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Based on records reviewed and interviews the Hospital failed to implement a comprehensive improvement project after it identified that Patient #1 underwent a wrong site procedure in the Comprehensive Pain Service (CPS) unit. While a thorough improvement plan was launched in the CPS unit, the Hospital lacked a widespread program to include the Operating Room in the case investigation to ensure that any preventive actions and mechanisms were in place to prevent a like occurrence of wrong site surgery.

Findings included:

The Surveyor interviewed the Director of Surgical Services at 9:00 A.M. on 6/22/2020. The Director of Surgical Services said that he was aware that a wrong site procedure had occurred in the Comprehensive Pain Clinic (CPC) but he did not know the details of the case. The Director of Surgical Services said he did not know Patient #1 and was not involved in the incident's investigation but was aware of the Practitioners involved in the case.

The Surveyor interviewed the Director of the Comprehensive Pain Clinic at 10:40 A.M. on 6/22/2020. The Director of the CPC said that after the incident of a wrong site procedure she had reviewed the existing protocols, redesigned the Universal Protocol tool (still pending due to COVID disruption of committees) and in-serviced all staff on Universal Protocol and site marking. In addition the Director of the CPC redesigned some process steps and she was also continuing to monitor 100% of the CPC cases for compliance. The Director of the CPC provided the Surveyor with the educational sign in sheet dated 2/6/2020 and the procedure monitoring tool dated 3/2/2020 through 6/16/2020 indicating 100% case compliance. The Director of the CPC said that three of the four providers involved in the wrong site procedure in the CPS also practiced in the Operating Room of the Hospital.

The Surveyor interviewed the Chief Quality Officer at 10:50 A.M. on 6/22/2020. The Chief Quality Officer said that the incident was shared with the Safety Committee, the Hospital Board of Directors and the Operating Room huddle.

The Surveyor interviewed the Certified Registered Nurse Anesthetist (CRNA #2) at 9:05 A.M. on 6/23/2020. CRNA #2 said he had been present for the wrong site procedure on Patient #1. CRNA #2 said that Patient #1 was lying prone on the table and CRNA #2 was concentrating on Patient #1's airway when the team realized that they had done the procedure on the wrong side. CRNA #2 said it was then that he realized that a time out had not been done. (The surgical "time out" represents the last part of the Universal Protocol and is performed in the procedure room immediately before the procedure is initiated. The "time out" represents the final step to ensure accurate patient identity, surgical site, and planned procedure.) CRNA #2 said since the event he attended the in-services provided in the Comprehensive Pain Clinic. CRNA #2 said that he also regularly practices in the Hospital's main Operating Room. CRNA #2 said that he was not interviewed by the Operating Room staff about the incident. CRNA #2 said that while the Operating Room staff seemed more focused and diligent about the time out process, he did not know how that increased engagement came about.

The Surveyor interviewed Physician #1 at 1:15 P.M. on 6/23/2020. Physician #1 performed the procedure on Patient #1. Physician #1 said he was unable to say exactly what happened at the wrong site procedure but now more emphasis is placed on marking the site and the time out process in the CPS procedure room. Physician #1 said that he attended the in-services provided in the Comprehensive Pain Clinic. Physician #1 indicated he is aware that his cases are being observed in the Comprehensive Pain Clinic but he is not sure his cases are being observed in the main Operating Room. Physician #1 said there were no changes in the Operating Room process.

The Surveyor interviewed Radiology Tech #1 at 1:30 P.M. on 6/23/2020. Radiology Tech #1 participated in the procedure on Patient #1 . Radiology Tech #1 did not recall pausing for the time out prior to Patient #1's procedure. Radiology Tech #1 said that she attended the in-service training after the incident with Patient #1 in the Comprehensive Pain Clinic. Radiology Tech #1 said that she also assists with procedures in the Operating Room and did not receive any retraining on Operating Room procedures after the incident with Patient #1 in the Comprehensive Pain Clinic.

Based on observations, records reviewed and interviews the Hospital failed to follow acceptable standards of care for medication management, use of biohazard bags, storage of a high level disinfected bronchoscope, documentation of the malignant hyperthermia (MH) emergency equipment and correct completion of an informed surgical consent for one patient (Patient #1) in a sample of eight patients requiring informed consents.

Findings included:

1.) The Surveyor and the Director of Surgical Services toured the peri-operative area at 8:20 A.M. on 6/22/2020. The Surveyor reviewed the medication refrigerator used by the Surgical Day and Post Anesthesia Care Unit (PACU). The refrigerator contained an opened multi-dose vial of insulin that was labeled as expired on 5/9/2020. The Director of Surgical Services said it was the pharmacy who monitored the expiration dates of the medication and that the insulin vial should have been removed when it reached the expiration date.

2.) The Surveyor and the Director of Surgical Services reviewed the emergency airway cart in the PACU at 8:30 A.M. on 6/22/2020. In the top draw of the cart a biohazard bag had been used to store various airway supplies. The universal biohazard symbol is used to warn people to take precautions to prevent exposure to biohazardous substances. The Director of Surgical Services immediately removed the biohazard bag and replaced it with a clear plastic zip lock bag appropriate for storage.

3.) According to the Center for Disease Control's publication, Essential Elements of a Reprocessing Program for Flexible Endoscopes - Recommendations of the Healthcare Infection Control Practices Advisory Committee, dated January 25, 2017; "After reprocessing is complete, store endoscopes and accessories in a manner that prevents recontamination, protects the equipment from damage, and promotes drying. Store processed flexible endoscopes in a cabinet that is of sufficient height, width, and depth to allow flexible endoscopes to hang vertically without coiling and without touching the bottom of the cabinet."

The Surveyor, the Director of Surgical Services and Anesthesia Tech #1 reviewed the emergency airway cart in the Operating Room at 9:15 A.M. on 6/22/2020. Anesthesia Tech #1 said that a bronchoscope was stored in the cart for emergency use (a bronchoscope is a medical instrument that is inserted into the airways to allow the practitioner to examine the patient's throat and pass into the lungs) and that the bronchoscope was reprocessed regularly to maintain it for immediate use. The Surveyor, the Director of Surgical Services and Anesthesia Tech #1 observed the bronchoscope curled up in one of the drawers of the cart. This type of bronchoscope was reprocessed using an automated endoscope reprocessor (a machine that uses a high level disinfectant solution) and required that the bronchoscope be stored horizontally (hung) to promote drying.

4.) The Surveyor and the Director of Surgical Services reviewed the emergency malignant hyperthermia cart (MH is a condition that triggers a severe reaction to certain drugs used as part of anesthesia for surgery. Without prompt treatment, the disease can be fatal) in the Operating Room at 9:30 A.M. on 6/22/2020. The Director of Surgical Services said that the MH cart is checked daily. The Surveyor reviewed the MH daily log where the staff checked the equipment and logged the lock number to ensure the cart is intact and ready for an MH emergency. The log indicated that the lock on the MH cart had been changed on 6/20/2020 however two subsequent checks did not reflect the new lock number but instead were logged using the number of the broken lock from two days earlier.

5.) The Surveyor reviewed the informed consent for Patient #1 dated 1/24/2020. The consent indicated an injection of Orthovisc (a medication used to treat knee pain in patients with joint inflammation). According to the procedure note for 1/24/2020, the medication was injected into Patient #1's right knee but the informed consent lacked both the location of the injection and the laterality of the knee.