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/