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.

STANFORD HEALTH CARE 300 PASTEUR DRIVE STANFORD, CA 94305 Sept. 27, 2018
VIOLATION: QAPI Tag No: A0263
Based on interview and record review, the hospital failed to perform adequate analysis of and follow-up to 2 of 2 sampled patient deaths (Patients 1 and 2). Refer to A-286 Part 1. This systemic problem resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on interview and record review, the hospital failed to ensure its governing body approved the frequency and details of data collection to be used in the QAPI (quality assessment and performance improvement) program. The deficient practice limited the governing body's role in leading the QAPI program.

Findings:

In an interview and record review on 9/27/18 at 1:18 p.m., the director of accreditation and regulatory affairs (DARA) stated the approval of the data specifications for the quality dashboard in use by the hospital occurred at the Quality, Patient Safety & Effectiveness Committee (QPSEC) on 12/20/17, and that decisions by the QPSEC rolled up to higher level committees and eventually to the governing body. Review of the QPSEC minutes dated 12/20/17 indicated the specifications of the "Quality and Service Dashboard" were presented to the QPSEC, but no approval by the QPSEC was documented. The DARA acknowledged the approval was not documented in the minutes.

Refer to A-309 Part 2 regarding the lack of documented decision-making by the hospital's governing body regarding QAPI.
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to perform adequate analysis of and follow-up to 2 of 2 sampled patient deaths (Patients 1 and 2). For Patient 1, the hospital failed to follow its own policy and state law regarding follow-up to medical device failures. For Patient 2, the hospital failed to address an allegation by one of its own employees that the medical staff had used the wrong type of guidewires (devices used during insertion of tubes into blood vessels), and failed to address a subset of the patient's intraoperative complications during peer review (when another doctor reviews a doctor's work). The hospital also failed to track drug incompatibilities (when drugs interfere with each other), and failed to adopt policies supporting a non-punitive approach to patient safety reporting. The deficient practices had the potential to cause problems to go unrecognized and unchanged for all the hospital's future patients.

Findings:

1. Review of a facsimile transmission (FAX) from the complainant to the California Department of Public Health (CDPH) dated 4/27/18 indicated the complainant was an employee of the hospital . The FAX indicated an unspecified patient had suffered an air embolism (air in the blood) while receiving perfusion (mechanical support of circulation) and died at the hospital during the week of 9/24/17, and a different unspecified patient had a perforated right internal jugular vein while receiving ECMO (extracorporeal membrane oxygenation, a type of perfusion that provides both cardiac and respiratory support) and died at the hospital the week of 9/24/17. The complainant's FAX alleged the use of a straight-tipped guidewire rather than a curved guidewire contributed to the perforated vein. The complainant's FAX indicated the same concerns had already been raised with the hospital administration.

In an interview and record review on 9/24/18 at 9:44 a.m., the lead perfusionist (LP) stated he had reviewed the complainant's allegations and could not find any instances where the standard of care had not been followed. The LP stated Patient 1 was the patient with the air embolus and Patient 2 was the patient with the perforated vein. The LP stated the surgeon rather than the perfusionist was responsible for selecting the type of guidewire and the complainant's allegations regarding physician judgment had been shared with the medical staff. The LP stated the hospital's risk management office and chief quality officer (a physician) were both aware of the complainant's allegations. When the surveyor asked the LP to provide documentation of his follow-up to the allegations, the LP showed the surveyor a printout of a state law specifying the scope of practice of perfusionists as well as printouts from the medical records of Patients 1 and 2. The LP did not provide documentation reflecting an analysis of the care provided at the hospital.

In an interview on 9/24/18 at 11:05 a.m., the assistant vice president of claims and litigation (AVPCL) stated she had reviewed the complainant's allegations and commissioned a review by an outside perfusionist. The AVPCL stated she sent the outside reviewer the medical records of the patients in question, but not the complainant's allegations. The AVPCL stated she later used the complainant's allegations to pose follow-up questions to the outside reviewer.

In an interview and record review on 9/25/18 at 10:02 a.m., the chief risk officer (CRO) stated the review by the outside perfusionist was subject to attorney-client privilege, so the surveyor could read a redacted copy during the limited time the CRO was available, but the hospital would not provide an unredacted copy or provide a copy to the surveyor for subsequent review. Time-limited review of a heavily redacted letter from a redacted outside reviewer dated 6/26/18 indicated the review did not address the circumstances surrounding Patient 1's air embolism or Patient 2's vascular perforation.

In an interview on 9/25/18 at 4:02 p.m., the chief medical officer (CMO) stated the redacted portions of the outside review pertained to an individual's management style and the interaction between tubing size and pressures in the perfusion circuit. The CMO did not indicate that the redacted portions pertained to Patients 1 or 2.

Review of invoices from a redacted vendor to the AVPCL regarding "Perfusion Consultation" dated 3/4/18, 3/31/18, 5/2/18, and 6/26/18 indicated the invoices listed the initials of the patients the consultant had reviewed. The initials of Patients 1 and 2 were not included on the invoices.

Review of Patient 1's medical record indicated a "Procedure Note" dated 9/4/17 stated, "...the decision was made to remove the oxygenator [a membrane that adds oxygen and removes carbon dioxide from a patient's blood] from the RVAD [right ventricular assist device, a pump used to boost a patient's weak right ventricle, one of the chambers in the heart] system... when applying a stopcock there was an audible cracking sound. We noted blood dripping from around this connector, and saw that air was being entrained. This air created an air-lock, which stopped the RVAD from circulating. The patient quickly became bradycardic [low heart rate] and hypotensive [low blood pressure]. We attempted to remove the air from the circuit which was not effective. We then brought in a new RVAD circuit with oxygenator." A "Death Summary" dated 9/7/17 indicated, "...patient had a PEA [pulseless electrical activity, when the heart is generating electrical signals but is not pumping blood] arrest 9/4 following oxygenator removal from the RVAD with air entry into the circuit... never recovered neurologic function... the patient's family made the decision to withdrawal [sic] care..."

Review of a medical staff peer review (when another doctor reviews a doctor's work) regarding Patient 1 dated 10/9/17 indicated a failure of the stopcock was a possibility and the surgeon had adequate experience to change the circuit. The review indicated the event would be included in trending data regarding the surgeon and that internal reporting of adverse events would be reviewed. The peer review did not discuss follow-up to the suspected medical device failure with the hospital's biomedical engineering department, the manufacturer, or the FDA (Food and Drug Administration, the federal agency that regulates medical devices).

Review of the hospital policy "Medical Devices Incident Investigation and Reporting Policy (SMDA) [Safe Medical Devices Act, a federal law requiring reporting of medical device failures]" (3/2014) indicated, "When any employee or physician becomes aware that a medical device has or may have caused or contributed to the death, serious illness or injury or other significant adverse experience of a patient, he/she should immediately contact Attending Physician, Risk Management, and Clinical Technology & Biomedical Engineering. In an addition, an incident report must be completed... As part of the investigation, the device itself (along with the packaging), if not within the patient's body, should be isolated and labeled and sent to [CTBE] with a request to inspect the device for malfunction... The employee or his/her supervisor should contact [CTBE] and Risk Management and inform them that an Incident Report Involving a device that may fall under the FDA reporting requirements has been completed and requires investigation by CTBE... If the result of the device investigation shows a reasonable likelihood that device failure has or may have caused or contributed to a death or serious illness or injury or other significant adverse experiences, Risk Management should be immediately notified... Risk Management will be responsible for any reporting requirements to regulatory agencies or manufacturers... Under SMDA, reports must be sent to the FDA (in the event of patient death) or the manufacturer (for serious illness or injury or other significant adverse experience)..."

Review of the California Health & Safety Code, Section 1279.1 indicated, "A health facility... shall report an adverse event to the department [California Department of Public Health] no later than five days after the adverse event has been detected... 'adverse event' includes any of the following... Patient death or serious disability associated with the use or function of a device in patient care in which the device is used or functions other than as intended."

Review of Patient 2's medical record indicated an "Operative Report" dated 9/28/17 stated the patient had a history of radiation to the chest and was having cardiogenic shock (inadequate circulation due to heart problems). The report indicated Patient 2 was brought to the operating room for circulatory support, where lines were placed in the right femoral artery and vein and superficial femoral artery (blood vessels in the groin). The report indicated the surgical team started ECMO using the blood vessels in the groin, but were not able to achieve adequate blood flow, so added additional lines in the right subclavian vein (a blood vessel in the chest), and the right and left internal jugular veins (blood vessels in the neck). The report indicated there were still "significant problems with our flows and the right atrium was collapsed, and there was likely a mediastinal [inside the chest] hematoma [collection of blood] compressing the right-sided vascular structures. The decision was made to emergently open the patient's chest... The bleeding... was around the... trifurcation of the internal jugular vein, innominate vein, and superior vena cava [blood vessels inside the chest]... there was a major vascular injury of that venous confluence which was densely adhesed and scarred in... In addition, there seemed to be an arterial injury of the innominate artery and potentially the [DIAGNOSES REDACTED] [blood vessels inside the chest]. In addition, during the resuscitation and sternotomy [opening the chest], the patient had a right femoral venous Cordis [a brand of vascular catheter] placed... the anesthesiologist noticed that we were no longer able to flow through this Cordis anymore, and we also noticed that the patient's abdomen was tense. I then opened up the diaphragm and was met by frank large volume hemoperitoneum [blood in the abdominal cavity]. We attempted to repair the vascular injuries... but it became apparent... that we would not be able to gain control of the full extent of these injuries... the patient expired." The operative report did not indicate what types of guidewires were used.

Review of a medical staff peer review regarding Patient 2 dated 12/11/17 indicated Patient 2's head and neck tissue were abnormal as a result of prior radiation therapy for cancer, and no further action was required. The review did not address the types of guidewires used, nor did it address the vascular injuries in Patient 2's abdomen.

Review of an undated "RCA [root cause analysis] Tracker" indicated the document listed RCAs performed by the hospital during the period 7/17/17 through 7/7/18. None of the incidents listed matched Patient 1 or Patient 2.

In an interview and record review on 9/26/18 at 11:50 a.m., the senior quality consultant (SQC) stated there had not been much additional follow-up to Patients 1 and 2 beyond what the hospital had already presented to the surveyor. Review of an e-mail dated 9/26/18 from the clinical quality specialist to the SQC indicated for Patient 1, the hospital's adverse event escalation card was reviewed with the cardiothoracic surgery department. The e-mail indicated Patient 2 "did not go to full review" and there were no documents found regarding additional follow-up.

Review of a "M&M [morbidity and mortality] CASE REVIEW WORKSHEET" dated 9/25/17 regarding Patient 1 indicated it included a summary of Patient 1's hospital stay. A section labeled "Brief Description of the Findings During M&M Review of Case" had handwritten notes stating, "death [right arrow] PPEC [professional practice evaluation committee, a committee responsible for performing peer review]". No additional analysis of Patient 1's case was present.

Review of a "M&M CASE REVIEW WORKSHEET" dated 10/16/17 regarding Patient 2 indicated it included a summary of Patient 2's hospital stay. The section labeled "Brief Description of the Findings During M&M Review of Case" was blank. No additional analysis of Patient 2's case was present.

In an interview on 9/27/18 at 11:47 a.m., the vice president of quality, safety, and clinical excellence stated there had been no incident reports or root cause analyses regarding Patients 1 or 2. The LP stated during Patient 1's care, there had been a crack in a tubing connector which introduced air into the RVAD circuit. The LP stated he reviewed the incident, and the perfusionists did what they should have done, which is to change the connector and get the air out of the circuit quickly. The LP stated he was not privy to the medical staff reviews of the incident. The LP stated the complainant's allegations regarding a stiff wire causing Patient 2's perforated veins had not been substantiated, then stated those allegations had not been discussed in his area. The LP stated Patient 1's failed device had been thrown out at the time of the incident, and the incident had not been reported.

Review of the hospital's "ECMO Task Force" agendas dated 3/1/18 and 8/23/18 indicated the ECMO task force reviewed deaths on ECMO.

In an interview and record review on 9/27/18 at 1:37 p.m., the director of critical care quality (DCCQ) stated the ECMO task force had been started in 9/17, partially in response to the episodes involving Patients 1 and 2. He stated the ECMO task force did not have minutes, but there were copious notes. Review of records shown to the surveyor by the DCCQ on his laptop indicated they included an undated "ECMO Task Force Tracker" which included "ECMO Case Review" as one of the action items. The tracker indicated that item was in progress; the notes indicated, "Case review with clinical plan identified and linked to ELSO [Extracorporeal Life Support Organization, a non-profit consortium of healthcare entities which has published national guidelines regarding ECMO]. The "ECMO Task Force Tracker" did not mention Patients 1 or 2. Review of an undated line listing of ECMO patients shown to the surveyor by the DCCQ indicated it included listings for Patients 1 and 2, which included demographic information and a description of each patient's clinical course. No analysis regarding the appropriateness of care or potential preventable causes of adverse outcomes was present for Patients 1 or 2. The DCCQ stated there was nothing in his computer records regarding the appropriateness of care for Patients 1 and 2, and the ECMO task force was not the venue for such discussions, which occurred at departmental M&M conferences or the PPEC. The DCCQ stated he would check if there was any further information regarding Patients 1 and 2 in his handwritten notes. When the DCCQ was challenged by the surveyor regarding the apparent discrepancy between his comments that the committee had been chartered to address issues identified during the care of Patients 1 and 2 and his comments that the committee had not reviewed the appropriateness of care for Patients 1 and 2, the DCCQ stated the task force reviewed deaths in the context of establishing criteria to initiate ECMO.

In an interview on 9/27/18 at 3:10 p.m., the SQC stated the DCCQ had no further notes regarding Patients 1 or 2.

In an interview during the exit conference on 9/27/18 at 3:25 p.m., the director of accreditation & regulatory affairs (DARA) stated he did not have access to the minutes of the M&M conferences at which Patients 1 and 2 were discussed. The CMO stated the hospital would have provided any additional information it had. The DARA stated he was under the impression that only misuse and not malfunctions of medical devices were reportable under state law.

2. Review of a "QPSEC [Quality, Patient Safety, & Effectiveness Committee] Reporting Profile -2018" (revised 9/7/18) indicated the pharmacy department reported to the QPSEC in March, and the pharmacy & therapeutics committee (P&TC) reported to the QPSEC in March, June, and September. Review of the QPSEC minutes dated 3/21/18, the QPSEC agendas dated 6/20/18 and 9/19/18, and the attachments from the pharmacy department and P&TC presented at each meeting indicated there was no mention of drug incompatibilities.

Review of the "Medication Safety/Adverse Drug Events Committee" minutes dated 9/12/18, the P&TC minutes dated 3/16/18 and 6/15/18, and the P&TC agenda dated 9/21/18 indicated there was no mention of drug incompatibilities at the hospital.

In an interview on 9/27/18 at 1:59 p.m., the DARA stated the hospital did not track drug incompatibility events separately.

3. Review of the hospital policy "Adverse Event Reporting-SAFE [Stanford Alerts for Events]" (9/1/14) indicated the policy did not address a non-punitive approach to adverse event reporting. In an interview on 9/24/18 at 3:15 p.m., the SQC stated she could not find language regarding a non-punitive approach in the adverse event reporting policy either. The SQC stated she would ask human resources if the issue was addressed in another policy. In an interview on 9/24/18 at 3:42 p.m., the SQC stated there was no policy regarding a non-punitive approach to adverse event reporting.

Review of a an undated, untitled binder provided by the hospital to the surveyor on 9/26/18 indicated it included an undated document titled "Compliance Department & Privacy Office" which contained contact information and indicated, "...Stanford Health Care [has] a policy that protects against retaliation for reporting a compliance or privacy concern in good faith or for cooperating with a compliance or privacy investigation with good intentions." The policy mentioned in the contact information was not attached.
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
Based on interview and record review, the hospital failed to have a current QAPI (quality assessment and performance improvement plan) approved by the governing body, and failed to document the governing body's decisions regarding QAPI. The deficient practices limited the governing body's involvement in the QAPI program, thereby creating the potential for a lack of direction and focus of the hospital's QAPI efforts.

Findings:

1. Review of the QAPI plan presented by the hospital indicated it was titled "Performance Improvement Plan 2016", was approved by the governing body's "Credentials, Policies and Procedures Committee" (CPPC) in July 2016, and discussed the hospital's goals for the 2016 fiscal year.

In an interview and record review on 9/26/18 at 12:09 p.m., the senior quality consultant (SQC) stated the 2018 plan was under review and waiting to be signed. Review of two additional policies presented by the SQC indicated both were titled "Performance Improvement Plan", and both had removed references to a specific year from the title of the policy. The approvals section of both documents indicated they had been approved by members of the quality department in May 2018, after they had been approved by the CPPC in July 2016, the same date that the CPPC had approved the "Performance Improvement Plan 2016". When the surveyor asked the SQC how it was possible that the governing body had approved a draft policy two years earlier than the departmental approvers, the SQC stated there must have been a misunderstanding.

2. Review of the "Board of Directors Quality and Service Committee" (QSC) meeting minutes dated 4/24/18 indicated quality topics were discussed; no decisions were documented other than approval of minutes from prior meetings. Review of the QSC meeting agenda dated 9/12/18 indicated five categories and 14 subcategories of quality topics would be discussed at the meeting. The only agenda item requiring action by the QSC was approval of the prior meeting's minutes.

Review of the "Board of Directors" meeting minutes dated 11/15/17, 1/31/18, and 4/25/18 indicated discussions held at the QSC were discussed further at the board. No decisions related to quality were documented in any of the minutes.

In an interview on 9/25/18 at 4:02 p.m., the chief medical officer stated the chair of the QSC was heavily involved in issues of quality, but he was not sure how he could prove that. In an interview and record review on 9/26/18 at 12:45 p.m., the SQC stated she had discussed the issue of documenting the governing body's decision-making regarding quality with the former acting vice president of quality, and had brought a note with her reply. Review of an undated, untitled adhesive note presented by the SQC indicated, "How decisions are documented - may be opportunities to improve on documentation."
VIOLATION: OFF-CAMPUS EMERGENCY POLICIES AND PROCEDURES Tag No: A0094
Based on interview and record review, the hospital failed to adopt policies addressing emergencies other than code blue (when a person stops breathing or has a cardiac arrest) at its clinics away from the main hospital campus. The deficient practice had the potential to create delays for patients experiencing an off-campus emergency on hospital property, not rising to the severity of code blue.

Findings:

Review of the policies presented by the hospital in response to a surveyor request for policies pertaining to off-campus emergencies indicated they included a policy titled "EMTALA - Compliance With Emergency Medical Treatment and Active Labor Act (EMTALA)" (EMTALA policy, revised 9/1/15) and a second policy titled "Medical Emergency Code Blue Response" (code blue policy, approved 6/30/16). Review of the EMTALA policy indicated it did not apply to off-campus departments. Review of the code blue policy indicated it did not address lesser emergencies.

In an interview on 9/26/18 at 12:09 p.m., the Manager of Nursing Quality and Practice stated the EMTALA policy and the code blue policy were the only policies the hospital had regarding emergencies away from the main hospital campus.