HospitalInspections.org

The facility failed to meet the regulatory requirements for the Condition of Participation: §482.51 Surgical Services as evidenced by:

1. Based on interview and record review, the hospital failed to ensure surgical mesh positioning system (scaffolding - flexible structure used to assist in placement of mesh [material used to repair hole in the abdominal wall] was removed at completion of surgical repair of a ventral hernia (when tissue or organs protrude through a weak spot in the abdominal wall). for one of three sampled patients (Patient 1). (refer to A-0951)

2. Based on interview and record review, the facility failed to follow its "Sponge, Instrument and Sharps Count," policy and procedure (P&P) and national standards of practice for one of three sampled patients (Patient 1) when surgical mesh scaffolding was not removed at the conclusion of Patient 1's ventral hernia repair.(refer to A-0951).

These failures resulted in an additional abdominal surgical procedure to remove the retained surgical mesh scaffolding under general anesthesia (GA - medical treatment that uses medications to make patient unconscious) for Patient 1 and had the potential for infection and adverse health outcomes.

3. Based on interview and record review, the facility failed to follow its "Informed Consent for Surgical, Diagnostic, or Therapeutic Procedure" and "Interpreter Services" P&Ps for five of 12 sampled patients (Patient 2, Patient 6, Patient 5, Patient 18 and Patient 17) when informed consent (the process in which a healthcare provider educates a patient about the surgery and the risks, benefits, and alternatives [RBAs]) was not provided in a language they could understand prior to surgical procedure.

These failures resulted in Patient 2, Patient 6, Patient 5, Patient 18 and Patient 17, not being given the opportunity to make an informed decision based on RBAs of procedure. (refer to A-0955)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure safe quality health care, in compliance with Conditions of Participation for Surgical Services.

1. Based on interview and record review, the hospital failed to ensure surgical mesh positioning system (scaffolding - flexible structure used to assist in placement of mesh [material used to repair hole in the abdominal wall]) was removed at completion of surgical repair of a ventral hernia (when tissue or organs protrude through a weak spot in the abdominal wall) for one of three sampled patients (Patient 1).

2. Based on interview and record review, the facility failed to follow it's "Sponge, Instrument and Sharps Count," policy and procedure (P&P) and national standards of practice for one of three sampled patients (Patient 1) when surgical mesh scaffolding was not removed at the conclusion of Patient 1's ventral hernia repair.

These failures resulted in Patient 1 undergoing an additional abdominal surgical procedure to remove the retained surgical mesh scaffolding under general anesthesia (GA - medical treatment that uses medications to make patient unconscious) which had the potential for infection and adverse health outcomes.

Findings:

1. During a review of Patient 1's "General Surgery Consultation (GSC)," dated 10/29/24, the GSC indicated Medical Doctor (MD) 1 advised Patient 1 to undergo a ventral hernia repair surgical procedure. The GSC indicated Patient 1 had a history of coronary artery disease (CAD - arteries that supply blood to the heart become narrowed or blocked) and had a coronary artery bypass graft (CABG -surgical procedure to improve blood flow to the heart).

During a review of Patient 1's "Informed Consent for Surgical, Diagnostic or Therapeutic Procedure (IC)," dated 11/15/24 at 7:10 a.m., the IC indicated Patient 1 signed the IC for surgical procedure "laparoscopic [minimally invasive surgical procedure] possible open [incision in abdomen] Repair of Ventral Hernia with mesh."

During a review of Patient 1's "Operative/Procedures (OP)," dated 11/15/24 at 9:53a.m.m, the OP indicated, "Operation Repair Hernia Ventral Laparoscopy, with mesh. . . Complications Scaffold of mesh left intraperitoneal [inside the abdomen]." was performed by MD 1 [primary surgeon] and MD 2 [surgical resident - a doctor who has completed medical school and is training in surgical specialty]. The OP indicated MD 1 documented an addendum at 9:57 a.m. MD 1's addendum indicated, "I [MD 1] was present till the mesh was placed and then left the Room and was immediately available if the need arose. Electronically Signed [by MD 1] on 11/15/24 9:58 AM."

During a concurrent interview and record review on 1/2/25 at 10:41 a.m. with RN 1, Patient 1's "Surgical Documentation (SD)," dated 11/15/24 was reviewed. The SD indicated MD 1 was in the operating room (OR) from 7:50 a.m. to 8:49 a.m. MD 2 was in the OR from 7:50 a.m. To 9:03 a.m. The SD indicated the procedure performed was "Repair Hernia Ventral Laparoscopy with mesh." RN 1 stated MD 1 left the OR after the mesh was secured in Patient 1's abdomen. RN 1 stated MD 2 closed the abdominal surgical incisions.

During a concurrent interview and record review on 1/2/25 at 11:41 a.m. with MD 3, Patient 1's "Preanesthesia Evaluation (PAE)," dated 11/15/24 at 7:33 a.m. was reviewed. The PAE indicated Patient 1 had a medical history of hypertension (high blood pressure), CAD, CABG, peripheral artery disease (PAD - arteries that supply blood to the legs and arms become narrowed or blocked), and ischemic cardiomyopathy (condition when heart muscle is damaged due to reduced blood supply). MD 3 stated every time a patient goes under GA there were risks and factors that needed to be considered including cardiac and respiratory instability and loss of airway. MD 3 stated administering GA was challenging when there was risk for cardiac instability. MD 3 stated there were many risk factors to consider prior to Patient 1's return to surgery and beforeadministeringg GA which included the half life of medications (the time it takes the amount of a drug's active substance to reduce by half strength) given in previous surgery, if a reversal medication (used to reverse sedatives or narcotics) was given and risks for the airway obstruction. MD 3 stated Patient 1's cardiac status could become unstable and Patient 1 was a risk for forming blood clots post operatively.

During an interview on 1/2/25 at 1:30 p.m. with MD 2, MD 2 stated he had used the surgical mesh with scaffold used on Patient 1, approximately 10 times in the last four years. MD 2 stated under the direct supervision of MD 1, he placed the mesh in Patient 1's abdomen, tacks were used to secure the outer edge of the mesh, then he deflated the scaffolding to prepare for removal from Patient 1's abdomen. MD 2 stated he started to remove the scaffolding through the trocar (a surgical instrument used in minimally invasive surgery) incision site, when MD 1 told him to stop and remove the scaffolding later. MD 2 stated the scaffolding was left in Patient 1's abdomen while tacks were placed to secure the middle area of the mesh. MD 2 stated they closed the hernia incision, then went back into Patient 1's abdomen through the trocars to check the mesh placement and placed more tacks. Once completed, MD 2 stated he was told by MD 1 to close the patient's surgical incisions, then MD 1 broke scrub (removed sterile gown and gloves) and left the OR. MD 2 stated the routine process, when surgical mesh with scaffolding was used, included placement of the tacks around the edge of the mesh, deflate and then remove the scaffold from the abdomen through the trocar incision site. MD 2 stated once the scaffold was removed the center of the mesh was to be tacked. MD 2 stated he realized the scaffold had not been removed from Patient 1's abdomen after Patient 1 had transferredd to post anesthesia care unit (PACU - nursing unit where patient starts to wake up from anesthesia). MD 2 stated he immediately notified MD 1 of the retained scaffolding and Patient 1 was returned to OR, placed under GA and a surgical procedure to retrieve the retained scaffolding (approximately one hour later) was performed. MD 2 stated if the scaffolding had remained in Patient 1's abdomen the patient could have developed an infection, adhesions (scar tissue that forms between internal organs and tissue) or even a bowel obstruction (a serious condition when the small or large intestine is blocked, preventing food, liquid, gas, and stool from passing).

During an interview on 1/2/25 at 1:50 p.m. with MD 1, MD 1 stated MD 2 reported, after Patient 1 was taken to PACU, that the mesh scaffold was not removed from Patient 1's abdomen during the surgical repair of a ventral hernia. MD 1 stated as the attending surgeon, he was responsible for the outcome of the surgery, and for ensuring the scaffolding was removed from Patient 1's abdomen.

During a review of the "Ventralight ST [soft tissue] Mesh [used for Patient 1's ventral hernia repair] with Echo PS [mesh positioning system] Instructions for Use (IFUs)," dated 11/2022, the IFUs indicated "Warnings. . . 11. Ventralight ST Mesh is the only permanent implant component of the device. The Echo PS Positioning System [used during Patient 1's ventral hernia repair]. . . must be removed from the patient and appropriately discarded. It is not part of the permanent implant. . . Precautions. . . 4. Visualization must be maintained throughout the course of the entire procedure. Additionally, laparoscopic removal of the Echo PS Positioning System must be performed under sufficient visualization of the entire device and surrounding anatomy to ensure proper removal. Once the positioning system is verified to be fully intact, discard the Echo PS Positioning System appropriately."

During a review of the "Association of periOperative Registered Nurses [RN] [AORN] eGuidelines+ Guidelines for Perioperative Practice: Retained Surgical Items," dated 1/9/25, the AORN guidelines indicated, "Surgeons and surgical first assistants should actively participate in safety measures to prevent RSIs [retained surgical items]. The surgeon and surgical first assistant should. . . maintain awareness of the location of items in the surgical wound during the course of the procedure; communicate placement of surgical items in the wound to the perioperative team for notation in a visible location (eg, the count board); . . . perform a methodical wound exploration before closing the patient, using both visualization and touch when feasible; notify the scrub person and RN circulator about surgical items returned to the surgical field to complete the final count; . . . participate in count reconciliation activities."

During a review of the hospitals "Medical Staff Rules and Regulations (R&R)," dated 7/24/24, the R&R indicated, "2.2 Responsibilities of Attending Physician: (a) The attending physician will be responsible for the following while in the District [hospital system]: (1) the medical care and treatment of the patient while in the District including appropriate communication among the individuals involved in the patient's care."

2. During an interview on 1/2/24 at 10:25 am with Surgical Technician (ST - assists during surgical procedure), ST stated he was in the OR for Patient 1's ventral hernia repair procedure on 11/15/24. St stated MD 1 was the only surgeon who used the surgical mesh implant (medical item that stays inside the patient) with the scaffold. ST stated the scaffolding around the mesh was not part of the implant and was to be removed from the patient after use and before closing the surgical incisions. ST stated the mesh scaffold was not included in surgical counts. ST stated the mesh scaffold should have been included in the surgical count since the scaffold goes went into Patient 1's abdomen during the procedure and was not to remain inside the abdomen permanently. ST stated if the scaffolding was included in the surgical count, the surgical team would have had to verify removal of the scaffold before closing Patient 1's surgical incisions. ST stated he did not verify the scaffold was removed at the end of Patient 1's surgical procedure.

During a concurrent interview and record review on 1/2/25 at 10:52 a.m. with RN 1, Patient 1's "SD Counts Verification - OR (CV)," dated 11/15/24 was reviewed. RN 1 stated the mesh scaffold was not included in the surgical counts for Patient 1's procedure. RN 1 stated the mesh scaffold should have been included in Patient 1's initial and final surgical count.

During a review of the "Association of periOperative Registered Nurses eGuidelines+ Guidelines for Perioperative Practice: Retained Surgical Items," dated 1/9/25, the AORN guidelines indicated, "Surgeons and surgical first assistants should actively participate in safety measures to prevent RSIs [retained surgical items]. The surgeon and surgical first assistant should. . . maintain awareness of the location of items in the surgical wound during the course of the procedure; communicate placement of surgical items in the wound to the perioperative team for notation in a visible location (eg, the count board); . . . perform a methodical wound exploration before closing the patient, using both visualization and touch when feasible. . .participate in count reconciliation activities."

During a review of the hospitals policy and procedure (P&P) titled, "Sponge, Instrument and Sharps Count," dated 3/29/21, the P&P indicated, "A consistent multidisciplinary approach for preventing retained surgical items will be used during all surgical and invasive procedures. . . IV. Counting Procedure For Sharps & Other Miscellaneous Items. . . 2. Miscellaneous items includes, but is not limited to, the following items: a. Scalpels and scalpel blades b. Cautery tips c. Hypodermic needles d. White Clips e. Suture reels."

Based on interview and record review, the facility failed to follow its "Informed Consent for Surgical, Diagnostic, or Therapeutic Procedure" and "Interpreter Services" P&Ps for five of 12 sampled patients (Patient 2, Patient 6, Patient 5, Patient 18, and Patient 17) when informed consent (the process in which a healthcare provider educates a patient about the surgery and the risks, benefits, and alternatives [RBAs]) was not provided in a language they could understand prior to surgical procedure.

These failures resulted in Patient 2, Patient 6, Patient 5, Patient 18, and Patient 17, not being given the opportunity to make an informed decision based on RBAs of procedure

Findings:

a. During a concurrent interview and record review on 1/3/25 at 10:22 a.m. with Registered Nurse (RN) 5, Patient 2's "Patient Information (PI)," dated 12/30/24 and "Informed Consent for Surgical, Diagnostic or Therapeutic Procedure (IC)," dated 12/31/24, were reviewed. The PI indicated Patient 2's preferred language was Spanish. The IC indicated Patient 2 signed the IC (English version) on 12/31/24 at 12:53 p.m. for a "Laparoscopic [minimally invasive surgery] cholecystectomy [removal of gallbladder], possible open [incision in abdomen] possible umbilical [bellybutton] hernia [hole in the abdominal wall] repair, possible mesh [mesh - material used to repair hole in the abdominal wall]" surgical procedure. The IC indicated Medical Doctor (MD) 4 signed Patient 2's IC on 12/31/24 at 8:37 a.m., no documentation of use of interpreter or declination. RN 5 stated MD 4 signed Patient 2's IC and there was no documentation an interpreter was used to explain the surgical procedure or the RBAs. of the surgical procedure to Patient 2. RN 5 stated Patient 2's IC form was in English and Patient 2's preferred language was Spanish. RN 5 stated when the IC form was completed in the hospital, the nurse can choose from an English or Spanish version. RN 5 stated she routinely used the English IC form because she was unable to read Spanish.

b. During a concurrent interview and record review on 1/3/25 at 10:44 a.m. with RN 5, Patient 6's "PI," dated 1/3/25 and "IC," dated 1/3/25 were reviewed. The PI indicated Patient 6's preferred language was Spanish. The IC indicated Patient 6 signed the IC (English version) on 1/3/25 at 8:59 a.m. for "Right breast Mastectomy [removal of breast], Sentinel lymph node [the first lymph node (small bean-shaped structure in the body) in the drainage pathway] biopsy [tissue removed from the body]" surgical procedure. RN 5 stated there was no documentation an interpreter was used to explain the surgical procedure or the RBAs of the surgical procedure to Patient 6.

During an interview on 1/3/25 at 10:56 a.m. with RN 3, RN 3 stated a certified healthcare interpreter is required when the medical provider explained RBA's of procedures and obtained informed consent for surgery from patients whose preferred language was not English.

c. During a concurrent interview and record review on 1/3/25 at 11:05 a.m. with RN 4, Patient 5's "PI," dated 1/3/25 and "IC," dated 1/3/25 were reviewed. The PI indicated Patient 5's preferred language was Spanish. The IC indicated Patient 5 signed the IC on 1/30/25 at 10:09 a.m. for "L4 [lumbar level four (middle backbone)] - S1 [sacral level one (lower backbone)] Posterior [the back] Spinal Instrumentation [use of medical devices to stabilize and support the spine] and Fusion [permanently joins two or more bones in the spine] with Decompression [removing bone or tissue to take pressure off of nerve in the spine]." RN 4 stated MD 6 signed Patient 5's IC on 1/3/24 at 10:41 a.m. and there was no documentation an interpreter was used to explain the surgical procedure or the RBAs of the surgical procedure to Patient 5.

During a concurrent interview and record review on 1/3/25 at 3:13 p.m. with RN 3, the hospitals "IC" form, Section II, was reviewed. The IC form indicated, "The following has been read or explained to me [patient] in order for me to decide whether to give consent to the surgery or special procedure being recommended." RN 3 stated in addition to explaining the proposed surgical procedure and the RBA's, the provider was responsible for ensuring the patient had the opportunity to read and understand the information on the IC form (including consent for photographing or other imaging of the procedure, presence of observers in the operating room, disclosure of social security number if implant used). RN 3 stated a patient whose preferred language was Spanish or language other than English, would likely not be able to read and understand the IC form written in English. RN 3 stated in the hospital and in the providers office, patients with preferred language Spanish needed to be provided an IC form written in Spanish.

During an interview on 1/3/25 at 3:42 p.m. with RN 3, RN 3 stated providers were required to use the hospital IC form when obtaining patient consent for surgical procedure. RN 3 stated providers (in the hospital and in the providers office) were expected to follow hospital policies and procedures for obtaining informed consent, including use of an interpreter.


44134

d. During a concurrent interview and record review on 1/3/25 at 3:32 p.m. with RN 3, Patient 18's "PI," dated 4/5/24 and "IC," dated 4/5/24 were reviewed. The PI indicated Patient 18's preferred language was Spanish. The IC indicated, Patient 18 signed the IC (English Version) on 4/5/24 at 8:29 a.m. for "Laparoscopic/ Open Repair of Recurrent Ventral [front or belly area] Hernia with Mesh." The IC indicated, there was no documentation an interpreter was used to explain the surgical procedure or the RBAs. of the surgical procedure to Patient 18. RN 3 stated Patient 18 should have received the Spanish version of IC and an interpreter should have been provided.

e. During a concurrent interview and record review on 1/3/25 at 3:44 p.m. with RN 3, Patient 17's "PI," dated 5/10/24 and "IC," dated 5/10/24 were reviewed. The PI indicated Patient 17's preferred language was Spanish. The IC indicated, Patient 17 signed the IC (English Version) on 5/10/24 at 5:49 a.m. for "Laparoscopic possible open Repair of Ventral Hernia with Mesh." The IC indicated, there was no documentation an interpreter was used to explain the surgical procedure or the RBAs. of the surgical procedure to Patient 17. RN 3 stated Patient 17 should have received the Spanish version of IC and an interpreter should have been provided.

During a review of the hospitals policy and procedure (P&P) titled, "Informed Consent for Surgical, Diagnostic, or Therapeutic Procedure," dated 11/23/21, the P&P indicated, "3. It is the provider's responsibility to obtain informed consent and to document this consent in the patient's hospital medical record. . . 3. Capacity: a person's ability to understand the nature and consequences of a decision and to make and communicate a decision, and includes in the case of proposed health care, the ability to understand its significant benefits, risks and alternatives. Procedure: . . . 2. The provider is responsible to document that this discussion occurred by signing the "Informed Consent for Surgical, Diagnostic or Therapeutic Procedure" (Informed Consent form) form prior to the procedure. . . 5. Considerations when completing Informed Consent Form: a. Prior to the initiation of the procedure, the provider performing the procedure will ensure that documentation is completed using the approved Informed Consent Form and is placed in the patient's medical record."

During a review of the hospitals P&P titled, "Interpreter Services," dated 2/27/23, the P&P indicated, "A. [hospital name] recognizes that individuals and Health Care Providers must be able to communicate effectively. When language barriers exist between providers and patients, the quality of information is diminished and the outcome of the patient encounter may be unsatisfactory. This may lead to decreased patient compliance and increased potential for medical errors and misdiagnosis. . . C. . . The following types of encounters and procedures which are performed by providers who do not speak the primary language spoken by the patient/surrogate decision-maker, and which require the use of healthcare interpreter services, including, but not limited to: . . . f. Explaining any medical procedures, tests or surgical interventions; . . . i. Obtaining informed consent."

During a review of the hospitals "Medical Staff Rules and Regulations (R&R)," dated 7/24/24, the R&R indicated, "3.2. Content and Timeliness of Medical Record Documentation . . . (f) Informed Consent: Informed consent is required prior to surgery and prior to special diagnostic or therapeutic procedures, including blood transfusion, in accordance with District [hospital system] policy. . . It is the responsibility of the practitioner ordering blood or performing the procedure to discuss with the patient or responsible party the risks, benefits, and alternatives of the procedure, and document this discussion in the patient's medical record before performing any procedure that requires consent. The consent form is used to document this discussion."