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Based on interview and record review, the hospital failed to comply with the Condition of Participation for Surgical Services as evidenced by:

1. Failure to identify and communicate the use of the acorn uterine manipulator (a medical device used in gynecological surgery to stabilize and manipulate the uterus during procedures) and added in the surgical count (Refer to A-951).

2. Failure to follow the policy and procedure when informed consent was not included in the medical chart prior to sterilization procedure and required waiting period not met (Refer to A-951).

The cumulative effect of these deficient practice resulted in the facility's inability to provide quality health care. Patient 2 had a retained surgical item after a procedure. Required informed consent for sterilization was not used and waiting period not met for Patient 1.

Based on interview and record review, the facility failed to implement surgical services policies for two of 30 sampled patients (Patient 2 and Patient 1) when:

1. Hospital staff failed to implement their policy and procedure (P&P) titled "Universal Protocol Policy" and "Surgical Count (Sponge, Sharp, Needle, Miscellaneous Small Items, and Instruments) during a laparoscopic procedure for Patient 2 to ensure no surgical item was retained.

2. Hospital staff failed to implement their P&P, titled " Universal Protocol Policy", "Informed Consent", and "Elective Sterilization" during a sterilization procedure for Patient 1 to ensure all requirements were met.

These failures resulted in:

1. Patient 2 had a retained surgical item after a laparoscopic procedure.

2. The sterilization requirements for Patient 1 were not met when:
a. No informed consent in medical chart.
b. Verification of consent not done.
c. Waiting period of 72 hours not met.
d. Required form Physician Memo (PM) 284 was not used.

Findings:

1. Patient 2 was admitted to the hospital on 12/13/24 for diagnostic laparoscopy (a minimally invasive surgical procedure that allows a surgeon to directly visualize and examine the organs in the abdomen and pelvis), probable right ovarian cystectomy (a surgical procedure to remove a cyst from the ovary), possibly oophorectomy (a surgical procedure to remove one or both ovaries).

During an interview on 2/5/25 at 10:29 a.m., with the Operating Room Charge Nurse (ORCN), the ORCN stated the opened laparoscopic set with the Cohen acorn (part of laparscopic set) uterine manipulator was not included in the initial count for the laparoscopic procedure. The ORCN stated they do not count all instruments in the opened laparoscopic set as hospital practice. The ORCN stated the scrub technician and circulator nurse would perform the count. The ORCN also stated if the count was correct, and the surgeon would verbalize agreement.

During an interview on 2/5/25 at 11:00 a.m., with the Director Quality and Patient Safety (DQPS), the DQPS stated the circulator nurse assigned for Patient 2 during cystectomy procedure was on medical leave of absence. Circulator nurse was unavailable to be interviewed.

During an interview on 2/5/25 at 11:02 a.m., with the Chief Nursing Executive (CNE), the CNE stated Patient 2 called her own medical provider and was connected to the on-call medical provider. The CNE stated that the medical provider called her on 12/16/24 informing that something fell out of Patient 2 while having a bowel movement.

During an interview on 2/5/25 at 12:06 p.m., with Scrub Technologist (ST), the ST stated that she did not see the surgeon grab the Cohen acorn uterine manipulator from the opened laparoscopic set on the back table (a medical table used to store and access surgical instruments and supplies) during the cystectomy procedure. The ST stated she does not recall if the surgeon stated she will use the uterine manipulator. The ST stated she just assumed that the surgeon grabbed it from the opened laparoscopic set. The ST stated she found out that the surgeon used the uterine manipulator during the case once it was inserted. The ST stated the surgeon pulled the uterine manipulator out and placed it on the Mayo table (portable surgical table to hold sterile instruments during surgeries). The ST stated the uterine manipulator was not counted because it was not part of the initial count. The ST stated two counts were performed during the procedure and the count was correct.

During an interview on 2/6/25 at 9:30 a.m., with the CNE, the CNE stated the opened laparoscopic set will be cleaned at the Sterile Processing Department. Once the laparoscopic set was cleaned, the sterile processing technician have to count the instruments by comparing the recipe sheet included in the set to check for any missing instrument. The CNE stated the sterile processing technician would inform the ORCN for any missing item.

During a concurrent interview on 2/6/25 at 11:30 a.m., with the CNE, the CNE stated the sterile processing technician did not inform the ORCN that a piece of the uterine manipulator was not in the laparoscopic set that was used during the procedure.

During an interview on 2/6/25 at 12:41 p.m., with the Obstetrics and Gynecologist (OBGYN) A, the OBGYN A stated she did not inform the scrub technologist that she would use the uterine manipulator. The OBGYN A stated she did not think that she informed the scrub technologist that she used the uterine manipulator. The OBGYN A stated she cannot say that she checked if the uterine manipulator was complete. The OBGYN A stated she put the uterine manipulator down immediately to the mayo table after it was removed from the patient. The OBGYN A stated she did agree that the count was correct and that she was not aware that the uterine manipulator was not counted. The OBGYN A stated she was informed of the retained piece of the uterine manipulator few days later by the on-call provider.

During an interview on 2/7/25 at 10:07 am, with the Sterile Processing Technician (SPT), the SPT stated she did not follow the process of checking for missing pieces of the laparoscopic set and informing the team leader or the operating room charge nurse for any discrepancy in the set. The SPT stated she did not see the Cohen acorn piece of the uterine manipulator was missing. The SPT stated she then assembled and packed the laparoscopic set. The SPT stated if she would have noticed at that time that there was a missing piece in the set, she would have informed the team leader, or the operating room charge nurse.

During an interview on 2/7/25 at 10:39 a.m., with the Director of Perinatal Unit (DPU), the DPU stated the Association of periOperative Registered Nurses Guidelines (AORN) was followed.

During an interview on 2/11/25 at 11:25 a.m., with the Chief Executive Officer (CEO), the CEO stated the AORN guidelines was being followed as a basis for the surgical count policy.

During an interview on 2/11/25 at 11:28 a.m., with the Operating Room Manager (ORM), the ORM stated the scrub technologist and circulator nurse would have check the content of the Mayo table. The ORM stated the uterine manipulator on the Mayo table was not added to the count and not counted probably because it was not in the initial count.

During a concurrent interview on 2/11/25 at 11:35 a.m., with the CNE, the CNE stated the uterine manipulator was not counted because it was not in the initial count. The CNE stated the uterine manipulator was not added during the case.
During a concurrent interview on 2/11/25 at 11:40 a.m., with the ORM, the ORM stated the large cervical cone of the uterine manipulator was missing from the laparoscopic set. The ORM stated there should have been team-based communication in the operating room. The ORM stated the recipe sheet was used as a validation that the laparoscopic set was complete.

During a record review of Patient 2's "Operative/Procedure Notes", dated 12/13/24, the Report indicated "Procedure performed: 1. Laparoscopic right ovarian cystectomy, 2. Laparoscopic appendectomy (surgical procedure to remove the appendix) ...Kahn cannula was placed into the cervix and attached to the single tooth tenaculum for uterine manipulation ...All laps, instruments and needles were accounted for 2x."

During a review of the hospital's policy and procedure (P&P), titled "Universal Protocol Policy", dated 4/28/22, indicated "Purpose ...B. To improve overall patient care and safety by improving communication among patient care providers. 1. Ensuring patient safety is a team effort that begins with the surgeon/proceduralist assessment and formulation of the surgical/procedural plan and ends at the completion of the surgical and/or procedure)s) ...F. Sign Out 1. Before the Surgeon/Proceduralist and patient leave the procedure area, a sign out will take place ...b.II. Instrument, sponge, and sharp(s) counts are reconciled."

During a review of the hospital's P&P, titled "Surgical Count (Sponge, Needle, Miscellaneous Small Items, and Instruments), dated 1/20/22, indicated "The entire surgical team is accountable for counts during a surgical procedure ...When to Count (A) Counts are conducted on all procedures for which: (1) There exists a possibility that an item may be retained... How to Count ...(D) Counts are conducted ...a systematic sequence is used, moving from sterile field to the periphery (i.e., surgical site, Mayo stand, back table, and completed with items removed from the sterile field) ... General Count Procedures ...(G) Verification of instruments/medical device integrity is performed as follows: 1. all instruments, uterine manipulators ...will be visually inspected by the surgical team, prior to and after use, to ensure its integrity is intact and all pieces are accounted for ...Procedural/Surgical Counts: Instruments (A)(3) Whenever a uterine manipulator is used, all pieces will be counted... (C) Instrument counts will include every item in the set. Individual pieces of assembled instruments (e.g., acorn tip) will be counted separately."

Review of the AORN Guidelines Retained Surgical Items, dated 2019, indicated "Recommendation I A consistent multidisciplinary approach should be used for preventing RSIs (Retained Surgical Items) during all surgical and invasive procedures ...I.a. Improving teamwork and communication in an effort to foster a just culture focused on patient safety is part of a systems approach to reducing surgical errors such as RSIs ...I.a.1. The Registered Nurse (RN) circulator should actively participate in safety measures to prevent RSIs. The RN circulator should perform room survey ...consult with the team about whether any supplies will be needed before initiating the closing count ...I.a.2. The scrub person should maintain awareness of the location of instruments on the sterile field during the course of the procedure ...I.a.3. The surgeon and surgical first assistant should notify the scrub person and RN circulator about surgical items returned to the surgical field to complete the final count ...Accurately accounting for items used during a surgical procedure is a primary responsibility of the surgeon and surgical first assistant ...Recommendation IV Instruments should be accounted for in all procedures for which the likelihood exists that an instrument could be retained ...IV.b.1. Instruments should be counted when sets are assembled for sterilization."


2. During a review of Patient 1's "History & Physical Notes" (H&P), dated 12/20/24, the Report indicated "Reason for Admission: Induction of Labor."

During a review of Patient 1's "Progress Notes", dated 12/21/24, the Report indicated "Decision was made to proceed to urgent cesarean section for fetal intolerance of labor...recalled that she wanted a bilateral tubal ligation. She and I had discussed this at our office visit yesterday and she signed the consent forms. I had a very busy day at the office, and did not fax these forms to the facility, and also didn't scan them ...had the forms with me to manually bring to the hospital ...should have presented the paperwork ...mentioned this to OBGYN B ...who stated that there isn't any waiting period mandated ...tubes were removed ..."

During a concurrent interview and record review on 2/5/25 at 12:46 p.m., with the Perinatal Charge Nurse (PCN), the PCN stated she saw the Primary Care Physician (PCP) leaned over the drape and talked to the patient. The PCN heard someone asking for LigaSure (a surgical device used to seal blood vessels and other tissues during surgery). The PCN asked about the informed consent. The PCN stated the PCP stated the consent was not scanned and it was left in the PCP's vehicle. The PCN stated Patient 1 was seen in the clinic and tubal ligation was discussed.

During an interview on 2/7/25 at 9:50 a.m., with the CNE, the CNE stated the consent was not in the medical chart. The CNE stated the tubal ligation procedure proceeded even though it was not the standard practice in the hospital.

During a concurrent interview on 2/11/25 at 12:56 p.m., with the CNE, the CNE stated the PCP stated the sterilization consent was completed. The CNE stated the PCP stated the sterilization consent was in the car. The CNE stated the sterilization consent should have been faxed or scanned to be part of the medical record. The CNE stated the sterilization consent was not faxed or scanned.

During an interview on 2/11/25 at 1:00 p.m., with the DQPS, the DQPS stated Patient 1 have private insurance.

During an interview on 2/11/25 at 1:10 pm, with the DPU, the DPU stated the tubal ligation would have not been done if the consent was not in the chart and that the waiting period was not met. The DPU stated the assumption was that the consent was signed within that timeframe. The DPU stated the standard of practice was for the consent to be in the medical chart and consent verification done before the procedure. The DPU stated the doctor did not inform any of the staff that the consent was signed on 12/20/24. The DPU stated the PCP did not say anything about the waiting period. The DPU stated no one thought that the sterilization was outside of that waiting period of 72 hours.

The Director of Quality & Patient Safety (DQPS) responded through email on 2/12/25 at 10:37 a.m., when asked if Patient 1 signed the form PM 284 which was the required informed consent for sterilization. The DQPS responded "If the form had been in the chart, we would have asked the physician and the patient about the form. Because it was not available, no one could verify the correct form was used."


During a review of the facility's P&P, titled "Universal Protocol Policy", dated 4/28/22, indicated "A. All relevant documents and related information or equipment will be available, correctly identified and labeled, and matched to the patient before the procedure starts ...C. Each step of this procedure requires a responsible/accountable person to ensure core steps are completed, as required. Surgeon/proceduralist completed informed consent, documents in medical record prior to procedure; verified for correct patient, procedure scheduled prior to procedure."

During a review of the facility's P&P, titled "Informed Consent", dated 7/21/22, indicated "2.a. Verifying that the patient informed consent was documented by the physician in the medical record, 2.b. Verifying the patient/surrogate signed other required procedure specific consents, such as consent to sterilization (statutorily required PM 284) ...Procedure 3. The nurse or other licensed/certified health care professional reviews the medical record for the presence of physician documentation of informed consent ...Informed consent must be documented for each procedure planned ...If there is no evidence of physician documentation of informed consent on the current medical record, the patient may not proceed with the procedure until the documentation is provided ..."

During a review of the facility's P&P, titled "Informed Consent", dated 7/21/22, indicated "Types of Consents ...E.1. State and federal Regulations impose special informed consent requirements for certain elective reproductive sterilizations ...c. Elective sterilization procedures which are not federally funded require the completion of the PM 284 form, as well as a waiting period of no less than 72 hours. This is in addition to the SMSC Verification of Consent to Surgery o Special Procedure form."

During a review of the facility's P&P, titled "Sterilization, Elective", dated 11/21/24, indicated "To ensure all state and federal regulations are met ...patient has had the proper amount of time to make an informed decision ...Policy F.3. A sterilization that is performed at the same time as an emergency abdominal surgery ...is considered elective under the regulations ...Procedure A. An elective sterilization may be performed when the following conditions are met ...3. The required waiting period has been satisfied ...F.1.b. The "Sterilization Consent Form (Non-Federally Funded)", PM 284, must be used for private pay patients."