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.

KAISER FOUNDATION HOSPITAL-SANTA CLARA 700 LAWRENCE EXPRESSWAY SANTA CLARA, CA 95051 Nov. 9, 2018
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on interview and record review, the hospital failed to comply with the Condition of Participation for Patient's Rights as evidenced by:

1. Failure to honor a patient's desire to not remove her ovaries as outlined in the surgical consent (refer to A131).

2. Failure to inform a patient regarding placement of an expired hip implant (a device used to keep an incision open during surgery) (refer to A131).

3. Failure to inform a patient regarding a retained foreign object (surgical complication resulting from foreign materials accidentally left in a patient's body) of a needle in the abdominal cavity (refer to A131).

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 RIGHTS: INFORMED CONSENT Tag No: A0131
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure patient' rights were honored for three of 30 sampled patients (Patients 1, 3 and 5). Patient 3's instruction in the surgical consent to not remove her ovaries (an organ found in the female reproductive system that produces eggs) was not followed. Patient 1 was not informed of having an expired hip implant (medical device used to replace a body part) placed. Patient 5 was not informed of having a retained foreign object (RFO, surgical complication resulting from a foreign material accidentally left in a patient's body) of a needle in her abdominal cavity. The failure of removing the ovaries without consent caused distress to Patient 3. The failure of not informing patients regarding the expired implant and RFO resulted in patients not fully understanding their course of treatment.

Findings:

1. Review of Patient 3's surgical consent form, dated 4/25/18, indicated the patient agreed to undergo a hysterectomy (a surgery to remove all or part of the uterus [the organ in the lower body of a woman where offspring are conceived and in which they gestate before birth]) and bilateral (both sides) salpingectomy (a surgical removal of fallopian tubes, which allow eggs to travel from the ovaries to the uterus) with an instruction to preserve ovaries.

Review of Patient 3's Operative Note, dated 4/25/18, indicated the procedures performed was "Robot assisted laparoscopic (a surgical procedure in which a fiber-optic instrument is inserted through the abdominal wall to view the organs in the abdomen or to permit a surgical procedure) Hysterectomy and Bilateral salpingo oophorectomy (removal of fallopian tubes and ovaries)"

Review of the telephone appointment progress notes dated a day after surgery indicated Patient 3 was "upset" regarding having her ovaries removed as she had intended to keep them.

During an interview on 11/8/18 at 10:55 a.m., registered nurse (RN) A, who reviewed the record, confirmed Patient 3's surgical consent indicated to preserve the ovaries but the surgery had the ovaries removed.

2. Review of Patient 1's Long Operative Report (LOP), dated 3/2/18, indicated Patient 1 underwent surgery including right total hip arthroplasty (also known as total hip replacement whereby the diseased cartilage and bone of the hip joint is replaced with artificial materials, or implants). The LOP indicated the femoral head (head of the femur, the highest part of the thigh bone resembling a ball) implant that was used in surgery, had expired on [DATE].

Review of Patient 1's Discharge Summary, dated 3/5/18, indicated Patient 1 had an infection on the right hip and "Right hip infection seems more chronic."

During an interview on 11/8/18 at 9:15 a.m., RN A, who reviewed the record, did not find documentation of Patient 1 being informed about the expired implant and stated the patient should have been informed.

3. Review of Patient 5's operative report, dated 2/23/18, indicated she underwent a robot assisted laparoscopic procedure including myomectomy, tubal ovarian lysis of adhesions (removal of uterine and ovarian fibroids) and morcellation of pelvic mass (removal of soft scar tissue to treat a complication or to prevent a future problem).

Review of Patient 5's Anesthetic Record (notation of the administration of anesthetic agents, fluids, blood products, and other medications and for recording vital signs, anesthetic, and surgical interventions, and airway maintenance), dated 2/23/18, indicated at 6:05 p.m., the surgical wound was reopened to search for a needle.

During an interview on 11/6/18 at 10:40 a.m., RN B who reviewed Patient 5's clinical record, stated there should have been and there was no documentation indicating Patient 5 was informed about having her surgical wound reopened to remove the missing needle.

During an interview on 11/7/18 at 11:15 a.m., the anesthesiologist (ANE), who attended to Patient 5's surgery, stated the surgeon had to reopen the surgical wound to retrieve a missing needle.

Review of "PATIENT RIGHTS AND RESPONSIBILITIES" policy, dated 11/7/17, indicated the hospital was to provide considerate and respectful care focused upon the patient's individual needs, wishes, and beliefs. It indicated patients have the right to receive information from the physician about the illness, the course of treatment, and the prospects for recovery in terms that the patient can understand. The patients have the right to receive as much information about any proposed treatment or procedure as the patient may need in order to give informed consent or to refuse this course of treatment.
VIOLATION: QAPI Tag No: A0263
Based on interview and record review, the hospital failed to comply with the Condition of Participation for Quality Assessment and Performance Improvement Program (QAPI), as evidenced by:

1. Failure to complete a comprehensive systematic analysis (CSA) as required by its own policy for a medication error which was associated with a transfusion reaction for Patient 3 (refer to A286).

2. Failure to expand the training and audits it conducted in follow-up to 3 of 6 sampled surgical adverse events (Patients 2, 4, and 5) to its ambulatory surgery unit (ASU) (refer to A286).

3. Failure to conduct audits of vendor compliance with the hospital's decision to require a non-expired implant plus a backup following an adverse event (Patient 1) in which an expired implant was used on a patient (refer to A286).

4. Failure to conduct audits specific to practices the hospital identified as contributing to 2 of 6 sampled surgical events (Patients 2 and 3) (refer to A286).

5. Failure to ensure 1 of 3 sampled peer reviews (regarding Patient 5) addressed concerns regarding the provider's documentation (refer to A286).

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
Based on interview and record review, the hospital failed to:
1) complete a comprehensive systematic analysis (CSA) as required by its own policy for a medication error which was associated with a transfusion reaction for Patient 31;
2) expand the training and audits it conducted in follow-up to 3 of 6 sampled surgical adverse events (Patients 2, 4, and 5) to its ambulatory surgery unit (ASU);
3) conduct audits of vendor compliance with the hospital's decision to require a non-expired implant plus a backup following an adverse event (Patient 1) in which an expired implant was used on a patient;
4) conduct audits specific to practices the hospital identified as contributing to 2 of 6 sampled surgical events (Patients 2 and 3);
5) ensure 1 of 3 sampled peer reviews (regarding Patient 5) addressed concerns regarding the provider's documentation.

The deficient practices limited the hospital's ability to ensure the problems it had identified as causing or contributing to surgical adverse events did not recur and therefore had the potential to cause similar problems on future patients.

Findings:

1. Review of Patient 31's "ICU [intensive care unit] Attending [supervising physician] Progress Note" dated 4/25/18 indicated, "Developed dyspnea and wheezing shortly after starting PRBC [packed red blood cells] transfusion... BP [blood pressure] increased. Transfusion stopped. Improved symptomatically with bronchodilators and benedryl [sic]... Discussed possible transfusion reaction with Path[ology]... Definite concern for hemolysis [bursting of red blood cells] which appears to have been present prior. Transfusion was mixed with D5W [5% dextrose in water] which is against transfusion policy due to theoretical concern for hemolysis. Clinically, patient's presentation c/w [consistent with] TRALI [transfusion related acute lung injury, a rare but potentially fatal complication of blood transfusion]..."

Review of a "TRANSFUSION REACTION INVESTIGATION" dated 4/25/18 regarding Patient 31 indicated, "Clinical behavior of acute respiratory distress, pulmonary edema, acutely worsening chest X ray at time of transfusion makes this suspicious for TRALI... Also, coinfusion with D5 noted, unclear if this is reason for hemolysis vs. underlying medical condition causing hemolysis. An acute hemolysis transfusion reaction cannot be excluded." The investigation report did not address underlying causes or corrective actions regarding the coadministration of the transfusion with D5W.

In an interview and record review on 11/6/18 at 10:59 a.m., the ICU Assistant Manager stated there had been a supply mix-up such that D5W had been comingled with other types of IV (intravenous) fluids. She stated the different IV fluids had been separated, the nurses had been instructed to double check the type of IV fluid, and the topic had been covered in weekly huddle meetings. Review of a "WEEKLY HUDDLE For the week of May 6th" provided by the ICU Assistant Manager indicated, "Last week we had a blood transfusion reaction. When the tubing was sent down to lab it was noted that the blood was hung with dextrose. Luckily the patient was ok. Please remember in addition to checking the blood product, you need to double check the fluids to ensure we are hanging with NS [normal saline]". When the surveyor asked how the patient was OK if he developed TRALI, the ICU Assistant Manager replied that he survived and did not need a ventilator. When the surveyor asked if there had been additional analysis of the event or follow-up audits, the ICU Assistant Manager replied that there was nothing written down.

Review of the hospital policy "EVENT MANAGEMENT" (effective 7/24/18) indicated, "Definitions... Sentinel Events: A patient safety event (not primarily related to the natural course of the patient's illness or underlying condition) that reaches a patient and results in death, permanent harm, severe temporary harm, and other defined events... Significant events include systems issues referred by quality... Comprehensive Systematic Analysis (CSA) is the process used to identify the causal and contributing factors associated with an event. The most common form of a CSA is a root cause analysis, which focuses on systems and processes... The medical center will conduct a CSA on all Sentinel Events. The process will utilize performance improvement methods and tools to identify cause(s) of variation or deviation in system performance. Based on identified causal factors, an action plan will be developed and implemented in order to reduce the risk of a similar event occurring in the future... The medical center will complete an investigation on all significant events... An action plan will be developed based upon the results of the investigation... Copies of the final CSA or investigation and action plan will be filed... Paper files of sentinel, significant, and other events will be maintained by the medical center for 10 years..."

2. Review of an "Event Analysis Summary & Action Plan" dated 4/3/18 indicated Patient 2 had an unintentionally retained wound protector (a device used to keep an incision open during surgery) following a hernia repair on 4/14/17. The hospital's action plan included, "100% of OR [operating room] nurses and Surgical Technicians will be re-educated regarding the Standard Surgical Count process based on the Prevention of Retained Foreign Items Policy. Due date: May 31, 2018... 30 audits... per month will be conducted... to assess for... surgical counts..." Review of the attached documentation indicated "Hallway In-Service" training regarding surgical counts had been conducted in the main OR between 1/25/18 and 4/26/18. No documentation was present indicating the training had also been conducted in the ASU. An undated attachment showing audit results did not specify whether the audits were conducted in the main OR or the ASU.

Review of an undated, untitled document indicated Patient 4 had fallen off the OR table on 5/4/18. The document indicated, "The importance of verbally communicating to the team that no one leave the patient's side UNTIL the patient is secure with seat belts has been discussed weekly in huddles." Review of eight attached documents regarding the training on fall prevention (dated 5/7/18 through 5/31/18) indicated they were all titled "Main OR Morning Huddle Message". There was no documentation indicating the issue had been discussed in the ASU.

Review of an "Event Analysis Summary & Action Plan" dated 4/10/18 indicated Patient 5 had an unintentionally retained needle following gynecologic surgery on 2/23/18. The hospital's action plan included, "100% of... OR nurses and Surgical Technicians will be educated on Prevention of Retained Foreign Items Policy. Due date: June 30, 2018... 100% of all OR staff will be educated on Chain of Command policy. Due Date: May 31, 2018... 30 audits... per month will be conducted... to assess for... surgical counts, escalation concerns... 100% of... OR Nurses will receive an in-service about the accurate documentation of patient care. Due Date: May 31, 2018..." Review of the attached documentation indicated it included training regarding documentation on 5/10/18 in the main OR, training regarding chain of command in the main OR on 3/8/18, and training regarding prevention of retained surgical items in the main OR on 4/12/18. No documentation was present indicating the training had also been conducted in the ASU. An undated attachment showing audit results did not specify whether the audits were conducted in the main OR or the ASU.

In an interview on 11/8/18 at 10:19 a.m., the Area Quality Leader (AQL) stated the findings of the analyses had been shared in the Risk Management and Patient Safety Committee, but there had not been action plans in other areas of the hospital aside from where the incidents had occurred. After the surveyor stated the expectation was to expand the action plan to other areas of the hospital at risk of the same event, the AQL stated the topics had been covered in a Patient Safety Summit on 7/12/18 which included all perioperative staff. The AQL then stated training and audits had been conducted in the ASU, but the documentation had not been included in the packet presented to the surveyor and would be provided.

In an interview on 11/8/18 at 10:50 a.m., the Director of Perioperative Services (DPS) stated hernia repairs were also done in the ASU.

Review of additional documents presented by the AQL indicated they included thirty documents titled "Main OR Morning Huddle Message" with dates ranging from 2/23/18 through 5/31/18. None of the documents indicated they pertained to training or audits in the ASU.

Review of a PowerPoint presentation titled "Periop Patient Safety Summit 7/12/18" indicated it described how deviations from policies and procedures resulted in an adverse event for Patient 2. The PowerPoint did not, however, review the surgical count process. Slide 20 of the PowerPoint presentation indicated a "Video Demonstration of Surgical Safety Practices" was available and provided a web address. The surveyor's attempt to access the video at the web address provided resulted in a message that the video was unavailable.

3. Review of an "Event Analysis Summary & Action Plan" dated 3/23/18 indicated Patient 1 had an expired prosthetic hip implanted on 3/2/18. The hospital's analysis concluded the causal factors included failure by the vendor to verify the expiration date of the implant prior to bringing it to the hospital and failure of the vendor to have a back-up implant available at the time of surgery. The hospital's "Action Item(s)" included, "Vendors to verify products are not expired... Vendor to bring a backup of all products." The hospital's analysis indicated the measure of success of the action items regarding the vendor would be "Periop[erative] Director to contact Vendor to inform of event. - Completed". There was no documentation indicating the hospital had audited the vendor's compliance with its request to only bring unexpired items and to have a backup available for all implants.

In an interview on 11/8/18 at 10:33 a.m., the DPS stated the hospital had conducted audits regarding whether its own staff called out the expiration date of implants before introducing them onto the sterile field, but had not conducted audits of the vendor bringing unexpired items and backups.

4. Review of the "Event Analysis Summary & Action Plan" dated 4/3/18 regarding Patient 2 indicated the hospital had identified "variable surgical count practices, specifically for miscellaneous items" as a causal factor for the retained wound protector; "Some OR nurses place the wound retractor on the count board and some do not." The hospital's action plan included, "30 audits of Highly Reliable Surgical Team (HRST) rounds per month will be conducted... to assess for... surgical counts..." Review of an undated "HRST Rounding Tool" indicated the tool included checks of whether closing was announced and music was stopped, whether the final count was completed before closing, whether wound or cavity exploration was performed, and whether a RF (radio frequency) scan was done before closing to confirm the count. The HRST tool did not pose questions regarding whether or not miscellaneous items had been properly counted.

In an interview on 11/8/18 at 11:25 a.m., the surveyor asked the DPS how the audit tool addressed consistency of miscellaneous counts. The DPS replied that there had been "lots of education" on the topic.

Review of an "Event Analysis Summary & Action Plan" dated 4/27/18 indicated Patient 3 received the wrong surgery on 4/25/18. The hospital's analysis indicated inconsistencies in documentation regarding the planned procedure and distraction during the pre-operative briefing and time out were causal factors. The hospital's "Action Item(s)" included having nurse practitioners (NPs) check for inconsistencies regarding planned procedures between progress notes, the pre-operative history and physical exam, and the consent form. The action items also included posting a surgical safety checklist in each operating room. The action plan indicated the hospital would measure its success implementing the NP cross checks by educating the NPs on the process. The plan did not indicate there would be any assessment of whether or not the NP cross checks were occurring. The action plan indicated the hospital would measure its success regarding distractions during the briefing and time out by conducting training, then conducting "30 audits of Highly Reliable Surgical Team (HRST) rounds per month... to assess for: Briefing, Timeout, and Debriefing." There was no mention of an audit to assess use of the checklist.

Review of a "SURGICAL SAFETY CHECKLIST" (revised 10/27/17) indicated it included sections regarding a briefing before anesthesia, a time out immediately before starting the procedure, counting before the end of surgery, and debriefing before the patient leaves the OR. The briefing section included a requirement for the surgeon to check whether the informed consent was correct.

Review of an undated "HRST Rounding Tool" indicated the tool addressed whether the briefing was initiated by the surgeon; whether there was active engagement by all staff; whether sterility was confirmed; whether procedure specific needs were discussed; whether the time out included the [patient's] name, procedure, and visible site marking; and whether the debriefing included six elements. The audit tool did not address use of the surgical safety checklist, nor did it address the surgeon checking the accuracy of the consent form.

In an interview on 11/8/18 at 11:26 a.m., the DPS stated the hospital was not able to audit the NP cross checks due to workflow. When the surveyor asked how the HRST rounding tool addressed use of the surgical safety checklist, the DPS replied that the active engagement question on the audit tool covered all the steps on the surgical safety checklist; the Quality Director then stated the checklist was part of the time out.

Comparison of the "SURGICAL SAFETY CHECKLIST" to the comments by the DPS and Quality Director indicated the checklist covered more specific requirements than whether or not all personnel were actively engaged, and the time out was one of four sections on the checklist.

5. Review of the "Event Analysis Summary & Action Plan" dated 4/10/18 regarding Patient 5 indicated there had been inaccurate documentation regarding the incident by the surgeon in the patient's medical record.

Review of a "Peer Review Worksheet" dated 5/22/18 regarding Patient 5 indicated one of the issues to be addressed was, "Unable to refute or substantiate allegations of retained surgical needle due to insufficient documentation in electronic medical record." The section titled "Review Findings and Rationale: Must address ALL issues above and provide Rationale for P score" did not address the concern regarding documentation.

In an interview on 11/9/18 at 1:31 p.m., the Director of Quality acknowledged the peer review regarding Patient 5 had not addressed the concern regarding documentation.
VIOLATION: MEDICAL STAFF PERIODIC APPRAISALS Tag No: A0340
Based on interview and record review, the hospital failed to consider whether 1 of 1 sampled anesthesiologists (Provider 4) and 1 of 1 sampled nurse anesthetists (Provider 5) had adequate recent experience in the privileges (a list of procedures a provider is allowed to do) requested before renewing them. The deficient practices eliminated the hospital's ability to only grant privileges to providers to perform those procedures for which they had demonstrated current competence as required by state law and the hospital's own bylaws. The deficient practice therefore had the potential to allow all patients of the affected providers to undergo procedures which their provider was not qualified to perform.

Findings:

Review of the California Code of Regulations, Title 22, section indicated, "(a) The governing body shall:... (7) Require that the medical staff establish controls that are designed to ensure the achievement and maintenance of high standards of professional ethical practices including provision that all members of the medical staff be required to demonstrate their ability to perform surgical and/or other procedures competently and to the satisfaction of an appropriate committee or committees of the staff, at the time of original application for appointment to the staff and at least every two years thereafter."

Review of the hospital's professional staff bylaws (effective 12/4/16) indicated, "Delineation of privileges shall be based at least upon the applicant's training, experience, demonstrated competence, and health status. The applicant's credentials record shall reflect education and/or experience to support the granting of privileges."

Review of Provider 4's credentials file indicated she was reappointed to the hospital's medical staff on 3/4/17 for a two year term. Provider 4's DOP approved 3/4/17 indicated she was granted the anesthesiology core privilege, which included but was not limited to general anesthesia, epidural steroid injections, placement and management of central venous lines, plexus blocks, and ultrasound guided procedures including nerve blocks. The DOP indicated the criteria for granting anesthesiology core privileges at reappointment included, "an adequate volume of experience, including a minimum of 125 Anesthesiology activities/procedures, reflective of the scope of privileges requested within the past 24 months..." Provider 4's credentials file contained a profile dated 7/3/18 which indicated how many cases Provider 4 had performed during the 2nd quarter of 2018 which fell under the core privilege, and how many operating room (OR) procedures she had performed overall during the 1st quarter of 2018. There was no indication how often Provider 4 had performed each of the procedures enumerated in the anesthesiology core privilege; therefore there was no indication that Provider 4's experience reflected the scope of privileges requested and granted.

Review of Provider 5's credentials file indicated he was reappointed to the hospital as a CRNA (certified registered nurse anesthetist) on 9/10/18 for a two year term. Provider 5's DOP dated 9/10/18-9/9/20 indicated Provider 5 requested and was granted privileges listed under the CRNA core "including subarachnoid, epidural, and caudal blocks; IV [intravenous] regional anesthesia..." The DOP indicated the criteria for granting core privileges at reappointment included, "a minimum of 125 CRNA activities/procedures, reflective of the scope of privileges requested, within the past 24 months..." Provider 5's DOP indicated he requested and was granted a special privilege to place and manage arterial lines; the DOP indicated the criteria for granting that privilege at reappointment included "a minimum of 5 placement and management of arterial line activities/procedures, within the past 24 months..." Provider 5's DOP indicated he requested and was granted a special privilege to place and manage central venous lines; the DOP indicated the criteria for granting that privilege at reappointment included "an adequate volume of experience reflective of the scope of privileges requested, within the past 24 months..." Provider 5's DOP indicated he requested and was granted a special privilege to perform "thoracic epidural placement"; the DOP indicated the criteria for granting that privilege at reappointment included "a minimum of 5 thoracic epidural placement activities/procedures, within the past 24 months..." Provider 5's DOP indicated he requested and was granted a special privilege to perform "Basic nerve blocks (such as femoral blocks)"; the DOP indicated the criteria for granting that privilege at reappointment included "a minimum of 10 basic nerve blocks (such as femoral blocks... within the past 24 months..." Provider 5's DOP indicated he requested and was granted a special privilege to perform "Advanced nerve blocks (such as paravertebral blocks)"; the DOP indicated the criteria for granting that privilege at reappointment included "a minimum of 5 advanced nerve blocks (such as paravertebral blocks)... within the past 24 months..." Provider 5's credentials file included no data dated prior to the start of the survey which indicated how many of which procedures he had performed recently.

Review of a facsimile transmission from the hospital dated 11/9/18 indicated it included a profile dated 8/14/18 indicating the number of times Provider 5 had performed any of his core privileges during the 2nd quarter of 2018 as well the number of times Provider 5 had performed any OR procedure during the 1st quarter of 2018. The profile did not indicate how often Provider 5 had performed subarachnoid, epidural, or caudal blocks; arterial lines; central venous lines; thoracic epidural placement; basic nerve blocks; or advanced nerve blocks.

In an interview on 11/9/18 at 10:22 a.m., the Director of Quality stated the hospital did a count of the total number of procedures falling under core and special privileges.
VIOLATION: MEDICAL STAFF CREDENTIALING Tag No: A0341
Based on interview and record review, the hospital failed to consider whether 1 of 1 sampled anesthesiologists (Provider 4) and 1 of 1 sampled nurse anesthetists (Provider 5) had adequate recent experience in the privileges (a list of procedures a provider is allowed to do) requested before renewing them. The deficient practices eliminated the hospital's ability to only grant privileges to providers to perform those procedures for which they had demonstrated current competence as required by state law and the hospital's own bylaws. The deficient practice therefore had the potential to allow all patients of the affected providers to undergo procedures which their provider was not qualified to perform.

Findings:

Review of the California Code of Regulations, Title 22, section indicated, "(a) The governing body shall:... (7) Require that the medical staff establish controls that are designed to ensure the achievement and maintenance of high standards of professional ethical practices including provision that all members of the medical staff be required to demonstrate their ability to perform surgical and/or other procedures competently and to the satisfaction of an appropriate committee or committees of the staff, at the time of original application for appointment to the staff and at least every two years thereafter."

Review of the hospital's professional staff bylaws (effective 12/4/16) indicated, "Delineation of privileges shall be based at least upon the applicant's training, experience, demonstrated competence, and health status. The applicant's credentials record shall reflect education and/or experience to support the granting of privileges."

Review of Provider 4's credentials file indicated she was reappointed to the hospital's medical staff on 3/4/17 for a two year term. Provider 4's DOP approved 3/4/17 indicated she was granted the anesthesiology core privilege, which included but was not limited to general anesthesia, epidural steroid injections, placement and management of central venous lines, plexus blocks, and ultrasound guided procedures including nerve blocks. The DOP indicated the criteria for granting anesthesiology core privileges at reappointment included, "an adequate volume of experience, including a minimum of 125 Anesthesiology activities/procedures, reflective of the scope of privileges requested within the past 24 months..." Provider 4's credentials file contained a profile dated 7/3/18 which indicated how many cases Provider 4 had performed during the 2nd quarter of 2018 which fell under the core privilege, and how many operating room (OR) procedures she had performed overall during the 1st quarter of 2018. There was no indication how often Provider 4 had performed each of the procedures enumerated in the anesthesiology core privilege; therefore there was no indication that Provider 4's experience reflected the scope of privileges requested and granted.

Review of Provider 5's credentials file indicated he was reappointed to the hospital as a CRNA (certified registered nurse anesthetist) on 9/10/18 for a two year term. Provider 5's DOP dated 9/10/18-9/9/20 indicated Provider 5 requested and was granted privileges listed under the CRNA core "including subarachnoid, epidural, and caudal blocks; IV [intravenous] regional anesthesia..." The DOP indicated the criteria for granting core privileges at reappointment included, "a minimum of 125 CRNA activities/procedures, reflective of the scope of privileges requested, within the past 24 months..." Provider 5's DOP indicated he requested and was granted a special privilege to place and manage arterial lines; the DOP indicated the criteria for granting that privilege at reappointment included "a minimum of 5 placement and management of arterial line activities/procedures, within the past 24 months..." Provider 5's DOP indicated he requested and was granted a special privilege to place and manage central venous lines; the DOP indicated the criteria for granting that privilege at reappointment included "an adequate volume of experience reflective of the scope of privileges requested, within the past 24 months..." Provider 5's DOP indicated he requested and was granted a special privilege to perform "thoracic epidural placement"; the DOP indicated the criteria for granting that privilege at reappointment included "a minimum of 5 thoracic epidural placement activities/procedures, within the past 24 months..." Provider 5's DOP indicated he requested and was granted a special privilege to perform "Basic nerve blocks (such as femoral blocks)"; the DOP indicated the criteria for granting that privilege at reappointment included "a minimum of 10 basic nerve blocks (such as femoral blocks... within the past 24 months..." Provider 5's DOP indicated he requested and was granted a special privilege to perform "Advanced nerve blocks (such as paravertebral blocks)"; the DOP indicated the criteria for granting that privilege at reappointment included "a minimum of 5 advanced nerve blocks (such as paravertebral blocks)... within the past 24 months..." Provider 5's credentials file included no data dated prior to the start of the survey which indicated how many of which procedures he had performed recently.

Review of a facsimile transmission from the hospital dated 11/9/18 indicated it included a profile dated 8/14/18 indicating the number of times Provider 5 had performed any of his core privileges during the 2nd quarter of 2018 as well the number of times Provider 5 had performed any OR procedure during the 1st quarter of 2018. The profile did not indicate how often Provider 5 had performed subarachnoid, epidural, or caudal blocks; arterial lines; central venous lines; thoracic epidural placement; basic nerve blocks; or advanced nerve blocks.

In an interview on 11/9/18 at 10:22 a.m., the Director of Quality stated the hospital did a count of the total number of procedures falling under core and special privileges.
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on interview and record review, the hospital failed to comply with the Condition of Participation for Surgical Services as evidenced by:

1. Failure to grant specific surgical privileges (a list of procedures a provider is allowed to do) to 4 of 8 sampled medical staff (refer to A945).

2. Failure to consider procedure-specific experience before granting surgical privileges to an anesthesiologist and a nurse anesthetists (refer to A945).

3. Failure to prevent a retained foreign object (RFO, surgical complication resulting from foreign materials accidentally left in a patient's body) of a wound retractor (a device used to keep an incision open during surgery) resulting in discomfort and a second surgery a year later for removal (refer to A951).

4. Failure to prevent a RFO of a metallic port/trocar (instrument to hold open a body cavity and to insert a camera and/or instrument) requiring a second surgery for retrieval (refer to A951).

5. Failure to prevent a RFO of a needle requiring reopening of the surgical wound for retrieval (refer to A951).

6. Failure to ensure a hip implant (medical device used to replace a body part) was not expired (refer to A951).

7. Failed to clearly state its policy for reconciling discrepancies in surgical counts (refer to A951)

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
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to grant specific surgical privileges (a list of procedures a provider is allowed to do) to 4 of 8 sampled medical staff (Providers 3, 6, 7, and 9) who were instead granted all-encompassing surgical privileges. The hospital also failed to consider procedure-specific experience before granting surgical privileges to 1 of 1 sampled anesthesiologists (Provider 4) and 1 of 1 sampled nurse anesthetists (Provider 5). The deficient practices eliminated the hospital's ability to only grant privileges to providers to perform those surgical procedures for which they had demonstrated current competence as required by state law. The deficient practices therefore had the potential to allow all patients of the affected providers to undergo surgical procedures which their provider was not qualified to perform.

Findings:

Review of the California Code of Regulations, Title 22, section indicated, "(a) The governing body shall:... (7) Require that the medical staff establish controls that are designed to ensure the achievement and maintenance of high standards of professional ethical practices including provision that all members of the medical staff be required to demonstrate their ability to perform surgical and/or other procedures competently and to the satisfaction of an appropriate committee or committees of the staff, at the time of original application for appointment to the staff and at least every two years thereafter."

Review of the hospital's professional staff bylaws (effective 12/4/16) indicated, "Delineation of privileges shall be based at least upon the applicant's training, experience, demonstrated competence, and health status. The applicant's credentials record shall reflect education and/or experience to support the granting of privileges."

1. Review of Provider 3's credentials file indicated he was reappointed to the hospital's medical staff on 5/14/18 for a two year term. Provider 3's AMA (American Medial Association) Physician Profile dated 3/30/95 indicated Provider 3 had completed a general surgery residency in 6/95 and had not completed a subspecialty fell owship. Provider 3's ABMS (American Board of Medical Specialties) Board Certification Credentials Profile dated 10/13/17 indicated Provider 3 was certified as a general surgeon, but his certification had expired on [DATE]. Provider 3's delineation of privileges (DOP) dated 5/14/18-5/13/20 included, "...perform surgical procedures for patients to correct or treat various conditions, diseases, disorders, and injuries of the alimentary [digestive] tract; skin, soft tissues, and breast; endocrine system; head and neck; surgical oncology, trauma, and non-operative trauma; and the vascular system." A more specific list of surgical procedures followed, some of which had check marks next to them. There was no indication that the overarching privilege excluded specifically enumerated procedures unless they were marked.

Review of Provider 6's credentials file indicated he was reappointed to the hospital's medical staff on 8/8/17 for a two year term. Provider 6's AMA Physician Profile dated 6/15/89 indicated Provider 6 had completed an orthopedic surgery residency in 6/90 and had not completed a subspecialty fell owship. Provider 6's reappointment application dated 1/12/17 indicated Provider 6 was board certified as an orthopedic surgeon. Provider 6's DOP dated 8/8/17-8/7/19 included, "Admit, evaluate, diagnose, treat, and provide consultation to patients to correct or treat various conditions, illnesses, and injuries of the extremities, and associated structures by medical, surgical, and physical means, including but not limited to congential deformities, trauma, infections, tumors, metabolic disturbances of the musculoskeletal system, deformities, injuries, and degenerative diseases of the hands, feet, knees, hips, shoulders, and elbows, including primary and secondary muscular problems and the effects of central or peripheral nervous system lesions of the muscuoloskeletal system... Examples of core privileges in this specialty include, but are not limited to, the activities/ procedures outlined below and other activities/procedures that are extensions of the same techniques and skill. This list is not all inclusive..."

Review of Provider 7's credentials file indicated he was reappointed to the hospital's medical staff on 11/12/16 for a two year term. Provider 7's AMA Physician Profile dated 8/5/16 indicated Provider 7 had completed a general surgery residency in 6/12 and a thoracic surgery fell owship in 6/14, and was board certified in general surgery as well as thoracic and cardiac surgery. Provider 7's cardiac surgery DOP dated 8/16/18 indicated, "Core privileges may include, but are not limited to, a common list of conditions, activities, and/or procedures and are not intended to be all-inclusive... Evaluate, diagnose, treat, and provide preoperative, intraoperative, and postoperative surgical care to patients with structural abnormalities involving the heart and major blood vessels, as well as correction or treatment of various conditions of the heart and related blood vessels within the chest, including surgical care of coronary artery disease, abnormalities of the great vessels and heat valves (such as infections, trauma, tumors, and metabolic disorders), and congenital anomalies of the heart." A more specific list of surgical procedures followed, some of which had check marks next to them. There was no indication that the overarching privilege excluded specifically enumerated procedures unless they were marked. Provider 7's thoracic surgery DOP dated 8/16/18 indicated, "Core privileges may include, but are not limited to, a common list of conditions, activities, and/or procedures and are not intended to be all-inclusive... Evaluate, diagnose, and provide operative, perioperative, and critical care to patients with pathological conditions within the chest." A more specific list of surgical procedures followed, some of which had check marks next to them. There was no indication that the overarching privilege excluded specifically enumerated procedures unless they were marked.

Review of Provider 9's credentials file indicated he was reappointed to the hospital's medical staff on 1/10/17 for a two year term. Provider 9's AMA Physician Profile dated 5/10/01 indicated Provider 9 had completed two years of a general surgery residency in 6/98 and had not completed a subspecialty fell owship. Provider 9's reappointment application dated 6/19/18 indicated Provider 9 was board certified in general surgery. Provider 9's delineation of privileges (DOP) dated 10/8/18 indicated, "Core privileges may include, but are not limited to, a common list of conditions, activities, and/or procedures and are not intended to be all-inclusive... perform surgical procedures for patients to correct or treat various conditions, diseases, disorders, and injuries of the alimentary tract; skin, soft tissues, and breast; endocrine system; head and neck; surgical oncology, trauma, and non-operative trauma; and the vascular system." A more specific list of surgical procedures followed, some of which had check marks next to them. There was no indication that the overarching privilege excluded specifically enumerated procedures unless they were marked.

In an interview on 11/9/18 at 10:22 a.m., Provider 9, the chief of surgery, stated the DOP's were regional documents that were intended to cover any and all procedures, except providers were not allowed to do the procedures for which the box next to the name of the procedure had been unchecked. When the surveyor asked Provider 9 where the DOP contained language reflecting what he had just said, Provider 9 did not reply. In an interview on 11/9/18 at 11:04 a.m., the Area Quality Leader stated the DOP's contained general terms to allow flexibility and that it was not feasible to list every surgical procedure.

2. Review of Provider 4's credentials file indicated she was reappointed to the hospital's medical staff on 3/4/17 for a two year term. Provider 4's DOP approved 3/4/17 indicated she was granted the anesthesiology core privilege, which included but was not limited to general anesthesia, epidural steroid injections, placement and management of central venous lines, plexus blocks, and ultrasound guided procedures including nerve blocks. The DOP indicated the criteria for granting anesthesiology core privileges at reappointment included, "an adequate volume of experience, including a minimum of 125 Anesthesiology activities/procedures, reflective of the scope of privileges requested within the past 24 months..." Provider 4's credentials file contained a profile dated 7/3/18 which indicated how many cases Provider 4 had performed during the 2nd quarter of 2018 which fell under the core privilege, and how many operating room (OR) procedures she had performed overall during the 1st quarter of 2018. There was no indication how often Provider 4 had performed each of the procedures enumerated in the anesthesiology core privilege; therefore there was no indication that Provider 4's experience reflected the scope of privileges requested and granted.

Review of Provider 5's credentials file indicated he was reappointed to the hospital as a CRNA (certified registered nurse anesthetist) on 9/10/18 for a two year term. Provider 5's DOP dated 9/10/18-9/9/20 indicated Provider 5 requested and was granted privileges listed under the CRNA core "including subarachnoid, epidural, and caudal blocks; IV [intravenous] regional anesthesia..." The DOP indicated the criteria for granting core privileges at reappointment included, "a minimum of 125 CRNA activities/procedures, reflective of the scope of privileges requested, within the past 24 months..." Provider 5's DOP indicated he requested and was granted a special privilege to place and manage arterial lines; the DOP indicated the criteria for granting that privilege at reappointment included "a minimum of 5 placement and management of arterial line activities/procedures, within the past 24 months..." Provider 5's DOP indicated he requested and was granted a special privilege to place and manage central venous lines; the DOP indicated the criteria for granting that privilege at reappointment included "an adequate volume of experience reflective of the scope of privileges requested, within the past 24 months..." Provider 5's DOP indicated he requested and was granted a special privilege to perform "thoracic epidural placement"; the DOP indicated the criteria for granting that privilege at reappointment included "a minimum of 5 thoracic epidural placement activities/procedures, within the past 24 months..." Provider 5's DOP indicated he requested and was granted a special privilege to perform "Basic nerve blocks (such as femoral blocks)"; the DOP indicated the criteria for granting that privilege at reappointment included "a minimum of 10 basic nerve blocks (such as femoral blocks... within the past 24 months..." Provider 5's DOP indicated he requested and was granted a special privilege to perform "Advanced nerve blocks (such as paravertebral blocks)"; the DOP indicated the criteria for granting that privilege at reappointment included "a minimum of 5 advanced nerve blocks (such as paravertebral blocks)... within the past 24 months..." Provider 5's credentials file included no data dated prior to the start of the survey which indicated how many of which procedures he had performed recently.

Review of a facsimile transmission from the hospital dated 11/9/18 indicated it included a profile dated 8/14/18 indicating the number of times Provider 5 had performed any of his core privileges during the 2nd quarter of 2018 as well the number of times Provider 5 had performed any OR procedure during the 1st quarter of 2018. The profile did not indicate how often Provider 5 had performed subarachnoid, epidural, or caudal blocks; arterial lines; central venous lines; thoracic epidural placement; basic nerve blocks; or advanced nerve blocks.

In an interview on 11/9/18 at 10:22 a.m., the Director of Quality stated the hospital did a count of the total number of procedures falling under core and special privileges.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure staff had prevented the occurrences of retained foreign objects (RFO, surgical complication resulting from foreign materials accidentally left in a patient's body) of a wound retractor (a device used to keep an incision open during surgery), metallic port/trocar (instrument used to hold open a body cavity and/or to insert camera or instrument), and needle for three of 30 sampled patients (Patients 2, 5, and 6) and failed to ensure staff used an unexpired hip implant (medical device replacing a body part) for one of 30 sampled patients (Patient 1). The hospital also failed to clearly state its policy for reconciling discrepancies in surgical counts (counting items to prevent RFOs). This failures resulted in Patients 2 and 6 requiring a second surgery to remove the RFOs and had the potential to impact patient health complications.

Findings:

1. Review of Patient 2's Surgery Encounter record, dated 4/14/2017, indicated the patient underwent hernia repair (condition in which an organ or other structure protrudes through a weak part of tissue or muscle in the groin area) and a wound retractor was used. The surgical count section of the record indicated an "other" device was used during the initial count. A surgical count is the counting of the exact number of sponges, instruments, and other materials before, during, and after an operation to reduce the likelihood of leaving an object inside a body cavity. There was no accounting for the "other" item by the end of surgery.

Review of Patient 2's telephone appointment visit, dated 3/30/2018, indicated a surgeon received a computed tomography scan (CT or CAT scan, a diagnostic test that produces multiple images or pictures of the inside of the body) findings and it stated "large ovoid ring" in the patient's small bowl had a potential for obstruction (blockage of the intestines which prevents the normal movement of the products of digestion).

Review of patient 2's Surgery Encounter note, dated 4/3/18, indicated the patient received a surgery to remove the foreign body.

Review of Patient 2's History and Physical note, dated 4/4/18, indicated since her hernia repair a year ago, the patient had abdominal discomfort and felt something was protruding from her left abdomen. A CT scan was obtained showing partial bowel obstruction. Patient 2 underwent a second surgery on 4/3/18 and a retained and eroding wound protector was removed.

During an interview on 11/7/18 at 1:15 p.m., registered nurse A (RN A), who reviewed Patient 2's Surgery Encounter record, dated 4/14/2017, stated the "other" item in the initial surgical count was most likely the wound retractor. There should have been but there was no record of the retractor being accounted for by the end of surgery.

Review of the "PREVENTION OF THE RETAINED FOREIGN ITEMS (FORMERLY COUNT POLICY), dated 11/28/17, indicated the policy was to establish a system that provided guidance in accounting for items opened and used during invasive/surgical procedures. It indicated miscellaneous small items/devices are items, that could be retained in a wound or body cavity if not counted pre-operatively and at all closing counts and miscellaneous items are counted.

2. Review of Patient 5's operative report, dated 2/23/18, indicated she underwent a robot assisted laparoscopic (operation performed in the abdomen or pelvis using small incisions with the aid of a camera) procedure including myomectomy, tubal ovarian lysis of adhesions (removal of uterine and ovarian fibroids), and morcellation of pelvic mass (removal of soft scar tissue to treat a complication or to prevent a future problem).

Review of Patient 5's Anesthetic Record (notation of the administration of anesthetic agents, fluids, blood products, and other medications and for recording vital signs, anesthetic, and surgical interventions, and airway maintenance), dated 2/23/18, indicated at 6:05 p.m., the surgical wound was reopened to search for a needle.

Review of Patient 5's Surgery Encounter, dated 2/23/28, indicated the closing and final counts of needles/sharps were correct. There was no nursing or surgeon documentation indicating the needle was missing.

During an interview on 11/7/18 at 11:15 a.m., the anesthesiologist (ANE), who attended to Patient 5's surgery, stated the surgeon had to reopen the surgical wound to retrieve a missing needle.

During an interview on 11/8/18 at 11 a.m., RN A who reviewed the record stated there should have been documentation that a needle/sharps was missing during a final count and the needle/sharps count was correct during the second final count.

During an interview on 11/8/18 at 3 p.m., the circulating nurse (CN, a surgical nurse who circulates in the operating room to monitor the procedure and functions to ensure the conditions in the operating room remain safe and sterile) C (CN C) stated during Patient 5's surgery he told the surgeon two to three times a needle was missing. The surgeon then stated the needle was not in the patient's body cavity and he closed the surgical wound. When the needle could not be found, the wound was reopened and the needle retrieved. The surgery ended so quickly that there was no time to document closing and final counts. The CN B stated if there was something missing, the wound should not be closed.

Review of the "PREVENTION OF THE RETAINED FOREIGN ITEMS (FORMERLY COUNT POLICY), dated 11/28/17, indicated sharps (e.g., scalpels, needles) counts was to be performed before the procedure, when wound closure begins and at skin closure at the end of the procedure (final count). The surgeon was to immediately stop closing and explore the wound for any retained surgical items.

3. Review of Patient 6's Surgery Encounter, dated 9/26/18 at 7:30 a.m., indicated the patient underwent surgery including video assisted thoracoscopic (a procedure using a thoracoscope [a thin and flexible viewing tube inserted through a small incision in the chest]) lung lobectomy (a surgery to remove one of the lobes of the lungs), lung wedge resection (removal of a part of lung), and mediastinal node dissection (removal of lymph nodes for laboratory analysis). It indicated the initial count of sponge, needles/sharps, and instruments, was correct. The closing count of sponge, needles/sharps, and "other" counts were incorrect with a comment indicating, "staff member think one of missing trocar outside the drape (sterile fabric or fabric-like material used to isolate the surgical site from the rest of the body and other possible sources of contamination)." It indicated the final count was performed and it was documented as incorrect for sponge, needles/sharps, and "other". The patient left the operating room at 2:39 p.m. There was no documented evidence staff searched the missing item.

Review of Patient 6's Long Operative Report (LOR), dated 10/2/18 at 10:12 p.m., indicated on 9/26/18, after Patient 6 was extubated (removal of a breathing tube) and taken to the recovery room. An immediate chest X-ray was done as the count in the operating room was not correct and a metallic foreign body in the chest was identified.

Review of Patient 6's LOR, dated 10/2/18 at 10:14 p.m., indicated on 9/26/18, the patient was brought back to the operating room for the second surgery to remove the retained foreign body.

During an interview on 11/9/18 at 9:48 a.m., circulating nurse D (CN D) stated she was a circulating nurse for Patient 6's surgery. She stated the staff was aware the port was missing during the surgery and she documented under "other" for the missing port. She stated when they started the final count, the patient's skin was not closed but, the skin closure was done very quickly. She stated she felt everyone was busy and the staff did not have enough time to check items. She stated she did not have time to document the actions taken to search the missing items.

Review of the "PREVENTION OF THE RETAINED FOREIGN ITEMS (FORMERLY COUNT POLICY), dated 11/28/17, indicated the surgeon was to immediately stop closing and explore the wound for any retained surgical items and the circulator and scrub person will search drapes, trash, linen receptacles and operating room/procedure suite. It indicated "Skin closure will not occur until after an x-ray is taken and the surgeon sees the x-ray and ok's skin closure."

Review of AORN Guideline for Retained Surgical Items, indicated when a discrepancy in the count is identified, the RN circulator should call for assistance, search the room, including the area near the sterile field, floor, kick buckets, linen, and trash receptacles and recount with the scrub person. When a discrepancy in the count is identified, the surgeon and surgical first assistant should suspend closure of the wound if the patient's condition permits, perform a methodical wound examination which actively looking for the missing item, participate in the attainment of intraoperative radiographs or other imaging modalities as indicated to find the missing item, and remain in the OR until the item is found or it is determined not to be in the patient. If the missing item is not recovered, intraoperative imaging should be performed to rule out a retained item before final closure of the wound. Unresolved count discrepancies must be documented in the patient's record, including all measures taken to recover the missing item.

4. Review of Patient 1's LOP, dated 3/2/18, indicated Patient 1 underwent surgery to include right total hip arthroplasty (also known as total hip replacement whereby the diseased cartilage and bone of the hip joint is replaced with artificial materials, or implants). The report indicated the femoral head (head of the femur, the highest part of the thigh bone resembling a ball) implant had expired on [DATE] and the surgeon was "ok" with the implant.

During an interview on 11/7/18 at 9 a.m., RN D stated the vendor who brought the implant was responsible for checking the expiration date and the hospital did not have a supply of the implant.

During an interview on 11/8/18 at 8:30 a.m., the operating room nurse stated there was a discussion during surgery with the surgical team including the surgeon and vender of the implant and the expired hip implant was placed.

Review of the AORN (Association of periOperative Registered Nurses) Guideline for Sterile Technique indicated items that have an expiration date should not be used after the date has passed. Manufacturers will not typically guarantee that a product meets expected parameters after the expiration date and the product could have reduced effectiveness.




5. Review of the hospital's policy, "PREVENTION OF RETAINED FOREIGN ITEMS (FORMERLY COUNT POLICY)" (revised 9/20/17) indicated, "5.24 The Surgeon, team and management will be notified. 5.24.1.1 The Surgeon will immediately stop closing and explore the wound for any retained surgical items. 5.24.1.2 The Circulator and Scrub person will search drapes, trash & linen receptacles & OR [operating room]/Procedure suite 5.24.2 RF [radio frequency] wand will be used to search for the missing RF item in all areas of the room. For incorrect and unresolved counts, an x-ray is taken..." The policy did not indicate that items 5.24 through 5.24.1.2 pertained to efforts to reconcile count discrepancies or locate missing items.

In an interview on 11/8/18 at 10:09 a.m., the Director of Perioperative Services (DPS) acknowledged that sections 5.24 through 5.24.1.2 of the policy did not state they were to be performed in the event of a count discrepancy. The DPS stated the hospital followed AORN (Association of periOperative Registered Nurses) guidelines regarding surgical counts.

Review of the AORN Guideline for Prevention of Retained Surgical Items (RSI, 1/15/16) indicated, "Policies and procedures for the prevention of RSI should include... multidisciplinary team actions and procedures for count discrepancy reconciliation... the health care organization should establish policies that define when additional measures for RSI prevention should be performed or when they may be waived..."