HospitalInspections.org

The Condition of Participation of Quality Assessment & Performance Improvement Program was not met.

Findings included:

The Hospital failed to identify opportunities for improvement, consider the incidence, prevalence, and severity of problems and implement changes that will lead to improvement for 1 (Patient #1) of 10 patient records reviewed.

Refer to TAG: A-0283.

Based on review of the Hospital's internal investigation, medical record review, supporting documentation review and staff interviews, the Hospital failed to prevent the potential for a similar event, following a medication omission (Insulin, a medication to control blood sugars) over a period of 3 days and with multidisciplinary oversight from medicine, nursing and pharmacy.
The Insulin omission and failure of staff to recognize or communicate abnormal (rising) blood glucose levels, required one Patient #1 to be transferred to the intensive care unit for higher level of care due to ketoacidosis (a serious diabetes complication where the body produces excess blood acids), from a total sample of 10. The Hospital:

* failed to document the re-education of nursing or medical staff regarding the on-going communication of patients' history/physicals (especially problem-prone during "hand-off" and abnormal laboratory values (prior to becoming critical level).
* failed to identify other potential problem-prone clinical areas and relevant staff related to the "24-hour order" reviews (also referred to as electronic "work lists"), across other clinical units.
* failed to identify and implement an alternative solution to the pharmacy software system incompatible with an Insulin "hold" medication order (the insulin was never formally communicated and not listed on the Patient's inpatient medication orders.
* failed to identify and report the incident in a timely matter.

Findings include:

Review of the Hospital's Quality and Safety Plan, effective for calendar year 2020 - 2021, indicated that the Hospital shall have "Patient Safety Strategies". The Hospital will identify opportunities for improvement and prioritize for system redesign.

Staff members are encouraged to report all recognized safety risks, error and harm in accordance with the requirements and processes outline in the Hospital's policies.

Review of adverse events and systems and process failures that meet certain criteria will be accomplishment in part through the mechanism of a systemic approach of individual or pattern problem identification, followed by the institution of appropriate measures to improve patient care, safety and patient satisfaction and reduce the likelihood of recurrence. The Quality and Patient Safety team tracks recommendations until all are implemented by the team identified as responsible for the action plan.

Review of the Hospital's Incident Reports: General Overview policy, dated 1/7/2020, indicated that any event which is not consistent with the desired care of a patient or the customary operations of the hospital, regardless of whether harm has occurred, should be reported as soon as possible to the immediate supervisor and to the Risk Manager (at a minimum). Department of Quality and Safety (Q/S) ensures a timely investigations and corrective action plans ...

Patient #1 was admitted to the hospital in 9/2020 through the Emergency Department with diagnoses of diabetes, atrial fibrillation (abnormal heart rate), right breast cancer with a chronic would and was complaining of chest pain.

Review of the General Medicine History and Physical, dated 9/14/20 at 1:05 P.M. indicated that the patient's glucose level was 162 which is considered high. The review further indicated that Patient #1 was on insulin NPH Humulin 70/30 Kwikpen at home. Review of the General Medicine History and Physical, dated 9/14/20 at 1:05 P.M. does not indicate that the patient was started on insulin NPH Humulin 70/30 Kwikpen upon admission to the hospital. There is no further documentation in the General Medicine History and Physical which determines why the insulin NPH Humulin 70/30 Kwikpen was not ordered when the patient was admitted to the hospital.

Review of the nursing assessment teaching record, dated 9/14/20 at 4:00 P.M., indicated that Patient #1 was a diabetic with blood sugar monitoring/per license independent practitioner (LIP) and insulin injections.

Review of the nursing assessment teaching record, dated 9/14/20 at 11:52 P.M., indicated that Patient #1 was a diabetic with blood sugar monitoring/per LIP, understands management of higher and lower blood sugars and had insulin injections.

Review of Patient #1's laboratory results indicated a trending increase in the patient's glucose levels throughout his/her admission:

9/14/20 at 8:42 A.M. Patient #1's glucose level was 162 in the Emergency Department.
9/15/20 at 4:40 A.M. Patient #1's glucose level was 204 on the cardiac unit, which is considered high.
9/16/20 at 5:10 A.M. Patient #1's glucose level was 399 on the cardiac unit.
9/17/20 at 5:29 A.M. Patient #1's glucose level was 667 on the cardiac unit.

Review of the General Medicine Progress Note dated 9/15/20 indicated the Physician #1 attested to reviewing all pertinent laboratory findings, confirmed results, documented a relevant problem and problem plan for the visit, and confirmed the problem. The General Medicine progress note does not indicate that the patient's Blood Glucose Level was abnormal with a high reading of 204.

Review of the General Medicine Progress Note, dated 9/16/20 indicated that Physician #1 attested to reviewing all pertinent laboratory findings, confirmed results, documented a relevant problem and problem plan for the visit, and confirmed the problem. The General Medicine progress note does not indicate that the patient's Blood Glucose Level was abnormal with a high reading of 399.

During and interview on 1/15/20 at 9:30 A.M., the Director of Nursing Operation said that she met individually with Nurse #1 to discuss the case. She said there were huddles and discussions about the incident, but that there was no formal education provided to staff members regarding the missed escalating glucose levels.

During a telephone interview on 1/15/21 at 10:00 A.M., Physician #1 said that she recalled that she took care of Patient #1. Physician #1 said that when Patient #1 was admitted his/her glucose levels were fine and the next day when Patient #1's blood glucose levels began to rise, she reviewed the medicine and realized the insulin was never started. Physician #1 said that when a patient is admitted she would look at the medical history and see that the medications they should be on are initiated. Physician #1 said that the nurses should let the physicians know when the blood sugars are going up. Review of Physician #1's notes indicated that she saw the patient on 9/15/20 and 9/16/20 without acknowledging the glucose levels rising from 162 on 9/14/20, to 204 on 9/15/20 and 399 on 9/16/20. Physician #1 said that she did not report this event to the Risk Management Department because she was transferring the patient to the intensive care unit for treatment of DKA.

During an interview on 1/15/21 at 10:30 A.M., Nurse #1 said that she doesn't recall if she noticed or told the physician caring for Patient #1 that the glucose levels were rising. She said that she did not document that she acknowledged the rising glucose levels or if she told the physician caring for the patient about the rising glucose levels.

During and interview on 1/15/21 at 11:00 A.M., the Chief Medical Officer said that elevated blood sugars should be basic nursing knowledge so there was no formal education, but there were pre-shift huddles to discuss elevated blood sugars. He further said that the Hospital's investigation determined that the Nurse Practitioner that wrote the admitting orders, while omitting the insulin, meant to hold the medicine, not omit it. He said that the Nurse Practitioner was under the impression that the patient was going to have surgery the next day so he "held" the insulin and wrote an order for the patient to have nothing by mouth (NPO). He said the standard practice for a patient going to surgery would be to make them NPO and decrease insulin, not stop it. He said that the nurse practitioner should have discussed this with the physician and documented the reason for not ordering the insulin and did not.

During an interview on 1/15/21 at 11:40 A.M., the Nurse Educator said that the Director of Nursing Operations spoke with the nursing staff regarding the incident. She said that she would expect that if a lab was ordered, the ordering physician should be reviewing the results for follow-up.

During an interview on 1/15/21 at 12:00 P.M. the Director of Pharmacy said that the pharmacists usually will do a second medication reconciliation check to be sure that the home medications aren't missing. He said that after the discovery of the omitted insulin, he spoke with his staff about reviewing the whole record, including lab results. He said pharmacist consistency is key. This patient had three different pharmacists due to staffing/schedule conflicts, so the escalating lab results were not identified by pharmacy. The Director of Pharmacy said that he looked into the medical record system and the enterprise for the hospital system to see about changing the hold orders, but the software doesn't support that.

During an interview on 1/19/21 at 9:30 A.M., the Director of Nursing Operations said that she updated the communication tool for nursing to utilize during hand-off between shifts. She said that this communication tool is available to all the nurses for better communication, but it is not a mandatory form. She said that this incident was human error and there is no formal education for human error. The Director of Nursing Operations said that during multidisciplinary rounds the escalating labs should have been discussed.

Review of the Hospital's internal investigation indicated that the physician and the nurse practitioner were both re-educated on caring for diabetic patients. There was no documentation in the re-education provided that addressed the lack of documentation in the medical record to indicate why the insulin was held or why the incident wasn't reported to the Risk Department in a timely manner as detailed in the Hospital's policy.

The investigation determined that there were human factors involved in the error made. Those being a lack of follow through noted of both the MD and registered nurse awareness of escalating glucose levels. Staff competencies were being reviewed for status. Staff did not address critical indications for treatment of abnormal glucose levels. Staff did not address critical indications for treatment of abnormal glucose levels. There was a lack of communication between RN and MD to address abnormal lab values. The hospital looked into reviewing the critical value for hyperglycemia (high glucose levels) and to consider > 300 for a diabetic patient with escalating glucose values. Determine how other sites are doing to manage insulin orders for an insulin dependent diabetes mellitus patient that require holding/discontinuing orders.

Review of the outcomes of the investigation indicated that due to software issues, the Hospital is unable to change the system to decrease lab critical values and change the process for "holding" a medication.

Lab work indicated that this insulin dependent patient's glucose levels steadily rose and continued to rise, reaching the critical level of 667 resulting in the patients DKA. At no time, was there an intervention provided by medical, nursing, or pharmacy intervention.

The Hospital did not identify a systemic issue which could be measured and corrected to prevent a like occurrence from happening again.