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Based on record reviews and interviews, the hospital failed to have an effective system in place to meet the requirements of the Condition of Participation for Patient's Rights as evidenced by the hospital failing to ensure patients received care in a safe setting. This deficient practice was evidenced by the hospital failing ensure the surgical Time Out procedure was effectively implemented and the correct surgical procedure was performed on the correct site for 1 (#2) of 5 (#1-#5) patients reviewed for surgical procedures. (See findings in tag A-0144).

Based on record reviews and interviews, the hospital failed to have an effective system in place to ensure ensure patients received care in a safe setting. This deficient practice was evidenced by the hospital failing to ensure the surgical Time Out procedure was effectively implemented and documented and the correct surgical procedure was performed on the correct site for 1 (#2) of 5 (#1-#5) patients reviewed for surgical procedures.

Findings:

A review of the hospital policy titled, Universal Protocol, Pre-Procedure, Checklist, Surgical Site Marking, Time Out revealed in part:

Purpose: Enhance safety by correctly identifying the patient, the appropriate procedure, and correct site of the procedure.
Scope: Applies to all patients undergoing surgical and non-surgical invasive procedures.
Responsibility/ Authority:
A. The Registered Nurse and or Licensed Practical Nurse performing the preoperative/ pre-procedure process is responsible for:
1. Ensure that universal protocol has been implemented and followed including pre-verification, site marking and time- out.
Policy/ Procedure:
Pre-Procedure Verification:
1. All relevant documents are collected and documented and are: 1. Available prior to the start of the procedure,
2 Correctly identified, labeled and matched to the patient's identifiers, Reviewed and consistent with patient's expectations and with the team's understanding of the intended patient, procedure and site.

As the patient flows from pre-admit through admission process, pre-procedure verification information is verified at all stages. The pre-procedure checklist (is utilized to assure that all required information is obtained to verify the correct procedure, for the correct patient on the correct site is performed.

3. Time Out
A time- out is conducted as a final assessment to assure that the correct patient, site, and procedure are identified. It is conducted immediately before starting the invasive procedure or making the incision. The entire staff, including the individual performing the procedure, the anesthesia providers, the circulating nurse, the operating room technician and other participants who will be participating in the procedure from the beginning will participate in the time-out. The time out will be initiated by the primary nurse (example: OR circulator, ED nurse in procedure etc.). During time-out, all activities are suspended. The following will be verified out loud:
1. The correct patient
2. The correct procedure
3. The correct surgical site

This will be verified by checking consent, radiology site markings if appropriate etc.

Time- out procedures will be documented in the patient's medical record.




On 09/20/2022 at 12:30 p.m. a review of the incidents/ accidents reports revealed Patient #2's incident was reported on 06/30/2022 at 8:54 a.m.

A review of the QA data for the last 6 months revealed: August 19, 2022 a RCA was conducted for wrong site procedure.

A review of the Cath Lab schedule for the last 6 months revealed Patient #2 was listed on the Cath Lab schedule on 06/06/2022, 06/29/2022 and again on 07/18/2022 for S3MD.

A review of Patient #2's medical record admission date 06/06/2022 revealed:
H & P was dated 05/31/2022 at 10:30 a.m.
The H&P Update was dated 06/06/2022 at 7:52 a.m. No changes per S3MD
68 year old male with left leg claudication and right leg claudication but not nearly as much as the left.

Assessment and plan:
PAD- CTA- Computerized Angiogram report from 05/20/2022 reviewed and demonstrates severe stenosis of the right SFA and Left SFA CTO. Recommend intervention to both of these vessels. Discussed risk, benefits and alternatives. Consent form signed and witnessed.

Note:
9:29:55 a.m. Time Out: Physician and staff present, verification of correct patient, site and procedure confirmed. All team members are in agreement. Per Physician no change in previous airway assessment.

Intervention:
Unsuccessful ante grade attempt at crossing the SFA CTO in the left lower extremity.
Successful angio-guided retrograde laser atherectomy, balloon angioplasty with drug eluding stent at the ostium of the left SFA and drug coated balloon treatment followed by bare metal stenting of the distal left SFA (>10%) . There is residual distal Sufalac Femoral Artery dissection incident to the intervention with inflow covered by BMS.
Return to clinic 7-10 days with S6MD followed by scheduling RLE intervention via pedal access.

A review of Patient #2's admission for 6/29/2022.
Updated H&P Patient examined. No changes from changes from previous physical status. Signed by S3MD on 6/29/2022 at 8:47 a.m.
H& P on Patient #2's Medical Record dated 5/31/2022 at 10:30 a.m.
In an interview on 09/22/2022 at 1:05 p.m. S2Risk verified the H& P for the second visit was the same H&P as the visit on 06/06/2022.

A review of the consent revealed:
S3MD for Peripheral Angiogram Intervention "Right" was checked and has a line drawn through it, dated 6/29/2022 at 8:50 a.m. and initialed but is not legible.
In an interview on 09/20/2022 at 1:10 p.m. S2Risk verified she conducted a root cause analysis for a wrong site procedure in the Cath Lab, Patient #2.

On 09/20/2022 at 1:30 p.m. in an interview with S2 Risk stated the RCA for Patient #2 revealed:

May 20, 2022 Patient #2 had a CT with stenosis to both legs.
May 31, 2022 Patient #2 went to Facilty B, S3MD and scheduled for left on 6/6/2022 and right lower extremity procedure on 6/29/2022.

In an interview on 09/22/2022 at 1:23 p.m. S2Risk stated S3MD made the change and initialed the change on the consent for 06/29/2022. She also verified Patient #2 did not initial the change on the consent. S2Risk confirmed S3MD should have completed a new consent and documented the reasoning in the medical record or updated the H&P.

A review of Patient #2 medical record for the 06/29/2022 admission revealed the order S3MD's office faxed over on 06/28/2022 at 12:50 p.m. for scheduling. The order was a verbal order taken by S7LPN on 06/28/2022 for right lower extremity revascularization June 29, 2022, S3MD. The order was electronically signed by S3MD on 07/05/2022 at 10:10 p.m.
A review of the Pre-OP Worksheet for Patient #2 revealed, Procedure RLE Revascularization 6/29/2022.

Consent signed by Patient #2 on 6/29/2022 at 8:57 a.m.
Time Out at 9:14 a.m. Physician and staff present, verification of correct patient, site and procedure confirmed. All team members are in agreement. Per physician no change in previous airway assessment. Begin Procedure.

Intervention:
Successful IVUS guided angioplasty and treatment with DCB, Drug Coated Balloon, of the left distal SFA Stenosis (-> 0% with non-flow limiting dissection incident to the intervention).

Patient was discharged on 06/29/2022 at 2:30 p.m. return to clinic in 7-10 days with S6MD. Schedule right lower extremity via pedal access.

A review of the Cardiology Progress Note electronically signed by S3MD dated 06/29/2022 at 8:27 p.m. revealed:
Patient had B PA today with intervention to his left distal SFA. Unfortunately, that was not the planned intervention today. I realized this after the procedure when speaking with the patient and his wife. I researched the situation further and then informed the patient and his wife of the following: I reviewed his clinic note from 05/31/2022 which documented B PA via R CFA. After that procedure, which was done in early June, patient followed up with S6MD in order to save him a trip back to the clinic just for a post-procedure appointment. This has been protocol. He followed up with S6MD and then RLE PA via pedal access was scheduled as documented in my plan after his last intervention. Unfortunately though, I reviewed the most recent note (from 5/31) and didn't realize that that note was outdated. As such, I proceeded with the original plan, not the plan status post recent intervention. I have informed the patient and his wife of the mistake and that we will schedule the correct procedure > 7 days out (likely next week). S8CathMgr was present during the conversation. I also called and informed referring MD, S6MD.

In an interview on 09/22/2022 at 1:50 p.m. S2Risk verified S3MD completed the incorrect procedure on Patient #2 and documented as such in the MR. She also stated the nurses questioned S3MD during the time out; however they failed to utilize the Time Out to identify the issue and correct the mistake.

In an interview on 09/22/2022 at 2:05 p.m. S4RN, stated he was involved with the procedure. He stated nursing staff questioned S3MD about the procedure that was to be conducted. S4RNdoes not recall the response from S3MD; but the procedure was changed to the left leg. S4RN verified the Time Out in the medical record should have reflected the questioning of the procedure and site.

In an interview on 09/22/2022 at 4:13 p.m. S8CathMgr verified the verbal order taken by S7LPN for the right lower extremity revascularization and Pre-OP Worksheet for Patient #2.

Based on record review and interview, the hospital failed to ensure the hospital wide QAPI program's performance improvement activities implemented preventative actions for an adverse event. This deficient practice is evidenced by failure to implement preventative actions after identifying an incorrect procedure being performed on 1 (#2) of 5 (#1-#5) patients reviewed for surgical procedures.

Findings:

On 09/20/2022 at 12:30 p.m. a review of the incidents/ accidents revealed Patient #2 had an incident reported on 06/30/2022 at 8:54 a.m.

A review of the Quality Assurance data for the last 6 months revealed: August 19, 2022 a RCA was conducted for wrong site procedure.

In an interview on 09/20/2022 at 1:10 p.m. S2Risk verified a wrong site procedure RCA as Patient #2 Cath Lab procedure. S2Risk verified S3MD admitted in his notes to performing the incorrect procedure. She also verified no action plans were initiated by the hospital after the incident because the physician involved was contracted employee and not a hospital employee.