163

Request for Proposal

Situation overview
The post anesthesia care unit (PACU) at our acute care facility consists of two separate departments under the same management. The combined bed capacity of 20 can be expanded to include 6 more overflow beds when patient saturation is high. Maximum saturation occurs when there are no in house available beds, which means the PACU patients convert to “floor care”, and will remain in our unit until a regular hospital bed becomes available. Our patient population is 95% adult, including geriatrics, the 5% being pediatric outpatient procedures of ages 1 month to 16 years. (Above 16 is considered adult.) We recover patients following various surgery procedures from appendectomies to craniotomies, radiological intervention procedures, and any procedure requiring conscious sedation or general anesthesia. The only surgery clientele we do give post operative care to are the cardiac surgery patients.
A significant number of our clients on any given day are diabetics, so finger sticks for accuchecks to measure glucose levels are frequently done in the PACU. When an anesthesiologist deems one to be needed during a surgical procedure, a PACU nurse will be called into the OR suite to perform the test. While this is only a 5 minute task in all, it can often occur when the PACU nurse is already caring for her own fresh post operative patients who are still emerging from anesthesia.
Task
The task our PACU hopes to accomplish is to augment finger stick accuchecks with continuous glucose monitoring (CGM) during the perioperative stay on all known and suspected diabetic patients. In addition to accuchecks increasing the nurses’ workload while being uncomfortable to the patient, accuchecks only provide an isolated glimpse of what a patient’s glucose level is. While peritoneal glucose levels are not as accurate as serum blood levels, a constant measurement of trends can be observed every 1 to 15 minutes, depending on the external monitor setting. This affords a great advantage to the patient because glucose swings can be detected before becoming extreme. (medronics 2010).

When a trend towards hyper or hypoglycemia is observed, a finger stick will accurately assess the necessary intervention. Elevated blood sugars will be averted and hypoglycemic episodes will be prevented. If the trends are fairly consistent and within designated parameters, then routine accuchecks only need to be done every 12 hours instead of the traditional four throughout the patient’s hospital stay.

Product Description
Of the 7 FDA approved continuous glucose monitoring devices (CGMD) currently on the U.S. market (George 2009), our PACU has decided to work with three different vendors; Abbot, Medtronics, and DexCom. Abbot offers the Free Style Navigator, Medronics offers the Guardian Heal, and DexCom offers the Seven Plus. All three of these companies are U.S. based with international expansion and all present as solid companies who will be around for years to come (medronics, abbott, dexCom 2010).

California based Abbot Diabetes Care (http://www.abbottdiabetescare.com/) is “devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products” to “reduce the discomfort and inconvenience of blood glucose monitoring…”(abbott 2010). Medronics, http://www.medronicdiabetes.com/, a stable company, also California based, was founded in 1949 and incorporated in 1957 is one of the world’s largest vendors for a multitude of different medical products. Their mission statement is to “alleviate pain, restore health and extend life” (medronics). Their continuous glucose monitoring product, the Guardian Heal, is similar to the Seven Plus offered by DexCom with minor variations (Holt 2008).
The president and CEO of DexCom, (www.dexCom.com) founded in 1999, became such after retiring from Medtronics in 2002. From 2003-2004, Mr. Terrance Gregg served as the Chair of the Research Foundation Board of the American Diabetes Association. DexCom focuses 100% on continuous glucose sensing technologies, working toward a future permanent implantable “pancreas” (dexCom 2010).
While all of these devices use the same technology, for the purpose of avoiding redundancy, only the DexCom Seven Plus is portrayed below.






All three companies have a wireless receiver as pictured above, about the size and weight of a cell phone which receives input then portrays it on a screen. The receiver can only be 5 to 10 feet from the patient to transmit (medronics, abbot, and dexCom 2010). This one allows a distance of 5 feet (dexCom 2010).
The enlarged photo of the Seven Plus screen shows the glucose reading of 160, a large arrow indicating a current increase or decrease in sugar levels, and a trend graph which can be manipulated to display 1, 3, 6, 12, and 24-hour glucose trends (dexCom 2010).
The horizontal dotted lines are the alarm settings of high and low glucose ranges which do respond audibly if limits are exceeded. They also provide clear demarcation of any spikes in either direction as they are happening (medronics, abbott, dexCom 2010).
The sensor, the second of three components of CGMD, is a glucose oxidase/based electrochemical sensor placed beneath the skin into the subcutaneous tissue, the feeling of insertion being equivalent to a finger stick (George 2009). It is about the size of two human hairs and is very soft, flexible, and attaches to the skin with an adhesive patch. It is good for up to 7 days in the Seven Plus, 5 in the Medronics Guardian, and only 3 in the Abbott Navigator (medronics, abbot, dexCom 2010).







The adhesive patch attaches the sensor to the transmitter, which sends interstitial glucose levels to the receiver usually every 5 minutes, and is water proof (medronics, abbott, and dexcom 2010).

In addition to the previously mentioned advantages of patient comfort, rapid recognition of abnormal glucose swings, and less nursing time on the task, the greatest advantage to the patient is comparable to the accucheck being like a snapshot whereas the CGMD is like a video, hence much quicker at detecting undesirable glucose levels. And while interstitial glucose levels lag behind serum levels on the average of 7 minutes, recent studies show that when glucose levels are falling, the interstitial glucose fluid may drop faster than the serum level, which would further prevent an acute hypoglycemic event (Oliver 2009).
The greatest disadvantage for all of these products is the cost, compounded by very few insurance companies covering any expenses, although some are starting to. DexCom is slightly more costly, but its sensor lasts the longest. And of course, the parts are not interchangeable from the different manufactures. The receiver and transmitter have a year warranty, but can last up to 18 months. The receiver is battery operated with an overnight electric charger, much like a cell phone. The transmitter costs around $300, the receiver around $400, and the sensor $50 to $70 each, the DexCom more because it lasts longer. The adhesive patches are about a dollar each (medronics, abbott, dexCom 2010).
For this product to be effective in our perioperative setting, there would need to be several transmitters and receivers in the OR, one per room, in addition to several in the pre and post op areas. The initial investment would have to be repeated on an annual to semiannual basis, in addition to the weekly costs of the disposable sensors and patches. Unless the patient happens to have the same product at home use, he would not be able to utilize the sensor once discharged from the hospital.

Proposal
Because these 3 companies are well established, reputable and financially stable, and their products are so similar in quality and expense, and insurance companies are beginning to cover some of these costs, a proposal will be extended to each of these companies for the best pricing and company support, with the hope that competitive marketing can work toward our hospital’s most equitable investment, and our clients financial advantage.

REFERENCES
1. medronicdiabetes.com
2. George, Christa M. (2009) Future Trends in Diabetes Management. American Nephrology Nurses’ Association, 36(5), 477-483

3. http://www.medronicdiabetes.com/, http://www.abbottdiabetescare.com/, http://www.dexcom.com/

4. http://www.abbottdiabetescare.com/

5. http://www.abbottdiabetescare.com/
6. Medline Plus > Blood glucose monitoring Update Date: 6/17/2008. Updated by: Elizabeth H. Holt, MD, PhD. In turn citing: American Diabetes Association. Standards of medical care in diabetes -- 2008. Diabetes Care. 2008;31:S12-S54.
7. http://www.dexcom.com/

8. http://www.medronicdiabetes.com/, http://www.abbottdiabetescare.com/, http://www.dexcom.com/

9. http://www.dexcom.com/

10. http://www.medronicdiabetes.com/, http://www.abbottdiabetescare.com/, http://www.dexcom.com/

11. George, Christa M. (2009) Future Trends in Diabetes Management. American Nephrology Nurses’ Association, 36(5), 477-483

12. http://www.medronicdiabetes.com/, http://www.abbottdiabetescare.com/, http://www.dexcom.com/

13. Ibid

14. Oliver, N., Toumazou, C., Cass, A., & Johnston, D. (2009). Glucose sensors: a review of current and emerging technology. Diabetic Medicine, 26(3), 197-210. doi:10.1111/j.1464-5491.2008.02642.x.

15. http://www.medronicdiabetes.com/, http://www.abbottdiabetescare.com/, http://www.dexcom.com/

Strategic Planning

Strategic Planning of
Implementing Continuous Glucose Monitoring in the
Surgical Patient Population

Aim of the Project
The aim of this project is to achieve the standardized practice of implementing a continuous glucose monitoring device on all diabetics experiencing surgery at Hoag Hospital. The ultimate goal being a reduction in the risks and complications secondary to hyperglycemia which currently prolong hospital stays.
Outline of the Project
Upon admission to the Post Anesthesia Care Unit, all known and suspected diabetics, (i.e. those with abnormally elevated glucose levels in their presurgical blood work) will have their glucose levels monitored with the traditional finger stick method, noting pre and post operative level disparities to clearly define the problem. An MD order will need to be obtained to perform any accuchecks not already ordered.
A data collection sheet will be created to log the results of pre and post operative glucose levels, as well as any done intraoperatively. On each of these patients the times of the glucose level checks, along with the dosage and time of any insulin will be noted in the survey. In addition, the ordered frequency of postoperative glucose monitoring will also be recorded. Surgical start and finish times will be documented. This study will commence over a 10 day period, with at least 25 patients monitored, or until 25 patients are studied. Upon the conclusion of this collection of data, pre and post operative sugars will be correlated to the length and type of surgery.
Simultaneous to the above mentioned data collection; external research will be conducted on the potential choices of continuous monitoring devices. A thorough investigation of products available via the internet and the EBSCO library at Vanguard, in addition to recommendations or endorsements by the American Diabetic Association or the American Association of Clinical Endocrinologists will be conducted. Letters and personal interviews with vendors of the various companies selling these products will also take place. The vendor interviews will include a discussion of the application and usage of their product, in addition to the projected expense and feasibility of implementation to the clients and /or hospital. If possible, samples of product options will be procured from the vendors as well.
The culmination of the above external and internal research will first be presented to the perioperative staff of anesthesiologists and nurses, along with the perioperative nurse educators and managers in an informal presentation. A vendor of the most favored product will hopefully be a part of the presentation. If possible, any samples of products will be shared. The pros and cons of the different devices will be demonstrated. In addition to the presentation of the various devices, the evidence procured by the results of the patient glucose monitoring study will be displayed. If indeed the random data collection concludes there is a marked elevation of glucose relative to the surgical type and length, the need for intraoperative monitoring will be particularly stressed.
A power point presentation of all of the above mentioned efforts will be presented to the nursing informatics class.

Statement of the Problem

One in five patients over the age of 60 is a diabetic (Gavi & Hensley 2009). One in five of all patients admitted for surgery are undiagnosed diabetics (Mathias 2007). In view of these statistics, the patient population requiring glucose monitoring during surgical admissions will predictably increase. The current practice of multiple finger sticks for glucose samples throughout the perioperative experience is uncomfortable for the patient, an additional task for already busy nurses, and logistically challenging intraoperatively. A continuous glucose monitoring device placed on the patient preoperatively could alleviate patient discomfort, avoid delays of treatment, and avert many postoperative complications secondary to hyperglycemia.

Review of the Literature
Research suggests that because of the acute hyperglycemia which occurs intraoperatively, in known or suspected diabetics, glucose levels should be monitored every 1 to 2 hrs throughout the surgery (Maser, Ellers & Decherney 1996). However with the patient’s hands relatively inaccessible while covered under sterile drapes, glucose testing tends to be delayed until the patient reaches Phase I recovery, resulting in “chasing” elevated blood sugars with insulin injections (Allen 2008).
For the diabetic patient undergoing surgery, this acute hyperglycemic reaction puts him at risk for many complications. Intraoperatively, cardiovascular or neurological complications may occur (Maser, Ellers & Decherney 1996). Postoperative sustained blood glucose levels above 250 mg dL result in prolonged hospital stays due to delayed wound healing, and infections (Maser, Ellers & Decherney). The American Diabetic Association recommended in 2009 that glucose levels of critically ill patients be maintained between 140 and 180 mg dL(). In another study the recommended blood sugar intraoperatively was between 180 and 200 mg dL (Mathias 2007) . Therefore stringent monitoring of glucose levels throughout the perioperative process of diabetic patients is imperative to averting undesirable medical or surgical outcomes.
A continuous glucose monitoring device could prevent undetected detrimental glucose swings while lessoning the work load of the nursing staff. Currently there are 7 FDA approved devices on the market which are usually combined with an insulin pump (George 2009). Continuous glucose monitoring is now being utilized in some facilities during hospitalized labor and delivery on diabetic mothers (Stenninger & Lindqvist 2008). Subcutaneous glucose monitoring “Involves placing a glucose oxidase-based electrochemical sensor beneath the skin once every 3 to 7 days. The sensor measures interstitial glucose levels at regular intervals and transmits them wirelessly to a receiver where they are stored” (George 2009).

Aim of the Project
The aim of this project is to decrease the frequency of intermittent finger sticking for glucose results, while achieving continuous glucose monitoring throughout the hospital stay. The desired outcome being glucose levels of diabetics are maintained within the ADA recommended range of 140 to 160 mg dL as deviations will be promptly recognized and treated. The risks and complications secondary to hyperglycemia will be averted, and hospital stays will be shortened.
Outline of the Project
The first step will be to monitor glucose levels on patients who admit to the PACU, noting pre and post operative level disparities to clearly define the problem. Length of surgery will also be noted in addition to insulin requirements. This will be done over a 10 day period. As results are accumulating, external research will be conducted on the potential choices of continuous monitoring devices, the expense and feasibility of implementation. Ongoing internal assessments through casual interviews with anesthesiologists and perioperative coworkers will be performed throughout the process. Samples of product options will be procured and through the help of vendors, a trial run may be implemented if approval can be obtained from the unit managers and anesthesiologists. Results of these efforts will be presented to the perioperative staff and the nursing informatics class.







Reference list
Gavi, Shai, MD & Hensley, Jennifer, MD (2009). Diagnosis and management of type 2 diabetes in adults: A review of the ICSI guideline. Geriatrics , 64(6)
Mathias, J. (2007). Aiming for tighter glucose control... this article originally appeared in the September 2006 OR Manager. OR Manager, 10-12.
Maser, R., Ellers, J., & DeCherney, G. (1996). Glucose monitoring of patients with diabetes mellitus receiving general anesthesia: a study of the practices of anesthesia providers in a large community hospital. AANA Journal, 64(4), 357-361. Retrieved from CINAHL with Full Text database.
Allen, G. (2008). Evidence for practice. Continuous glucose monitoring during surgery. AORN Journal, 87(5) 1016 -1017

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