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Tag No.: A0286
Based on records reviewed and interviews, the Hospital failed to analyze, in one (Patient #1) of ten records reviewed, a patient adverse event after Surgeon #1 operated on Patient #1's right knee instead of the left knee, in error.
1.) The Hospital internal investigation did not analyze or develop correction actions regarding documentation of the second time out procedure, for surgery on the correct knee, according to Hospital Universal Protocol Policy.
2.) The Hospital internal investigation did not analyze or develop correction actions regarding the unavailability of diagnostic radiographic imaging (MRI) to the Operating Room Team.
Findings included:
The Medical Record form titled Progress Note, dated 5/17/17 and documented by Surgeon
#1, indicated treatment for Patient #1's left knee condition required surgery.
The Medical Record form titled Request for and Consent to Operation, dated 5/17/17, indicated Patient #1 consented to left knee surgery.
The Medical Record form titled Operative Note, dated 5/25/17 and documented by Surgeon
#1, indicated Surgeon #1 started surgery on Patient #1's right knee and within minutes of making an incision it was discovered that Patient #1 consented to left knee surgery.
The document titled Quality Patient Safety and Patient Care Assessment Plan, dated 2016-2017, indicated the Hospital internal investigation (Root Cause Analysis) of significant adverse events consisted of a thorough root cause analysis and identification of potential improvement processes.
1.) The Hospital policy titled Universal Protocol, dated 1/2001, indicated the form titled Universal Protocol for Operative, Invasive, Non-Invasive Procedures was used to conduct the time out (procedure for identification, verification and documentation of correct site, correct procedure and correct patient for surgical procedures).
The Medical Record did not indicate the form titled Universal Protocol for Operative, Invasive, Non-Invasive Procedures was used to conduct a second time out procedure for identification, verification and documentation of correct site, correct procedure and correct patient for the surgery of Patient #1's left knee, the correct knee after discovery of the right knee surgery error.
The Surveyor interviewed the Quality Director at 3:30 P.M. on 7/19/17. The Quality Director said that the time out procedure for Patient #1's left knee surgery, the correct knee, was not documented on a form titled Universal Protocol for Operative, Invasive, Non-Invasive Procedures.
2.) The Hospital policy titled Universal Protocol, dated 1/2001, indicated the patient identification process was verified with diagnostic radiographic images.
The document titled Cause Map (Hospital internal investigation), dated 7/25/17, indicated diagnostic radiographic images were not available to the Operating Room Team.
The Medical Record form titled Universal Protocol for Operative, Invasive, Non-Invasive Procedures, dated 5/25/17 at 12:30 P.M. and for the incorrect knee, indicated by signature that a Registered Nurse (RN) completed a pre-procedure verification that indicated diagnostic radiographic images were available. The form did not indicate that diagnostic radiographic images were not available to the Operating Room Team.
The Surveyor interviewed the Chief Nursing Officer and Quality Director at 9:30 A.M. on 7/5/17 and the Chief of Orthopedics at 1:00 P.M. on 7/19/17. The Chief Nursing Officer, Quality Director and Chief of Orthopedics said that diagnostic radiographic images were not available because Patient #1 forgot to bring the images the day of surgery.
The Surveyor interviewed RN #2 at 2:16 P.M. and RN #3 at 2:30 P.M. on 7/5/17. RN #2 and RN #3 said that the Hospital mailed the pre-surgery envelope, that contained patient information about their scheduled surgery, to patients prior to surgery and they would review the information with the patient on the day of surgery. RN #2 and RN #3 said that surgeons instructed patients to bring diagnostic radiologic images with them to their pre-admission testing appointment or to bring the images the day of the scheduled surgery. RN #3 said that when patients bring images to their pre-admission testing appointment she would put the images (disk) in the patient's medical record or she would tell the patient to bring the images the day of the scheduled surgery. Registered Nurse #2 and #3 said there was no clear process to manage diagnostic radiographic images patients brought to the Hospital.
The Medical Record form titled Patient Instructions for Surgery, dated 5/19/17, did not indicate instructions for Patient #1 to bring diagnostic radiologic test images the day of surgery.
The Hospital policy titled Required Pre-Operative Documentation for Elective Surgery, dated 4/2016, did not indicate a process to inquire about diagnostic radiographic imaging required or requested by the surgeon that were necessary for the surgery. The policy did not indicate a process to include diagnostic radiographic images into a patient's medical record.
The Hospital policy titled Pre-Admission Testing Program, dated 6/2016, did not indicate a procedure for staff to process the diagnostic radiographic imaging to be included in the patient's medical record.
The document titled Pre-Admission Testing (PAT) Required Documentation Notice, dated 8/2015, did not indicate a process to inquire about diagnostic radiographic imaging or a process to include the imaging into a patient's medical record.
The pre-surgery patient information mailed to patients did not indicate instructions for patients to bring diagnostic radiologic test images to their pre-admission testing appointment.
The Pre-Admission Testing Department letter to surgical patients, dated 8/2015, did not indicate instructions to patients to bring diagnostic radiologic test images to a pre-admission appointment.
The Pre-Admission Testing Order Sheet form, dated 4/2017, did not indicate a request or requirement for diagnostic radiographic images.
The document titled SBAR Holding PAT (report form), dated 7/5/17, did not indicate a template to document diagnostic radiographic images.
RN #3 said that the SBAR Holding PAT form was not a part of the patient's medical record and was disposed of after use.