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Based on interview, documentation in 4 of 5 medical records of patients with orders for insulin (Patient's 2, 3, 4, and 5), and review of policies and procedures, it was determined that the hospital failed to ensure that insulin was administered in accordance with physician's orders.

Findings include:

1. The review of the medical record of Patient 3 reflected that the patient was admitted on 03/10/2014 and discharged on 03/13/2014. Physician's orders for "NovoLog - Medium" sliding scale insulin dated 03/11/2014 at 0147 reflected that insulin was to be administered by subcutaneous injection after each meal and at bedtime as follows:
* FSBG 70 to 139 give no insulin;
* FSBG 140 to 170 give 1 unit insulin;
* FSBG 171 to 220 give 3 units insulin;
* FSBG 221 to 270 give 5 units insulin;
* FSBG 271 to 320 give 7 units insulin;
* FSBG 321 to 370 give 9 units insulin; and
* FSBG greater than 370 give 9 units and call the physician.

The Point of Care FSBG record reflected that on 03/11/2014 at 2041, the patient's BG was 145 which required 1 unit of insulin. There was no documentation on the MAR which reflected that the insulin was administered, nor was there explanation in the record for the omission.

The Point of Care FSBG record reflected that on 03/12/2014 at 1058, the patient's BG was 274 which required 7 units of insulin. Documentation on the MAR reflected that the next dose of sliding scale insulin administered was 3 units on 03/12/2014 at 1328. There was no documentation to reflect that the BG was taken again prior to 1328.

2. The review of the medical record of Patient 4 reflected that the patient was admitted on 04/17/2014 and discharged on 04/29/2014. Physician's orders for "NovoLog - Medium" sliding scale insulin dated 04/18/2014 at 0348 reflected that insulin was to be administered by subcutaneous injection after each meal and at bedtime as follows:
* FSBG 70 to 139 give no insulin;
* FSBG 140 to 170 give 1 unit insulin;
* FSBG 171 to 220 give 3 units insulin;
* FSBG 221 to 270 give 5 units insulin;
* FSBG 271 to 320 give 7 units insulin;
* FSBG 321 to 370 give 9 units insulin; and
* FSBG greater than 370 give 9 units and call the physician.

The Point of Care FSBG record reflected that on 04/19/2014 at 0756, the patient's BG was 165 which required 1 unit of insulin; on 04/24/2014 at 2015, the patient's BG was 150 which required 1 unit of insulin; on 04/27/2014 at 1439, the patient's BG was 181 which required 3 units of insulin; and on 04/27/2014 at 2020. the patient's BG was 225 which required 5 units of insulin. There was no documentation on the MAR which reflected that those insulin doses were administered, nor was there explanation in the record for the omissions.

Documentation on the MAR dated 04/23/2014 at 0909 reflected that Lantus insulin 25 units was administered by subcutaneous injection to the patient. The MAR documentation included a notation that the order for that medication was written on 04/18/2014 at 0348. The physician's orders reflected that the only physician's order for Lantus insulin 25 units was dated 04/18/2014 at 0348 and was written to be administered one time. The stop date on that order was recorded as 04/18/2014 at 0348.

3. The review of the medical record of Patient 5 reflected that the patient was admitted on 05/25/2014 and discharged on 05/28/2014. Physician's orders for "NovoLog - Medium" sliding scale insulin dated 05/26/2014 at 0234 reflected that insulin was to be administered by subcutaneous injection after each meal and at bedtime as follows:
* FSBG 70 to 139 give no insulin;
* FSBG 140 to 170 give 1 unit insulin;
* FSBG 171 to 220 give 3 units insulin;
* FSBG 221 to 270 give 5 units insulin;
* FSBG 271 to 320 give 7 units insulin;
* FSBG 321 to 370 give 9 units insulin; and
* FSBG greater than 370 give 9 units and call the physician.

Documentation on the Point of Care FSBG record reflected the last BG recorded for the patient was on 05/28/2014 at 0830 and was 207. The MAR reflected that the last insulin the patient received while in the hospital was 3 units of NovoLog insulin at 0846.

Dietary department documentation reflected that the patient ordered cream of chicken soup and two diet cokes on 05/28/2014 at 1054 and ordered cream of chicken soup again on 05/28/2014 at 1247.

Physician's orders reflected an order to discharge to home written on 05/28/2014 at 1321. The time patient discharge instructions were printed was recorded as 1423, and the hospital Admission Record reflected that the patient was discharged from the hospital on 05/28/2014 at 1442.

There was no documentation to reflect that the patient's BG was monitored and insulin administered in conjunction with the noon meal, in accordance with the physician's orders, prior to the patient's discharge home at 1442.

4. The review of the medical record of Patient 2 reflected that the patient was admitted on 02/17/2014 and discharged on 02/21/2014. The physician's history and physical recorded on 02/17/2013 at 1524 reflected that the patient had high blood sugar with a history of diabetes and had an insulin infusion pump which the patient and family managed at home. Documentation by the physician and RN staff in the record reflected that the patient was receiving doses of insulin via the pump during the hospitalization. However, there were no physician orders related to the patient's self-administration of insulin while in the hospital.

Refer to the interview and record review findings related to the patient's insulin administration recorded under Tag A412, CFR 482.23(c)(6).

5. The policy and procedure titled "Administration of Subcutaneous Insulin (Including Basal, Combination, Mealtime, and Correction) and Carb Counting dated as reviewed "May 2010" reflected that "Subcutaneous Correction Dose (Sliding Scale) Insulin shall be administered as outlined in preprinted orders..." The "Guidelines" section of the policy which addressed meal time Novolog correction insulin (sliding scale) included: "Hold Meal Time Novolog if patient eats less than 1/2...Give Meal Time and/or Correction doses of Novolog 0-15 minutes after each meal...If patient orders their meal at a different time, change Meal Time Insulin administration time accordingly in the MAR...If Correction dose is not given within 30 minutes after the [blood sugar level] was taken, repeat the [blood sugar level].

The policy and procedure titled "Glycemic Control - Hyperglycemia" dated as revised" May 2010 reflected that for blood sugar levels greater than 500 staff were to retest the blood sugar, page phlebotomist to perform a blood draw, notify the physician and document. For all episodes of blood sugar levels greater than 180 staff were to "Document assessment, treatment, physician notification (if applicable) and evaluation of patient response in appropriate portions of the chart."

6. The onsite review of medical records was conducted electronically on 06/17 and 06/18/2014. Hospital staff present during all or some of the electronic medical records review included: Director of Standards and Performance Improvement, Clinical Improvement Coordinator, Patient Safety Advocate/Risk Manager, Pharmacy Director, and the Clinical Application Analyst. The findings identified in this deficiency were shared during and at the conclusion of the electronic review and no additional information was provided.

Based on interview, documentation in 1 of 1 medical record reviewed of a patient with an implanted insulin infusion pump (Patient 2), and review of policies and procedures, it was determined that the hospital failed to ensure that the insulin pump had been evaluated, the patient assessed, and insulin self-administration ordered, managed, and documented in accordance with its own policies and procedures.

Findings include:

1. The review of the medical record of Patient 2 reflected that the patient was admitted on 02/17/2014 and discharged on 02/21/2014.

The physician's history and physical recorded on 02/17/2013 at 1524 reflected that the patient had high blood sugar with a history of type 1 diabetes and had an insulin infusion pump which the patient and family managed at home. Documentation in physician progress notes dated 02/19/2014 at 1213 and 02/20/2014 at 1323, and in the physician's discharge summary dated 02/21/2014, reflected physician communications with the patient and two family members related to the patient's insulin pump management in the hospital and at home. However, there were no physician orders related to the patient's use of his/her insulin pump while in the hospital.

Two entries by RNs on patient history and assessment forms dated 02/17/2014 at 0925 and 02/17/2014 at 1220 identified "Medical Devices : Insulin pump".

Patient education notes by an RN recorded on 02/18/2014 at 1710 included reference to the patient's insulin pump.

Documentation in RN notes dated 02/19/2014 at 1102 reflected "[Patient], RN, [two family members] collaborated to get insulin pump going. Pt was unsure about several steps, however, this RN feels as though it was initiated successfully. [Diabetes Educator] will be by later to check on [patient]."

Documentation in RN progress notes dated 02/20/2014 at 0059 reflected the patient's blood sugar was 503 and that the physician was notified and insulin orders were received. The note reflected "[Patient] thinks [his/her] insulin pump is programmed for 'bolus' doses. Insulin pumps not used on this unit."

Documentation in RN progress notes dated 02/20/2014 at 1310 reflected that the "Night shift RN stated in report that the patient's insulin pump was not working and that patient had elevated blood sugars...[family member met with physician] notified [family member] that the [patient] stated [his/her] pump was not working." The note reflected that the patient stated that the Diabetes Educator had adjusted settings on the pump. The note also reflected that the patient's [spouse] had refilled the pump and the patient had primed the tubing.

Documentation by an RN on a Patient and Family Education form on 02/21/2014 at 1503 reflected the patient acknowledged having the insulin "pump educators contact information."

There was no other assessment or intervention documentation by RN staff related to the insulin pump.

2. The policy and procedure titled "Use of Patient's Own Medical Equipment" dated as reviewed "August 2010" contained the following requirements:
"If the medical equipment is part of the patient's pre-existing medical care and the patient wishes to continue the same care, the patient may do so only when:
* A physician order is in the patient's chart indicating that the patient may use their own devise and the medical indication for the use of the device...
* The patient or family member demonstrates they are competent to safely operate the device including what to do if a malfunction occurs...
* The device must meet basic exterior visual safety criteria...
* The patient agrees that the hospital may provide substitute equipment if the patient is unable to safely use or maintain the equipment or it would be in the best interest of the patient to do so...
* The patient accepts full responsibility for the operation, maintenance, safety and functioning of the equipment and for providing and replacing any supplies or medication that the equipment may require...
* Hospital staff is responsible for documenting the use of patient-owned medical equipment as part of their routine patient assessment processes...
* The Hospital's Patient Medication/Equipment Release Form is signed and included in the patient's chart...
* If any problem arises or if the patient/family is unable to operate the equipment, Hospital staff will discontinue the patient owned equipment...
* During the patient admission process, the nurse shall ask the patient if any electrical or battery-operated medical equipment has been brought into the hospital. The device shall be visually inspected by the nurse for any obvious damage...
* When Attachment A (Release of Hospital Responsibility for Use of Patient's Own Equipment) is completed it will be dated, signed, and added to the patient's chart..."

Inconsistent with the policy language, the policy Attachment A was a form titled "Staff Checklist for Using a Patient's Own Medical Equipment". The form consisted of six items comprising the requirements of the policy. Those included: "A physician order in the patient's chart states that the patient may use his or her own electrical or battery-operated medical device and indicated the purpose of the device (e.g. 'patient may use own insulin infusion pump')."

The policy also included an Attachment B titled "Release of Hospital Responsibility Use of Patient's Own Equipment".

3. The policy and procedure titled "Medication - Use of Patient Own" dated as revised "May 2011" reflected that the "Use of own medication shall be limited to: Topical eye preparations...Oral contraceptives...Medications not available in the hospital pharmacy, on a case-by-case basis."

4. On 06/17/2014 at 1500, during the review of the record of Patient 2, an interview was conducted with the Pharmacy Director and the Director of Standards and Performance Improvement. They confirmed that it was not clear if the patient's self-administration of insulin while in the hospital was incorporated into the patient's diabetes management plan. The Pharmacy Director stated "I think we need an order" and further indicated that a team was talking about the issue of patient "glycemic control" for inpatients.

During interview on 06/17/2014 at 1600, the Director of Standards and Performance Improvement indicated that the hospital did not have a policy and procedure or physician's order set for the use of insulin pumps by inpatients and that staff should document a narrative which reflected that the patient could take care of his/her own pump during the hospitalization. They confirmed that a team was working on developing a "draft" policy and procedure.

During interview on 08/14/2014 at 1000, the Patient Safety Advocate/Risk Manager confirmed that the hospital's current policies and procedures identified under 2 and 3 above had not been followed and that the "Staff Checklist for Using a Patient's Own Medical Equipment" and the "Release of Hospital Responsibility Use of Patient's Own Equipment" had not been used for Patient 2.