The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

EL CAMINO HOSPITAL 2500 GRANT ROAD MOUNTAIN VIEW, CA 94040 June 21, 2019
VIOLATION: MEDICAL STAFF Tag No: A0338
Based on interview and record review, the hospital failed to ensure 2 of 3 sampled medical staff (Providers 2 and 3) had data regarding the quality of their work considered at the time of reappointment. For 1 of 3 sampled medical staff (Provider 1), the hospital failed to ensure the quality data considered at the time of reappointment was accurate. For 1 of 3 sampled medical staff (Provider 3), the hospital failed to ensure the physician met its own experience requirements for renewing privileges (a list of procedures a physician is allowed to perform). For 1 of 3 sampled medical staff (Provider 1), the hospital failed to ensure the provider had demonstrated current competence in procedures for which it renewed privileges. Refer to A-340. For 1 of 3 sampled medical staff (Provider 1), the hospital failed to verify the physician's compliance with two of five requirements (assistant initials on scheduling form, physician signature on scheduling form) of a focused professional practice evaluation (FPPE) implemented in response to two adverse events. For an additional one of five requirements (name of a radiologist on the pre-operative note) of the FPPE, the hospital failed to consistently document the results of its own verifications. The hospital failed to document that it had implemented follow-up recommendations from its Care Review Committee (CRC) regarding Provider 1's compliance with FPPE for 2 of 16 sampled CRC meetings. Refer to A-347. The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.
VIOLATION: MEDICAL STAFF PERIODIC APPRAISALS Tag No: A0340
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure 2 of 3 sampled medical staff (Providers 2 and 3) had data regarding the quality of their work considered at the time of reappointment. For 1 of 3 sampled medical staff (Provider 1), the hospital failed to ensure the quality data considered at the time of reappointment was accurate. For 1 of 3 sampled medical staff (Provider 3), the hospital failed to ensure the physician met its own experience requirements for renewing privileges (a list of procedures a physician is allowed to perform). For 1 of 3 sampled medical staff (Provider 1), the hospital failed to ensure the provider had demonstrated current competence in procedures for which it renewed privileges. The deficient practices eliminated or ignored multiple sources of information regarding what procedures the medical staff being considered for reappointment had experience doing, and the quality of that work. The deficient practices therefore undermined the usefulness of the credentialing process at the hospital, thereby creating the potential for patients to receive care from physicians who did not have recent experience performing the procedures in question, or who had track records demonstrating poor quality.

Findings:

Review of Provider 1's credentials file indicated he was reappointed to the hospital's medical staff on 11/8/17. Provider 1's delineation of privileges (DOP, requested 7/18/17, approved 11/8/17) indicated Provider 1 was granted privileges to perform carotid endarterectomy (removal of plaques from an artery in the neck), laser surgery, and microvascular anastomosis (attaching small blood vessels) even though he had not performed these procedures in the last two years. No information was present in the file regarding other means by which Provider 1 had demonstrated current competence in these procedures, nor was there any indication Provider 1 would be proctored when he performed them. A "Practice Evaluation Profile" dated 2nd through 4th quarters 2016 indicated Provider 1's inpatient mortality rate was 0.45%, in spite of the numerator being zero and the denominator being 19. The profile indicated Provider 1's bleeding complications were zero patients out of 108, but were nevertheless occurring in 0.33% of patients.

In an interview on 6/20/19 at 1:56 p.m., the Director of Medical Staff Services (DMSS) stated there were no criteria for a minimum number of cases "in this case" but that other DOP's had a minimum number on the form. The DMSS stated if a surgeon had not a done a type of procedure recently, her office suggested proctoring. When the surveyor asked how a numerator of zero could result in a percentage greater than zero, the DMSS stated a consultant was working on the quality data, and the hospital had changed the systems used to calculate the data.

Review of Provider 2's credentials file indicated he was reappointed to the hospital's medical staff on 5/8/19. No recent data regarding the quality of Provider 2's work was in the file.

In an interview on 6/20/19 at 3:44 p.m., the DMSS acknowledged there was no OPPE (ongoing professional practice evaluation, a commonly used name for quality data) in Provider 2's file.

Review of Provider 3's credentials file indicated she was reappointed to the hospital's medical staff on 4/10/19. No OPPE was present in Provider 3's file. Provider 3's DOP indicated she was granted privileges in neurophysiological monitoring (tests measuring the function of the nervous system). Provider 3's DOP did not specify how often she had performed neurophysiological monitoring recently; the DOP indicated the hospital required a minimum of 20 cases in the past 24 months. An undated case log was present, indicating Provider 3 had performed one case for the hospital on [DATE]. No other information was present in the file regarding Provider 3's recent experience.

In an interview on 6/21/19 at 9:57 a.m., the DMSS acknowledged there was no OPPE for Provider 3. The DMSS stated she was disappointed that there were not activity reports showing Provider 3 had met the minimum number of cases.
VIOLATION: MEDICAL STAFF ACCOUNTABILITY Tag No: A0347
Based on interview and record review, for 1 of 3 sampled medical staff (Provider 1), the hospital failed to verify the physician's compliance with two of five requirements (assistant initials on scheduling form, physician signature on scheduling form) of a focused professional practice evaluation (FPPE) implemented in response to two adverse events. For an additional one of five requirements (name of a radiologist on the pre-operative note) of the FPPE, the hospital failed to consistently document the results of its own verifications. The hospital failed to document that it had implemented follow-up recommendations from its Care Review Committee (CRC) regarding Provider 1's compliance with FPPE for 2 of 16 sampled CRC meetings. The deficient practices undermined the credibility of the medical staff's own mechanisms for holding its members accountable for the quality of care, had the potential to cause the hospital's corrective action to the adverse events to not be implemented for future patients, and thereby increased the risk that they would recur.

Findings:

Refer to A-951 Part 1 regarding Patient 1's wrong site surgery by Provider 1. Refer to A-286 Part 2 regarding a discrepancy between the consent and the procedure performed by Provider 1 for Patient 35.

1. Review of a letter from the CRC Chair to Provider 1 dated 7/15/17 indicated, "In order to assist you, and to prevent another wrong-side surgery, we request that you implement the following: In every case for which an imaging study has been performed, you will write a note in the EMR [electronic medical record] just before the procedure documenting the Radiologist who wrote the report you read, or with whom you reviewed the findings. This will assure that you have not only reviewed the images, but also the report (or the verbal report with the Radiologist if the final report is not yet transcribed)."

Review of a letter from the CRC Chair to Provider 1 dated 4/3/18 indicated, "the following will be added to the FPPE [focused professional practice evaluation] requirements: 1. The handwritten surgery scheduling form will be correlated with the dictated note and initialed by your assistant. 2. Prior to final scheduling your assistant will confirm correct procedure with you and you will sign off. 3. You will review and sign the consent but also review and initial the consent form in the portion describing the procedure to be performed at time of your signing the consent."

Review of a letter from the CRC Chair to Provider 1 dated 6/6/18 indicated, "in your documentation in the EMR just before the procedure, in addition to documenting the Radiologist who wrote the report that you read, or with whom you reviewed the findings; you are required to also document the exact surgical procedure, surgical site, right or left side, and levels if the spinal column is involved and ensure that this corresponds with the informed consent."

Review of a letter from the CRC Chair to Provider dated 6/3/19 indicated, "At its April 23, 2019 meeting, the CRC concluded that the FPPE should be discontinued at this time based upon your successful fulfillment of all requirements."

Review of a spreadsheet titled "Data Tracking January 2019 - Present" indicated it contained the results of chart reviews regarding Provider 1's compliance with FPPE. 23 of 23 chart reviews did not contain an entry in the column labeled "FPPE Met". 23 of 23 chart reviews included a "Note Time" which indicated a note was written prior to the "Actual Start Time"; however none of the chart reviews indicated whether or not the note documented the name of a radiologist, the name of the procedure, the side of the procedure, or whether those matched the consent. 22 of 23 chart reviews indicated a spinal procedure was performed; none of the chart reviews indicated whether or not the pre-operative note documented the level of the spinal procedure or confirmed that the level matched the consent. None of the 23 chart reviews addressed FPPE requirements regarding the scheduling form.

Review of an undated, untitled spreadsheet indicated it contained chart reviews of Provider 1's compliance with FPPE for 2018. 1 of 41 chart reviews contained a "Y" in the column labeled "FPPE Met"; the remaining 40 of 41 chart reviews did not indicate whether or not the FPPE had been met. The spreadsheet did not indicate whether or not immediate pre-operative notes documented the name of a radiologist. None of the 32 chart reviews for dates of service after 6/6/18 indicated whether or not the pre-operative note had documented the name or side or spinal level of the procedure or whether these matched the consent. None of the 32 chart reviews addressed FPPE requirements regarding the scheduling form.

In an interview on 6/19/19 at 12:43 p.m., the Director of Medical Staff Services (DMSS) acknowledged the monitoring spreadsheets had some blanks and that there was nothing regarding the scheduling requirements. In an interview on 6/20/19 at 10:17 a.m., the DMSS stated the hospital could not monitor Provider 1's compliance with requirements regarding scheduling forms since those were completed at his office. When the surveyor asked whether they were reviewed once they were sent to the hospital, the DMSS replied that the hospital does not keep the scheduling forms. The DMSS stated the Medical Director of Quality (MDQ) was supposed to complete the column labeled "FPPE Met" but the MDQ would just say his findings at the CRC meetings.

Review of CRC minutes dated 6/26/18 indicated Provider 1 "continues to show lack of understanding of documentation improvements required. Committee recommends clarification to practitioner with brief bulleted points and provision of sample documentation where detailed notes are missing. Draft another letter form [sic] CRC chair and provide only the areas to focus on for improvement." The minutes did not clarify what information was missing or how it could be improved.

Review of the documentation provided by the hospital regarding Provider 1's FPPE as well as Provider 1's credentials file indicated there were no letters from the CRC chair between 6/26/18 and 6/3/19.

Review of a "Monthly Status Report to Care Review Committee" dated 7/1/18 indicated "Concern with how MD is documenting progress note to reflect item #1 above [name of radiologist who reviewed the imaging study]. Note states name of radiologist..." An attached spreadsheet indicated 15 of Provider 1's charts had been reviewed. For 10 of 15 charts, the "FPPE Met" column was blank; for 3 of 15 charts, the "FPPE Met" column had the letter "N"; for 1 of 15 charts the "FPPE Met" column had the letter "Y". The report did not clarify the apparent contradiction between the statements that Provider 1's notes did document the name of a radiologist, but yet there was concern regarding how he was documenting the name of the radiologist.

Review of CRC minutes dated 7/24/18 indicated Provider 1 "Continues to have same issues and areas of concern noted. Discussed the criteria and intent of the FPPE. Committee was provided an example of practitioner's documentation and discussed whether there is valid reason to require additional information. Conclusion - Compliant with criteria of the FPPE and speak with the practitioner of what may make the documentation clearer to the reviewers." The minutes did not clarify what the specific concern was, provide the example which was discussed, or clarify why the concern was dismissed.

Review of the documentation provided by the hospital regarding Provider 1's FPPE as well as Provider 1's credentials file indicated there was no documentation of a discussion with Provider 1 regarding the 7/24/18 CRC meeting.

In an interview on 6/19/19 at 12:56 p.m., the DMSS stated there was no letter sent to Provider 1 after the 6/26/18 CRC meeting. The DMSS stated the MDQ may have met with Provider 1.

In an interview on 6/20/19 at 12:36 p.m., the MDQ stated he went over Provider 1's compliance with FPPE at each CRC meeting based on the monitoring spreadsheets. The MDQ clarified the concern was that although Provider 1 was compliant with the requirement to state the name of the radiologist and the radiologist's conclusion via templates in the EMR which automatically carried forward that information from elsewhere, he felt Provider 1 needed to integrate those findings into his own words in order to demonstrate that he was processing the findings. The MDQ stated follow-up which the CRC requested was done verbally and with a follow-up letter, except when the CRC asked him to discuss, which he did. The MDQ stated the only documentation of what he had just described was the CRC meeting minutes, the monitoring spreadsheets, the status reports to the CRC, and the FPPE letters to Provider 1.
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on interview and record review, the hospital failed to implement its own policies during the care of 1 of 34 sampled patients (Patient 1) when diagnostic imaging was not reviewed during marking of the surgical site, when diagnostic imaging was not displayed during the time out (a pause just before surgery to verify everything is correct), and when there were no efforts made to reconcile a count discrepancy (missing surgical item) beyond obtaining an x-ray. The hospital also failed to ensure its policies regarding prevention of wrong site surgery reflected current standards of practice by incorporating a pre-operative briefing with review of imaging. Refer to A-951. The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.
VIOLATION: SURGICAL PRIVILEGES Tag No: A0945
Based on interview and record review, the hospital failed to delineate specific surgical privileges (a list of procedures a doctor is allowed to do) for 2 of 3 sampled medical staff (Providers 1 and 2). The deficient practice eliminated the hospital's ability to customize privileges according to the skills of each physician.

Findings:

Review of the credentials files for Providers 1 and 2 indicated both were neurosurgeons. Both DOP's (delineations of privileges) indicated the physician was granted "Core Privileges in Neurosurgery: Core privileges in neurological surgery include... surgical treatment of patients of all ages presenting with illnesses, injuries, and disorders of the central and peripheral nervous system, including their supporting structures and vascular supply." Nine more specific surgical procedures were listed on each physician's DOP.

In an interview on 6/20/19 at 10:17 a.m., when the surveyor pointed out that everything plus nine is not a specific delineation, the Director of Medical Staff Services replied, "This is the current structure of the privileges."
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on interview and record review, the hospital failed to implement its own policies during the care of 1 of 34 sampled patients (Patient 1) when diagnostic imaging was not reviewed during marking of the surgical site, when diagnostic imaging was not displayed during the time out (a pause just before surgery to verify everything is correct), and when there were no efforts made to reconcile a count discrepancy (missing surgical item) beyond obtaining an x-ray. The hospital also failed to ensure its policies regarding prevention of wrong site surgery reflected current standards of practice by incorporating a pre-operative briefing with review of imaging. The deficient practices contributed to Patient 1 receiving surgery on the wrong side, and increased the risk of retained surgical items and wrong site surgeries for future patients.

Findings:

1. Review of Patient 1's medical record indicated Patient 1 received a CT scan (computed tomography, a computer constructs cross-sectional images of the body from multiple x-rays) of his head on 1/4/17 at 12:09 p.m. due to head trauma. The CT scan result dated 1/4/17 at 12:36 p.m. indicated Patient 1 had an "extensive" left subarachnoid hemorrhage (blood in a space between the inner and middle layers of three membranes covering the brain), "Several parenchymal hemorrhages" (bleeding inside the brain) on both sides of the brain, rightward midline shift (pressure pressing the brain toward the right), an effaced left lateral ventricle (squeezing of a hollow space on the left side of the brain), and "a soft tissue contusion [bruise] overlying the right parietal skull" (the sides and roof of the skull). The CT scan result did not mention subdural hematomas (blood between the middle and outer layers of three membranes covering the brain) on either side of the brain.

Review of Patient 1's "Consent to Surgical and/or Medical Procedures" dated 1/4/17 indicated Patient 1 would receive "RIGHT FRONTO-PARIETAL [front, top, and side of the skull] CRANIOTOMY [opening the skull] WITH EVACUATION OF ACUTE SUBDURAL HEMATOMA" performed by Provider 1.

Review of Patient 1's "Full Operative Report" dated 1/7/17 indicated Patient 1 had bilateral craniotomies performed by Provider 1 on 1/4/17. The report indicated, "CT scan of the head demonstrated evidence of severe head trauma, characterized by bilateral subdural hematoma, left greater than right... The patient was positioned with a bolster under the right shoulder and the head turned to the left [position for surgery on the right side of the skull]... a frontotemporal parietal [names of three bones in the skull] craniotomy was performed. A large Pacchionian granulation [a growth of the middle membrane layer] was present in the right frontal area... A small subdural hematoma was noted in the temporal area [side and base of the skull]... At this point, the CT scan of the brain was reviewed. It was evident that in fact the larger subdural hematoma and contusion was on the left... The drapes were then removed and that [sic] the patient repositioned with a bolster under the left shoulder and the head turned to the right... An essentially identical procedure was then performed... The dura [outer layer of three membranes covering the brain] was opened and inspection revealed the markedly contused [bruised] brain with a large amount of blood in the subarachnoid space in addition to what appeared to be venous infarcts [damage caused by inadequate blood flow] and a significant subdural hematoma..." The operative report did not address marking of the surgical site or review of images while marking the surgical site.

Review of Patient 1's "Surgery Report" (intraoperative nursing record) dated 1/4/17 indicated the timeout was conducted on 1/4/17 at 3:31 p.m. The section of the "Surgery Report" labeled "Timeout Questions" included the notations, "Site marked? Yes... Radiology studies available? N/A [not applicable]". The "Patient Preparation" section of the "Surgery Report" indicated the right side of Patient 1's head was prepared for surgery.

In an interview on 6/19/19 at 8:59 a.m., Provider 1 stated Patient 1 had bilateral subdural hematomas, but was consented to evacuate the right subdural hematoma. Provider 1 stated he had discussed the possibility of doing both sides with Patient 1's son. When Provider 1 realized during surgery on the right side that the right subdural hematoma was small and the left was larger, he did both sides. When the surveyor asked why the consent was for the right side when the plan was to do both sides, Provider 1 replied that he thought he could get away with doing just the right side, but in retrospect the consent should have said bilateral. When the surveyor asked why he would evacuate only the right subdural hematoma when the left was larger, Provider 1 stated he would have done the left, but transposed the sides. Provider 1 stated the radiology report was not in the chart at the time of the surgery and the patient was deteriorating. Provider 1 stated Patient 1's CT scan was available in the OR (operating room). Provider 1 stated he had looked at the CT scan in the emergency department (ED), and reviewed it again after performing the surgery on Patient 1's right side. When the surveyor asked Provider 1 if he had reviewed the CT scan in the OR prior to starting Patient 1's surgery, Provider 1 replied that he had just left the ED, and had looked at the CT scan there.

In an interview on 6/19/19 at 11:00 a.m., the President of the radiology group (PRG) stated Patient 1's 1/4/17 head CT showed a subarachnoid hemorrhage on the left, bilateral brain contusions, "maybe a little" subdural hematoma on the right, another subdural hematoma on the left, parenchymal hemorrhages, a scalp hematoma on the right, mild to moderate rightward shift of the brain, and evidence of increased intracranial (inside the skull) pressure on the left. The PRG stated the 1/4/17 CT scan report had correctly captured the salient features of the head CT.

In an interview on 6/21/19 at 1:42 p.m., Provider 1 stated the site marking of Patient 1 was done before he was brought into the OR, but was not done in the emergency department. Provider 1 stated there were "no images up" during the site marking. When the surveyor asked Provider 1 whether Patient 1's CT scan was displayed during the time out, Provider 1 stated the team re-read Patient 1's consent during the time out.

Review of the hospital policy "Universal Protocol Verification & Site Marking (Correct Site Procedure Site Marking)" (approved 4/15) indicated, "Before marking the site, verify the patient's identity, consent, medical records data, including radiographs and history and physical as applicable, to confirm accuracy.. The Boarding Pass is a sign off verifying that components of correct site have been completed. They include... Relevant images - properly labeled and displayed... Just prior to any invasive or surgical procedures, a "TIME-OUT" will be conducted using active communication. Time outs will include... Address the following standard information... Confirm the relevant images and results are properly labeled and appropriately displayed..."

2. Review of Patient 1's "Full Operative Report" (dictated 1/6/17) indicated Patient 1 had a right craniotomy (opening in the skull), followed by a left craniotomy, both on 1/4/17, both performed by Provider 1. Review of Patient 1's "Surgery Report" indicated the final count of "Needles/Sharps" for "Procedure 1" was incorrect because there was a missing needle. The report indicated an x-ray was performed and the surgeon was notified. The "Needles/Sharps" count for "Other" indicated the "FINAL COUNT ON LEFT SIDE" was correct. Patient 1's imaging result for "XR [x-ray] Lost Device or Image" dated 1/4/17 indicated the missing needle was not located by the x-ray. Patient 1's "Surgery Report" made no mention of other efforts (beyond the x-ray) to reconcile the discrepancy. Patient 1's "Full Operative Report" made no mention of the count discrepancy or the efforts to reconcile the discrepancy.

In an interview on 6/18/19 at 1:05 p.m., the Director of Critical Care Services (DCCS) stated she did not see any discussion of the missing needle in the "op note" (the full operative report). In an interview on 6/18/19 at 1:24 p.m., the DCCS stated she was searching for a note regarding the incorrect count. In an interview on 6/18/19 at 1:25 p.m., the DCCS stated she couldn't find anything else in Patient 1's medical record regarding the count discrepancy.

In an interview on 6/19/19 at 8:59 a.m., Provider 1 stated reconciling count discrepancies was the hospital nursing staff's responsibility. Provider 1 stated, "If the x-ray shows it's not in the head, then we accept it's elsewhere." Provider 1 did not state that the surgeon would inspect the surgical site in the event of a missing item.

In an interview on 6/19/19 at approximately 2:30 p.m., the Director of Risk Management and Patient Safety stated the 2012 policy regarding counts was in effect in 1/17.

Review of the hospital policy "SURGICAL COUNTS, SPONGES, SHARPS, INSTRUMENTS AND OTHER SPECIFIED ITEMS, PERFORMING" (5/12) indicated it referenced AORN (Association of periOperative Registered Nurses) guidelines. The policy indicated, "The location of items used in and around the sterile field is the shared responsibility of the surgeon and surgical team... Incorrect or questionable counts... A thorough search is conducted in the O.R. [operating room] The Charge Nurse is immediately informed to assist with the search/retrieval process... If missing item is not found, the Attending Surgeon is notified... It is the responsibility of the Attending Surgeon to inspect the surgical site for the retained Foreign Body (Sponge, Needle, Instrument etc.) before closing the incision... If the missing item is not found, an X-Ray is ordered... The Attending Surgeon must document in the patient chart that it is permissible for the patient to leave the OR suite when a Missing Foreign Body event has occurred and is irreconcilable... The RN [registered nurse] Circulator will document an incorrect count on the Peri-Operative Record. Documentation of action will be recorded in the Peri-Operative Nursing Record to include: 1. Name of the Radiologist reading the final x-ray with interpretation 2. Any additional interventions..."

Review of the AORN Guideline for Prevention of Retained Surgical Items (effective 1/15/16) indicated, "Unresolved count discrepancies must be documented in the patient's record, including all measures taken to recover the missing item, description and location of the item if known, patient notification and consultation, and the plan for follow-up care."

In an interview on 6/19/19 at 2:44 p.m., the DCCS stated she had spoken to the OR Manager, who stated the resolution to an incorrect count is imaging. The DCCS stated if an item is missing, the hospital does a follow-up x-ray and files an incident report. The DCCS did not state any other efforts beyond obtaining an x-ray would be made.

3. Review of the hospital policy "Universal Protocol Verification & Site Marking (Correct Site Procedure Site Marking)" (approved 4/15) indicated it referenced AORN guidelines. The policy required pre-operative verification "of the correct site, procedure, and patient"; site marking; a "Boarding Pass" documenting components of the verification; and "Just prior to any invasive or surgical procedures, a 'TIME-OUT'". The policy did not describe a pre-operative briefing of the entire surgical team.

Review of the AORN Guideline for Team Communication (effective 1/15/18) indicated a pre-operative briefing was recommended in addition to pre-procedure verification, site marking, and time out. The guideline indicated, "The health care organization should establish and implement a standardized briefing process before the surgical procedure. The collective evidence supports the use of briefings to improve teamwork and team communication and improve the quality of patient care by increasing efficiency, decreasing interruptions and delays, and improving patient outcomes. Briefing improves team communication by allowing teams to develop a shared mental model... Although evidence supports the performance of the time out just before the incision, further research is needed to determine the ideal timing for the briefing... The briefing process should include... the consent signed; the planned procedure and side; the goals of the procedure... a review of laboratory results and radiographs... questions, safety concerns..."

In an interview on 6/20/19 at 1:12 p.m., the Medical Director of Quality stated the hospital was considering instituting a pre-operative briefing, but he did not know if the hospital would do so.
VIOLATION: OPERATING ROOM REGISTER Tag No: A0958
Based on interview and record review, the hospital did not have an operating room register. This had the potential of missed surgeries performed by the surgery unit.

Findings:

During an interview and record review on 6/20/19 at 12:39 p.m. with the O.R. Clinical Manager, she stated the hospital does not have an operatiing room register which have all the required information in the register.
VIOLATION: OPERATIVE REPORT Tag No: A0959
Based on interview and record review, for 4 of 34 sampled patient records (Patients 1, 15, 20, 25), the hospital failed to ensure the operative report describing the techniques used during surgery was written or dictated immediately following surgery. When the operative report for Patient 1 was dictated, it failed to describe efforts taken to reconcile a discrepancy in surgical counts (inventories of surgical items conducted during surgery to ensure none are unintentionally left inside the patient). The deficient practices had the potential to cause inaccurate operative reports and lack of awareness by other providers of what had transpired during surgery. The deficient practices limited accountability regarding efforts to prevent retained surgical items.

Findings:

1. Review of Patient 1's medical record indicated it included a "Surgery Report" dated 1/4/17 which indicated Patient 1 was brought to the operating room on 1/4/17 at 2:31 p.m., had surgery on 1/4/17 from 3:32 p.m. to 7:54 p.m., and left the operating room on 1/4/17 at 8:18 p.m. The "Surgery Report" did not describe the techniques used during surgery. A "NEUROSURGERY POST PROCEDURE NOTE" created on 1/4/17 at 8:25 p.m. was present which indicated the names of the surgeries which had been performed, but did not describe the techniques used during surgery. A "Full Operative Report" was present which described the techniques used during surgery; the "Full Operative Report" indicated it was dictated on 1/6/17 at 3:49 p.m., over 24 hours following completion of the surgery.

In an interview on 6/18/19 at 1:05 p.m., the Director of Critical Care Services (DCCS) acknowledged the full operative report had been dictated on 1/6/17. In an interview on 6/18/19 at 1:25 p.m., the Quality Review Coordinator acknowledged the full operative report had been dictated two days after Patient 1's surgery.

During an interview and record reviews on 6/19/19 at 1:22 p.m., the Infection Prevention Director confirmed Patients 15, 20, and 25 did not have operative reports in their charts and should have had them within 24 hours after their operative procedures.

Review of the hospital's policy "Operative Report" dated 2/2017 indicated "an operative report describing techniques, findings, and tissues removed or altered must be entered into the electronic health record or dictated within 24 hours of surgery and signed by the surgeon".

2. Review of Patient 1's "Full Operative Report" (dictated 1/6/17) indicated Patient 1 had a right craniotomy (opening in the skull), followed by a left craniotomy, both on 1/4/17. Review of Patient 1's "Surgery Report" indicated the final count of "Needles/Sharps" for "Procedure 1" was incorrect because there was a missing needle. The report indicated an x-ray was performed and the surgeon was notified. The "Needles/Sharps" count for "Other" indicated the "FINAL COUNT ON LEFT SIDE" was correct. Patient 1's imaging result for "XR [x-ray] Lost Device or Image" dated 1/4/17 indicated the missing needle was not located by the x-ray. Comparison of the "Surgery Report" to the "Full Operative Report" indicated the "Full Operative Report" made no mention of the count discrepancy or the efforts to reconcile the discrepancy.

In an interview on 6/18/19 at 1:05 p.m., the DCCS stated she did not see any discussion of the missing needle in the "op note" (the full operative report).

In an interview on 6/19/19 at approximately 2:30 p.m., the Director of Risk Management and Patient Safety stated the 2012 policy regarding counts was in effect in 1/17.

Review of the hospital policy "SURGICAL COUNTS, SPONGES, SHARPS, INSTRUMENTS AND OTHER SPECIFIED ITEMS, PERFORMING" (5/12) indicated it referenced AORN (Association of periOperative Registered Nurses) guidelines. The policy indicated, "Incorrect or questionable counts... A thorough search is conducted in the O.R. [operating room]... If missing item is not found, the Attending Surgeon is notified... It is the responsibility of the Attending Surgeon to inspect the surgical site for the retained Foreign Body (Sponge, Needle, Instrument etc.) before closing the incision... If the missing item is not found, an X-Ray is ordered..." The policy indicated the surgeon was responsible for documenting incorrect counts in the post-op note when the surgeon waived an x-ray. The policy did not address documentation in the post-op note when the surgeon did not waive an x-ray.

Review of the AORN Guideline for Prevention of Retained Surgical Items (effective 1/15/16) indicated, "Unresolved count discrepancies must be documented in the patient's record, including all measures taken to recover the missing item, description and location of the item if known, patient notification and consultation, and the plan for follow-up care."
VIOLATION: CONTRACTED SERVICES Tag No: A0084
Based on interviews, the hospital failed to have a mechanism to evaluate the quality of a contracted service and incorporate it with their QAPI plan. This had the potential of provision of unsafe contracted service.

Findings:

During an interview on 6/19/19 at 3:30 p.m. with director of Maternal Child Health (DMCH) and clinical manager of Neonate ICU (CM), they stated they do not conduct onsite visits to one of the contracted service which provided breast milk to their patients. They further stated this contracted service is an FDA approved contractor and had a license to provide such service.

DMCH and CM did not provide any documentation indicating onsite visits were conducted and well as integration of the quality reports to their QAPI.
VIOLATION: PATIENT RIGHTS: ADVANCED DIRECTIVES Tag No: A0132
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to document in 1 of 34 sampled patient records (Patient 1) that it had provided written notice of the patient's rights regarding advance directives. The deficient practice limited accountability that the hospital was providing required notices, thereby creating the potential for patients to be unaware of their rights regarding advance directives.

Findings:

Review of Patient 1's medical record indicated Patient 1 was admitted on [DATE]. Patient 1's "Nursing Screening Assessments" flowsheet indicated on 1/5/17 at 8:00 a.m., hospital staff were unable to assess whether Patient 1 had an advance directive or wanted information on advance directives. The flowsheet indicated on 1/5/17 at 11:00 a.m., Patient 1's son stated Patient 1 did not have an advance directive and did not want information about advance directives. The flowsheet did not document that Patient 1 or his family had been given a notice of Patient 1's rights regarding advance directives.

In a concurrent interview and record review on 6/18/19 at 2:04 p.m., the Director of Critical Care Services (DCCS) stated patient rights notices were contained in a "Hello/Goodbye" folder given to each patient. When the surveyor asked the DCCS if the booklet titled "Your Hospital Stay" (7/18) was the "Hello/Goodbye" folder, the DCCS stated it was. Review of the "Your Hospital Stay" booklet indicated it did include notices regarding each patient's right to formulate advance directives as well as a summary of the hospital's policies regarding advance directives. Review of Patient 1's patient education flowsheets indicated they included a section labeled "Topic/Hello Goodbye". The section included entries dated 1/5/17 through 1/14/17 addressing medications, features of the room, pain management, infection control, skin care, smoking cessation, fall prevention, patient belongings, discharge planning, and prevention of urinary tract infections. There was no documentation that Patient 1 or his family had been given the "Your Hospital Stay" booklet or any other notice regarding advance directives. The DCCS stated there was no documentation in Patient 1's medical record that the patient rights packet, otherwise known as the hello/goodbye folder, had been given, only that policies other than advance directives had been gone over.

In an interview on 6/19/19 at 4:18 p.m., the DCCS stated there was no documentation that Patient 1 had been given the hello/goodbye folder.
VIOLATION: QAPI Tag No: A0263
Based on interview and record review, for 2 of 4 sampled adverse events (Patients 1 and 35), the hospital failed to identify and correct problems with its own implementation of existing policies in addition to addressing lapses in physician judgment. Refer to A-286. The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, for 2 of 4 sampled adverse events (Patients 1 and 35), the hospital failed to identify and correct problems with its own implementation of existing policies in addition to addressing lapses in physician judgment. The deficient practice increased the risk of similar adverse events recurring for future patients.

Findings:

1. Refer to A-951 Part 1 regarding the hospital's failure to ensure diagnostic imaging was reviewed during marking of the surgical site and displayed during the time out (a pause just before surgery to verify everything is correct) during care of Patient 1 by Provider 1, as well as Patient 1 receiving surgery on the wrong side.

In an interview on 6/19/19 at 9:36 a.m., the Director of Risk Management & Patient Safety (DRMPS) stated the hospital had not done a root cause analysis (RCA) regarding Patient 1's surgery. The DRMPS stated the patient had in fact received surgery on the right side as indicated on Patient 1's consent form, and the surgeon had stated it was his plan to do bilateral surgery. The DRMPS stated the hospital had therefore concluded the matter should be addressed through peer review (a mechanism for addressing problems with physician judgment) rather than a formal RCA (a mechanism for addressing systems issues at the hospital).

In an interview on 6/19/19 at 8:59 a.m., Provider 1 stated the hospital's corrective action in follow-up to Patient 1 included requiring Provider 1 to document review of the relevant imaging study as well as the presence of a radiologist's report just before starting surgery for future patients. Provider 1's description of the hospital's corrective action did not address review of imaging studies during marking of the surgical site or displaying them during the time out.

Review of a letter from the Chair of the Care Review Committee to Provider 1 dated 7/15/17 indicated, "In order to assist you, and to prevent another wrong-side surgery, we request that you implement the following: In every case for which an imaging study has been performed, you will write a note in the EMR [electronic medical record] just before the procedure documenting the Radiologist who wrote the report you read, or with whom you reviewed the findings. This will assure that you have not only reviewed the images, but also the report (or the verbal report with the Radiologist if the final report is not yet transcribed)." The letter did not address review of images during surgical site marking or display of images during the time out.

2. Review of the hospital's Care Review Committee (CRC) minutes dated 2/9/18 indicated Patient 35 had surgery at the hospital on [DATE]. The minutes stated Patient 35's consent was inaccurate regarding both procedure and level. During the time out after the patient was anesthetized, Provider 1 noted the discrepancies and performed the procedures indicated on Patient 35's H&P (medical history and physical exam) rather than those listed on Patient 35's consent. The CRC concluded that there were opportunities for improvement in Provider 1's practices as well as "multiple system errors that need to be addressed..." The minutes described how the CRC would follow up regarding Provider 1, but did not address follow-up to the system issues that the CRC had identified.

Review of a letter from the CRC Chair to Provider 1 dated 4/3/18 indicated, "the following will be added to the FPPE [focused professional practice evaluation] requirements: 1. The handwritten surgery scheduling form will be correlated with the dictated note and initialed by your assistant. 2. Prior to final scheduling your assistant will confirm correct procedure with you and you will sign off. 3. You will review and sign the consent but also review and initial the consent form in the portion describing the procedure to be performed at time of your signing the consent." The letter did not indicate what actions, if any, the hospital would take to address system issues broader than Provider 1's practice.

In an interview on 6/20/19 at 12:36 p.m., the Medical Director of Quality (MDQ) stated the usual process at the hospital was for the surgeon to place an order in the computer for the nurse to complete the consent form. The MDQ stated Provider 1 was required to sign and initial the consent form. In an interview on 6/20/19 at 1:12 p.m., the MDQ stated the CRC had thought about whether the nurse or anesthesiologist should have performed differently in Provider 1's cases the CRC had reviewed, and they concluded it was the surgeon's responsibility. The MDQ did not further explain what the systems issues referenced in the 2/9/18 CRC minutes were, or how they had been addressed.

In an interview on 6/21/19 at 2:02 p.m., the Director of Accreditation, Regulatory & Public Reporting stated none of the members of the CRC had contacted the Chief Nursing Officer or Director of Risk Management regarding the system issues raised in the 2/9/18 CRC, all the attendees were physicians, and the hospital did not follow up.

Refer to A-951 Part 2 regarding the hospital's failure to conduct pre-operative briefings as recommended by national guidelines.
VIOLATION: QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT Tag No: A0308
Based on interviews and record reviews, the governing body failed to have oversight over the quality of a contracted service and incorporate it with their QAPI plan. This had the potential of provision of unsafe contracted service.

Findings:

During an interview on 6/19/19 at 3:30 p.m. with director of Maternal Child Health (DMCH) and clinical manager of Neonate ICU (CM), they stated they do not conduct onsite visits to one of the contracted service which provided breast milk to their patients. They further stated this contracted service is an FDA approved contractor and had a license to provide such service.

DMCH and CM did not provide any documentation indicating onsite visits were conducted and well as integration of the quality reports for this particular contractor were reported to their QAPI program.