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.

UNIVERSITY OF CALIFORNIA DAVIS MEDICAL CENTER 2315 STOCKTON BOULEVARD SACRAMENTO, CA 95817 Aug. 30, 2012
VIOLATION: GOVERNING BODY Tag No: A0043
Based on staff interview, patient record and document review, the hospital failed to effectively govern the activities and conduct of the hospital staff to provide safe and quality care to all patients as evidenced by:

A. The governing body failed to ensure that the medical staff was accountable to the governing body for the quality of care provided to all patients and acted in accordance with federal laws/regulations and hospital policies. (Refer to A 0049 and A 0347)

B. The governing body failed to ensure that patient care products obtained from an outside resource were safe and effective, and complied with federal laws/regulations and all Center for Medicare and Medi-caid Conditions of Participation. (Refer to A 0083)

C. The hospital's governing body failed to ensure an effective quality assessment and performance improvement (QAPI) program to reflect the complexity of services (to include research activities in accordance with acceptable standards of practice, laws and regulations). The governing body failed to ensure the QAPI program involved all hospital departments in response to a departure from standards, in order to prevent and reduce future harm to other patients. This failure put patients at risk for harm. (Refer to A 0263)

D. Surgical care was not performed in accordance with hospital policies and acceptable standards of practice for Patient 1 resulting in additional medical interventions and contributing to adverse effects from a non-standard, experimental treatment. Failure to recognize violations of safety practices and policies in the care of Patient 1 resulted in repeated non-compliance with safety policies, actual and potential harm to Patients 2 and 3, including death for Patient 3. (Refer to A 0940)

These failures resulted in a potential for increased infections and adverse events or death for all patients. The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Governing Body.

Findings:

In an interview on 8/28/12 at 2 p.m. with the vice-chancellor and dean of a university medical school who served as the hospital's governing body (GB 1) through a delegated authority from a university chancellor who was accountable to the owners of the hospital (university regents), GB 1 acknowledged that in accordance with the governing body bylaws, the governing body was responsible for all hospital operations, including the safety and quality of the care provided to hospital patients.

Review of the governing body bylaws outlined in a university policy and procedure manual, Chapter 200, Organization and Management, Section 40 hospital and clinics, revised 9/7/11, indicated:

Item II-A-1-b the hospital's scope of services would satisfy the legal requirements for hospitals of its classification. Item III-A-2-c further charged the governing body as responsible for seeing that the activities of the hospital conformed to applicable Federal laws and regulations.

Item III-A-2-b directed the governing body to receive periodic reports from leadership managers to determine that the hospital was properly administered, that the safety management program was effectively maintained, that the quality improvement program was operating effectively, and that deficiencies in administrative, safety management, or patient-care activities were identified and actions taken for their correction.

Item III-B-3 noted that the chief of the medical staff and the governing body shall provide reports necessary to document implementation of an effective quality improvement/patient safety program. The reports shall contain description of significant deficiencies identified in the patient-care system and actions taken or to be taken for their correction.
VIOLATION: MEDICAL STAFF - ACCOUNTABILITY Tag No: A0049
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on staff interview, patient record, and document review, the governing body failed to ensure that the medical staff was accountable to the governing body for the quality of care provided to patients when:

1. Two physician members of the medical staff (MD 1 and MD 2) performed non-standard, experimental treatments on 3 patients (Patients 1, 2, and 3) resulting in medical complications and the need for additional medical interventions, and contributing to or causing the death of at least one patient (Patient 3).

2. The medical staff failed to monitor the subsequent activities of MD 1 and MD 2 in order to verify compliance with hospital policies and federal regulations that they had violated.

3. The medical staff failed to direct other hospital and quality leadership managers to analyze possible aspects of hospital systems of care that contributed to the harm incurred by the actions of MD 1 and MD 2.

4. The medical staff failed to develop and implement a process to verify compliance of all medical staff members with safety practices for research related patient care activities performed on hospital patients.

Findings:

In an interview on 8/28/12 at 2 p.m. with the vice-chancellor and dean of a university medical school who served as the hospital's governing body (GB 1) through a delegated authority from a university chancellor who was accountable to the owners of the hospital (university regents), GB 1 acknowledged that in accordance with the governing body bylaws, the governing body was responsible for all hospital operations, including the safety and quality of the care provided to hospital patients. GB 1 delegated the day to day management of these tasks to various hospital leadership members who served on the Governance Advisory Council, which included the Hospital Chief Executive Officer (CEO), Senior Patient Care Services Officer (SPCSO) who was responsible for nursing services throughout the hospital (also known as CPCSO), Chief Medical Officer (CMO) and Chief of Staff (COS), as well as to the Director of Legal Affairs (DLA) and Chief Compliance Officer (CCO). GB 1 relied on these experts and managers to ensure hospital systems were safe and to report on hospital activities regularly, including the state of patient care quality and safety.

Review of the governing body bylaws outlined in a university policy and procedure manual, Chapter 200, Organization and Management, Section 40 hospital and clinics, revised 9/7/11, indicated:

Item II-A-1-b required the hospital's scope of services to satisfy the legal requirements for hospitals of its classification. Item III-A-2-c further charged the governing body as responsible for seeing that the activities of the hospital conformed to applicable Federal, state and local laws and regulations.

Item III-A-2-b directed the governing body to receive periodic reports from leadership managers to determine that the hospital was properly administered, that the safety management program was effectively maintained, that the quality improvement program was operating effectively, and that deficiencies in administrative, safety management, or patient-care activities were identified and actions taken for their correction.

Item III-A-6 required the governing body to provide appropriate medical sciences planning to ensure coordination with the hospital, medical staff, and school of medicine.

Item III-A-7 directed the governing body to maintain adequate interaction among administrative offices at the university campus, Office of the President, and the hospital.

Item III-B-3 noted that the COS and GB 1 shall provide reports necessary to document implementation of an effective quality improvement/patient safety program. The reports shall contain description of significant deficiencies identified in the patient-care system and actions taken or to be taken for their correction.

1. Reviews of patient records with a registered nurse who served in the information management department (RN 5) on 8/27/12 at 2 p.m., and further on 8/30/12, indicated the following:

Patient 1, [AGE], had a non-standard, experimental treatment for brain cancer (surgical removal of a tumor with implantation of material coated with a type of live bowel bacteria) performed by MD 1 and MD 2 without the proper consent and approvals on 10/15/10. Per interview on 8/28/12 at 4:15 p.m. with MD 4, an expert in infectious diseases, the live bowel bacteria was known to commonly reside in the bowel of both animals and humans, but was considered harmful when active in body locations outside of the bowel. The bowel bacteria was considered a human pathogen (disease causing), and sometimes a cause of infections unintentionally acquired (nosocomial) by hospital patients, particularly patients with depressed immune systems.

Patient 1 experienced life-threatening complications and multiple infections which compromised critical life functions (breathing, circulation, consciousness, movement) and which were not managed in accordance with acceptable medical practices for timely antibiotic administration. Patient 1 experienced functional decline from increased pressure in his brain from residual tumor tissue and abscess formation resulting in his death on 11/22/10.

Patient 2, [AGE], had a similar non-standard, experimental treatment for the same type of brain cancer also performed by MD 1 and MD 2 on 11/19/10. Patient 2 experienced worsening of her abilities to move and speak, which required placement in a nursing home. Over the coming year, increased pressure in the brain and chronic drainage from a wound infection of the original surgical site required additional surgical interventions. Patient 2 did not experience significant functional benefit, and upon her death on 11/28/11 recurrences of the tumors and chronic infection of the brain were identified.

Patient 3, [AGE], presented to the hospital emergency department with recent-onset of brain cancer symptoms. Instead of providing standard brain cancer treatment, MD 1 and MD 2 performed the non-standard, experimental treatment that was given to Patients 1 and 2, now to Patient 3 on 3/3/11. Patient 3 rapidly experienced life-threatening effects from the experimental treatment (blood infection, brain infection, increased brain pressure) with breathing/clotting complications and multiple infections, and died from these complications on 3/17/11.

2 and 3. Medical staff failed to monitor MD 1 and MD 2 for compliance with hospital policies and federal regulations; Medical Staff failed to direct analysis of systems failures.

In a telephone interview on 8/28/12 at 10:30 a.m. with a research assistant (RA), RA indicated that she was asked by MD 2 to procure and transport a type of live bowel bacteria (a biologic material) from a university campus animal research laboratory to the hospital to be administered during the surgeries for Patients 1, 2, and 3 on 10/15/10, 11/19/10, and 3/3/11 respectively. RA indicated that no formal procedures or filing for approvals by the campus Environmental Health and Safety Department or approvals by the hospital pharmacy were performed. Although she requested them, RA never received the biosafety packaging instructions from the original product purchase. RA indicated that she did not follow any formal written protocols or procedures to package, label and transport the biologic material, but relied on her knowledge and training for handling the material in the animal laboratory. RA wrote the name of the bacteria on the package she created for transport, but did not identify the name or license number of the manufacturer, the expiration date, or the name of the intended recipient (patient). RA indicated that the biologic material was acquired from a laboratory in another state some years ago. The laboratory manager had divided the original volume into small portions, which were kept frozen until needed. The portions that RA thawed for use in Patients 1, 2, and 3, were from the original product sent from another state, and were not sub-cultured in a California laboratory. The original product was labeled for animal use, and was not approved for use in humans.

Review of federal regulations related to the procurement, labeling, handling, quality control, and transport of biologic materials indicated that the procedures described by RA above, violated the federal requirements as outlined in the United States Government Code Regulation of Biological Products. Compliance with federal regulations was directed by the governing body bylaws, Item III-A-2-c (see above).

In a concurrent review with an administrative manager (AM 1) of Governance Advisory Council meeting minutes on 8/27/12 at 12:45 p.m., AM 1 indicated that a medical staff peer review committee convened in March 2011 after learning that MD 1 and MD 2 had performed a non-standard, experimental treatment on 3 patients after being warned not to. The peer review committee also determined that MD 1 and MD 2 violated hospital policies and federal safety regulations for use of a non-approved biologic material. A letter of expectations/warning reprimand was issued to MD 1 and MD 2 as a result of the peer review committee's investigation, and no formal disciplinary actions were taken. MD 1's qualifications to continue practice in the hospital (reappointment and clinical privilege renewal) were reviewed and approved by a credentials committee in August 2011, following the reprimand, and the credentials committee recommended to the medical executive committee (MEC) and governing body that the renewal also be approved by them, which it was. The Governance Advisory Council considered all this information, in addition to reviewing more than 200 patient complaints and misconduct and competence concerns by other medical staff members, all in a one-hour meeting on 11/14/11. Themes related to communication problems were identified but no action plan was documented. No actions to monitor the activities of MD 1 and MD 2 were directed by the governing body. The medical staff had conducted no audits of surgical cases performed by MD 1 and MD 2 to verify compliance with the policy and federal safety regulation violations. No further actions were documented to investigate potential hospital systems problems related to the repeated violations from standard care practices by MD 1 and MD 2. Attending this meeting were the following leaders: the CMO, the COS, a member of the MEC, the hospital CEO who managed the acquisition of patient supplies including biologic agents, and the SPCSO who managed nursing services.

In an interview on 8/28/12 at 2 p.m., GB 1 stated that she was kept informed of the peer review committee's investigation of MD 1 and MD 2 as it was being conducted beginning in March 2011, and of its results in a timely manner. GB 1 stated she and the Chief Compliance Officer (CCO) and the Director of Legal Affairs (DLA) were aware of research restrictions that had been placed on MD 1 and MD 2 by a university institutional review board (IRB), where these issues were discussed at Compliance Executive Committee meetings on 3/23/11, 7/18/11 and 9/28/11. The Compliance Executive Committee carefully monitored activities of both the university and the hospital in order to ensure compliance with state, federal, and payment and human experimentation rules related to those activities. The IRB was accountable to a university Office of Research, and did not report to the hospital or to GB 1. Therefore, the hospital had no direct authority for oversight of the IRB. But the Compliance Executive Committee did provide an opportunity for some sharing of information between the university and the hospital.

Review of the Compliance Executive Committee minutes dated 5/23/11, 7/18/11, and 9/28/11 referenced standing reports regarding potential research misconduct lacking IRB approval. Attending these meetings were GB 1, CCO, DLA, and the hospital CEO. The final meeting indicated that the CCO was "working with Perioperative Services to implement policy changes to ensure all foreign items brought into the OR (operating room) are cleared with proper approval."

GB 1 indicated that a new policy titled "Innovative Use" was drafted as a result of the university and peer review committee's investigations of MD 1 and MD 2, to ensure recurrences of the improper conduct would never again happen by them or by others, despite the same provisions already in place among other hospital policies at the time of the incidents. GB 1 stated that creation of the Innovative Policy was sufficient to ensure patient safety and quality, and no other evaluation of hospital systems was necessary or planned.

Review of a letter from the university institutional review board (IRB) to the federal food and drug administration (FDA) dated 10/17/11, posted on the website of a local newspaper at www.sacbee.com on 7/28/12, claimed that the hospital had developed a new Innovative Use Policy designed to avoid any future confusion regarding the applicability of FDA regulations to locally manufactured drugs and devices. The policy prohibited any use of non-FDA approved drug, biologic, or device without formal IRB and, as required, FDA approval - regardless of the purpose of the use. "A final policy was expected to be approved and implemented before the end of the year. Once approved, it will be communicated to all medical staff members."

Review of Policy 2516 titled "Innovative Use Policy," new as of 3/22/12, documented no procedures for hospital systems or staff (non medical staff) to follow when a therapy, device, or medication was used "in a manner that departs in a significant way from standard or accepted practice." The hospital, which routed the policy to the hospital attorney (DLA), the Director of Perioperative Services, and the medical staff executive committee, presented no evidence that the policy was approved by the governing body and final. The policy repeated the same requirements for physicians who wished to utilize an unapproved drug, biologic, or device (not approved or cleared for marketing by FDA) to first obtain approval from the IRB, or in an emergency from the FDA with notification to the IRB, documented in the following hospital policies previously in effect between 8/09 and 2012:

Policy (date 8/7/09) 1509 titled "Emergency Treatment Use of an Investigational Drug, Device or Biologic (FDA Regulated Products) in a Life-Threatening Situation."

Policy (date 8/09) 1509 (same number, different content) titled "Emergency or 'Compassionate' Use of Unapproved Drugs or Biologic."

Policy (revised 11/16/11) 1508 titled "Distribution of Investigational Drugs."

Review of an electronic communication dated 9/27/11 from a compliance investigator indicated that CCO had met with a perioperative manager (MOR) to discuss a policy gap that would prevent people from bringing in unapproved substances [the bowel bacteria used in treatments for Patients 1, 2, and 3] into the OR. "Will also draft a policy re this matter and circle back to Compliance by October 2011." The hospital presented no evidence of resolving this policy gap or implementing the final Innovative Use policy (intended to prevent recurrence of MD 1 and 2's violations) subsequent to this communication. In fact, on 7/12/12 the investigator contacted MOR again inquiring about what MOR recalled about the improper handling of materials in the OR, and reminding MOR to revise the policy to present to the hospital attorney. Instead of analyzing the systems failures that contributed to the improper procedure, MOR responded on 7/13/12 that no additional perioperative procedures were needed and restated the physician responsibility portion of the Innovative Use policy.

The new Policy 2516 Innovative Use did add a new requirement for the CMO to review innovative use requests, monitor outcomes to minimize continued use of ineffective or unsafe practices, and assure that the physician and institution met ethical and legal obligations. As this required a physician to approach the CMO with a request, no process captured use of these agents if the step to contact the CMO were bypassed, which occurred for Patients 2 and 3. Policy 2516 did not, in addition, specify that the procurement and distribution of innovative use items be accomplished in accordance with hospital pharmacy policies, such as policy 1508 - Distribution of Investigational Drugs, with IRB rules, or with FDA rules. Policy 2516 included no provision for hospital staff to verify that innovative use activities complied with all these and other safety policies to protect patients and staff prior to point of use.

4. There was no process to verify compliance of all medical staff members with safety practices for research related patient care activities.

As described above in an interview on 8/28/12 at 2 p.m., GB 1 stated that various members of the medical staff performed research activities on hospital patients under the authority of formal research protocols and approvals governed by the IRB. A new policy titled "Innovative Use" was drafted to ensure recurrences of the improper conduct by MD 1 and MD 2 would never again happen by them or by others, despite the same provisions already in place among other hospital policies at the time. GB 1 stated that the new Innovative Use policy was sufficient to ensure patient safety and quality, and no other evaluation of hospital systems, or surveillance of medical staff compliance with hospital policies and FDA rules, was necessary or planned.

In an interview on 8/29/12 at 12:10 p.m., the CMO indicated that the medical staff did not have a process in place to specify or restrict the authority to perform research in its privileging processes for physicians. The medical staff did not evaluate the conduct or compliance for research related work performed on hospital patients. Instead, the research activities conducted by medical staff members were governed by a university body (IRB, under the authority of the university's Office of Research) and not by the hospital governance. The IRB did not share the results of its compliance oversight for researchers directly and formally to the medical staff leadership, and vice versa. If medical staff members violated IRB rules which could threaten the health and safety of hospital patients, no process was required for the hospital to be formally notified of misconduct and potential harm to its patients. Therefore, the medical staff did not consider those aspects of patient care when determining competence and qualifications for renewal of hospital privileges and making recommendations to the governing body.
VIOLATION: CONTRACTED SERVICES Tag No: A0083
Based on interviews and document reviews, the governing body failed to ensure that services were furnished under a formal arrangement or contract to ensure the biologic materials acquired from an outside resource for use in Patients 1, 2, and 3 complied with federal safety regulations, and was transported and labeled to ensure its integrity and security in accordance with hospital policies and to satisfy Center for Medicare and Medi-caid Conditions of Participation. This failure put Patients 1, 2, and 3 at risk for exposure to contaminated or unsafe material which was placed into their brains, and/or put Patients 1, 2, and 3 at risk for an ineffective treatment.

Findings:

Review of the governing body bylaws outlined in a university policy and procedure manual, Chapter 200, Organization and Management, Section 40 hospital and clinics, revised 9/7/11, indicated:

Item II-A-1-b required the hospital's scope of services to satisfy the legal requirements for hospitals of its classification. Item III-A-2-c further charged the governing body as responsible for seeing that the activities of the hospital conformed to applicable Federal, state and local laws and regulations.

In an interview on 8/30/12 at 4 p.m. with the hospital Chief Executive Officer (CEO), who was responsible for hospital operations including oversight for the purchase of drugs and supplies for hospital patients, the CEO acknowledged that non-approved biologic materials were procured and transported from a university animal research laboratory by a non-hospital research assistant (RA) for use in surgical treatments performed on Patient 1 on 10/15/10, Patient 2 on 11/19/10, and Patient 3 on 3/3/11. CEO stated that the hospital had no contract or formal arrangement for obtaining the biologic material that was used for Patients 1, 2, and 3. The CEO acknowledged that there was no safety oversight for how the biologic material was obtained and brought into the hospital.

In a telephone interview on 8/28/12 at 10:30 a.m. with a research assistant (RA), RA indicated that she was asked by MD 2 to procure and transport a type of live bowel bacteria (a biologic material) from a college university animal research laboratory to the hospital to be administered during the surgeries for Patients 1, 2, and 3 on 10/15/10, 11/19/10, and 3/3/11 respectively. RA indicated that no formal procedures or filing for approvals by the campus Environmental Health and Safety Department or approvals by the hospital pharmacy were performed. Although she requested them, RA never received the biosafety packaging instructions from the original product purchase. RA indicated that she did not follow any formal written protocols or procedures to package, label and transport the biologic material, but relied on her knowledge and training for handling the material in the animal laboratory. RA wrote the name of the bacteria on the package she created for transport, but did not identify the name or license number of the manufacturer, the expiration date, or the name of the intended recipient (patient). RA indicated that the biologic material was acquired from a laboratory in another state some years ago. The laboratory manager had divided the original volume into small portions, which were kept frozen until needed. The portions that RA thawed for use in Patients 1, 2, and 3, were from the original product sent from another state, and were not sub-cultured in a California laboratory. The original product was labeled for animal use, and was not approved for use in humans.

Review of federal regulations related to the procurement, labeling, handling, quality control, and transport of biologic materials indicated that the procedures described by RA above, violated the federal requirements as outlined in the United States Government Code Regulation of Biological Products. Compliance with federal regulations was directed by the governing body bylaws, Item III-A-2-c (see above).

In an interview on 8/29/12 at 10 a.m. with the Director of Pharmacy (DOP), the DOP indicated that hospital policies required all drugs and biologic materials administered to hospital patients to be approved for human use by the FDA. The DOP stated that biologic agents intended for hospital patients but not listed on the hospital formulary (regularly stocked inventory) would be considered investigational; they would be subject to the hospital procedures which require the agent to be routed through the investigational pharmacy to ensure the integrity, security, safety and storage of the agent in accordance with the manufacturer's recommendations. The biologic agent would also be subject to the standard drug labeling and controls in the distribution throughout the hospital to the bedside. The DOP referred to hospital policy 1508 for definitions of the categories for use of investigational drugs and biologic agents, including "compassionate use" procedures for non-standard unapproved drugs or biologics for patients with no alternative standard treatments.

Review of hospital policy 1508 titled "Distribution of Investigational Drugs," revised 11/16/11 but considered effective between October 2010 and March 2011 when Patients 1, 2, and 3 were treated, under Section II Definitions listed the following:
B. Investigational - a non-FDA approved drug or biologic, an approved drug or biologic for non-FDA approved indication, or any other compound permitted by the FDA to be tested in humans but not yet determined to be safe and effective for a particular use in the general population and not yet licensed for marketing.
D. Biologic - any therapeutic serum, toxin, anti-toxin or analogous microbial product applicable to the prevention, treatment or cure of disease or injuries. Biologics were regulated by the FDA's Center for Biologics Evaluation and Research. Such investigational treatments were required to have institutional review board (IRB) approvals, protocols, and be handled and processed through the hospital pharmacy's investigational drug service.
I. FDA's Expanded Access Program - a mechanism for obtaining an investigational drug, biologic or device to treat a patient with a serious disease or condition who does not have comparable or satisfactory alternative therapies to treat the disease or condition. The primary objective is patient treatment as opposed to a clinical trial where the primary intent is research. The FDA encourages drug sponsors and investigators to obtain meaningful data and further knowledge about the drug (or biologic). The five mechanisms for expanded access use all required approvals by the FDA.

Section V-B of policy 1508 addressed the storage and distribution requirements for items maintained outside the pharmacy, transfer and disposal of the item, and providing a copy of the protocol for use. Labeling requirements were described in Section V-C, with the requirement for all inpatient investigational drugs and biologics to be dispensed by the pharmacy.

Review of hospital policy 1509 titled "Emergency Treatment Use of an Investigational Drug, Device or Biologic (FDA Regulated Products) in a Life-Threatening Situation," revised 8/7/09, addressed the requirements for use when there was insufficient time to obtain institutional review board approval before rendering the investigational biologic to save a life. The same requirements for dispensing through the investigational drug services pharmacy unit and notifying the FDA or other oversight agency held. In addition, an independent assessment by an uninvolved physician must be obtained.

A separate hospital policy also numbered as 1509 and dated 8/09, titled "Emergency or 'Compassionate' Use of Unapproved Drugs or Biologic," contained similar but not identical language as 1509 above. This policy expected use of investigational drugs and biologics intended for use in the diagnosis, cure, mitigation and treatment or prevention of disease to be recognized in the official United States Pharmacopoeia (USP), which lists all drugs and biologic materials legally approved for sale and use in the U.S. This policy also defined Innovative Use as the application of a therapy, device, or medication in a manner that departs in a significant way from standard or accepted practice, and included unapproved biologics which had IRB approval. FDA rules still applied to these categories for use.

The hospital presented no other policy that directed the purchase and acquisition of patient care products from outside sources to be in accordance with state and federal laws/regulations and quality control systems to ensure that they were safe and effective.
VIOLATION: QAPI Tag No: A0263
Based on interview, documents and record review, the hospital failed to maintain an effective quality assessment and performance improvement program in accordance with acceptable standards of practice for the care and safety of Patients 1, 2 and 3 when hospital leadership, including members of the Quality and Safety Committee, did not complete a comprehensive investigation of three related incidents within a six month period (10/15/10-3/3/11) that met the hospital's criteria for sentinel events.

A. The Quality and Safety Committee did not follow the hospital policy and procedure for identifying sentinel events and conducting a root cause analysis of systems and processes to protect patients and employees from further occurrences of human error. (Refer to A 286)

B. The Quality and Safety Committee did not implement preventive actions or a plan for ongoing monitoring to ensure the appropriate and safe use of an unapproved biologic for the treatment or prevention of disease. (Refer to A 286)

C. The Quality and Safety Committee did not ensure nursing staff and physicians were fully educated on the approval, scheduling, procurement, processing, labeling, storage or use of an investigational drug, device or biologic including the need to seek appropriate consults and direction as needed. (Refer to A 286)

D. The Governing Body did not ensure clear expectations were identified and established for the safe use of a therapy, device or medication that departed from standard or accepted practice. (Refer to A 286)

These failures resulted in the potential for further incidents which would jeopardize the safety of staff and result in adverse outcomes for patients.

The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Quality Services.
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview, patient record and document reviews, the hospital failed to ensure that the scope of its Quality Assessment Performance Improvement (QAPI) program included high risk and adverse patient events as indicators to identify and reduce medical errors when multiple hospital staff and leadership members failed to identify and report unsafe care practices that departed from acceptable standards of practice and produced harm for Patient 1, practices that violated multiple hospital policies, thereby missing opportunities to correct similar care practices for Patients 2 and 3.

Evidence for this failure included:

1. A request prior to Patient 1's surgery on 10/15/10 for compassionate use of an unapproved, experimental and high risk treatment for brain cancer using a non-approved biologic material was made to hospital leadership members (Chief Medical Officer-CMO, hospital attorney - (DLA), who were responsible for risk management services and payment compliance), who did not verify approvals in accordance with hospital policies and procedures.

2. For Patient 1's surgery on 10/15/10, multiple direct care staff were involved with the harmful effects of Patient 1's care resulting from an unapproved, experimental treatment for brain cancer using a non-approved biologic material as follows:

a. The experimental treatment was scheduled with perioperative staff excluding the information that an unapproved, experimental bacterial biologic was to be placed in the open wound. Pre-operative nursing staff verified the surgical consents, which listed an unusual and experimental treatment for which the standard pre-operative antibiotic treatments were withheld, without verifying the policy-required approvals were in place.

b. The biologic material was brought into the operating room without a formal arrangement, where perioperative nursing and surgery staff members handled the material.

c. The biologic material was not processed and distributed by the investigational pharmacy in accordance with hospital policy.

d. The documentation of Patient 1's care following surgery showed rescue efforts by multiple staff members to treat shock, caused by suspected bacteria in the blood as a result of the experimental treatment, without identifying the practice as harmful or non-standard.

e. Nursing staff, who monitored Patient 1's persistent fevers related to the experimental treatment lasting for several weeks after surgery, failed to identify and report the practice as harmful and non-standard. The same nursing staff administered antibiotics in a manner that departed from acceptable standards of practice, and still did not identify and report as an unusual care practice.

f. Physician staff, including experts in infectious disease, hematology-oncology (blood and cancer), trauma surgery, lung diseases, and anesthesia care, who knew of no human experience to safely use this treatment for Patient 1, documented non-standard practices to selectively use antibiotics to treat only some infections but at the same time to not affect the implanted brain bacteria. These physicians failed to identify and report the unsafe and harmful experimental treatment as being outside acceptable standards of practice.

g. Pharmacy staff monitored a restricted medication used to stimulate the immune system (Leukine) in the face of positive bacterial cultures and the withholding of antibiotics, but failed to identify the practice of withholding antibiotics as non-standard. Pharmacy staff failed to identify that the bacteria implanted at surgery caused the harmful infections, which were not consistently being treated with antibiotics. Pharmacy staff monitored antibiotic usage which was ordered for shorter treatment intervals than was standard, and for infections resulting from the experimental non-standard treatments, but failed to identify and report the use of an unapproved biologic as a medication error and in violation of hospital policies.

h. Physical therapy, occupational therapy, speech therapy and nursing staff members provided services after review of Patient 1's needs, which were partly induced by a non-standard and experimental treatment, without identifying and reporting the care practices as outside acceptable standard of practice.

3. Billing staff, who reported to risk management and the Director of Legal Affairs (DLA), were consulted prior to Patient 2's experimental treatment on 11/19/10 (similar to Patient 1) without verifying compliance with the CMO's instructions for Patient 1's one-time compassionate use, and subsequent Institutional Review Board (IRB) approval for any other patients. Risk management and compliance leaders failed to identify and report non-compliance with hospital policies which put Patient 2 at risk for similar outcomes of infections and harm as Patient 1. Many of the same types of direct care staff members cared for Patient 2 (perioperative staff, nurses, physicians, pharmacists, physical therapy, occupational therapy, speech therapy, plus Psychiatry consultants) failed to identify and report the unsafe practice with resulting lack of benefit to Patient 2.

4. After Patient 1's death and prior to Patient 3's surgery on 3/3/11, pathology physician staff identified evidence of infection resulting from an unapproved, experimental treatment in Patient 1's brain, but failed to identify and report the practice as outside acceptable standards. The Neurosurgery Department's quality unit failed to identify Patient 1's death/autopsy as associated with an unusual (and non-standard, high risk, experimental) treatment. An opportunity was missed for a department peer review to be conducted, and for reporting to the hospital's quality and safety committee as an unusual event, outside the standard of practice.

5. Again prior to Patient 3's surgery on 3/3/11, billing staff, perioperative scheduling and nursing staff, failed to identify and report plans to arrange for an unapproved, experimental treatment in violation of the CMO's instructions and hospital policies, thereby missing an opportunity to intervene and prevent the devastating infections experienced by Patient 3, which resulted in death.

This failure put Patient 2 at risk for harm, and directly caused or contributed to the death of Patient 3 from life-threatening infections of the blood and nervous system.

Findings:

During the period from 10/15/10 to 3/3/11, MD 1 and MD 2 performed or participated in surgery on three patients (Patients 1, 2, and 3) with end stage glio[DIAGNOSES REDACTED] multiforme (a quickly-growing cancerous [DIAGNOSES REDACTED]). In addition to the removal or partial removal of the tumors, Patients 1 (10/15/10), 2 (11/19/10), and 3 (3/3/11) underwent implantation of a live Enterobacter aerogenes (a bacteria commonly found in the gastrointestinal tract but produces disease and harm when active in other body locations, and defined by hospital policies as a biologic) into the brain and surrounding bone tissue with the intention to create a wound infection that would attack tumor cells. The bacterial agent used had never been tested on humans and both the Institutional Review Board (IRB) and the Food and Drug Administration (FDA) had not formally approved its use in the treatment of human diseases.

The two neurosurgeons (MD 1, MD 2) who performed or participated in the three surgeries did not inform the physician Director of Peri-Operative Services (DPS) or the Manager of the OR (MOR) of their plan to use the experimental biologic and there was no mention of the use of the biologic at the time of the scheduling of the procedure. The biologic agent was transported from a university animal research laboratory and taken in to the OR by a Research Assistant (RA) who was not registered as a visitor on the OR medical records of Patients 1 and 2. The biologic agent had been diluted with a solution and placed in a 15 cc (cubic centimeter) vial without patient labeling or instructions for handling, use or disposal. None of the perioperative nurses interviewed stated they were familiar with the term probiotic (the term used by the surgeon to designate the introduction by the physician of the biologic into the brain on the Informed Consent of two of the three patients); however, they never questioned Perioperative Services leadership about the definition or the appropriateness of the biologic's acquisition, packaging, handling or use. None of the OR nurses interviewed, who had either circulated or scrubbed on the three cases, considered informing their Manager of the occurrence of a treatment and processes outside of the expected and established OR standards of care. (Refer to A 0951)

Review of medical records on 8/27/12 at 2 p.m. with a registered nurse who served in the information management department (RN 5), and further on 8/30/12 indicated the following:

Patient 1, [AGE], failed conventional treatment for brain cancer and had an unapproved, unsafe, and experimental treatment performed during surgery by MD 1 and MD 2 on 10/15/10. The treatment involved saturating absorbent sponges and Patient 1's skull bone flap, which was removed to perform removal of [DIAGNOSES REDACTED], in a solution mixed with a type of live bowel bacteria. The saturated items were implanted into the cavity where the tumor had been removed. The skull bone flap was placed back over the brain, and the scalp closed over that. Within 5 hours of the completion of the surgery, Patient 1 required rescue for breathing difficulty, loss of consciousness, and signs of shock related to suspected bacteria in the blood that caused harm to major organ systems (sepsis), resulting from the experimental treatment. Through all but two days of Patient 1's hospitalization between 10/15/10 and his death on 11/22/10, Patient 1 exhibited depressed consciousness and fever, a leading sign of infection, and culture-evidence of several discrete infections of the brain/spinal fluid, surgical wound, lung secretions, urine, and rectum, some directly related to the experimental treatment, others related to his weakened state from both the experimental treatment and the original surgery and cancer. Standard antibiotic treatments for identified infections were not consistently and effectively administered.

Medical and other hospital staff documented knowledge and understanding of the treatment-related complications and withholding of standard antibiotic treatments as evidenced by progress notes from Anesthesia physicians before and after surgery on 10/15/10 and on 10/17/10, and again on 10/31/10, Hematology-Oncology Consultant on 10/20/10, Pulmonary Critical Care Consultant on 10/31/10, Infectious Disease Consultants on 11/2/10, 11/3/10, 11/4/10, Trauma Surgery Consultants daily between 11/5/10 and 11/12/10 when additional surgeries were performed, Radiology Consultant on 11/7/10 who reported scan results related to immune response at the site of implantation of bacteria into the brain, and finally a Pathologist who performed an autopsy on 11/23/10 where he documented awareness of positive cultures of various body locations for which standard treatments were withheld or ineffective. Progress notes from nurse practitioners, physical therapists, occupational therapists, speech therapists and nursing staff similarly documented awareness of the unusual care. Pharmacy staff tracked the use of Leukine (a restricted medication that stimulates the immune system) which was ordered 10/22/10, and various antibiotics that were intermittently ordered, which were documented in notes entered between 11/1/10 and 11/22/10 in a log outside of the medical record. On 11/16/12, a Critical Care Medicine consultant considered Patient 1 to again be experiencing septic shock. Surgical relief of brain pressure was attempted on 11/17/12 to treat shock related to that condition, but Patient 1's condition continued to deteriorate and he expired on [DATE]. The hospital presented no reports to the Quality and Safety Committee (QSC) of unusual occurrence or incidents (per interview with acting QSC chair on 8/29/12 at 9:23 a.m.).

Patient 2, [AGE], failed conventional treatment of a [DIAGNOSES REDACTED] and was also treated on 11/19/10 with the same type of unapproved, experimental treatment as Patient 1. In the weeks following surgery between 11/19/10 and 12/16/10, Patient 2 developed worsening of left sided weakness and speaking ability, refused to eat for extended periods and was diagnosed with [DIAGNOSES REDACTED]. Antibiotics were not administered. Patient 2's worsened condition required transfer to a nursing home upon her release. Patient 2 did not show functional improvement but did require additional surgical interventions in April 2011 to relieve pressure in the brain, in July 2011 for new tumor appearance on imaging test, and in October 2011 for persistent infection and drainage of 3 different types of bacteria at the implantation surgical site requiring removal of the implanted materials, wound cleansing, closure and antibiotic treatments. Patient 2's condition continued to decline and she expired on [DATE], with evidence of tumor recurrence and chronic infection of the brain (meningitis).

Progress note entries by Anesthesia physicians before and after surgery, by Psychiatry consultant on 12/1/10, by Physical Medicine and Rehabilitation consultant on 12/8/10, by physical therapy, occupational therapy, speech therapy, and nursing staff throughout Patient 2's hospital stay indicated knowledge and understanding of Patient 2's functional decline and presence of an infection for which antibiotics were not administered. Pharmacy staff documented tracking of Leukine use as well. A Pathologist performed an autopsy on 11/28/11 which summarized the care above including the implantation of bacteria into the brain and autopsy findings of chronic meningitis. The hospital presented no evidence that any direct care staff submitted an unusual occurrence or incident reports related to her care.

Patient 3, [AGE], presented to the hospital emergency department with recent-onset of brain cancer symptoms. Instead of providing conventional treatment, MD 1 and MD 2 performed on 3/3/11 the same type of experimental treatment as Patient 1 and 2. Patient 3 rapidly experienced life-threatening effects associated with the surgery and experimental treatment and weakened state, including blood infection, brain infection and increased pressure, lung infection, urine infection, mouth infection, shock, blood clots, and died from these complications on 3/17/11.

Progress note entries by Anesthesia physicians, by Neurology consultant, by Cardiology consultant, by Pulmonary and Critical Care Medicine consultant, as well as entries by dietary, speech therapy, occupational therapy, physical therapy and nursing staff indicated knowledge and understanding of Patient 3's critical condition resulting from the non-standard surgical treatment. Pharmacy staff documented tracking of Leukine as well as some of the antibiotics ordered for selective (but not all) infections. A Pathologist performed an autopsy on 3/17/11 which identified "multiple areas of pus over the brain," a swollen and bloody operative site, diffuse brain swelling, pressure pushing the brain against the skull base, and described the initial withholding of antibiotics for 12 days as "according to the experimental protocol" (of which there was none). The hospital presented no evidence that any direct care staff submitted an unusual occurrence or incident reports related to her care.

Following are interviews with staff who had knowledge prior to Patient 1's surgery on 10/15/10:

In an interview on 8/28/12 at 3:30 p.m. with the Chief Medical Officer (CMO), the CMO indicated that MD 1 approached him for approval to treat Patient 1 in early October, 2010 as a single, one-time compassionate use situation. The CMO directed MD 1 to perform specific tasks prior to proceeding with the proposed non-standard and unproven treatment to place bowel bacteria into the evacuated [DIAGNOSES REDACTED] site. The CMO's instructions (confirmed in an electronic communication document) were to obtain consultation by experts in medical ethics, and to not proceed if the Ethics experts did not concur that the treatment was necessary and in the patient's best interest. Furthermore, the CMO's instructions included planning with the patient and family for possible complications and adverse effects from the treatment, in order to establish agreement on the scope of treatment and end point in care before proceeding with the treatment. In addition, a clear understanding of the family's payment obligations needed to be arranged. Specific documentation in the medical records about MD 1's conversations with the Human Subjects committee was directed. The CMO indicated that MD 1 did not comply with these instructions prior to performing Patient 1's treatment on 10/15/10.

The CMO learned about the non-compliance sometime afterward and warned MD 1 not to perform the treatment on any other hospital patients until formal approvals by the IRB and appropriate regulatory agencies was obtained. However, MD 1 arranged for Patient 2's treatment on 11/19/10 without the CMO's knowledge and without complying with the CMO's instructions from October 2010. The CMO again warned MD 1 to not perform other treatments without approvals, but MD 1 went ahead to treat Patient 3 on 3/3/11. MD 2 participated in each case under the direction of MD 1, who was his mentor and Chair of his department (neurosurgery).

In an interview with the hospital attorney (DLA) who oversees risk management services on 8/29/12 at 4 p.m., the DLA stated she heard about the planned surgery shortly before the first case when she was copied on an e-mail from the CMO who was seeking feedback regarding the patient consent. The DLA stated: "I was asked to weigh in myself, but didn't respond...was just aware". The DLA stated she was told the procedure had IRB approval for "humanitarian use" but did not clarify legal responsibilities for the nature of the surgery or the use of the biologic. The DLA stated she was not consulted nor had any knowledge after that until after Patient 3's surgery when she heard from the Compliance Department that MD 1 and MD 2 had been restricted from human research activities. No one from Risk Management at any time reported an unusual occurrence or sentinel event, or verified compliance with the CMO's directives prior to Patient 1.

In the 8/28/12 at 3:30 p.m. interview with the CMO, he indicated that during Patient 3's hospitalization , he was made aware MD 1 and MD 2 were planning on performing the experimental surgery on an additional five patients. The CMO acknowledged he alone determined that the investigation to be conducted would be limited to Peer Review as he did not see this as an adverse or sentinel event. This Peer Review was conducted in March of 2011 and MD 1 and MD 2 were "reprimanded" by imposed restrictions for any human research. The CMO further stated a new policy titled Innovative Use Policy, dated 3/3/12, had been written to avoid any future confusion regarding the use of a non-FDA approved drug, biologic, or device without IRB or FDA approval.

In review of the new hospital policy ID: 2516 Innovative Use Policy, dated 3/22/12, there was stipulation: "Any physician who wishes to utilize an Unapproved Drug, Biologic or Device shall first obtain approval from the IRB (or, in an emergency, from the FDA with notification to the IRB)." The policy did not direct this approval to be formally documented in writing to avoid any misinterpretation of the approval and to provide evidence of approval to staff working with the Unapproved Drug, Biologic or Device. The policy further directed: "The CMO shall review requests, monitor outcomes to minimize continued use [not prevent continued use] of ineffective or unsafe practices." The policy did not address any operational issues including directions on how to schedule the procedure, how to acquire, store, handle, use or dispose of the Unapproved Drug or Biologic or what departmental processes were needed to ensure all environmental and patient safety measures were in place. The hospital was unable to provide evidence the Governing Body had approved the final draft.

In review of the hospital policy ID: 1509 Emergency or "Compassionate" Use of Unapproved Drugs or Biologic, dated 8/09 and presented by the hospital as an active policy, there was a definition of Innovative Use that also stipulated the need to have IRB approval prior to use.

In review of a hospital policy ID: 1507 titled [University name] Institutional Review Board, dated 05/10/10, instructions were given for the emergency use of a test article or drug without prior IRB review which included the stipulation that the "investigator" (the person or persons seeking approval) "must...obtain documented approval from the Chairperson of the IRB or Other IRB member formally delegated by the Chair to give emergency approval."

In review of a hospital policy ID: 1440 titled Sentinel Events, dated 05/10/10, a sentinel event was defined as "an unexpected occurrence or health care associated infection resulting in death or serious physical or psychological injury or the risk thereof." The policy further directed the occurrence be evaluated with the established criteria defined which included: "C. There has been more than one event of the same type within a six month period; or D. The nature of the event could potentially undermine public confidence in the hospital ". The policy stipulated the individual most directly involved ... will be responsible for reporting the event immediately to Risk Management (during the day) or the Nurse Manager/Nursing Supervisor (after hours). The policy further directed: "If the event is determined to be a sentinel event, a root-cause analysis will be conducted."

In review of a hospital policy ID: 1513 titled Reporting Serious Adverse Events, there was also definition of specific adverse outcomes that would qualify to be reported as an adverse event. This included: "B. Product or device events, including the following: 1. Patient death or serious disability associated with the use of a...biologic provided by the hospital."

From 8/27/12 through 8/30/12 interviews were conducted with multiple leadership staff, some of whom were not aware of any of these three cases until an article appeared in the local newspaper on 7/22/12 reporting the university had alerted the FDA on 10/17/11 of "the unauthorized use of biologic and notification of finding of serious and continuing noncompliance" related to the care and treatment of Patients 1, 2 and 3 after undergoing experimental treatments for brain cancer.

In an interview on 8/27/12 at 10:15 a.m., the Associate CMO (former Chief of Staff) stated that any drugs related to research must be dispensed by the Investigational Drug Pharmacy, a division of the hospital Pharmacy. He stated a protocol would be developed and was to be expected for all unusual, innovative, or non-standard treatments. The Associate CMO acknowledged the medical staff currently had no ongoing audits or plans to conduct audits to identify non-standard treatments or to verify IRB or FDA approval for such treatments. When asked how the treatments would be identified, the Associate CMO responded, "By common sense, someone will recognize ... such as OR staff."

a. In an interview with the Operating Room Manager (MOR) on 8/27/12 at 10:30 a.m., he stated he was not aware of any issues regarding the use of the non-approved biologic until he was called by the Risk Management office in mid March of 2011. He stated he talked with the nurses at that time and "found nursing was not involved", "they didn't know anything about it." Although he was concerned that something was brought into the OR without his knowledge, he did not conduct an internal investigation. The MOR stated he had interviewed the nurses and they didn't remember anything "exchanging hands". He stated "they [the physicians] did something on the sterile field nursing staff was not involved with". He revealed the "product" was transferred directly from the Research Assistant (RA) to MD 1 "on the side" and MD 1 delivered it directly into the wound. The MOR acknowledged it was his expectation "every visitor should be documented" and stated nurses were "counseled" regarding the lack of documentation of a visitor in the OR. He was unable to produce the evidence of this verbal counseling or any evidence this had been discussed with staff regarding their role. The MOR stated he didn't know specifically what a probiotic was and did not know why the nurses had not sought information on the definition of the word probiotic used on the Informed Consent. The MOR stated Patient 1, 2 and 3's cases were never discussed at any departmental or hospital committee meeting he attended. The MOR revealed there was no necessity to develop, implement or revise any policies regarding the use of an unapproved biologic in the OR. The MOR stated he did not file an Incident Report (IR) as he was informed the incidents "were being handled by Clinical Affairs." The MOR acknowledged he had not conducted any formal re-training or education for the nursing staff on existing policies, standards, care, practice, safety or conduct in the OR.

In an interview with the MOR and the Medical Director of Peri-Operative Services (DPS) on 8/29/12 at 11 a.m., he acknowledged it would be beneficial to have a protocol for innovative use to direct staff on expected procedures.

In review of Compliance Executive meeting minutes between 5/11 and 9/11 there was evidence the three cases of Patients 1, 2 and 3 had been discussed, including the actions taken to reprimand MD 1 and MD 2. In an electronic communication dated 9/27/11 there was reference to a meeting held with the MOR to discuss "an apparent policy gap to prevent people from bringing in unapproved substances into the OR." The MOR was asked to discuss this with the involved OR staff and draft a policy on this.

In an interview conducted with the MOR on 8/30/12 at 8:50 a.m., he stated he did not recall any contact from the Compliance staff to review OR policies and procedures. That afternoon, with the prompting of several documented e-mails, the MOR recalled a meeting held with two staff members from the Compliance Office on 9/27/11 whereby the MOR was instructed to draft a policy that would prevent people from bringing in unapproved substances to the OR. In a subsequent e-mail on 7/13/12, the MOR responded he had asked the assistant manager to work on this at the time and they had agreed that the "IRB polices covered this", and a specific OR policy was not necessary. The MOR acknowledged there had been a 10 month delay in notifying the Compliance staff of the decision not to revise or develop any new OR policies.

In review of the OR policies and procedures, there was no reference to 1) how staff would verify the approval of a non-standard, non-approved biologic, or 2) what steps staff would take to ensure a protocol was present which included instructions for the safe scheduling, acquisition, packaging, use, handling and disposal of a biologic.

In an interview with the RA on 8/28/12 at 10:30 a.m., she stated MD 2 had told her the biologic agent had been approved for use on Patients 1, 2 and 3 prior to the procedures. In each case she prepared the biologic agent the same way. The RA stated she put the solution into a 15 cc conical tube wrapped in parafilm and double bagged it. The tube was labeled only with the date and the name of the bacteria. She transported it to the hospital from the outlying lab by private vehicle in a Styrofoam cooler. In the first two surgeries, the RA stated she handed the package to one of the neurosurgeons (MD 2) outside of the room while she changed, and when she returned MD 2 stated he had passed it to someone else. She stated both surgeons spoke to the surgical team and told them to keep the bacteria isolated from other "tools." The RA said she observed the scrub nurse "clear off the bench" and put down blue pads. She observed the solution being poured into a blue bowl. She observed the gel foam and the bone flap being soaked in the bowl. In the second surgery, the RA stated the nursing staff asked her during the procedure if it was safe to handle "the material." She replied "yes," if it was handled correctly without a spill. For the third case, the RA acknowledged the biologic was given to a physician in training to take in to the OR. The RA revealed "what I do is experimental," ...and added "what I observed at the hospital was not according to my animal lab procedures."

In an interview with the Infection Prevention Manager (IPM) on 8/27/12 at 2:55 p.m., she stated she first heard about the three neurosurgery cases when she read it in the paper on 7/22/12. She stated no one had asked her for any policies, procedures or clarification either before or after this was published. The IPM revealed it was "unlikely we would have approved it." The IPM "hoped" appropriate handling and cleaning of the OR had been done.

In an interview with the Medical Director for Infectious Disease (MD 4) on 8/28/12 at 4 p.m., MD 4 was asked about using the treatment of placing a type of bowel bacteria into the surgical site of a patient's brain. MD 4 stated that he knew of no other medical treatments carrying this degree of risk that were not preceded by animal studies and experience in humans before they were offered as a medical treatment. He indicated that he expected formally-approved research protocols to be in place for procedures lacking experience to frame the plan of care and provide staff with education on risks, preparations, and what to expect, including a plan to rescue the patient from sepsis and meningitis or other life-threatening effects. He expected treatments to be FDA-approved, channeled through the investigative pharmacy, with clear procedures for handling and disposal. MD 4 stated it was not possible to treat sepsis without affecting the viability of bacteria at the surgical site in the brain. MD 4 stated he had been consulted by MD 1 after Patient 3's surgery. He stated he contacted a member of the IRB, but did not file an incident report. MD 4 acknowledged the three surgical cases, all which involved serious infections, had not been discussed at any Infection Control meeting and no discussion had been held on what to do if a situation such as this arose again.

In an interview with the DPS on 8/29/12 at 11 a.m., he explained the process defined to arrange for surgical procedures which involved research or innovative treatment. The DPS indicated there was a procedure for staff to follow for formally conducted research activities. DPS acknowledged that for innovative, compassionate, or otherwise non-standard surgical treatments conducted in the OR, there were no formal procedures for staff to follow.

The DPS stated he first heard about the experimental surgery cases from the MOR after the third case (Patient 3). The DPS stated, "I am bad about keeping notes," but did not recall any departmental review of the cases of Patients 1, 2 or 3. At the time he learned of the concerns, the DPS said he didn't feel it was emergent to address as it was a "surgeon driven" process. The DPS stated if a physician claimed a case was approved, it would not be questioned. When asked if the three cases triggered any need to consider Quality Review for improvement needs, the DPS responded, "No, these were isolated cases, no opportunities for improvement." The DPS stated he "never addressed this as a standard of care issue."

In an interview with the Director of the Pharmacy (DOP) on 8/29/12 at 10 a.m., he stated he was not aware of the use of the unapproved bacterial biologic as the Investigational Pharmacist had not been consulted by MD 1 or MD 2 prior to the surgical procedures of Patients 1. 2 and 3. The DOP stated when non-formulary biologics are used to treat hospital patients, policy directs them to be processed through the investigational pharmacy which tracks the attached protocols, handling and distribution. The DOP stated all drugs, biologics and therapeutics used for patients are required to have a physician order. The DOP stated "FDA approval for animal use does not mean human use" and "it
VIOLATION: MEDICAL STAFF Tag No: A0338
Based on interview, medical record and document review, the medical staff failed to be responsible for the quality of medical care provided to patients by the hospital, in accordance with medical staff bylaws when:

A. Two physicians (MD 1 and MD 2) performed non-standard, experimental treatments to 3 patients (Patients 1, 2, and 3), subjected them to additional medical interventions for treatment-related adverse effects, and caused or contributed to the death of at least one patient (Patient 3). Refer to A 0347.

B. Medical staff leadership identified breaches from standard care and noncompliance with leadership instructions by 2 physicians (MD 1 and MD 2), issued sanctions to the physicians, but presented no process to closely monitor the subsequent activities of MD 1 and MD 2 to ensure compliance with breached hospital policies, the ethical code of conduct, and high standards of medical practice. Refer to A 0347.

C. The medical staff failed to verify compliance with human research safety rules for members who conducted research activities, including experimental treatments, on hospital patients to ensure the safety for all patients. Refer to A 0347.

These failures put all hospital patients at risk for injury and harm, including death.

The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the Condition of Participation: Medical Staff.

Findings:

In an interview on 8/28/12 at 10 a.m. with the Chief Medical Officer (CMO), the CMO indicated that the medical staff was responsible to ensure the quality of care and safety for all hospital patients.

Review of the Medical Staff Bylaws, approved January 2012 and unchanged from the periods when Patients 1, 2, and 3 were treated, documented under Article II-A that the purposes of the medical staff shall include, "To provide that all patients admitted to the hospital or treated in the ambulatory sites receive quality care and treatment." Article III, Section 1-B noted that medical staff members were required to document their ability to provide patient care and treatment in accordance with generally accepted standards of quality care.

Article VII, Section 2-B-4 documented as a duty and responsibility of the Clinical Department Chairs, to establish an ongoing review process to evaluate the quality of patient care rendered within the Department. Section 2-B-7 noted for the Chairs to use the privileging criteria, supervise and evaluate the clinical work performed by members of the department and provide that department members practice within the privileging limits granted to them by the Governing Body. Section 2-B-11 directed the Chairs to promptly report the failure of any staff member to discharge patient care responsibilities in accordance with the standard practice within the community and the university.

Article VIII-F documented that the duties and authority of the Chief of Staff (COS) may be delegated to the Chief Medical Officer (CMO). Among the COS duties was VIII-F-1-a, to exercise such authority as he/she deemed necessary so that at all times patient welfare took precedence over all other concerns. The authority of the COS, VIII-F-2, included (c) to require consultations whenever, in his/her discretion, it was deemed necessary, and (f) to require all Staff members to comply with the hospital and medical staff bylaws, rules and regulations, policies and procedures, or face disciplinary action.
VIOLATION: MEDICAL STAFF ACCOUNTABILITY Tag No: A0347
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview, medical record and document review, the medical staff failed to be accountable to the governing body for the quality of care provided to patients, in accordance with medical staff bylaws, rules and regulations, and hospital policies, when two physicians (MD 1 and MD 2) performed non-standard, experimental treatments to 3 patients (Patients 1, 2, and 3), subjected them to additional medical interventions for treatment-related adverse effects, and which resulted in the death of at least one patient (Patient 3). Medical staff leadership identified breaches from standard care and noncompliance with leadership instructions by 2 physicians (MD 1 and MD 2), administered sanctions to the physicians, but presented no process to closely monitor the subsequent activities of MD 1 and MD 2 to ensure compliance with hospital policies, the ethical code of conduct, and high standards of medical practice. The medical staff failed to verify compliance with human research safety rules for members who conducted research activities, including experimental treatments, on hospital patients to ensure the safety for all patients.

Findings:

Reviews of patient records with a registered nurse who served in the health information management department (RN 5) on 8/27/12 at 2 p.m., and further on 8/30/12, indicated the following:

1. Patient 1, [AGE], had failed conventional treatment (surgical removal, radiation, and chemotherapy) for a [DIAGNOSES REDACTED] between January 2010 and August 2010 at another medical facility. Starting in August 2010, Patient 1 developed right-sided body weakness from recurrence of the [DIAGNOSES REDACTED] in a location of the brain served by the same fluid circulation as the original tumor. Patient 1 was receiving chemotherapy and suffered a heart attack in the weeks leading up to admission for care at the hospital on [DATE]. A standard alternative treatment (surgical removal with implantation of a chemotherapy-soaked material into the evacuated brain space) was planned, but an x-ray showed that the tumor had grown rapidly in a 2 week period raising concern the treatment might not be effective. As a different alternative, Patient 1 consented to an untried and unproven treatment (surgical removal of tumor with implantation of a type of live bowel bacteria into the vacant space and replacement of a bacteria-soaked skull bone flap over the brain incision site) to be performed by MDs 1 and 2 on 10/15/10. Per interview on 8/28/12 at 4:15 p.m. with MD 4, an expert in infectious diseases, the live bowel bacteria was known to commonly reside in the bowel of both animals and humans, but was considered harmful when active in body locations outside of the bowel. The bowel bacteria was considered a human pathogen (disease causing), and sometimes a cause of infections unintentionally acquired (nosocomial) by hospital patients, particularly patients with depressed immune systems.

Further record review indicated that within 5 hours of arrival to the recovery room on 10/15/10 after the brain surgery described above, Patient 1 had seizures, severe body shaking (rigors), became unresponsive and needed to have an artificial airway (intubation) connected to a machine (ventilator) for suspected bacteria in his blood. Fevers (a leading sign of infection) were continuously noted over the first 13 post-surgical days. Antibiotics were administered from 10/15/10 to 10/17/10, but not continued despite a decline in nervous system function displayed by low or absent consciousness, responsiveness, voluntary movement, and independence. Patient 1 remained dependent on the ventilator to breathe effectively for the first 8 post-surgical days (until 10/23/10). Between 10/22/10 and 10/24/10 Patient 1 showed a higher level of alertness, but remained weak and sleepy thereafter. His right-sided weakness remained unimproved throughout his hospital course. By 10/26/12, speech therapy and physician entries noted, "Patient significantly depressed LOA (level of alertness) and difficulty following commands," swallowing difficulty, "somnolent," with a plan to treat with an antibiotic if Patient 1 showed signs/symptoms of [DIAGNOSES REDACTED]. An entry by MD 1 dated 10/29/10 noted, "Will get culture of sputum (airway secretions) so in case of pneumonia we can treat with targeted ABX (antibiotics) without killing the 'good bugs.'" However, by 10/31/10, the breathing tube was needed again to protect Patient 1's airway and relieve the work of breathing.

Fevers returned on 10/31/10 and persisted. Also on 10/31/10, distinct and different types of bacteria (different from the bacteria placed in the brain) were cultured from Patient 1's urine, lung secretions, and buttocks wound. Two antibiotics were started. A request was made for consultation from experts in infectious diseases "to find an abx that won't kill off the therapeutic Enterobacter aerogenes (bacteria placed in the brain at surgery on 10/15/10)." However, Patient 1's brain imaging tests were showing signs of tumor and abscess in the original surgical site. The infectious disease experts continued to record Patient 1's clinical course and debate strategies to restrict the use of antibiotics to protect the brain bacteria, despite other sites of infection being identified. By 11/5/10, a culture from the brain fluid grew a bacteria strain that had become resistant to one of the antibiotics previously given.

Between 11/5/10 and his death on 11/22/10, Patient 1 never regained independent breathing function, neurologic function, or eating function, and required additional surgical procedures to support these functions and to drain infection sites. Starting on 11/17/10, Patient 1 was described as having "septic shock," (low blood pressure affecting critical organ function resulting from bacteria in the blood). Pressure in his brain related to tumor and abscess formation contributed to the shock condition. Brain function was determined to not be capable of recovery. On 11/22/10, Patient 1's family agreed to withdraw support and Patient 1 expired. An autopsy report showed the presence of tumor cells and abscess cavity in the area of the surgical site, with pressure on brain structures that interfere with life functions.

2. Patient 2, [AGE], was diagnosed with [DIAGNOSES REDACTED]. Upon completion of the standard treatments, a brain imaging test showed recurrence of tumor adjacent to the original surgical site. Treatment options included hospice or MD 1's experimental surgery with implantation of bacteria into the brain. The latter treatment was performed by MD 1 and MD 2 on 11/19/10. Patient 2's operative report reflected the same surgical technique used for Patient 1, although the location where the tumor was removed was different and further away from critical brain processes. Also different for Patient 2 was the administration of a selective antibiotic immediately prior to the surgical incision.

Patient 2 was hospitalized from [DATE] to 12/16/10. In the weeks following surgery, Patient 2's left sided weakness worsened, she lost the limited speaking ability that she had, she refused to eat for extended periods and was diagnosed with [DIAGNOSES REDACTED]. Persistent fevers did not occur and antibiotics were not administered at all. But Patient 2's worsened condition required transfer to a skilled nursing facility upon discharge.

According to Tumor Board notes dated 12/9/10, 6/23/11 and 9/27/11, and an Autopsy Report dated 11/28/11, imaging studies in the months after surgery initially showed abscess formation and tumor regression at the surgical site. However, Patient 2's nervous system function did not improve. Additional surgical procedures were performed in April 2011 to relieve pressure in the brain, July 2011 for new tumor presence, and breakdown of the surgical wound with persistent drainage between June and September 2011 requiring surgical removal of the coated bone flap and screws, irrigation and antibiotic treatments. Wound cultures grew three types of bacteria, including the one implanted on 11/19/10. Patient 2's condition continued to decline and she expired on [DATE]. The autopsy report identified two distinct tumor masses (recurrence) and tumor activity in the connections between the two sides of the brain, which was also noted at the time of original diagnosis. The autopsy report also identified chronic meningitis. The features of Patient 2's tumor type were associated with a median overall survival of approximately 1 year.

3. Patient 3, [AGE], (MDS) dated [DATE] with recent onset over 3 weeks of stabbing neck pain traveling down the right arm, right hand tingling, possible seizures, episodes of right leg weakness causing falls, and episodic nausea and vomiting with headache. An imaging test was suspicious for a large [DIAGNOSES REDACTED]. MD 1 provided treatment consultation, offered standard and clinical research trial options, as well as the non-standard experimental treatment performed on Patients 1 and 2. On 3/3/12 MD 1 and MD 2 performed removal of the tumor with implantation of the bowel bacteria into the evacuated tumor site, and in addition placed a plastic dome device outside the skull beneath the scalp but connected to a plastic tube tracking back into the brain cavity (Ommaya reservoir, designed for sampling of ventricular fluid or administration of medications into the brain cavity). Pre-operative antibiotics were not administered.

According to the Death Summary, immediately following surgery, Patient 3 was slow to wake up and possibly seizing, for which anti-seizure medications were administered. After 1 week she was conscious to follow commands, but developed breathing difficulties that required placement of a tube into the airway and connected to a machine (ventilator). On day 12 after surgery, "she began to decline and no longer followed commands." Patient 3 "had multiple CSF (spinal/brain fluid) and blood cultures that were positive for this bacteria which was injected as part of a clinical trial. On day 0 (day of surgery) she did exhibit signs and symptoms of [DIAGNOSES REDACTED]... multiple subgaleal (beneath the scalp outside of the skull) fluid aspirations, which documented effective implantation of the bacteria into the tumor cavity and the CSF space. On 3/16/2011 her neurologic exam declined significantly and the decision was made to begin treating her [name of bowel bacteria implanted into the brain] infection as well as her [name of different bacteria type] pneumonia."

Patient 3 also developed a viral infection of the mouth typically associated with an altered immune system, and a yet different bacterial infection of the urinary tract for which treatment was withheld. Similar to Patient 1, infectious disease consultations tried to produce a rationale for treating some infections and not others. Blood clots in Patient 3's lower legs were also not treated and progressed to extensive clots throughout both legs and traveling to the lungs. Patient 3 developed increased pressure in the brain related to the brain infection, which required surgical placement of a drain on 3/16/11. She did not recover from the brain swelling which was putting pressure on the portion of the brain that controls critical life functions. Patient 3 expired on [DATE]. The death summary documented, "A formal autopsy was requested by the family, given her participation in a clinical research study (research trial) and unexpected development of [brain swelling]."

Patient 3's autopsy report noted multiple areas of pus over the brain, meningitis (infection of the membranes covering the brain), midline shift to the left side, compression of the brain into the base of the skull, and the operative site was bloody and swollen. "The immediate cause of death was most likely postoperative complications after surgery for [name of [DIAGNOSES REDACTED]], including diffuse [brain swelling] leading to [increased pressure inside the skull] and brain [compression into the base of the skull.]"

In an interview on 8/27/12 at 10:15 a.m. with the Chief of Staff (COS) at the time of the treatments for Patients 1, 2, and 3, the COS stated that no research investigational protocol was in place for Patient 3 as described in the medical record, nor for Patients 1 and 2. "It (research protocol) was needed." The COS stated that a research investigational protocol was expected for all unusual, innovative, or non-standard treatments.

In an interview on 8/27/12 at 3 p.m. with MD 3, a neurosurgeon peer of MDs 1 and 2, MD 3 indicated that the [DIAGNOSES REDACTED] treatments given to Patients 1, 2, and 3 (i.e., placement of bowel bacteria directly into the brain as described above) was not standard, was not ever studied scientifically in humans, was not proven to be effective, and was "highly unprecedented." MD 3 acknowledged that a clear benefit to Patients 1, 2, and 3 was not established and the treatment used was very high risk for harm.

In an interview on 8/28/12 at 4:15 p.m. with MD 4, an expert in infectious diseases, MD 4 indicated that the infusion of bacteria that routinely inhabit the bowel but become harmful in other body locations such as the nervous system, was not a standard treatment for [DIAGNOSES REDACTED]s. MD 4 stated that this type of treatment in humans would be investigational and subject to formal approvals, protocols, published experience in animal testing, and approved by the FDA. Research in humans had not been conducted to scientifically determine whether the treatment was safe, effective, or what outcomes were to be expected. MD 4 stated that it was not possible to precisely balance preserving a chronic low-grade infection within the brain when infections developed in other body locations that required standard treatment to preserve body functions. Such experience in the specialty world of infectious disease care had not been studied and was not standard.

In a telephone interview on 8/28/12 at 10:30 a.m. with a research assistant (RA), RA indicated that she was asked by MD 2 to procure and transport the live bacteria (a biologic material) from a university campus animal research laboratory to the hospital to be administered during the surgeries for Patients 1, 2, and 3 on 10/15/10, 11/19/10, and 3/3/11 respectively. RA indicated that no formal procedures or filing for approvals by the campus Environmental Health and Safety Department or approvals by the hospital pharmacy were performed. Although she requested them, RA never received the biosafety packaging instructions from the original product purchase. RA indicated that she did not follow any formal written protocols or procedures to package, label and transport the biologic material, but relied on her knowledge and training for handling the material in the animal laboratory. RA indicated that the biologic material was acquired from a laboratory in another state some years ago, was labeled for animal use, and was not approved for use in humans.

In an interview on 8/29/12 at 10 a.m. with the Director of Pharmacy (DOP), the DOP indicated that hospital policies required all drugs and biologic materials administered to hospital patients to be approved for human use by the U.S. Food and Drug Administration (FDA). The DOP stated that biologic agents intended for hospital patients but not listed on the hospital formulary (regularly stocked inventory) would be considered investigational; they would be subject to the hospital procedures which require the agent to be routed through the investigational pharmacy to ensure the integrity, security, safety and storage of the agent in accordance with the manufacturer's recommendations. The biologic agent would also be subject to the standard drug labeling and controls in the distribution throughout the hospital to the bedside. The DOP referred to hospital policy (dated 11/16/11) 1508 for definitions of the categories for use of investigational drugs and biologic agents, including "compassionate use" procedures for non-standard unapproved drugs or biologics for patients with no alternative standard treatments. The DOP indicated that the bacteria implanted into the brains of Patients 1, 2, and 3 was not processed through the investigational pharmacy in part because no physician order for the material was submitted to the pharmacy. The DOP acknowledged that the use of bacteria approved for animal use but not FDA-approved for human use, and procured from an animal research laboratory would meet the hospital definition of a medication error. However, the hospital had not identified and investigated medication errors for Patients 1, 2, and 3.

Review of hospital policy 1508 titled "Distribution of Investigational Drugs," revised 11/16/11 but considered effective between October 2010 and March 2011 when Patients 1, 2, and 3 were treated, under Section II Definitions listed the following:
B. Investigational - a non-FDA approved drug or biologic, an approved drug or biologic for non-FDA approved indication, or any other compound permitted by the FDA to be tested in humans but not yet determined to be safe and effective for a particular use in the general population and not yet licensed for marketing.
D. Biologic - any therapeutic serum, toxin, anti-toxin or analogous microbial product applicable to the prevention, treatment or cure of disease or injuries. Biologics were regulated by the FDA's Center for Biologics Evaluation and Research. Such investigational treatments were required to have institutional review board (IRB) approvals, protocols, and be handled and processed through the hospital pharmacy's investigational drug service.
I. FDA's Expanded Access Program - a mechanism for obtaining an investigational drug, biologic or device to treat a patient with a serious disease or condition who does not have comparable or satisfactory alternative therapies to treat the disease or condition. The primary objective is patient treatment as opposed to a clinical trial where the primary intent is research. The FDA encourages drug sponsors and investigators to obtain meaningful data and further knowledge about the drug (or biologic). The five mechanisms for expanded access use all required approvals by the FDA.

Section V-B of policy 1508 addressed the storage and distribution requirements for items maintained outside the pharmacy, transfer and disposal of the item, and providing a copy of the protocol for use. Labeling requirements were described in Section V-C, with the requirement for all inpatient investigational drugs and biologics to be dispensed by the pharmacy.

Review of hospital policy 1509 titled "Emergency Treatment Use of an Investigational Drug, Device or Biologic (FDA Regulated Products) in a Life-Threatening Situation," revised 8/7/09, addressed the requirements for use when there was insufficient time to obtain institutional review board approval before rendering the investigational biologic to save a life. The same requirements for dispensing through the investigational drug services pharmacy unit and notifying the FDA or other oversight agency held. In addition, an independent assessment by an uninvolved physician must be obtained.

A separate hospital policy also numbered as 1509 and dated 8/09, titled "Emergency or 'Compassionate' Use of Unapproved Drugs or Biologic," contained similar but not identical language as 1509 above. This policy expected use of investigational drugs and biologics intended for use in the diagnosis, cure, mitigation and treatment or prevention of disease to be recognized in the official United States Pharmacopoeia (USP), which lists all drugs and biologic materials legally approved for sale and use in the U.S. This policy also defined Innovative Use as the application of a therapy, device, or medication in a manner that departs in a significant way from standard or accepted practice, and included unapproved biologics which had IRB approval. FDA rules still applied to these categories for use.

Review of the Medical Staff Bylaws, approved January 2012 and unchanged from the periods when Patients 1, 2, and 3 were treated, documented under Article II-A that the purposes of the medical staff shall include, "To provide that all patients admitted to the hospital or treated in the ambulatory sites receive quality care and treatment." Article III, Section 1-B noted that medical staff members were required to document their ability to provide patient care and treatment in accordance with generally accepted standards of quality care.

Article VII, Section 2-B-4 documented as a duty and responsibility of the Clinical Department Chairs, to establish an ongoing review process to evaluate the quality of patient care rendered within the Department. Section 2-B-7 noted for the Chairs to use the privileging criteria, supervise and evaluate the clinical work performed by members of the department and provide that department members practice within the privileging limits granted to them by the Governing Body. Section 2-B-11 directed the Chairs to promptly report the failure of any staff member to discharge patient care responsibilities in accordance with the standard practice within the community and the university.

Article VIII-F documented that the duties and authority of the Chief of Staff (COS) may be delegated to the Chief Medical Officer (CMO). Among the COS duties was VIII-F-1-a, to exercise such authority as he/she deemed necessary so that at all times patient welfare took precedence over all other concerns. The authority of the COS, VIII-F-2, included (c) to require consultations whenever, in his/her discretion, it was deemed necessary, and (f) to require all Staff members to comply with the hospital and medical staff bylaws, rules and regulations, policies and procedures, or face disciplinary action.

In an interview on 8/28/12 at 3:30 p.m. with the Chief Medical Officer (CMO), the CMO indicated that MD 1 approached him for approval to treat Patient 1 in early October, 2010 as a single, one-time compassionate use situation. The CMO directed MD 1 to perform specific tasks prior to proceeding with the proposed non-standard and unproven treatment to place bowel bacteria into the evacuated [DIAGNOSES REDACTED] site. The CMO's instructions (confirmed in an electronic communication document) were to obtain consultation by experts in medical ethics, and to not proceed if the Ethics experts did not concur that the treatment was necessary and in the patient's best interest. Furthermore, the CMO's instructions included planning with the patient and family for possible complications and adverse effects from the treatment, in order to establish agreement on the scope of treatment and end point in care before proceeding with the treatment. In addition, a clear understanding of the family's payment obligations needed to be arranged. Specific documentation in the medical records about MD 1's conversations with the Human Subjects committee was directed. The CMO indicated that MD 1 did not comply with these instructions prior to performing Patient 1's treatment on 10/15/10. The CMO learned about the non-compliance sometime afterward and warned MD 1 not to perform the treatment on any other hospital patients until formal approvals by the IRB and appropriate regulatory agencies was obtained. However, MD 1 arranged for Patient 2's treatment on 11/19/10 without the CMO's knowledge and without complying with the CMO's instructions from October 2010. The CMO again warned MD 1 to not perform other treatments without approvals, but MD 1 went ahead to treat Patient 3 on 3/3/11. MD 2 participated in each case under the direction of MD 1, who was his mentor and Chair of his department (neurosurgery).

Following the treatment and death of Patient 3 in March 2011, the CMO issued a written directive for MD 1 and MD 2 to stop any activity related to this non-standard, experimental treatment, and to not perform the treatment in any location. MD 1 and MD 2 were invited to appear before a medical staff peer review committee to explain their conduct. On 5/16/11 the Peer Review Committee issued a written reprimand (Letter of Expectations/Warning) to MD 1 and MD 2 for not complying with the CMO's instructions, for performing outside the standard of practice, and for exercising poor judgment by using bacteria from a non-approved source. The Committee expected MD 1 and MD 2 to seek consultation when contemplating procedures or treatment outside of the standard of care and to fully comply with all directives from the CMO or Chief of Staff.

The CMO indicated that the actions against MD 1 and MD 2 by the medical staff leadership ended with this letter. No education and training on the violated policies or the Code of Conduct were mandated for MD 1 and MD 2. No monitoring of the compliance with the expectations of the reprimand letter for MD 1 and MD 2 was arranged or implemented. No audits of their craniotomy surgeries or [DIAGNOSES REDACTED] treatments had been conducted to verify that the non-standard treatment was not being used. No objective evaluations for compliance with hospital policies for investigational drug and biologic use were conducted. The CMO stated that a new Innovative Use policy was approved in March of 2012 to ensure these events never happened again, but no validation of education and training on this policy by MD 1 and MD 2, or any other medical staff members, was performed.

In an interview on 8/27/12 at 10:15 a.m., COS stated that no neurosurgery department peer reviews for the care of Patients 1, 2, and 3 had been conducted. No quality investigations related to the processes of care for Patients 1, 2, and 3 by the neurosurgery department had been conducted. No surveillance audits, or mechanism to identify whether non-standard, experimental treatments were currently being performed by MD 1 or MD 2, were arranged or planned. COS expected any unusual treatments to be recognized by hospital staff by "common sense," and reported, even though perioperative staff had not formally registered any concerns through the hospital's incident-driven quality system when such treatments occurred on 10/15/10, 11/19/10, and 3/3/11.

In an interview on 8/27/12 at 12:45 p.m. with Administrative Manager (AM) 1, AM 1 confirmed that no neurosurgery department peer reviews for the care of Patients 1, 2, and 3 had been conducted. No quality investigations by the neurosurgery department had been conducted or concerns communicated to the greater hospital quality and safety committee related to the non-standard treatments and outcomes for Patients 1, 2, and 3. Following the medical staff leadership reprimand action against MD 1 and MD 2 described above, no ongoing peer review activities focused on the policy and ethics violations by MD 1 and MD 2 were implemented by the neurosurgery department. Up until recently, MD 1 served as the Chair of the neurosurgery department, with management power over the members of the department who were less positioned to monitor his activities. In addition, MD 1 had not conducted a review of his own performance .

In an interview on 8/29/12 at 12:10 p.m., the CMO indicated that the medical staff did not have a process in place to specify or restrict the authority to perform research in its privileging processes for physicians. The medical staff did not evaluate the conduct or compliance for research related work performed on hospital patients. Instead, the research activities conducted by medical staff members were governed by a university body (IRB, under the authority of the university's Office of Research) and not by the hospital governance. The IRB did not share the results of its compliance oversight for researchers directly and formally to the medical staff leadership, and vice versa. If medical staff members violated IRB rules which could threaten the health and safety of hospital patients, no process was required for the hospital to be formally notified of misconduct and potential harm to its patients. Therefore, the medical staff did not consider those aspects of patient care when determining competence and qualifications for renewal of hospital privileges and making recommendations to the governing body.

Review of a letter from the university IRB to the federal Food and Drug Administration (FDA) dated 10/17/11 (posted on the website of a local newspaper, www.sacbee.com <http://www.sacbee.com>) indicated that MD 1 and MD 2 violated IRB and FDA rules when they performed non-standard treatments with an unapproved biologic on human subjects (to Patients 1, 2, and 3) without IRB and FDA approvals. Only MD 2 was required to enroll in a research investigator training course. No remediation for MD 1 was documented.

Review of the April 2012 Medical Staff Rules and Regulations documented under item XI-L, "The Institutional Review Board (which was accountable only to the university Office of Research and not to the hospital) shall review and approve all investigational drugs and experimental procedures." Thus, the medical staff had no authority to enforce this rule.

Review of the January 2012 Medical Staff Bylaws documented under Article III, Section 2-A that the principles of medical ethics of the American Medical Association shall govern the professional conduct of the members of the medical staff.

Review of the AMA standards of conduct presented by AM 2 as correlating with the Medical Staff Bylaws noted under item III that a physician shall respect the law. Review of a statement posted on the AMA's website at www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code/ <http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code/> titled Opinion 8.20-Invalid Medical Treatment, documented under item (3): Among the treatments that are scientifically valid, medically indicated, and offer a reasonable chance of benefit for patients, some are regulated or prohibited by law; physicians should comply with these laws.
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on interview, document and medical record review, the hospital failed to safely provide surgical services when:
A. Standards of professional practice, including those of the Association of periOperative Registered Nurses, were not met (Refer to A 951),
B. Hospital policies and procedures that required compliance with federal regulations were not followed (Refer to A 951),
C. A comprehensive Perioperative Services Department investigation into the circumstances surrounding the surgical implantation of an unapproved biologic into three patients was not completed (Refer to A 951), and
D. Corrective action to prevent recurrence was absent or ineffectual (Refer to A 951).

These failures put all surgical patients at risk for injury and harm, including death.

The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the Condition of Participation: Surgical Services.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview, document and medical record review, the hospital failed to:
1) Recognize potential risk for harm and advocate for safety when Department of Perioperative Services staff did not question whether a non-approved biologic (microorganism capable of causing disease used instead to treat disease) implanted during the surgical procedures of Patients 1 (on 10/15/10), 2 (on 11/19/10) and 3 (on 3/3/11) had been approved by appropriate Department leadership, and
2) Develop and/or operationalize policies which assured standards of perioperative medical and nursing practice were met for all surgical patients.
Opportunities to identify and correct policy and procedure violations and departure from standard practice emerged during the care of Patient 1 which could have prevented repeated policy and procedure deviations and potential harm to Patients 2 and 3.

Findings:

Summary of Events
During the period from 10/14/10 to 3/3/11, two neurosurgeons (MDs 1 & 2) performed surgery on three patients (Patients 1, 2, 3) with end-stage glio[DIAGNOSES REDACTED] multiforme (quickly-growing cancerous [DIAGNOSES REDACTED]s). In addition to the attempted removal of the tumors, Patients 1 (10/14/10), 2 (11/19/10) and 3 (3/3/11) underwent implantation of a live bacteria, Enterobacter aerogenes (E.aero, a bacteria found normally in the bowels of humans and animals which could produce disease when outside the gastrointestinal tract) into the brain and surrounding bone tissue with the intent to cause a wound infection to attack any remaining tumor cells.

In an interview with a Research Assistant (RA) on 8/28/12 at 10:35 a.m., she stated the use of E. aero had never been tested on humans and had not approved by any safety organization for use in this way. The bacteria had been originally produced in an out-of-state laboratory, sent to a local area animal research laboratory, then brought to the hospital's operating rooms (ORs) by the RA on three occasions at the request of the neurosurgeons. The bacteria had been placed in a suspension and transferred into a tube without patient labeling or instructions for handling, use or disposal.

Implantation of the organism was accomplished by soaking Gelfoam pads (absorbable gelatin surgical sponges manufactured for use in controlling bleeding) and a piece of the patient's skull bone in the bacterial suspension, then placing the Gelfoam where the tumor had been. The bacterial implantation had not been listed on the surgery schedule forms and OR nursing staff had not been prepared in advance for the expected receipt, use and necessary post-operative disposal of the "probiotic" (term used to denote the bacteria on the operative consent forms). Participating OR nursing staff did not identify potential safety hazards for patients and staff with the bacteria's procurement, packaging, handling or use. Nursing documentation of the procedures and plans of care were incomplete. Nursing staff did not question or report to Perioperative Services leadership clinical treatment and processes not conforming to expected and established hospital and professional standards of care, either before or after any of the procedures.

Once knowledge of the events was acquired by Perioperative Services Department leadership, the investigation failed to discover why:
? the planned use of the bacteria was not communicated to the Department as part of surgery scheduling information,
? the surgeons did not initiate a plan to assure staff were knowledgeable and adequately prepared in advance of the procedures,
? the process by which an unknown material was allowed to be brought into the OR on three occasions,
? the nursing staff participating in the surgeries did not recognize the arrival and surgical implantation of the unknown material as potentially harmful to patients and surgical team members,
? staff did not inquire, either before or after the surgeries, whether the procedures had been approved by appropriate Perioperative Services Department leadership.

In addition, the investigation failed to determine:
? If biologic labeling met patient safety standards,
? If nursing documentation of the surgeries was complete and accurate,
? If perioperative plans of nursing care for these patients were complete, and
? What, if any, action was required to correct any process failures.

Patient Profiles
As determined by review of medical records:

Patient 1 was a [AGE] year-old admitted [DATE] with a 10-month history of glio[DIAGNOSES REDACTED]. After undergoing surgery, chemotherapy and radiation therapy at another hospital in 1/10, another tumor was found in 3/10. He requested neurosurgical consultation from MD 1 in 10/10. Patient 1 underwent surgery 10/15/10 in which his tumor was partially removed and "implantation of probiotic therapy" with live E. aero into the brain and surrounding bone tissue. Post-operatively Patient 1 experienced life-threatening complications including septic shock (low blood pressure resulting from bacteria in the blood which affects critical organ function) and functional decline due in part to brain abscess formation (an enclosed collection of liquefied tissue, pus) somewhere in the body, and died [DATE]. Glio[DIAGNOSES REDACTED] and brain abscess were listed among his causes of death.

Patient 2 was a [AGE] year-old admitted [DATE] with a glio[DIAGNOSES REDACTED]. Her tumor was diagnosed in May 2010 and MD 1 performed surgery that month, followed by radiation therapy and chemotherapy. Patient 2's tumor recurred and her condition worsened. She returned to MD 1 for further care and underwent additional surgery 11/19/10, including the implantation of the E. aero bacteria. She experienced worsening of her abilities to move and speak and required nursing home placement on 12/16/10. In the following months, increased pressure within the brain and chronic drainage from the surgery's resulting wound infection required additional surgical procedures. She died [DATE] with brain cancer and chronic brain infection among her causes of death.

Patient 3 was a [AGE] year-old admitted [DATE] after the diagnosis of [DIAGNOSES REDACTED][DIAGNOSES REDACTED] and instilled E. aero bacteria into the brain. Patient 3 experienced life-threatening effects related to the bacteria implantation, including brain infection, increased pressure within the brain, and sepsis (severe body response to bacteria or other germs, producing shock) and died [DATE]. Autopsy results showed multiple areas of pus over the brain, meningitis (infection of the membranes covering the brain and spinal cord), encephalitis (irritation and swelling of the brain, most often due to infection) and compression of the brain into the base of the skull, along with the brain cancer as among the causes of death.

Issues Identified
1) Nursing staff members did not recognize the potential risk for harm to patients and staff when a foreign material described as bacteria from an unknown source contained in improperly labeled bags delivered to the OR by a research assistant (RA) unfamiliar to them was surgically implanted in the brains of patients on three occasions. The staff did not inquire, either before or after the surgeries, whether these procedures had been approved by appropriate Perioperative Services Department leadership.

During a 10:35 a.m., 8/28/12 interview, the RA described the E. aero bacteria as having been prepared in a university campus microbiology animal research laboratory. She noted she had "never received [organism-]specific biohazard safety materials " and stated the bacteria was not approved for use in humans. She was unaware of any publications citing use of E. aero in human tumor treatment, "only compilations or anecdotes."

After being asked by MD 2 to bring the bacteria to the hospital OR before Patient 1's surgery, the RA placed it in a tube and transported it inside two plastic bags labeled only with the date and the name of the bacteria, noting she had not been provided a patient name. Inside the Perioperative Services Department, she "handed the [tube of] bacteria directly to [MD 2]" before entering the OR. The RA reported MD 2 gave it to someone else to bring into the OR. There "the doctors told the team it was bacteria." A surgical team member "poured it into a high-walled dish" where the Gelfoam and bone flap were to absorb the bacteria. The RA remained in the OR to observe the surgery.

Before Patient 2's surgery, the RA also gave the tube of bacteria directly to MD 2. She went to the dressing room to change into scrubs and when she entered the OR to observe the surgery, MD 2 "didn't have it when [she] came in." She was asked by a nurse if the bacteria was safe for the staff to work with, then "a nurse or orderly brought the dish [of bacteria] over and set it on the sterile field." She recalled MD 5, another neurosurgeon, "came into the OR and observed for a few minutes." She stated, "There were also some medical students there for a few minutes." The RA stated MD 2 "sent a resident [post-graduate physician in training] out of the OR to take the [tube of] bacteria" from her prior to Patient 3's surgery on 3/3/11.

During an 11:14 a.m., 8/30/12 interview, MD 1 stated, "There was no meaningful data to support this [use of probiotics]." He indicated he had not approached the Investigational Review Board (IRB) in advance of Patient 3's surgery and added, "Retrospectively, I should have asked permission from the IRB...It went against all OR rules."

In an interview at 3 p.m., 8/27/12, MD 3, a neurosurgeon peer of MDs 1 & 2, described the implantation of bowel bacteria into the brain as not standard tumor treatment. He stated the procedure had not been scientifically studied in humans, had not yet been proven to be effective and was "highly unprecedented."

In a 4 p.m., 8/28/12 interview, infectious disease specialist MD 4 was asked about the treatment of placing a type of bowel bacteria into the surgical site of a patient's brain. MD 4 stated he knew of no other medical treatments carrying this degree of risk that were not preceded by animal studies and experience in humans before being offered as a medical treatment. He indicated he expected formally-approved research protocols to be in place for procedures lacking experience to frame the plan of care and prepare staff about risks and use, including a plan to rescue the patient from sepsis (severe body response to bacteria or other germs, producing shock), meningitis or other life-threatening effects. He expected treatments to be FDA-approved and channeled through the investigative pharmacy, with clear procedures for handling and disposal.

In a 10:10 a.m., 8/27/12 interview, the OR Manager (MOR) stated he first learned of the biologic implantation in March, 2011 after Patient 3's surgery when Risk Services called inquiring about his and his staff's knowledge of the situation. The MOR notified the physician Director of Perioperative Services.

Staff told the MOR the biologic had been delivered to the ORs by "someone from the surgeon's [MD 2's] lab." The MOR indicated he "could see it being the process that staff would talk to the surgeon [who] would say [a procedure] was approved and we'd take the surgeon's word for it." The MOR stated "staff did not recall anything changing hands" and "didn't recall delivery to the [sterile surgical] field." He stated staff "didn't know if it [biologic] was introduced [into the patients] before or after the surgeon closed" and "didn't realize anything was put into or onto the wounds." He noted the neurosurgical resource nurse at the time of the procedures was also unaware of the implantation of the bacteria.

In a 1:35 p.m., 8/29/12 interview, RN 4, scrub nurse for Patient 1, stated if a consent form was in the medical record and the patient "seems to know what's going on," he "takes the surgeon's word" about whether a non-standard procedure has been approved and does not independently verify.

In a 3:14 p.m., 8/28/12 interview, RN 3, primary circulating nurse for Patients 2 and 3, could not verify the identity of the RA or identify the substance the RA brought into the OR. He was unable to recall the bacteria being placed on the operative field, its application to patients or its disposal.

Nurses participating in the three surgeries were familiar with neurosurgical practice. The MOR indicated "most" of Perioperative Services nursing staff were assigned within specialties such as neurosurgery/spine. He attempted to "keep staff in specialty 80% of the time" and indicated scrub personnel, which included "1 - 2 [OR] technicians" and a group of Registered Nurses, generally assisted only for cases in their specialty.

Review of the hospital's "Circulating Duties" policy, revised 2/15/11, revealed, "The circulating [Registered] nurse...Notes abnormalities...[Will] continuously monitor sterile field...Ensure correct implants...Obtain/dispense medications/solutions for sterile field...."

Review of the Association of periOperative Registered Nurses' Perioperative Standards and Recommended Practices, 2012 Edition, revealed, "The perioperative RN acts as a patient advocate...Seeks specialized dialogue appropriate to the patient...Facilitates communication between health care professionals to enhance patient outcomes...Consults with the appropriate health care providers to determine a need for new treatments..."

2A) Staff were not adequately prepared in advance of three surgical procedures when they lacked essential information from approved sources regarding the nature of, safe handling, use and disposal of a non-approved biologic used in the surgeries.

The hospital's "Distribution of Investigational Drugs" policy, revised 11/16/11, defined a biologic as "any therapeutic...analogous microbial product applicable to the...treatment...of disease." The policy further stipulated, "These agents are regulated by the FDA's 'Center for Biologics Evaluation and Research'." An investigational biologic was defined as "non-FDA-approved...."

The policy mandated, "Prior to the distribution of an investigational...biologic, its use within a research or treatment protocol must be approved by the IRB for Clinical Research. Distribution of all investigational...biologic products will be coordinated and supervised by the Investigational Drug Service (IDS). Dispensing and administration of biologics will be described in the protocol...and must be reviewed and approved by the IRB...Exception to the requirements...must be approved by the IDS. Receipt and storage...at any location outside the IDS must be approved and monitored by the IDS...Study-specific educational programs in the distribution and associated clinical implications of investigational drugs shall be conducted for all involved pharmacy and nursing personnel prior to initiation of study procedures."

In a 1:35 p.m., 8/29/12 interview, RN 4, scrub nurse for Patient 1, stated he had not been given any information about the procedure before surgery was ready to begin.

In a 3:14, 8/28/12 interview, RN 3, the circulating nurse for Patients 2 and 3, was unable to describe probiotics, the term used for the bacteria on patient consent forms. He was unable to recall any discussions with the surgeons regarding the organism.

In a 2:05 p.m., 8/28/12 interview, RN 2, the relief circulating nurse for Patient 2, was unable to define what a probiotic was. She was unable to recall any discussion about the bacteria or their use during the procedure.

During a 1:50 p.m., 8/28/12 interview, RN 1, the relief circulating nurse for Patient 3, could not recall being informed by the primary circulator that probiotics were being used in the procedure. She stated, "I didn't know what probiotics were."

In an 11:14 a.m., 8/30/12 interview, MD 1 stated he was unsure if he had discussed the procedure in advance with the nursing staff and did not recall if he had advised the MOR prior to the surgeries. He indicated he "didn't give them [nursing staff] instructions" regarding disposal of the bacteria remaining at the end of the cases.

In a 2:53 p.m., 8/27/12 interview, the Infection Prevention Manager (IPM) stated she learned of the use of E. aero in the three neurosurgeries "from the newspaper." She identified the organism as a bacteria "rarely seen in the hospital." She stated it was "unlikely [Infection Prevention leadership] would have approved" the use of the biologic, had advance knowledge of its proposed use been known. She described safe handling as needing to have included guarding the bacteria's container "to prevent a spill." She indicated the Infection Prevention department would have followed the post-operative clinical care of the patients, had notification of the procedures been received. In a 4:39 p.m., 8/28/12 interview, the physician Director of Hospital Epidemiology & Infection (MD 4) Control added, "If you bring anything live into the facility, you should have a policy and procedure for it."

In a 4:25 p.m., 8/28/12 interview, the interim hospital clinical laboratory leader (ICAO)stated she was unaware of anyone in laboratory leadership having been contacted regarding the bacteria or its use.

In a 9:34 a.m., 8/29/12 interview, neurosurgery resource nurse CRN 1 described his responsibilities to include working with physicians on new procedures, working with outside vendors on acquiring new products, and arranging for staff education. He stated he was not aware of the three procedures involving probiotics at the time they were done. In response to an inquiry on 8/29/12, he discovered Patients 1 and 3 were "add-ons" [additions to the daily surgery schedules after publication], a process which circumvented his involvement in case preparation unless specifically asked by surgeons. Patient 2 was scheduled through the usual scheduling process but probiotics implantation was not included in the scheduling information provided by the surgeon.

CRN 1 stated had he known of the cases before they were done, he "would have asked about IRB approval, reviewed patient consents and asked the Manager if he knew" about the surgeries. "I do this all the time with new equipment and procedures."

During a 9:09 a.m., 8/29/12 interview, the MOR stated staff weren't knowledgeable about probiotics "because it wasn't a [formal research] study." He did not know why the nurses had not sought information on the definition of the word "probiotic" on the Informed Consents.

In a 10:05 a.m., 8/30/12 interview, the CPCSO added, "There was no protocol associated with this research component [for staff to use as a reference]. Infection Control should have been consulted."

2B) Perioperative plans of nursing care for Patients 1, 2, and 3 did not address surgical implantation of a biologic during neurosurgery and potential risks of infection associated with the intentional withholding of antibiotics in the absence of a protocol for postoperative care.

Review of Patient 1's perioperative care plan revealed "Risk for impaired skin integrity" identified as the only potential problem. Patient 2's and 3's care plans included risks for "anxiety, fluid imbalance, hypothermia and impaired skin integrity" as the only potential issues.

While post-operative infection was intended to develop as a result of biologic implantation, this aspect of medical care represented a significant departure from conventional treatment. None of the patients' perioperative care plans communicated the bacteria implantation, the expectation of infection development or criteria for nursing intervention.

Review of the Association of periOperative Registered Nurses' Perioperative Standards and Recommended Practices, 2012 Edition, revealed, "The perioperative RN develops an individualized plan of care to attain expected outcomes...Designs a plan...that included strategies for health promotion and restoration...Creates a plan...that supports continuity among providers."

Standards of nursing care include observation and intervention for the development of infection. In the absence of a clinical protocol to guide post-operative care, nursing care planning was imperative for these patients.

2C) Planned use of a non-approved biologic in three procedures was not noted at the time of surgery scheduling.

Review of the "Scheduling Surgical Procedures" policy, revised 4/25/11, revealed, "If a special room, instruments, supplies and/or patient conditions...exist that would set the procedure apart from the routine, this must be indicated on the request...at the time the request is submitted."

During the 10:10 a.m., 8/27/12 interview, the MOR affirmed the surgery scheduling form had a prompt for special needs requests. Form information was extracted and input into scheduling "grids" which perioperative staff, including specialty resource nurses, used to prepare for cases.

During 9:34 a.m. and 1:55 p.m., 8/29/12 interviews, CRN1 produced scheduling information from the initial scheduling of the three surgical cases. Instillation of probiotics was not included as part of original scheduling information for Patients 1 and 3.

In a 2:23 p.m., 8/28/12 interview, CRN 2 stated the probiotics "should have been listed on the [surgery] schedules." He indicated this process would have enabled the neurosurgery resource nurse at the time to have had advance knowledge of the intended probiotics implantation, raised questions about the procedure and planned for staff education and environmental safety.

2D) Biologic used in three surgeries was not labeled in accordance with patient safety standards.

Review of the hospital's "Medication/Solution Identification on Operating Room Set-Up" policy, revised 10/24/11, revealed, "A means of readily identifying all medications and solutions on a sterile set-up is needed to prevent an error in administration of injectable, topical and irrigant drugs and solutions...The scrub person is responsible for providing a safe means of identification of the drug and solution to be administered...The scrub person will verbally and visually identify all drugs and solutions on sterile set-up...The scrub person will keep track of the drug/solution amounts administered...All medications and solutions, both on and off the sterile field, their labels, and amount of medication administered are to be reviewed by entering and exiting staff responsible for the management of medications.... "

In a 2:23 p.m., 8/28/12 interview, CRN 2 affirmed all solutions on the sterile operative field were to be labeled.

In an 11:14 a.m., 8/30/12 interview, MD 1 was asked how the biologic had been labeled. He stated, "I hadn't thought about [the labeling]. Some things I just hadn't thought of."

During a 10:10 a.m., 8/27/12 interview, the MOR indicated he did not become aware of the implantation of the biologic until the Risk Management department called him after Patient 3's surgery. He stated "it was very concerning to us" when Perioperative Services leadership learned that a non-approved biologic had been brought into ORs without their knowledge.

In a 10:05 a.m., 8/30/12 interview, the CPCSO added, "There was a gap in education regarding the labeling. The research assistant probably should have labeled it. Our process would be that this [a biologic] would go through Pharmacy."

2E) Circulating nurse documentation on intraoperative records lacked information regarding OR observers and/or use of the biologic.

According to the hospital's "Main Operating Room Structure Standards, "revised 9/29/11, "The RN is responsible for documentation of care delivered based on...AORN (Association of periOperative Registered Nurses) recommended practices for documenting perioperative nursing care.... "

The hospital policy "Operating Room Record Completion," revised 12/1/11, stipulated, "Accurate documentation is done on every patient undergoing surgical intervention...Intra-Operative Care/Observation...d. Implants: defined as material/devices that are surgically and permanently placed within the body."

Review of Patient 1's 10/15/10 "Operating Room Record" revealed no documentation of the presence of MD 2 or the RA in the OR. Procedure description documentation made no reference to the implantation of live bacteria into the brain. The physician's Operation Record listed MD 2 as one of two surgeons on the case.

Review of Patient 2's 11/19/10 "Operating Room Record" revealed no documentation of MD 5, medical students or the RA in the OR.

Review of Patient 3's 3/3/11 "Operating Room Record" revealed no documentation that MD 2 had been a part of the surgical team. The physician's Operation Record listed MD 2 as an assistant surgeon on the case.

During a 1:50 p.m., 8/28/12 interview, RN 1 reviewed Patient 1's Operating Room Record and was unable to find documentation of the probiotics, including the amount implanted.

In a 3:14 p.m., 8/28/12 interview, RN 3 indicated he had failed to document the RA's presence in the OR during Patient 2's surgery.

In a 2:05 p.m., 8/28/12 interview, RN 2 stated observers in the OR and surgical materials such as probiotics should be documented in the "Operating Room Record."

In a 2:23 p.m., 8/28/12 interview, CRN 2 stated all surgeons and individuals not part of the surgical staff were to be documented in the "Operating Room Record."

During the 10:10 a.m., 8/27/12 interview, the MOR stated, "There was no documentation of the process in the patients' medical records, including the [name of the] person delivering [the bacteria]." He articulated it was a circulating nurse responsibility to document the presence of persons in the OR. He stated, "My expectation is if someone comes in the OR, they are on the Operating Room Record."

2F) Corrective actions by perioperative leadership to address the aforementioned issues were not taken.

Review of the Association of perioperative Registered Nurses' Perioperative Standards and Recommended Practices, 2012 Edition, revealed, "The perioperative RN administrator guides the improvement of care delivery...Uses analysis to develop and enact new policies to improve perioperative nursing service.... "

In a 2:23 p.m., 8/28/12 interview, CRN 2 denied having [DIAGNOSES REDACTED].

In a 9:34 a.m., 8/29/12 interview, CRN 1 stated he learned of the cases earlier this year but "only learned this morning how the [probiotics] procedure was done."

During a 10:10 a.m., 8/27/12 interview, the MOR defined probiotics as "some type of live culture introduced to promote wound healing." He was unable to state what type of bacteria had been used in the procedures. He indicated there was no policy or procedure for the use of biologics in the Department. He was unable to articulate if two of the three supplemental consents developed by the surgeons explained that resulting infection from the procedures would be expected. He had not reviewed the original surgery scheduling "grids " to learn how the cases had been scheduled. He explained the lack of nursing documentation as "a communication issue." While he indicated he had verbally counseled involved staff members regarding their roles and responsibilities in the procedures, no documentation of the MOR's actions could be produced. He stated he knew of no incident reports filed.

During interviews at 9:09 a.m. and 11:08 a.m., 8/29/12 the MOR stated, "I'm not sure what we could have done differently...We trusted our surgeons...I have not done any huge investigation...Risk was working on it...We made assumptions this was very surgeon-related...I didn't consider if there should be tighter controls in place...I agree there's work to be done." He acknowledged the need to monitor innovative use of biologics through either accompanying protocols or through established standards of care.

In a 10:05 a.m., 8/30/12 interview, the CPCSO stated, "I'm responsible for [hospital-wide] nursing practice...I'm not aware of nursing failure in these cases ...I'm not aware of anything the OR would have done which would have prevented these cases from going forward. I see areas for improvement...The flaw in the process was in not having innovative care [policies and procedures] in place. We should have done an investigation when we [first] knew about it. We could have done an RCA (root cause analysis, a problem solving method designed to identify the root cause of a problem or event). It was a missed opportunity for performance improvement."

In an 11:08, 8/29/12 interview, the DPS indicated he had assumed the issue had been handled through medical staff channels and had not considered whether practices surrounding the surgeries were in accordance with acceptable professional standards. He stated, "If we had proper policies in place, these patients would have been treated anyway...The occurrence of these cases didn't trigger a huge CQI (continuous quality improvement) problem for me."

Department leadership failed to recognize that 1) policies and procedures addressing the identified issues already existed, and 2) staff were not compliant with them.