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Tag No.: A0385
Based on staff interview, record review, review of facility policies and procedures (including IV Insulin Titration order sets and internal investigations), 2 of 15 sampled patients (Patients 7 and 12) did not receive critical time sensitive medications as ordered by the physicians. Patient 7 did not receive anti seizure medication (Depakote) which resulted in the patient having multiple seizures and being moved to the Intensive Care Unit - extending the patients need for care and treatment in the hospital. Patient 12 was admitted to the Intensive Care Unit for multiple issues including high blood sugars (BS). Patient 7 had an order for an insulin drip and this order was not initiated leading to the patient having continued high blood sugars. These failures resulted in the determination by the Centers for Medicare and Medicaid (CMS) that the Condition of Participation for Nursing Services was not met, and that Immediate Jeopardy (IJ) conditions exist posing a threat of potential serious injury, harm, impairment or death of patients admitted requiring time sensitive medication's and monitoring by laboratory results and nursing.
The failure to implement immediate effective action plans has the potential to affect the care of all patients in the facility. The administrative staff implemented measures to remove the immediate jeopardy noncompliance on 1/3/18 by implementing the following:
-Education for TRANSCRIPTION OF MEDICATION for all inpatient nursing staff regarding double checking written orders for completeness, legibility and accuracy of the orders (dose, route, frequency, prn indication) and signed by two RN's. Each nursing staff received the education before beginning their shift and signed in when completed.
-Education for VERIFICATION OF MEDICATION ORDERS for all inpatient nursing staff regarding during the end of shift report on inpatient areas two RN's will verify all medication orders were carried out per order and sign the paper chart. All nursing staff were informed of this change and written instructions were reviewed by each nurse before beginning their shift and signed in when completed.
-Education for VERIFICATION OF MEDICATION ORDERS for all patients from the Emergency Department being handed off to the inpatient nursing staff will review the admission orders. The Emergency Department nursing staff and the inpatient nursing staff will review the written orders and conduct a chart check to ensure that the inpatient nurse is aware of all orders. The Emergency Department nursing staff were informed of the expectation to review orders with hand off report and conduct chart checks on hand off.
-Education for MEDICATION PRACTICE for all nurses and pharmacists on the standard work process related to medications not administered according to the provider's order. Standard work process includes prompt notification of provider for any non-administered mediations. All inpatient nursing staff and pharmacists were educated on the standard work process and related procedures before beginning their shift and signed in when completed and competency validated.
-Education for MEDICATION PRACTICE - NURSING: When medications are not administered per order, the situation is reviewed by staff nurse and nursing leadership for all nurses and pharmacists on the standard work process related to medications not administered according to the provider's leadership or designee within one hour of scheduled administration time. All inpatient nursing staff were educated on this changes in expectation before beginning their shift and signed when completed.
-Education for MEDICATION PRACTICE - PHARMACY: Pharmacy leadership and staff pharmacists monitor a query that reports medications which are not administered. The pharmacists conducts a therapeutic evaluation of omissions that could cause patient risk, including insulin, antibiotics, and other medications that require therapeutic blood levels to optimize efficacy; such as those listed on the National Institute of Health Narrow Therapeutic Index Medications list. The Pharmacist contact the nurse &/or the provider for resolution as indicated. All pharmacists were educated before the beginning of their shift and signed in when completed and competency validated.
Refer to A-405
Tag No.: A0405
Based on staff interview, record review, review of facility policies and procedures and internal investigations revealed that 2 of 15 sampled patients (Patients 7 and 12) did not receive critical time sensitive medications as ordered by the physicians. Patient 7 did not receive anti seizure medication (Depakote) which resulted in the patient having multiple seizures and being moved to the Intensive Care Unit - prolonging the need for inpatient care and treatment. Patient 12 was admitted to the Intensive Care Unit for multiple issues including high blood sugars (BS). Patient 7 had an order for an insulin drip and this order was not initiated leading to the patient having continued high blood sugars. These failures resulted in the determination by the Centers for Medicare and Medicaid (CMS) that the Condition of Participation for Nursing Services was not met, and that Immediate Jeopardy (IJ) conditions exist posing a threat of potential serious injury, harm, impairment or death of patients admitted requiring time sensitive medication's and monitoring by laboratory results and nursing.
Findings are:
A. A review of Patient 7's medical record revealed that Pt 7 was admitted on 9/15/17 following an outpatient appointment at the patients oncology (cancer) clinic. The oncologist (cancer doctor) ordered a CT (computerized axial tomography) Scan of the abdomen and pelvis which revealed a dislodged gastrostomy tube (G-Tube a tube that is inserted through the abdominal wall into the stomach to receive nutrition and medication when the patient is unable to take nutrition and medications by mouth). The CT Scan indicated that the G-Tube was not in the right place and the tube feeding was going into the abdominal cavity. The History and Physical (H & P) dated 9/15/17 revealed that Pt 7 had Adenoid Cystic Carcinoma (cancer of the secretory glands/salivary glands of the head and neck) involving the base of the tongue.
Pt 7's medical record included 2 sets of admission orders:
-A typed 4 page set of Admission orders identified as "Physician Standard Orders" that were dated 9/15/17 at 1500 revealed the patient was to be admitted as an inpatient for general level of care; diet- NPO (Nothing by mouth) per condition now except meds; a consult with (gastrointestinal doctor) for G-tube replacement -see today. The 4 page order set was noted by the nurse on 9/15/17 at 1946 (7:46 PM)
-Hand written admission orders by the oncologist dated 9/15/17 included home meds-Coreg (a blood pressure medication) 6.25 mg (milligram) daily; Depakote (anti seizure medication) 1000 mg BID (twice a day); Gabapentin (medication for nerve pain) 600 mg TID (three times a day) and Rosuvastatin (cholesterol medication) 20 mg daily. These hand written orders lacked a route for administration of these medications, and lacked clarification of the orders by the nurse or pharmacist. The orders were noted by the nurse at 1948 (7:48 PM).
Review of the "Home Medication List for Medical Record" document completed by the Hospital Pharmacist (RP Z) on 9/15/17 at 8:11 PM for Pt 7 revealed, "Medications reviewed 9/15/17. Per RN Interview with patient, Cancer Center H & P - scanned. Meds are all by PEG (percutaneous endoscopic gastrostomy; [G-Tube]). Pt had AM (morning) meds today at 13:40 (1:40 PM)." The medication on this list included, "Depakote 500 mg tablet, delayed release 2 tablet PEG twice a day".
Review of Pt 7's Medication Administration Record (MAR) revealed, an order for Depakote 1000 mg PO Twice daily -BID Give with Food; Start 9/15/17 16:51 (4:51 PM) Stop 9/15/18 at 9:00 AM. The MAR identified the Depakote as NOT ADMINISTERED on 9/15/17 2100 (9:00 PM), 9/16/17 0900 (9:00 AM), 9/16/17 2100 (9:00 PM), 9/17/17 0900, 9/17/16 2100. The charted reason for the Depakote not being administered was NPO status of the patient.
Review of charting on the 4 Rapid Response Team Intervention Forms (RRT-A RRT call is initiated by the care giver of the patient when the patient displays unstable condition including acute changes in vital signs (VS) and level of consciousness/alertness.) identified:
1) On 9/17/17 at 1551 (3:51 PM) a RRT call was initiated due to the patient having a seizure and VS of 222/114 (elevated (BP) blood pressure- normal adult 120/70), Heart Rate 136 (fast heart beat- normal adult 80), Respirations 24, Temperature 98.8 and Oxygen Saturation 92 % on 3 liters of oxygen. Notes by RRT team stated, "Seizure appeared to stop at 1558 (3:58 PM). RN performing jaw thrust (method to keep airway open) upon arrival. Patient opening eyes at 1604 (4:04 PM). Nodded yes to being tired at 1607 (4:07 PM). FC (follows commands) x (by) 4, Patient bleeding from biting tongue, Pt talking/sleepy at 1621 (4:21 PM)." PA (Physician Assistant) notified at 1600 (4:00 PM) and Neurologist (Dr B) notified at 1615 (4:15 PM). PA orders: Consult hospitalist neurologists; Depacon (IV [Intravenous] anti seizure medication) 1000 mg IVPB (Intravenous piggy back-diluted medication in small bag administered through a port in an established IV line.) now. Depacon 1000 mg IV at 2200 (10:00 PM) tonight, Depacon 1000 mg IV BID starting AM (morning) of 9/18/17. PA then canceled neuro-hospitalist consult at 1630 (4:30 PM)
2) On 9/17/17 at 1819 (6:19 PM) a RRT call was initiated due to the patient having a seizure for 20-30 seconds and VS of 201/190 (elevated blood pressure), Heart Rate 64, Respirations 22, Temperature 98.4 and Oxygen Saturation 99 % on 3 liters of oxygen. Notes by RRT team stated, "PA aware patient started on Depakone, states to call if BP does not come down. At 1826 (6:26 PM) patient alert, orients and follows commands x 4.
3) 9/17/17 2013 (8:13 PM) a RRT call was initiated due to the patient having a seizure and VS of 138/77, Heart Rate 88, Respirations 17, Temperature 98.3 and Oxygen Saturation 100 % on 3 liters of oxygen. Notes by RRT team stated, "Movement and strength, Pt became weak and not able to move to command on left side with stroke scale at 2020 (8:20 PM). Stroke Scale done at 2020 with score 10. PA on way at 2025 (8:25 PM).
PA orders: Pt to be Progressive Status. Urgent consult (Dr B).
Dr B Orders: CT Scan of head without contrast, indication left side weakness; Depakote level in AM, Ammonia level, Hepatic panel in am
PA orders: Give 2000 mg of Depacon instead of 1000 mg; OK to transfer to ICU.
4) 9/17/17 2210 (10:10 PM) a RRT call was initiated due to the patient having a seizure and VS of 189/79, Heart Rate 72, Respirations 16, Temperature 99.7 and Oxygen Saturation 99% on 3 liters of oxygen. Left arm and leg flaccid. Notes by RRT team stated, "Going to CT then to ICU. 2243 (10:43 PM) to CT, 2255 (10:55 PM) to ICU
Dr B Orders: Depacon 100 mg IV q 8 hr (every 8 hours) to restart 9/18/17;
PA Orders at 2315 (11:15 PM) Give Phosphenytoin (anti seizure medication) 1000 mg 15 ml/kg (milliliters per kilogram) IV STAT (Immediately)
Dr B Orders at 2317 (11:17 PM) For first seizure after moved to ICU give additional 400 mg IV phosphenytoin; for 2nd seizure give 1 gram Depacon IV, for 3rd seizure call (Dr B) for tonight only.
Review of Physician Progress note by PA dated 9/17/17 9:30 PM, "Pt has had several seizures today. Takes Depakote at home usually via PEG (which wasn't working) so unsure how much was getting at home. Unfortunately Depakote wasn't given IV so now is behind doses. (Pt) was loaded with Depacon at 4:30 PM but still catching up." "Seizures lasting 2-3 minutes or less, Haven't given Valium, left sided weakness when postictal (after seizures) improving. Neuro seeing and plans to CT head. Loading with Depacon tonight to catch up."
Review of the Discharge Summary dated 9/23/17 with an addendum added 9/27/17 revealed, "Upon arrival, the patient was placed on TPN and lipids (Nutrition provided via intravenous fluids.), given the NPO status as (Pt 7) had a history of aspiration (getting food or fluids into lungs) even prior to starting concurrent chemotherapy and radiation. Medications were switched over from oral to IV, given that there was no longer G-Tube access." "Unfortunately, the seizure medicines did not get resumed. (Pt 7) suffered approximately 3 seizures on 9/17/17. (Pt 7) was transferred to the ICU after RRT was called and Neurology was consulted, and was placed on IV antiseizure medications. Since that time, had no further seizures. Given the seizures, unfortunately, IR (Interventional Radiology-procedures performed under x ray) could not replace the G-Tube for 1 week."
A review of the facility investigation and an interview with RN-A on 12/20/17 at 2:15 PM revealed, that the facility did look at this medication error related to the omission of giving the Depakote to Pt 7. RN-A stated that the outcome of this investigation resulted in identifying a few opportunities to improve. The issue's included:
-The initial hand written order for home medications, including the Depakote, did not have a route and the nurse taking off the order did not clarify the route with the provider that wrote the orders.
-The pharmacist that reconciled the home medication list did identify that Pt 7 took all med's through the PEG tube, (which was malfunctioning and why the patient was admitted) but when the orders were entered by the pharmacist the route was identified as PO and due to distractions occurring while doing the reconciliation process did not follow up with the provider for clarification.
-The nurses would document "Not administered due to the patient being NPO" but did not clarify the route with the provider even though it was documented that the patient had said med's were given via the tube.
-The nurses also did not critically think about this medication being a seizure medication and if another route would be available.
-We forwarded the information to the pharmacy managers and nurse managers for follow up related to ensuring the medication orders were written correctly and if not to clarify with the provider.
The facility investigation identified the medication error related to the omission of giving the Depakote to Pt 7. The facility followed up with the staff involved but failed to do a systemic analysis of the issue and failed to provide re-education to all nursing and pharmacy staff to prevent future medication omissions.
Review of the Policy/Procedure titled "Medication Management" with an effective date of 9/8/17 revealed:
-Information Required on Medication Orders include, name of medication; drug strength and dose; route of administration; frequency of administration; all orders must be dated and timed; the orders must include the practitioner's identification.
-Questions regarding orders should be referred to the medical practitioner writing the order. When an order needs to be clarified and it was placed by a provider, the Pharmacist will call the provider to clarify the order.
Order Processing-The Pharmacy will be provided with all written providers' medication orders requiring processing. Written orders will be scanned to pharmacy utilizing unit-based multifunction scanning devices that are pre-programmed with priority designations.
B. A review of Patient 12's medical record revealed that Pt 12 was admitted on 9/21/17 following a motor vehicle accident (MVA) from the patient "passing out." The patient was brought to the Emergency Department following the accident for evaluation and was admitted to the hospital. The History and Physical (H & P) dated 9/21/17 revealed that Pt 12 had a past history of Insulin Dependent Diabetes Mellitus (needs insulin medication to manage blood sugars); Parkinson's disease (a progressing disease effecting the nerve cells in the brain); heart disease; peripheral vascular disease (disease that effects the circulation to the legs and feet). The H & P identified that the patient currently had:
-Sepsis (blood infection) due to cellulitis (skin infection) of the left lower extremity wound. Plan to culture wound and treat with IV antibiotics.
-Loss of consciousness while driving possibly due to the sepsis and hypotension (low blood pressure). Plan to get an ECHO (An ultrasound)
-Hypotension due to sepsis. Plan to get IV fluids and norepinephrine (medication that helps with the rate and force the heart pumps), pressors (medications that help raise the blood pressure).
-Fever due to sepsis. Plan to continue antibiotics and IV fluids.
-Rhabdomyolysis (the breakdown of muscles with proteins being released into the blood system). Plan to give fluids.
-Severe Malnutrition (lack of proper food and fluids). Plan to provide hydration.
-Parkinson's Disease - Plan to continue medications.
-Hyperglycemia (High Blood Sugars). Plan to start an INSULIN DRIP (continue infusion of insulin via an IV).
Overall plan identified that Pt 12 will be admitted to ICU. Monitor closely. Begin IV fluid hydration, antibiotics, steroids, INSULIN DRIP and pressors.
Review of Pt 12's physician order revealed a typed order set titled, "IV Insulin Titration Order". The Physician signed the order set on 9/21/17 at 1700 (5:00 PM), the 2 page order set lacked a nurse noting the orders identifying the initiation of the order set.
Review of Pt 12's Medication Administration Record for 9/21/17 to 9/22/17 at 0746 (7:46 AM) lacked the start of the Insulin Drip. On 9/22/17 at approximately 7:35 AM the on coming nurse (RN D) for the 7:00 AM- 7:00 PM shift found the orders on the chart. The orders had not been initiated. RN D notified the physician, the pharmacy and acknowledged and initiated the Insulin Drip at 7:46 AM.
Review of Pt 12's Physician Progress Notes dated 9/22/17 at 8:32 AM revealed, "Seen in follow up due to hypotension, MVA and elevated blood sugars. Pt was not started on Insulin drip last night- will start today this morning." Lab chemistry test dated 9/22/17 at 5:30 AM identified Pt 12's glucose level at 401 HIGH (Normal range 65-99). Review of lab chemistry test dated 9/23/17 at 4:35 AM identified Pt 12's glucose level at 94 NORMAL. Pt 12 was receiving the insulin drip at the 9/23/17 lab test.
Review of the glucose testing lab from 9/21/17 at 1349 (1:49 PM) through 9/22/17 at 8:53 AM ranged from 311-430 with the normal range 65-99.
Review of the internal investigation revealed that the Insulin Drip order set was placed on the chart on 9/21/17 at 1700 (5:00 PM) while in the Emergency Department. The patient was than admitted to ICU at 1859 (6:59 PM) per the Admission database documentation. The staff receiving the patient and doing the 24 hour chart check on 9/22/17 at 0147 (1:47 AM) missed the order set when reviewing the chart.
A review of the facility investigation and an interview with RN-A on 12/20/17 at 2:30 PM revealed, that the facility did look at this medication error related to the omission of initiation of the Insulin Drip Protocol on Pt 12. RN-A stated that the investigation of this situation resulted in identifying a few opportunities to improve. The issue's included:
-The 2 page Insulin Drip Protocol was placed on the chart in the Emergency Department and not initiated there. The order protocol was found in the orders section behind a blank order sheet and was not processed.
-The patient was moved from the Emergency Department to an ICU room, and during the handoff of the patient the order protocol was not found. Since the order protocol was not found the pharmacy was unaware of the order for the Insulin Drip.
-The nurse that did the 24 hour chart check on did not find the order protocol sheets on the chart.
The facility investigation identified the medication error related to the omission of initiation of the Insulin Drip Protocol on Pt 12. The facility followed up with the staff involved but failed to do a systemic analysis of the issue and failed to provide re-education to all nursing staff to prevent future medication omissions due to missing the paper/typed protocols and /or written orders during patient hand off or chart checks.
Review of the Policy and Procedure titled "Physician Orders" dated effective October 2, 2017 and originated November 12, 1976, revealed the End-of-shift and 24-Hour Chart Check verifies:
-By signing the end-of-shift chart check as complete, the nurse confirms that all medications currently ordered for the patient are accurately listed on the medication summary tab.; That discontinued medications are not listed on the active medications tab - discontinued medication orders will display on the medication summary tab for 26 hours after verification of the discontinued order.
-By signing the 24-hour Chart Check review of orders will be done by the night shift at approximately 0005 (12:05 AM). For orders written on Physician Order document, the last chart check is designated by a yellow highlighted line and RN signature, date and time. Validate all orders from this date and time to the current date and time.