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Based on record review and interview, the facility failed to ensure an effective process for fully investigating and resolving a grievance with clinical complaint elements. (Patient ID # 1).

Findings included:

Record review of HSHC intake for Patient ID #1 was received via e-mail on 7/12/23 by complainant. It stated "the doctor violated hospital policy of no site markings which in turn caused a wrong site procedure which he cut a nerve causing permanent foot drop ... I filed a complaint and was assigned Staff ID #74" (System General Council) ...After a year of dealing with him and their risk management department they concluded (he) received 'Standard of care.' "

Record review of facility grievance log included entry for Patient ID #1 which stated "notified 1/4/2022." Progress letter sent "2/2/22" and "resolved 3/4/22." "Response letter sent 3/24/22."

Record of facility policy and procedure titled "Patient Grievance Policy", policy 09.03.05., last reviewed 04/15/2022, showed the following information: "Manager/departmental responsibilities for responding to a grievance: Each department, unit or clinical manager is accountable for investigating and resolving grievances and for providing the outcome of their investigation in a timely manner in accordance with the Grievance/Complaint progress. The outcome of the investigation will be provided to the patient advocate or handler who is responsible to the patient. Definitions: Grievance: A patient grievance is a complaint by a patient or their representative regarding the patient's care, alleged patient abuse or neglect, or issues related to the hospital's compliance with the Center for Medicare/Medicaid Services (CMS) Hospital Conditions of Participation or billing practices ... A complaint is considered a grievance when a patient ...requests a response from the hospital."

Record review of "Addendum B for the Grievance Policy Workflow", dated 8/21/17, stated "Grievance - Assign an advocate - Is this a neglect or abuse case? No - Review grievance, Is grievance resolved? No, Within 7 days send letter to patient on status of grievance and every 30 days until resolved."

Interview with Director of Patient Services, Staff ID # 69 on 8/31/23 at 1:45 pm confirmed Patient ID #1 grievance had been referred from risk management referral to onsite facility patient service liaison, Staff ID #70, on 1/5/2022. However, she confirmed there was no evidence of a referral/evaluation by any facility nursing, physician, clinical or quality personnel. She stated their department has "a list they reference to route grievances based on facility and/or department" but stated she did not know how "this case fell through the cracks" with involvement/investigation from on-site leadership.

Interview with System Risk Manager, Staff ID #78 on 8/31/23 at 2:05 pm confirmed when cases include requests for claim compensation and are routed to their office, they "evaluate for claim perspective." She stated, "action items can sometimes be identified and routed back to facility." She confirmed that a "quality referral" was made to Chair of Orthopedics Quality committee Staff ID # 80 on 4/27/2022 regarding "surgical markings." She confirmed that no information had been sent to the facility regarding their investigation or findings.

Interview with Director of Perioperative Services, Staff ID #61 on 8/31/23 at 2:40 pm confirmed he had no knowledge of a grievance at the facility, which involved allegation of wrong site surgery marking or issues with surgical consents and therefore had not participated in an investigation. He stated he would have been included in an investigation of grievance for surgical clinical care issues.

Interview with Interim Chief Nursing Officer, Staff ID #51 on 8/31/23 at 3:10 pm confirmed she had no knowledge of a grievance at the facility, which involved allegation of wrong site surgery marking or issues with surgical consents and therefore had not participated in an investigation.

Interview with Associate Chief Medical Officer, Staff ID #62 on 8/31/23 at 9:00 am confirmed he had no knowledge of any cases or case reviews, at the facility, which involved complaints involving Staff MD ID# 81 or improper surgical site markings.

Based on interview and record review, the facility failed to document an occurrence report for an incident in the operating room, where consent for surgery was incompletely completed per facility policy. This deficient practice resulted in:

a. lack of full investigation and oversight by facility surgical services department.

b. a lack of trigger for quality surgical case review, potential physician peer review and ongoing quality monitoring, tracking and trending.

Findings included:

Record review of medical record for Patient ID# 1 included a surgical consent page 1 which stated: "I voluntarily request my physician/health care provider (Staff MD ID #81) and other health care providers, to treat my condition which is: "Adductor" (circled with 'Left' handwritten underneath), "Hamstring" (circled with 'Bil' handwritten underneath), "Gastrocnemius" has an "X" across it and handwritten 'Bil Obturator'. "I understand that the following care/procedures are planned for me: "Left hip joint injection" (handwritten).

Record review of facility policy "Unusual Event Reporting", policy 09.13.13, last reviewed 06/20/23, stated "Definition: Patient Safety Event - an event, incident, or condition that could have resulted or did result in harm to a patient and can be but is not necessarily the result of a defective system or process design, a system breakdown, equipment failure, or human error. They can also include adverse events, no-harm events, near misses and hazardous conditions." The policy further stated "Procedures: Reporting of an Unusual Event. The unusual even reporting tool is accessed by using UTMB intranet home page. Event reports should be completed within 24 hours by the person who is involved in, observed, or discovered the unusual event. Any documentation of the event separate from the event report must be requested from Quality & Healthcare Safety with authorization from the organization's safety oversight committee."

Interview with Director of Perioperative Services, Staff ID # 61 on 8/31/23 at 12:30 pm, he confirmed the surgical consent reviewed for Patient ID #1 for date of service 11/18/2021 was improperly filled out. He stated he would have expected incomplete or inaccurate surgical consent to be identified during time out and corrected prior to case initiation for Patient ID #1. He stated that he would have expected a variance to be entered in the variance reporting system if an incomplete or inaccurate surgical consent had been identified.

Interview with Assistant Director of Quality, Staff ID # 54 on 8/31/23 at 2:40 pm, she confirmed there was no variance or incident pertaining to Patient ID #1 located in the incident/variance logs and therefore no quality analysis of the case had occurred.

Based on record review and interview, the hospital failed to ensure that the procedure verification process resulted in procedures being performed in accordance with surgical consent obtained for six (ID#s 1, 12, 13, 14, 15 and 16) of nine surgical patient records reviewed.

Findings included:

Record review of facility policy titled "Universal Protocol for Invasive and Surgical Procedures" showed the following information:

III Procedures:
A. Pre-operative/ Procedure Verification Process
Prior to initiating the procedure, the following verification will occur and will involve the patient, when possible. Exception: emergency situations.

5. informed consent for medical, surgical and invasive procedures and informed consent for anesthesia must be complete.

an attending faculty physician or surgeon, or their advanced practitioner nurse (APN) for physician assistant (PA) designee, who will be present for the procedure will:
2. Confirm the procedure with the patient and review appropriate informed consent form.

B. Time Out
a time out will be completed immediately prior to any invasive procedure. All other activity will be suspended, and all participants will focus and participate fully in the timeout. The attending physician must participate in the timeout as well as all relevant members of the procedural team, including but not limited to, anesthesiologist, certified registered nurse anesthetist (CRNA), or their representative, procedural or circulating RN, surgical/procedural tech.
1. The time out will include and verify:
a. agreement on procedure to be performed
2. Discrepancies must be resolved prior to the beginning of the procedure.

Medical record review of surgical consent for patient (ID#1) for date of service 11/19/2021 showed the following information:
Description of Medical Care and Surgical Procedure(s):
I voluntarily request my physician/healthcare provider [name/credentials] and other healthcare providers, to treat my condition which is: (typed) Adductor, Hamstring, Gastrocnemius, Alcohol Injections, and other indicated procedures
(handwritten) Left underneath adductor with both words circled, Bil underneath hamstring with both words circled, the word gastrocnemius crossed out, and Bil obturator. I understand that the following care/procedure(s) are planned for me: Left hip joint injection.

Operative Note showed the following procedures were completed: bilateral myofascial lengthening single hamstring at knee: R biceps femoris, L semi membranous, left hip percutaneous adductor tenotomy, bilateral alcohol block obturator nerve 5cc each, left hip joint injection with c-arm guidance: 20 cc 75% ethanol

Medical record review of surgical consent for patient (ID# 12) for date of service 5/19/23 showed the following:
I voluntarily request my physician/healthcare provider [name/credentials] and other healthcare providers, to treat my condition which is: (typed) contracture
I understand that the following care/procedure(s) are planned for me: (typed) Adductor, Hamstring, Gastrocnemius, Alcohol Injections, and other indicated procedures. (handwritten) Bil underneath adductor with both words circled, Bil underneath hamstring with both words circled, Bil underneath the word gastrocnemius with both words circled, and Bil obturator.

Operative note showed the following procedures were performed: bilateral percutaneous adductor tenotomy, bilateral alcohol block obturator nerve, bilateral semitendinosus percutaneous tenotomy, bilateral lengthening multiple hamstrings at knee, bilateral gastrocs, bilateral short leg application.


Medical record review of surgical consent for patient (ID# 13) for date of service 4/21/23 showed the following:
I voluntarily request my physician/healthcare provider [name/credentials] and other healthcare providers, to treat my condition which is: (typed) contracture
I understand that the following care/procedure(s) are planned for me: (typed) Adductor, Hamstring, Gastrocnemius, Alcohol Injections, and other indicated procedures. (handwritten) Bil underneath adductor with both words circled, Bil underneath hamstring with both words circled, the word gastrocnemius crossed out, Bil underneath the word hamstring with both words circled, and Bil obturator, Bil Rectus, Bil Pecteralis, Bil rec release, Bil Rectus Release, Bil Hip Flexors.

Operative note showed the following procedures were performed: bilateral semi tendinosis percutaneous tenotomy, bilateral percutaneous adductor tenotomy, CL hip flexor-sartorius tenotomy, bilateral alcohol block obturator nerve, bilateral rectus femoris nerve blocks, bilateral pectoralis nerve blocks, bilateral rectus femoris tenotomies, bilateral pectoralis lengthening.

Medical record review of surgical consent for patient (ID#14) for date of service 4/7/2023 showed the following information:
Description of Medical Care and Surgical Procedure(s):
I voluntarily request my physician/healthcare provider [name/credentials] and other healthcare providers, to treat my condition which is: contracture
I understand that the following care/procedure(s) are planned for me: (typed) Adductor, Hamstring, Gastrocnemius, Alcohol Injections, and other indicated procedures (handwritten) Left underneath adductor with both words circled, Bil underneath hamstring with both words circled, the word gastrocnemius crossed out, and Bil obturator.

Operative note showed the following procedures were performed: bilateral semitendinosis percutaneous tenotomy, bilateral myofascial lengthening single hamstring at knee (semimembranosis), bilateral percutaneous adductor tenotomy, bilateral alcohol block obturator nerve.


Medical record review of surgical consent for patient (ID#15) for date of service 6/23/2023 showed the following information:
Description of Medical Care and Surgical Procedure(s):
I voluntarily request my physician/healthcare provider [name/credentials] and other healthcare providers, to treat my condition which is: contracture
I understand that the following care/procedure(s) are planned for me: (typed) Adductor, Hamstring, Gastrocnemius, Alcohol Injections, and other indicated procedures (handwritten) the word adductor crossed out, Bil underneath hamstring with both words circled, Right underneath gastrocnemius with both words circled, and Bil obturator and right tib post.

Operative note showed the following procedures were performed: Right
Gastric recession, Bilateral Semitendinosis tenotomy, bilateral obturator alcohol block, right tibialis posterior nerve block

Medical record review of surgical consent for patient (ID#16) for date of service 6/23/2023 showed the following information:
Description of Medical Care and Surgical Procedure(s):
I voluntarily request my physician/healthcare provider [name/credentials] and other healthcare providers, to treat my condition which is: contracture
I understand that the following care/procedure(s) are planned for me: (typed) Adductor, Hamstring, Gastrocnemius, Alcohol Injections, and other indicated procedures (handwritten) Right underneath adductor with both words circled, the word hamstring crossed out, Bil underneath gastrocnemius with both words circled, and Bil obturator, Right tib post, right tib post open, left biceps, and Left sec.
Operative note showed the following procedures were performed: Bilateral adductor tenotomy, bilateral obturator nerve block, Bilateral big toe flexor tenotomy, Right rectus femoris nerve block, left pectoralis nerve block, left bicep nerve block, right rectus tenotomy, Left pectoralis lengthening.

Interview with Director of Surgical Services (ID# 61) on 8/31/23 at 12:15 PM stated that the procedure performed were not in alignment with procedures on the consents for the above-mentioned patients. He stated that the consents, surgical postings, procedures were all different. He went on to say that the time out is performed based on procedures on the consent. When the consented procedure(s) do not match the procedure(s) that is performed, an incident report should be completed. He confirmed that incident reports for the six patients mentioned above were not completed.

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Based on record review and interview, the hospital failed to ensure that there was a properly executed informed consent for six (ID#s 1, 12, 13, 14, 15 and 16) of nine surgical patient records reviewed.

Findings include:
Record review of facility policy titled "Consent- Overview and Basic Requirements" showed the following information:

Policy
In accordance with state and federal law, prior to providing care, treatment, or services, informed consent must be obtained from the patient or the person with the right to provide consent on behalf of the patient (e.g, parent in the case of a minor patient or surrogate decision maker 4 an incapacitated patient), in that person's preferred language. The informed consent process includes a discussion about the potential health benefits, risks, and side effects of the patient's proposed care, treatment, and services, as well as any reasonable alternatives (including not receiving the proposed care); the likelihood of the patient achieving his or her goals; and any potential complications that might occur during recuperation.
III. General Consent
1. Physicians are required to obtain written consent for procedures or treatments indicated by the Texas medical disclosure panel (TMDP).
2. informed consent must be obtained for all procedures listed and the Texas medical disclosure panel List A (procedures requiring Full disclosure of specific risks and hazards).
C. Discussion and Education
Adult patients or when appropriate, their surrogate decision makers must receive from their attending physician information regarding the risks and benefits of a proposed treatment and/or procedure ...
Except in emergencies, this information may include, but is not limited to:
1. the patient's diagnosis, if known;
2. The general nature and purpose of the procedure or treatment, including its risks and benefits and whether it is experimental
3. the names of the person(s) performing the procedure or administering the treatment
4. the benefits, risks, discomforts, side effects, complications, and potential problems related to recuperation associated with the procedure or treatment
5. the likelihood of success
6. the patient's prognosis and risks and benefits of not receiving or undergoing a treatment or procedure
7. Reasonable alternatives

Medical record review of surgical consent for patient (ID#1) for date of service 11/19/2021 showed the following information:
Description of Medical Care and Surgical Procedure(s):
I voluntarily request my physician/healthcare provider [name/credentials] and other healthcare providers, to treat my condition which is: (typed) Adductor, Hamstring, Gastrocnemius, Alcohol Injections, and other indicated procedures
(handwritten) Left underneath adductor with both words circled, Bil underneath hamstring with both words circled, the word gastrocnemius crossed out, and Bil obturator.
I understand that the following care/procedure(s) are planned for me: Left hip joint injection.

Medical record review of surgical consent for patient (ID# 12) for date of service 5/19/23 showed the following:
I voluntarily request my physician/healthcare provider [name/credentials] and other healthcare providers, to treat my condition which is: (typed) contracture
I understand that the following care/procedure(s) are planned for me: (typed) Adductor, Hamstring, Gastrocnemius, Alcohol Injections, and other indicated procedures.
(handwritten) Bil underneath adductor with both words circled, Bil underneath hamstring with both words circled, Bil underneath the word gastrocnemius with both words circled, and Bil obturator.

Medical record review of surgical consent for patient (ID# 13) for date of service 4/21/23 showed the following:
I voluntarily request my physician/healthcare provider [name/credentials] and other healthcare providers, to treat my condition which is: (typed) contracture
I understand that the following care/procedure(s) are planned for me: (typed) Adductor, Hamstring, Gastrocnemius, Alcohol Injections, and other indicated procedures.
(handwritten) Bil underneath adductor with both words circled, Bil underneath hamstring with both words circled, the word gastrocnemius crossed out, Bil underneath the word hamstring with both words circled, and Bil obturator, Bil Rectus, Bil Pecteralis, Bil rec release, Bil Rectus Release, Bil Hip Flexors.

Medical record review of surgical consent for patient (ID#14) for date of service 4/7/2023 showed the following information:
Description of Medical Care and Surgical Procedure(s):
I voluntarily request my physician/healthcare provider [name/credentials] and other healthcare providers, to treat my condition which is: contracture
I understand that the following care/procedure(s) are planned for me: (typed) Adductor, Hamstring, Gastrocnemius, Alcohol Injections, and other indicated procedures
(handwritten) Left underneath adductor with both words circled, Bil underneath hamstring with both words circled, the word gastrocnemius crossed out, and Bil obturator.

Medical record review of surgical consent for patient (ID#15) for date of service 6/23/2023 showed the following information:
Description of Medical Care and Surgical Procedure(s):
I voluntarily request my physician/healthcare provider [name/credentials] and other healthcare providers, to treat my condition which is: contracture
I understand that the following care/procedure(s) are planned for me: (typed) Adductor, Hamstring, Gastrocnemius, Alcohol Injections, and other indicated procedures
(handwritten) the word adductor crossed out, Bil underneath hamstring with both words circled, Right underneath gastrocnemius with both words circled, and Bil obturator and right tib post.

Medical record review of surgical consent for patient (ID#16) for date of service 6/23/2023 showed the following information:
Description of Medical Care and Surgical Procedure(s):
I voluntarily request my physician/healthcare provider [name/credentials] and other healthcare providers, to treat my condition which is: contracture
I understand that the following care/procedure(s) are planned for me: (typed) Adductor, Hamstring, Gastrocnemius, Alcohol Injections, and other indicated procedures
(handwritten) Right underneath adductor with both words circled, the word hamstring crossed out, Bil underneath gastrocnemius with both words circled, and Bil obturator, Right tib post, right tib post open, left biceps, and Left sec.

Interview with Director of Surgical Services (ID# 61) on 8/31/23 at 12:15 PM stated that when completing consent forms abbreviations should not be used. He also stated it was not clear what procedures were to be done on the above-mentioned consents based on the way they were completed.