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Based on observation, interview, and record review, the facility failed to develop and implement policies and procedures to include the posting of signage to identify hazardous radiation areas; and failed to ensure clear signage was posted in the X-Ray machine locations, identifying hazardous radiation areas ¹. This deficient practice had the potential to affect all patients and staff utilizing the radiation services. Findings include:

A review of the facility's policy and procedure titled, Radiation Protection of Patients, IS420, last revised on 1/22, showed, "Purpose To outline procedures to provide a radiation-safe environment. Policy Staff caring for patients at [facility name] follow procedure to ensure a radiation safe environment for staff, patients and their family members..."[sic] The policy and procedure did not include the posting of signage to identify hazardous radiation areas.

During an observation on 6/21/22 at 10:10 a.m., signs were attached above the doorways of the three X-Ray rooms which showed, "X-Ray in Use." There were no signs posted to identify a hazardous radiation area.

During an interview on 6/21/22 at 10:37 a.m., staff member Q stated the X-Ray rooms had "X-Ray in Use", signs above each entry door and when they were in use, the signs light up. He stated no hazardous radiation signs were posted on the X-Ray rooms, radiation was only emitted when the machines were in use.

¹ Alara | nrc.gov. (n.d.). Retrieved June 23, 2022, from https://www.nrc.gov/reading-rm/basic-ref/glossary/alara.htm

Based on observation, interview, and record review, the facility failed to follow their policy requiring surgical staff to change their mask after each surgical case for 2 (#'s 11 and 12) of 30 sampled patients. Findings include:

Review of the facility's policy and procedure titled, Attire, Surgical, OR730, last reviewed 4/2021, showed, "Masks are changed after each case or if soiled."

During an observation on 6/21/22 at 7:30 a.m., of a surgical procedure for patient #11, staff entering and exiting the patient's operating room did not change their surgical masks.

During an interview on 6/21/22 at 7:39 a.m., staff member GG stated, "We used to change masks for every case but since Covid hit, and we have to wear them all the time, we have stopped changing masks every time we come in or out of a room."

During an observation on 6/22/22 at 8:00 a.m., of a surgical procedure for patient #12, staff did not change their masks as they entered and exited the patient's surgical suite.

Based on observation, interview, and record review, the facility failed to follow their policy and procedure for obtaining informed consent for an out-patient EGD for 1 (#30); failed to ensure an informed consent was obtained prior to the insertion of a chest tube for 1 (#21); failed to develop a policy and procedures for obtaining informed consent for surgical or invasive procedures; and failed to provide informed consent for an invasive procedure by having the patient sign the consent prior to having the risks and benefits explained to them by the physician performing the procedure for 2 (#s 11 and 12) of 30 sampled patients. Findings include:

1. A review of the facility's policy and procedure titled, Informed Consent, OSCOR01, last revised on 5/2021, showed:

- "1. The patient is provided the opportunity to give an "informed consent" prior to: ...B. the performance of operative and/or invasive procedures, C. diagnostic or therapeutic procedures...

- 3. Informed consent consists of: ...C. The nature of the treatment. D. The risks, drawbacks, complications and expected benefits or effects of the treatment/procedure. E. Potential problems related to recuperation. F. Any alternatives to the procedure and their risks and benefits... I. The patient understanding the information. J. The patient being verbally informed about the anesthesia or procedure. K. The patient having had the opportunity to ask questions is needed for complex procedures, not for simple and common procedures (i.e., blood counts) and is needed for any procedure where anesthesia is planned.

- B. Non-physician personnel may not answer patient's questions about the nature of the anesthesia or procedure and its benefits or risks or alternatives..."

During an observation on 6/21/22 at 3:10 p.m., staff member UU introduced themself as the physician completing patient #30's EGD. Staff member UU stated to the patient that the patient had three previous EGD's. The patient stated she did not recall having three EGD's and that she believed this EGD was the third. Staff member UU stated to the patient that their primary provider had gone over the procedure and the risks and benefits. When staff member UU asked patient #30, if they had any questions, patient #30 repeated to staff member UU that she was confused why he thought she had already had three previous EGD's. Staff member UU stated he did not want to "quibble" over numbers and told her the nurse would be back in shortly to bring her to the procedure room.

During an interview on 6/21/22 at 3:20 p.m., patient #30 stated her primary provider had not gone over what to expect with the procedure and she still had questions about the procedure she was having.

During an observation on 6/21/22 at 3:22 p.m., staff member PP introduced themself as the nurse who would be providing the anesthesia. Staff member PP then handed patient #30 a consent form for the procedure and had the patient sign the consent. After staff member PP obtained the signed consent for the EGD from the patient, she asked patient #30, if they had any questions. Patient #30 stated she was confused why they thought she had already had three previous EGD's. She also stated she was not sure what exactly they would be doing during the procedure. Staff member PP then explained to the patient that staff member UU would be putting a camera down her throat to look at her stomach. Stating staff member UU may take some biopsies and if there were any constricted areas in her stomach, those may be enlarged with a balloon. Patient #30 stated she did not know they would take biopsies and asked staff member PP how that worked. Staff member PP explained how staff member UU would complete a biopsy. The patient then asked what the "balloon" was and if it stayed inside her after the procedure. Staff member PP explained that staff member UU would use a "balloon" to open any constricted areas, and the balloon would not stay inside the patient. Staff member PP then wheeled patient #30 to the procedure room. Staff member PP did not ask staff member UU, the provider conducting the procedure, to return and answer the patient's questions about the nature of the procedure and its benefits, risks or alternatives.

During an interview on 6/21/22 at 3:40 p.m., staff member UU stated the risks and benefits and informed consent were reviewed previously by patient #30's primary provider.

During an interview on 6/21/22 at 3:49 p.m., staff member PP stated she obtained the informed consent prior to a patient's procedure. She stated it was the responsibility of the provider to discuss the risks and benefits of the procedure. Staff member PP stated she would try to answer any questions the patient may have regarding the procedure and did not usually have the provider return.

During an interview on 6/21/22 at 4:00 p.m., staff member NN stated it was the expectation of the provider performing the procedure to ensure the patient was informed of the procedure and to answer any questions the patient may have regarding the procedure. Stating it was the nurse's responsibility to observe the patient sign the consent, and if the patient had any further questions, they were to have the provider return to answer those questions for the patient.


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2. A review of the facility's policy and procedure titled, Informed Consent, OSCOR01, last revised on 5/2021, showed, "...The original copy of the informed consent must be placed in the medical record before the anesthesia or procedure is performed."

A review of the facility document titled, Governing Documents of the Medical Staff, dated 1/30/20, showed, "It is the physician's responsibility to obtain patient informed consent, to make an appropriate entry in the medical record regarding the information given to the patient, and to assure that the patient's signature is on the proper consent confirmation form."

Record review of patient #21's medical record, viewed on 6/22/22, showed the patient had multiple procedures since her admission to the facility on 6/10/22. A chest X-ray performed to confirm the location of a PICC line after an adjustment, dated 6/14/22, showed an incidental finding of a left-sided pneumothorax which had increased in size since 6/13/22. Patient #21's medical record showed a left-sided chest tube was inserted on 6/14/22 without obtaining an informed consent for the insertion of the chest tube.

During an interview and record review on 6/22/22 at 11:18 a.m., staff member SS, after reviewing patient #21's electronic and paper medical records, was not able to find the informed consent for the insertion of the chest tube on 6/14/22. Staff member SS stated she was not sure if a consent had been completed for the insertion of patient #21's chest tube on 6/14/22.

During an interview and record review on 6/22/22 at 11:25 a.m., staff member TT stated there should have been an informed consent completed prior to the chest tube insertion which was performed on 6/14/22. Staff member TT stated it might have been misplaced or not done at all.


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3. A review of the facility's policy and procedure titled, Informed Consent, OSCOR01, last revised 5/2021, did not show the process for surgical or procedural providers.

A surgical consent policy was requested on 6/21/22, no policy for surgical consent was provided prior to survey exit.

During an interview on 6/21/22 at 3:27 p.m., staff member B stated, "I have emailed [staff member HH] to see if there is one [policy for surgical consent] but since I don't find one that probably means we don't have one."

A review of the facility's Governing Documents of the Medical Staff, approved by the Board of Trustees on 1/30/20, and amended by Medical Staff on 1/14/20, showed, "5.6 Informed Consent:
It is the physician's responsibility to obtain patient informed consent, to make an appropriate entry in the medical record regarding the information given to the patient, and to assure that the patient's signature is on the proper consent confirmation form..."

During an observation on 6/21/22 at 6:18 a.m., staff member XX asked patient #11 to sign his consent for surgery. Patient #11 signed the consent without discussion.

During an observation on 6/21/22 at 7:10 a.m., staff member YY, the individual performing the procedure, entered patient #11's room and described the surgery and discussed the risks and benefits of the surgery with patient #11. Then staff member YY signed the consent that had been previously signed by the patient.

Review of patient #11's History and Physical, dated 6/17/22 at 3:16 p.m., did not include documentation of the explanation of the procedure, or a discussion of risks and benefits of surgery, with the patient.

Review of patient #11's Operative Report, dated 6/21/22 at 9:06 a.m., showed documentation of a discussion of the risks and benefits of the procedure. The risks and benefits were discussed after patient #11 signed the informed consent.

4. During an interview and record review on 6/22/22 at 6:30 a.m., a surgical consent for patient #12 showed it was signed by the patient on 6/21/22 at 3:30 p.m. Staff member VV stated the consent was signed by the patient, with the registered nurse, during the patient's pre-operative appointment.

During an interview on 6/22/22 at 7:00 a.m., staff member WW stated the doctor was supposed to explain the procedure and the risks and benefits of surgery before the patient signs the consent. Staff member WW stated the nurse usually had the patient sign the consent either before surgery or during the pre-operative discussion.

During an observation on 6/22/22 at 7:02 a.m., staff member ZZ, the provider performing the procedure, entered patient #12's room and explained the surgery, including the risks and benefits to the patient. Staff member ZZ then signed the consent that had been previously signed by the patient.

Based on interview and record review, the facility failed to ensure an operative report was dictated immediately after the completion of a procedure and failed to ensure authentication, by written or electronic signature, was completed by the surgeon within 24-hours of completing the dictation for the procedure for 1 (#24) of 30 sampled patients. Findings include:

A review of the facility's Governing Documents of the Medical Staff, approved by the Board of Trustees on 1/30/20, and amended by Medical Staff on 1/14/20, showed, "5.4 Invasive Procedure and Operative Report: The report of every operative and invasive procedure must be dictated immediately following the procedure and must include at least the following elements: ...h. authentication by written or electronic signature..."

Review of patient #24's medical record, reviewed on 6/22/22, showed the patient was admitted to the facility on 6/7/22 after he had sustained a spinal fracture during a fall. The surgical procedure was performed on 6/8/22. The operative report showed a dictation date of 6/17/22, a transcription date and time of 6/17/22 at 9:33 a.m., and failed to show the document had been signed by the surgeon as of 6/22/22.

During an interview on 6/22/22 at 1:30 p.m., staff member B stated medical providers were given 24-hours to sign dictated documents within the medical record. Staff member B stated the providers received a message within the electronic medical record system which notified them there was a document to be signed. Staff member B was not able to explain why the provider had not signed the operative report within the required timeframe.

Based on interview and record review, the facility failed to follow their Medical Staff Bylaws to complete a post-anesthesia assessment within 48-hours of surgery for 1 (#14) of 30 sampled patients. Findings include:

A review of the facility's Governing Documents of the Medical Staff, approved by the Board of Trustees on 1/30/20, and amended by Medical Staff on 1/14/20, showed, "5.13 Other General Provisions Affecting Patient Care: 5.13.1 Anesthesia: Anesthesia will be administered only by appropriately qualified and credentialed practitioners approved by the Medical Staff and the Board of Trustees... With respect to inpatients, a post anesthesia follow-up report by the individual who administers the anesthesia will be written in the patient chart within 48 hours after surgery..."

Record review of patient #14's electronic medical record showed no post-anesthesia assessment for his 6/16/22 surgery.

A post-anesthesia assessment for patient #14 for a surgery on 6/16/22, was requested on 6/22/22, no document was provided prior to survey exit.

During an interview on 6/21/22 at 8:22 a.m., staff member AAA stated he completed the post-anesthesia assessment in the recovery room or in the intensive care unit within 24-hours of the surgery. Staff member AAA stated he typically did the post-anesthesia assessment immediately after taking the patient to the recovery room.

During an interview on 6/22/22 at 10:02 a.m., staff member BB attempted to find the post-anesthesia assessment for patient #14, in the electronic medical record, and could not find it. Staff member BB stated the medical records department told her there was not one in the patient's medical record and that the provider must not have dictated it yet.

During an interview on 6/22/22 at 3:32 p.m., staff member B stated the facility's policy was for the providers to have the post-anesthesia assessment completed within 24-hours.