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Based on document review, observation and interview, the facility failed to follow its policy/procedures and ensure adverse patient outcomes were investigated and analyzed for their causes and implement corrective measures to prevent future occurrences for 1 of 8 adverse patient events reviewed (Patient #1).

Findings include:

1. Review of the policy/procedure Cause Analysis (approved 5-16) indicated the following: "Consideration of performance expectations should include internal as well as external courses such as internal policies, procedures, or protocols... Table 3. RCA [root cause analysis] Pathway... RCA analyst team completes initial investigation including identifying and "Extent of Condition" issues...RCA analyst team prepares sequence of events and begins to construct an Events and Causal Factor Chart (or other analytical tool). Meet with whole RCA analyst team to present "what" occurred agree on facts and proximate causes, build consensus for possible root causes. The analyst presents the sequence of events/steps and potential inappropriate acts and causes. The team determines failure scenario including individual system failures for each inappropriate act... RCA analyst team develops recommendations for correction of all root causes and high-risk and/or sub-standard conditions... Meet with RCA project (sic) team to build consensus with the action plan and to monitor the effectiveness of recommendations. Complete effectiveness monitoring of recommendations. Close case. [Due by day 45]."

2. Review of the facility administrative documentation titled RCA Action Plan indicated the following: "Pyxis machines will be brought over to [the facility] from facility #2 to put in Room 1 and Room 4... Target Completion Date 9/1/18... Completion Date CER [capital expense request] placed 8/9...[and]...Re-education to all Endoscopy nursing staff regarding 5 Rights, not touching anesthesia trays, and STAR training... Target Date 8/12/18... Completion Date 7/13/18."

3. Review of a copy of the CER documentation identified above indicated several department-level approvals were obtained on 8-9-18 and the approval of the CFO (Chief Financial Officer) was obtained on 8-30-18. No documentation provided for review on 9-4-18 indicated when the two Pyxis machines were expected to be delivered and installed in the 2 procedure rooms or indicated the activity was monitored for completion and a RCA team meeting was conducted to re-evaluate the status of the indicated action and revise the completion date.

4. On 9-4-18 at 1550 hours, the Risk Manager, staff A6 confirmed a goal of the RCA investigation was to complete the event within 45 days, the RCA Action Plan was not completed (52 days) at the time of the investigation, and the date(s) for completion (9-1-18) identified on the RCA Action Plan provided for review had not been revised accordingly.

5. Review of facility administrative documentation titled Daily Endoscopy Safety Huddle dated 7-13-18, 8-7-18, 8-8-18 and 8-10-18 failed to indicate the Endoscopy Registered Nurses N14, N15, N16 and N17 (who were confirmed to be working on one or more of the indicated dates) participated in the Safety Huddle education regarding the 5 Rights of Medication Administration [Right Patient, Right Drug, Right Dose, Right Route & Right Time], the STAR acronym [Stop, Think, Act & Review] and/or notice that Anesthesia Medication Trays are only for use by Anesthesia staff.

6. On 9-5-18 at 1615 hours, the Quality Manager, staff A4 confirmed the Daily Endoscopy Safety Huddle documentation dated 7-13-18, 8-7-18, 8-8-18 and 8-10-18 lacked documentation indicating staff N14, N15, N16 and/or N17 participated in the unit re-education provided in response to the 7-12-18 adverse patient event.

7. Review of the policy/procedure High Alert Medications (reviewed 7-18) indicated the following: "High Alert Medications are safeguarded by storage, preparation, access limitations, and alerts/labeling. Storage: See Appendix A for specific storage requirements... Neuromuscular Blockers (e.g. succinylcholine, rocuronium, vecuronium)... Limit NBA [neuromuscular blocking agents] in unit-based medication dispensing cabinets to the surgical and critical care areas and will be in high capacity lock lidded pockets or High Alert lidded storage containers..."

8. During a tour of the outpatient endoscopy unit on 9-4-18 at 1135 hours, in the company of A2, A4, A6 and the Endoscopy Supervisor, staff A7, ten (10) anesthesia medication trays were observed in procedure room 1 on an open-sided 6 foot tall rolling cart covered with a semi-transparent acrylic mesh netting material. Upon close inspection, each anesthesia medication tray was secured with two (2) green plastic zip-tie inventory control locks and taped to the outside of each medication tray was a clear plastic bag containing two (2) capped 10 ml syringes with red-colored labeling indicating each syringe contained Succinylcholine (20 mg/ml).

9. On 9-5-18 at 1110 hours, the Network Pharmacy Director, staff A10 confirmed the observed practice of storing Succinylcholine syringes outside of Pyxis medication dispensing cabinets, anesthesia medication trays and/or High Alert lidded storage containers was not in compliance with the High Alert Medications policy.

10. Review of the Medical Staff Bylaws (approved 5-17) indicated the following: "Pharmacy-Therapeutics Committee. 13.8(a) This committee shall be responsible for the development and surveillance of pharmacy and therapeutics policies and practices, and of all drug utilization policies and practices within the Hospital in order to promote desirable clinical results and reduce the potential for hazard..."

11. Review of the 8-24-18 Pharmacy-Therapeutics Committee minutes indicated the following: "Medication variances and ADRs [adverse drug reactions] were presented. See mailed out packet for additional information..." and no documentation indicated a review of the 7-12-18 High Alert medication incident or indicated a committee recommendation to revise the High Alert Medication policy, or address the current practice of storing Succinylcholine syringes outside of Pyxis machines, anesthesia medication boxes or High Alert lidded storage containers, or continue the current practice in conflict with facility policy until the two anesthesia Pyxis machines were delivered and installed in the outpatient endoscopy suites.

Based upon document review and interview, the facility failed to follow its policy/procedures and ensure its medical records (MR) were accurately written for 1 of 10 MR reviewed (Patient #1).

Findings include:

1. Review of the policy/procedure Medical Record Access and Documentation Guidelines (reviewed 4-18) indicated the following: "Documentation, created in the sequence of events as they occur, will be sufficiently comprehensive to support the diagnoses and outcomes and justify the treatment. Documentation in the medical record will follow the guidelines set forth in the Medical Staff Rules and Regulations..."

2. Review of the Medical Staff Rules and Regulations (approved 5-17) indicated the following: "2.14(a) Electronic/Written/Verbal/Telephone Treatment Orders: Orders for treatment shall be completed by electronic order entry (computer physician order entry-CPOE) by the ordering practitioner."

3. Review of the policy/procedure Physician Order Receiving and Processing (revised 1-17) indicated the following: "Orders are directly entered into CPOE by the Physician/LIP [licensed independent practitioners], or by the Nurse who has taken a verbal or telephone order from the Physician/LIP... Verbal orders are limited to emergency situations only (e.g. code blue, actively involved in procedure, etc.)."

4. Review of the Upper GI endoscopy procedural record for Patient #1 entered on 7-12-18 at 1140 hours by the Gastroenterologist, staff MD11 indicated the following: "One oozing cratered gastric ulcer was found in the gastric fundus. The lesion was 7 mm in largest dimension. Area was successfully injected with 10 ml/200 mg Succinylcholine (even though the RN was asked to inject epinephrine..." and no MR documentation indicated an order for Epinephrine was entered by MD11 or by the Registered Nurse N11.

5. On 9-4-18 at 1315 hours, the Director of Endoscopy, staff A6 confirmed the MR for Patient #1 lacked documentation indicating an order for Epinephrine was entered in CPOE around the time of the procedure.

Based on document review, observation and interview, the facility failed to ensure its policy/procedure for high alert medications was followed and ensure safeguards for storage and access were maintained at the facility for 1 of 3 adverse patient events reviewed (Patient #1).

Findings include:
1. Review of the policy/procedure High Alert Medications (reviewed 7-18) indicated the following: "High Alert Medications are safeguarded by storage, preparation, access limitations, and alerts/labeling. Storage: See Appendix A for specific storage requirements... Neuromuscular Blockers (e.g. succinylcholine, rocuronium, vecuronium)...Limit NBA [neuromuscular blocking agents] in unit-based medication dispensing cabinets to the surgical and critical care areas and will be in high capacity lock lidded pockets or High Alert lidded storage containers..."

2. Review of the MR for Patient #1 indicated on 7-12-18 at approximately 1112 hours the Registered Nurse N11 administered 200 mg of Succinylcholine into the gastric mucosa of Patient #1 in error.

3. On 9-4-18 at 1110 hours, the Director of Endoscopy, staff A6 indicated the anesthesia medication trays used in the outpatient endoscopy unit have one medication (Succinylcholine) available in pre-filled syringes that are too large to fit in the compartments of the anesthesia medication tray. Staff A6 indicated a total of two (2) syringes containing Succinylcholine are secured in a plastic bag that is taped to the outside of the anesthesia medication tray.

4. On 9-4-18 at 1110 hours, the Director of Quality, staff A2 and the Quality Manager, staff A4 were requested to provide a policy/procedure regarding the use and storage of anesthesia medication trays or anesthesia drug boxes utilized at the facility and none was provided prior to exit.

5. During a tour of the outpatient endoscopy unit on 9-4-18 at 1135 hours, in the company of A2, A4, A6 and the Endoscopy Supervisor, staff A7, ten (10) anesthesia medication trays were observed in procedure room 1 on an open-sided 6 foot tall rolling cart covered with a semi-transparent acrylic mesh netting material. Upon close inspection, each anesthesia medication tray was secured with two (2) green plastic zip-tie inventory control locks and taped to the outside of each medication tray was a clear plastic bag containing two (2) capped 10 ml syringes with red-colored labeling indicating each syringe contained Succinylcholine (20 mg/ml).

6. On 9-5-18 at 1110 and 1115 hours, the Network Pharmacy Director, staff A10 confirmed the identified practice of storing Succinylcholine syringes outside of Pyxis medication dispensing cabinets, anesthesia medication trays and/or High Alert lidded storage containers was not in compliance with the High Alert Medications policy. Staff A10 confirmed the practice of filling 10 ml syringes with Succinylcholine (20 mg/ml) for use with the anesthesia medication trays was implemented in response to a request from Anesthesia Services and no other documentation was available.