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Based on observation, interview, and record review, the facility's Governing Body failed to assume full legal responsibility for implementing, and monitoring policies governing the facility's total operation. The facility's Governing Body failed to provide oversight for quality health care in a safe environment. The facility did not meet the condition for coverage in governing body and management by failing to:

1. Ensure the medical staff was accountable to the governing body for the quality of care provided to patients. This deficient practice resulted in a reoccurrence of surgical service staff failing to follow facility's Policy and Procedure (P&P) to ensure surgeries were performed in a safe manner to avoid potential wrong-site surgeries. (refer to A049)

2. Ensure surgical services perform surgeries in accordance with policy and procedure (P&P). This deficient practice resulted in a reoccurrence of surgical service staff failing to follow facility's P&P to ensure surgeries were performed in a safe manner to avoid potential wrong-site surgeries. (refer to A063)

3.Ensure Quality Improvement Performance Improvement (QAPI) formulated an effective plan to prevent the reoccurrence of surgical services not following the facility's policies and procedures during surgery. (Refer to A263, A283 and A286)

4. Document a pre-op checklist prior to surgery for one of thirty sampled patient (Patient 9). (refer to A395)

5. Ensure surgical services followed the facility's policies and procedures in order to perform surgeries in a safe manner to prevent the reoccurrence of a potential wrong-site surgery.

On 7/18/2022, at 4:25 P.M., the survey team called an Immediate Jeopardy (IJ - a situation in which the facility's noncompliance with one or more requirements has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient) situation in the presence of the Director of Risk Management (DRM), the Chief Executive Officer (CEO), and the Chief Nursing Officer (CNO). The facility failed to ensure Patient 1's surgical site marking was visible after Patient 1 was prepped and draped for surgery. This deficient practice had the potential to result in a wrong-site surgery.

On 7/19/2022, at 4:21 P.M., the IJ was removed in the presence of the facility's DRM, CEO, and CNO after the hospital presented an acceptable Plan of Action (POA, intervention to correct the IJ situation) and the survey team validated the hospital's POA through observations, interviews and limited record review. (Refer to A940, A951, A952, and A955)

The cumulative effect of these systemic practices resulted in the facility's inability to ensure the governing body had oversight and accountability for all the facility's activities and total operations.

Based on observation, interview, and record review, the facility's Governing Body failed to ensure the medical staff was accountable to the governing body for the quality of care provided to patients.
This deficient practice resulted in a reoccurrence of surgical service and Medical staff failing to follow facility's Policy and Procedure (P&P) to ensure surgeries were performed in a safe manner to avoid potential wrong-site surgeries.

On 7/18/2022, at 4:25 P.M., the survey team called an Immediate Jeopardy (IJ - a situation in which the facility's noncompliance with one or more requirements has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient) situation in the presence of the Director of Risk Management (DRM), the Chief Executive Officer (CEO), and the Chief Nursing Officer (CNO). The facility failed to ensure Patient 1's surgical site marking was visible after Patient 1 was prepped and draped for surgery. This deficient practice had the potential to result in a wrong-site surgery. (refer to A0951)

On 7/19/2022, at 4:21 P.M., the IJ was removed in the presence of the facility's DRM, CEO, and CNO after the hospital presented an acceptable Plan of Action (POA, intervention to correct the IJ situation) and the survey team validated the hospital's POA through observations, interviews and limited record review. (refer to A0951)

Findings:

During an interview on 7/20/2022, at 2:24 P.M., with the DRM, DRM stated that a root cause analysis (RCA) was performed on July 6, 2022 regarding a wrong-site surgery for Patient 2 that occurred on April 13,2022. (refer to A951)

During a concurrent interview and record review on 7/20/2022, at 2:30 P.M., with the DRM, the facility's "Clinical Support and Patient Safety Committee Meeting Summary," dated July 6, 2022, was reviewed. The Safety Committee Meeting Minutes indicated, under the Safety Dashboard, one case of wrong site surgery occurred in the second quarter of 2022. The DRM stated that the safety summary went to MEC (Medical Executive Committee) and MEC needs to act on it, then it will be addressed by the governing body next week July 26,2022.

Based on observation, interview, and record review, the facility's Governing Body failed to ensure surgical services perform surgeries in accordance with the facility's policy and procedure (P&P).
This deficient practice resulted in a reoccurrence of surgical service staff failing to follow facility's P&P to ensure surgeries were performed in a safe manner to avoid potential wrong-site surgeries.

On 7/18/2022, at 4:25 P.M., the survey team called an Immediate Jeopardy (IJ - a situation in which the facility's noncompliance with one or more requirements has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient) situation in the presence of the Director of Risk Management (DRM), the Chief Executive Officer (CEO), and the Chief Nursing Officer (CNO). The facility failed to ensure Patient 1's surgical site marking was visible after Patient 1 was prepped and draped for surgery. This deficient practice had the potential to result in a wrong-site surgery. (refer to A0951)

On 7/19/2022, at 4:21 P.M., the IJ was removed in the presence of the facility's DRM, CEO, and CNO after the hospital presented an acceptable Plan of Action (POA, intervention to correct the IJ situation) and the survey team validated the hospital's POA through observations, interviews and limited record review. (refer to A0951)

Findings:

1. For Patient 1;
a. The surgical site marking was marked with an "X" instead of the surgeon's initials.
b. The sterile drape was lifted during the "time out" (used to verify essential information to minimize the risk of medical errors during the procedure) to visualized the site marking.
c. The site marking was not visible after Patient 1 was prepped and draped for the surgery.
These deficient practices had the potential for Patient 1 to have a surgical procedure to the wrong side of the body. (refer to A0951)

2. For patient 2,
a. The site marking was not visible before the patient entered the operating room (OR).
b. The surgeon (MD 1) exited the OR after calling the "time out" to scrub his hands, then returned to the OR and draped the wrong eye (right). The surgical consent was for the left eye.
c. The site marking was not visible after the patient was prepped and draped for surgery. MD 1 performed the surgical procedure on the right eye instead of the left eye. (refer to A951)

On 7/20/2022, at 2:30 P.M., during an interview with the Director of Risk Management (DRM). The DRM stated that following the incident of wrong-site surgery for Patient 2, the facility conducted a root cause analysis on July 6, 2022. The DRM stated that the surgical and Medical staff failed to follow the policy and procedure that included the surgical site to be visible after patient is prepped and draped. The DRM stated that the facility revised their policy to include an eye shield to be placed on the non-surgical eye. The DRM stated that the surgeon (MD 1) who performed the wrong site surgery on Patient 2 on April 13,2022 was supposed to conduct an in-service for all surgeons regarding adhering to the facility's policy and procedure, titled "Universal Protocol for Preventing wrong-site, wrong-procedure and wrong-person invasive or surgical procedure." However, the inservice for all surgeons has not been done yet.

A review of the document titled, "Board of Directors Meeting," dated 5/24/2022, indicated that an incident of a wrong site surgery on 4/13/2022 was reported to California Department of Public Health (CDPH) for investigation. The document indicated that the site was not draped in accordance with the facility's policy and procedure.

Based on interview and record review, the facility failed to meet the condition of participation of QAPI (Quality Assessment & Performance Improvement):

1. The QAPI Committee failed to implement an effective plan of correction that ensured staff adherence to the facility's P&P (policy and procedure) titled "Universal Protocol for Preventing Wrong - Site, Wrong - Procedure, and Wrong Person and Invasive or Surgical Procedure" after an incident of wrong site surgery on Patient 2 that occurred on 4/13/2022. This deficient practice resulted to a reoccurrence of a potential wrong-site surgery for Patient 1 on 7/18/2022 (Refer to A283 and A951)

2. The QAPI Committee failed to implement effective preventative measures to prevent the potential reoccurrence of a wrong site surgery after an incident of a wrong site surgery on Patient 2 that occurred on 4/13/2022. This deficient practice resulted to a reoccurence of a potential wrong-site surgery for Patient 1 on 7/18/2022 (Refer to A286, and A951)

On 7/18/2022, at 4:25 P.M., the survey team called an Immediate Jeopardy (IJ - a situation in which the facility's noncompliance with one or more requirements has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient) situation in the presence of the Director of Risk Management (DRM), the Chief Executive Officer (CEO), and the Chief Nursing Officer (CNO). The facility failed to ensure Patient 1's surgical site marking was visible after Patient 1 was prepped and draped for surgery. This deficient practice had the potential to result in a wrong-site surgery. (refer to A0951)

On 7/19/2022, at 4:21 P.M., the IJ was removed in the presence of the facility's DRM, CEO, and CNO after the hospital presented an acceptable Plan of Action (POA, intervention to correct the IJ situation) and the survey team validated the hospital's POA through observations, interviews and limited record review. (refer to A0951)

The cumulative effect of these systemic practices resulted in the facility's inability to ensure the condition of participation for quality assurance and performance improvement was met.

Based on interview and record review, the QAPI (Quality Assessment & Performance Improvement) Committee failed to implement an effective plan of correction that ensured staff adherence to the facility's P&P (policy and procedure) titled "Universal Protocol for Preventing Wrong - Site, Wrong - Procedure, and Wrong Person and Invasive or Surgical Procedure" after an incident of a wrong site surgery on Patient 2 that occurred on 4/13/2022. This deficient practice resulted to a reoccurrence of a potential wrong-site surgery for patient 1 on 7/18/2022 (Refer to A951)

Findings:

During a concurrent interview and record review on 7/20/2022, at 2:24 P.M., with the DRM, the facility's QAPI meeting minutes from 4/2022 to 6/2022 was reviewed. The minutes did not address the incident of wrong site surgery for Patient 2 on 4/13/2022. The DRM stated that the facility's QAPI Committee has not addressed the wrong-site surgery incident of Patient 2. The DRM added that the QAPI committee plans to address the incident on 7/26/2022. The DRM stated that the surgeon (MD 1) who performed the wrong site surgery on Patient 2 on 4/13/2022 was supposed to conduct an in-service for all surgeons regarding adhering to the facility's policy and procedure, titled "Universal Protocol for Preventing wrong-site, wrong-procedure and wrong-person invasive or surgical procedure." However, the inservice for all surgeons has not been done yet.

Based on interview and record review, the QAPI (Quality Assessment & Performance Improvement) failed to implement effective preventative measures to prevent the potential reoccurrence of a wrong site surgery after an incident of wrong site surgery on Patient 2 that occurred on 4/13/2022. This deficient practice resulted to a reoccurrence of a potential wrong-site surgery for Patient 1 on 7/18/2022 (Refer to A951)

On 7/18/2022, at 4:25 p.m., the survey team called an Immediate Jeopardy (IJ - a situation in which the facility's noncompliance with one or more requirements has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient) situation in the presence of the Director of Risk Management (DRM), the Chief Executive Officer (CEO), and the Chief Nursing Officer (CNO). The facility failed to ensure Patient 1's surgical site marking was visible after Patient 1 was prepped and draped for surgery. This deficient practice had the potential to result in a wrong-site surgery. (refer to A0951)

On 7/19/2022, at 4:21 p.m., the IJ was removed in the presence of the facility's DRM, CEO, and CNO after the hospital presented an acceptable Plan of Action (POA, intervention to correct the IJ situation) and the survey team validated the hospital's POA through observations, interviews and limited record review. (refer to A0951)

Findings:

On 7/20/2022, at 2:24 p.m., during a concurrent interview and record review with the DRM, the facility's QAPI meeting minutes from 4/2022 - 6/2022 was reviewed. The minutes did not address the incident of wrong site surgery for Patient 2 on 4/13/2022. DRM stated that the facility's QAPI committee has not addressed the wrong-site surgery incident of Patient 2. DRM added that the QAPI committee plans to address the incident on 7/26/2022. DRM stated that the surgeon (MD 1) who performed the wrong site surgery on Patient 2 on 4/13/2022 was supposed to conduct an in-service for all surgeons regarding adhering to the facility's policy and procedure, titled, "Universal Protocol for Preventing wrong-site, wrong-procedure and wrong-person invasive or surgical procedure," however, it has not been done yet.

Based on interview and record review, the facility failed to document a pre-op (pre-operative) checklist prior to surgery for one of thirty sampled patient (Patient 9).

Findings:

During a concurrent interview and record review, on 7/19/2022, at 10:27 p.m., with Registered Nurse 5 (RN 5) Patient 9's Electric Medical Record (EMR) was reviewed. Patient 9's EMR indicated that there was no pre-operative checklist completed when Patient 9 had a left foot debridement (surgical removal of damaged tissue from a wound) on 7/7/2022. RN5 verified that there was no pre-operative checklist completed for patient 9. RN5 also stated that the nurse assigned should have completed a pre-operative checklist prior to sending Patient 9 surgery.

A review of the facility's policy and procedure (P&P), titled "Pre-Operative Care," dated 5/2021, indicated that nurse "must complete the pre-procedure checklist. Record all nursing care measures and pre-operative medications, results of diagnostic tests, and the time the patient is transferred to the surgical area. The chart and the surgical checklist must accompany the patient to surgery."

Based on observation, interview, and record review, the facility failed to meet the Condition of Participation for Surgical Services, as follows;

1. Based on observation, interview, and record review, the facility failed to ensure surgical services followed the facility's policies and procedures to ensure surgical procedures were performed in a safe manner for two of 30 sampled patients (Patients 1, 2), as follows;

a. For Patient 1, during the observation of the patient tracer, the surgical site marking was marked with an "X" instead of with the surgeon's initials. The sterile drape was lifted during the "time out" (used to verify essential information to minimize the risk of medical errors during the procedure) to expose the correct side of the surgery. The site marking was not visible after Patient 1 was prepped and draped for the procedure. This deficient practice had the potential for Patient 1 to have a surgical procedure to the wrong side of the body. This led to an immediate jeopardy situation. (Refer to A0951)

b. For Patient 2, the site marking was not visible before or after draping the left eye. A "time out" was called, then the surgeon exited the operating room to perform the hand scrub. The surgeon returned to the room, then draped the patient (Patient 2). The site marking was still not visible after the patient (Patient 2) was prepped and draped for surgery. This deficient practice resulted in Patient 2 having surgery on the right eye instead of the left eye. (Refer to A0951)

2. Based on interview and record review, the facility failed to ensure a a medical history and physical examination was completed no more than 30 days before or within 24 hours after admission for one of thirty sampled patients (Patient 27) prior to Patient 27's surgical procedure (Refer to A0952)

3. Based on interview, and record review, the facility failed to ensure the surgical consent included which side of the body the surgery would be performed on for one of thirty sampled patients (Patient 28) prior to Patient 28's surgical procedure.

The cumulative effects of these systemic failures of surgical services resulted in Patient 2 having surgery on the wrong eye, Patient 1 having the potential for a wrong-site surgery, Patient 27 having surgery without a current History & Physical (H&P) examination, and Patient 28 having a surgical procedure without a properly executed informed consent.

Based on observation, interview, and record review, the facility failed to ensure surgical services followed the facility's policies and procedures to ensure surgical procedures were performed in a safe manner for two of 30 sampled patients (Patients 1, 2), as follows;

1. For Patient 1;
a. The surgical site marking was marked with an "X" instead of the surgeon's initials.
b. The sterile drape was lifted during the "time out" (used to verify essential information to minimize the risk of medical errors during the procedure) to visualized the site marking.
c. The site marking was not visible after Patient 1 was prepped and draped for the surgery.


2. For Patient 2;
a. The site marking was not visible before the patient (Patient 2) entered the operating room (OR).
b. The surgeon (MD 1) exited the OR after calling the "time out" to scrub his hands, then returned to the OR and draped the wrong eye (right eye).
c. The site marking was not visible after the patient (Patient 2) was prepped and draped for surgery. MD 1 performed the surgical procedure on the right eye instead of the left eye.

These deficient practices had the potential to result in:
1. wrong site surgery (a broad term that encompasses surgery performed on the wrong part, wrong side of the body, wrong patient, or at the wrong level of the correctly identified anatomical side) for Patient 1,
2. resulted in a wrong site surgery for Patient 2, and
3. had the potential for contamination of the sterile field (an area created by placing sterile surgical drapes around the patient's surgical site) for Patient 1.

On 7/18/2022, at 4:25 p.m., the survey team called an Immediate Jeopardy (IJ - a situation in which the facility's noncompliance with one or more requirements has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient) situation in the presence of the Director of Risk Management (DRM), the Chief Executive Officer (CEO), and the Chief Nursing Officer (CNO). The facility failed to ensure Patient 1's surgical site marking was visible after Patient 1 was prepped and draped for surgery. This deficient practice had the potential to result in a wrong site surgery.

On 7/19/2022, at 4:21 p.m., the IJ was removed in the presence of the facility's DRM, CEO, and CNO after the hospital presented an acceptable Plan of Action (POA, intervention to correct the IJ situation) and the survey team validated the hospital's POA through observations, interviews and limited record review.

Findings:

1. During the observation of patient tracer for Patient 1 on 7/18/2022, beginning at 10:26 a.m., Patient 1 arrived at the pre-operative area. The surgeon (MD 2) marked Patient 1's left lower abdomen with an "X". The registered nurse (RN 2) instructed MD 2 to mark the site with his initials. Patient 2 was then taken to the OR. RN 3 prepped Patient 1's perineal area (area with between the thighs, where the vagina and anus are located). MD 2 entered the OR, donned asterile gown and gloves. MD 2 draped Patient 1, covering the site marking in the process and exposing the perineal area. RN 3 called the "time out" and lifted the sterile (free of bacteria) drape with gloved hands to visualize the site marking, then placed the drape over the site marking. MD 2 started the surgical procedure via the perineal area.

During an interview, on 7/18/2022, at 12:34 p.m., MD 2 stated he (MD 2) was not able to visualize the site marking after draping Patient 1. MD 2 stated it was not necessary to visualize the marking because he had actually marked the site and he (MD 2) knew the location of the marking. MD 2 stated site marking was covered by the drape, and the drape should not be manipulated due to the risk of contaminating the area.

During an interview, on 7/19/2022, at 3:23 p.m., RN 2 stated MD 2 marked Patient 1 on the left lower abdomen with an "X". RN 2 stated the site should be marked with the surgeon's initials. RN 2 stated she reminded MD 2 to mark the site with his (MD 2) initials, in accordance with the facility's policy and procedures. RN 2 stated the site marking should be visible at all times during the surgery.

During an interview, on 7/19/2022, at 3:52 p.m., RN 3 stated that the site marking for Patient 1 was not visible during the surgery, she (RN 3) had to lift the sterile drape in order to visualize the site marking. RN 3 stated the drape should not be moved in order to prevent it from becoming contaminated. RN 3 stated site marking should be visible after the patient is prepped and draped.

A review of Patient 1's history and physical examination, dated 7/16/2022, at 8 a.m., indicated Patient 1 was admitted to the facility on 7/15/2022 for a left lower abdominal pain and left flank (side of a person's body between the ribs and the hip) pain. Patient 1's diagnoses included an acute infected kidney stone (stones that form because or urinary tract infections and can obstruct the urinary tract. Treatment including passing or removing the stones).

A review of Patient 1's informed consent, dated 7/18/2022, indicated Patient 1 consented for a placement of a stent (a metal or plastic tube) to the left ureter (tube that propel urine from the kidneys to the urinary bladder).

2. During an interview, on 7/19/2022, at 3:49 p.m., the Registered Nurse (RN 6) stated she (RN 6) worked in the operating room (OR) during Patient 2's eye surgery on 4/13/2022. RN 6 stated when Patient 2 entered the OR, the site marking was not glaringly (high obvious) visible due to tape being placed above both eyes. RN 6 stated she (RN 6) initially prepped the right eye for surgery, but the anesthesiologist reminded her (RN 6) the surgery was to be performed on the left eye. RN 6 stated that after the "time out" was called MD 1 left the OR to scrub his (MD 1) hands. RN 6 stated that during this time the surgical technical (ST 1), who was present during the "time out" left for lunch and (ST 2) continued with the case. RN 6 stated MD 1 returned to the OR, and draped Patient 2. RN 6 stated the site marking was still not visible after Patient 2 was draped. RN 6 stated MD 1 performed the procedure on the right eye, instead of the left, and nobody noticed. RN 6 stated all staff should pay attention to ensure the procedure is performed on the correct eye. RN 6 stated there was a gap between the "time out" and the start of the procedure. RN 6 stated the MD (MD 1) should not leave the OR after the "time out" is called. RN 6 stated the site marking should be visible at all times.

During an interview, on 7/20/2022, at 11:29 am, MD 1 stated he (MD 1) performed the eye surgery for Patient 2 on 4/13/2022. MD 1 started Patient 2 originally consented for surgery to be performed on the left eye, however, the surgical procedure was actually performed on the right eye. MD 1 stated he (MD 1) marked the left eye in the pre-operative area. MD 1 stated that he (MD 1) called the "time out" then left the OR to perform a hand scrub. MD 1 stated he (MD 1) returned to the OR, and draped Patient 2. MD 1 stated the site marking was not visible after draping. MD 1 stated he (MD 1) proceeded to perform surgery on the right eye and nobody in the OR noticed he (MD 1) was operating on the wrong eye. MD 1 stated he (MD 1) realized he (MD 1) performed surgery on the wrong eye at the end of the surgery. MD 1 stated he (MD 1) notified Patient 2. MD 1 stated Patient 2 did not have a problem with the surgery being done to the right eye because he (Patient 2) actually needed surgery to both eyes. MD 1 stated the possible complications of this surgery to the wrong eye could include, infection, bleeding, and scarring to the eye.

A review of Patient 2's face sheet indicated Patient 2 was admitted to the facility on 4/13/2022 for left eye conjunctivochalasis (loose, redundant conjunctiva [the mucous membrane that covers the front of the eye and lines the inside of the eyelids] considered to occur due to aging).

A review of Patient 2's "Pre-Surgical History and Physical", dated 3/18/2022, at 4:30 p.m., indicated Patient 2 had a diagnosis of conjunctivochalasis to the left eye. A procedure: Conjuncitval plasty (repair of the conjunctiva) with amniotic membrane graft (AMG, a combination of tissues and cells used as a graft or dressing) and tisseel glue (a sealant) was to be performed on 4/13/2022.

A review of Patient 2's "Surgical Consent," dated 4/13/2022, at 9:50 a.m., indicated Patient 2 consented to a conjunctival plasty with AMG and tissel glue to the left eye.

A review of Patient 2's "Operative Report," dated 4/13/2022, at 1:03 p.m., indicated the procedure performed was a conjunctivalplasty with placement of AMG to the right eye.

A review of Patient 2's procedure note, dated 4/13/2022, at 1:14 p.m., written by Surgeon 1, indicated "the surgical procedure was performed on the incorrect eye. The patient consented for surgery to the left eye. I marked the left eye and time out was performed to verify correct surgical site and procedure...I went out to scrub and when I came back I placed the drape over the right eye and proceeded with surgery. After I completed the case, I realized what happened...In the PACU (post-anesthesia care unit), I discussed what happened with the patient. The patient stated that both eyes needed to be done [so not a problem]."

During an interview, on 7/19/2022, at 2:39 p.m., the nurse manager (NM 2) for the OR stated that site marking should be visible after a patient is prepped and draped for surgery, and during the "time out". NM 2 stated the "time out" should not be performed before the patient is prepped and draped. NM 2 stated the surgery should start right away, after the "time out" is called. NM 2 stated after the patient has been prepped and draped for surgery, the sterile should not be moved to maintain a sterile field.

During an interview, on 7/19/2022, at 3:52 p.m., RN 3 stated site marking should be visible after the patient is prepped and draped. In addition, RN 3 stated the surgeon should not leave the OR after calling the "time out." RN 3 stated a patient should prepped and draped for surgery prior to calling the "time out" and surgery should start at that time.

A review of the facility's policy and procedure (P&P), titled "Universal Protocol for Preventing Wrong-Site, Wrong-Procedure, and Wrong Person Invasive or Surgical Procedure," dated 9/2013, indicated the purpose was to promote patient safety by proving guidelines for verification of correct side, correct procedure, and correct patient for invasive/surgical procedure(s) as well as any regional anesthesia.
Policy, Section C, indicated the following including;
"2. All patients having an invasive/surgical procedure involving right/left distinction, multiple structure (e.g. fingers, toes) or multiple levels (e.g. spinal surgery), must have their site marked.
7. The operating physician or physician performing the procedure must do the site marking.
8. The site must be marked with an approved skin marker that must be visible after the skin prep and drape are applied.
12. Once the patient has been prepped and draped and the site is visible, a "time out" will be performed prior to the incision or start of the procedure to validate the following, including the correct patient identity, the correct side and site markings...
The "time out" will be done in the location where the procedure is to be performed, immediately before the start of the case."

Procedure, Section C: Site Mark, indicated the following including;
"1. The site must be marked with an approved skin marker prior to the patient being transferred to the procedure/operating room. The marking must be done by the physician performing the procedure with he participation of the patient as appropriate unless the anatomical site is exempt from marking.
2. Placement of the mark (initials) with the patient or legal representative involved partly in the procedure shall occur prior to moving patient into the operating room (OR) suite or procedure room.
5. A site mark must be made at or adjacent to the incision site, with "initials" and must be visible after the patient is prepped and draped.
6. The site will not be marked with the letter "X" or the word "No."
Section D: Time Out, indicated the following, including;
3. A verbal "Time Out" must be done in the location where the procedure is to be performed, immediately before the start of the procedure (after the patient is draped and prior to the incision or start of procedure) by the entire surgical/procedural team.
5. Site marking must be visible during the "time out"."

A review of the facility's policy and procedure (P&P), titled, "Gowning, Gloving and Draping," dated 6/2020, indicated all patients undergoing a surgical procedure will be draped according to area of surgical intervention. This will be done using protective drapes and sterile technique to create an area of asepsis (absence of bacteria).

Based on interview and record review, the facility failed to ensure a a medical history and physical examination was completed no more than 30 days before or within 24 hours after admission for one of thirty sampled patients (Patient 27) prior to Patient 27's surgical procedure.

This deficient practice had the potential for surgical staff to be unaware of any underlying health conditions.

Findings:

During a concurrent interview and record review for Patient 27, on 7/20/2022, at 10:46 p.m., with the director of risk management (DRM), the DRM stated Patient 27 was admitted to the facility for a left orchiopexy (a surgery to move the testicle into the scrotum and permanently fix it there). The DRM verified history and physical (H&P) examination in the medical record was not dated or time. The DRM also verified the history and physical exam were not assessed by the physician. The DRM stated no update to the H&P was performed or documented in the medical record. The DRM stated the H&P had to be completed prior to surgery and the surgeon and staff are aware of the any potential health conditions before the surgery.

A review of Patient 27's History and Physical (H&P), undated and un-timed, indicated Patient 27 was an eight (8) year old male with a LUDT (left undescended testicle) and the plan was to perform a left orchiopexy. There was no other documentation in the H&P.

A review of the facility's policy and procedure (P&P), titled "Guidelines for Medical Record Entries," dated 10/2013, indicated all medical records should be dated and signed. A complete medical History and Physical examination shall be completed by a physician for all patients no more than thirty (30) days prior to or within twenty-four (24) hours of admission. For a medical History and Physical that was completed within thirty (30) days prior to admission, an updated History and Physical examination shall be documented to reflect any changes to the patient's condition and shall be completed within twenty-four (24) hours after admission or prior to surgery/invasive procedure.

Based on interview and record review, the facility failed to document which side a surgical procedure was to be performed in the informed consent for one of thirty sampled patients (Patient 28), prior to Patient 28's surgical procedure.

This deficient practice had the potential for the patient to be uninformed of which side of the body the surgical procedure would be operated on.

Findings.

During a concurrent interview and record review on 7/20/2022, at 11 a.m., with the director of risk management (DRM), Patient 28's medical record was reviewed. The director of risk management (DRM) stated Patient 28 was admitted to the facility with a diagnosis of a right ectopic pregnancy (a fertilized egg that implants outside the uterus [womb]) with hemoperitoneum (bleeding in the abdomen). The DRM verified Patient 28's surgical consent did not indicate whether the right or left fallopian tube would be removed. The DRM stated the surgical consent needs to indicate which side would be operated on.

A review of Patient 28's operative report, dated 6/13/2022, at 4:43 a.m., indicated Patient 28 was admitted to the facility with a diagnosis of a right ectopic pregnancy with hemoperitoneum.

A review of the surgical consent, dated 6/13/2022, at 3:15 a.m., indicated Patient 28 consented to a laparotomy salpingectomy (surgery to remove fallopian tube). The side was not documented on the consent.

A review of the facility's policy and procedure (P&P), titled "Consent/Informed Consent," dated 4/2016, indicated "to document the procedure to include site and side, as obtained from the physician's order. No abbreviations are to be used."