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Based on a review of facility documents, medical records (MR), and staff interview (EMP), it was determined that the facility failed to ensure high standards of medical practice in surgical services, failed to ensure preoperative medical records are completed accurately and failed to ensure staff followed approved facility policies to provide sterile practices in the Operating Room (OR).


Findings include:

On December 7, 2022, review of facility Policy Title: Universal Protocol for Patient Identification and Eliminating Wrong Site Surgery (Policy No.2.05.0 )- PERIOP last revised December 30, 2021, revealed "Policy Purpose: The purpose of this policy is to assure that the appropriate steps are taken prior to the operative and invasive procedure, in order to prevent wrong site, wrong procedure, or wrong person surgery ... Pre-Procedural Site Marking Process - 5. The procedural site mark or marks address the following:
a. Is made at or near the procedure site or incision site (within 2" of the surgical site). The Time-Out Process (Including Anesthesia Time Out/Sign In and the Surgical Time Out) b. Confirmation that the correct laterality/site are marked and surgeon initials are visible
after the prep and drape."

On December 7, 2022, review of facility Policy Title: Guidelines for Use of Tourniquet in Surgery (Policy No. 7.57.0) - PERIOP last revised April 2021 revealed "Policy Purpose: To provide guidelines for the application of a pneumatic tourniquet during surgery ... Application of the Tourniquet - 1. Verify the correct limb/procedure/surgical site ... 6. Position the tourniquet cuff tubing on or near the lateral aspect of an extremity. Tubing should
be located on top of cuff facing away from the surgical sight."

On December 7, 2022, review of MR1 Assessment Plan noted by EMP6 on 12/1/2022 at 1641 revealed, "Pt has LEFT ankle pain after an injury on 10/24/21. We discussed proceeding with a LEFT ankle arthroscopy and partial synovectomy, possible drilling of an OCD, lateral ankle ligament reconstruction with internal brace, peroneal tenosynovectomy, and gastrocnemius recession using a posterior approach ..." Operative note entered on December 2, 2022, at 1610 by EMP7 revealed, "Procedure: Operation performed:
Right ankle arthroscopy and partial synovectomy; Right Modified Brostrom Lateral ankle ligament reconstruction with internal brace augmentation; Right peroneal tenosynovectomy; Right gastrocnemius recession ..." Anesthesia Quick Note Events revealed on December 2, 2022, at 1515 EMP5 noted "Surgical team realizes procedure done on wrong side."

During interview with EMP7 on December 7, 2022, EMP7 confirmed surgery was performed on the incorrect limb. EMP7 stated, during the pre-operative assessment EMP7 marked the correct limb at a location higher on the extremity away from the surgical site to prevent the marking from being removed with the cleaning process.

During interview with EMP8 on December 7, 2022, EMP8 confirmed EMP8 placed the tourniquet on the right extremity which was the incorrect surgical site.

Further review of policy "Universal Protocol For Patient Identification and Eliminating Wrong Site Surgery" on December 7, 2022, revision 12/30/21, revealed, "Policy Purpose: The purpose of this policy is to assure that the appropriate steps are taken prior to the operative and invasive procedure, in order to prevent wrong site, wrong procedure, or wrong person surgery ... Pre-Procedural Site Marking Process 1. The surgeon will confirm the identity of the patient using two identifiers (first/last name and date of birth) and will confirm the correct operative site and laterality with the patient ..."

A review of medical records MR6 and MR8, conducted on December 7, 2022, revealed no documentation that the surgeon identified the patient after the patient was placed on the operating room table and prior to the start of the surgery.

Interview conducted on December 7, 2022, with EMP4 confirmed that there was no documentation that the surgeon identified the patient after the patient was placed on the operating table and prior to the start of the surgery.

Further review on December 16, 2022, of facility policy Recommendations for Maintaining Sterility in the Operating Room (Policy No. 7.58.0) - Periop Last revised November 3, 2022, revealed "Policy Purpose: To provide guidance to perioperative team members for opening, dispensing, and transferring sterile items while preparing, maintaining, and monitoring a sterile field...Procedure: 2. All personnel must perform hand hygiene practices to prevent the transmission of infection and to reduce healthcare-associated infections for patients and healthcare personnel."

On December 16, 2022, review of facility policy Lancaster General Hospital Infection Control Policy, Section 3A: Hand Hygiene, last revised September 2022, revealed "Hand hygiene is the single most important procedure for preventing healthcare associated infections. I. Perform Hand Hygiene A. Before 1. Applying gloves 2. Entering patient environment 3. Performing a clean or invasive procedure B. After 1. Exposure to body fluids, non-intact skin or wound dressing 2. Completing a dirty procedure 3. Leaving patient environment 4. Removing gloves."

Observation of staff in Operating Room (OR) two (2) on December 7, 2022, revealed EMP8 completed a surgical procedure, removed gloves and exited OR without performing hand hygiene. EMP9 touched blood soiled gauze, without performing hand hygiene, adjusted drapes on patient and performed direct patient contact without changing gloves or performing hand hygiene.

Observation in OR four (4) on December 7, 2022, revealed EMP10 removed gloves after collecting patient specimen, proceeded to document on computer and wait in OR without performing hand hygiene.

Interview with EMP1 on December 7, 2022, confirmed that EMP8, EMP9, and EMP10 had failed to follow the facility's policy.