HospitalInspections.org

Based on observation, interview and record review, the hospital failed to have an effective governing body that is legally responsible for the conduct of the hospital when:

1. Attending physicians and residents (physician in training) did not follow established pre-procedure protocols, and documentation for six of 10 sampled patients (Pts), Pt 1, Pt 2, Pt 3, Pt 59, Pt 61, and Pt 68 who had surgical procedures. (Refer to A49 and A347)

2. Pt 1 and Pt 2 were not provided essential information in their primary language in order to way the benefits and risks of informed consent for surgical procedures. (refer to A49 and A131, A955)

3. Surgical staff did not complete the required time-out protocol prior to performing surgical procedures and performed a wrong site surgery on Pt 1. (refer to A49, A951, A955)

4. Supervising/attending physicians (MD) did not provide the necessary supervision of residents required for the safe medical care for four of 10 sampled Pts, Pt 1, Pt 57, Pt 58, and Pt 60. (refer to A49, A347)

5. Patient private health information, informed consent records, were stored in an unsecured location in the resident physicians' lounge. (refer to A49)

6. Anesthesiologists did not follow established professional standards when Anesthesiologist 1 left the operating room while administering anesthesia to Patient 1 prior to handing off to a qualified anesthesiologist. (refer to 1001, 1002)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and responsible manner.

Based on interview and record review, the hospital's Governing Body failed to have a system and provide oversight to ensure physicians followed Medical Staff Bylaws and policies and procedures when:

1. Attending physicians and residents (physician in training) did not follow established pre-procedure protocols, and documentation for six of 10 sampled patients (Pts), Pt 1, Pt 2, Pt 3, Pt 59, Pt 61, and Pt 68 who had surgical procedures.

2. Pt 1 and Pt 2 were not provided essential information in their primary language in order to way the benefits and risks of informed consent for surgical procedures.

3. Surgical staff did not complete the required time-out protocol prior to performing surgical procedures.

4. Supervising/attending physicians (MD) did not provide the necessary supervision of residents required for the safe medical care for four of 10 sampled Pts, Pt 1, Pt 57, Pt 58, and Pt 60.

5. Patient private health information, informed consent records, were stored in an unsecured location in the resident physicians' lounge.

These failures affected patient safety, the quality of care, and had the potential to contribute to poor patient outcomes for all hospital patients who received medical care at the hospital.


Findings:

1. During interview on 8/31/20 at 2:45 p.m., with resident (R) 1, R 1 stated he did not evaluate Pt 1, he did not read Pt 1's medical record or write a pre-procedure note prior to entering the OR for Pt 1's surgery and he did not review Pt 1's informed consent form prior to Pt 1's surgery. R 1 stated he believed Pt 1 wanted a tubal ligation (sterilization) and instead of determining Pt 1 had a consent for sterilization during the time-out, he waited until mid-operative procedure to speak up. R1 stated he "made an error" and "confused" Pt 1 with another patient.

During concurrent interview and record review on 9/2/2020 at 9:50 a.m. with Registered (RN) 6, RN 6 validated the medical records for Pts 1, 2, 3, 59, 61, and 68 did not have documentation to indicate a pre-procedure note or informed consent discussion had been completed by the supervising surgeon or resident prior to entering the OR.

During an interview on 9/3/2020 at 9:00 a.m. with the Medical Staff President (MSP), the MSP stated the primary surgeon (supervising/attending) had the primary responsibility for the surgery and to ensure the pre-procedure requirements were followed according to policy and procedure. The MSP stated both the surgeon and anesthesiologist must document a pre-procedure interval note or short history and physical and obtain informed consent prior to entering the OR and performing a surgical procedure.

During interview on 9/4/20 at 9:15 a.m., with MD 1, MD 1 stated he did not discuss with Pt 1 any aspects of the medical history , informed consent, plan of care, labs, risks, benefits, and alternatives, or review Pt 1's medical record prior to entering the OR for Pt 1's surgery. MD 1 stated it was the "usual" process to have a "conversation" with the patient and review the medical record in the OR during the spinal (a pre-surgical procedure to deliver medication). MD 1 stated the pre-procedural process he followed for Pt 1 was "not standard practice" and that he "fell short." MD 1 stated the standard of care was to review documentation, read the chart, review labs and pathology, confirm the plan of care, write interval notes, update the history and physical, and obtain informed consent before performing a surgical procedure.

Review of Policy and Procedure (P&P) titled, #25032 titled "Medical Education- House Staff/Fellows", effective date 1/22/2018 and next review date 1/21/2021 documented healthcare practitioners residents and fellows participating in the teaching programs must abide by the Medical Staff Bylaws, Policies and Procedures established by [hospital].

Review of Policy and Procedure (P&P), titled "Medical Record Electronic Health Record", dated 9/12/18, indicated, " ...all pre-operative or pre-procedure history and physicals (H&P) must have documented that the indications, alternatives, benefits and risks, were discussed with the patient ..."

Review of Policy and Procedure (P&P), titled, "Universal Protocol", dated 12/8/16, indicated, " ...III, in the pre-procedure area, the health care team "ensures that all the relevant documents and studies are available prior to the start to the procedure, that they have been reviewed and are consistent with each other, with the patient's expectations, and with the team's understanding of the intended patients, procedure ...verification of the correct person, site and procedure occurs ...before the patient enters the procedure room ...with the patient wake and aware ..."

Review of Policy and Procedure (P&P) titled, "Cesarean Section", dated 9/25/17, indicated, " ... III ...the physician must discuss the risks, benefits and alternatives of a C-section with the patient prior to the procedure...Required pre-procedure documentation must be completed before the patient may be taken to the operating room, except in the case of an emergency ...If the patient is also having a bilateral tubal ligation during the procedure, follow the policy for Postpartum Sterilization ..."

Review of Policy and Procedure (P&P) titled, "Postpartum Sterilization", dated 1/13/19, indicated, " ...II ...sterilization consent is to be completed in the physician's office prior to admission...All safety elements (e.g. correct patient, correct procedure, etc.) are to be verified prior to surgery...physician must complete all of the documentation required for permanent sterilization prior to the beginning of the procedure ...IV ...pre-procedure/surgical preparation items to be available and/or in the EHR includes such items surgical and sterilization consents ..."

Review of Policy and Procedure (P&P) titled "Consents" dated 6/21/17, indicated, " ...III ...the physician has the legal responsibility and ethical duty to obtain the patient's informed consent or the informed consent of the patient's legal representative, for medical treatment, or for procedures...informed consent must occur prior commencement of the procedure. If there is no physician documentation the procedure shall not begin ... If an interpreter is used to assist with the informed consent process, he/she will document on the consent form..."


2. During concurrent interview and record review on 9/2/20 at 9:50 a.m. with Registered (RN) 6, the medical records for Pt 1 and Pt 2 were reviewed. RN 6 validated RN 6 validated Pt 1's and Pt 2's primary language was Spanish and there was no documentation in their medical records to indicate an interpreter was used to communicate with Pt 1 and Pt 2.

During concurrent interview and record review on 9/3/20 at 12:21 p.m., with the Medical Staff Manager (MSM) R1, R2, R4, R5, MD 3, R8, R9 and R10's personnel records were reviewed. The MSM stated Anesthesiologist (ANES) 1's signed attestation (statement to indicate individual is qualified) indicated ANES spoke Spanish, but he was not fluent in Spanish. The MSM stated R1, R2, R4, R5, MD 3, R8, R9 or R10 the physicians did not complete the testing, training and/or receive the language Buddy Badge according to hospital policy. The MSM stated she was unable to provide attestation records or documentation to indicate R1, R2, R4, R5, MD 3, R8, R9 or R10 were fluent in the Spanish language. The MSM stated the Medical Staff Bylaws indicated only an attestation was necessary to provide hospital interpreter services.

During an interview on 9/10/20 at 1:10 p.m., with the Governing Body (GB) members, MD 7 stated the main cause of Pt 1'a wrong site surgery was a communication problem with Pt 1 who was a "Spanish speaking" patient. MD 7 stated he did not follow the informed consent and language translation processes according to policy.


Review of Policy and Procedure (P&P) titled, "Interpreters/Translation: Non-English/Limited English Proficient & Deaf/Hearing Impaired", dated 4/9/20, indicated, " ...II ...any staff member who communicates in languages other than English when caring for patients is referred to as a Care and Conversation Communicator ...Upon testing and training, such a staff member is assigned a Tier 1 or Tier 2 buddy badge ...Professionals (Tier 2): a. Any clinically trained professional who is bilingual and fluent (read, write and speak) in both English and another language and who is knowledgeable about specialized healthcare terms and concepts...b. Physicians and Advanced Practice Professionals are required to complete the attestation as part of their application for privileges stating they are fluent in both English and the specified language ...Tier Two Badge Buddies will be assigned ...Certified Healthcare Interpreter (Tier 3): A certified professional whose exclusive job description is INTERPRETER- 1, 2, 3- Healthcare ...III ...must be able to communicate effectively with their healthcare providers in order to improve the quality of information, the outcome of the encounter ...It is the policy of [hospital] to use competent medical interpreters (i.e. certified or licensed bilingual staff during critical health services or treatment situation ...A certified healthcare interpreter (Tier 3) or badged bilingual staff (Tier 2) shall be used ..."

Review of Policy and Procedure (P&P) titled, "UCSF Fresno Department of Obstetrics and Gynecology Policy and Procedure Manual" dated 1/30/18, indicated, " ...there will be a mutual resident-Attending responsibility to recognize the need for increased communication and supervision ...for ... significant deterioration in clinical status, any patient with a high risk condition a significant uncertainty regarding diagnosis or management of the patient, decreased experience of the trainees, patients requiring procedures or interventions...An attending should attend all deliveries...the Attending should be consulted on any patient requiring surgery, ICU transfers or hospital admission ...All operative procedures must have a supervising physician present...Medical procedures by residents ...All operative procedures performed must have a supervising physician present ..."


3. During interview on 8/31/20 at 3:00 p.m., with R 2, R 2 stated she was present for Pt 1's surgical time-out and "everyone" in the OR was in agreement about Pt 1's planned C-section. R 2 stated she heard R 1 and MD 1 discussing the tubal ligation and she heard R 1 state Pt 1 "needs a tubal [ligation]".

During an interview 9/1/2020 at 10:05 a.m. with RN 1, RN 1 operating circulator initiated the time-out and "everyone" including the ANES nurses, surgeons, residents and OR scrub technicians (stands next to surgeon during procedure and gives surgeon sterile tools to surgery) were required to participated in the time-out. RN 1 stated Pt 1 did not consent for a tubal ligation and she [RN 1] "knew for a fact", the patient did not want a tubal ligation because she [RN 1] spoke to Pt 1 prior to the procedure. RN 1 stated the surgery was supposed to "stop" if the patient did not consent for a procedure.

During an interview 9/1/2020 at 12:33 p.m. with R4, R4 stated at the start of the time-out process, everyone in the OR involved with patients' surgical procedure must agree with the time-out and if anyone disagreed or was discontent with the time-out process, the surgical procedure did not proceed until there was clarified and everyone agreed.

During an interview on 9/2/2020 at 9:10 a.m. with Anesthesiologist (ANES) (doctor that provides pain control and puts patients to sleep for surgeries) 1, ANES 1 stated anesthesia staff were required to participate in the surgical time-out process with the OR team prior to starting a surgical procedure. ANES 1 stated he left the OR during Pt 1's surgery without having another responsible anesthesiologist to assume the care of Pt 1. ANES 1 state he was not present for the intra-operative time-out or during any discussion about Pt 1's consent for a tubal ligation and subsequent removal the Pt 1's right tube.

During an interview on 9/8/2020 4:55 p.m. with Quality Director (QDir), the QDir stated time-outs were a "critical part of a surgery".

Review of Policy and Procedure (P&P) titled "Universal Protocol" dated 12/8/16, indicated, " ...II ...Universal Protocol must be followed on all procedures that require informed consent. This includes all invasive/operative procedures. Universal Protocol must be followed in all areas of the organization where the procedure is preformed...III ...verification of the correct person, site and procedure occurs ...before the patient enters the procedure room ...with the patient wake and aware...Time-out occurs immediately before start of the procedure, verify and document all elements of the time Out ... If there is a concern by any team member or difference of opinion on any element of the time-out, clarification is to be made by the primary Surgeon or proceduralist before the procedure is allowed to begin and all members of the team must accept and be in agreement ..."

4. During concurrent interview and record review on 9/2/2020 at 9:50 a.m. with RN 6, Pt 58's medical record was reviewed. RN 6 validated R 1 cared for Pt 58 and was the physician of record for the delivery of Pt 58's newborn infant. RN 6 stated the attending physician was not present for the care of the patient and infant during the delivery.

During an interview and record review on 9/2/2020 at 10:00 a.m. with RN 6, Pt 57's medical record was reviewed. RN 6 validated R 10, a first year resident delivered Pt 57's newborn infant and R10 was supervised by R 1, a second-year resident. RN 6 validated the supervising/attending physician or senior resident (four-year resident can supervise junior residents) were not present during the delivery of Pt 57's newborn infant or to provide care to Pt 57. RN 6 stated R 9, the senior resident should have been present during the delivery but was not and R 9 co-signed Pt 57's medical record the following day on behalf of junior residents, R 10 and R 1.

During an interview on 9/3/20 at 9:00 a.m., with the MSP, the MSP stated all care provided by residents must be supervised by an authorized attending physician with current medical staff membership and privileges. The MSP stated when residents were involved in a procedure, the supervising/attending physician must "attest" to supervision of resident.

During an interview and record review on 9/8/2020 at 9:31 a.m. with RN 6, Pt 60's medical record was reviewed. RN 6 validated two residents, R 3 and R 8 provided medical care for Pt 60. Pt 60's baby was born with breathing problems that required care from a neonatologist (doctor specializing in newborn infants) and the Neonatal Intensive Care Unit (NICU) team that should have been alerted, but were not, to be present during the delivery of Pt 60's newborn infant. Pt 60's medical record delivery note indicated Doctor of Osteopathy (DO) 2 was the attending physician of record.

During a concurrent interview and record review on 9/10/20, at 9:35 a.m., with the Charge Nurse (CN) for Labor and Delivery floor, Pt 60's medical record was reviewed. The CN validated Pt 60's pregnancy and condition of the baby (possible problems were identified before the baby's birth) was "high risk" and R 6 and MD 3 were the assigned physicians for the delivery of Pt 60's baby. The CN stated R 6 had canceled the NICU team (hospital practice to have NICU team present for high-risk births) prior delivery of Pt 60's baby. The CN stated when she went to the delivery room just prior to delivery of Pt 60's baby, DO 2, the attending physician, was not present in the room and was not present at any time during the delivery of Pt 60's baby. The CN stated the NICU team and a neonatologist (doctor specializing in newborn infants) should have been called and present at the birth of Pt 60's baby. The CN validated R 6 was a third-year resident with an unrestricted California medical license. On 9/9/20, 9/10/20, and 9/11/20 requests were made to interview R 6. R 6 was unavailable and did not participate in the interview process at any time during the survey.

During an interview on 9/10/2020 at 1:10 p.m. with the GB, the GB stated the attending physician has the "ultimate responsibility" for the care of patients. The supervising attending is responsible for care provided by residents. The Medical Executive Committee (MEC) has oversight of the medical staff membership and privileges. The GB has an "overarching" responsibly for all patient care.

Review of Policy and Procedure (P&P) titled, "Medical Education- House Staff/Fellows", dated 1/22/18, indicated, " ... II ...Supervision of house staff shall be conducted by members of the faculty in individual departments and be in compliance with the requirements as specified by the Accreditation Council for Graduate Medical Education (ACGME) and the program's Residency Review Committee or other accrediting bodies for non-ACGME training programs ...All Faculty Attending Physicians shall have current clinical privileges at the facility they are providing supervision and appropriate to the care of the patient. For patients assigned to a teaching program, the attending physician shall be responsible for the quality of and appropriateness of the care that is provided by house staff. The responsibility of the attending physician for the care to the patient on the teaching service is no different than an attending that is caring for a non-teaching patient ...The patient's medical record shall reflect the attending physician's supervision of the house staff ..."

Review of Policy and Procedure (P&P) titled, "Supervision and Accountability" dated 5/20/19, indicated, " ...each patient must have an identifiable, appropriately-credentialed, and privileged attending physician (or licensed independent practitioner as specified by AG=CGME Review Committee) who is responsible and accountable for the patient's care ...This information must be available to residents, fellows, faculty members, other members if the health care team, and patients. Trainees and faculty members must inform each patient of their respective roles in that patient's care when providing direct patient care ...The program must demonstrate that the appropriate level of supervision in place for all trainees is based on each trainee's level of training and ability, as well as patient complexity and acuity ..."

5. During an interview on 9/4/20 at 9:15 a.m., with MD 1, MD 1, stated during Pt 1's surgery, R 1 informed him, the sterilization consent for Pt 1 was in the "resident room [residents' lounge]" and there were no copies of an informed consent for Pt 1 in the OR. MD 1 stated the time-out conducted prior to the start of Pt 1' C-section procedure was only for the C-section and not for a tubal [ligation (sterilization)]. MD 1 stated he had relied on R 1 to know about Pt 1's informed consents.

During an interview on 8/31/20 at 2:45 p.m., with R 1, R 1 stated at the time of Pt 1's surgery, he [R 1] believed Pt 1 wanted a tubal ligation. R 1 stated Pt 1's informed consent form could not be found in the OR and it was not discussed or included in the time-out process. R 1 stated when MD 1 asked for Pt 1's signed informed consent form, he [R 1] advised MD 1 that Pt 1's signed inform consent form was in the resident workroom [lounge]. R 1 stated he knew Pt 1's signed informed consent form was in the lounge and that Pt 1 wanted a tubal ligation. R 1 stated it was common practice to store other patients' signed inform consent forms in the resident lounge. R 1 stated he made an "error" when "thinking" Pt 1 wanted a tubal ligation and he "confused" Pt 1 with another patient. R 1 validated after Pt 1's C-section, Pt 1's right fallopian tube (a sterilization surgery, so a woman cannot get pregnant) was removed in error and without Pt 1's informed consent. R 1 stated it was a "human error."

During an observation, interview, and record review on 9/1/20 at 12:33 p.m., with R4 and R5, the area identified as the residents' workroom (lounge) was observed. R4 opened the unlocked resident education cabinet. R 4 validated the cabinet was left unlocked even though the keys remained positioned in the lock. The cabinet contained unorganized stacks of miscellaneous papers, gloves, suture sets, anatomy models, and a black accordion paper file organizer. R 5 removed the accordion paper file organizer and estimated there were approximately 75 to 100 informed consent forms for sterilization procedures that included patient names, date of birth, and signatures in the file organizer. R4 and R5 stated according to HIPPA (protection of patient's medical information), consents should be stored in a "safe, locked environment."

During an interview on 9/2/20 at 3:00 p.m. with R 4, R 5, and MD 3 (supervising physician), R 4 and R 5 stated informed consents for sterilization were usually obtained during the patient's clinic appointments. R 4 and R 5 stated the common practice was for residents to take phone pictures of the informed consent forms and download the document to patients' electronic health records (EHR). R 4 and R 5 stated patients were provided a copy of their signed informed consent form and a hard paper copy of patients' informed consent forms were stored in the accordion file in the resident workroom.

During an interview on 9/2/20 at 3:30 p.m., with RN 11, labor and delivery nurse, RN 11 stated residents keep a copy of patients' informed consent for sterilization in the residents' workroom and the informed consents were sometimes, not always scanned into patients' EHR.

Review of Policy and Procedure (P&P) titled, "Corporate Community Medical Centers Rules & Regulations" dated 8/28/19, indicated, " ...physicians and dentists participating in the teaching programs as residents must abide by the Medical Staff Bylaws. Rules and Regulations, and Policies and Procedures established by the Community Medical Center (CMC) Medical Staff adopted General Rules and Regulations ..."

Review of Policy and Procedure (P&P) titled "Medical Record Electronic Health Record" dated 9/12/18, indicated, " ...Access to Medical Record/Electronic Health Record" documented, access to medical record/electronic health record are limited to the Medical Staff that are directly involved in the patient's care ... All users must have a legitimate reason for accessing the patient record...All records are the property of [hospital name] and shall not otherwise be removed, copied or printed without the permission of Hospital Counsel ..."

Review of Policy and Procedure (P&P) titled, "HIPPA Patient Privacy" dated 1/24/19, indicated, " ...commitment to Privacy Rule compliance Medical staff and Advance Practice Professionals shall protect the privacy of patients' health information as required by the Privacy Rule, the HITECH Act, and applicable state law...Medical Staff Members are expected to know what information comprises PHI (personal Health information...In addition to HIPPA Privacy Rule, the Medical staff members and Advanced Practice Professionals shall comply with the standards for security pursuant to HIPPA ("Security Rule") well as subsequent amendments promulgated in the HITECH Act ..."

Review of Policy and Procedure (P&P) titled "Preoperative & Postoperative Care" dated 2/5/18, indicated, " ...II ...informed consent discussion must occur between the physician and patient for legal representation and the documents in the EHR (electronic Health Record) before the patient undergoes the procedure. Consent documentation includes the following: 1. Patient's statement of informed consent signed by the patient (or legal representative) and witnessed ...2. Informed Consent Statement by the physician performing the procedure (or designee with privileges), including risks, benefits, and alternatives and must state the specific planned procedure, and when necessary use a competent or certified interpreter (refer to Interpreter - Non-English/Limited English Proficient & Death/Hearing Impaired Policy) ... "

Review of hospital document titled, "MEDICAL STAFF BYLAWS Volume 1: Governance, Structure and Function of the Medical Staff" dated 2/4/20, the document indicated, " ...2.3 ...Furthermore, each member of the Medical Staff by accepting Medical Staff appointment or privileges agrees: m. To abide by these bylaws and Medical Staff manuals, Medical Staff policies, rules and regulations, and [name of hospital] policies and procedures ..."

Based on interview and record review, the hospital failed to protect and promote patient's rights when:

1. Surgeon (MD 1) and Resident (R 1 physician in training) failed to provide one of 5 patients (Pt 1) and her husband the information necessary
(risk, benefits, and alternatives) to make an informed decision prior to the sterilization procedure (tubal ligation-procedure to prevent future pregnancies)
they (MD 1 and R 1) performed on Pt 1. (refer to A131)

2. The hospital failed to ensure one of 68 patients sampled (Pt 1) had the right to be free from all forms of abuse or harassment when Pt 1's wishes to
not have a sterilization procedure were neglected and not respected. Pt 1 underwent a right tubal ligation without having been provided informed consent
prior to the start of surgery for a tubal ligation. (Refer to A145)

3. Two of 68 patients sampled (Pt 5 & Pt 40) were not fully informed in a timely manner about the conditions of admission and patient rights; two of 68
patients sampled (Pt 14 & Pt 27) condition of admission (COA- consent to treat and bill the patient) were obtained over the telephone and the forms were
not signed by a second witness per the hospitals policy. (Refer to A117, finding 1 and 2)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and
responsible manner.

Based on interview and record review, the hospital failed to ensure two of 68 patients sampled (Pt 5 & Pt 40) were fully informed in a timely
manner about the conditions of admission and patient rights, and failed to obtain two signatures on telephone conditions of admission (COA- consent to
treat and bill the patient) forms for two of 68 patients sampled (Pt 14 & Pt 27) according to the facility's policy when:

1. Pt 5's COA was not obtained until 8/28/20 (18 days after admission), Pt 40's official COA and patient rights forms were not obtained until
9/1/20 (27 days after admission) and Pt 40's initial telephone COA and patient rights forms were deleted from the electronic medical record
(EMR).

2. Pt 14 and Pt 27 "COA Part 1 & 2" was obtained over the telephone and the forms were not signed by a second witness according to hospitals
policy.

This failure resulted in Pts 5 & 40's and their representatives being uninformed of the hospital's Conditions of Admission and Services and about
their patient rights during hospitalization in a timely manner and resulted in Pt 14 and Pt 27's COA's were not signed by a second witness.

Findings:

1. During a review of patient Pt 5's electronic medical record (EMR), the demographic sheet (basic information about a patient including
address, emergency contact, financial resources, dates of service, and other personal information), dated 9/1/20, indicated Pt 5 was admitted to the hospital
on 8/10/20 at 9:44 a.m. The space to indicate the discharge date and time was blank. Pt 5's EMR indicated a scanned document titled, "Conditions
of Admission or Service Part 1 [COA P1]," dated 8/16/16, signature page (P), three (3) indicated in handwritten form, "phone consent," with the name
of Pt 5's family member, Patient Admissions Specialist (PAS) and witnesses' signatures, all dated 8/28/20 at 9:50 a.m. Pt 5's EMR also indicated a
scanned document titled, "Conditions of Admission or Service Part 2 [COA P2]," dated 8/16/16, signature page (P), four (4) indicated in handwritten
form, "phone consent," with the name of Pt 5's family member and PAS and additional witness's signatures, all dated 8/28/20 at 9:50 a.m.

During a review of Pt 40's EMR, the demographic sheet, dated 9/1/20, indicated Pt 40 was admitted to the hospital on 8/5/20 at 2:54 p.m. The space to
Indicate the discharge date and time was blank. Pt 40's EMR indicated, a scanned document titled, "Conditions of Admission or Service Part 2 [COA P2],"
dated 8/16/16, signature page (P), four (4) indicated in handwritten form, "phone consent," name of Pt 40's family member and Patient Admissions
Specialist (PAS) 1's signature. The COA P2 had two handwritten dates and times, 9/1/20, 125 (1:25 p.m.) and 9/11/20, 1325 (1:25 p.m.). The COA P2
indicated the scan (paper record timed into the EMR) date and time stamp, 9/1/20 12:53 p.m.

During a concurrent interview and record review on 9/1/20, at 1:48 p.m., with the Admissions Director (AD) and PAS 1, Pt 40's EMR was
reviewed. The COA P2 scanned document with the date and time stamp 9/1/20 at 12:53 p.m. was deleted from Pt 40's EMR and separate second
COA P2 was viewed in Pt 40's EMR. The second COA P2 had Pt 40's, spouse's handwritten signature and was dated and timed, 9/1/20 at
1:31 p.m. The second COA P2 had the scan date and time stamp, 9/1/20 at 1:35 p.m. PAS 1 reviewed the paper copy of the first COA P2
and stated she had written the incorrect time and the correct time of 12:25 p.m. should have been documented on the first COA P2. The AD and
PAS 1 stated they did not know why the first COA P2 was deleted from Pt 40's EMR. The AD stated her expectation was that both
documents should remain in Pt 40's EMR, the first COA P2 should not have been deleted. The AD validated Pt 40's COA P2 was signed on
9/1/20, 27 days after Pt 40 was admitted, 27 days was too long, and it was her expectation for the COA P2 to be signed and completed as
soon as possible after admission.

During an interview on 9/2/20, at 10 a.m., with the AD, the AD stated it was not an acceptable practice at any time to delete information in a
patient's EMR.

During a review of the hospital's policy and procedure (P&P) titled, "Consents," dated 6/21/17, it indicated, " ...I. Purpose ...A. To describe the
principles of consent, protect the rights of patients ...B. To clarify the responsibilities of the hospital for consent to services and verification of
informed consent ...III. Policy ...A ...1. [hospital name] is responsible for obtaining the patient's or legal representative's consent for hospital services or
activities: a. Consent for hospitalization. b. Consent for any other hospital activities which, without consent, would impinge on the patient's rights
...c. Consent for these activities is included in the Conditions of Admission form ..."

2. During an interview on 9/4/20, at 9:01 a.m., with the AD, Pt 14 and Pt 27's "Condition of Admissions or Service Part 1&2" (COA) were reviewed.
The COA Parts 1&2 were obtained by telephone consent and missing a second witness signature on both patients' consents. The AD stated that the
process for obtaining a COA telephone consent was to have two witnesses sign and print their name, date and time the consent. AD stated the policy is
to get a second witness signature when obtaining a telephone consent. The AD stated the reason for two witnesses is to make sure the phone consent was
heard by two parties so that the responsible party does not come back and say that they did not give the consent.

During an interview on 9/8/20, at 3:50 p.m., with the Inpatient Follow up Specialist (IFS), Pt 14 and Pt 27's "Condition of Admissions or
Service Part 1&2" (COA) were reviewed. The COA Parts 1&2 were obtained by telephone consent and were missing a second witness signature
on both patients' consents. The IFS stated the process for obtaining a COA telephone consent is to document who they obtained consent by,
their relationship to the patient, the date, and time. The IFS stated that she signs and prints her name with title and gets a second signature
from a co worker. IFS stated that she always gets a second signature on phone consents at her desk.

During a review of the hospital's P&P titled, "Consents", dated 6/21/17, indicated, " ...IV. PROCEDURE ...6. Obtaining Consent ...i.
Telephone ...The telephone discussion between the patient's legal representative ...should be witnessed ..."

Based on interview and record review the Surgeon (MD 1) and Resident (R 1 physician in training) failed to provide one of 5 surgical patients (Pt 1)
and her husband the information necessary (risk, benefits, and alternatives) to make an informed decision prior to the sterilization procedure (tubal
ligation- used to prevent further pregnancies) they (MD 1 and R 1) performed on Pt 1.

This failure resulted in the surgical removal of Pt 1's right fallopian tube (tube in the female reproductive system that carries a human egg to the uterus)
and partial sterilization without Pt 1's or her husband's informed consent.

Findings:

During a review of Pt 1's Electronic Medical Records (EMR), the "History and Physical (H&P)", dated 8/12/20, the H&P indicated Pt 1 was admitted
on 8/12/20 for preterm labor (labor that starts before 37 weeks of pregnancy). This was the second pregnancy for Pt 1 and her previous child was
delivered by Cesarean Section (C-section- surgical procedure to remove a baby from the abdomen at time of birth). Pt 1 was assessed to require a
repeat C-section, due to her last meal being at 11 a.m., surgery was scheduled for 6 8 hours later on 8/12/20. Pt 1's "Operative Report," dated 8/12/20,
indicated she entered the OR at 7:23 p.m. and the surgery started at 7:40 p.m. The "Operative Report," dated 8/12/20, indicated the C-section for Pt 1
was performed without difficulty and the DO 1 wrote the report and it was cosigned by MD 1, it indicated "The right fimbriae [tube]was transected after
miscommunication between patient consent and patient verbal consent wanting tubal. After discussion post fimbriaectomy [tubal ligation- a surgical
procedure for female sterilization which involves severing and tying the fallopian tubes] patient declined tubal and so there fore left tubal was not
transacted and patient made aware."

During an interview on 8/31/20, at 1:22 p.m., with Surgical Technician (ST) 3, ST 3 stated she was the surgical technician (person who sets up the
instruments for surgery and hands them to the surgeon) for Pt 1's C-section. ST 3 stated she was present for the timeout (an immediate pause by the
entire surgical team to confirm the correct patient, procedure, and site) and the procedure was for C-section, there was no mention of a tubal ligation
during the timeout. ST 3 stated after the baby was delivered, she heard R 1 say "we aren't going to have time for this patient's tubal [tubal ligation]."
ST 3 stated she then heard RN 1 say "we do not have consent for a tubal [tubal ligation]."

During an interview on 8/31/20, at 3:45 p.m., with R 1, R 1 stated he did not look at Pt 1's consent for surgery prior to surgery. R 1 stated he
received report from the off going shift and was informed that Pt 1 was getting a C-section. R 1 stated he assisted in Pt 1's C-section, and
after the baby was delivered the charge nurse (night supervisor NS 1) came to the door of the OR and stated there was an emergent patient
needing a C-section. R 1 stated, "I made a human error and I think I was getting confused with the next patient." R 1 stated he did not obtain
informed consent for a tubal ligation for Pt 1. R 1 explained that during the C-section while Pt 1 was on the OR surgical table he asked Pt 1
if she wanted her 'tubes cut'. R 1 stated he did not define or explain 'tubes cut' because he did not have time.

During an interview on 9/3/20, at 5:45 p.m., with Pt 1, Pt 1 stated, "they [MD 1 and R 1] did her C-section and they tied [surgically
removed] one of her tubes in error." Pt 1 stated she did not give her consent for the tubal procedure and at no time had MD 1, R 1, or any
other medical professional discussed the tubal (permanent sterilization) procedure prior to performing the surgery. Pt 1 stated she worries and
was constantly sad because the surgical tubal procedure performed by MD 1 and R 1 may affect her chances of having another baby. Pt 1
stated it has affected her sleep pattern; she is sleeping less.

During an interview on 9/3/20, at 6 p.m., with Pt 1's husband, the husband stated, MD 1 and R 1 did not discuss surgery consent with Pt 1,
nor did Pt 1 sign consent for a tubal ligation. Pt 1's husband stated she was just supposed to have a C-section and they cut one tube before
asking them for consent, and the reason they asked was because they were "unsure of what they were doing." Pt 1's husband stated, "they
should not be trying to get consent while my wife was under sedation ... I am sad and still upset with the doctors for their mistake." Pt 1's
husband stated, "we do plan on having more children but am worried this may not be possible."

During an interview on 9/4/20, at 9:13 a.m., with MD 1, MD 1 stated, he was the primary surgeon for Pt 1's C-section and that he did not
review Pt 1's chart nor her surgery consent prior to entering the operating room. MD 1 stated the consent in the OR read "C-section repeat"
and there was nothing written about a tubal ligation. MD 1 stated after the baby was delivered the charge nurse (NS 1) came to the door and
informed them of an emergent C-section being placed in the next OR. MD 1 stated Pt 1 was still on the table and surgical incision was still
open and R 1 stated, "this patient won't have time for her tubal." MD 1 stated he clarified with R 1 that Pt 1 wanted a tubal and then he
leaned over the drape and asked Pt 1 if she wanted her tubes cut in Spanish her primary language. MD 1 stated he did not explain or define
what 'tubes cut' meant.

During an interview on 9/4/20, at 9:20 a.m., with MD 1, MD 1 stated, a tubal ligation requires a separate consent called a PM 330 (Form
needed by Medi Cal for consent for sterilization). MD 1 stated this consent was not in the operating room during Pt 1's surgery. MD 1
stated, a copy of all consents should be in the operating room during surgery.

During an interview on 9/4/20, at 12:20 p.m., with the Director of Residents (DOR) from the University (State, City), the DOR stated, after
receiving report from the off going staff the oncoming doctors should go and introduce themselves to the patients and review their charts. The
DOR validated the informed consent for surgery should be done at this time before going into the OR. The DOR stated the residents should be
reviewing their patient's charts and confirming the informed consent with the patients before going into the OR. The DOR stated the PM330
should be reviewed and signed by the surgeon prior to entering the OR and should be in the OR during the surgery, if the form is not in the OR
and the mention of a tubal comes up there should be a hard stop to confirm, if there is no consent we would not proceed with the procedure.

During an interview on 9/10/20, at 8:14 a.m., with the President of Medical Staff (PMS), the PMS stated, "Unless there is a life or death
situation the resident or faculty should do a short H&P [History & Physical] with the patient and review consent before the surgical procedure.
...we do this to prevent errors from happening." PMS stated the only time a timeout should not be done is in a life and death situation.


During a review of the hospital's policy and procedure (P&P) titled, "Consents," dated 6/21/17, it indicated, " ...I. Purpose ...A. To describe the
principles of consent, protect the rights of patients ...B. To clarify the responsibilities of the hospital for consent to services and verification
of informed consent ...III. Policy ...A ...1. [Hospital name] is responsible for obtaining the patient's or legal representative's consent for hospital services
or activities ...D. Informed Consent for Surgery or Special Diagnostic and Therapeutic Procedures 1. The physician has the legal and ethical
duty to obtain the patient's informed consent, or the informed consent of the patient's legal representative, for medical treatment, or for
procedures which have been determined to be invasive and/or complex in nature ...a ...iv. The treating physician is responsible for providing
the patient or patient's surrogate decision maker with the information that is necessary to allow an informed decision to be made ..."

Review of the hospitals P&P titled, "Universal Protocol (UP)", dated 12/8/16, the UP indicated. " ...II.A. Universal Protocol must be followed
on all procedures that require informed consent. This includes all invasive/ operative procedure ... Section III ... verification of the correct
person, site, and procedure occurs ... before the patient enters the procedure room ... the patient awake and aware ..." The UP indicated,
verification process occurs anytime the responsibility of care of the patient is transferred to another member of the procedural team. The UP
indicated, the timeout occurs "immediately before start of the procedure, verify and document all elements of the timeout ..."

Based on interview and record review, the hospital failed to ensure one in 68 patients sampled (Pt 1) had the right to be free from all forms of abuse
or harassment when Pt 1's wishes to not have a sterilization procedure (tubal ligation- procedure to prevent future pregnancies) were neglected and not
respected. Pt 1 underwent a right tubal ligation without having been provided the necessary information to make an informed consent prior to the start
of surgery for a tubal ligation.

This failure resulted in an unnecessary surgical procedure causing permanent physical injury, neglect of staff to follow procedures meant to
protect patient rights and mental and emotional distress to Pt 1.

Findings:

During an interview on 8/31/20, at 3:45 p.m., with R 1, R 1 stated that he was the assistant surgeon for Pt 1's cesarean section (C-section- a
surgical procedure to remove a baby from the abdomen at time of birth). R 1 stated he did not review Pt 1's medical records or determine if Pt 1
had signed a consent for sterilization (surgical procedure requiring patient consent, often completed in conjunction with C-section) prior
entering the operating room (OR) to perform Pt 1's C-section surgery. R 1 stated he did not discuss the sterilization procedure with Pt 1 prior
to surgery. R 1 stated he should have had a discussion with Pt 1 about the surgical sterilization procedure; including the risks, benefits, and
alternatives and he should have obtained Pt 1's consent for the procedure prior to entering the OR to perform the surgical sterilization
procedure.

During an interview on 8/31/20, at 3:55 p.m., with R 1, R 1 validated Pt 1's consent for surgery was for a C-section and did not include a
tubal ligation. R 1 stated the charge nurse (night supervisor NS 1) came to the door of the OR and stated there was an emergent patient
needing a C-section. R 1 stated, he told MD 1 that Pt 1 wanted a tubal ligation and MD 1 questioned him to confirm that is what the patient wanted.
R 1 stated, we asked Pt 1 after the baby was delivered if she wanted her 'tubes cut' in Spanish (Pt 1's primary language). R 1 stated, "I did not
have time to explain this to the patient (Pt 1)." R 1 stated, "I made a human error and I think I was getting confused with the next patient,"
when he told MD 1 that Pt 1 wanted a tubal ligation.

During an interview on 9/1/20, at 11:10 a.m., with Registered Nurse (RN) 1, RN 1 stated she was the circulating nurse during Pt 1's
C-section. RN 1 stated prior to surgery she had reviewed Pt 1's medical history with Pt 1 and her husband and discussed Pt 1's plan to
have more children. RN 1 stated she also discussed Pt 1's preferred choice for birth control; an implanted device (a temporary birth control
method where small device is implanted in the arm to prevent pregnancy) with Pt 1 and her husband. RN 1 stated after the baby was delivered,
MD 1 leaned over the drape and asked Pt 1 and her husband if they wanted Pt 1's tubes cut. RN 1 stated, "Let me check for consent [there was
no consent for sterilization in Pt 1's record]," and "I had talked with the patient and this is not what they asked for." RN 1 stated R 1 was nodding
his head to indicate that he had Pt 1's consent for the tubal. RN 1 stated MD 1 cut the right fallopian tube before she [RN 1] was able to clarify
with Pt 1 and her husband whether Pt 1 consented to the tubal procedure. RN 1 stated Pt 1 and her husband clarified they wanted the implanted
device as a temporary birth control method, and they did not want the tubal (permanent sterilization) procedure.

During an interview on 9/3/20, at 5:45 p.m., with Pt 1, Pt 1 stated, "they [MD 1 and R 1] did her C-section and they tied [surgically
removed] one of her tubes in error." Pt 1 stated she did not give her consent for the tubal procedure and at no time had MD 1, R 1, or any
other medical professional discussed the tubal (permanent sterilization) procedure prior to performing the surgery. Pt 1 stated she worries and
was constantly sad because the surgical tubal procedure performed by MD 1 and R 1 may affect her chances of having another baby. Pt 1
stated it has affected her sleep pattern; she is sleeping less.

During an interview on 9/3/20, at 6 p.m., with Pt 1's husband, the husband stated, MD 1 and R 1 did not discuss surgery consent with Pt 1,
nor did Pt 1 sign consent for a tubal ligation. Pt 1's husband stated she was just supposed to have a C-section and they cut one tube before
asking them for consent, and the reason they asked was because they were "unsure of what they were doing." Pt 1's husband stated, "they
should not be trying to get consent while my wife was under sedation ... I am sad and still upset with the doctors for their mistake." Pt 1's
husband stated, "we do plan on having more children but am worried this may not be possible."


During an interview on 9/4/20, at 9:13 a.m., with MD 1, MD 1 stated, he was the primary surgeon for Pt 1's C-section. MD 1 stated, "I did
not review that chart [Pt 1's]." MD 1 stated, "The first time he saw it [Pt 1's consent for surgery] was in the operating room" and "During the
timeout [an immediate pause by the entire surgical team to confirm the correct patient, procedure, and site] the nurse [RN 1] was standing next
to me and I looked over and saw the consent on her clip board, [it read] "C-section repeat." MD 1 stated, during the timeout everyone agreed
we were doing a C-section, at that time there was no mention of a tubal ligation. MD 1 stated, after the baby was delivered another nurse came
in stating there was an emergency with another patient and at that time R 1 stated, that there won't be time for Pt 1's tubal. MD 1 stated that he
clarified with R 1 that Pt 1 wanted a tubal and he confirmed yes. MD 1 stated, he leaned over the drape and asked Pt 1 and her husband if they
wanted her tubes cut in Spanish and they said "yes." MD 1 stated, "I did not explain what tubes tied meant [tubes cut]." MD 1 stated, RN 1 stated
that the patient did not want her tubes tied. MD 1 stated, he cut the right tube before RN 1 was able to clarify with Pt 1 and her husband that the
tubal ligation was not wanted.

During a concurrent interview and review of the facility's Medical Staff Bylaws, on 9/10/20, at 8:14 a.m., with the President of Medical
Staffing (PMS), "[Name of hospitals associated] Medical Staff MEDICAL STAFF BYLAWS Volume 1: Governance, Structure and Function
of the Medical Staff (MSB's)," dated 2/4/20, was reviewed. The MSB's indicated, " ...2.3 Responsibilities of Membership ... g. Complete histories
and physicals where required and in accordance with Article/Section 10.6 of these bylaws; ... 10.6 Histories and Physicals ... A history and
physical must be completed prior to any surgery or procedure requiring anesthesia services ... the Medical Staff member or other qualified
licensed individuals in accordance with state and federal statute must complete and document an updated examination of the patient within
twenty four (24) hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services ..." The PMS stated,
"Unless there is a life or death situation the resident or faculty should do a short H&P [history and physical] time with the patient and review
the consent before the surgery procedure ... we do this to prevent errors from happening."

During a review of the Operative Report written by R 1 for Pt 1, dated 8/12/20, at 8:21 p.m., the Operative Report indicated, "Procedure
performed: repeat low transverse c section ...Surgeon: [MD 1] Assistants: [R 1] ...Informed Consent: Patient agrees to the cesarean section
and a possible blood transfusion ...Procedure Details ...The right fimbriae [fingerlike projection at the end of the fallopian tube near the
ovary] was transected [cut] after miscommunication between patient consent and patient verbal consent wanting tubal. After discussion post
fimbriaectomy [tubal cut] patient declined tubal and so therefore left tubal was not transected ..."

During a review of the Post Operative Note written by MD 1 for Pt 1, dated 8/12/20, at 9:14 p.m., the Post Operative Note indicated, "I was
informed that patient [Pt 1] desired permanent sterilization. I proceeded to ask patient and her husband if they were sure they desired tubal
ligation in Spanish, and both responded in the affirmative. The husband responded to my question said, "si, amarrar los". At this point I did
not want to deprive the patient of her desired contraceptive choice and we proceeded with the distal right salpingectomy [surgical removal of
the fallopian tubes]. The nurse then informed us that the patient, in fact, did not desire a tubal ligation but the right tube had already been
ligated."

During a review of the facility's policy and procedure titled, "Consents," dated 6/21/17, indicated, " ... The physician has the legal and
ethical duty to obtain the patient's informed consent, or in the informed consent of the patient's legal representative, for medical treatment, or
for procedures which have been determined to be invasive and/or complex in nature ... The treating physician shall furnish the patient ... with
sufficient information to make an intelligent, informed choice of whether or not to undergo the procedure ..."

Based on interview and record review, the hospital failed to develop an on-going process to monitor medical errors and adverse events when a comprehensive plan of correction was not created and implemented in a timely manner to prevent future occurrences of sterilization without informed consent

Review of medical record for Pt. 1 indicated on 8/12/20, at 7:40 p.m. a tubal ligation was performed on Pt. 1 without informed consent. The error was identified by the facility on 8/12/20 and reported to CDPH on 8/18/20, at 9: 24 a.m.

During an interview on 8/20/20, at 9:40 a.m., with Obstetrics and Gynecology Risk Manager (OBRM), the OBRM stated they have 45 business days to complete their investigation, deadline is in October, "so we haven't done it yet".

During a concurrent interview and record review on 9/3/20, at 4:50 p.m., with the Manager of Risk Management (MRM), a facility document titled "Event and Causal Factor Diagram" was provided. The MRM stated the document represented the investigation that was completed for the "never event." The document does not include the date of the investigation for Pt 1 nor the names of persons who participated in the investigation. No root cause was identified on the document.

On 9/4/20, at 4:10 p.m., the hospital was placed in immediate jeopardy and an immediate plan of correction was required. Version 3 of the plan of correction was completed and accepted on 9/6/20, 25 days after the adverse event.

Based on observation, interview and record review, the hospital's medical staff failed to operate under bylaws approved by the govering body and failed to provide quality medical care to patients when:

1. Doctor of Osteopathy (DO) 1 and physician (MD) 3 provided medical and surgical care to patients, and did not have medical staff membership and privileges and GB approval. (refer to A347 finding 1)

2. Hospital administrators and the director of OBGYN (division medicine who care for women's health and pregnancy) program granted Advance Healthcare Practitioners (APH, which include nurse practitioners, midwives and physician assistants) hospital privileges to supervise residents without medical staff review and GB approval. (refer to A347 finding 2)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and responsible manner



42125

Based on observation, interview and record review, the hospital's medical staff failed to operate under bylaws approved by the Governing Body and failed to provide quality medical care to patients when:

1. Two of 9 medical staff records reviewed, Doctor of Osteopathy (DO) 1 and physician (MD) 3 provided medical and surgical care to patients, and did not have medical staff membership and privileges and GB approval. (Refer to A347 finding 1)

2. Hospital administrators and the director of OBGYN (division medicine who care for women's health and pregnancy) program granted Advance Healthcare Practitioners (APH, which include nurse practitioners (NP) 49 of 49, midwives (CNW) 2 of 2, physician assistants (PA) 79 of 79, 2 of 2 dieticians (RD), and 1 of 1 social workers (SW)) hospital privileges to supervise residents (physicians in training) without medical staff review and GB approval. (Refer to A347 finding 2)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and responsible manner.

Based on observation, interview, and record review the hospital failed to have a well-organized medical staff that reviewed all practitioners of [name of university training hospital] staff (103 of 103 physicians and 133 of 133 Advance Healthcare Practitioners (APHs, which included nurse practitioners (NP), nurse midwifes (CNW), physician assistants (PA), registered dieticians (RD), and social workers (SW)) eligibility for medical staff membership and privileges to supervise residents, and oversee the conduct of practitioners providing patient care when:

1. Doctor of Osteopathy (DO) 1 and physician (MD) 3 (2 of 9 physician staff records reviewed) provided medical and surgical care to patients and did not have medical staff membership and privileges and governing body (GB) approval.

2. Hospital administrators and [name of university training hospital] Residency Director of Obstetrics and Gynecology (OBGYN-division medicine who care for women's health and pregnancy) program granted [name of university training hospital] nurse midwives (2 of 2) and 131 of 131 other APHs, (49 of 49 NPs, 79 of 79 PAs, 2 of 2 RDs, and 1 of 1 SWs), and 103 of 103 physicians hospital privileges to supervise residents without medical staff review and GB approval.

These failures resulted in physicians 103 of 103 and AHP providers 133 of 133 whose competency, qualifications and professional abilities to provide medical services and/or supervision of residents were not vetted by the medical staff and approved by the GB, and potentially endangered the health and safety of patients.

Findings:

1. During an interview on 9/3/20, at 9:00 a.m., with the Governing Body (GB), the GB Chief Executive Operator (CEO) stated the GB has "oversight" of safe practice, quality of care for all hospital patients and conduct of the hospital. The President of Medical Staff (PMS) stated like medical staff members, residents "undergo privileges and credentialing, but
are not members."

During a concurrent observation and interviews on 9/8/20, at 2:25 p.m., with registered nurse (RN) 4 and RN 5 and DO 1 in the operating room (OR), DO 1 was the assisting in the surgery of Pt 53. DO 1 was asked if he was a Family Practice physician. He stated, "I'm MCH [maternal child health]". RN 4 and RN 5 looked up DO 1's privileges on the hospital computer. They were was not able to verify DO 1's physician privileges and medical staff membership at the hospital. RN 5 explained, "This has happened before (in the past) in the main OR (operating room). We couldn't find (confirm) the surgeon's (unknown name) privileges and had to ask him to leave [the OR]." DO 1 was allowed to finish the operation and continue working.

During an interview on 9/8/20, at 4:50 p.m., with the Quality Director (QD), the QD stated the hospital maintains a roster for medical staff and another for residents and fellows who have privileges at the hospital. The QD verified DO 1 was not on either roster, and did not have medical staff privileges. Without having medical staff membership, DO 1 started caring for patients and assisted in surgeries in August 2020. QD stated DO 1 was not a surgeon and finished a Family practice residency and was a maternal child health (MCH) fellow (completed physician training in a specialty, i.e. Family Practice). DO 1 was required to obtain medical staff membership and privileges in order to provide medical care to patients. The QD stated administration was "working on" getting DO 1 "auto-privileges". The QD did not provide any documentation for DO 1's education, training, licensure, qualification or competencies needed to place him on the "auto-privilege" list or provide medical care to patients.

During a concurrent interview and chart review on 9/9/20, at 4:35 p.m., with MD 3, MD 3 stated she finished medical school five years ago, was a resident and did not have a medical license or training license. MD 3 stated she participated in the care of Pt 60 and verified she wrote Pt 60's delivery note. During the delivery MD 3 was assisted by R6. Pt 60 was documented to have a high risk pregnancy and a fetus (unborn infant) to have medical problems. MD 3 was not capable of caring for a new born infant with medical problems, and a physician specializing in illnesses of new born infants, a neonatologist, was required to attend the delivery. MD 3 stated the infant was born vaginally (birth canal) with "problems" and was "floppy ... not crying". The neonatologist was called after the infant's birth. The infant was transferred to the NICU (new born intensive care unit (NICU), an area of the hospital where very sick infants are cared for).

During concurrent interview and record review on 9/10/20, at 8:35 a.m., with the Vice President of Medical Education and Research (VPMER), the Accredited Educational Sponsoring Program's electronic residency application service (ERAS) (a repository data base system that retains information about medical personnel with credentials and privileges to practice in the hospital) was reviewed. The VPMER validated the information in the ERAS and stated he did not realize the ERAS system had not been updated, the hospital had relied on the sponsoring educational institution to input the data, and he did not know who was doing it. The VPMER stated, "no one was following up to see if that was actually the case [inputting the data into the ERAS system] ..." During a review of the hospital document titled, "2020-2021 Residents and Fellows [educational organization name] Fresno Medical Education Program [RFMEP (a document that implies privilege approval for Residents and Fellows, physicians in training)]," received date 9/8/20, the RFMEP document indicated all participants in the hospital's Residency and Fellowship program and the participants year in the program. The RFMEP did not indicate MD 3 had privileges and was approved to provide care to patients. Review of the California Medical Board license verification system indicate MD 3
was not licensed as a Medical or other practitioner. MD 3's personnel (credential) file was requested and not received. The VPMER stated "in essence," MD 3 was practicing without a valid license required for the practice of medicine.

During a concurrent interview and record review on 9/10/20, at 9:15 a.m., with MSP, MSP stated the medical staff has oversite of physician conduct and patient care, and reports to the GB. MSP stated all members of the medical staff must meet Medical Staff Bylaw credentialing requirements like completion of an approved residency program, hold an unrestricted license to practice in California, hold an unrestricted Drug Enforcement Agency (DEA) registration, participate in peer review and supervise Advanced Healthcare Providers (APH, which include nurse practitioners, midwives and physician assistants). MSP stated, after the application has been vetted and reviewed, it is submitted to the GB for approval for medical staff membership and privileges.

During an interview on 9/10/2020 at 1:10 p.m. with the Governing Body (GB), in attendance were Chief Operating Officer-CRMC (COO), Director of Quality Management, Medical Director of Quality (MDQ), Quality Director (QD),Director of Risk Management (DRM), Quality Manager, Chief Nursing Officer, President of Medical Staff (PMS), Assistant Chief Operating Officer and MD 7. The CEO was not present and no one at the GB interview knew why he was absent. COO and MDQ, stated the main cause of the wrong site surgery, was a "communication problem", and failing to follow consent and language interpretation processes and policies. MDQ stated the GB has "oversight" of safe practice, quality of care for all hospital patients and conduct of the hospital. MSP and MDQ stated the GB has the "overarching" responsivity for all patient care. The supervising attending is responsible for care provided by residents. MDQ stated, "Realize" the process "not very good".

During a concurrent interview, medical staff record and policy review, on 9/10/20 at 2:25 p.m. with medical staff manager (MSMGR), MSMGR stated DO 1 and MD 3 do not have medical staff membership, and there was no application or documentation files for DO 1. MSMGR stated supervision of residents was not on privilege forms for physicians. MSMGR did not have a list of physicians qualified to supervise residents.

During a concurrent interview and record review on 9/11/20, at 7:23 a.m., with VPMER, VPMER stated DO 1 and MD 3 were placed on the auto-privilege resident roster. VPMER did not provide any documentation for DO 1's or MD 3's education, training, licensure, qualification or competencies needed to place him on the "auto-privilege" list.

During a concurrent interview and record review on 9/11/20, at 10:30 a.m., with medical staff assistant (MSS) and Medical Director of Quality, (MDQ), MDQ verified, Quality Director (QD) placed DO 1 on the "auto-privilege" list. MDQ and MSS stated DO 1 did not have any documentation verifying education, training, criminal history, licensure, certificate, competency, medical practice or insurance to support a medical staff membership appointment.

During a review of the hospital's Policy and Procedure (P&P) titled, "[name of hospitals associated] Medical Staff, Medical Staff Bylaws, Volume I, Governance, Structure and Function of the Medical Staff", dated 2/4/20, the P&P defined medical staff as "the formal organization created by the Board of Trustees to carry out delegated functions at [hospital and associates] and comprised of all Practitioners (a physician, podiatrist dentist or clinical psychologist) who are appointed to it by the Board." The P&P defines Members as "a Practitioner who has been appointed by the Board to the Medical staff. Credentialing is defined as, "the Medical staff may enter into arrangements with other [hospitals] Medical staff or clinical entities (if any) to collaborate in credentialing activities." Documented under section Medical Staff Eligibility and Qualifications for Membership and/or Privileges, Article II documented, "membership and/or clinical privileges on the Medical Staff are privileges granted to professionally competent physicians, dentist, podiatrists and clinical psychologists. The P&P indicated "applicants wishing to be on the Medical Staff and/or requesting clinical privileges must have" an applicable current and unrestricted license to practice in California, have a current unrestricted DEA (prescription drug license) registration, current valid insurance Accreditation Council for Graduate Medical Education [ACGME, responsible for accrediting all graduate medical training programs for physicians in the United States] or American Osteopathic Association [AOA, promotes public health and certifies Doctors of Osteopathy) approved residency training program or a residency training program accredited by the Royal College of Physicians and Surgeons of Canada.

During a review of P&P titled, "Medical Staff Credentials Policy", dated 4/13/19, P&P indicated under section Credential Subcommittee: A subcommittee of the Board's Professional Affairs and Quality Committee with delegated Board authority to render initial appointment, reappointment and renewal or modification of clinical privileges decisions that meet certain criteria. The applicant must complete a pre-application form to determine his/her eligible for membership and/or privileges. If the new applicant meets [the hospitals] qualification than an application shall be sent via mail or electronically. The policy indicated, "any individual, facility or entity must notify the MSO [Medical Staff Office] in writing of an applicant that will need membership and/or privileges to practice... The applicant's responsibility and burden to produce the needed documents. If the application meets the criteria, the MEC [Medical Executive Committee] shall recommend appointment. The credential Subcommittee shall review the application and make the final decision. Residents/Fellows will submit their
applications as outlined above."

During a review of the hospital's P&P titled, "Bylaws of [name of hospital] Hospital and Medical Center", dated 12/4/17, the P&P indicated in "...Article V President/Chief Executive Officer... this corporation shall be given the necessary authority and responsibility to operate this Cooperation in all its activities ... and act as the duly authorized representative of the Board. Article VI documented the duties and responsibilities... 1. Recommend policy. 2. Review and approve medical staff appointment recommendations, to advise management. 3. Review all and approve all quality management. 4. Performance improvement, utilization review, professional education, and patient care related activities and polices. 5. Ensure compliance with professional, regulatory and accreditation standards and mandates. 6. Review and approve medical staff policies. 7. Review and approve amendments to the Rules and Regulations of the medical staff, 8. Review and approve the medical education program."


2. During a concurrent interview and record review 9/8/20, at 9:31 a.m., with registered nurse (RN) RN 8, RN 8 verified that Pt 54's medical care was provided by Resident (physician in training) 1, Resident (R) 1 and R 10 and a non-physician nurse midwife (CNW) co-signed the notes as the supervising provider for R 1 and R 10.

During a concurrent interview and record review on 9/10/20, at 9:15 a.m., with MSP, MSP stated according to Medical Staff Bylaws, APH, including midwives, are not independent practitioners like physicians, podiatrist, dentist or clinical psychologist, and do not meet the Medical Staff Bylaw credentialing requirements, such as completion of an approved residency program and are not hold medical staff membership. APH require supervision for medical care provide to patients by a physician who hold medical staff membership and privileges. All physicians who supervise residents (physician in training) must hold medical staff membership and privileges and follow the [name of university training hospital] resident supervision policies. MSP stated Bylaws are approved by the GB and the GB has oversight over all providers and quality of care.

During an interview and concurrent document review on 9/10/20, at 11:00 a.m., Director of Risk Management (DRM) and Administrator of Quality (ADMQ), provided "[name of university training hospital] Faculty list" which included names of physicians, physician assistants, nurse practitioners and nurse midwives. They also provide a section of the ACGME Common Program Requirements (Residency) revision 2/3/2020; effective 7/1/2020, and pointed to highlighted section under Background and Intent on the ACGME document, "The leadership team may include physician and non-physician personal with varying levels of education, training and experience." ADMQ stated, this gave the hospital the authority to allow "anyone on the [name of university training hospital] list" and were "approved to supervise residents", including physician assistants, nurse practitioners and nurse midwives. The list included 49 nurse practitioners, 2 midwives, 2 dieticians, 79 physician assistants, 1 social worker and 103 physicians. This stance was not consistent with [name of university training hospital] Supervision and Accountability, policy approved 5/21/2019. At 3:07 p.m., ADMQ returned and provided an email print-out from Director of OB GYN Residency Program, "CNW has been approved by me as program director to supervise residents." There was no documentation from the Medical staff office, MEC or GB verifying nurse midwives, PAs, RDs, SW or physicians had the authority and privileges to supervise residents.

During a concurrent interview, medical staff record and policy review on 9/10/20, at 2:25 p.m., with MSMGR, MSMGR stated CNW does not hold medical membership and privileges, and does not have privileges to supervise residents, the CNW requires supervision by a physician to provide medical care to patients. MSMGR stated AHP, including nurse midwives are not independent practitioners and require supervision by physician with medical staff membership and privileges. MSMGR stated CNW's do not meet the requirements for medical staff membership and privileges. Medical staff members are physician, podiatrist, clinical psychologist or dentist.

During a concurrent interview and record review on 9/11/20, at 7:23 a.m., with VPMER, VPMER stated, supervising physicians must have an academic [name of university training hospital] appointment and be a member of the medical staff and hold privileges. "[name of university training hospital] Faculty List" was reviewed. The list included physicians and Advance Healthcare Providers (nurse practitioners, physician assistants and nurse midwives. VPMER stated, APH, including midwives are "not describe as having the authority to supervise residents."

During a concurrent interview and record review on 9/11/20, at 9:22 a.m., with R1, R1 stated midwives supervise residents, as the supervising physician and sign their History and Physicals and Progress notes that attesting the resident provided appropriate medical care. After the midwife leaves the hospital, the "attending [physician] assumes the role [for supervision]."

During a review of policy and procedures (P&P) titled, "Bylaws of [City] Hospital and Medical Center, last amended 12/4/2017, Article V President/Chief Executive Officer last amended 12/4/2018... this corporation shall be given the necessary authority and responsibility to operate this Cooperation in all its activities ...and act as the duly authorized representative of the Board. Article VI documented the duties and responsibilities such as review approve medical staff appointment recommendations, review professional education and patient care related activities and policies, ensure compliance with professional, regulatory and accreditation standards and mandates, review and approve amendments to the Rules and Regulations of the medical staff, and review and approve the medical education program."

During a review of P&P titled, "[Hospital name and association] Medical Staff, Medical Staff Bylaws, Volume I, Governance, Structure and Function of the Medical Staff", dated 2/4/20, defined medical staff as "Practitioners (a physician, podiatrist dentist or clinical psychologist) who are appointed to it by the Board." Members are defined as "a Practitioner who has been appointed by the Board to the Medical staff. Documented under section Medical Staff Eligibility and Qualifications for Membership and/or Privileges, Article II indicated applicants wishing to be on the Medical Staff and/or requesting clinical privileges must have an applicable current and unrestricted license to practice in California, have a current unrestricted DEA (prescription drug license) registration, current valid insurance liability insurance, successfully completed an approved residency training program or a residency training program."

During a review of P&P titled, "Medical Education- House Staff/Fellows", dated 1/22/18, the P&P indicated under section II.B, D "supervision of house staff shall be conducted by members of the faculty in individual departments and be in compliance with the requirements as specified by the Accreditation Council for Graduate Medical Education (ACGME) and the program's Residency Review Committee or other accrediting bodies for non-ACGME training programs .... All Faculty Attending Physicians shall have current clinical privileges at the facility they are providing supervision and appropriate to the care of the patient. For patients assigned to a teaching program, the attending physician shall be responsible for the quality of and appropriateness of the care that is provided by house staff. The responsibility of the attending physician for the care to the patient on the teaching service is no different than an attending that is caring for a non-teaching patient ....The patient's medical record shall reflect the attending physician's supervision of the house staff."

Review of Policy and Procedure titled, "Supervision and Accountability", revised 5/20/2019 date 1/22/2018 and next revision date 5/21/2022 documented "each patient must have an identifiable, appropriately-credentialed, and privileged attending physician (or licensed independent practitioner as specified by ACGME Review Committee) who is responsible and accountable for the patient's care.

Based on observation, interview and record review, the hospital failed to provide a well-organized surgical service in accordance with acceptable standards of practice when:

1. MD (Medical Doctor) 1 did not obtain the required informed consent for a tubal ligation (sterilization-surgical procedure requiring patient (Pt) consent, often completed in conjunction with C-section (surgical procedure to remove a baby from the abdomen at time of birth)) procedure for one of 17 patients, (Pt 1), prior to performing a right tubal ligation. (refer to A951 finding 1 and A955)

2. MD 1 did not review Pt 1' s chart and confirm there was a consent for C-sectionprocedure for Pt 1, pre-operatively. MD 1 and obstetric (OB) resident physicians (physicians in training for the specialty of obstetric medicine) practiced in a manner that did not include consistently reviewing the medical record and informed consent for the procedures performed on patients prior to the start of surgery for each patient. (refer to A951 finding 2)

3. Doctor of Osteopathy (DO) was permitted to assist in Pt 53's surgery without verification of privileges (confirmation of the right to practice medicine at this hospital). (refer to A951 finding 3 and A945)

4. Surgical Technician (ST) 1, did not perform operating room aseptic and sterile technique prior to surgical procedure on Pt 53 on 9/8/20. (refer to A951 finding 4)

5. Operating Room (OR) staff did not wear the required OR attire. (refer to A951 finding 5)
6. Two of three sterile surgical instrument trays contained multiple brown discolorations on instruments with flaking and peeling identification markers. (refer to A951 finding 6)

Because of the serious actual harm to Patient 1 and the serious potential harm to all patients undergoing surgical procedures related to physicians and surgeons not reviewing the medical record and following the procedure for informed consent and not following intraoperative procedures meant to protect patient safety, an Immediate Jeopardy (IJ) situation was called under CFR 482.51(b) A951 on 9/4/20 at 4:30 p.m. in the presence of Corporate CNO, Vice President of Quality, Associate Chief Nursing Officer (ACNO), Director of Risk Management (DRM), and Director of Quality Management (DQM). An Action Plan (AP) was submitted to address the need for immediate action and Version 3 of the AP was accepted on 9/7/20 at 9:31 a.m. The hospital implemented elements of the AP including a hard stop for each surgical procedure. The hard stop for each surgical procedure was meant to ensure the protocols and steps were in place to provide informed consent and a review of the medical record for the patient undergoing surgery prior to surgery. MD 1 and OB residents as well as nursing OB staff were in-serviced on the requirements to follow pre-procedural protocols, intraoperative protocols as well documentation needed to verify the medical record of each patient was reviewed prior to surgical procedures to include the consent for surgery. The AP was fully implemented, the need for immediate action was addressed, and the IJ was removed on 9/10/20 at 4:20 p.m., with DRM, DQM, and the ACNO.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and responsible manner.

Based on observation, interview, and record review, the hospital failed to maintain an accurate roster of practitioners with their approved privileges when one of four physicians, Doctor of Osteopathy (DO) 1, was permitted to participate in patient care and the surgical case of Patient (Pt) 53 without first being appointed to the medical staff and having approved privileges.

This failure resulted in Pt 53 receiving a surgical procedure and medical care from a physician whose competency, qualification and status as a physician and surgeon were not verified; and thus, potentially endangering the health and safety of the patient.

Findings:

During a concurrent observation, interview, and review of electronic database on 9/8/20, at 2:25 p.m., in the Labor and Delivery Operating Room (LDOR), with Registered Nurse (RN) 4, DO 1 was assisting the surgeon with a C-section for Pt 53. When asked to determine the privileges of DO 1, RN 4 was unable to verify DO 1 had privileges to practice at this hospital.

During an interview on 9/8/20, at 2:30 p.m., with RN 5, RN 5 stated she was in the LDOR for the express purpose of auditing for compliance in surgical procedures. RN 5 stated individuals who do not have privileges should not participate in surgeries. RN 5 stated the DO should have been asked to leave the OR, but was not asked to leave the OR. At 2:52 p.m., the DO was still in the LDOR and assisting when surgery was completed.

Review of Policy and Procedure (P&P) titled, "Department of Surgery Rules and Regulations (DSRR)," dated 8/9/19, was reviewed. The DSRR indicated, " ...I. Assistants ... 2. Any member of the Department of Surgery with a surgical privilege card on file shall be deemed to have "Surgery Assist" privileges. Members of other Departments requesting surgery assist privileges must meet criteria established by the Department and provide documentation of appropriate professional liability coverage ..."

During an interview on 9/8/20, at 4:55 p.m., with Quality Director (QD), the QD validated that DO 1 is not a surgeon, he finished his Family Practice residency and is here doing a yearlong fellowship in OB connected with University of California San Francisco (UCSF). The QD stated DO 1 started caring for patients at the hospital in August 2020. QD stated DO 1 had not been approved for medical staff membership, was not approved for privileges. QD stated DO 1 was considered a "Junior Faculty" member and should have been approved by the medical staff prior to providing patient care services. The QD validated, DO 1 was not in their electronic database and should have been placed there before being allowed to work with patients. The QD stated, the administration is "working on getting auto-privileges (automatic privileges that the hospital put in their electronic database that state what the DO is qualified to do)" for DO 1. The QD did not provide any documentation for DO 1's education, training, licensure, qualifications or competencies needed to place him on the resident fellow auto-privilege list.

During an interview and record review on 9/10/20, at 2:25 p.m., with the Medical Staff Manager (MSM), the hospitals electronic database (EDB), was reviewed. The EDB indicated that there was no file found for DO 1. The MSM validated DO 1 is not a member of the medical staff nor does he have privileges at the hospital.

During an interview on 9/11/20, at 7:23 a.m., with the Vice President of Medical Education & Research (VPMER), the VPMER stated DO 1 was placed on the auto-privilege resident roster after being brought to their attention yesterday.

During an interview and record review on 9/11/20, at 10:30 a.m., with the Medical Director of Quality (MDQ), the hospitals EDB, was reviewed. The EDB indicated that that DO 1 was now on the resident auto-privilege roster. The MDQ stated DO 1 did not have a medical staff file; DO 1 "just has e-privileges", required for residents and fellows. The MDQ validated that the hospital had no documentation verifying DO 1's education, training, criminal history, licensure, certificates, competency, medical practice or insurance to support DO 1's appointment to the resident and fellow roster.

During a review of facility's policy and procedure (P&P) titled, "Department of Surgery Rules and Regulations," dated 8/9/19, the P&P indicated, " ...V.I. Any members of the Department of with surgical privilege card on file shall be deemed to have 'Surgery Assistant' privileges... Members of other departments requesting surgery assist privileges, must meet criteria established by the department and provide documentation of appropriate professional liability coverage ..."

During a review of [name of hospital corporation] Medical Staff, Medical Staff Bylaws, Volume I, Governance, Structure and Function of the Medical Staff, dated 2/4/20, " ... Medical Staff Eligibility and Qualifications for Membership and/or Privileges ... membership and/or clinical privileges on the Medical Staff are privileges granted to professionally competent physicians, dentist, podiatrists and clinical psychologists. ... applicants wishing to be on the Medical Staff and/or requesting clinical privileges must have an applicable current and unrestricted license to practice in California, have a current unrestricted DEA (Drug Enforcement Agency - prescription drug license) registration, current valid liability insurance, successfully completed an Accreditation Council for Graduate Medical Education (ACGME) or American Osteopathic Association (AOA) approved residency training program or a residency training program accredited by the Royal College of Physicians and Surgeons of Canada ..."

During a review of the facility's P&P titled, "Medical Staff Credentials Policy", dated 4/13/19, the P&P indicated, " ... Credential Subcommittee: A subcommittee of the Board's Professional Affairs and Quality Committee with delegated Board authority to render initial appointment, reappointment and renewal or modification of clinical privileges decisions that meet certain criteria. The applicant must complete a pre-application form to determine his/her eligible for membership and/or privileges. If the new applicant meets [hospital corporation] qualification then an application shall be sent via mail or electronically ... any individual, facility or entity must notify the MSO [Medical Staff Office] in writing of an applicant that will need membership and/or privileges to practice.
The applicant's responsibility and burden to produce the needed documents. Notification of applicant to Medical Staff Office, qualifications for membership and/or privileges is delineated in the Medical Staff bylaws. If the application meets the criteria, the MEC [Medical Executive Committee] shall recommend appointment. The credential Subcommittee shall review the application and make the final decision ..."

Based on observation, interview, and record review, the hospital failed to ensure the achievement and maintenance of high standards of medical practice and patient care in accordance with the hospital's policies and procedures and/or acceptable standards of practice for all surgical patients from 8/12/20 to 9/10/20 when:

1. MD 1 did not obtain the required informed consent for a tubal ligation (sterilization surgical procedure requiring patient consent, often completed in conjunction with a Cesarean section (C-section-surgical procedure to remove a baby from the abdomen at time of birth)) procedure for one of 5 patients (Pt 1) on 8/12/20 prior to performing Pt 1's right tubal ligation.

2. MD 1 did not review one of 5 patient charts (Pt 1's) on 8/12/20 and confirm there was a consent for a C-section procedure for Pt 1, pre operatively (before surgery). Multiple MD's and obstetrics (OB) resident physicians (physicians in training for the specialty of obstetric medicine) practiced in a manner that did not include consistently reviewing the medical record, informed consent for the procedures performed, nor write pre-procedure notes on five of 17 C-section patients (Pt's 1, 2, 3, 59, & 61) prior to the start of surgery.

3. Doctor of Osteopathy (DO-doctor that emphasizes on physical manipulation of muscle and bones) 1, was permitted to assist in one of 4 scheduled OB surgeries for 9/8/20 (Pt 53's), without verification of privileges (confirmation of the right to practice medicine at this hospital).

4. Surgical Technicians (ST- person who sets up the instruments for surgery and hands them to the surgeon) 1 & 2 did not perform operating room (OR) aseptic and sterile technique (proper hand hygiene/washing) for two out of 6 sampled OR patients (Pt 53 & Pt 56).

5. Operating Room (OR) staff did not wear the required OR attire for one of 6 sampled OR patients (Pt 53).

6. Two of three sterile surgical instrument trays contained multiple brown discolorations on instruments with flaking and peeling identification markers.

These failures resulted in a sterilization procedure to Pt 1 without informed consent, subsequent emotional and psychosocial distress and injury; had the potential to cause harm to Pt's 1, 2, 3, 53, 56, 59, 61, & 68 and the potential for transmission of infectious germs to all surgical patients.

Because of the serious actual harm to Patient 1 and the serious potential harm to all patients undergoing surgical procedures related to physicians and surgeons not reviewing the medical record and following the procedure for informed consent and not following intraoperative (during surgery) procedures meant to protect patient safety, an Immediate Jeopardy (IJ) situation was called under CFR 482.51(b) A951 on 9/4/20 at 4:30 p.m. in the presence of Corporate CNO, VP of Quality, Associate Chief Nursing Officer (ACNO), Director of Risk Management (DRM), and Director of Quality Management (DQM). An Action Plan (AP) was submitted to address the need for immediate action and Version 3 of the AP was accepted on 9/7/20 at 9:31 a.m. The hospital implemented elements of the AP including a hard stop for each surgical procedure. The hard stop for each surgical procedure was meant to ensure the protocols and steps were in place to provide informed consent and a review of the medical record for the patient undergoing surgery prior to surgery. MD 1 and all other attending's on OB, OB residents as well as nursing
OB staff were in serviced on the requirements to follow pre procedural protocols, intraoperative protocols as well documentation needed to verify the medical record of each patient was reviewed prior to surgical procedures to include the consent for surgery. The AP was fully implemented, the need for immediate action was addressed, and the IJ was removed on 9/10/20 at 4:20 p.m., with DRM, DQM, and the ACNO.

Findings:

1. During a review of Pt 1's Electronic Medical Records (EMR), the "History and Physical (H&P)", dated 8/12/20, the H&P indicated Pt 1 was admitted on 8/12/20 for preterm labor (labor that starts before 37 weeks of pregnancy). This was the second pregnancy for Pt 1 and her previous child was delivered by C-section. Pt 1 was assessed to require a repeat C-section, due to her last meal being at 11 a.m., surgery was scheduled for 6-8 hours later on 8/12/20. Pt 1's "Operative Report," dated 8/12/20, indicated she entered the OR at 7:23 p.m. and the surgery started at 7:40 p.m. The "Operative Report," dated 8/12/20, indicated the C-section for Pt 1 was performed without difficulty and the DO 1 wrote the report and it was cosigned by MD 1, it indicated "The right fimbriae [tube]was transected after miscommunication between patient consent and patient verbal consent wanting tubal. After discussion post fimbriaectomy [tubal ligation- a surgical procedure for female sterilization which involves severing and tying the fallopian tubes] patient declined tubal and so there fore left tubal was not transacted and patient made aware."


During an interview on 8/31/20, at 1:22 p.m., with ST 3, ST 3 stated she was the surgical technician for Pt 1's C-section. ST 3 stated she was present
for the timeout (an immediate pause by the entire surgical team to confirm the correct patient, procedure, and site) and the procedure was for C-section,
there was no mention of a tubal ligation during the timeout. ST 3 stated after the baby was delivered, she heard R 1 say "we aren't going to have time
for this patient's tubal." ST 3 stated she then heard RN 1 say "we do not have consent for a tubal."

During an interview on 8/31/20, at 3:45 p.m., with Resident 1(R physician in training), R 1 stated he did not look at Pt 1's consent for
surgery prior to surgery. R 1 stated he received report from the off going shift and was informed that Pt 1 was getting a C-section. R 1 stated
he assisted in Pt 1's C-section, and after the baby was delivered the charge nurse (night supervisor NS 1) came to the door of the OR and
stated there was an emergent patient needing a C-section. R 1 stated, "I made a human error and I think I was getting confused with the next
patient." R 1 stated he did not obtain informed consent for a tubal ligation for Pt 1. R 1 explained that during the C-section while Pt 1 was on
the OR surgical table he asked Pt 1 if she wanted her 'tubes cut'. R 1 stated he did not define or explain 'tubes cut' because he did not have
time.

During an interview on 9/3/20, at 5:45 p.m., with Pt 1, Pt 1 stated, "they [MD 1 and R 1] did her C-section and they tied [surgically
removed] one of her tubes in error." Pt 1 stated she did not give her consent for the tubal procedure and at no time had MD 1, R 1, or any
other medical professional discussed the tubal (permanent sterilization) procedure prior to performing the surgery. Pt 1 stated she worries and
was constantly sad because the surgical tubal procedure performed by MD 1 and R 1 may affect her chances of having another baby. Pt 1
stated it has affected her sleep pattern; she is sleeping less.

During an interview on 9/3/20, at 6 p.m., with Pt 1's husband, the husband stated, MD 1 and R 1 did not discuss surgery consent with Pt 1,
nor did Pt 1 sign consent for a tubal ligation. Pt 1's husband stated she was just supposed to have a C-section and they cut one tube before
asking them for consent, and the reason they asked was because they were "unsure of what they were doing." Pt 1's husband stated, "they
should not be trying to get consent while my wife was under sedation ... I am sad and still upset with the doctors for their mistake." Pt 1's
husband stated, "we do plan on having more children but am worried this may not be possible."

During an interview on 9/4/20, at 9:13 a.m., with MD 1, MD 1 stated, he was the primary surgeon for Pt 1's C-section and that he did not
review Pt 1's chart nor her surgery consent prior to entering the operating room. MD 1 stated, the consent in the OR read "C-section repeat"
and there was nothing written about a tubal ligation. MD 1 stated, after the baby was delivered the charge nurse (NS 1) came to the door and
informed them of an emergent C-section being placed in the next OR. MD 1 stated Pt 1 was still on the table and surgical incision was still
open and R 1 stated "this patient won't have time for her tubal." MD 1 stated he clarified with R 1 that Pt 1 wanted a tubal and then he
leaned over the drape and asked Pt 1 if she wanted her tubes cut in Spanish her primary language. MD 1 stated he did not explain or define
what 'tubes cut' meant.

During an interview on 9/4/20, at 9:20 a.m., with MD 1, MD 1 stated, a tubal ligation requires a separate consent called a PM 330 (Form
needed by Medi Cal for consent for sterilization). MD 1 stated this consent was not in the operating room during Pt 1's surgery. MD 1
stated, a copy of all consents should be in the operating room during surgery.

During an interview on 9/4/20, at 12:20 p.m., with the Director of Residents (DOR) from the University of (State, City), the DOR stated, after
receiving report from the off going staff the oncoming doctors should go and introduce themselves to the patients and review their charts. The DOR
validated the informed consent for surgery should be done at this time before going into the OR. The DOR stated the residents should be reviewing
their patient's charts and confirming the informed consent with the patients before going into the OR. The DOR stated the PM330 should be
reviewed and signed by the surgeon prior to entering the OR and should be in the OR during the surgery, if the form is not in the OR and the
mention of a tubal comes up there should be a hard stop (surgery is stopped) to confirm, if there is no consent we would not proceed with the procedure.

During an interview on 9/10/20, at 8:14 a.m., with the President of Medical Staff (PMS), the PMS stated, "Unless there is a life or death
situation the resident or faculty should do a short H&P with the patient and review consent before the surgical procedure... we do this to
prevent errors from happening." PMS stated the only time a timeout should not be done is in a life and death situation.

During a review of the hospital's policy and procedure (P&P) titled, "Consents", dated 6/21/17, the P&P indicated, "The physician has the
legal and ethical duty to obtain the patient's informed consent... The treating physician shall furnish the patient, or the person responsible for
the decision making of the patient, with sufficient information to make an intelligent, informed choice of whether or not to undergo the
procedure."

Review of the hospitals P&P titled, "Universal Protocol (UP)", dated 12/8/16, the UP indicated. " ...II.A. Universal Protocol must be followed
on all procedures that require informed consent. This includes all invasive/ operative procedure ... Section III ... verification of the correct
person, site, and procedure occurs... before the patient enters the procedure room... the patient awake and aware..." The UP indicated,
verification process occurs anytime the responsibility of care of the patient is transferred to another member of the procedural team. The UP
indicated, the timeout occurs "immediately before start of the procedure, verify and document all elements of the timeout ..."

2. During an interview on 8/31/2020, at 3 p.m., with R 2, R 2 stated she was a resident who helped to assist during Pt 1's C-section. R 2
stated, prior to Pt 1 surgical procedure, she did not read Pt 1's chart, consent, labs, or discuss the procedure and consents or medical history
with Pt 1, nor MD 1, nor the supervising physician. R 2 stated the expectation is that the residents will review the patient's chart, medical
history, labs, and discuss the procedure and consents with the patient before assisting with the patient's surgery. There was no documentation
in Pt 1's records by R 2 to indicate that a pre procedure evaluation was completed.

During an interview on 8/31/20, at 3:45 p.m., with R 1, R 1 stated that he was the assistant surgeon for Pt 1's C-section. R 1 stated he did not
review Pt 1's medical records or determine if Pt 1 had signed a consent for sterilization prior to entering the OR to perform Pt 1's C-section
surgery. R 1 stated he should have had a discussion with Pt 1 about the C-section, that included the risks, benefits, and alternatives. R 1
stated he should have obtained Pt 1's consent for the procedure prior to entering the OR to perform the C-section and surgical sterilization
procedures.

During an interview on 9/4/2020, at 9:15 a.m., with MD 1, MD 1 stated he did not meet with Pt 1, write a pre procedure note, review the
consent, nor read the chart before entering the OR. MD 1 stated, he did not discuss or review the patient's history and physical and consents
with the residents prior to Pt 1's surgery. MD 1 stated he had a "conversation" with Pt 1 while Anesthesiologist (ANES) 1 was performing the
spinal (pain medication inserted in the spine for the C section). MD 1 stated he did not explain the procedure further nor discuss the risk,
benefits and alternatives, and did not discuss Pt 1's medical history and exam with Pt 1 prior to surgery.

During a concurrent interview and record review, on 9/2/20, at 9:50 a.m., with RN 6, the EMR for Pt 3 & Pt 61, were reviewed. RN 6 validated
there were no written pre procedure notes or informed consent discussions documented by the primary surgeon and/or resident before entering the
operating rooms for Pt 3 & Pt 61.

During a concurrent interview and record review, on 9/2/20, at 10 a.m., with RN 7, the EMRs for Pt 1 & Pt 2, were reviewed. RN 7 validated
there were no written pre procedure notes or informed consent discussions documented by the primary surgeon and/or resident before
entering the operating rooms for Pt 1 & Pt 2.

During a concurrent interview and record review, on 9/8/20, at 9:31 a.m., with RN 7, the EMR for Pt 59, was reviewed. RN 7 validated that
there was no written pre procedure note or informed consent discussion by the primary surgeon and/or resident before entering the operating
room for Pt 59.

Review of the hospitals P&P titled, "Medical Record Electronic Health Record (MREHR)", dated 9/12/18, was reviewed. The MREHR
indicated all pre operative or pre procedure history and physicals (H&P) must have documented the indication, alternatives, benefits and
risks, were all discussed with the patient ... pre operative history and physical may be performed by the surgeon, anesthesiologist or
practitioner or APP (within the scope of practice such as NP's and PA's). The surgeon must review and co sign for any APP performing the
H&P prior to commencement of surgery. The MREHR indicated interval updates [pre-procedure notes] to the H&P are to be completed prior to scheduled


cases/procedures, "the following must be physically present in the medical record prior to the start of the procedure except in an emergency
... History and Physical, Diagnostic tests ... pre operative anesthesia evaluation ... verification of consent ... informed consent ... informed
consent for anesthesia."

Review of the hospitals P&P titled, "Universal Protocol (UP)", dated 12/8/16, the UP indicated. " ...II.A. Universal Protocol must be followed
on all procedures that require informed consent. This includes all invasive/ operative procedure ... Section III ... verification of the correct
person, site, and procedure occurs ... before the patient enters the procedure room ... the patient awake and aware ..." The UP indicated,
verification process occurs anytime the responsibility of care of the patient is transferred to another member of the procedural team. The UP
indicated, the timeout occurs "immediately before start of the procedure, verify and document all elements of the timeout ..."

3. During a concurrent observation, interview, and review of electronic database on 9/8/20, at 2:25 p.m., in the Labor and Delivery Operating
Room (LDOR), with RN 4, DO 1 was assisting the surgeon with a C-section. RN 4 was unable to verify that the DO 1 had privileges to
practice at this hospital.

During a concurrent observation and interview on 9/8/20, at 2:30 p.m., in the LDOR, with RN 5, RN 5 stated she was in the LDOR for the express
purpose of auditing for compliance in surgical procedures (job was to make sure surgery procedures were being followed). RN 5 stated individuals
who do not have privileges should not participate in surgeries, DO 1 should have been asked to leave the OR. At 2:52 p.m., DO 1 was still in the
LDOR and assisting when surgery was completed.

During an interview on 9/8/20, at 4:55 p.m., with the Quality Director (QD), the QD stated once DO 1 was identified as not having
privileges they should have asked him to leave the OR. The QD stated, "I spoke with [DO 1] and told him since he was not in the EPRIV
[the electronic database the hospital uses to look up privileges for residents and fellows] he needed to go home. He will see no other patients
until this has been fixed."

Review of Policy and Procedure (P&P) titled, "Department of Surgery Rules and Regulations (DSRR)," dated 8/9/19, was reviewed. The
DSRR indicated, " ...I. Assistants ... 2. Any member of the Department of Surgery with a surgical privilege card on file shall be deemed to
have "Surgery Assist" privileges. Members of other Departments requesting surgery assist privileges must meet criteria established by the
Department and provide documentation of appropriate professional liability coverage ..."

4. During an observation on 9/8/20, at 2:01 p.m., in the LDOR, ST 1 did not perform hand hygiene after removing gloves and donning sterile
gloves to assist with the C-section on Pt 53.

During an observation on 9/9/20, at 10:30 a.m., in the LDOR for Pt 56, ST 2 was observed picking up sutures from the ground, discarding them, and
going back to open another suture to place on a sterile field without first washing her hands.

During an interview on 9/9/20, at 11:35 a.m., with the Supervisor of Obstetrics (SO) 1, the SO 1 stated, ST 2 should have washed her hands
before opening up any further sutures onto the sterile field.

During a review of the facility's policy and procedure (P&P) titled, "Hand Hygiene", dated 8/24/2018, the P&P indicated, "...III POLICY A.
Hand hygiene is the single most important means of preventing the spread of infection ...IV. PROCEDURE ...b. Specific indications for
hand hygiene ...v. Before donning sterile gloves ...viii. After removing gloves ..."

5. During an observation on 9/8/20, at 2:01 p.m., in the LDOR, the Certified Registered Nurse Anesthetist (CRNA- certified to give anesthesia) 1 and
ST 1 were not wearing shoe coverings in the OR during a C-section procedure for Pt 53 and CRNA 1's hair was exposed with the lower back half
showing below the head covering.

During an interview on 9/10/20, at 7:55 a.m., with ST 1, ST 1 stated the proper OR attire is hospital issued scrubs, goggles, mask, shoe
covers, and hair coverings that cover all hair and ears.

During an interview on 9/10/20, at 10:06 a.m., with circulating Registered Nurse (RN) 8, RN 8 stated the required OR attire to be worn,
is hospital issue surgical scrubs, blue jacket, hair bonnet, surgical mask, and shoe covers.

During a review of the facility's P&P titled, "OR Surgical Attire and Restrictions", dated 10/18/18, the P&P indicated, "... III. POLICY A. All
persons who enter the restricted... of the operating room must wear clean... and other protective coverings. 2. Head... i. All personnel are to
cover/confine, head... restricted areas... d. Shoe covers..."

6. During a concurrent observation and interview on 9/1/20, at 10:30 a.m., with the Director of the Sterile Processing Department (SPD Dir),
and two Supervisors of Sterile Processing Department (SPD Sup 1 and SPD Sup 2), three sterilization containers filled with various cleaned
and sterilized surgical instruments were opened and inspected. The following was observed:

Tray 2 contained 77 instruments. Fourteen of the 77 instruments had identification tape partially peeled off and/or not wrapped securely
around the instrument. SPD Sup 1 stated the expectation is there would be zero instruments where the tape was not wrapped securely or was
partially peeled off. SPD Sup 1 stated tray 2 was not acceptable, and the instruments should not have been in the tray.

Tray 3 contained 43 instruments. Four of the instruments had brown stains. One instrument had plastic like substance used as an
identification marking. The plastic like substance was flaking and coming off on the handle. SPD Sup 2 inspected the identification


markings on the handle and stated, "this is flaking." SPD Sup 2 inspected the brown stains on the four instruments and stated, "This is rust."

During a concurrent interview with Sterile Processing Technician (SPT) and Sterile Processing Technician Lead (SPDL) on 9/3/20, at 3:50
p.m., the SPT stated she inspects instruments when she cleans, and if she notices any defects, she places the instrument in a separate bin, the
repair bin. The SPT stated she inspects to see if the instrument was completely cleaned, and if there was tape on it she inspects to see if the
tape was cracked or damaged. The SPT stated the tape must be wrapped 1½ times around the instrument. The SPDL stated if the tape was
not secured 1½ times around the instrument it was put in the repair bin. The SPDL stated a piece of tape stuck to an instrument without
being wrapped around 1½ times was unacceptable and should go into the repair bin, and "if it isn't wrapped, send it back." SPT stated if
there was any discoloration or rust on the instruments, they must go into the repair bin because of the risk of infection. SPDL 2 stated, "rust
and loose tape are a significant source of infection a high risk for infection."

During an interview on 9/3/20 at 2 p.m., the Director of Quality provided the Manufacturer's Instructions for Use (IFU) for the identification
tape and stated, "We don't have a policy, this is what we use." The manufacturer's IFU's for Identification Tape dated 6/18 indicated, "...5.
Wrap tape 1.5 times on a stainless steel instrument..." and " ...INSPECTION: ... identification tape is not intended as a permanent mark and
will discolor, break, chip or flake over time. Replace as soon as these are noticed..."

A review of AAMI (Association for the Advancement of Medical Instrumentation an organization for advancing the development, and safe
and effective use of medical technology), "Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities",
CDC (Centers for Disease Control) Guidelines, and AORN (Association of perioperative Registered Nurses leaders in advocating for
excellence in perioperative [during the course of an operation] practice and healthcare) guidelines, their recommendations, indicated the
following: "Instruments should undergo an inspection for proper function and cleanliness. 1. Instruments should be inspected for a)
cleanliness b) proper functioning and alignment, corrosion, pitting, burrs, nick, and cracks, sharpness of cutting edges c) any other defects...
2. Instruments in disrepair should be labeled and taken out of service until properly repaired or replaced ..." "Standards and Recommended
Practice, Safe Handling and Biological Decontamination of Medical Devices in Heath Care Facilities and in Non Clinical Settings,
ANSI/AAMI ST 35:2003, keeping in mind this process is in two steps: 1. Complete cleaning and 2. Washing and Sterilization."

Based on interview and record review the facility failed to ensure implementation of their informed consent policy and procedure for surgical services when the attending surgeon and the resident surgeon did not obtain informed consent from Patient (Pt) 1 prior to performing a surgical sterilization procedure.

This failure resulted in the surgical removal of Pt 1's right fallopian tube (tube in the female reproductive system that carries a human egg to the uterus) and partial sterilization without Pt 1's or her representative's informed consent.

Findings:

During a review of Pt 1's Electronic Medical Records (EMR)), dated 8/12/20, the EMR indicated Pt 1 was admitted on 8/12/20 for preterm labor. This was the second pregnancy for Pt 1 and her previous child was delivered by C-section (surgical procedure to remove a baby from the abdomen at time of birth). Pt 1 was assessed to require a repeat C-section, due to her last meal being at 11 a.m., surgery was scheduled for 6-8 hours later on 8/12/20. Pt 1's EMR indicated she entered the OR at 7:23 p.m. and the surgery started at 7:40 p.m. The EMR indicated the C-section was performed without difficulty and the operative report by Doctor of Osteopathy (DO) 1 cosigned by Medical Doctor (MD) 1 indicated "The right fimbriae [tube]was transected after miscommunication between patient consent and patient verbal consent wanting tubal. After discussion post fimbriaectomy [tubal ligation] patient declined tubal and so there fore left tubal was not transacted and patient made aware."

During an interview on 8/31/20, at 1:22 p.m., with Surgical Technician (ST) 3, ST 3 stated she was the surgical technician for Pt 1's C-section. ST 3 stated she was present for the timeout and the procedure was for C-section, there was no mention of a tubal ligation during the timeout. ST 3 stated after the baby was delivered, she heard R 1 (Resident -physician in training), say "we aren't going to have time for this patient's tubal." ST 3 stated she then heard RN 1 say "we do not have consent for a tubal."

During an interview on 8/31/20, at 3:45 p.m., with R 1 stated he did not look at Pt 1' s consent for surgery prior to surgery. R 1 stated he received report from the off going shift and was informed that Pt 1 was getting a C-section. R 1 stated he assisted in Pt 1' s C-section, and after the baby was delivered the charge nurse (night supervisor -NS 1) came to the door of the OR and stated there was an emergent patient needing a C-section. R 1 stated, "I made a human error and I think I was getting confused with the next patient." R 1 stated he did not obtain informed consent for a tubal ligation for Pt 1. R 1 explained that during the C-section while Pt 1 was on the OR surgical table he asked Pt 1 if she wanted her 'tubes cut'. R 1 stated he did not define or explain 'tubes cut' because he did not have time.

During an interview on 9/3/20, at 5:45 p.m., with Pt 1, Pt 1 stated, "they [MD 1 and R 1] did her C-section and they tied [surgically removed] one of her tubes in error." Pt 1 stated she did not give her consent for the tubal procedure and at no time had MD 1, R 1, or any other medical professional discussed the tubal (permanent sterilization) procedure prior to performing the surgery. Pt 1 stated she worries and was constantly sad because the surgical tubal procedure performed by MD 1 and R 1 may affect her chances of having another baby. Pt 1 stated it has affected her sleep pattern; she is sleeping less.

During an interview on 9/3/20, at 6 p.m., with Pt 1's husband, the husband stated, MD 1 and R 1 did not discuss surgery consent with Pt 1, nor did Pt 1 sign consent for a tubal ligation. Pt 1's husband stated she was just supposed to have a C-section and they cut one tube before asking them for consent, and the reason they asked was because they were "unsure of what they were doing." Pt 1's husband stated, "they should not be trying to get consent while my wife was under sedation ... I am sad and still upset with the doctors for their mistake." Pt 1's husband stated, "we do plan on having more children but am worried this may not be possible."

During an interview on 9/4/20, at 9:13 a.m., with MD 1, MD 1 stated, he was the primary surgeon for Pt 1' s C-section and that he did not review Pt 1' s chart nor her surgery consent prior to entering the operating room. MD 1 stated, the consent in the OR read "C-section repeat" and there was nothing written about a tubal ligation. MD 1 stated, after the baby was delivered the charge nurse (NS 1) came to the door and informed them of an emergent C-section being placed in the next OR. MD 1 stated Pt 1 was still on the table and surgical incision was still open and R 1 stated "this patient won't have time for her tubal." MD 1 stated he clarified with R 1 that Pt 1 wanted a tubal and then he leaned over the drape and asked Pt 1 if she wanted her tubes cut in Spanish her primary language. MD 1 stated he did not explain or define what 'tubes cut' meant.

During an interview on 9/4/20, at 9:20 a.m., with MD 1, MD 1 stated, a tubal ligation requires a separate consent called a PM 330 (Form needed by Medi-Cal for consent for sterilization). MD 1 stated this consent was not in the operating room during Pt 1' s surgery. MD 1 stated, a copy of all consents should be in the operating room during surgery.

During an interview on 9/4/20, at 12:20 p.m., with the Director of Residents (DOR) from [medical school], the DOR stated, after receiving report from the off going staff the oncoming doctors should go and introduce themselves to the patients and review their charts. The DOR validated the informed consent for surgery should be done at this time before going into the OR. The DOR stated the residents should be reviewing their patient's charts and confirming the informed consent with the patients before going into the OR. The DOR stated the PM330 should be reviewed and signed by the surgeon prior to entering the OR and should be in the OR during the surgery, if the form is not in the OR and the mention of a tubal comes up there should be a hard stop to confirm, if there is no consent we would not proceed with the procedure.

During an interview on 9/10/20, at 8:14 a.m., with the President of Medical Staff (PMS), the PMS stated, "Unless there is a life or death situation the resident or faculty should do a short History and Physical with the patient and review consent before the surgical procedure. ...we do this to prevent errors from happening." PMS stated the only time a timeout should not be done is in a life and death situation.

During a review of the hospital's policy and procedure (P&P) titled, "Consents," dated 6/21/17, indicated, " ...I. Purpose ...A. To describe the principles of consent, protect the rights of patients ...B. To clarify the responsibilities of the hospital for consent to services and verification of informed consent ...III. Policy ...A ...1. [Hospital] is responsible for obtaining the patient's or legal representative's consent for hospital services or activities ...D. Informed Consent for Surgery or Special Diagnostic and Therapeutic Procedures 1. The physician has the legal and ethical duty to obtain the patient's informed consent, or the informed consent of the patient's legal representative, for medical treatment, or for procedures which have been determined to be invasive and/or complex in nature ...a ...iv. The treating physician is responsible for providing the patient or patient's surrogate decision-maker with the information that is necessary to allow an informed decision to be made ..."

Review of the hospitals P&P titled, "Universal Protocol (UP)", dated 12/8/16, the UP indicated. " ...II.A. Universal Protocol must be followed on all procedures that require informed consent. This includes all invasive/ operative procedure ... Section III ... verification of the correct person, site, and procedure occurs ... before the patient enters the procedure room ... the patient awake and aware ..." The UP indicated, verification process occurs anytime the responsibility of care of the patient is transferred to another member of the procedural team. The UP indicated, the timeout occurs "immediately before start of the procedure, verify and document all elements of the timeout ..."

Based on observation, interview and record review, the hospital failed to provide anesthesia services for 2 of 2 in a well-organized manner in when:

1. Anesthesiologist 1 (ANES - a doctor that provides pain control and puts patients to sleep for surgeries) did not transfer the care of patient (Pt) 1 on 8/12/2020 to another qualified anesthesia provider before leaving the operating room (OR) to administer anesthesia to another patient in another OR. (Refer to A1001)

2. Anesthesiologist 1 did not participate in 2 of 3 operative time-outs for Pt 1 and contributed to intra-operative procedure errors on 8/12/20. (Refer to A1002 finding 1)

3. Certified nurse anesthetist (CRNA, a nurse who can provide anesthesia to patients undergoing surgery), CRNA 1, did not perform hand hygiene, maintain aseptic and sterile technique, and did not wear proper operating room attire while administering spinal anesthesia for Pt 53 on 9/8/20. (Refer to A1002, finding 2)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and responsible manner.


42321


Based on observation, interview and record review, the hospital failed to provide anesthesia services in a well-organized manner when:

1. Anesthesiologist 1 (AN - a doctor that provides pain control and puts patients to sleep for surgeries) did not transfer the care of Pt 1 on 8/12/2020 to another qualified anesthesia provider before leaving the operating room (OR) to administer anesthesia to another patient in another OR. (refer to A1001)

2. Anesthesiologist (ANES- a doctor that provides pain control and puts patients to sleep for surgeries) 1 did not participate in 2 of 3 operative time-outs for Pt 1 and contributed to intra-operative procedure errors on 8/12/20. (refer to A1002 finding 1)

3. Certified nurse anesthetist (CRNA, a nurse who can provide anesthesia to patients undergoing surgery), CRNA 1, did not perform hand hygiene, maintain aseptic and sterile technique, and did not wear proper operating room attire while administering spinal anesthesia for Pt 53 on 9/8/20. (refer to A1002, finding 2)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and responsible manner.

Based on interview and record review, for one patient (Pt 1) of two patients the hospital failed to ensure a qualified anesthesia provider gave continuous anesthesia care for the duration of an operative procedure when:

1. Anesthesiologist 1 (ANES - a doctor that provides pain control and puts patients to sleep for surgeries) did not transfer the care of Pt 1 on 8/12/2020 to another qualified anesthesia provider before leaving the operating room (OR) to administer anesthesia to another patient in another OR.

This failure resulted in patient anesthesia care and monitoring under the responsibility by unqualified operating room staff and physician without anesthesia experience or privileges and could have led to potential harm to Pt 1.


Findings:

During interview on 9/2/2020 at 9:10 a.m. with ANES 1, ANES 1 stated Pt 1 was scheduled for a Cesarean section (C-section: a surgery where an incision is made in the mother's abdomen to deliver a baby) and he was the anesthesiologist. ANES 1 stated, during the surgery, the OR staff member announced he was needed for a procedure in another operating room. ANES 1 stated he had to "balance risks to benefits" of abandoning one patient for another. ANES 1 stated, Pt 1 was "stable", and the on call anesthesiologist and/or CRNA (certified nurse anesthetist, a nurse who can provide anesthesia to patients undergoing surgery) would take 10 to 30 minutes to arrive and help. Before another qualified anesthesia provider arrived in the OR to assume the care of Pt 1, ANES 1 decided to leave Pt 1 while she was "still on the [surgery] table in the OR" and under his anesthesia care. ANES 1 explained he did not return to OR 1 and resume the anesthesia care for Pt 1. He stated, ANES 2, an anesthesiologist, would "take over". ANES 1 stated, the anesthesiologist "should never leave a patient" during continuous anesthesia.

During interview on 9/2/2020 at 12:10 p.m. with ANES 2, ANES 2, an anesthesiologist, stated he was called to help with PT 1's C-section case. ANES 2 stated when he arrived the surgeon was sewing the abdomen skin closed and a "nurse was at the head of the bed ...trying to comfort the patient ...anesthesiologist [ANES 1] was not there". ANES 2 stated the anesthesiologist's "primary responsibility is to the patient in the OR" under continuous anesthesia.

During an interview and concurrent document review on 9/3/2020 at 2:00 p.m. with Director of Risk Management (DRM), DRM stated the hospital follows American Society of Anesthesiologists Guidelines (ASA) for care of patients and provided a copy of "Standards for Basic Anesthetic Monitoring" from the ASA.

During interview on 9/4/2020 at 9:15 a.m. with MD 1, MD 1 stated he was the OBGYN (Obstetrics (OB) and gynecology (GYN), medical specialty and physicians who care for women's health and pregnancy) surgeon for Pt 1's C-section. MD 1 stated, "I am not an anesthesiologist". "[ANES 1] left the room ... didn't inform the surgical team ...at very least tell me ...and not assume I would perform anesthesia ...if anesthesia had to leave, call in resources, call back-up system ...I did not know he [ANES 1] left, until I saw a different anesthesiologist, [ANES 2]".

Review of Policy and Procedure (P&P) titled, American Society of Anesthesiologists, Standards for Basic Anesthetic Monitoring, guidelines advised, "qualified anesthesia personnel shall be present in the room throughout the conduct of all general anesthetics, regional anesthetics and monitored anesthesia care ...Because of the rapid changes in patient status during anesthesia, qualified anesthesia personnel shall be continuously present to monitor the patient and provide anesthesia care ...Note that 'continuous' means 'prolonged without interruption at any time". The ASA guidelines indicated, this "requirement may not be waived".

Review of Policy and Procedure (P&P) titled, #24967 , "Physician Coverage and Response Responsibilities", effective date 10/10/2019 and next review date 10/9/2022 section II.A.2 documented, "if a physician is unable to provide care for his or her patients, then the physician must provide coverage through another qualified approximately credentialed physician. The covering physician must be available and qualified to assume responsibility for the patient during the entirety of the attending's absence".

Review of Policy and Procedure (P&P) titled, #12053, "Universal Protocol", effective date 12/8/2016 and next review date 12/20/2020 documented under section III, time-out and consent "verification process occurs anytime the responsibility for care of the patient is transferred to another member of the procedural care team. Time-out occurs "immediately before start of the procedure, verify and document all elements of the time Out".

Based on observation, interview and record review, anesthesia failed to ensure 2 of 2 anesthesia providers followed the requirements for preoperative anesthesia according to policy and procedures (P&P), and standards of practice when:

1. Anesthesiologist (ANES- a doctor that provides pain control and puts patients to sleep for surgeries) 1 did not participate in one of two operative time-outs for patient (Pt) 1, the second time-out which occurred during the surgery, and contributed to intra-operative procedure errors on 8/12/20.

2. Certified Registered Nurse Anesthetist (CRNA, a nurse who can provide anesthesia to patients undergoing surgery), CRNA 1, did not perform hand hygiene, maintain aseptic and sterile technique, and did not wear proper operating room attire while administering spinal anesthesia for Pt 53 on 9/8/20.

These failures resulted in:

1. Pt 1 receiving a procedure she did not want or consent to.
2. Potential risk of post-procedure infections for Pt 53.

Findings:

1. During interview 9/1/20, at 10:05 a.m., with Registered Nurse (RN) 1 (operating room circulating nurse), RN 1 stated the operating circulator initiates the timeout and "everyone" is required to participate, this includes anesthesia, nurses, surgeon, residents (physician in training), and operating room (OR) scrub tech. RN 1 stated, Pt 1 did not have a consent for a tubal ligation (a sterilization surgery, so a woman cannot get pregnant) and "knew for a fact", that Pt 1 did not want a tubal ligation, she had spoken with Pt 1 before the procedure. RN 1 stated, the surgery is supposed to "stop" if the patient did not consent for a procedure.

During interview 9/1/20, at 12:33 p.m., with Resident 4, Resident (R) 4 stated the timeout process requires everyone who is part of the OR team to participate and agree that the procedure is correct. R 4 stated if there is a disagreement or inconsistencies with the consent, everyone on the team must stop, pause, and clarify.

During an interview on 9/2/20, at 9:10 a.m., with ANES 1, ANES 1 stated anesthesia is required to participate in surgical timeouts. ANES 1 stated he participated in the required timeout with the OR team before the case started. ANES 1 stated he left the OR when Pt 1 was "still on the [surgical] table in OR" for a separate surgery and was not present for the intra-operative discussion regarding the tubal ligation, the missing consent, and subsequent removal the Pt 1's right fallopian tube (tube that connects ovary to uterus). ANES 1 stated if there were any "inconsistencies" he would "speak-up" and another timeout should occur.

During an interview on 9/4/20, at 9:15 a.m., with Medical Doctor (MD) 1, MD 1 explained after the baby was delivered, he "paused" and asked Pt 1 in Spanish do you "want tubes tied" and "both (husband and patient) said yes". MD 1 stated "ANES 1 left the room ... didn't inform the surgical team" that he was leaving, and recalled at the end of the surgery, a different anesthesiologist entered the OR during skin suturing. MD 1 stated he did not write a note regarding the discussion about the tubal ligation, missing consent, the "pause", or the failure to complete a second timeout.

During an interview on 9/8/20, at 4:55 p.m., with the Quality Director (QD), the QD stated the timeouts are a "critical part of a surgery", and the anesthesiologist is a part of the surgical team. The QD stated, timeouts need to be completed for every procedure according to hospital policy and procedures.

During an interview on 9/10/20, at 1:10 p.m., with the Governing Body (GB) in attendance with Chief Operating Officer-CRMC (COO), Director of Quality Management, Medical Director of Quality (MDQ), Quality Director (QD), Director of Risk Management (DRM), Quality Manager, Chief Nursing Officer, President of Medical Staff (PMS), Assistant Chief Operating Officer, MD 7, the COO and MDQ stated the main cause of the wrong site surgery for Pt 1 was a "communication problem", failure to follow informed consent, and language interpretation policies and procedures.

During a review of hospital P&P titled, "Universal Protocol [UP]", dated 12/8/16, the UP indicated under " ...Section II. A Universal Protocol must be followed on all procedures that require informed consent. This includes all invasive/operative procedures ... Section III ... verification of the correct person, site, and procedure occurs ... before the patient enters the procedure room ... with the patient awake and aware ... verification process occurs anytime the responsibility for care of the patient is transferred to another member of the procedural care team ... immediately before start of the procedure, verify and document all elements of the timeout ..."

During a review of hospital P&P titled, "Consents", dated 6/21/17, the P&P indicated under policy item Section " ...III.D ... the physician has the legal responsibility and ethical duty to obtain the patient's informed consent or the informed consent of the patient's legal representative, for medical treatment, or for procedures... Verbal and written discussion, audio cassette and verbal discussion are acceptable methods by which the treating physician may inform in order to obtain informed consent ... informed consent must occur prior commencement of the procedure. If there is no physician documentation the procedure shall not begin ... Section III.E ... If an interpreter is used to assist with the informed consent process, he/she will document on the consent form..."


2. During observation on 9/8/20, at 1:25 p.m., CRNA 1 was observed in the OR with his hair bonnet partially covering his hair when approximately 3 inches of hair was exposed from the level of his ears downward. He was not wearing shoe covers or gloves. CRNA 1 did not wash his hands before setting-up the sterile spinal tray nor before putting on a pair of sterile gloves in preparation of providing a spinal anesthesia to the patient. CRNA 1 cleaned skin over Pt 53's spine with a brown solution that was obtained from the spinal kit. After the drape from the spinal kit was placed, CRNA 1 injected medication into the Pt 53's spine. CRNA 1 did not remove the dirty gloves or wash his hands after completing the spinal procedure. With dirty gloves still on, CRNA 1 threw away trash, repositioned the patient and touched operating room items. After these actions, he removed his dirty gloves. He did not don clean gloves or wash his hands. CRNA 1 was observed performing hand hygiene upon exit from the OR with the patient. He pumped the wall alcohol sanitizer dispenser one time and rubbed his hands together.

During an observation on 9/8/20, at 2:01 p.m., in the Labor and Delivery operating room (LDOR), Scrub Technician (ST) 1 did not perform hand hygiene after removing gloves and donning sterile gloves to assist with the C-section on Pt 53.

During an interview on 9/8/2020 at 4:50 p.m. with Quality Director (QD) and Director of Risk Management (DRM), discussed CRNA 1 did not dress or follow infection control standards according to policy and AORN guidelines for the operating room (OR). DRM stated the operating rooms follow hospital policies and AORN (Association of Peri-Operative Registered Nurses) for operating room procedures, surgical attire, and hand hygiene.

During an interview on 9/10/20, at 7:55 a.m., with ST 1, ST 1 stated the proper OR attire is hospital issued scrubs, goggles, mask, shoe covers, and hair coverings that cover all hair and ears.

During an interview on 9/10/20, at 10:06 a.m., with circulating Registered Nurse (RN) 8, RN 8 stated the required OR attire to be worn, is hospital issue surgical scrubs, blue jacket, hair bonnet, surgical mask, and shoe covers.

During a review of the hospital's Policy and Procedure (P&P) titled, "OR/Short Stay- Surgical Site Infection Prevention ", dated 12/12/18, the P&P indicated, in " ...Section II ... exogenous sources of pathogens can come from the surgical team, the Operating Room (OR) environment and air, or contaminated decides, instruments, and materials introduced into the sterile field." The P&P indicated, preventative measures are to focus on both prophylactic interventions and reducing opportunities for microbial contamination of the patient's tissues or the sterile surgical field. Furthermore, the policy indicates Pre-operative care includes performing frequent hand hygiene before and after each patient encounter, Intra-operative care includes adhering to strict sterile technique, using appropriate barriers and surgical attire, preforming frequent hand hygiene and appropriate surgical hand scrub. The policy requires staff to "follow ARON", the Association of per-operative Registered Nurses, for surgical OR attire, proper skin antiseptics, hand hygiene, OR environmental care.

During a website review of "Association of Peri-Operative Registered Nurses (ARON)", dated 2012-2020, the AORN guidelines indicated " ...Hand Hygiene ...Surgical Hand Antisepsis ...4.1 Perform surgical hand antisepsis before donning sterile gowns and gloves for operative and other invasive procedures ..."

During a review of the hospital's policy and procedure (P&P) titled, "Hand Hygiene", dated 8/24/18, the P&P indicated, "...III POLICY A. Hand hygiene is the single most important means of preventing the spread of infection ...IV. PROCEDURE ...b. Specific indications for hand hygiene ...v. Before donning sterile gloves ...viii. After removing gloves ..."

During a review of the hospital's P&P titled, "OR-Surgical Attire and Restrictions", dated 10/18/18, the P&P indicated, "... III. POLICY A. All persons who enter the restricted... of the operating room must wear clean... and other protective coverings. 2. Head... i. All personnel are to cover/confine, head... restricted areas... d. Shoe covers..."