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Based on record review and staff interview, the facility pharmacy staff failed to clarify the nutritional enteral (to be given via tube feeding) formula feeding administration directions via gastric tube (G-tube - a tube permanently inserted through the abdomen into the stomach to provide nutrition when patients are unable to swallow) when completing the admission order reconciliation (the process of listing home medications and nutritional enteral formula) and requesting an enteral formula substitution from the physician for 1 of 10 sampled patient (Patient 7). This failure had the potential to cause harm to all patients being admitted to the hospital with an established g-tube enteral formula regimen.

Findings are:

A. On 5/17/22 at 10:22 AM, Patient 7 a 63 yr old with profound intellectual disability, unable to speak, gets nutrition via a G Tube with Glucerna enteral formula, wheelchair dependent with contractures and spastic quadriplegia (a condition that the arms and legs are drawn up and are unable to be straightened), type 2 insulin dependent diabetes (when the body is unable to regulate its own blood sugar and requires daily insulin to control the blood sugars), and neurogenic bladder (an inability to control the bladder due to nerve damage) requiring an indwelling catheter (a tube in the bladder to drain the urine) was transported to the emergency department (ED) from a facility for the developmentally disabled (DD). The patient had been displaying agitated behaviors and was brought to be evaluated. Vital signs (vs) 97.8-122-22-94% oximetry in the ED; lab work in the ED was obtained and identified an elevated White Blood Count 30.2 (WBC normal 4-11 -elevation indicates infection); Glucose elevated 195 (BS normal 74-100); Lactic acid elevated 6.5 (normal 0.7-2.1 -elevation indicates infection/possible sepsis); C-Reactive Protein -elevated 32.9 (CRP normal 0.0-0.9 elevation indicates infection); Procalcitonin elevated 5.22 (Pro-Cal <=0.5 -elevation indicates infection/possible sepsis); Urinalysis positive for urine protein, urine glucose, urine ketones and urine blood, nitrate positive and Leukocyte esterase positive at 25 (normal is negative -elevation indicates infection). The patient was admitted to the hospital for a urinary tract infection, possible urosepsis (infection from the urinary tract system that gets into the blood system and causes a potentially deadly infection of sepsis); diabetes mellitus type 2; and tachycardia (fast heart rate elevation indicates infection).

B. Review of the Medication Administration Record paperwork sent with Patient 7 from the DD Facility where the patient resided identified the enteral nutritional support included:
-Glucerna 1.2 cal (calorie) liquid 120 ml/hour (milligram per hour) = 6 cans over 12 hours 8:00 AM-8:00 PM nutrition via Kangaroo Joey Pump (a system with bags that enteral formula cans can be poured into with tubing that can be placed into the pump for accurate dispensing at a specific rate over a specific timeframe) [instructions "At 8:00 AM place 4 cans into feeding bag and start Kangaroo Joey at 120 cc (cubic centimeters)/hour for 12 hours. 2 cans will need to be added at 4 PM.]
-Water Flush G Tube scheduled give 150 cc 6 times per day at 12:00 AM; 4:00 AM; 8:00 AM; 12:00 PM; 4:00 PM and 8:00 PM

C. Per the manufacturer Glucerna 1.2 cal is a formula often used for people with diabetes. Specialized nutrition for enhanced glycemic (sugar) control compared to a standard formula. For patients with type 1 or 2 diabetes or abnormal glucose. Used for tube or oral feeding.

D. Review of the Physician Orders for the Enteral nutritional feeding for Patient 7 from 5/17/22 -5/20/22 revealed:
-5/17/22 at 1505 (3:05 PM) Physician Assistant D (PA D) gave a telephone order to continue the Glucerna 1.2 Cal at 120 ml/hr over 12 hours BID (twice daily -24 hour/day).
-5/17/22 at 16:13 (4:13 PM) Pharmacist K (RP K) placed the order into the medication system and verified the Glucerna 1.2 Cal at 120 ml/hr over 12 hours BID.
-5/17/22 at 21:23 (9:23 PM) RP K placed the order into the medication system to "Formulary substitute for nutritional supplement "Jevity (a standard formula that does not offer glycemic control) 1.2 Cal for the Glucerna 1.2 cal" BID.
-5/20/22 at 12:30 PM, RP K placed the order into the medication system to "non-Formulary medication" Glucerna 1.2 cal at 120 ml/hr over 12 hours stop at 8:00 PM.

F. In an interview with Pharmacist K (RP K) on 8/8/22 at 2:13 PM, a review of Patient 7's medication orders from 5/17/22-5/20/22 were completed. Inquired of RP K if (gender) recalled this patient and the incidents surrounding the Glucerna/Jevity Enteral nutritional formula. RP K stated, "Yes, I was the pharmacist on duty when the patient was admitted. I saw the glucerna on the paperwork from the sending facility and thought it was a dietary supplement. Then the nurse called me, and I re-looked at it. I read it again when I was reconciling the medications and I read their Medication Administration Record (MAR) as they were giving (Patient 7) Glucerna 120 ml/hr over 12 hours BID (or over 24 hours). We didn't have Glucerna so I looked back on her previous records and saw we substituted Jevity 1.2 for it so I did a formulary substitute." When asked if the RP K called the provider to get an order to substitute the formula, RP K replied "No". Then a few days later (Patient 7's) provider asked us to call to her sending facility and clarify what and how they were providing the patients tube feedings. "I called the sending facility and they said it had ran Glucerna 1.2 from 8:00 AM-8:00 PM, and we arranged for them to bring some of their supply to us to change to until we could get an order in." "It was then changed from Jevity back to Glucerna 1.2 to be given from 8:0 AM - 8:00 PM."

G. An interview with the Pharmacy Director on 8/8/22 at 2:45 PM revealed, that (gender) was made aware of the issue. "It is our practice to call the provider for a substitution of medications or formula if we need to substitute it or if the patient comes from another facility and we have a question related to the administration of a medication/formula we should call for clarification." When inquired if the pharmacy had a medication reconciliation policy or an Enteral Formula policy? The Pharmacy Director replied, "Not that I can find at this time."

H. Review of Patient 7's bloodsugar results from 5/17/22-5/21/22 revealed, the bloodsugar readings remained labile after changes to insulin and formula. The bloodsugars ranged from 195 on 5/17/22; 305 on 5/18/22; 408 on 5/19/22; 612 on 5/20/22; 540 on 5/21/22 at 6:12 AM. The patient passed away on 5/21/22 at 8:50 AM.

J. A telephone interview on 8/16/22 at 8:35 AM with Physician Assistant D (provider caring for Patient 7 during the hospital stay) revealed, "I believe that the sepsis and the raging infection played a larger part on the patient having such high blood sugars. The Jevity formula could have played a minor role in the elevated blood sugars but, overall the infection was the main player. I was glad to hear that they now carry the Glucerna formula in house for the diabetics if needed."

Based on record review and staff interviews, the facility nursing staff failed to document the management and potential titrated rate of enteral (intake of nutrition through a tube that goes directly to the stomach) feedings for 1 of 10 sampled patients (Patient 5). The nursing staff failed to document the gastric residual volume (the amount of liquid drained from the stomach) before starting the g-tube(a tube inserted through the wall of the abdomen directly into the stomach) feeding for the shift. Prior to providing the ordered free water when g-tube formula is not running the gastric residual volume should be checked and documented. This failure has potential to effect all patients admitted to the hospital with established and new g-tube enteral feedings.

Findings are:

A. Record review for Patient 5 revels, on 7/1/2022 at 5:02PM Provider A enteral feeding order for Peptide 1.5 to start at 25mls (milliliters) per hour and increase to 81mls per hour as patient tolerates. On for 12 hours 2000-0800 (8PM-8AM) off during the day. The record lacked documentation identifying what rate the titrate enteral formula was running when documented. The record lacked documentation of the volume infused on the intake and output form for the enteral feeding in the electronic medical record.

B. Record review for Patient 5's nursing assessment reveals that nursing staff lacked documentation for gastric residual volume. On July 6th at 9:36AM Provider A was notified that "patient vomited large amt of tube feeding. Required suctioning". Patient had received 160ml of water flush at 9:23AM with no evidence of checking residual prior to flush.

C. Record review for Patient 5 reveals an order from Provider A, dated 7/1/2022 at 5:33PM for 80ml water flush every 4 hours. Review of the patient medication administration record (MAR) for 7/2/2022, 7/3/2022, 7/4/2022, 7/5/2022 and 7/6/2022 revealed Nursing Staff signed for the 80ml water flush and documented that 160mls of water was flushed every 4 hours on each entry. The Nursing documentation on the volume given for flushing the g-tube varies in amount from 0ml-320ml on each entry on the patient's intake and output form in the electronic medical record.

D. In an interview on 8/9/22 at 11:00 AM with the Chief Nursing Officer (CNO), it was revealed that the facility does not have a specific Nursing Policy and procedure for the Management of Enteral Feedings. The CNO provided documentation from "Nursing Reference Center for Enteral Feeding: Preventing or Managing Complications" dated 10/2018 that staff uses for guidance with enteral feedings. The document has a place for patient signature on receiving and understanding instruction handout. The CNO also verified that Patient 5's medical record lacked documentation of checking for residual and documentation for the titrated rate the enteral feeding of Peptide 1.5 was running.

E. Review of the pharmacy "Medication Administration Policy" last reviewed 12/22/2021, identified "For enteral administration; see that part of Pharmacy Policy and Procedures." An interview with the Pharmacy Director on 8/8/22 at 2:10 PM revealed, "I am unable to find any additional policy or procedures related to enteral administration."