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Based on review of personnel files, staff interview, and review of physician credentialing files, it was determined the facility failed to ensure that medical staff privileges and physician documentation in the medical record is in accordance with the facility's medical bylaws and policies and procedures.

Findings include:

1. The facility failed to identify in writing, approved clinical privileges for physicians or allied health professionals (AHPs). (Cross refer to Tag A-363).

Based on review of five (5) of eleven (11) medical credentialing files (#7, #8, #26, #35, #38), staff interview, and review of the facility's medical bylaws, it was determined the facility failed to identify in writing, approved clinical privileges for physicians or Allied Health Professionals (AHP).

Findings include:

Reference: Facility document, "[Name of Facility] Medical Staff Bylaws" states, "... 2.11. Delineation of Clinical Privileges... 2.11.1 Each practitioner shall be entitled to provide clinical services and/or admit patients at the Hospital only in accordance with the clinical privileges specifically granted to the practitioner. ... 3.4.4. Department and Division Action... 3.4.4.3... The department director and division chief, or the individuals or committees reviewing the application, shall provide written recommendations as to staff appointment, reappointment, clinical privileges, and category or status. If appointment or reappointment is recommended, the recommendation shall identify... clinical privileges to be granted, and any special conditions to be attached to the appointment. ... ."

1. Review of Staff #7's credentialing file on 5/11/21, revealed the following:

a. An appointment letter dated 3/31/21, indicated that during a meeting of the Board of Directors, held on 3/24/21, Staff #7 was appointed as Provisional Staff in the Department of Surgery with "privileges in Orthopedics."

b. A list of twenty-two (22) surgical privileges were present in the credentialing file, with seventeen (17) of the privileges circled.

(i) Upon interview on 5/11/21 at 2:00 PM, Staff #4 stated the facility was transitioning to a new company responsible for completing physician credentialing files. He/she stated that under the previous company, physicians requesting privileges were required to circle the privileges they were requesting.

c. There was no evidence of a signature by the department director, division chief, or any other individual reviewing the application, which indicated the physician's requested privileges were granted.

2. Review of Staff #8's credentialing file on 5/11/21, revealed the following:

a. An appointment letter dated 7/31/20 indicated that during a meeting of the Board of Directors held on 7/29/20, Staff #8 was appointed as Provisional Allied Health Staff with "privileges as a Physician Assistant."

b. Staff #8 placed his/her initials next to the following privileges, indicating his/her request for privileges: "Age Categories; Core Privileges in Operating Room and/or Surgery Department; Specialty Procedures - Operating Room and/or Surgery Department."

c. There was no evidence of a signature by the department director, division chief, or any other individual reviewing the application, to indicate the physician assistant's requested privileges were granted.

3. Review of Staff #26's credentialing file on 5/13/21 revealed the following:

a. An appointment letter dated 5/28/20 indicated that Staff #26 was reappointed to the Medical Staff for the period from June 1, 2020 to May 31, 2020.

b. On the "Request for Clinical Privileges - Reappointment" form, the box marked, "No changes to existing clinical privileges" was checked. The form was signed by Staff #26 and dated 1/29/20.

c. On the "Request for Clinical Privileges - Reappointment" form, the section marked, "Recommendation" states, "I have reviewed the requested clinical privileges and supporting documentation for the above-named applicant and make the following recommendation(s): Recommend all requested clinical privileges... Recommend clinical privileges with the following conditions/modifications... Do not recommend the following requested clinical privileges." The "Recommendation" section of the form was left blank. The section marked "Division Chief's Signature" and "Department Chairman's Signature" was left blank.

(i) There was no evidence of a signature by the department director, division chief, or any other individual reviewing the application, to indicate the physician's requested privileges were granted.

4. Review of Staff #35's credentialing file on 5/13/21 revealed the following:

a. An appointment letter dated 2/25/21 indicated that Staff #35 was granted temporary privileges in Orthopedics "pending completion of the full credentialing process."

b. A list of twenty-two (22) surgical privileges was present in the credentialing file, with Staff #35 requesting six (6) of the privileges by writing "yes" next to them.

c. There was no evidence of a signature by the department director, division chief, or any other individual reviewing the application, to indicate the physician's requested privileges were granted.

5. Review of Staff #38's credentialing file on 5/13/21 revealed the following:

a. An appointment letter dated 3/31/21 indicated that during a meeting of the Board of Directors, held on 3/24/21, Staff #38 was appointed as Provisional Allied Health Staff with "privileges as a Physician Assistant."

b. Staff #38 circled the following privileges, indicating his/her request for privileges: "Age Categories; Core Privileges in Operating Room and/or Surgery Department; Specialty Procedures - Operating Room and/or Surgery Department."

c. There was no evidence of a signature by the department director, division chief, or any other individual reviewing the application, to indicate the physician assistant's requested privileges were granted.

6. Staff #1, Staff #2, Staff #4, and Staff #5 confirmed the above findings on 5/13/21 at 2:00 PM.

Based on staff interview and review of one (1) of three (3) personnel files (#9), it was determined the facility failed to ensure all contracted staff receive orientation and competency evaluations.

Findings include:

1. Review of the personnel record for Staff #9 on 5/11/21, revealed the following:

a. Staff #9 was an agency contracted registered nurse working in the operating room (OR). There was no evidence of a documented orientation and competency evaluation in Staff #9's personnel file.

b. Upon interview with Staff #2 at 2:47 PM, he/she stated Staff #9's orientation and competency evaluation had been "purged" from the system and was unavailable.

2. Staff #1, Staff #2, Staff #3, Staff #4, and Staff #5 confirmed the above findings on 5/13/21 at 2:00 PM.

Based on review of medical records, staff interview, and review of facility policies and procedures, it was determined the facility failed to ensure surgical services are provided in accordance with acceptable standards of practice.

Findings include:

1. The facility failed to ensure a properly executed informed consent is performed for every patient undergoing a surgical procedure (Cross refer to Tag A-955).

2. The facility failed to ensure documentation of the time-out verification process is included in the medical record by the circulating RN for all surgical procedures (Cross refer to Tag A-951).

3. The facility failed to ensure errors in the medical record are properly corrected (Cross refer to Tag A-951).

4. The facility failed to ensure all anesthesia records and surgical consents are complete (Cross refer to Tag A-951).

5. The facility failed to ensure documentation on pre-anesthesia assessments and surgical history and physicals includes the date and time (Cross refer to Tag A-951).

6. The facility failed to ensure an updated history and physical is documented for all patients prior to surgery (Cross refer to Tag A-953).

A. Based on review of one (1) of one (1) medical record (#8), staff interview, and a review of facility policy and procedure, it was determined the facility failed to ensure that documentation of the time-out verification process is included in the medical record, by the circulating RN, for all surgical procedures.

Reference: Facility policy, "Assessment of Perioperative Patient" states, "Standard: A registered nurse (RN) will perform the nursing assessment of each patient admitted to... the operating room... Policy... 4. Intra-operative documentation will be performed by circulating RN... to include a timeout verification #1 and verification #2. ... ."

1. Review of Medical Record #8, on 5/13/21 at 10:03 AM, was conducted with Staff #3 and revealed the following:

a. The patient had a surgical procedure on 4/22/21. The "Surgical Case Record" portion of the medical record did not contain intra-operative documentation by the circulating RN, that a time out verification #2 was completed.

2. Staff #1, Staff #2, Staff #3, Staff #4, and Staff #5 confirmed the above findings on 5/13/21 at 2:00 PM.

B. Based on review of three (3) of six (6) medical records (#4, #7, #8), staff interview, and review of facility policy and procedure, it was determined the facility failed to ensure all anesthesia records and surgical consents are complete.

Reference: Facility policy, "Medical Record Documentation and Completion" states, " ... II. Purpose... Dating and Timing of Entries in the Medical Record... All entries in the medical record (manual or electronic) shall be dated and timed by the individuals making such entries. ... Completeness... When making entries in the medical record, document all facts and pertinent information related to an event, course of treatment, condition, response to care... Make sure entry is complete and contains all significant information. ... ."

1. Review of Medical Record #4 on 5/13/21 at 10:03 AM, revealed the following:

a. On form "Consent To Operation Or Special Procedure," the name of the patient was left blank in section "1".

2. Review of Medical Record #7 on 5/13/21 at 10:03 AM, revealed the following:

a. On form "Consent To Operation Or Special Procedure," the name of the patient was left blank in section "1".

b. The "Pre-Op (pre-operative) Dx (diagnosis)", "Post-Op Dx", and "Surgeon" sections of the facility form "Anesthesia Record" was left blank.

3. Review of Medical Record #8 on 5/13/21 at 10:03 AM, revealed the following:

a. On form "Consent To Operation Or Special Procedure," the name of the patient was left blank in section "1".

b. The "Pre-Op Dx", "Post-Op Dx", and "Surgeon" sections of the facility form "Anesthesia Record" was left blank.

4. Staff #1, Staff #2, Staff #3, Staff #4, and Staff #5 confirmed the above findings on 5/13/21 at 2:00 PM.


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C. Based on review of two (2) of two (2) medical records (#1, #5), staff interview, and review of facility policy and procedure, it was determined the facility failed to ensure documentation on pre-anesthesia assessments and surgical history and physicals include the date and time.

Findings include:

Reference: Facility policy, "Medical Record Documentation and Completion" states, "... II. Purpose... Dating and Timing of Entries in the Medical Record... All entries in the medical record (manual or electronic) shall be dated and timed by the individuals making such entries... Completeness... Make sure entry is complete and contains all significant information... ."

1. Review of Medical Record #1 on 5/11/21 at 10:25 AM revealed the "Date" section of the facility form "Pre-Anesthesia Assessment" was left blank.

2. Review of Medical Record #5 on 5/13/21 at 11:00 AM revealed that the "Date" and "Time" section of the facility form "History and Physical" was left blank.

3. Staff #1, Staff #2, Staff #3, Staff #4, and Staff #5 confirmed the above findings on 5/13/21 at 2:00 PM.

D. Based on review of one (1) of two (2) medical records (#1), staff interview, and review of facility policy and procedure, it was determined he facility failed to ensure errors in the medical record are properly corrected.

Findings include:

Reference: Facility policy, "Medical Record Documentation and Completion" states, "... Proper Error Correction Procedure... When an error is made in a medical record, the proper correction procedure must be followed: Draw a line though the entry (thin pen line). Make sure that the inaccurate information is still legible. Initial and date entry. State the reason for error (i.e. in the margin or above the note if room) Document the correct information... ."

1. Review of Medical Record #1 on 5/11/21 revealed the following:

a. The patient was admitted to the facility on 4/22/21 for a right total knee surgery. On the "Pre-Anesthesia Assessment" form, in the section labeled "Presenting Condition," the word "knee" was crossed out and the word "Hip" was written above it.

(i) There was no evidence of an initial and date entry regarding the correction.

(ii) There was no evidence of a stated reason for the error.

b. In the section labeled "Planned Procedure," the word "knee" was crossed out and the word "Hip" was written underneath it.

(i) There was no evidence of an initial and date entry regarding the correction.

(ii) There was no evidence of a stated reason for the error.

2. Upon interview on 5/13/21 at 10:46 AM, in the presence of Staff #4, Staff #5 and Staff #26, Staff #6 confirmed he/she crossed out the word "knee" and replaced it with "hip" on the "Pre-Anesthesia Assessment" form.

a. Staff #6 stated, "I'm sorry for not putting my initials and dating" the alteration to the "Pre-Anesthesia Assessment" form.

3. Staff #4, Staff #5, Staff #6, and Staff #26 confirmed the above findings on 5/13/21 at 10:55 AM.

Based on review of one (1) of two (2) medical records (#1), staff interview, and review of facility policy and procedure, it was determined the facility failed to ensure an updated history and physical is documented for all patients prior to surgery.

Findings include:

Reference: Facility policy, "Medical Record Documentation and Completion" states, " ... History and Physicals... If the history and physical was performed within Thirty (30) days prior to admission, the patients history and physical examination record completed by the attending physician shall be included in the medical record with any subsequent changes recorded at the time of admission. ... ."

1. Review of Medical Record #1 on 5/11/21 revealed there was no evidence of an updated history and physical prior to surgery.

2. Staff #1, Staff #2, Staff #3, Staff #4 and Staff #5 confirmed the above findings on 5/13/21 at 2:00 PM.

Based on review of one (1) of one (1) medical records (#1), staff interview, and review of facility policy and procedure, it was determined the facility failed to ensure a properly executed informed consent form is completed for every patient undergoing a surgical procedure.

Findings include:

Reference: Facility policy, "Consent for Admission and Treatment" states, "... The following standards are required for an informed consent. Each disclosure must be made in such a way that the patient understands it. ... b. Specific procedure/treatment to be performed and a general description stated in plain language or layman's terms. The location must be unambiguous if there are any questions of laterality (e.g., left/right), multiple structures (fingers/toes), or multiple levels (spinal)... 11. Completion of the Documentation for Informed Consent. After the informed consent discussion, a health care provider, which may include a person who participated in the discussion, is to fill out the Informed Consent that acknowledges the discussion. The physician or practitioner who provides the information to the patient or Legally Authorized Person for informed consent will document on the practitioner certification portion of the consent to operate... 22. A separate informed consent process and separate or new Informed Consent must be obtained whenever: a. The course of treatment or the patient's condition is substantially altered. ... ."

1. Review of Medical Record #1 on 5/11/21 revealed the following:

a. The patient was admitted to the facility on 4/22/21 for a right total knee surgery. On the "Pre-Anesthesia Assessment" form, in the section labeled "Presenting Condition," the word "knee" was crossed out and the word "Hip" was written above it. In the section labeled "Planned Procedure," the word "knee" was crossed out and the word "Hip" was written underneath it.

b. Upon interview on 5/13/21 at 10:46 AM, in the presence of Staff #4, Staff #5 and Staff #26, Staff #6 stated that a portion of the "Pre-Anesthesia Assessment" form was pre-filled. He/she stated, "Everything on the front is already filled out, including the "Presenting Condition" and the "Planned Procedure." Staff #6 confirmed he/she crossed out the word "knee" and replaced it with "hip" on the "Pre-Anesthesia Assessment" form.

(i) Staff #6 was asked why he/she crossed out the initial planned procedure of a right total knee and replaced it with a right total hip. Staff #6 stated, "I listened to the patient about what would be done and confirmed the procedure with the patient. The patient stated she was getting a hip."

(ii) Staff #6 was asked if he/she confirmed the procedure with the surgeon, due to the discrepancy between the patient's verbal confirmation of the procedure and the written information on the "Pre-Anesthesia Assessment" form. Staff #6 stated, "No. I did not talk to the surgeon."

c. Upon interview on 5/13/21 at 10:53 AM, Staff #4 confirmed that if a discrepancy occurs with informed consent between the patient's verbal confirmation of the procedure and the written name of the procedure, "the expectation is that the procedure will be verified by the surgical team prior to the procedure."

2. Upon interview on 5/11/21 at 10:40 AM, Staff #1, Staff #2, Staff #4, and Staff #5 confirmed that Patient #1 was scheduled for a right total knee and instead had a right total hip performed.

3. Staff #1, Staff #2, Staff #4, and Staff #5 confirmed the above findings on 5/13/21 at 2:00 PM.