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Based on record review and interviews, the facility failed to ensure that all adverse events were reported for 1 of 4 patients (Patient #1) (see A0286) and 3 of 3 surgical staff (Surgeon H, Registered Nurse U, Surgical Assist R) failed to report an adverse event as defined in hospitals policies and procedures and Medical Staff Bylaws. The cumulative effects of the systemic failures prevent this facility from having an effective Quality Assurance Program. The total number of surgeries performed during this survey was 47 inpatient and 19 out patient and total universe 11 patients. (also see tag A0338).

Based on record review and interview, the hospital failed to ensure 3 of 3 surgical staff (Surgeon H, Nurse U, and Surgical Assist R) followed hospital policy and procedure and medical staff by-laws to report an adverse events for 1 of 4 patients incidents (patient #1). The total patient sample was 11. This deficiency could potentially affect all surgical patients at this facility (total number of surgeries performed during survey 47 inpatient/ 19 outpatient).

Findings include:

Review of policy #149 titled Procedural Safety Policy (Universal Protocol for Prevention) revision date 8/2014 states under 5.5 Sign-Out a. "A standardized "Sign-Out" will be performed at procedure end ... c. All appropriate team members will be notified of any significant events that occur following the Sign-Out Process".

Review of policy #166 titled Incident (Patient Safety Event) Reporting/Sentinel Event Management with the last revision date of 4/2015 stated under 3. Definitions, 3.2 Patient Safety Event: "An event, incident, or condition that could have resulted or did result in harm to a patient ... Event analysis is warranted in order to identify weaknesses and whether remedial action is indicated". Under 5. Procedures, 5.1 Reporting c) "Refer to Addendum 1 for a patient safety event reporting guide that outlines types of errors that should be reported". Policy Addendum #1 Patient Safety Event Reporting page 12 under Patient Safety Events Related to Surgery or other Procedures - Must Report "unintended retention of foreign object in a patient after surgery or other procedure". Under 5.2 Immediate Response to Events b) i. "All potential Sentinel Events ... shall be phoned to the responsible manager or director and the facility Risk Management Department immediately ... ii. Any caregiver who discovers, witnesses, or is in involved in a Patient Safety Event shall complete a web-based incident report as soon as possible".

Review of Aurora Health Care Job Description for Registered Nurse (RN) I on 5/02/2017 states under Major Responsibilities "provides ongoing patient centered nursing care ... according to protocol and established guidelines ...and collaborates with other health care team members to coordinate patient centered care".

Per review of Patient #1's medical record on 5/02/2017 at 8:30 AM with Operating Room Director C, Patient #1 was admitted through Outpatient Surgery on 2/21/17 at 6:50 AM for excision of subcutaneous fluid collection from lump, lower anterior abdomen by general Surgeon H. Operative report revealed Surgical Assist R assisted in procedure. Operative report dated 2/21/17 at 2:24 PM revealed "Pre-Procedure Diagnosis: Chronic draining sinus tract of the anterior abdominal wall, Post-Procedure Diagnosis: Same, Findings: Excision of 25 cm2 from the anterior abdominal wall surrounding a chronic draining sinus tract. Removal of retained VAC [Vacuum Assisted Closure] sponge 5 cm X 1.5 cm overlying the patient's prior placed biologic mesh." Pathology Report dated 2/22/2017 at 10:56 AM showed Pathologic Diagnosis: "Retained abdominal wall foreign body, removal: - Sponge-like foreign body material" Wound VAC sponges are used with a device in wound management systems which help create an environment that increases tissue perfusion and granulation to promote wound healing.

During an interview of Operating Room Director C while reviewing Patient #1's medical record on 5/02/2017 at 8:30 AM, C revealed "I don't remember seeing that verge report", "I would have thought one would have been filled out".

Per interview with Surgical Assist R on 5/02/2017 at 12:15 PM, when interviewed about when incident reports are completed, R stated he/she has written up many incident reports but is frustrated with that process because he/she feels that some things just don't change and that "the attention to detail is just not there". When asked specifically if R had ever encountered a foreign object being taken out of a patient during surgery, R had no recall of any such incident but stated if something like this happened, a supervisor or manager would "definitely" be notified. When asked if an incident report would be filled out, R stated direction would be taken from the surgeon; "probably" an incident report would be written.

During interview on 5/02/2017 at 12:45 PM with Registered Nurse U, when asked when staff were expected to fill out incident reports, RN U stated not many incidents reports are filled out, they are filled out if something is missed in another department, to make that department know they did something wrong. When asked if U recalled any foreign objects being taken out of a patient, U recalled what "looked like a sponge" being taken out of a patient. RN U stated they sent the object to the lab and talked about it with the surgeon and staff, wondering how it got there. U stated they did not fill out an incident report at that time "the surgeon didn't make a big deal out of it".

During interview on 5/03/2017 at 8:30 AM with Quality Director B while looking at policy #166 titled Incident (Patient Safety Event) Reporting/Sentinel Event Management, B stated that when the unanticipated VAC sponge was removed from Patient #1's abdomen during surgery on 2/21/2017, a supervisor should have been notified and an incident report should have been completed by the surgical staff or surgeon. B stated that the verge report (incident report) would have been reviewed by the Event Review Committee and would have triggered both a Root, Cause, Analysis (a comprehensive systematic analysis used to identify basic or causal factors underlying variation in performance) and Peer Review (a process by which a committee of physicians examines the work of a peer and determines whether the physician under review has met accepted standards of care in rendering medical services). When asked if this was a sentinel event, B stated that it would have been determined by the Verge system (incident report system) process and stated "yes, this was probably a sentinel event".

Based on record review and interviews, the medical staff failed to ensure Medical Staff Bylaws policies and procedures were followed when staff identified an adverse event had occurred for 1 of 1 patient (Patient #1). Total patient sample 11. This deficiency could potentially affect all surgical patients at this facility (surgeries scheduled during survey on 5/01/2017 were 19, 5/02/2017 were 14 and 5/03/2017 were 14).

Findings include:

Review of Aurora Medical Center Summit Medical Staff Bylaws v 27 AMC (Aurora Medical Center) Summit dated 3-21-2016 Article 2 - Staff membership and clinical privileges 2.8.17 Unanticipated Outcome Disclosure to Patient states "The Applicant agrees to disclose unanticipated medical outcomes to the Medical Center and patients in accordance with applicable policies".

Review of policy #166 titled Incident (Patient Safety Event) Reporting/Sentinel Event Management with the last revision date of 4/2015 stated under 3. Definitions, 3.2 Patient Safety Event: "An event, incident, or condition that could have resulted or did result in harm to a patient ... Event analysis is warranted in order to identify weaknesses and whether remedial action is indicated". Under 5. Procedures, 5.1 Reporting c) "Refer to Addendum 1 for a patient safety event reporting guide that outlines types of errors that should be reported". Policy Addendum #1 Patient Safety Event Reporting page 12 under Patient Safety Events Related to Surgery or other Procedures - Must Report "unintended retention of foreign object in a patient after surgery or other procedure". Under 5.2 Immediate Response to Events b) i. "All potential Sentinel Events ... shall be phoned to the responsible manager or director and the facility Risk Management Department immediately ... ii. Any caregiver who discovers, witnesses, or is involved in a Patient Safety Event shall complete a web-based incident report as soon as possible". Under 5.5 Patient Disclosure of Sentinel Events states "The unanticipated patient outcome should be discussed with the family by the attending physician or his or her designee. Prior to discussing the unanticipated outcome with the patient and/or patient's family, site administration, the attending physician or designee should, unless time constraints or circumstances dictate otherwise, consult with Risk Management, hospital administration, or legal counsel".

Review of policy #2050 titled Retained Surgical Items dated 11/2013 states under 1. Purpose "To prevent the retention of surgical items (sponges, sharps, instruments) in patients undergoing surgery or other invasive procedures", under 4. Policy, 4.5 "Any retained surgical item is considered a sentinel event and is reported following the system incident reporting process".

Review of policy #146 titled Disclosure of unanticipated Outcomes dated 1/2004 last revised 5/2017 states under III. Definitions D. 3. "Outcome was unanticipated and there was temporary patient harm", IV Procedure A. 1. "The LIP, and/or other appropriate staff should determine if the outcome differs significantly from the expected. Timely, voluntary reporting of unanticipated events is essential to ensure timely intervention and help rectify unanticipated patient harms" 3. a. "Upon discovery of unanticipated outcome ... personnel shall report the unanticipated outcome to their immediate supervisor or the head of their department". G. Documentation 1. "The LIP or designee who makes the disclosure shall note the circumstances of the disclosure in the progress notes section of the patient's medical records".

Per review of Patient #1's medical record on 5/02/2017 at 8:30 AM with Operating Room Director C, patient #1 admitted through Outpatient Surgery on 2/21/17 at 6:50 AM for excision of subcutaneous fluid collection from lump, lower anterior abdomen by Surgeon H. Operative report revealed Post-Procedure Diagnosis: Same, Findings: Excision of 25 cm2 from the anterior abdominal wall surrounding a chronic draining sinus tract. Removal of retained VAC sponge 5 cm X 1.5 cm overlying the patient's prior placed biologic mesh." Pathology Report dated 2/22/2017 at 10:56 AM showed a Pathologic Diagnosis: "Retained abdominal wall foreign body, removal: - Sponge-like foreign body material"

Per interview on 5/03/2017 at 9:25 AM with Chief Medical Officer D, D was informed of the findings of the sponge identified in patient #1's abdomen during a surgical procedure on 2/21/2017. D stated he/she was not aware of the incident prior to this investigation. D stated he/she would expect the surgeon to follow the policies and procedures of the hospital as defined in the Medical Staff Bylaws.. When asked who this surgeon should have reported this incident to, D shrugged his shoulders and said "I couldn't say".

Based on observation, record review and interview, the hospital failed to ensure proper use of alcohol-based skin prep solution to reduce the risk of fires in 1 of 1 surgical procedures observed (Patient #3) (See tag A0951) and failed to ensure Surgical Assist (SA) staff were competent to perform suturing for 9 of 9 SA staff (Surgical Assist I, L, R, Z, AA, BB CC, DD, EE). (See tag A0943). The cumulative effect of these deficiencies has the potential to adversely affect all patients obtaining surgical services at this hospital.

Based on observation, record review and interview, the hospital failed to delineate duties or have competencies for 9 of 9 Surgical Assists (SA)(SA - I, L, R, Z, AA, BB CC, DD, EE). This deficiency could potentially affect the care of all surgical patients at this facility (total number of surgeries performed during survey 47 inpatient/ 19 outpatient).

Findings include:

Review of Aurora Health Care Job Description for Surgical Assists (SA) on 5/02/2017 stated under Major Responsibilities, "Under the direct supervision of the Surgeon, assists with and performs a variety of procedures such as injecting local anesthetic, retracting tissue, suturing, cauterizing to the extent of coagulating bleeding vessels, wound closures ...". Under Education Required: "completion of an accredited or approved program in Surgical Technology". Experience Required: "Typically requires 5 years of experience in a Surgical Technologist or Surgical Assistant position"

During observation of a cholecystectomy (the surgical removal of the gallbladder) on 5/01/2017 at l:07 PM on Patient # 3, SA I was observed assisting Surgeon H perform this procedure. SA I was observed suturing the umbilical incision of Patient #3 at the end of the procedure.

Per interview of SA I on 5/01/2017 at 2:37 PM, SA I stated prior to getting this job, I's education included completion of a one year Surgical Tech program and a few years experience in that role prior to getting the current position. I states they attend a yearly mandatory education fair and education as directed by the manager, but they did not have to obtain any other education prior to obtaining the surgical assist position.

Per interview on 5/02/2017 at 2:25 PM with Operating Room Director C, C stated this facility has 9 total SAs and 3 of those are certified. (requiring 3 years of surgical tech experience).

Per interview on 5/02/2017 at 2:30 PM with Surgical Nurse Educator N, N stated there is no documentation of competencies, duties, or sign off of competencies for the SAs.

Based on observation, record review, and interview, the hospital failed to reduce the risk of fires by ensuring the alcohol based skin prep was dried prior to draping 1 of 1 surgical patient (Patient #3). Total sample reviewed 11. This deficiency could potentially affect the care of all surgical patients at this facility (total number of surgeries performed during survey 47 inpatient/ 19 outpatient).

Findings include:

During observation of a cholecystectomy (surgical removal of the gallbladder) on 5/01/2017 beginning at 12:43 PM for Patient # 3 by Surgeon H, an abdominal prep was performed an alcohol based betadine scrub at 1:17 PM. The staff monitored the surgical prep dry time for 3 minutes, then Patient #3 was draped by Surgical Assist I without the surgical prep being completely dry, as noted by the pooled wet area on Patient #3's abdomen.

Per reviewed of the manufacturers instructions for the betadine scrub used on Patient #3 (3M DuraPrep Surgical Solution Iodine Povacrylex (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w)), information revealed "Solution contains alcohol and gives off flammable vapors. Do not drape or use ignition source (e.g. cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin)" .

During interview with Operating Room Director C on 5/02/2017 at 2:20 PM, C stated their process was to wait 3 minutes and then drape the patient, the staff was not expected to check if the surgical area was dry prior to draping.