The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.
|GENESIS MEDICAL CENTER-DAVENPORT||1227 EAST RUSHOLME STREET DAVENPORT, IA 52803||Dec. 14, 2015|
|VIOLATION: SURGICAL SERVICES||Tag No: A0940|
|I. Based on review of policies, medical records, and staff interviews, the hospital's administrative staff failed to ensure the operating room staff and providers performed the time out procedure in accordance with the hospital policy to ensure patient's surgical procedures were performed on the correct surgical side. (Refer to A-0951)
The cumulative effect of these failures and deficient practices resulted in the hospital's inability to ensure patients received surgery on the correct side prior to the beginning of the surgical procedure.
II. During the complaint investigation, the surveyor identified an Immediate Jeopardy (IJ) situation, a situation that placed the patient at risk for harm, related to Condition of Participation, Surgical Services 42 CFR 482.31.
1. The Administrative staff, Chief Medical Officer, and Director of Operating Room failed to perform an analysis, develop, and implement a corrective action plan to ensure providers/surgeons performed all surgical procedures on the correct side for patients following the initiation of a wrong side surgery on Patient #1 on 10/23/15.
2. The Administrative staff, Chief Medical Officer, and Director of Operating Room again failed to perform an analysis, develop, and implement a corrective action plan to ensure providers/surgeons performed all surgical procedures on the correct side for patients after a surgeon performed a wrong side surgery on Patient #2 on 11/5/15.
3. The Administrative staff were informed of the IJ and the Administrative staff took action to put a corrective action plan in place. The Immediate Jeopardy was removed prior to the exit date of the complaint investigation. A condition level deficiency remained for the Condition Surgical Services.
The corrective action plan included in summary:
The hospital administration reported the administrative staff completed a root cause and analysis [RCA] on 12/7/15 (during the survey) regarding the hospital's noncompliance with Universal Protocol Time Out (Final Verification) Policy. The Administrative staff reported the Operating Room (OR) staff and providers did not follow the Universal Protocol Time Out (Final Verification) policy.
The hospital administrative staff revised the Universal Protocol/Time Out (Final Verification) policy to include a pre-procedure verification. During the pre-procedure verification the circulating nurse together with the patient will confirm the correct patient, correct surgical side and site is marked by the physician, the patient is in the correct position, the correct surgical procedure consent form is signed. Both the circulating nurse and the patient are in agreement of procedure to be done, the relevant images and results are present, the circulating nurse will administer antibiotics or fluids for irrigation if needed, and review the history and physical to ensure it is accurate and complete. The circulating nurse will document all these elements in the OR Nurse Operative Record.
The revised Universal Protocol Time Out (Final Verification) policy designated the surgeon to be responsible for the initiation of the "time out" final verification. The surgeon will lead and all team members in the OR room will participate in the time out/final verification. The entire surgical team will confirm the correct patient, correct surgical side and site are marked by the physician, the patient is in the correct position, and the correct surgical procedure consent form is signed. In addition, the entire surgical team will agree on the procedure being performed, confirm all relevant images and results are properly labeled and appropriately displayed, ensure the circulating nurse administered antibiotics or fluids for irrigation purposes if needed, and ensure all safety precautions are in place based on the patient's history and/or medications are used during the time out/final verification.
During the time out/final verification, all activities, music and communication in operating room would cease or the time out would not proceed. The OR scrub personnel and surgeon would confirm the site marking was visible after skin prep and draping procedures are completed. If the site marking was not visible at that time, the surgeon and entire surgical team would pause, verify the correct surgical side and site with documentation, and the surgeon would re-mark with a sterile marker or re-prep and re-drape. If the surgeon would refuse to re-mark site, the surgical case will not proceed and the circulating nurse will notify the OR leadership, who would speak with surgeon. If the surgeon would still not be compliant, the on call administrator will be immediately notified.
The hospital required all providers, mid-level providers, operating room, Endoscopy, and Birth Center staff that perform surgical procedures to review the revised Universal Protocol/Time Out (Final Verification) policy prior to performing any surgical procedure.
The hospital developed and implemented an audit process of the new pre-procedure verification practice to include direct observation by the OR manager or charge nurse for 20% of cases a day but no less than 2 a day. The weekly results of the audit will be submitted to the OR Manager/Director. Monthly, the results will be tabulated and submitted to the Quality Specialist, Quality and Safety Committee, Medical Executive Committee, and Quality and the Safety Committee of the Board.
The hospital revised the patient electronic medical record to include the language from the revised Universal Protocol Time Out (Final Verification) policy. The patient electronic medical record will include both the pre-procedure verification and the time out/final verification elements. (The correct patient, correct surgical side and site marked, correct position, correct surgical procedure consent form, agreement on procedure being done, relevant images and results are properly labeled and appropriately displayed, need to administer antibiotics or fluids for irrigation purposes, safety precautions based on patient history and/or medication use).
|VIOLATION: OPERATING ROOM POLICIES||Tag No: A0951|
|Based on review of policies, medical records, and staff interviews the hospital operating room staff and providers failed to perform the time out procedure in accordance with the hospital policy to ensure patient's surgical procedures were performed on the correct surgical side.
Failure to ensure the hospital operating room staff and providers performed the time out procedure in accordance with the hospital policy resulted in the hospital operating room staff and providers performed 2 of 2 patient's surgical procedures on the wrong surgical side. (Patient #1 and 2)
1. Review of hospital policy titled, "Universal Protocol/Time Out (Final Verification) " dated 6/15/15, included in part, " ...All departments that prepare for or perform procedures verify that the required elements are completed for site verification and 'time out'. Completion of 'time out' and verification process are documented in the patient record...The site marked must be visible after the patient has been prepped and draped ... 'Time out' (Final Verification Immediately before starting the procedure...The time out/final verification must be done in the location where the procedure will be done, immediately prior to the beginning of the procedure..."
2. Review of hospital document titled, "Genesis Code E Meeting 12/2015" (A meeting to evaluate the seriousness of an unusual occurrence.) included in part, "...Event Date: October 23, 2015 at West OR [Patient #1]...RN prepped patient leg and time out done...Site not verified at this point...Both scrubs and circulators noted that the position of people around the table was odd for a right hip and RN stopped the line to verify, however incision already done... Procedure completed on correct hip...Meeting held October 30, 2015...Interventions Staff huddles, pay attention to detail. Adhere to having images available during timeout...."
Review of hospital document titled, "Genesis Code E Meeting 12/2015" included in part, "...Event Date: November 5, 2015 at East OR [Patient #2]...History of present illness included plan of fine needle aspiration biopsy. First note in documentation stated "left lobe benign and right not clear....Impression from path report is that right lobe benign and left lobe not clear...After left lobe was removed, surgeon contacted pathologist about results from the OR, and pathologist informed him that biopsy had been done on Right Lobe. At that point, [Physician H] proceeded with removing the rest of the thyroid. In OR do not use Path Reports as a "relevant document" because it cannot be viewed fully from the OR. ...Meeting held 11/23/15...Interventions: Surgical Group now has process to verify documents with primary sources, i.e. pathology report. Universal protocol was followed appropriately in the OR..."
3. Review of Patient #1's medical record revealed the following:
a. On 10/22/15 the patient presented to the emergency department with complaint of right hip injury, hip pain after a fall on steps at home that resulted in a right hip fracture. Orthopedic services consulted with the patient in the emergency room and recommended a right hip hemiarthroplasty (the top part of the thigh bone - femur - is replaced by a metal implant). The patient was admitted to the hospital for pain control and surgery was scheduled for 10/23/15.
b. Review of the consent form included in part, "...10/23/15 at 10:45 AM, Patient #1 signed "Consent for Surgery or Other Procedure and Administration of Anesthesia" for "Hemiarthroplasty Right Hip"..."
c. Review of document titled, "IntraOp" included in part, "...Time Out - 1:08 PM - Elements of a Time Out - Current patient identity, confirmation that the correct side and site are marked..."1:21 PM by Registered Nurse (RN) F.
d. Review of document titled, "Operative Report" included in part, "...10/23/15... Complications: The left hip was accidentally incised down to the subcutaneous tissue and closed prior to recognition...the wound was subsequently closed...the patient was positioned properly for right hip hemiarthroplasty after a dressing was applied...The patient was initially placed into the right lateral decubitus position with the left hip elevated....A time-out was performed and incision is made along the posterior lateral aspect of the left hip through the skin only. At this time stop the line was performed as we realized that the patient was positioned improperly..."
4. During an interview on 12/10/15 at 9:05 AM, Physician G, Orthopedic Surgeon reported he saw the patient preoperatively in consultation regarding the procedure that was scheduled later in the day. Physician G reported he assisted with the moving and positioning of the patient on the operating room table. Physician G reported he did not see the mark he had made on the patient's surgical site. Physician G said he had not looked for the mark. Physician G stated, the nurse prepped the patient's hip and leg. Physician G reported he scrubbed in and draped the patient. Physician G reported he was not engaged in a time out and he did not remember the engagement of the team in a time out. Physician G reported he made an incision and at that point [RN E] told [Physician G] to hold on. Physician G reported the procedure was stopped immediately and the team cleared the air as to what the problem was. Physician G reported he washed out the patient's hip, stapled the incision, and placed a dressing on the incision. Physician G stated, the patient was repositioned, the team performed a time out and the surgery was performed on the correct side.
During an interview on 12/9/15 at 1:10 PM, RN E, Operating Room (OR) Nurse, reported she met the patient in the OR but did not discuss which hip was broken. RN E reported [Physician G] assisted moving and positioning the patient onto the OR table on the patient's wrong side. RN E reported she prepped the patient's hip and leg that [Physician G] positioned up. RN E reported she did not question the physician about the patient's position. RN E stated, "I did the time out and [Physician G] stated okay." RN E stated, "I went to the chart and said stop." RN E reported she read the consent and told the OR staff we are suppose to be doing the right hemiarthroplasty hip. RN E reported the physician stopped the procedure. RN E reported however, the physician had already made an incision on the wrong side. RN E stated, "[Physician G] took the drapes off and repositioned the patient to do the right hip." RN E reported she did the time out for the first incision. RN E reported she did not document the time out in the patient's medical record.
During an interview on 12/9/15 at 1:45 PM, RN F reported when she returned from lunch the physician and staff were putting a dressing on the patient's wrong hip. RN F reported RN E told her they did the procedure on the wrong hip. RN F stated the OR staff repositioned the patient and did another time out. RN F stated upon review of Patient #1's medical record she did not see RN E documented a prior time out.
5. Review of Patient #2's medical record revealed the following:
a. The patient was admitted for surgery on 11/5/15 for "Left Thyroid Lobectomy (Removing half of the thyroid that has a nodule.) Possible Total Thyroidectomy (Removal of the total thyroid.)".
b. Review of History and Physical dated 10/29/15 and verified by Physician H on 11/5/15 included in part, "...Patient had a thyroid mass noted on exam and ultrasound showed a suspicious nodule...a size more than 1 cm. A fine needle laceration was done demonstrated a follicular neoplasm (an abnormal mass of tissue)...Standard approach in this situation is proceed with Thyroid Lobectomy on the afflicted side and if malignant, a total thyroidectomy with central neck dissection...."
c. Review of physician's orders revealed on 11/5/15 at 6:07 AM, Physician H, General Surgeon, wrote an order "Consent for Left Thyroid Lobectomy, Possible Total Thyroidectomy".
d. Review of consent form revealed on 11/5/15 at 6:45 AM, Patient #2 signed "Consent to Surgery or Other Procedure and Administration of Anesthesia" for "Left thyroid lobectomy, possible total thyroidectomy".
e. Review of OR Nursing Record dated 11/5/15 included in part, "...IntraOp - Time Out - 8:45 AM - Elements of a Time Out - Current patient identity, confirmation that the correct side and site are marked, and accurate procedure consent form, agreement on the procedure to be done, correct patient position, relevant images and results are properly labeled and appropriately displayed..." However, the OR staff and providers failed to ensure the pathologist report relevant results was available in the OR to show the preoperative abnormal fine-needle aspiration was from the right lobe of the thyroid and not from the left.
f. Review of Operative Report for procedure 11/5/15 included in part, "...Preoperative Diagnosis: Follicular neoplasm of right thyroid with suspicious ultrasound left thyroid...
...Procedure: Total thyroidectomy...Description of Procedure...A time-out was performed being led by the surgeon with participation of all staff members...The left lobe was removed and sent to the pathologist and incision sutured...the pathologist...noted...the preoperative abnormal fine-needle aspiration was from the right lobe of the thyroid and not from the left....the left thyroid mass...a fine-needle aspiration was benign....The wound was reopened and the right lobe of the thyroid was removed and sent to the pathologist who reported a Hurthle cell (a rare cancer affecting the thyroid) neoplasm of indeterminate nature..."
g. Review of Post Operative Note dated 11/5/15 included in part, "...Complications: Left lobe marked by surgeon and patient pre-operatively incorrectly based on pre-operative incorrect association of abnormal left...the fact that the actual concerning...fine-needle aspiration...was from the right side..."
6. During an interview on 12/2/15 at 2:00 PM related to Patient #2, Physician H, reported his impression was the patient's left thyroid lobe was suspicious and the right side was normal. Physician H reported his orders and consent were for a left thyroid lobectomy. Physician H reported he marked the surgical site for the left side and the time out was performed for the left side.