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Based on interview, clinical record review, hospital documents and during the course of a complaint investigation, it was determined surgery patients were not given the information needed to give informed consent for a surgery for five (5) out of seven (7) patients included in the sample. (Patients #2, #4, #9, #10 and #11)

The findings are:

The surveyor reviewed records on 3/11/30 with the assistance of a navigator Staff Member (SM) #16 and in the presence of SM #11.

Review of clinical records revealed:

Patient #2-- Had a right total hip replacement on 10/7/19. Review of the "Intra-Op events" log documents the surgeon out of OR at 12:23 PM and the incision close at 12:47 PM, indicating someone other than the surgeon closed the incision. Review of the "Intra-OP staff log" documents a vendor was present during the surgery. Review of the "Consent for Operation/Procedure" failed to list an assistant (assisting the surgeon with significant tasks, i.e. closing the operative site) to the surgeon and fails to identify the presence of a vendor in the operating room (OR).

Patient #4-- Had a right total hip replacement on 12/11/19. Review of the "Intra-Op events" log documents the surgeon out of OR at 2:18 PM and the incision close at 2:38 PM. indicating someone other than the surgeon closed the incision. Review of the "Intra-OP staff log" documents a vendor was present during the surgery. Review of the "Consent for Operation/Procedure" failed to list an assistant (assisting the surgeon with significant tasks, i.e. closing the operative site) to the surgeon and fails to identify the presence of a vendor in the operating room (OR).

Patient #9-- Had a right total knee replacement on 10/7/19. Review of the "Intra-Op events" log documents the surgeon out of OR at 10:44 AM and the incision close at 11:01 AM. indicating someone other than the surgeon closed the incision. Review of the "Intra-OP staff log" documents a vendor was present during the surgery. Review of the "Consent for Operation/Procedure" failed to list an assistant (assisting the surgeon with significant tasks, i.e. closing the operative site) to the surgeon and fails to identify the presence of a vendor in the operating room (OR).

Patient #10-- Had a left total knee replacement on 10/7/19. Review of the "Intra-Op events" log documents the surgeon out of OR at 1:41 PM and the incision close at 2:00 PM. indicating someone other than the surgeon closed the incision. Review of the "Intra-OP staff log" documents a vendor was present during the surgery. Review of the "Consent for Operation/Procedure" failed to list an assistant (assisting the surgeon with significant tasks, i.e. closing the operative site) to the surgeon and fails to identify the presence of a vendor in the operating room (OR).

Patient #11-- Had revision of left total knee replacement on 10/7/19. Review of the "Intra-Op events" log documents the surgeon out of OR at 5:16 PM and the incision close at 5:43 PM. indicating someone other than the surgeon closed the incision. Review of the "Intra-OP staff log" documents a vendor was present during the surgery. Review of the "Consent for Operation/Procedure" failed to list an assistant (assisting the surgeon with significant tasks, i.e. closing the operative site) to the surgeon and fails to identify the presence of a vendor in the operating room (OR).

Surveyor review of Policy number BSR 01-01 "Informed Consent" revised 4/19 revealed the following in part: 2.2.1 "It is the medical staff's responsibility to ensure consent is informed consent." "Include identification of all other practitioners who will perform important surgical tasks that will be conducted by practitioners other than the primary credentialed medical staff, surgeon, or proceduralist." Review of the Addendum to the aforementioned policy reveals the following in part: "6. Informed Written Consent: Patient rights include, but are not limited to, the opportunity to be informed and to receive from and discuss with their physician the following: f. The identity of the physician or surgeon who will perform the treatment or procedure, and that other practitioners and/or assistants, including those under the direct supervision of the primary physician or surgeon, may be performing tasks related to the proposed treatment or procedure." Review of hospital policy number 4.16 "Patient Rights and Responsibilities" revised 6/17 reads in part as follows: "We consider you a partner in your healthcare. While you are a patient at one of our facilities, you have the following rights: 8. You have the right to know the names and roles of the people who are treating you."

On 3/12/20 at 12:10 PM, the surveyor interviewed SM #27 related to the presence of vendors in the OR, and what the role of a vendor would be. SM #27 confirmed that a vendor was usually present in the OR when an implant is being used as in the case of a total knee replacement or total hip replacement. SM #27 stated the vendor was present to ensure the surgeon had the right implant for the case and received the parts in the order needed for that surgery. SM #27 stated the vendor did not enter the sterile field and only opened the box to allow the nurse to access the implant part needed. SM #27 also stated that "to my knowledge the MD does not inform the patient that a vendor will be present in the OR." SM #27 was present for surgeries for Patients #2, #9, #10 and #11. SM #27 stated that he/she left the OR at the same time the surgeon did and that it was not unusual that the surgeon did not close the incision. SM #27 was unaware if the surgeon informed the patient that (the surgeon) would not be closing the incision. SM #27 stated that it was possible the surgeon may have informed the patient during an office visit prior to the surgery.

The surveyor asked SM #11 how the vendors were vetted and what training vendors received prior to being present in the OR. SM #11 provided the surveyor with evidence of completed vendor credentialing by an outside agency and the records of completed vendor training including but not limited to: OR Protocol training, bloodborne pathogens, national background check, HIPAA training, and required vaccines.

The findings were shared with SM #11 at the time of discovery and with the management team prior to exit on 3/17/20. No further evidence was provided to the survey team.

Based on interview and document review, it was determined hospital staff failed to ensure operating room temperatures were maintained within acceptable standards of practice as reflected by hospital policy.

The findings are:

On March 12, 2020 the surveyor conducted a review of the facility's documentation of temperature and humidity in the surgical suites. Documentation was reviewed for the main hospital operating rooms (ORs) and those ORs in ambulatory surgery.

Review of hospital policy number SS2-111 "Temperature and Humidity Areas Affected: Surgical Services" last revised 1/19 found the following in part: "2. Monitoring is performed by automated and/or manual methods. A. If a temperature or humidity reading is noted to be out of range, an attempt is made to adjust the level. A recheck of the out of range value is performed in one hour. 1. If the reading has corrected to within range, no further action is required. 2. If the reading has not corrected, then the supervisor and hospital engineering is notified for further action." Per the policy temperatures in the operating rooms should be maintained at 68-75 degrees Fahrenheit.

Daily temperature and humidity logs were reviewed for the ambulatory surgery operating rooms for a six (6) week period beginning February 3, 2020. The surveyor found twenty-four (24) occasions that hospital staff found the temperature reading was out of range and made adjustments to correct the out of range reading. The temperature and humidity logs failed to provide evidence of staff completing a recheck of the temperature in one hour to ensure the adjustment made had corrected the out of range reading.

On March 12, 2020, the surveyor discussed the failure of staff to perform and document a recheck of the out of range temperature with Staff Member (SM) #17, the Administrative Director of Engineering, Safety and Security. After reviewing the documents SM #17 confirmed there should have been a temperature check performed one hour after the adjustment was made and there was no documentation this had happened.

The above issue was shared with the management team prior to exit on March 17, 2020. No further evidence was provided to the survey team.

Based on interviews, clinical record review, hospital document review and during the course of a complaint investigation, it was determined hospital staff failed to:

obtain consent from surgery patients which included all individuals performing significant tasks during surgery for five (5) of seven (7) patients (Patients #2, #4, #9, #10 and #11), and;

failed to inform surgery patients of a vendors presence in the operating room for five (5) of seven (7) patients (Patients #2, #4, #9, #10 and #11).

The findings are:

The surveyor reviewed records on 3/11/30 with the assistance of a navigator Staff Member (SM) #16 and in the presence of SM #11.
Review of clinical records revealed:

Patient #2-- Had a right total hip replacement on 10/7/19. Review of the "Intra-Op events" log documents the surgeon out of OR at 12:23 PM and the incision close at 12:47 PM, indicating someone other than the surgeon closed the incision. Review of the "Intra-OP staff log" documents a vendor was present during the surgery. Review of the "Consent for Operation/Procedure" failed to list an assistant (assisting the surgeon with significant tasks, i.e. closing the operative site) to the surgeon and fails to identify the presence of a vendor in the operating room (OR).

Patient #4-- Had a right total hip replacement on 12/11/19. Review of the "Intra-Op events" log documents the surgeon out of OR at 2:18 PM and the incision close at 2:38 PM. indicating someone other than the surgeon closed the incision. Review of the "Intra-OP staff log" documents a vendor was present during the surgery. Review of the "Consent for Operation/Procedure" failed to list an assistant (assisting the surgeon with significant tasks, i.e. closing the operative site) to the surgeon and fails to identify the presence of a vendor in the operating room (OR).

Patient #9-- Had a right total knee replacement on 10/7/19. Review of the "Intra-Op events" log documents the surgeon out of OR at 10:44 AM and the incision close at 11:01 AM. indicating someone other than the surgeon closed the incision. Review of the "Intra-OP staff log" documents a vendor was present during the surgery. Review of the "Consent for Operation/Procedure" failed to list an assistant (assisting the surgeon with significant tasks, i.e. closing the operative site) to the surgeon and fails to identify the presence of a vendor in the operating room (OR).

Patient #10-- Had a left total knee replacement on 10/7/19. Review of the "Intra-Op events" log documents the surgeon out of OR at 1:41 PM and the incision close at 2:00 PM. indicating someone other than the surgeon closed the incision. Review of the "Intra-OP staff log" documents a vendor was present during the surgery. Review of the "Consent for Operation/Procedure" failed to list an assistant (assisting the surgeon with significant tasks, i.e. closing the operative site) to the surgeon and fails to identify the presence of a vendor in the operating room (OR).

Patient #11-- Had revision of left total knee replacement on 10/7/19. Review of the "Intra-Op events" log documents the surgeon out of OR at 5:16 PM and the incision close at 5:43 PM. indicating someone other than the surgeon closed the incision. Review of the "Intra-OP staff log" documents a vendor was present during the surgery. Review of the "Consent for Operation/Procedure" failed to list an assistant (assisting the surgeon with significant tasks, i.e. closing the operative site) to the surgeon and fails to identify the presence of a vendor in the operating room (OR).

Surveyor review of Policy number BSR 01-01 "Informed Consent" revised 4/19 revealed the following in part: 2.2.1 "It is the medical staff's responsibility to ensure consent is informed consent." "Include identification of all other practitioners who will perform important surgical tasks that will be conducted by practitioners other than the primary credentialed medical staff, surgeon, or proceduralist."

On 3/12/20 at 12:10 PM, the surveyor interviewed SM #27 related to the presence of vendors in the OR and what the role of a vendor would be. SM #27 confirmed that a vendor was usually present in the OR when an implant is being used as in the case of a total knee replacement or total hip replacement. SM #27 stated the vendor was present to ensure the surgeon had the right implant for the case and received the parts in the order needed. SM #27 stated the vendor did not enter the sterile field and only opened the box to allow the nurse to access the implant part needed. SM #27 also stated that "to my knowledge the MD does not inform the patient that a vendor will be present in the OR."

The surveyor asked SM #11 how the vendors were vetted and what training vendors received prior to being present in the OR. SM #11 provided the surveyor with evidence of completed vendor credentialing by an outside agency and the records of completed vendor training including but not limited to: OR Protocol training, bloodborne pathogens, national background check, HIPAA training, and required vaccines.

The findings were shared with SM #11 at the time of discovery and with the management team prior to exit on 3/17/20. No further evidence was provided to the survey team.