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Based on staff interview and document review, the hospital failed to ensure that hospital-wide surgical services were provided in a well-organized manner in accordance with acceptable standards of practice as evidenced by:

a. The hospital failed to ensure that the organization of surgical services reflected the scope and complexity of services provided by the hospital and were in accordance with acceptable standards of practice. (refer to A941, A942, A943, A944, A945, A951, A952, A955, and A957)

b. The hospital failed to ensure that the hospital's surgical services were supervised or managed by a physician or nurse supervisor, experienced and competent in the management of surgical services (refer to A942 ).

c. The hospital failed to ensure that the surgical technologists (operating room technicians) were under the supervision of a Registered Nurse (RN) (refer to A943).

d. The hospital failed to ensure that circulating duties (includes retrieving necessary supplies for members of the surgical team directly involved in un-interruptible patient procedures) were supervised by a Registered Nurse (RN) that was immediately available to respond to emergencies (refer to A944).

e. The hospital failed to ensure that surgical privileges (the authority to perform patient care tasks) were delineated in accordance with the competencies of each practitioner, in accordance with acceptable standards of practice and medical staff bylaws (refer to A945).

f. The hospital failed to ensure that policies governing surgical care were designed to assure the achievement and maintenance of high standards of medical practice and patient care (refer to A951).

g. The hospital failed to ensure that an accurate medical history and physical examination (H&P) was performed by a physician, or an accurate updated H&P, was documented prior to surgery or procedure requiring anesthesia services (moderate and deep sedation) in accordance with medical staff bylaws and acceptable standards of practice (refer to A952).

h. The hospital failed to ensure that a properly executed informed consent form for the operation was accurately documented prior to surgery (refer to A955).

i. The hospital failed to ensure adequate provisions for post-operative care when recovery space did not allow for provision of emergency rescue care without moving the patient to a larger space (refer to A957).

These failures put patients at risk for unsafe surgery and for care by persons lacking the skills to manage the effects of deep sedation, and for delays in recognition and rescue interventions for adverse effects.

The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Surgical Services.

Based on staff interview and document review, the hospital failed to ensure that hospital-wide anesthesia services were provided in a well-organized manner in accordance with acceptable standards of practice and under the direction of a qualified doctor of medicine or osteopathy as evidenced by:

a. The hospital failed to designate an anesthesia professional to direct and oversee its anesthesia services, to advise on medical staff privileging, policy development and training, to evaluate competence of staff providing anesthesia services, and to establish standards for evaluation and screening of patients at risk for anesthesia services (refer to A941 findings a, A941 findings b, A945 findings a, A 1001, A1003 A1004 and A1005).

b. The hospital leadership permitted the use of a general anesthetic agent by individuals who did not meet the definition of a qualified anesthesia practitioner [individuals who lacked documented training and proficiency in airway management, and lacked experience in managing patients under the effects of general anesthesia] (refer to A 1001).

c. The hospital failed to ensure that a pre-anesthesia evaluation was completed and documented by an individual qualified to administer anesthesia, prior to administration of a general anesthetic agent (refer to A 1003).

d. The hospital failed to ensure that documentation for intraoperative anesthesia records included monitoring of expired carbon dioxide gas exchange per standards of practice (refer to A 1004).

e. The hospital failed to ensure that post-anesthesia evaluations were completed and documented by an individual qualified to administer anesthesia following use of a general anesthetic agent (refer to A 1005).

These failures put patients at risk for unsafe anesthesia care by persons lacking the skills to manage the effects of deep sedation, and for delays in recognition and rescue interventions for adverse effects of anesthesia treatments.

The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Anesthesia Services.

Findings:

In an interview on 7/25/17 at 1:30 pm, the Chief of Staff (COS) indicated the following: There was no Anesthesia Director or anesthesiologist on staff. There were no Anesthesia Rules and Regulations. There was no designated medical staff committee or department led by a physician experienced in anesthesia care systems that actively provided oversight of anesthesia services for invasive procedures throughout the hospital. Matters that required patient care expertise were referred to a physician with experience in adult medicine, but there was no anesthesiology professional on the medical staff or under contract to advise or consult on policies and current sedation-anesthesia practices. The hospital had only one anesthesia policy (Sedation, Procedural, Adult, last revised 6/17), which listed a statement by the American Society of Anesthesiologists (ASA) upon which the policy was based. ASA was the only anesthesia expert organization affiliated with the one and only anesthesia policy but the medical staff had not formally determined which nationally recognized organization its anesthesia practices would mirror. The medical staff leadership did not reach out to anesthesiology experts for advice or consultation when they approved the anesthesia care services currently in place.

Review of an ASA statement titled The Organization of an Anesthesia Department, last amended 10/22/08, documented that the Anesthesia Department should assure the availability of quality anesthesia care where and when needed in the hospital. The Director of the department should be accountable to the medical staff leadership and responsible for:

1. Recommending clinical privileges for all individuals with primary anesthesia responsibilities.

2. Monitoring the quality of anesthesia care rendered throughout the hospital.

3. Recommending to the medical staff and administration the type and amount of equipment and supplies needed.

4. Developing regulations for anesthetic safety.

5. Ensuring quality assessment processes that were incorporated into the hospital's quality program.

6. Establishing a program of continuing education for all personnel having anesthesia privileges.

7. Participating in the development of, and enforcing policies and procedures related to anesthesia-related personnel and practices throughout the hospital. This should include a written policy defining the perioperative care of patients that may appropriately be provided in the facility, based upon consideration of age, risk categories, proposed procedure, and facility equipment and nursing capabilities.

8. Ensuring that qualified anesthesia personnel were available for the surgical schedule.

Based on staff interviews and document and patient record reviews, the hospital failed to ensure that the organization of surgical services reflected the scope and complexity of services provided by the hospital and were in accordance with acceptable standards of practice when:

a. The Medical Staff failed to demonstrate oversight of hospital-wide surgical procedures when it did not formally designate the responsibility to a qualified physician-led leadership body ( e.g., Surgical Department Director, Surgical/Perioperative Committee, experts in operative care) who was responsible for patient safety and quality for all surgical services and could be accountable to the top medical executive staff leadership and governing body of the hospital;

b. the Medical Staff failed to formally develop screening criteria for eligibility to have surgical procedures and anesthesia care services, with limits for the risk and acuity of patient conditions, in order for such care to occur safely in the hospital; and

c. The Nursing leadership failed to design oversight of nursing and support staff responsibilities for procedure-related care in a clear and effective manner in order for accountability at each level to occur.

These failures put patients at risk for unsafe surgery, and delays to recognize and rescue patients from adverse effects of surgical treatments.

Findings:

During a tour of the procedure suite on 7/24/17 at 2:10 pm, the Procedure Suite Manager (PSM) indicated that certain specialized invasive procedures related to the lungs or intestinal organs were performed as scheduled outpatient and inpatient cases in that location. Lung procedures included insertion of breathing tube devices through the skin of the front of the neck into the large airway beneath (tracheostomy), insertion of a endoscope device through the mouth into the upper and lower airway to inspect, treat and sample body fluids and tissues (bronchoscopy), insertion of a feeding tube device through the abdominal skin, into the stomach beneath, to directly instill nutrition products, insertion of an endoscope device through the mouth into the upper intestinal tract (UGI endoscopy) or through the rectum into the lower bowel tract (colonoscopy) to inspect, treat and sample tissue or lesions, or to inject laboratory-processed fecal material into the bowel to help fight infections (fecal microbiota transplant, FMT). In addition, chest tube insertions, needle aspirations of the chest and abdomen, and insertion of plastic tube catheters into large blood vessels that lead to the heart were routinely performed at the bedside of inpatients. The procedures were performed by physicians with expertise in lung diseases, in intestinal diseases, and in general diseases of adults. Anesthesia was limited to "moderate sedation" (the administration of sedative and narcotic pain medications to lower consciousness in order for a patient to tolerate an invasive procedure). The hospital had no general surgeons or anesthesiology professionals on its medical staff.

a. Medical Staff designation of leadership body for oversight of surgical services

In an interview on 7/25/17 at 1:30 pm, the Chief of Staff (COS) indicated the following: There was no designated medical staff committee or department led by a physician experienced in perioperative care systems that actively provided oversight of invasive procedures throughout the hospital. No nationally recognized expert perioperative organization served to guide the surgical policies and practices in place currently. Matters that required patient care expertise were referred to a physician with experience in adult medicine, but there was no surgeon on the medical staff to advise or consult on policies and current surgical practices. One committee that might be able to take that responsibility was the Critical Care Committee. But that committee was not currently active. The medical staff leadership did not reach out to surgeons or anesthesiologists for advice or consultation when they approved the invasive procedure services currently in place.

Review of the Medical Staff Rules, effective 9/2016, under Rule 4 for Committees, Appendix 4F documented that duties of the Critical Care Committee included, "2. Responsible for reviewing quality and services provided for critical care patients, including high risk procedures, protocols, code blues and rapid response. 3. Review policies, procedures and forms related to critical care." The committee was composed of a lung specialist, two active medical staff members, nursing director, and adult medicine medical director. No physician with surgical expertise was listed as a member.

In interviews on 7/25/17 at 10:45 a.m. and 4:30 p.m., the Medical Staff Coordinator (MSC) indicated that invasive lung procedures were established many years ago, FMT procedures were approved by the medical staff leadership in 2014, and the performance of other intestinal procedures was approved in September 2016. The intestinal procedures were not started until equipment and personnel were arranged more recently (earlier this year). The proposal to perform intestinal procedures was formulated by an informal interdisciplinary group representing nursing staff, respiratory therapy staff, an adult medicine doctor, an intestinal specialist doctor, and the billing department. None of the group members possessed expertise in perioperative or anesthesia services. The proposal was presented directly to the Medical Staff executive leadership on 8/23/16.

Review of the Medical Staff Executive Committee (MEC) minutes dated 8/23/16 documented presentation of a packet for Outpatient Procedural and Diagnostic Endoscopy and Colonoscopy. The proposed service with corresponding policies were approved and sent to the governing body, recommending approval. No MEC members present at the meeting were identified to have expertise in perioperative or anesthesia services.

Review of the intestinal procedure policies referenced in the MEC 8/23/16 meeting, plus review of established bronchoscopy and FMT policies, indicated various inconsistencies and departures from established standards of practice for surgical and anesthesia care as follows:

1. The hospital policy, Bronchoscopy, Fiberoptic, last revised 4/2014, Procedure item 7 directed the physician and assistant to don sterile gloves, a special mask, and eye protection. Several instructions referred to using "aseptic technique." However, no direction to perform a surgical scrub in advance, to wear commercially laundered scrub attire, to wear a sterile cover gown, to wear head coverings, to prepare a sterile field on which to lay sterile instruments or prepare sterile injection solutions. The procedure steps for obtaining specimens were very specific to instruct the assistant to operate biopsy forceps or aspiration needles.

2. In contrast to the Bronchoscopy policy, the Upper Gastrointestinal (UGI) Endoscopy Procedure, effective 7/2016, noted under Procedure item 13 that the assistant "will help physician with biopsy, cytology, photography, etc" without detailing the technical steps to operate the endoscopy equipment and instruments or "assist" with the acquisition and collection of specimens.

In an interview on 7/25/17 at 11:30 am, Physician G (a specialist in intestinal diseases who performed endoscopy procedures) stated that in contrast to endoscopy alone, surgical insertion of feeding tube required aseptic steps to prevent infection of the skin incision (e.g., pre-operative antibiotic, prepping the skin incision with an antiseptic solution).

In an interview on 7/26/17 at 5:30 pm, the Chief Nursing Officer (CNO) stated that no specific policy for feeding tube placement was developed, as it was incorporated into the UGI Endoscopy Procedure as an added on task.

However, review of the UGI Endoscopy Procedure showed no documented procedures for setting up a sterile field for sterile instruments when surgically inserting a feeding tube through the skin into the stomach, for performing hand scrub in advance, for prepping the skin with antiseptic solution, and for wearing full surgical attire with sterile gloves, masks, commercially laundered scrub attire, sterile cover gown, and head covering.

In a walk-through observation of procedures performed in the designated procedure room on 7/26/17 at 12:30 pm, in a concurrent interview, PSM and other staff familiar with routine care for intestinal procedures confirmed that aseptic practices for sterile procedures were not applied for any intestinal procedures, including the surgical insertion of feeding tube.

Review of the 2014 Association for peri-Operative Registered Nurses (AORN) Guideline for Surgical Attire documented that scrub attire laundered in a healthcare accredited facility should be worn in the semi-restricted and restricted perioperative care areas. Recommendation I-b noted that personnel should don clean scrub attire daily, any uncovered personal clothing should be laundered by a healthcare accredited laundry facility after use, and item I-c-1 directed that scrub attire should cover the arms when performing skin preparation with antiseptic solutions. Recommendation III read, Personnel entering the semi-restricted and restricted areas should cover the head, hair, ears, and facial hair.

The 2012 AORN Guideline for Sterile Technique gave detailed guidance for performing a surgical hand scrub before donning sterile gloves and gown, setting up a sterile field with drapes, and other steps to minimize contamination of the surgical site, in great contrast to the practices for aseptic tasks adopted by the hospital.

3. The hospital policy, Colonoscopy Procedure, effective 7/16, Procedure item 13 simply noted, "Biopsy, brush cytology and photographs may be taken," without specifying by whom and how. Steps to prepare the operative field with the equipment and supplies were not described in either of the intestinal procedure policies. The supply list included "disposable gloves, gowns and protective eyewear." No provisions for wearing masks, commercially laundered scrub attire, or head coverings were documented, despite the risk for splash and aerosol generation of patient blood and body fluids onto staff and the reverse deposit of particulate matter from staff onto sterile instruments used to sever intestinal tissues and onto disinfected equipment used in the procedure.

4. The hospital policy, Fecal Microbiota Transplantation via Colonoscopy, effective 1/15, noted disposable gloves, aprons and protective eyewear under Equipment and Supplies. The policy did not direct procedure personnel to wear commercially laundered scrub attire, masks, or head coverings, despite the handling and potential exposure to fecal material that may be splashed upon insertion into the colon or as a scope was removed.

5. A hospital sponsored course titled Procedural Sedation Manual for Bronchoscopy, Procedural and Diagnostic Endoscopy and Colonoscopy, FMT via Colonoscopy Adults/Older Adults, and ACLS Self Study Module 2017 contained education and descriptions of the types of surgical instrumentation involved in the procedures, e.g. introduction though the scope tubing of small folding forceps, scissors, brushes, snares, baskets, aspiration needles. The risks for the procedures and moderate sedation included bleeding, puncture of body cavities, spasm of the lung passages, low blood oxygen, low blood pressure, exposure to infectious materials, contamination of specimens or endoscopes, heart rhythm dysfunction, heart attack, shock, and death. The course did not specify the qualifications of staff assigned to assist in procedures beyond expertise in respiratory therapy.

Contrary to the descriptions of direct tissue excision and disturbances inside body cavities from the procedures, as well as actual hospital practices, the hospital policy Plan for Provision of Care, Treatment and Services, last revised 1/2017, documented that surgery was not performed at the hospital, and surgery requiring anesthesia was not performed. Yet, minor invasive and noninvasive procedures, which may or may not cause loss of reflexes, may be performed. The policy stated that only minimal and moderate sedation was provided at the hospital (omitting the use of a general anesthetic agent-propofol) and that patient care services provided through referral, consultation, and contractual arrangement included surgery and anesthesia (thereby not performed at the hospital). However, several "non-surgical invasive procedures" were listed as Outpatient Services: bronchoscopies, colonoscopy for FMT, esophagogastroduodenoscopy (UGI endoscopy), peripherally placed central lines (when clearly each procedure had elements of surgical care).

6. In an interview on 7/25/17 at 11:30 am, Physician G (a specialist in intestinal diseases who performed endoscopy procedures) stated that the "nurse" assisting for intestinal procedures was sometimes asked to press firmly onto the patient's abdomen to facilitate passage of the endoscope through the bowel cavity. Physician G indicated that a nurse may administer a general anesthetic drug (propofol) if directed by him during a procedure, even for a first and one-time dose.

None of the policies described a maneuver by the assistant to apply pressure to a patient's abdomen to assist the physician in passing an endoscope through the bowel passage. The assistant for bronchoscopy and endoscopy procedures was specifically called a respiratory therapist in these policies, and not a registered nurse.

7. The hospital policy, Sedation, Procedural Adult, last revised 6/2017, listed the American Society of Anesthesiologists (ASA) Statement on Granting privileges for Administration of Moderate Sedation to Practitioners Who are Not Anesthesia Professionals, October 19, 2011, as a reference upon which the policy was based. The hospital policy documented that a qualified Registered Nurse (RN) may administer medications intended for sedation/analgesia under the supervision of the procedural physician after successfully completing the hospital sponsored course titled Procedural Sedation Manual for Bronchoscopy, Procedural and Diagnostic Endoscopy and Colonoscopy, FMT via Colonoscopy Adults/Older Adults, and ACLS Self Study Module 2017. The policy instructed the RN to check equipment prior to the procedure, including capnography monitor (device to measure carbon dioxide gas exchange, ETCO2, generated from a breathing passage). However, during the procedure the RN was only required to use capnography and document the ETCO2 measurements for patients receiving a specific general anesthetic drug (propofol) and not for other moderate sedation drugs. The policy required the procedural physician to administer the initial dose of propofol, and consecutive doses may be administered by the qualified RN.

In an interview on 7/25/17 at 11:30 am, Physician G indicated that a nurse may administer a general anesthetic drug (propofol) if directed by him during a procedure, even for a first and one-time dose.

Further review of the hospital sponsored course titled Procedural Sedation Manual for Bronchoscopy, Procedural and Diagnostic Endoscopy and Colonoscopy, FMT via Colonoscopy Adults/Older Adults, and ACLS Self Study Module 2017 noted that the goal of procedural sedation was moderate sedation, where patients may be drowsy but still respond to verbal commands and light stimulation. The Manual documented, "RNs may not administer IV push anesthetic agents for procedural sedation including Etomidate, Ketamine, Sodium Thiopental, or Methohexital. RNs may not administer Nitrous Oxide. The RN will be able to administer Propofol IV push as an anesthetic agent only as a second or consecutive dose and under direct supervision and orders of the procedural physician." The drugs listed here including Propofol were all classified by the United States Pharmacopoeia and Federal Drug Administration (FDA) as general anesthetic drugs with high potential for patients to drift into deep sedation not easily aroused and at risk to lose breathing function, or even drift further with complete loss of breathing and movement. The hospital's training manual required that "informed consent for the procedure and moderate sedation" be obtained by the physician, without informing Propofol patients that their risk for deeper loss of reflexes and breathing (as labeled by the manufacturer and categorized by the FDA as a general anesthetic agent) was greater than other moderate sedation drugs. The hospital training manual explained that ETCO2 monitoring can add to the safety of procedural sedation by quickly detecting hypoventilation (shallow breathing that lowers oxygen absorption into the blood circulation to vital organs) early before oxygen desaturation takes place. "An increase in ETCO2 might be the only clue to hypoventilation and potential respiratory compromise." However, monitoring of ETCO2 was only directed "if ordered by physician," and not as part of the expected routine monitoring for all moderate sedation patients.

Review of the American Society of Anesthesiologists (ASA) statements related to both moderate and deep sedation [Statement on Granting Privileges for Administration of Moderate Sedation to Practitioners Who Are Not Anesthesia Professionals, amended 10/19/11, and Advisory on Granting Privileges for Deep Sedation to Non-Anesthesiologist Sedation Practitioners, approved 10/20/10] recommended capnography monitoring throughout all procedures utilizing sedation. The ASA Deep Sedation statement specified that the non-anesthesiologist sedation practitioner who administered and monitored deep sedation, or supervised that task, must be different from the individual performing the diagnostic or therapeutic procedure, i.e., dedicated to the anesthesia task.

In an interview on 7/25/17 at 11:30 am, Physician G stated that when propofol was given for procedures he was performing, he simultaneously supervised the RN administering and monitoring the sedation. Physician G indicated that a nurse may (and did at times) administer the general anesthetic drug (propofol) if directed by him during a procedure, even for a first and one-time dose.

In a 9/95 position statement titled "Conscious Sedation" (moderate sedation) from the California Board of Registered Nursing (BRN) retrieved at www.rn.ca.gov, the right and obligation of the RN caring for a sedation patient was documented as "to act as the client's advocate by refusing to administer or continue to administer any medication not in the client's best interest; this includes medications which would render the client's level of sedation to deep sedation and/or loss of consciousness." The BRN statement directed institutions that utilized registered nurses to administer moderate sedation to consult with national guidelines in establishing facility policies and procedures.

b. Screening criteria of patient condition and acuity for safe surgery and anesthesia

In an interview on 7/25/17 at 11:30 am, Physician G stated that he routinely performed a pre-procedure assessment of patients for whom intestinal procedures with moderate sedation were needed. His personal criteria for patients who should not have a procedure at the hospital (but should be transferred or scheduled at a higher level hospital) included severe systemic disease that is a constant threat to life, shortness of breath, borderline blood oxygen levels, high bleeding risk or medications that cause bleeding, uncontrolled heart rhythms. No system to obtain consultation with an anesthesia provider was in place. Physician G stated he knew of no formal criteria (developed by the hospital) to guide the decision, which was ultimately his to make.

Review of patient records indicated that Patient 1 was admitted to the hospital on 3/26/17 with pneumonia, respiratory failure, chronic lung disease, congestive heart failure, and a heart rhythm disorder (atrial fibrillation-AF, a quivering of the heart muscle that limits the efficiency of pumping blood). Patient 1 was 63 years old, weighed 297 pounds (lbs). Patient 1 had a history of cellular changes in the esophagus and developed dark stools, a sign of intestinal bleeding, for which Physician G consulted and recommended inspections of the upper and lower intestinal tracts via endoscopy procedures on 4/20/17. Although the pre-operative nurse noted abnormal heart rhythm and a recorded heart rhythm strip showed features of AF, Physician G recorded no abnormal physical findings for heart, lungs, or airway on the preoperative History and Physical update form. Physician G's pre-sedation assessment form did not assign a score for mouth opening (Mallampati score), did not note the history of respiratory failure and chronic lung disease, did not note the morbid obesity, all risks for difficulty to support and rescue the airway during sedation. The preoperative nurse noted allergy to Tetracycline antibiotic but Physician G recorded "no allergies." The informed consent verification form signed by Patient 1 prior to the procedure did not state the type of sedation planned.

The Procedure Record showed that moderate sedation drugs were given by a RN at 1:20 pm (Benadryl 50 milligrams-mg), 1:22 pm (Midazolam 2 mg), 1:24 pm (Fentanyl 100 micrograms-mcg), and 1:34 pm (Propofol 20 mg, a general anesthetic drug). Of note, the endoscope was inserted by Physician G at 1:30 pm, prior to administration of the initial and sole Propofol dose which was given by the RN at 1:34 pm. ETCO2 measurements were not recorded during or after the procedure that used Propofol, despite a physician order for it. The upper intestinal procedure with four biopsies followed by the lower intestinal procedure were completed in 25 minutes but the Procedure Record did not distinctly note start/stop times for each procedure within that 25 minutes. Neither the immediate post-operative physician note nor the dictated procedure note for the UGI portion documented that Propofol was administered during the procedure.

In an interview on 7/25/17 at 1 pm, the Chief of Staff (COS) acknowledged that the History and Physical pre-operative assessment and pre-sedation assessment for Patient 1 was "thin" and inaccurate and did not reflect Patient 1's risk profile for AF, obesity, chronic lung disease and heart failure. The COS expected the procedure physicians to use good judgment to decide whether procedures could be performed at the hospital safely without support by an anesthesia professional, or whether they should be performed at a center with higher level of support. The COS acknowledged that some inpatients who undergo invasive procedures were seriously ill and some dependent on ventilator machines to breath and had constant threat to their lives. Others were recovering from life-threatening blood loss, heart conditions, respiratory failure, and kidney failure. The medical staff had not developed formal guidance based on standards of care for the procedure staff that framed the capabilities of the hospital and the risk profiles of patients who may require more support than the hospital could offer, i.e., criteria to arrange for surgical care at hospitals with greater surgical support or obtain anesthesia consultation to help make such a decision.

Review of an ASA statement Distinguishing Monitored Anesthesia Care (MAC) from Moderate Sedation/Analgesia (Conscious Sedation), reaffirmed 10/16/13 documented the additional skills that an anesthesia professional brings to the assessment and management of a patient's actual or anticipated physiological derangements or medical problems that may occur during a diagnostic or therapeutic procedure. Such a professional can convert to general anesthesia when necessary, as well as rescue a patient's airway from sedation-induced compromise. If a patient's condition and/or a procedural requirement is likely to require sedation to a "deep" level or even to a transient period of general anesthesia, only a practitioner privileged to provide anesthesia services should be allowed to manage the sedation. In situations where the procedure is more invasive or when the patient is especially fragile, optimizing sedation level is necessary to achieve ideal procedural conditions.

Review of the ASA Statement on Granting Privileges for Administration of Moderate Sedation to Practitioners Who are Not Anesthesia Professionals, last amended 10/19/11, documented that education and training of physicians who administer or supervise administration of moderate sedation should assess the patient's airway for anatomic and mobility characteristics suggestive of potentially difficult airway management. The non-anesthesiologist sedation practitioner should be able to recognize those patients whose medical condition suggests that sedation should be provided by an anesthesia professional.

Review of ST-25 from the American College of Surgeons (ACS) titled ACS Statement on Principles Underlying Perioperative Responsibility, under item 4 documented that the surgeon was responsible for the proper preoperative preparation of the patient. Minimizing the risk of the operation, while providing maximal opportunity for a satisfactory outcome, required full appreciation by the surgeon of the patient's condition. Item 5 noted that the surgeon was responsible for the safe and competent performance of the operation. Part of this responsibility included planning for the operation with the anesthesiologist in order to ensure anesthesia that was best for the patient.

Review of the 2015 Association for peri-Operative Registered Nurses (AORN) Guideline for Care of the Patient Receiving Moderate Sedation/Analgesia noted that certain patients may not be candidates for moderate sedation/analgesia administered by perioperative registered nurses (RNs). Such patients may require care provided by an anesthesia provider qualified to administer monitored anesthesia care (MAC) and to rescue the patient from a deeper level of sedation, or qualified to convert to general anesthesia if needed. The RN should assess the patient for such, based on selection criteria defined by the health care organization. Conditions that may indicate difficulty with mask ventilation included age over 55 years, overweight (BMI>30), noisy breathing during sleep, short neck, limited neck extension, small mouth opening, missing teeth, enlarged tonsils, and others. Consultation with an anesthesia provider should be obtained if a patient presents with any one of the following: known history of respiratory or hemodynamic (lung or heart) instability; previous difficulties with anesthesia or sedation; severe sleep apnea (breathing disorder during sleep) or other airway related issues; one or more significant co-morbidities; inability to communicate or cooperate; multiple medications with potential for drug interaction with sedative analgesics; unstable severe systemic disease or disease that is a constant threat to life.

c. On 7/26/17 at 10:50 am, during an interview, the Chief Nursing Officer (CNO) confirmed that nursing oversight and support staff responsibilities were not clearly defined and did not include accountability at each level of procedure related care as follows. Procedure suite employee files were concurrently reviewed for job descriptions, education, training, and competencies specific to their job duties and organizational accountability. The CNO confirmed the positions for the Peri-Operative Nurse, Procedure Nurse, Surgical Technologist and the Circulating Respiratory Therapist did not have job descriptions specific to responsibilities for procedure related duties, or evidence of education, training, or related competencies (verifies level of competence). Procedure Nurse A (PN A) had a job description that included oversight of nursing related patient care in the procedure room; however PN A did not participate in employee evaluations or ensure competencies related to procedure room duties of the peri-operative nursing staff, Surgical Technologist or the Circulating Respiratory Therapist. While PN A did train and evaluate RN's preparing for Procedure Nurse and Moderate Sedation Nurse positions, PN A was not involved in the annual performance evaluation for these nurses. Review of the peri-operative nurse performance evaluations did not include evaluation of performance related to the procedure suite. Review of other annual performance evaluations revealed that the PN A's evaluation was completed by the Director of Business Development/Procedure Suite Manager; the Circulating Respiratory Therapist and the Surgical Technologist positions were evaluated by the Director of Respiratory Care and review of the performance evaluation form for these positions did not include evaluation of performance related to the procedure suite. The Director of Respiratory Care was evaluated by the Director of Business Development/Procedure Suite Manager and the evaluation form for this position did not include evaluation of performance related to the procedure suite. The Director of Business Development/Procedure Suite Manager was evaluated by the Chief Executive Officer (CEO). The CNO acknowledged the organizational design did not include nursing oversight for important surgical procedure-related care in an effective manner. As a result, managers were given responsibility to evaluate the performance of employee positions for which the manager did not have training, expertise, or tools to verify competence.

During the same interview on 7/26/17 at 10:50 am, the CNO confirmed the Facility Organization Chart, dated December 2016, did not include identification of the procedure room. The CNO explained the procedure room was part of Radiology Services. Radiology services were managed by the Respiratory Care Director who reported to the Director of Business Development/Procedure Suite Manager (also qualified as a Respiratory Care Therapist). The Director of Business Development/Procedure Suite Manager reported to the CEO. No nursing oversight was included in the organizational structure of the procedure room. The provision of surgical services in the procedure room included endoscopy and related procedures including fecal transplants, cautery (destruction of tissue such as by burning), and biopsies (removal of tissue); bronchoscopy (insertion of a endoscope device through the mouth into the upper and lower airway to inspect, treat and sample body fluids and tissues), tracheostomies (insertion of breathing tube devices through the skin of the front of the neck into the large airway beneath), and surgical insertion of feeding tubes. The service also included the administration of moderate sedation plus the use of propofol, a general anesthetic agent. The CNO explained that while nursing administration was integral in setting up the procedural processes that were currently in place, the CNO acknowledge that the organization of the service did not include nursing oversight in an effective manner. The CNO acknowledged the surgical procedure room did not include oversight by a nurse who had training and experience in the management of surgical services.

Based on interview and document review, the hospital failed to ensure that the facilities surgical services were supervised/managed by qualified personnel (a physician or nurse supervisor experienced and competent in the management of surgical services).

This failure had the potential to result in unsafe surgery which could negatively impact patient outcomes.

Findings:

During a tour of the procedure suite on 7/24/17 at 2:10 pm, the Director of Business Development/Procedure Suite Manager (PSM) indicated that certain specialized invasive procedures related to the lungs or gastro-intestinal organs were performed as scheduled outpatient and inpatient cases in that location. Lung procedures included insertion of breathing tube devices through the skin of the front of the neck into the large airway beneath (tracheostomy), insertion of a endoscope device through the mouth into the upper and lower airway to inspect, treat and sample body fluids and tissues (bronchoscopy), insertion of a feeding tube device through the abdominal skin, into the stomach beneath, to directly instill nutrition products, insertion of an endoscope device through the mouth into the upper intestinal tract (UGI endoscopy) or through the rectum into the lower bowel tract (colonoscopy) to inspect, treat and sample tissue or lesions, or to inject laboratory-processed fecal material into the bowel to help fight infections (fecal microbiota transplant, FMT). In addition, chest tube insertions, needle aspirations of the chest and abdomen, and insertion of plastic tube catheters into large blood vessels that lead to the heart were routinely performed at the bedside of inpatients. The procedures were performed by physicians with expertise in lung diseases, in intestinal diseases, and in general diseases of adults. Anesthesia was limited to "moderate sedation" (the administration of sedative and narcotic pain medications to lower consciousness in order for a patient to tolerate an invasive procedure). The hospital had no general surgeons or anesthesiology professionals on its medical staff.

On 7/26/17 at 10:50 am, during an interview, the Chief Nursing Officer (CNO) confirmed the circumstances as follows. Nursing management, for the surgical procedure suite, did not have specialized training in the provision of surgical services or management of surgical service operations. Job descriptions did not define required qualifications for the manager of surgical services operations. Four employee files for procedure suite staff Moderate Sedation/Procedure Registered Nurse Manager (PNM) A, Procedure Assistants (PA) B, PA C, and PN D) were reviewed. Review of these employee files, and CNO explanation, confirmed the organizational structure for job descriptions, performance evaluations and accountability as follows.

-The performance evaluation of the Procedure Assistant position were evaluated by the Director of Respiratory Care. The performance evaluation did not list duties specific to job functions in the procedure suite. No job description related to Procedure Assistant duties was found.

-The Director of Respiratory Care was evaluated by the Director of Business Development/Procedure Suite Manager and the evaluation form for this position did not include evaluation of performance related to the procedure suite.

-The Director of Business Development/Procedure Suite Manager was evaluated by the Chief Executive Officer (CEO).

-The performance evaluations for the peri-operative nurse and Moderate Sedation Procedure Nurses (MSPN) were completed by the Director of Nurses (not currently involved in overseeing operations in the surgical suite). The performance evaluation did not list duties specific to job functions in the procedure suite. No job description related to peri-operative nursing, or MSPN was found.

-Review of PNM A's annual performance evaluation revealed that the his evaluation was completed by the Director of Business Development/Procedure Suite Manager. While PN A did train and evaluate RN's preparing for Procedure Nurse and Moderate Sedation Nurse Positions, PN A was not involved in the annual performance evaluation for these nurses.

The CNO acknowledged the organizational design did not include nursing oversight for important surgical procedure-related care in an effective manner. As a result, managers were given responsibility to evaluate the performance of employee positions for which the manager did not have training, expertise, or tools to verify competence. The CNO confirmed the positions for the Peri-Operative Nurse, Procedure Nurse, Surgical Technologist and the Circulating Respiratory Therapist did not have job descriptions specific to responsibilities for procedure related duties, or evidence of education, training, or related competencies (verifies level of competence).

During the same interview on 7/26/17 at 10:50 am, the CNO confirmed the Facility Organization Chart, dated December 2016, did not include identification of the procedure room or identification of a nursing or physician management responsibilities. The CNO explained the procedure room was part of Radiology Services. Radiology services were managed by the Respiratory Care Director who reported to the Director of Business Development/Procedure Suite Manager (also qualified as a Respiratory Care Therapist). The Director of Business Development/Procedure Suite Manager reported to the CEO. No nursing oversight was included in the organizational structure of the procedure room. The provision of surgical services in the procedure room included endoscopy and related procedures including fecal transplants, cautery (destruction of tissue such as by burning), and biopsies (removal of tissue); bronchoscopy, tracheostomies, and surgical insertion of feeding tubes. The service also included the administration of moderate sedation plus the use of propfol, a general anesthetic agent. The CNO explained that while nursing administration was integral in setting up the procedural processes that were currently in place, the CNO acknowledge that the organization of the service did not define nursing or physician management responsibility. The CNO acknowledged the surgical procedure suite did not include oversight by a nurse or physician who had training and experience in the management of surgical services.

Based on interview, and document review, the hospital failed to ensure that the surgical technologists (operating room technicians) were under the supervision of a registered nurse.

This failure had the potential for nursing intervention to be unavailable if/when needed.

Findings:

On 7/24/17 at 3 pm, during an initial tour of the procedure suite, the Procedure Suite Manager (PSM) explained in an interview that staffing for endoscopy and bronchoscopy procedures (insertion of a endoscope device through the mouth into the upper and lower airway to inspect, treat and sample body fluids and tissues) included the physician, an procedure technologist (PT, assisted the physician during the procedure) and a Registered Nurse (RN) certified in Moderate Sedation (MS, is a drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation). The PSM explained that one additional Respiratory Care Therapist (RCT) was available during the procedure (either in the procedure room, or in the procedure suite). The PSM stated the RN administering MS had one responsibility during the procedure and that was to monitor the patient. The PSM confirmed the RN's role was not to supervise the PT.

Guidance for the scope of practice for registered nurses and personnel assisting in nursing duties was retrieved and reviewed from the California Board of Registered Nurses (BRN) website at www.rn.ca.gov. Document NPR-1-12 issued in 1991 explained the ultimate responsibility of a RN supervisor is to determine that all patient care assignments were made only to personnel who were qualified and competent to perform them. NPR-B-14 issued 09/1989, required for any individual not licensed to practice professional nursing who performed scrub nursing functions (technicians who assist in operative procedures) may do so only as an assigned technical function under the direct supervision of a perioperative registered nurse.

Based on interview and document review, the hospital failed to ensure that circulating duties (includes retrieving necessary supplies for members of the surgical team directly involved in un-interruptible patient procedures) were supervised by a Registered Nurse (RN) that was immediately available to respond to emergencies.

This failure had the potential for patient emergency procedures requiring RN qualifications to be delayed.

Findings:

On 7/24/17 at 3 pm, during an initial tour of the procedure/surgical suite, the Procedure Suite Manager (PSM) explained in a concurrent interview that staffing for endoscopy and bronchoscopy procedures (insertion of a endoscope device through the mouth into the upper and lower airway to inspect, treat and sample body fluids and tissues) included the physician, a procedure technologist (responsible to assist the physician during the procedure) and a Registered Nurse (RN) certified in Moderate Sedation (MS, is a drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation). The PSM explained that one additional Respiratory Care Therapist (RCT) was available during the procedure (either in the procedure room, or in the procedure/surgical suite). The PSM explained that the RN administering MS had one responsibility during the procedure and that was to monitor the patient. The PSM confirmed the MS RN's responsibilities did not include supervision of the procedure technologist or performance of other circulating nurse duties. PSM acknowledged surgical procedure room staffing did not include an RN (in addition to the MS RN) immediately available to intervene if necessary.

Review of the Association for peri-Operative Registered Nurses (AORN) Position Statements for One Perioperative Registered Nurse Dedicated to Every Patient Undergoing an Operative or Invasive Procedure 2014 documented, "The perioperative RN circulator delegates, supervises, and evaluates the activities of other team members while simultaneously executing immediate directives and interventions in urgent or emergent situations." The Statement further noted that a licensed practical nurse or surgical technologist may assist an RN in carrying out circulating duties, in accordance with applicable state laws and medical staff-approved policy, but the non-RN staff must be under the supervision of the RN circulator who is in the operating suite and who is available to immediately and physically respond to provide necessary interventions in emergencies. The supervising RN must not be engaged in other activities that prevent him/her from immediately intervening. The Statement concluded, "The perioperative RN retains accountability for the outcome of perioperative nursing care."

Review of the AORN guidelines for peri-operative practice, dated 2017, indicated "The consensus of professional guidelines and expert opinion supports the perioperative RN (monitoring moderate sedation) having no competing responsibilities. The care of the patient receiving moderate sedation/analgesia requires constant vigilance and monitoring to allow for an immediate response to any adverse reaction or complication.

Under AORN section III.a.1. Two perioperative RNs should be assigned to care for the patient receiving moderate sedation/analgesia. One RN should administer the sedation medication and monitor the patient and the other RN should perform the circulating role.

AORN maintains that every surgical patient deserves a perioperative RN for the duration of any operative or other invasive procedure and actively promotes laws and regulations to ensure the supervisory presence of the professional RN in the perioperative setting. A minimum of one perioperative RN circulator dedicated to each patient undergoing an operative or other invasive procedure facilitates the provision of safe, quality patient care in the perioperative setting.

Based on staff interviews, document and patient record reviews, the hospital failed to ensure that surgical privileges (the authority to perform patient care tasks) were delineated in accordance with the competencies of each practitioner, in accordance with acceptable standards of practice and medical staff bylaws, as evidenced by:

a. Two of three physicians (Physicians G and H) were granted moderate sedation (administration of sedative and narcotic pain medications to lower consciousness and enable a patient to tolerate a procedure) privileges without documented evidence of airway management proficiency and/or current rescue skills;

b. One of three physicians who performed procedures in the hospital (Physician G) utilized a general anesthetic agent without authority via specific delineated deep sedation (further loss of consciousness with potential to lose protective reflexes for vital breathing and heart function) privileges in the care of 7 of 14 sampled patient records reviewed (Patients 1, 2, 3, 4, 5, 6, 8);

c. Two of two Procedure Assistants (Procedure Assistants B, and C) routinely participated in surgical care by operating/manipulating surgical instruments without documented evidence of education, training, competence, and/or certification consistent with scope of practice for non-physicians.

These failures put patients at risk for an injury or adverse outcome from surgery performed by unqualified practitioners.

Findings:

Review of the American College of Surgeons standard ST-46, titled Statement on Patient Safety Principles for Office-based Surgery Utilizing Sedation/analgesia, Deep sedation/analgesia, or General anesthesia documented under Core Principle #10, "Physicians administering or supervising moderate sedation/analgesia, deep sedation/analgesia, or general anesthesia should have appropriate education and training."

a. Airway management proficiency for moderate sedation

Concurrent reviews of physician files with the Medical Staff Coordinator (MSC) on 7/25/17 at 10:45 am and 4:30 pm indicated that Physician G (adult intestinal specialist) was granted privileges to perform intestinal procedures and moderate sedation on 3/20/16 when first appointed to the medical staff. The criteria for initial moderate sedation privileges required advanced rescue skill certification and moderate sedation privileges at a local hospital or 70% (percent) score on a moderate sedation knowledge test. Physician G met the criteria but the medical staff had not added formal airway management proficiency criteria consistent with acceptable standards of practice for moderate sedation care. There was no documented evidence of airway management training or proficiency in the file for Physician G.

Physician H (adult general medicine doctor) was granted moderate sedation privileges at his reappointment on 2/9/16 without documented evidence of formal airway management proficiency. Renewal of moderate sedation privileges required only advanced rescue skill certification and an attestation of recent experience OR passing a knowledge test. The certificate of advanced rescue skills issued on 12/12/14 did not have an expiration date. Typical certificates expire every 2 years. No current rescue certificate was presented.

In a telephone interview on 7/28/17 at 4 p.m., the trainer for Physician H's rescue course stated that the course expired two years from issue and was now expired.

Review of the American Society of Anesthesiologists (ASA) Statement on Granting Privileges for Administration of Moderate Sedation to Practitioners Who Are Not Anesthesia Professionals, last affirmed 10/19/11, summarized the necessary education and training for a physician who wished to administer or supervise administration of moderate sedation to include current knowledge, rescue training, and formal training in proficiency of airway management with facemask and positive pressure ventilation. This latter training should include appropriately supervised experience in managing the airways of patients, or qualified instruction on an airway simulator (or both).

b. Use of deep sedation agent without delineated privilege

Review of patient records showed that a general anesthetic agent (Propofol) was administered/monitored under the direction of Physician G to Patients 1, 2, 3, 4, 5, 6, 8 during intestinal procedures. Physician G served as both the person supervising a registered nurse (RN) to administer/monitor the sedation drugs that included Propofol, and as the person performing the procedure simultaneously. The RN was not qualified to manage deep sedation or anesthesia. Carbon dioxide gas exchange monitoring was not documented for Patient 1.

In an interview on 7/25/17 at 11:30 am, Physician G confirmed the practice of simultaneously performing a procedure and supervising administration/monitoring of Propofol by a registered nurse (who was not a qualified anesthesia provider) for hospital procedures.

Concurrent review of physician files with the Medical Staff Coordinator (MSC) on 7/25/17 at 10:45 am indicated no specific privilege authority for the administration of a general anesthetic agent that was classified as a type of Monitored Anesthesia Care (MAC) or general anesthesia treatment, distinct and separate from moderate sedation. The MSC indicated that for Physician G, the moderate sedation privilege served as the authority to use propofol (a general anesthetic agent), thereby permitting anyone with moderate sedation privileges to also do so. The qualifications for moderate sedation privileges did not require current knowledge and demonstration of airway management proficiency. The package insert from the manufacturer of Diprivan (trade name for propofol) noted "For general anesthesia or monitored anesthesia care (MAC) sedation, Diprivan should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure." Physician G's file contained no documented evidence of experience in managing patients under the effects of general anesthesia or of airway management proficiency. There was no documented evidence of preceptorship or proctoring (direct observation) for deep sedation skills by a similarly qualified peer to verify demonstrated competence for the skill.

Review of the ASA Advisory on Granting Privileges for Deep Sedation to Non-Anesthesiologist Sedation Practitioners, approved 10/20/10, noted the potential for general anesthetic agents to quickly move a patient into a state of deep sedation or general anesthesia. Therefore, non-anesthesiology practitioners must demonstrate ability to recognize such states, and maintain the patient's vital functions until the patient has been returned to an appropriate level of sedation. The qualifications for such providers included completion of a formal training program in safe administration of the drugs and rescue from a deeper than intended level of sedation. If the training was not achieved in recent graduate medical education, it may be provided by a separate deep sedation educational program approved by an accrediting organization for medical education. The curriculum should include assessment skills to recognize patients whose condition required sedation by an anesthesia professional, such as morbidly obese patients, elderly patients, patients with severe systemic disease, sleep apnea or delayed stomach emptying. The training should be hands-on in order for the student to demonstrate competency in managing airways of patients during deep sedation and airway management using airway models and simulators. Clinical experience minimum was managing 35 patients or equivalent simulator volume, or more as advised by the facility Director of Anesthesia Services. All cases should be monitored for carbon dioxide gas exchange, and the non-anesthesiologist who administered and monitored deep sedation must be different from the individual performing the diagnostic or therapeutic procedure. Performance evaluation of the non-anesthesiologist provider should be conducted either by department heads or supervisors at an institution where privileges are previously held, or by proctoring or supervision by a currently privileged provider of deep sedation. Re-evaluation of airway management skills should be part of performance evaluation when privileges are renewed.

Review of the American Society of Anesthesiologists (ASA) Statement on Safe Use of Propofol, last amended 10/15/14 documented, "Due to the potential for rapid, profound changes in sedative/anesthetic depth and the lack of antagonist (rescue) medications, agents such as propofol require special attention. Even if moderate sedation is intended, patients receiving propofol should receive care consistent with that require for deep sedation." The physician should be proficient in airway management and trained to identify and manage the airway and cardiovascular changes which occur in a patient who enters a state of general anesthesia. The trained practitioner should be completely dedicated to the monitoring task.

The American Association of Nurse Anesthetists (AANA) and ASA prepared a Joint Statement Regarding Propofol Administrated dated 4/14/04 that read, "Whenever propofol is used for sedation/anesthesia, it should be administered only by persons trained in the administration of general anesthesia, who are not simultaneously involved in these surgical or diagnostic procedures. Failure to follow these recommendations could put patients at increased risk of significant injury or death."

Review of the Medical Staff Bylaws, approved 9/14/16, documented under item 5.3-2 that competencies for privilege requests were based on education, training, experience, demonstrated professional competence, judgment and clinical performance. Item 5.1 directed that every practitioner providing direct clinical services shall be entitled to exercise only those setting-specific privileges granted to him or her.

c. Procedure Assistants not privileged/qualified to participate in operating/manipulating surgical instruments

During a tour of the procedure suite on 7/24/17 at 2:10 pm, the Procedure Suite Manager (PSM) indicated in a concurrent interview that certain specialized invasive procedures related to the lungs or intestinal organs (endoscopy, the insertion of a device into body cavities to visualize tissue and through which to cut tissue-biopsy, wrap a compression band to stop tissue from bleeding, suck out material for testing, deposit therapeutic materials onto tissue) were performed as scheduled outpatient and inpatient cases in that location. Staffing for each procedure included a registered nurse (RN) to administer and monitor moderate sedation, a procedure assistant to set up equipment and assist the physician performing the procedure, and a respiratory therapist to retrieve items or assist any of the staff attending to the patient, or to help with rescue interventions as needed. Duties to assist the physician for some procedures included:

* hold a portion of the endoscope while the physician, using both hands to thread the fiberoptic tip through the body passage, viewed images displayed on a video screen,

* pass sterile instruments to the physician to thread down the scope passages,

* operate the controls located near the portion of the endoscope held by the assistant, to manipulate instruments that grasp, grab, cut, or band body tissues,

*apply pressure to the patient's abdomen to facilitate positioning of the endoscope within the body cavity beneath,

*prepare dilution of a vasoconstrictor (narrowing of blood vessels) medication and flush into a bleeding body cavity.

The PSM also indicated that Procedure Assistants set up equipment and supplies for sterile insertion of feeding tubes through the skin into the stomach aided by an endoscope that illuminated the inside of the stomach under the skin.

In an interview on 7/25/17 at 11:30 am Physician G indicated that during endoscopy procedures the duties of the Procedure Assistant included handing over sterile instruments to the physician who threaded them into an endoscope device. Once in position, the physician directed the Procedure Assistant to pull and push on handles at the end of the endoscope in ways to grasp, grab, clamp, cut, crush, suck or scoop targeted tissues at the opposite end of the scope to retrieve for microscopic examination by a laboratory. Procedure Assistants also applied pressure to a patient's abdomen to allow the physician to move the endoscope through the bowel cavity more easily. (Patients undergoing bowel procedures often experienced large amounts of gas with distention of the bowel over which the Procedure Assistant was pressing. This maneuver carried risk for the bowel to burst or injury to adjacent organs.) Physician G stated he informally trained the "nurses" to perform the assisting skills unless they were trained elsewhere.

Review of a hospital-sponsored training manual for endoscopy procedures titled Procedural Sedation Manual for Bronchoscopy, Procedural and Diagnostic Endoscopy and Colonoscopy, FMT via Colonoscopy Adults/Older Adults, 2017, described the endoscope as having ports for administration of drugs, suction, irrigation, and insertion of small folding instruments such as forceps, scissors, brushes, snares and baskets for tissue excision, sampling, or other purpose to aid in diagnosis and treatment. Hazards of the procedures included bleeding and perforation of a body passage. Endoscopy was to be performed by a specially trained physician. The manual made no provision for special training or duties of an assistant for intestinal procedures. For lung procedures, assistance by a specially trained Respiratory Therapist was expected, though the requirements for training were not specified.

View of the surgical techniques to use forceps and snare online at https://www.youtube.com/watch?v=7o5WJKYGkNw showed the delicate nature to control the timing and pace to operate such endoscopic instruments when applied directly to the surgical site. Precision of the degree of opening each instrument and the speed of closure affected the ultimate success of retrieving the correct amount of tissue without injuring the surrounding tissue.

Review of manufacturer literature for disposable forceps and snare instruments similar to that used by the hospital (Olympus Disposable Biopsy Forceps Instructions for alligator jaw-step FB-212U and Olympus Electrosurgical Snare SD-210U-10) warned that use of the instruments carried risk for bleeding or bowel perforation. The instructions indicated that tissue was collected by carefully and precisely placing the forceps at the target site. The risk for perforation and bleeding increased if the forceps pressed against body cavity tissue or grabbed a sample that was too large. To open and close the forceps teeth to grab the tissue required pushing a slider mechanism at the opposite end of the scope. The snare was opened and closed also using a slider. To cut a target tissue, the snare loop must be opened close to the tissue, then moved to surround the target, and closed just enough to squeeze down onto the tissue. The degree of opening and closing was operator controlled from the slider and required careful and precise skill.

Review of the employee files for Procedure Assistants B and C, on 7/26/17 at 10:50 am with the Chief Nursing Officer (CNO), no documented evidence was found of formal training or certification to operate endoscope instruments that grasp, grab, cut, suck scoop or otherwise sever/penetrate tissue from body cavities of patients undergoing procedures. Training and qualifications for Procedure Assistants to press on the abdomen during procedures were not documented. The job descriptions for the Procedure Assistants did not describe the technical tasks to assist the physician as described by PSM and Physician G. The Procedure Assistants were not licensed, registered, or certified as nurses or endoscopy technicians whose scope of practice might include some of the tasks. No annual or ongoing competency assessments for procedure-related technical skills were documented.

In review of the medical staff roster on 7/25/17 at 10:45 a.m., the MSC indicated in a concurrent interview that only 3 physicians were privileged to perform surgical procedures. No non-physician staff had surgical assistant privileges to assist in endoscopy procedures.

The hospital presented no policies to define the qualifications and duties of a Procedure Assistant, nor a complete listing of which procedures required assistants.

Review of the ACS Statements on Principles, revised 4/26/16, under item G for Surgical Assistants documented that "First Assistants" may be needed to participate in portions of a procedure. It may be necessary to utilize non-physicians with additional surgical training who should meet national standards and be credentialed by the appropriate local authority.

Review of the California Code of Regulations Title 22 for general acute care hospitals, under Division 5, Chapter 1, item 70217(m), indicated that unlicensed personnel were limited to assist with simple nursing procedures, tasks that did not require licensure as a registered or vocational nurse. The California Business and Professions Code Section 2725.3 documented that in a licensed general acute care hospital, unlicensed personnel shall not be assigned to perform nursing functions in lieu of a RN, and may not be allowed to perform functions under the direct clinical supervision of a RN that require a substantial amount of scientific knowledge and technical skills (such as invasive procedures and applying pressure to the abdomen). Review of a position statement from the California Board of Registered Nurses (BRN) effective January 2011 documented, "The BRN interprets any individual not licensed to practice professional nursing who performed scrub nursing functions may do so only as an assigned technical function under the direct supervision of a perioperative registered nurse." Therefore, when non-RN staff were performing nursing functions, an RN who was not also serving as the monitor for sedation was expected to directly supervise the "scrub" technician who assists for the procedure.

Review of the Medical Staff Bylaws, approved 9/14/16, documented under item 5.1 that every practitioner providing direct clinical services shall be entitled to exercise only those setting-specific privileges granted to him or her.

Based on interview, document and record review, the facility failed to ensure that policies governing surgical care assured the achievement and maintenance of high standards of medical practice and patient care when:

a. The policy for High Level Disinfection (a process used to decontaminate surgical devices that were inserted into body passages to inspect, obtain tissue samples, and treat lesions on patients with lung and intestinal disorders) was not complete.

b. Environmental cleaning and disinfection policy and procedures did not include specific cleaning requirements for the procedure suite.

c. No policy and procedure was in place regarding temperature and humidity monitoring of the surgical procedure room.

d. No policy and procedure was in place to address requirements for staff attire during aseptic (sterile) surgical procedures (e.g. surgical insertion of a feeding tube).

e. The hospital failed to ensure that surgical services consistently met the needs of surgical patients when environmental conditions and design, and staff practices, put patients at risk for exposure to potential pathogens (germs that make you sick).Policies related to these practices did not assure achievement and maintenance of high standards of medical practice and patient care when policies were either lacking or in opposition to acceptable standards published by experts in infection control, nursing, and surgical care.

These failures resulted in the potential for infectious cross-contamination to patients which had the potential to cause an avoidable increase in the risk for post-operative infections.

Findings:

During a tour of the procedure suite on 7/24/17 at 2:10 pm, the Procedure Suite Manager (PSM) indicated in a concurrent interview that certain specialized invasive procedures related to the lungs or intestinal organs were performed as scheduled outpatient and inpatient cases in that location. Lung procedures included insertion of breathing tube devices through the skin of the front of the neck into the large airway beneath (tracheostomy), insertion of a endoscope device through the mouth into the upper and lower airway to inspect, treat and sample body fluids and tissues (bronchoscopy), insertion of a feeding tube device through the abdominal skin, into the stomach beneath, to directly instill nutrition products, insertion of an endoscope device through the mouth into the upper intestinal tract (UGI endoscopy) or through the rectum into the lower bowel tract (colonoscopy) to inspect, treat and sample tissue or lesions, or to inject laboratory-processed fecal material into the bowel to help fight infections (fecal microbiota transplant, FMT). In addition, chest tube insertions, needle aspirations of the chest and abdomen, and insertion of plastic tube catheters into large blood vessels that lead to the heart were routinely performed at the bedside of inpatients. The procedures were performed by physicians with expertise in lung diseases, in intestinal diseases, and in general diseases of adults. Anesthesia was limited to "moderate sedation" (the administration of sedative and narcotic pain medications to lower consciousness in order for a patient to tolerate an invasive procedure). The hospital had no general surgeons or anesthesiology professionals on its medical staff.

a. Review of a policy titled Endoscopic Decontamination and High Level Disinfection, effective 12/9/14, described the cleaning procedures for disinfecting surgical devices that were inserted into body passages to inspect, obtain tissue samples, and treat lesions on patients with lung and intestinal disorders. The policy, however, did not document the steps to collect the devices and their accessories into a protective container following the procedure. The policy did not document to transport the materials from the procedure room to a cleaning location on another floor of the hospital. The policy did not document how to wrap the device after cleaning in order to transport back to its storage closet in the procedure room. No other policy for the containment and transport of contaminated and clean equipment was presented by the hospital.

On 7/26/17 at 4 pm, during an interview, the PSM explained the process to transport the endoscope from the procedure room to the high level disinfection room that was located on a different floor of the facility. The PSM stated a special bag, made specifically for the transportation of endoscopes, was used to contain the endoscope after use in a procedure. The bag was then carried to the high level disinfection room. No policy and procedure was found to provide specific guidelines for transportation of the endoscopes to and from the high level disinfection room.

b. On 7/25/17 at 4:15 pm, during an interview with Housekeeping Staff S (HSK S, responsible to clean the procedure suite), HSK S explained the process for cleaning after procedure days required deep cleaning with appropriate disinfectant agents. HSK S stated the room was always terminally cleaned (included deep cleaning procedures of the ceiling, walls, floors, all equipment and surfaces in the room) before the first procedure day, and every evening after all procedures had been completed. When asked for documentation regarding facility guidance for the cleaning procedure. The HSK S stated he was not aware of a written policy and procedure.

On 7/25/17 at 4:20 pm during an interview, the Housekeeping Manager (HSKM) explained the procedures in place for cleaning of the procedure room was consistent with HSK S's description. The HSKM acknowledged the facility did not have a policy and procedure in place to define the expectations for cleaning of the procedure room. HSKM stated housekeeping audits were completed as required by QAPI (Quality Assurance and Performance Improvement). A copy of the audit tool used to assess the quality of housekeeping services was provided.

On 7/26/17 at 10:30 am during an interview and concurrent review of the housekeeping audit tool, the Director of Risk Management and Quality (DMQ) confirmed the tool included expectations for the cleaning of a patient room in the general acute care areas of the facility. The DMQ acknowledged that the tool was not specific to the procedure suite, and would not be appropriate for monitoring of the procedure room environment.

c. In a interview on 7/26/17 at 10:50 am, the Chief Nursing Officer (CNO) confirmed no policies and procedures were in place with guidelines for the monitoring of the temperature and humidity of the surgical procedure room.

d. In an interview on 7/26/17 at 10:50 am, the CNO confirmed no policies and procedures were in place with guidelines regarding the requirements of surgical staff attire during aseptic surgical procedures.

The Guideline for Surgical Attire approved by the Association of peri-Operative Registered Nurses (AORN), effective November 15, 2014, indicated "AORN recognizes the many diverse settings in which perioperative nurses practice; therefore, this guideline is adaptable to all areas where operative and other invasive procedures may be performed....

Recommendation I
Clean surgical attire should be worn in the semi-restricted and restricted areas of the perioperative setting. The collective body of evidence supports wearing clean surgical attire in the perioperative setting to reduce the number of microorganisms in the environment and the patient's risk for developing an SSI (surgical site infection). Clean scrub attire has been laundered in a health care-accredited laundry facility and has not been previously worn....

Recommendation III
Personnel entering the semi-restricted and restricted areas should cover the head, hair, ears, and facial hair. Hair and skin can harbor bacteria that can be dispersed into the environment. The collective body of evidence supports covering the hair and ears while in the semi-restricted or restricted areas...."


e. Observations during a hospital tour on 7/24/17 beginning at 2:20 pm with the Procedure Suite Manager (PSM) showed the following patient safety concerns:

1. The physical condition of the Procedure Room had flooring without coved borders to prevent trapping of dirt, dust and bioburden (material contaminated with bacteria, fungi, and spores). The walls were not smooth and scrubbable as they were lined with multiple panels interrupted by metal track depressions and crevices that can harbor dirt, dust and bioburden. The surface of the ceilings tiles had perforated crevices and were not gasketed or clipped in to prevent deposits of dust, dirt and bioburden.

2. The ventilation of the Procedure Room was negative pressure drawing air from the room, and from the room outside while the door was open, up into ceiling ducts and exhausted to the outside. The room door was propped open when the room was not in use, drawing unfiltered air into the room where disinfected endoscopes were stored. The room served multiple purposes including invasive lung procedures (bronchoscopy), invasive intestinal procedures (endoscopy), sterile procedures (feeding tube insertion, breathing tube insertion, chest drainage-thoracentesis), swallow imaging studies, and sit-stand x-rays. Multiple staff and patients routinely entered the room in ordinary street-clothes without restriction or protections to prevent deposit of personal or outside bioburden contamination. Equipment intended for use by distant nursing units was stored in a cabinet inside, which outside staff would access without restriction or protective measures to limit unnecessary traffic and contamination of the room.

3. The Procedure Suite occupied space that was originally built as an imaging department, located down the hall from a nursing unit on the second floor. The Procedure Room was not designed and built as an operating room or endoscopy procedure room. When not in use, a large fluoroscopic imaging machine was stored inside the Procedure Room. No focus lighting was positioned in the Procedure Room to illuminate incision sites. The pre-operative and recovery rooms were narrow and too cramped to effectively provide emergent support and rescue of a procedure patient. No adjacent patient waiting room was provided. An anteroom was shared by a standby imaging technician with a portable x-ray machine to serve patients on the nursing units of the hospital. No dedicated nursing station for charting or medication preparation was provided. No scrub sink or clinical sink was provided in the anteroom. The Procedure Room had one sink to be shared for simple handwashing and disposal of fluids utilized in the procedure if needed. Although licensed as a general acute care hospital and expected to provide surgical services, there were no other operative facilities in the hospital building.

The following issues showed practices that conflicted with standards published by experts in the relevant areas.

1. PPE/Suitable Attire was not required to minimize contamination of equipment and staff.

Review of Occupational Safety Healthcare Administration Hospital-Wide Hazards summary, accessed online at https://www.osha.gov/SLTC/etools/hospital/hazards/ppe/ppe.html, noted that per the Blood-borne Pathogens Standard an employer was responsible to provide appropriate personal protective equipment (PPE), cleaned and laundered and properly disposed of, at no cost to the healthcare worker, if exposure to blood or other potentially infectious material was anticipated in the course of work duties. Examples of PPE guidelines included gloves when handling body fluids and safety shoes/boots/covers when hazardous substances were likely to splash.

Review of endoscopy device manufacturer instructions similar to devices used by the hospital (Olympus 180 GIF Videoscope Instructions) indicated that irrigation fluids mixed with blood and body fluids were suctioned periodically throughout a procedure that could splash out through uncapped ports, or as collection canisters were changed. "If a biopsy valve is not properly connected to the instrument channel port, it can reduce the efficacy of the endoscope's suction system and may cause patient debris to leak or spray from the endoscope."

Review of the Society for Gastrointestinal Nurses and Associates (SGNA) 2015 Standard of Infection Prevention in the Gastroenterology Setting stated, "Effective use of PPE includes proper removal and disposal of contaminated PPE to prevent exposure to infection among both the GI staff and others." It further stated, "Some studies support that controlled laundry of garments reduce the risk of transferring microorganisms from the health care facility to home." The SGNA Standard then listed the following as PPE applicable to endoscopy tasks:

*Gloves to protect hands;
*Gowns to protect skin and/or clothing;
*Masks to protect mouth/nose;
*Respirators to protect respiratory tract from airborne infectious agents;
*Goggles/eye shields to protect eyes;
*Face shields to protect face, mouth, nose, and eyes; and
*Head and shoe covers.

In an interview on 7/25/17 at 11:30 am, Physician G (who routinely performed endoscopy procedures that posed potential for splash of blood and body fluids to the workers performing the procedure) stated that he wore street-clothes under a disposable protective gown, nonsterile gloves, mask, faceshield, but no hat or shoe covers. After removing the disposable PPE, Physician G may walk to other hospital units to examine patients, or return to his office to examine patients, or go to another hospital to examine patients in that location, without changing clothes or shoes which may harbor splash contamination. Physician G described the medical conditions of some high risk endoscopy patients to include diarrhea from a toxic spore-containing infection, resistant bacterial infections or colonization, and blood-borne viruses.

During a tour on 7/24/17 at 4 pm of the location where endoscopes were reprocessed at a distance and on a different floor from the procedure suite, Procedure Suite Manager (PSM) showed a locker room at the opposite end of the corridor where technicians who had splash exposure from chemicals used to clean the endoscopes could shower and change clothes. However, no commercially laundered scrub clothing was stocked in that location. No containers to deposit soiled clothing to be commercially laundered were stationed in that location. The PSM stated that all procedure suite staff wore their street-clothes during procedures and during scope cleaning work, with selective PPE applied over them.

The SGNA cited several authorities on infection control in their statement. The expert authorities included the Association for peri-Operative Registered Nurses (AORN), the Association for Professionals in Infection Control (APIC), the Centers for Disease Control (CDC), and the American Institute of Architects (AIA, a collaborator with the Facilities Guidelines Institute Guidelines for Design and Construction of Hospitals and Outpatient Facilities).

Review of the 2014 AORN Guideline for Surgical Attire noted that reducing the patient's exposure to harmful bacteria that are shed from the skin and hair of perioperative personnel may reduce the patient's risk for surgical site infection (SSI). Patient safety is the primary consideration for perioperative personnel. The guideline directed that personnel entering the semi-restricted and restricted areas should wear scrub attire that has been laundered by a health care accredited laundry facility, or disposable attire provided by the facility. Visitors entering the restricted area for short periods should don protective garments. Healthcare personnel should change into street clothes to leave the building to prevent transference of bacteria deposited from the care environment to the external environment (home, office, community). Personnel entering the semi-restricted and restricted areas should cover the head, hair, ears and facial hair.

Review of the 2014 AORN Guideline for a Safe Environment recommended for the planning and design of care that clear delineation of personnel movement (traffic patterns) be established with doors and signage or visible cues to control ventilation and create movement from less clean to clean, the procedure area being the most clean (restricted). Recommendation II-a advised that lighting be provided to illuminate the surgical field and to monitor the patient during a procedure.

Review of the American College of Surgeons (ACS) Statement on Operating Room Attire, dated 8/4/16, set standards for procedures of all types. The ACS directed that scrubs and hats worn during dirty or contaminated cases should be changed prior to subsequent cases even if not visibly soiled. During invasive procedures, the mouth, nose, and hair (skull and face) should be covered to avoid potential wound contamination. Large sideburns and ponytails should be covered or contained. Operating Room scrubs should not be worn at any time outside of the hospital perimeter. (In most hospitals commercially laundered scrub uniforms are provided to perioperative staff to wear during each workday.)

Review of the 3rd Edition of the American Society for Anesthesiologists (ASA) Recommendations for Infection Control in the Practice of Anesthesiology documented multiple practices to prevent/minimize healthcare associated infections in hospitals. Under Intraoperative Considerations, ASA advised to keep operating room doors closed except as needed for passage of equipment, personnel, and the patient. Positive pressure prevents airflow from a less clean area into more clean areas. The germ level in the operating room air is directly proportional to the number of people moving about the room. Also recommended was to wear a surgical mask and cap or hood to cover hair when open sterile items and equipment were present.

Review of the 2015 ANSI (American National Standards Institute)/AAMI (Association for the Advancement of Medical Instrumentation) ST 91 Flexible and Semi-rigid Endoscope Processing in Healthcare Facilities indicated under item 4.6.1:
a) All personnel entering the (endoscope) processing area should change into clean uniforms that are provided by and donned at the facility. b) Attire should be changed daily or more often as needed (i.e., when wet, grossly soiled, or visibly contaminated with blood or other bodily fluids). c) Reusable uniforms should be laundered by a health care-accredited laundry (ANSI/AAMI ST65, AORN, 2015d). d) All head and facial hair (except for eyebrows and eyelashes) should be completely covered with a surgical-type hair covering. e) Jewelry and wristwatches should not be worn in the processing area. f) Shoes worn in the processing area should be clean, have non-skid soles, and be sturdy enough to prevent injury if an item drops on the foot. Liquid-resistant shoe covers should be worn if there is potential for shoes becoming contaminated and/or soaked with blood or other bodily fluids (OSHA 29 CFR 1910.1030). g) The use of cover apparel when employees leave the area to travel to other areas of the health care facility should be determined by each facility and should comply with state and local regulations. h) Employees should change into street clothes when they leave the health care facility or when traveling between buildings located on separate campuses. Rationale: Clean attire minimizes the introduction of microorganisms and lint from personnel to items being processed and to the environment.

During multiple observations of the Procedure Suite between 7/24/17 and 7/26/17, the door to the Procedure Room was repeatedly propped open and not in use. Hospital staff entered the room in street-clothes. No signs indicated the room was semi-restricted and required specialized attire. Two supply trays of airway rescue materials were stored in a cabinet in the Procedure Room to be accessed by nursing staff on patient units from outside the Procedure Suite.

Review of ventilation records indicated the room had negative pressure, sucking unfiltered air from outside the open doors into the room and up into the air ducts in the ceiling.

During an endoscopy procedure walk-through observation on 7/26/17 at 12:30 pm, workers who were involved in the procedure directly handling contaminated endoscope equipment with risk for splash donned cover gowns that did not cover shirt collars or pants of the lower legs, masks, nonsterile gloves, and face shields, but no head or shoe covers were donned.

The hospital presented no policy to direct staff to don head and shoe covers for invasive procedures. The hospital presented no policy for endoscope reprocessing personnel to wear commercially laundered uniforms and clean, non-skid, sturdy shoes with covers, hair covers, and to change clothes before leaving the building. The hospital presented no policy that defined restrictions to access to the Procedure Room. The hospital presented no policy to keep the procedure room door closed when not in use to limit unfiltered air entry.

2. Sanitary Environments, accommodations for space, staff and patients were out of compliance with standards.

a. Setup for reprocessing endoscopes did not conform with recommended practices.

Review of the SGNA 2015 Standard of Infection Prevention in the Gastroenterology Setting stated,
"Immediate pre-cleaning of the endoscope is required when the endoscope is withdrawn from the patient. Device-specific manufacturer's instructions for delayed reprocessing should be reviewed (Peterson et al., 2011). The transport container of a soiled endoscope should be closed and labeled as biohazardous to prevent exposure to staff and the environment (OSHA, 2012)." Review of the May/June 2011 issue of Biomedical Instrumentation and Technology, retrieved at http://s3.amazonaws.com/rdcms-aami/files/production/public/FileDownloads/Summits/Reprocessing/Endoscopes_BIT_MJ_2011.pdf, indicated that cleaning an endoscope should occur no longer than one hour after use to prevent drying and caking of patient soiled debris inside the passages that won't be effectively removed by routine cleaning and disinfecting procedures.

Review of the Centers for Disease Control (CDC) Essential Elements of a Reprocessing Program for Flexible Endoscopes, last updated 1/25/17, advised pre-cleaning endoscopes immediately following completion of the endoscope procedure to help prevent the formation of biofilm. CDC also directed for Policies to address the selection, use, transport, reprocessing, and storage of endoscopes and accessory devices to ensure compliance with endoscope and reprocessing equipment manufacturers' instructions for use. In addition, policies should clearly include requirements for documentation of adherence to essential reprocessing steps, parameters regarding the physical setting where endoscope reprocessing occurs, staff education, training, and assessment of competency, ongoing quality assurance procedures, and protocols for responding to equipment and HLD/sterilization failures or breaches.

Review of the 2015 ANSI/AAMI (Association for the Advancement of Medical Instrumentation) ST 91 Flexible and Semi-rigid Endoscope Processing in Healthcare Facilities indicated under item 5.2, to prevent buildup of bioburden, development of biofilms, and drying of secretions, precleaning should take place at the point of use immediately following the procedure. Then the scope shall be transported to the reprocessing location in a labeled, protected container taking care not to damage the device.

In an interview on 7/26/17 at 12:30 pm, the PSM stated that procedures were always staffed with two assistants, one to handle the endoscope for the physician, and a second to retrieve supplies, call for help, and clean the room between cases. If one assistant flushed the endoscope at the point of care following the case, and transported it to the reprocessing location on another floor, and started the next cleaning steps (enzymatic soak, leak test, brush ports, etc) there, only one assistant would be available for the next patient's procedure, possibly limiting the necessary support staff for the next patient.

The hospital presented no policy to direct the technicians to flush the scopes in the procedure room as is the practice in many facilities, to package them in a biohazard labeled container for transport to a distant floor, and to start cleaning and disinfecting within 1 hour. The hospital presented no policy for criteria to reprocess clean scopes that were stored but showed evidence of not being dry when stored, or exceeded a period of time from the last cleaning.

Endoscope decontamination workspace was described by the SGNA 2015 Standard of Infection Prevention in the Gastroenterology Setting as thus:

*The reprocessing area should be physically separated from the patient procedure rooms (AAMI, 2015; Alvarado & Reichelderfer, 2000). The area must be specifically designed and dedicated to address reprocessing activities of decontamination and disinfection (Beilenhoff et al., 2008; Facilities Guidelines Institute [FGI], 2014; Joint Commission, 2014). The area should be restricted to authorized personnel. The physical space should be an appropriate size in relation to the volume of equipment processed and the reprocessing equipment specifications. Space should be adequate to allow for the manual cleaning and rinsing of devices during decontamination. The work area identified should be sufficient so that "dirty" areas are physically separated from "clean" areas. The reprocessing work flow should be from dirty to clean to avoid cross-contamination (Petersen & Ott, 2008). There should be clean and soiled utility areas located outside of the reprocessing room.

*There should be negative air pressure in the reprocessing room and a minimum of 10 exchanges per hour, with at least two being fresh, outside air (The American Institute of Architects Academy of Architecture for Health [AIA], 2001; FGI, 2014; Joint Commission, 2014). Exhaust should be vented directly outside. It is also important that staff understand the concepts of negative airflow, when to use negative airflow, and how to properly use the negative airflow. Chemical vapors should not exceed allowable limits (Peterson et al., 2011). Air handling in procedure rooms should conform to current CDC guidelines (Alvarado & Reichelderfer, 2000). Temperature and humidity should be regulated according to local and facility requirements.

*Reprocessing areas should have dedicated plumbing and drains. The room must have more than one sink and separate handwashing facilities. Sinks should be deep enough to allow complete immersion of the endoscope to minimize aerosolization and wide enough to avoid tight coiling of the endoscope. There should be ergonomic considerations to prevent undue physical strain on personnel.

*Eye wash stations for immediate emergency use must be available in the GI Lab no greater than 10 seconds from the location of chemical use or storage (AORN, 2015; AAMI, 2015). The eye wash station must be activated weekly to ensure proper use during a potential chemical exposure. Refer to the eye wash manufacturer for proper maintenance of the device.

During a tour on 7/24/17 at 2:20 pm, the endoscope reprocessing room was observed located on a floor below the Procedure Suite. The reprocessing room had only one sink for immersion of the endoscope, and no separate handwashing sink. The eye wash setup was simply a squirt bottle of irrigation solution mounted on a wall near the sink. A staff locker room with shower to more effectively rinse eyes or skin was located over 50 feet down a hall from the reprocessing room, a difficult journey to make when vision is compromised from a chemical splash in the reprocessing work space.

Review of the Centers for Disease Control (CDC) Essential Elements of a Reprocessing Program for Flexible Endoscopes, last updated 1/25/17, advised that Staff should have access to a handwashing sink that is separate from the reprocessing sink(s). Eyewash stations should not be installed in a location that requires flushing of the eyes in the decontamination sink.

Review of the 2015 ANSI/AAMI (Association for the Advancement of Medical Instrumentation) ST 91 Flexible and Semi-rigid Endoscope Processing in Healthcare Facilities indicated under item 3.3.9, The hand hygiene sink should be separate from the sink used to clean endoscopes. Item 3.3.10 addressed eyewash standards: Suitable eyewash units must be available for immediate emergency use in all places where chemicals are used. The American National Standards Institute (ANSI) has established minimum performance criteria for eyewash units (ANSI Z358.1). ANSI Z358.1 requires that eyewash units provide a minimum of 0.4 gallons per minute continuously for at least 15 minutes, that they be designed to flush both eyes simultaneously, and that they have a "hands-free, stay open" feature once activated. Under the ANSI standard, drench hoses or eyewash bottles are not acceptable emergency eyewash units. Eyewash stations should be located: a) so that travel time is no greater than 10 seconds from the location of chemical use or storage, or immediately next to or adjoining the area of chemical use or storage, if the chemical is caustic or a strong acid; and b) on the same level as the hazard with the path of travel free of obstructions (e.g., doors) that may inhibit immediate use of the eyewash station (ANSI Z358). When walking at a normal pace, the average person covers a distance of 55 feet in 10 seconds; however, a person who has experienced a chemical splash to the eyes or face may be visually impaired, in discomfort or pain, and in a state of panic. For this reason, it is prudent to consider the physical and emotional state of the person as well as the availability of assistive personnel in the immediate area when determining the location of eyewash stations (ANSI Z358).

The PSM presented a log of temperature recordings for the Procedure Room and indicated that humidity was not monitored. The endoscopes were stored in a vented cabinet inside the Procedure Room. They were hung there after processing to dry further. Excess humidity in the Procedure Room could retard drying and facilitate bacteria to breed inside the scopes.

Review of the 2014 AORN Guideline for a Safe Environment under Recommendation IV directed to maintain humidity levels at 20-60% (percent) for both restricted rooms and unrestricted endoscopy rooms. Given that the tasks performed in the hospital's one and only procedure room included both non-sterile and sterile invasive procedures, the standard would be to provide the most stringent level of care for the space based on the work performed. Air pressure for an endoscopy room was positive pressure, while bronchoscopy was negative pressure.

According to the 2015 ANSI/AAMI (Association for the Advancement of Medical Instrumentation) ST 91 Flexible and Semi-rigid Endoscope Processing in Healthcare Facilities, AORN (2015e) recommended that flexible and semi-rigid endoscopes should be stored in a closed cabinet with venting that allowed air circulation around the endoscopes, internal surfaces composed of cleanable material, adequate height to allow endoscopes to hang without touching the bottom of the cabinet, and sufficient space for storage of multiple endoscopes without touching. Rationale: A storage area with good ventilation encouraged continued air-drying of the surfaces and prevents excessive moisture buildup, thus discouraging germ contamination. Correct storage of the endoscope will also prevent damage to the exterior of the instrument by protecting it from physical impact.

The ST 91 guideline discussed the lack of consensus for "hang time," i.e., maximum duration of storage time before the endoscope was processed for the next use. Existing guidelines ranged from 3 to 7 days. ANSI/AAMI advised the facility to conduct a risk assessment for their practice (in policy). Given the ongoing air contamination of the Procedure Room where air circulated into the endoscope procedure cabinet while drying, and the failure to monitor humidity, the hospital's endoscopes faced potential contamination fairly soon after cleansing, compared to those stored in a more controlled environment.

The hospital presented no policy for endoscope storage duration based upon a risk assessment that reflected the exposures described above.

b. Procedure space design was not in accordance with standards.

In an interview on 7/24/17 at 5:30 pm, the Chief Executive Officer (CEO) indicated that the hospital initially opened a couple decades

Based on staff interview and document and patient record review, the hospital failed to ensure that an accurate medical history and physical examination (H&P) performed by a physician, or accurate updated H&P, was documented prior to surgery or procedure requiring anesthesia services (moderate and deep sedation) for 8 of 14 sampled patient records reviewed (Patients 1, 2, 3, 4, 5, 6, 8 and 14), in accordance with medical staff bylaws and acceptable standards of practice.

This failure put patients at risk for unrecognized risks and conditions that could alter the decision to proceed with a planned procedure, or delays to rescue from adverse events occurring during the procedure.

Findings:

Review of a chapter from the online Merck Manual for Professionals titled Preoperative Evaluation retrieved at http://www.merckmanuals.com/professional/special-subjects/care-of-the-surgical-patient/preoperative-evaluation documented that a pre-operative evaluation was intended to minimize surgical risk by identifying correctable abnormalities and by determining whether additional monitoring was needed or whether a procedure should be delayed so to better control an underlying disorder. The preoperative physical examination should include not only the areas affected by the surgical procedure but also the cardiopulmonary (heart and lung) system and a search for any signs of ongoing infection (e.g., lungs, skin). Surgical risk factors were identified to include age greater than 70 years, heart attack within 6 months, poorly controlled heart failure, other heart diseases, co-existing infections, poor gas exchange in the lungs, obesity, low blood potassium level, and low blood protein level.

Review of ST-25 from the American College of Surgeons (ACS) titled ACS Statement on Principles Underlying Perioperative Responsibility, under item 4 documented that the surgeon was responsible for the proper preoperative preparation of the patient. Minimizing the risk of the operation, while providing maximal opportunity for a satisfactory outcome, required full appreciation by the surgeon of the patient's condition. Item 5 noted that the surgeon was responsible for the safe and competent of the operation. Part of this responsibility included planning for the operation with the anesthesiologist in order to ensure anesthesia that was best for the patient.

Review of the 2015 Association for peri-Operative Registered Nurses (AORN) Guideline for Care of the Patient Receiving Moderate Sedation/Analgesia noted that certain patients may not be candidates for moderate sedation/analgesia administered by perioperative registered nurses (RN). Such patients may require care provided by an anesthesia provider qualified to administer monitored anesthesia care (MAC) and to rescue the patient from a deeper level of sedation, or qualified to convert to general anesthesia if needed. The RN should assess the patient for such, based on selection criteria defined by the health care organization. Conditions that may indicate difficulty with mask ventilation included age over 55 years, overweight (BMI>30), noisy breathing during sleep, short neck, limited neck extension, small mouth opening, enlarged tonsils, and others. Consultation with an anesthesia provider should be obtained if a patient presents with any one of the following: known history of respiratory or hemodynamic (lung or heart) instability; previous difficulties with anesthesia or sedation; severe sleep apnea (breathing disorder during sleep) or other airway related issues; one or more significant co-morbidities; inability to communicate or cooperate; multiple medications with potential for drug interaction with sedative analgesics; unstable severe systemic disease or disease that is a constant threat to life.

a. Review of patient records indicated that Patient 1 was admitted to the hospital on 3/26/17 with pneumonia, respiratory failure, chronic lung disease, congestive heart failure, and a heart rhythm disorder (atrial fibrillation-AF, a quivering of the heart muscle that limits the efficiency of pumping blood). Patient 1 was 63 years old, weighed 297 pounds (lbs). Patient 1 had a past history of cellular changes in the esophagus and developed dark stools, a sign of intestinal bleeding, for which Physician G consulted and recommended inspections of the upper and lower intestinal tracts via endoscopy procedures under moderate sedation (administration of sedative and narcotic pain medications to lower consciousness in order for a patient to tolerate a procedure) on 4/20/17. Although the pre-operative nurse noted abnormal heart rhythm and a recorded heart rhythm strip showed features of AF, Physician G recorded no abnormal physical findings for heart, lungs, or airway on the 4/20/17 preoperative History and Physical update form. The preoperative nurse noted allergy to Tetracycline antibiotic but Physician G recorded "no allergies" on the H&P update. Physician G's pre-sedation assessment form did not assign a score for mouth opening (Mallampati score), did not note the history of heart failure, respiratory failure and chronic lung disease, did not note the morbid obesity, all risks for difficulty to support and rescue the airway during sedation. Patient 1's operative risks were not accurately documented by the physician responsible for performing the procedure. No consultation with an anesthesia provider was documented.

In an interview on 7/25/17 at 1 pm, the Chief of Staff (COS) acknowledged that the History and Physical pre-operative assessment and pre-sedation assessment for Patient 1 was "thin" and inaccurate and did not reflect Patient 1's risk profile for AF, obesity, chronic lung disease and heart failure. The COS expected the procedure physicians to use good judgment to decide whether procedures could be performed at the hospital safely without support by an anesthesia professional, or whether they should be performed at a center with higher level of support. The hospital had no general surgeons or anesthesiologists on staff or available by contract to consult on patient safety procedures. The Medical Staff had not developed criteria to guide physicians and nurses for selecting procedure patients who could safely be supported by the resources the hospital was prepared to offer.

b. Patient 14 was admitted to the hospital on 4/20/17 for an outpatient bronchoscopy procedure to examine the airway passages into the lungs, and surgically remove tissues to test for disease, by inserting a bronchoscope device into the airway under the effects of moderate sedation (the administration of sedative and narcotic pain medications to lower consciousness so that the procedure can be tolerated). The indications for the procedure were a lung mass identified on an imaging test and coughing up blood. The patient records documented Patient 14's age to be 51 years, weight 396 lbs, and current/prior medications for lung disease. A form titled Outpatient Nursing Record documented a pre-procedure assessment by a registered nurse that noted "no" for lung disease history. A form titled History & Physical - Outpatient Procedure documented an assessment by the operating physician (Physician P) with no note of Patient 14's obesity or reason for using medications for lung disease. A form titled Physician Documentation for Sedation (which served as a pre-sedation assessment) noted nothing about Patient 14's use of medications for lung disease, nothing about Patient 14's obesity or details of an examination to assess the risk to support and rescue breathing during the procedure (Mallampati score), and Physician P assigned a procedure risk (ASA-American Society of Anesthesiologists classification score for overall risk to tolerate surgical procedures) of mild disease (low risk). Physical features known to increase the risk to support breathing include chronic lung disease, short/thick neck, obesity, sleep apnea, and/or narrow opening between the mouth and large airway. Patient 14's risk score may have been underestimated had other areas of health been further explored and reconciled.

c. Review of patient records indicated that Patient 2, an 85 year old male, was admitted to the hospital on 5/22/17 for procedures that included insertion of an endoscope device through the mouth into the esophagus (long thin muscular tube that connects the throat to the stomach), stomach and upper intestinal tract (esophagogastroduodenoscopy, EGD) and through the rectum into the lower bowel tract (colonoscopy) to inspect, treat and sample tissue or lesions. No comprehensive history and physical was found in Patient 2's record.

Patient 2's "history and physical - outpatient procedure form", dated 5/22/17, was not comprehensive, accurate or complete when the areas of the form left blank included "indications for procedure", "pre-procedure diagnostic test results", "physical limitations", "pertinent social history" which included spaces to indicate information regarding smoking, alcohol use, recreational drug use, "pertinent family history" which included spaces to indicate information regarding a history of cancer in the family and bleeding tendencies, and "past surgical procedures". "Current medications" indicated see medication Med List while no evidence of a Med List was found in the procedure record. "Pertinent physical findings" related to the patients cardiac, neurological, gastrointestinal, pulmonary, the presence of sleep apnea and airway findings were all documented with a "zero" indicating no pertinent physical findings were found. The H&P was inconsistent with the documentation described below.

Patient 2's "procedure note", dated 5/22/17, documented the indication for the procedure was anemia (a blood deficiency resulting in blood not carrying enough oxygen to the rest of the body which can result in symptoms that include feeling tired, cold, dizzy, irritable, short of breath and headache) and heme-positive stools (blood in the feces, can be caused by a variety of conditions including internal bleeding), and suspected gastrointestinal bleed.

Patient 2's "outpatient nursing record", dated 5/22/17, indicated that he was allergic to Sulfa. Nursing documentation regarding Patient 2's medical history indicated a history of atrial fibrillation, current consumption of three to four drinks of alcohol per day, tobacco dependency, and high blood pressure.

d. Review of patient records indicated that Patient 3 was admitted to the facility on 5/24/17 for procedures that included insertion of an endoscope device through the mouth into the esophagus (long thin muscular tube that connects the throat to the stomach), stomach and upper intestinal tract (esophagogastroduodenoscopy, EGD) and through the rectum into the lower bowel tract (colonoscopy) to inspect, treat and sample tissue or lesions.

Patient 3's "procedure note", dated 5/24/17, dictated by Physician G, documented the indication for the procedure was anemia (a blood deficiency resulting in blood not carrying enough oxygen to the rest of the body which can result in symptoms that include feeling tired, cold, dizzy, irritable, short of breath and headache) and heme-positive stools (blood in the feces, can be caused by a variety of conditions including internal bleeding), chronic liver disease. No comprehensive history and physical was found in Patient 3's record.

Patient 3's "history and physical - outpatient procedure form", dated 5/24/17 and signed by Physician G, was not comprehensive, accurate or complete when the areas of the form left blank included "pre-procedure diagnostic test results" when test had been ordered; " known drug allergies" was blank, while documentation on the "outpatient nursing record", dated 5/24/17, indicated Patient 3 was allergic to Vicodin and Norco (narcotic pain medications) and adhesive tape; "current medications" indicated - "see attached Med List" while no medication list was found in the record; "physical limitations" was left blank; "pertinent social history" which included spaces to indicate information regarding smoking, alcohol use, recreational drug use, and "pertinent family history" which included spaces to indicate information regarding a history of cancer in the family and bleeding tendencies were left blank; and "past surgical procedures" were left blank. The form included space to indicate "pertinent physical findings" related to the patients cardiac, neurological, gastrointestinal, pulmonary, the presence of sleep apnea and airway findings. All of these areas were documented with a "zero" indicating no pertinent physical findings were found.

e. Review of patient records indicated that Patient 4 was admitted to the facility on 5/23/17 for procedures that included insertion of an endoscope device through the mouth into the esophagus (long thin muscular tube that connects the throat to the stomach), stomach and upper intestinal tract (esophagogastroduodenoscopy, EGD) and through the rectum into the lower bowel tract (colonoscopy) to inspect, treat and sample tissue or lesions.

Patient 4's "procedure note", dated 5/23/17, signed by Physician G, documented the indication for the procedure was anemia (a blood deficiency resulting in blood not carrying enough oxygen to the rest of the body which can result in symptoms that include feeling tired, cold, dizzy, irritable, short of breath and headache) and heme-positive stools (blood in the feces, can be caused by a variety of conditions including internal bleeding). No comprehensive history and physical was found in Patient 4's record.

Patient 4's "history and physical - outpatient procedure form", dated 5/23/17 and signed by Physician G, was not comprehensive, accurate or complete when the areas of the form left blank included "pre-procedure diagnostic test results"; "physical limitations" was left blank; "pertinent social history" which included spaces to indicate information regarding smoking, alcohol use, recreational drug use, and "pertinent family history" which included spaces to indicate information regarding a history of cancer in the family and bleeding tendencies were left blank; and "past surgical procedures" were left blank. "Current medications" indicated - "see attached Med List" while no medication list was found in the procedure record. The form included space to indicate "pertinent physical findings" included a space to indicate airway findings, which was left blank.

f. Review of patient records indicated that Patient 5 was admitted as an inpatient on 4/13/17 and later to the procedure suite, on 5/22/17, for procedures that included insertion of an endoscope device through the mouth into the esophagus (long thin muscular tube that connects the throat to the stomach), stomach and upper intestinal tract (esophagogastroduodenoscopy, EGD) and through the rectum into the lower bowel tract (colonoscopy) to inspect, treat and sample tissue or lesions.

A "procedure note" for the EGD and colonoscopy were not found on Patient 5's procedure record. The "outpatient physician progress note", dated 5/22/17, documented Patient 5's indications for the procedure included anemia (a blood deficiency resulting in blood not carrying enough oxygen to the rest of the body which can result in symptoms that include feeling tired, cold, dizzy, irritable, short of breath and headache) and heme-positive stools (blood in the feces, can be caused by a variety of conditions including internal bleeding). No comprehensive history and physical was found in Patient 5's record.

Patient 5's "history and physical - outpatient procedure form", dated 5/22/17 and signed by Physician G, was not comprehensive, accurate or complete when the areas of the form left blank included "known allergies" while the "Outpatient Nursing Record", dated 5/22/17, indicated Patient 5 was allergic to heparin (a blood thinning medication); and "pre-procedure diagnostic test results" was left blank; "pertinent social history" which included spaces to indicate information regarding smoking, alcohol use, recreational drug use, and "pertinent family history" including spaces to indicate information regarding a history of cancer in the family and bleeding tendencies, were left blank; "Current medications" indicated - "see attached Med List" while no medication list was found in the procedure record. The form included space to indicate "pertinent physical findings" included a space to indicate airway findings, which was left blank. The space to indicate pulmonary findings was documented with a "zero" indicating no pertinent findings, while Patient 5's history documented a procedure note, dated 5/3/17, which indicated a left sided thoracentesis was indicated due to symptomatic pleural effusion (fluid around the lung which can cause lung collapse). The procedure resulted in two liters of fluid being removed from the pleural cavity (surrounds the lung). The procedure note indicated that after the fluid was removed "The patient experienced mild cough as the lung reexpanded. Patient 5's record indicated a history of coronary bypass surgery (open heart surgery). The "outpatient physician progress note", dated 5/22/17 and signed by Physician G, included instructions to "Resume Coumadin" (prolongs blood clotting time, often used as a measure to reduce the risk for stroke) Since no comprehensive history and physical was found in Patient 5's procedure record, the current status of Patient 5's heart and lung status was not clearly identified. No pre-procedure lab tests were in place to indicated Patient 5's blood clotting status (if altered could cause a high risk for bleeding).

g. Review of patient records indicated that Patient 6, a 79 year old male, was admitted as an inpatient on 1/31/17 and later to the procedure suite, on 2/3/17, for procedures that included insertion of an endoscope device through the mouth into the esophagus (long thin muscular tube that connects the throat to the stomach), stomach and upper intestinal tract (esophagogastroduodenoscopy, EGD) and through the rectum into the lower bowel tract (colonoscopy) to inspect, treat and sample tissue or lesions.

Patient 6's "procedure note", dated 2/3/17 and signed by Physician G, documented the indication for the procedure was anemia (a blood deficiency that results in blood not carrying enough oxygen to the rest of the body which can cause symptoms that include feeling tired, cold, dizzy, irritable, short of breath and headache) with a drop in hemoglobin (a blood component that carries oxygen throughout the body) and a suspected gastrointestinal bleed.

Patient 6's "consultation report", dated 1/26/17 and signed by Physician G, included a history of present illness that documented Resident 6 had undergone two surgeries with resection of part of the small bowel which seemed to have become ischemic secondary to internal obstruction from an internal hernia versus tight adhesions. He was later transferred as an inpatient for rehabilitation. The consultation report indicated that though Resident 6 was feeling well, his most recent hemoglobin level, dated 1/25/17, was 7.2 (normal level is 13.5 to 17.5 grams per deciliter for males) which was down from 8.0 on 1/24/17. The report indicated Patient 6's current medications included a low dose aspirin (has a blood thinning effect), and lovenox (an anticoagulant medication that is used to treat or prevent a type of blood clot called deep vein thrombosis, which can lead to blood clots in the lungs (pulmonary embolism). The report assessment indicated "This is an elderly gentleman who is status post laparotomy for what appears to be ischemic bowel. He now has a slight downward trend of the hemoglobin, but no signs of overt gastrointestinal bleeding. ...Currently the risks of endoscopy outweigh the benefits in lieu of recent surgery and, therefore, a chance of wound dehiscence (separation) with insufflation of air into his stomach. The report indicated Physician G recommended conservative management with pantoprazole 40 mg (reduces acid in the stomach) intravenously (into the vein) two times a day to prevent stress ulcers and erosions. Recommendations included reserving an endoscopic workup in response to bleeding if there were overt signs of bleeding such as hematemesis (blood in vomited fluids) and/or melena with significant drop in hemoglobin." Review of the record did not indicate any such overt bleeding had occurred to necessitate the procedure.

Patient 6's "history and physical - outpatient procedure form", dated 2/3/17 and signed by Physician G, was not comprehensive, accurate or complete when the areas of the form left blank included "pre-procedure test diagnostic test results" and not indication was found in the record regarding the status of Resident 6's hemoglobin level (significant decline in hemoglobin status could cause a high risk of bleeding and the potential for clotting difficulties if bleeding should occur); Other areas left blank included "pertinent social history" which included spaces to indicate information regarding smoking, alcohol use, recreational drug use, and "pertinent family history" which included spaces to indicate information regarding a history of cancer in the family and bleeding tendencies; "past surgical procedures" was left blank, while the "outpatient nursing record", dated 2/3/17 indicated Patient 6 had a history of surgery that included the right hip, right shoulder, cholecystectomy (removal of the gall bladder), right foot reconstruction, coronary stent (to restore blood flow to an area of the heart), knee replacement, and a bowel resection three weeks ago. The nursing medical history documentation indicated Patient 6 had heart problems, and high blood pressure, a history of stroke, and current tobacco use. No documentation was found to provide evidence of medical clearance for this procedure subsequent to the plan described in the consultation report on 1/26/17 which indicated the procedure was contraindicated due to the patient's current condition.

h. Review of patient records indicated that Patient 8 was admitted as an inpatient on 3/30/17 and later to the procedure suite, on 4/5/17, for a colonoscopy procedure that included insertion of an endoscope device through the rectum into the lower bowel tract to inspect, treat and sample tissue or lesions.

A "procedure note", dated 4/5/17 and signed by Physician G, documented the indication for the procedure included a history of perirectal abscess (infected wound around the rectum) and needed to rule out chronic pathology contributing to the abscess.

Patient 8's "history and physical - outpatient procedure form", dated 4/5/17 and signed by Physician G, was not accurate or complete when the areas of the form left blank included "indications for the procedure", "pre-procedure diagnostic test results", "pertinent social history" (which included spaces to indicate information regarding smoking, alcohol use, recreational drug use), and "pertinent family history" including spaces to indicate information regarding a history of cancer in the family and bleeding tendencies. The area of the H&P to indicate "past surgical procedures" was left blank, while the "outpatient nursing record", dated 4/5/17, indicated Patient 8's surgical history included gall bladder removal and bilateral knee replacements. The H&P indicated Patient 8 had no known allergies, while the "outpatient nursing record", dated 4/5/17, indicated Patient 8 was allergic to morphine (a narcotic pain medication).

In an interview on 7/26/17 at 5:30 pm the Chief Nursing Officer (CNO) and the Director of Quality and Risk Management (DQM) stated that Physicians P and G repeatedly entered incomplete information on patient record forms. Although the Quality Program audited completion of H&P as an ongoing indicator for performance improvement, the audits did not evaluate the accuracy of the H&P entries nor the need for additional operative support identified in the preoperative assessment.

Review of the Medical Staff Bylaws approved 9/14/16 under section 5.4-3-b required a complete history and physical examination shall be performed by the admitting physician within 24 hours of admission or immediately preceding it. Item 5-4-3-c added, the H&P must be updated within 24 hours prior to any surgical procedure or other procedure requiring general anesthesia or moderate or deep sedation. The practitioner responsible for administering anesthesia may update the H&P.

Review of the National Integrated Accreditation for Healthcare Organization (NIAHO) standards for assessments prior to anesthesia services indicated that a pre-anesthesia or pre-sedation evaluation must be performed and documented, by an individual qualified to administer anesthesia/sedation, not more than 48 hours prior to surgery or procedure requiring anesthesia services. This evaluation must include airway assessment, anesthesia risk assessment and anesthesia drug and allergy history.

Based on staff interview, document and patient record review, the hospital failed to ensure that a properly executed informed consent form for the operation was accurately documented prior to surgery for 1 of 14 sampled patient records reviewed (Patient 1).

This failure put patients at risk for agreeing to have a procedure without understanding all risks/alternatives of the treatment.

Findings:

Review of patient records indicated that Patient 1 was admitted to the hospital on 3/26/17 with pneumonia, respiratory failure, chronic lung disease, congestive heart failure, and a heart rhythm disorder (atrial fibrillation-AF, a quivering of the heart muscle that limits the efficiency of pumping blood). Patient 1 was 63 years old, weighed 297 pounds (lbs). Patient 1 had a history of cellular changes in the esophagus and developed dark stools, a sign of intestinal bleeding, for which Physician G consulted and recommended inspections of the upper and lower intestinal tracts via endoscopy procedures on 4/20/17. Although the pre-operative nurse noted abnormal heart rhythm and a recorded heart rhythm strip showed features of AF, Physician G recorded no abnormal physical findings for heart, lungs, or airway on the preoperative History and Physical update form. Physician G's pre-sedation assessment form did not assign a score for mouth opening (Mallampati score), did not note the history of respiratory failure and chronic lung disease, did not note the morbid obesity, all risks for difficulty to support and rescue the airway during sedation. The informed consent verification form signed by Patient 1 prior to the procedure did not state the type of sedation planned. Sedation using both moderate and deep sedation drugs was administered to Patient 1 by a registered nurse (RN) under the direction of the procedure physician, and without the presence of a qualified anesthesia provider to distinctly monitor the deep sedation drug. There was no documented evidence that Patient 1 was informed of an option to have the procedure elsewhere with the support of an anesthesia provider to monitor high risk sedation treatments.

Review of the hospital sponsored course titled Procedural Sedation Manual for Bronchoscopy, Procedural and Diagnostic Endoscopy and Colonoscopy, FMT via Colonoscopy Adults/Older Adults, and ACLS Self Study Module 2017 noted that the goal of procedural sedation was moderate sedation, where patients may be drowsy but still respond to verbal commands and light stimulation. The Manual documented, "RNs may not administer IV push anesthetic agents for procedural sedation including Etomidate, Ketamine, Sodium Thiopental, or Methohexital. RNs may not administer Nitrous Oxide. The RN will be able to administer Propofol IV push as an anesthetic agent only as a second or consecutive dose and under direct supervision and orders of the procedural physician." The drugs listed here including Propofol were all classified by the United Stated Federal Drug Administration (FDA) as general anesthetic drugs with high potential for patients to drift into deep sedation not easily aroused and at risk to lose breathing function, or even drift further with complete loss of breathing and movement. The Manual required that "informed consent for the procedure and moderate sedation" be obtained by the physician, without informing Propofol patients that their risk for deeper loss of reflexes and breathing was greater than for other moderate sedation drugs.

Review of a policy titled Consent for Invasive Procedures, last revised 10/2016, documented that it is the treating practitioner's responsibility to provide the patient information in order to give an informed consent, including the nature of the procedure, including other care, treatment or medications, potential benefits, risks or side effects of the procedure, reasonable alternatives, and to document the patient's understanding and agreement by way of the patient's signature. The hospital's role shall be limited to verifying that the physician obtained and properly documented the patient's informed consent before the physician is permitted to perform the medical procedure/treatment.

Review of the American Society of Anesthesiologists (ASA) statements related to both moderate and deep sedation [Statement on Granting Privileges for Administration of Moderate Sedation to Practitioners Who Are Not Anesthesia Professionals, amended 10/19/11, and Advisory on Granting Privileges for Deep Sedation to Non-Anesthesiologist Sedation Practitioners, approved 10/20/10] required the non-anesthesiologist provider to obtain informed consent through pre-procedure counseling of patients regarding risks, benefits and alternatives to the administration of sedative and analgesic drugs to achieve sedation, but distinguishing between moderate and deep level.

Review of the 2015 Association of peri-Operative Registered Nurses (AORN) Guideline for Care of the Patient Receiving Moderate Sedation/Analgesia documented under Recommendation II, "The perioperative RN (registered nurse) should perform and document a patient nursing assessment before administering moderate sedation/analgesia." Under Recommendation II-a, "The nursing assessment should include a review of the patient's consent explaining the risks, benefits, and alternatives to sedation." The AORN has no provision for consent of deep sedation as it does not endorse administration/monitoring of general anesthetic agents by registered nurses who are not anesthesia professionals.

Based on staff interviews, document and patient record reviews, the hospital failed to ensure adequate provisions for post-operative care as evidenced by:

a. Recovery space was not adequate to provide emergency rescue care and required that a patient be moved to another space; and

b. Accurate documentation and timely assessments and care interventions were not performed/documented for two of 14 sampled patients (Patients 13 and 14) in accordance with nationally recognized standards of care and hospital policies in order to provide safe care.

These failures of staff to recognize patient conditions, perform assessments, and provide timely interventions put patients at risk for preventable life-threatening events.

Findings:

a. On 7/26/17 at 12:30 pm, a simulation of recovery room patient care in the Surgical Procedure Suite (SPS) took place. The post procedure recovery space measured 5 feet, 4 inches in width and 11 feet, 4 inches in length. Equipment in the recovery room included a supply cart, equipment for assessing patient vital signs (temperature, heart rate, and blood pressure), a sink, an IV (intravenous) pole, and the patient gurney. The gurney was located against the wall. The space was such, that in the case of an emergency, the patient gurney would need to be wheeled out into the hallway in order to provide necessary emergency care. In a concurrent interview, the Chief Nursing Officer (CNO) confirmed the staff had not performed a "mock code" (emergency drill) in the procedure suite to test the adequacy of the recovery room space. As a result the staff had not practiced the specific procedures involved in the case of a patient emergency. The CNO acknowledged the recovery room should have adequate space for emergency procedures if needed.

b. During a tour of the hospital procedure suite on 7/26/17 at 2:10 pm, the Procedure Suite Manager (PSM) stated that the post-operative patients were typically monitored for up to 30 minutes before discharge. Nursing staff that monitored patients after a procedure used a standard discharge scoring system to determine adequate recovery and readiness for return to home or to their pre-procedure care location.

Review of patient records with the Chief Nursing Officer (CNO) on 7/26/17 at 5:30 pm, indicated that Patient 14 was admitted to the hospital on 4/20/17 for an outpatient procedure (bronchoscopy) to examine the airway passages into the lungs, and surgically remove tissues to test for disease, by inserting a bronchoscope device into the airway under the effects of moderate sedation (the administration of sedative and narcotic pain medications to lower consciousness so that the procedure can be tolerated). The indications for the procedure were a lung mass identified on an imaging test and coughing up blood. The patient records documented Patient 14's age to be 51 years, weight 396 pounds (lbs.), and current/prior medications for lung disease. A form titled Outpatient Nursing Record documented a pre-procedure assessment by a registered nurse that noted "no" for lung disease history. A form titled History & Physical - Outpatient Procedure, documented an assessment by the operating physician (Physician P) with no note of Patient 14's obesity or reason for using medications for lung disease. A form titled Physician Documentation for Sedation (which served as a pre-sedation assessment) noted nothing about Patient 14's use of medications for lung disease, nothing about Patient 14's obesity or details of an examination to assess the risk to support and rescue breathing during the procedure (Mallampati score), and Physician P assigned a procedure risk (ASA-American Society of Anesthesiologists classification score for overall risk to tolerate surgical procedures) of mild disease (low risk). Physical features known to increase the risk to support breathing include chronic lung disease, short/thick neck, obesity, sleep apnea, and/or narrow opening between the mouth and large airway.

Review of Patient 14's Procedure Note (dictated by Physician P on 4/21/17 at 12:32 p.m.) noted that during the procedure, one biopsy site in the airway passage "started bleeding quite a bit" and required flushing the area several times with a drug mixture to constrict blood vessels to stop the bleeding. That occurrence was not documented on the Bronchoscopy Physician Progress Note (which served as an immediate post-operative note), nor on the intraoperative monitoring record, both of which would be available to the Recovery nursing staff following the procedure, partly to guide the nurse to consider a bleeding complication in connection with excessive oxygen need or other delays to the recovery.

Review of Patient 14's Bronchoscopy Procedure Record indicated that 5 doses of moderate sedation medications were administered by a registered nurse as verbally directed by Physician P between 11:10 am and 11:20 am. During that period, no vital sign measurements were recorded to monitor Patient 14's response and tolerance to the high risk medications. The procedure start time was recorded as 11:20 am, and finish time was 11:40 am. At baseline before the procedure and throughout the operative period, a measurement of oxygen and carbon dioxide breathing gas exchange (end-tidal carbon dioxide-ETCO2) was not recorded (though an order for it to be done appeared on the Physicians Order Set signed by Physician P at 10 a.m.) At 11:20 am as the procedure started, Patient 14's blood oxygen level was considerably lower (93 percent[%]) than the baseline level prior to the procedure (100%). At 11:20 a.m. Patient 14's breathing rate had slowed from baseline 18 breaths per minute to 11. No interventions to improve breathing function were documented. At 11:22 am, additional narcotic pain medication was administered (a medication known to depress heart and lung function) with no interventions to prevent further compromise to the blood oxygen and breathing rate. Ten minutes after arrival to the recovery area at 11:50 am, Patient 14's blood oxygen level was down to 88% and breathing rate was 13 breaths per minute. No adjustments to the supplemental oxygen flow or administration of sedation reversal drugs were documented. Supplemental oxygen was continued at the same flow for an additional 30 minutes until 12:20 pm because the blood oxygen level was not sustained above the discharge criteria level of 94%. A 94% oxygen level was not achieved until 12:40 pm after which Patient 14 was discharged to home at 12:45 pm. Physician P's untimed post-procedure assessment simply checked "awake, alert and oriented."

Review of Patient 13's record with the CNO indicated that Patient 13 was admitted to the hospital on 6/2/17 for an outpatient procedure (bronchoscopy) to examine the airway passages into the lungs, and surgically remove tissues to test for disease, by inserting a bronchoscope device into the airway under the effects of moderate sedation. The indication for the procedure was a lung mass seen on an imaging test. Patient 13 was 71 years old, 186 lbs, with a history of lung disease and diminished breath sounds noted by the admission nurse preoperatively. Details of Patient 13's airway assessment (Mallampati score) were not documented by Physician P who assigned a procedure risk of ASA 2 (mild disease).

During the bronchoscopy, Patient 13 was given a series of five moderate sedation drugs at standard (not reduced for age) doses over a 15 minute period, after which the blood oxygen level drifted down to 90% (baseline was 100%, safe level above 94%) at the end of the procedure. Patient 13 was then moved to the recovery area for further monitoring which showed persistent low blood oxygen levels (88-90%), need for supplemental oxygen, and low blood pressure for a period of 1 hour 15 minutes. After 40 minutes in recovery, the recovery nurse documented an increase in the intravenous fluid rate from 10 to 100 cubic centimeters per hour when Patient 13's blood pressure was 88/43 (baseline was normal 126/73), though no order for this intervention was documented. No physical assessment (direct examination of heart, lungs, skin color) by the nurse or physician related to the low blood pressure/oxygen level and need for fluid intervention was documented. No administration of sedation reversal agents was documented. No communications between nurse and physician were documented. At the same time as increasing the fluid support, the supplemental oxygen was removed. No ETCO2 measurements to add information about breathing efficiency and blood circulation were recorded during the procedure, or during the recovery period, despite the admission physician order to measure ETCO2. After the increase in IV fluids, Patient 13's blood pressure increased slightly but continued to fluctuate until five minutes prior to discharge. Physician P's illegibly timed post-procedure assessment simply checked "drowsy or asleep but arouses easily" and failed to document administration of the narcotic pain medication during the procedure and the extra fluids given during the recovery period.

In a concurrent interview the CNO agreed that assessments by nursing and physician staff of Patient 13's condition were warranted but not documented during the prolonged low blood pressure and low blood oxygen levels. The CNO agreed that communication between nurse monitors with the responsible physician should occur and be documented when patients exhibit signs of potential life-threatening conditions.

In an interview on 7/26/17 at 10 am, the Director for Risk Management and Quality (DRMQ) stated that all moderate sedation for procedure cases were reviewed by the nursing and quality services. Any concerns were then reviewed by the medical staff. The hospital's quality/performance improvement triggers did not lead to a review of Patient 13 or Patient 14's cases. The DRMQ stated that zero incidents of deaths, adverse drug reactions or rescue from life-threatening events, transfers to other hospitals, or complications related to Moderate Sedation care or procedures had occurred for over 2 years.

Review of the hospital policy for moderate sedation titled Sedation, Procedural: Adult, revised 6/17, indicated that the sedation and pain medications selected for Patients 13 and 14 should be reduced when combined, or in the elderly (over 60 years). Both situations applied to Patients 13 and 14. Side effects from the drugs included low blood pressure, depressed breathing and oxygen. Documentation of "any interventions and the patient's response" was required.

Review of the hospital sponsored course titled Procedural Sedation Manual for Bronchoscopy, Procedural and Diagnostic Endoscopy and Colonoscopy, FMT via Colonoscopy Adults/Older Adults, and ACLS Self Study Module 2017 under Post Procedure Care heading, item 2, directed "RN shall notify physician of ... Respiratory depression, blood pressure changes." Under Responses to Complications heading, interventions for low blood pressure were: Notify physician, fluid challenge per physician order, consider medications to raise blood pressure, consider reversing sedation, document patient assessment and your interventions.

Review of the ASA Statement on Granting Privileges for Administration of Moderate Sedation to Practitioners Who are Not Anesthesia Professionals, last amended 10/19/11, documented that education and training of physicians who administer or supervise administration of moderate sedation should assess the patient's airway for anatomic and mobility characteristics suggestive of potentially difficult airway management. Monitoring should include capnography (ETCO2 measurements) unless precluded by the nature of the patient, procedure, or equipment.

Review of the 2015 Association of peri-Operative Registered Nurses (AORN) Guideline for Care of the Patient Receiving Moderate Sedation/Analgesia documented under Recommendation II, "The perioperative RN (registered nurse) should perform and document a patient nursing assessment before administering moderate sedation/analgesia." Recommendation II-c listed multiple characteristics that increased the difficulty to support and rescue breathing, all of which should be assessed by the RN (in addition to the physician supervising sedation). ETCO2 measurements at baseline and throughout the procedure should be monitored and documented by the RN. ETCO2 may be continued into the post-operative period for patients experiencing prolonged or more severe responses to sedation, or at risk for complications of the procedure (like bleeding into the airway).

Based on staff interview and patient record and document review, the hospital permitted use of a general anesthetic agent by individuals who did not meet the definition of a qualified anesthesia practitioner (Physician G, and Moderate Sedation Procedure Nurse A), as the personnel lacked documented training and proficiency in airway management and performed practices that conflicted with acceptable standards of anesthesia care, for 7 of 14 sampled patient records reviewed (Patients 1, 2, 3, 4, 5 , 7, and 8).

This failure put patients at risk for life-threatening adverse events from high risk anesthetic medications administered and monitored by unqualified persons.

Findings:

In an interview on 7/26/17 at 10:10 am, the Director of Quality and Risk Management (DQM) stated that the use of propofol (a general anesthetic agent) during intestinal surgery procedures started in April 2017. To date 26 cases were performed with propofol. Propofol was administered by a non-anesthesiologist physician (Physician G, intestinal specialist) who was performing the procedure and simultaneously supervising registered nurses who monitored the effects of the propofol and other sedation drugs. The registered nurses had no advanced anesthesia training or experience beyond moderate sedation care. (Moderate sedation is the administration of sedative and narcotic pain medications to lower consciousness and enable a patient to tolerate an invasive procedure. The use of a general anesthetic agent poses risk for moving into a deeper level of sedation where protective reflexes for heart and lung function may be lost, or even further into a state of general anesthesia where support for heart and lung function is often necessary.)

Review of patient records indicated that propofol was administered to Patients 1, 2, 3, 4, 5, 7, and 8 during upper and/or lower bowel procedures.

Review of a policy titled Sedation, Procedural, Adult, last revised 6/17, endorsed the practice of registered nurses (RNs) administering second and subsequent doses of propofol as part of sedation administration and monitoring under the supervision of the physician performing a procedure. The policy listed propofol on its Medication Summary page, noting propofol to be an anesthetic drug class with actions for sedation and anesthesia.

Review of the American Society of Anesthesiologists (ASA) Statement on Safe Use of Propofol, last amended 10/15/14 documented, "Due to the potential for rapid, profound changes in sedative/anesthetic depth and the lack of antagonist (rescue) medications, agents such as propofol require special attention. Even if moderate sedation is intended, patients receiving propofol should receive care consistent with that required for deep sedation." The physician should be proficient in airway management and trained to identify and manage the airway and cardiovascular changes which occur in a patient who enters a state of general anesthesia. The trained practitioner should be completely dedicated to the monitoring task.

Concurrent review of physician files with the Medical Staff Coordinator (MSC) on 7/24/17 at 10:45 am, indicated that Physician G was granted privileges for moderate sedation, and not for deep sedation or general anesthesia. Physician G's file contained no documented evidence of experience in managing patients under the effects of general anesthesia or of airway management proficiency. There was no documented evidence of preceptorship or proctoring (direct observation) by a similarly qualified peer that was specific to moderate or deep sedation (or use of propofol) to verify demonstrated competence for the skill.

Review of the Medical Staff Bylaws, approved 9/14/16, documented under item 5.3-2 that competencies for privilege requests were based on education, training, experience, demonstrated professional competence, judgment and clinical performance. Item 5.1 directed that every practitioner providing direct clinical services shall be entitled to exercise only those setting-specific privileges granted to him or her.

Review of the ASA Advisory on Granting Privileges for Deep Sedation to Non-Anesthesiologist Sedation Practitioners, approved 10/20/10, noted the potential for general anesthetic agents to quickly move a patient into a state of deep sedation or general anesthesia. Therefore, non-anesthesiology practitioners must demonstrate ability to recognize such states, and maintain the patient's vital functions until the patient has been returned to an appropriate level of sedation. The qualifications for such providers included completion of a formal training program in safe administration of the drugs and rescue from a deeper than intended level of sedation. If the training was not achieved in recent graduate medical education, it may be provided by a separate deep sedation educational program approved by an accrediting organization for medical education. The curriculum should include assessment skills to recognize patients whose condition required sedation by an anesthesia professional, such as morbidly obese patients, elderly patients, patients with severe systemic disease, sleep apnea or delayed stomach emptying. The training should be hands-on in order for the student to demonstrate competency in managing airways of patients during deep sedation and airway management using airway models and simulators. Clinical experience minimum was managing 35 patients or equivalent simulator volume, or more as advised by the facility Director of Anesthesia Services. The non-anesthesiologist who administered and monitored deep sedation must be different from the individual performing the diagnostic or therapeutic procedure. Performance evaluation of the non-anesthesiologist provider should be conducted either by department heads or supervisors at an institution where privileges are previously held, or by proctoring or supervision by a currently privileged provider of deep sedation.

Physician G's file did not document the qualifications and competencies recommended by the ASA to administer/monitor and/or supervise use of propofol or deep sedation care. Therefore, Physician G was not qualified to assume that role.

Concurrent review of employee files with the Chief Nursing Officer (CNO) on 7/26/17 at 10:50 am indicated that Moderate Sedation Procedure Nurse A (MSPN A) was routinely assigned to administer and monitor moderate sedation. There was no documented training, experience, or competence in Deep Sedation care for the Moderate Sedation Procedure Registered Nurses. Yet, MSPN A s assigned to provide sedation care for the 7 patients who were given propofol.

The American Association of Nurse Anesthetists (AANA) and ASA prepared a Joint Statement Regarding Propofol Administrated dated 4/14/04 that read, "Whenever propofol is used for sedation/anesthesia, it should be administered only by persons trained in the administration of general anesthesia, who are not simultaneously involved in these surgical or diagnostic procedures. This restriction is concordant with specific language in the propofol package insert, and failure to follow these recommendations could put patients at increased risk of significant injury or death."

In a 9/95 position statement titled "Conscious Sedation" (moderate sedation) from the California Board of Registered Nursing (BRN) retrieved at www.rn.ca.gov, the right and obligation of the RN caring for a sedation patient was documented as "to act as the client's advocate by refusing to administer or continue to administer any medication not in the client's best interest; this includes medications which would render the client's level of sedation to deep sedation and/or loss of consciousness." The BRN statement directed institutions that utilized registered nurses to administer moderate sedation to consult with national guidelines in establishing facility policies and procedures.

Review of MSPN A's employee file indicated thta MSPN A neither possessed the documented qualifications and competencies for administration/monitoring of propofol/deep sedation, nor was such behavior endorsed by their state licensing board.

The hospital presented no policies that defined the qualifications of physicians and RNs to administer and monitor propofol that were in accordance with anesthesia expert organizations.

Based on staff interview, patient record and document review the hospital permitted use of a general anesthetic agent by individuals who did not meet the definition of a qualified anesthesia practitioner (Physician G, and Moderate Sedation Procedure Nurse A), as the personnel lacked documented training and proficiency in airway management and performed practices that conflicted with acceptable standards of anesthesia care) for 7 of 14 sampled patient records reviewed (Patients 1, 2, 3, 4, 5, 7 and 8).

This failure put patients at risk for life-threatening adverse events from high risk anesthetic medications administered and monitored by unqualified persons.

Findings:

In an interview on 7/26/17 at 10:10 am, the Director of Quality and Risk Management (DQM) stated that the use of propofol (a general anesthetic agent) during intestinal surgery procedures started in April 2017. To date 26 cases were performed with propofol. Propofol was administered by a non-anesthesiologist physician (Physician G, intestinal specialist) who was performing the procedure and simultaneously supervising registered nurses who monitored the effects of the propofol and other sedation drugs. The registered nurses had no advanced anesthesia training or experience beyond moderate sedation care. (Moderate sedation is the administration of sedative and narcotic pain medications to lower consciousness and enable a patient to tolerate an invasive procedure. The use of a general anesthetic agent poses risk for moving into a deeper level of sedation where protective reflexes for heart and lung function may be lost, or even further into a state of general anesthesia where support for heart and lung function is often necessary.)

Review of patient records indicated that propofol was administered to Patient's 1, 2, 3, 4, 5, 7, and 8 during upper and/or lower bowel procedures.

Review of a policy titled Sedation, Procedural, Adult, last revised 6/17, endorsed the practice of registered nurses (RNs) administering second and subsequent doses of propofol as part of sedation administration and monitoring under the supervision of the physician performing a procedure. The policy listed propofol on its Medication Summary page, noting propofol to be an anesthetic drug class with actions for sedation and anesthesia.

Review of the American Society of Anesthesiologists (ASA) Statement on Safe Use of Propofol, last amended 10/15/14 documented, "Due to the potential for rapid, profound changes in sedative/anesthetic depth and the lack of antagonist (rescue) medications, agents such as propofol require special attention. Even if moderate sedation is intended, patients receiving propofol should receive care consistent with that required for deep sedation." The physician should be proficient in airway management and trained to identify and manage the airway and cardiovascular changes which occur in a patient who enters a state of general anesthesia. The trained practitioner should be completely dedicated to the monitoring task.

Concurrent review of physician files with the Medical Staff Coordinator (MSC) on 7/24/17 at 10:45 a.m. indicated that Physician G was granted privileges for moderate sedation, and not for deep sedation or general anesthesia. Physician G's file contained no documented evidence of experience in managing patients under the effects of general anesthesia or of airway management proficiency. There was no documented evidence of preceptorship or proctoring (direct observation) by a similarly qualified peer that was specific to moderate or deep sedation (or use of propofol) to verify demonstrated competence for the skill.

Review of the Medical Staff Bylaws, approved 9/14/16, documented under item 5.3-2 that competencies for privilege requests were based on education, training, experience, demonstrated professional competence, judgment and clinical performance. Item 5.1 directed that every practitioner providing direct clinical services shall be entitled to exercise only those setting-specific privileges granted to him or her.

Review of the ASA Advisory on Granting Privileges for Deep Sedation to Non-Anesthesiologist Sedation Practitioners, approved 10/20/10, noted the potential for general anesthetic agents to quickly move a patient into a state of deep sedation or general anesthesia. Therefore, non-anesthesiology practitioners must demonstrate ability to recognize such states, and maintain the patient's vital functions until the patient has been returned to an appropriate level of sedation. The qualifications for such providers included completion of a formal training program in safe administration of the drugs and rescue from a deeper than intended level of sedation. If the training was not achieved in recent graduate medical education, it may be provided by a separate deep sedation educational program approved by an accrediting organization for medical education. The curriculum should include assessment skills to recognize patients whose condition required sedation by an anesthesia professional, such as morbidly obese patients, elderly patients, patients with severe systemic disease, sleep apnea or delayed stomach emptying. The training should be hands-on in order for the student to demonstrate competency in managing airways of patients during deep sedation and airway management using airway models and simulators. Clinical experience minimum was managing 35 patients or equivalent simulator volume, or more as advised by the facility Director of Anesthesia Services. The non-anesthesiologist who administered and monitored deep sedation must be different from the individual performing the diagnostic or therapeutic procedure. Performance evaluation of the non-anesthesiologist provider should be conducted either by department heads or supervisors at an institution where privileges are previously held, or by proctoring or supervision by a currently privileged provider of deep sedation.

Physician G's file did not document the qualifications and competencies recommended by the ASA to administer/monitor and/or supervise use of propofol or deep sedation care. Therefore, Physician G was not qualified to assume that role.

Concurrent review of employee files with the Chief Nursing Officer (CNO) on 7/26/17 at 10:50 am indicated that Moderate Sedation Procedure Nurse A (MSPN A) was routinely assigned to administer and monitor moderate sedation. There was no documented training, experience, or competence in Deep Sedation care for the Moderate Sedation Procedure Registered Nurses. Yet, MSPN A was assigned to provide sedation care for the 7 patients who were given propofol (Patients 1, 2, 3, 4, 5, 7, 8).

The American Association of Nurse Anesthetists (AANA) and ASA prepared a Joint Statement Regarding Propofol Administrated dated 4/14/04 that read, "Whenever propofol is used for sedation/anesthesia, it should be administered only by persons trained in the administration of general anesthesia, who are not simultaneously involved in these surgical or diagnostic procedures. This restriction is concordant with specific language in the propofol package insert, and failure to follow these recommendations could put patients at increased risk of significant injury or death."

In a 9/95 position statement titled "Conscious Sedation" (moderate sedation) from the California Board of Registered Nursing (BRN) retrieved at www.rn.ca.gov, the right and obligation of the RN caring for a sedation patient was documented as "to act as the client's advocate by refusing to administer or continue to administer any medication not in the client's best interest; this includes medications which would render the client's level of sedation to deep sedation and/or loss of consciousness." The BRN statement directed institutions that utilized registered nurses to administer moderate sedation to consult with national guidelines in establishing facility policies and procedures.

Review of MSPN A's employee file incidated that MSPN neither possessed the documented qualifications and competencies for administration/monitoring of propofol/deep sedation, nor was such behavior endorsed by their state licensing board.

The hospital presented no policies that defined the qualifications of physicians and RNs to administer and monitor propofol that were in accordance with anesthesia expert organizations.

Based on staff interview and document and patient record review, the hospital failed to ensure that documentation for intraoperative anesthesia records included monitoring of expired carbon dioxide gas exchange (ETCO2, capnography) per standards of practice in 9 of 14 sampled patient records reviewed (Patients 1, 2, 3, 4, 5, 6, 8, 13, and 14).

This failure put patients at risk for unrecognized breathing compromise that could progress to collapse of heart and lung function, delays to rescue, and death.

Findings:

Review of the ASA Statement on Granting Privileges for Administration of Moderate Sedation to Practitioners Who are Not Anesthesia Professionals, last amended 10/19/11, documented that education and training of physicians who administer or supervise administration of moderate sedation (administration of sedative and narcotic pain medications to lower consciousness in order for a patient to tolerate a procedure) should assess the patient's airway for anatomic and mobility characteristics suggestive of potentially difficult airway management. Monitoring should include capnography (ETCO2 measurements) unless precluded by the nature of the patient, procedure, or equipment.

Review of the 2015 Association of peri-Operative Registered Nurses (AORN) Guideline for Care of the Patient Receiving Moderate Sedation/Analgesia documented under Recommendation II, "The perioperative RN (registered nurse) should perform and document a patient nursing assessment before administering moderate sedation/analgesia." Recommendation II-c listed multiple characteristics that increased the difficulty to support and rescue breathing, all of which should be assessed by the RN (in addition to the physician supervising sedation). ETCO2 measurements at baseline and throughout the procedure should be monitored and documented by the RN. ETCO2 monitoring may be continued into the post-operative period for patients experiencing prolonged or more severe responses to sedation, or at risk for complications of the procedure (e.g., bleeding from the surgical site into the airway).

Review of the ASA Advisory on Granting Privileges for Deep Sedation to Non-Anesthesiologist Sedation Practitioners, approved 10/20/10 similarly recommended capnography to measure exhaled carbon dioxide gas as an indicator of breathing efficiency for patients under the effects of propofol/deep sedation.

According to the hospital's own 2017 sedation training manual, Procedural Sedation Manual for Bronchoscopy, Procedural and Diagnostic Endoscopy and Colonoscopy, FMT via Colonoscopy Adults/Older Adults, and ACLS Self Study Module 2017, capnography is a technique used to monitor ETCO2 and therefore may detect early cases of inadequate ventilation before oxygen desaturation takes place. An increase in ETCO2 might be the only clue to hypoventilation (shallow breathing) and potential respiratory compromise.

a. Review of patient records indicated that Patient 1 was admitted to the hospital on 3/26/17 with pneumonia, respiratory failure, chronic lung disease, congestive heart failure, and a heart rhythm disorder (atrial fibrillation-AF, a quivering of the heart muscle that limits the efficiency of pumping blood). Patient 1 was 63 years old, weighed 297 pounds (lbs). Patient 1 had a past history of cellular changes in the esophagus and developed dark stools, a sign of intestinal bleeding, for which Physician G consulted and recommended inspections of the upper and lower intestinal tracts via endoscopy (inspection of the upper and lower intestinal tracts by use of an invasive imaging device called an endoscope) procedures under moderate sedation on 4/20/17. Although the pre-operative nurse noted abnormal heart rhythm and a recorded heart rhythm strip showed features of AF, Physician G recorded no abnormal physical findings for heart, lungs, or airway on the 4/20/17 preoperative History and Physical update form. Physician G's pre-sedation assessment form did not assign a score for mouth opening (Mallampati score), did not note the history of heart failure, respiratory failure and chronic lung disease, did not note the morbid obesity, all risks for difficulty to support and rescue the airway during sedation.

Patient 1 had the upper and lower intestinal procedures with multiple tissue biopsies between 1:30 pm and 1:55 pm according to the Procedure Record documentation. During that interval Patient 1 also received 2 moderate sedation drugs plus propofol, a general anesthetic agent. No ETCO2 measurements were recorded at initial baseline or during the procedures.

b. Patient 14 was admitted to the hospital on 4/20/17 for an outpatient bronchoscopy procedure to examine the airway passages into the lungs, and surgically remove tissues to test for disease, by inserting a bronchoscope device into the airway under the effects of moderate sedation. The indications for the procedure were a lung mass identified on an imaging test and coughing up blood. The patient records documented Patient 14's age to be 51 years, weight 396 lbs., and current/prior medications for lung disease. A form titled Outpatient Nursing Record documented a pre-procedure assessment by a registered nurse that noted "no" for lung disease history. A form titled History & Physical - Outpatient Procedure documented an assessment by the operating physician (Physician P) with no note of Patient 14's obesity or reason for using medications for lung disease. A form titled Physician Documentation for Sedation (which served as a pre-sedation assessment) noted nothing about Patient 14's use of medications for lung disease, nothing about Patient 14's obesity or examination results for the risk to support and rescue breathing during the procedure (Mallampati score), and Physician P assigned a procedure risk (ASA-American Society of Anesthesiologists classification score for overall risk to tolerate surgical procedures) of mild disease (low risk). Physical features known to increase the risk to support breathing include chronic lung disease, short/thick neck, obesity, sleep apnea, and/or narrow opening between the mouth and large airway.

Review of Patient 14's Procedure Note (dictated by Physician P on 4/21/17 at 12:32 pm) noted that during the procedure, one biopsy site in the airway passage "started bleeding quite a bit" and required flushing the area several times with a drug mixture to constrict blood vessels to stop the bleeding. That occurrence was not documented on the Bronchoscopy Physician Progress Note (which served as an immediate post-operative note), nor on the intraoperative monitoring record, both of which would be available to the Recovery nursing staff following the procedure, partly to guide the nurse to consider a bleeding complication in connection with excessive oxygen need or other delays to the recovery.

Review of Patient 14's Bronchoscopy Procedure Record indicated that 5 doses of moderate sedation medications were administered by a registered nurse as verbally directed by Physician P between 11:10 am and 11:20 am. During that period, no vital sign measurements were recorded to monitor Patient 14's response and tolerance to the high risk medications. The procedure start time was recorded as 11:20 am, and finish time was 11:40 am. At baseline and throughout the operative period, ETCO2 measurements were not recorded (though an order for it to be done appeared on the Physicians Order Set signed by Physician P at 10 am). At 11:20 am as the procedure started, Patient 14's blood oxygen level was considerably lower (93 percent [%]) than the baseline level prior to the procedure (100%). At 11:20 am Patient 14's breathing rate had slowed from baseline 18 breaths per minute to 11. No interventions to improve breathing function were documented. At 11:22 am, additional narcotic pain medication was administered (a medication known to depress heart and lung function) with no interventions to prevent further compromise to the blood oxygen and breathing rate. Ten minutes after arrival to the recovery area at 11:50 am, Patient 14's blood oxygen level was down to 88% and breathing rate was 13 breaths per minute. No adjustments to the supplemental oxygen flow or administration of sedation reversal drugs were documented. ETCO2 was not measured in that setting either. Supplemental oxygen was continued at the same flow for an additional 30 minutes until 12:20 pm because the blood oxygen level was not sustained above the discharge criteria level of 94%. A 94% oxygen level was not achieved until 12:40 pm after which Patient 14 was discharged to home at 12:45 pm.

c. Review of Patient 13's record with the CNO indicated that Patient 13 was admitted to the hospital on 6/2/17 for an outpatient bronchoscopy under the effects of moderate sedation. The indication for the procedure was a lung mass seen on an imaging test. Patient 13 was 71 years old, 186 lbs, with a history of lung disease and diminished breath sounds noted by the admission nurse preoperatively. Details of Patient 13's airway assessment (Mallampati score) were not documented by Physician P who assigned a procedure risk of ASA 2 (mild disease).

During the bronchoscopy Patient 13 was given a series of five moderate sedation drugs at standard (not reduced for age) doses over a 15 minute period, after which the blood oxygen level drifted down to 90% (baseline was 100%, generally safe level above 94%) at the end of the procedure. ETCO2 measurements were not recorded at baseline or during the procedure. Patient 13 was then moved to the recovery area for further monitoring which showed persistent low blood oxygen levels (88-90%), need for supplemental oxygen, and low blood pressure for a period of 1 hour 15 minutes. After 40 minutes in recovery, the recovery nurse documented an increase in the intravenous fluid rate from 10 to 100 cubic centimeters per hour when Patient 13's blood pressure was 88/43 (baseline was normal 126/73), though no order for this intervention was documented. No physical assessment (direct examination of heart, lungs, skin color) by the nurse or doctor related to the low blood pressure/oxygen level and need for fluid intervention was documented. No administration of sedation reversal agents was documented. No communications between nurse and doctor were documented. At the same time as increasing the fluid support, the supplemental oxygen was removed. No ETCO2 measurements to add information about breathing efficiency and blood circulation were recorded during the procedure, or during the recovery period, despite the admission physician order to measure ETCO2. After the increase in IV fluids, Patient 13's blood pressure increased slightly but continued to fluctuate until 5 minutes prior to discharge.

In a concurrent interview, the CNO agreed that assessments by nursing and physician staff of Patient 13's condition were warranted but not documented during the prolonged low blood pressure and low blood oxygen levels.

d. Review of patient records indicated that Patient 2, an 85 year old male, was admitted as an inpatient, on 4/18/17, and for a procedure, on 5/22/17, under moderate sedation. The procedure included endoscopy of the upper gastrointestinal and lower intestinal tracts (by use of an invasive imaging device called an endoscope). No comprehensive history and physical was found in Patient 2's record.

Patient 2 had the upper and lower intestinal procedures between 5:40 pm and 6:00 pm according to the Procedure Record documentation, dated 5/22/17. During that interval Patient 2 also received 2 moderate sedation drugs plus propofol, a general anesthetic agent. Initial ETCO2 measurements were recorded pre-procedure but ended at 5:50 pm (10 minutes prior to the end of the procedure). No post procedure ETCO2 measurements were recorded.

e. Review of patient records indicated that Patient 3 was admitted to the hospital on 5/24/17 for procedures, under moderate sedation, that included insertion of an endoscope device through the mouth into the esophagus (long thin muscular tube that connects the throat to the stomach), stomach and upper intestinal tract (esophagogastroduodenoscopy, EGD) and through the rectum into the lower bowel tract (colonoscopy) to inspect, treat and sample tissue or lesions.

Patient 3 had the upper and lower intestinal procedures between 8:20 am and 8:35 am according to the Procedure Record documentation, dated 5/24/17. During that interval Patient 3 also received 2 moderate sedation drugs plus propofol, a general anesthetic agent. Pre-procedure ETCO2 measurement was not recorded. No post procedure ETCO2 measurements were recorded.

f. Review of patient records indicated that Patient 4 was admitted to the hospital on 5/23/17 for procedures, under moderate sedation, that included insertion of an endoscope device through the mouth into the esophagus (long thin muscular tube that connects the throat to the stomach), stomach and upper intestinal tract (esophagogastroduodenoscopy, EGD) and through the rectum into the lower bowel tract (colonoscopy) to inspect, treat and sample tissue or lesions.

Patient 4 had the upper and lower intestinal procedures between 12:20 pm and 8:50 pm according to the Procedure Record documentation, dated 5/23/17. During that interval Patient 4 also received 2 moderate sedation drugs plus propofol, a general anesthetic agent. Pre-procedure ETCO2 measurement was not recorded. No post procedure ETCO2 measurements were recorded.

g. Review of patient records indicated that Patient 5 was admitted as an inpatient on 4/13/17 and later to the procedure suite, on 5/22/17, for procedures, under moderate sedation, that included insertion of an endoscope device through the mouth into the esophagus (long thin muscular tube that connects the throat to the stomach), stomach and upper intestinal tract (esophagogastroduodenoscopy, EGD) and through the rectum into the lower bowel tract (colonoscopy) to inspect, treat and sample tissue or lesions.

Patient 5 had the upper and lower intestinal procedures between 1:40 pm and 2:10 pm, according to the Procedure Record documentation, dated 5/22/17. During that interval Patient 5 also received 2 moderate sedation drugs plus propofol, a general anesthetic agent. A pre-procedure ETCO2 measurement was not recorded. Post procedure ETCO2 measurements were not recorded.

h. Review of patient records indicated that Patient 6, a 79 year old male, was admitted as an inpatient on 1/31/17 and later to the procedure suite, on 2/3/17, for procedures, under moderate sedation, that included insertion of an endoscope device through the mouth into the esophagus (long thin muscular tube that connects the throat to the stomach), stomach and upper intestinal tract (esophagogastroduodenoscopy, EGD) and through the rectum into the lower bowel tract (colonoscopy) to inspect, treat and sample tissue or lesions.

Patient 6 had the upper and lower intestinal procedures between 4:20 pm and 4:35 pm, according to the Procedure Record documentation, dated 2/3/17. During that interval Patient 6 also received 2 moderate sedation drugs. No ETCO2 measurements were recorded. Post- procedure monitoring was recorded for 15 minutes (not meeting the 30 minute requirement). Post procedure monitoring was incomplete when missing documentation included the post procedure Aldrete Score measurements (used to assess patient status, includes an assessment of the reparations, oxygen saturation, level of consciousness, circulation, and activity). Facility required post-operative documentation that was not recorded included discharge status and time of discharge, IV (intravenous line) status, mode of transportation, and RN signature with date and time.

i. Review of patient records indicated that Patient 8 was admitted as an inpatient on 3/30/17 and later to the procedure suite, on 4/5/17, for a colonoscopy procedure, under moderate sedation, that included insertion of an endoscope device through the rectum into the lower bowel tract to inspect, treat and sample tissue or lesions.

Patient 8 had the lower intestinal procedures between 8:00 am and 8:25 am, according to the Procedure Record documentation, dated 4/5/17. During that interval Patient 8 also received 2 moderate sedation drugs plus propofol, a general anesthetic agent. No ETCO2 measurements were recorded before, during or after the procedure.

Review of the hospital's only anesthesia policy, Sedation, Procedural Adult, last revised 6/17, documented that a qualified Registered Nurse (RN) may administer medications intended for sedation/analgesia under the supervision of the procedural physician after successfully completing the hospital sponsored course titled Procedural Sedation Manual for Bronchoscopy, Procedural and Diagnostic Endoscopy and Colonoscopy, FMT via Colonoscopy Adults/Older Adults, and ACLS Self Study Module 2017. The policy instructed the RN to check equipment prior to the procedure, including capnography monitor (device to measure carbon dioxide gas exchange, ETCO2, generated from a breathing passage). However, during the procedure the RN was only required to use capnography and document the ETCO2 measurements for patients receiving a specific general anesthetic drug (Propofol) and not for other moderate sedation drugs. ETCO2 was not included in the required baseline nursing assessment, nor the "reassessment of the patient's readiness to receive sedation conducted immediately prior to the procedure."

Further review of the hospital sponsored course titled Procedural Sedation Manual for Bronchoscopy, Procedural and Diagnostic Endoscopy and Colonoscopy, FMT via Colonoscopy Adults/Older Adults, and ACLS Self Study Module 2017 documented that monitoring of ETCO2 was only directed "if ordered by physician," and not as part of the expected routine monitoring for all moderate sedation patients.

Based on staff interview, document and patient record review, the hospital failed to ensure that a post-anesthesia evaluation was completed and documented by an individual qualified to administer anesthesia for 7 of 7 smapledpatients who were given a general anesthetic drug during invasive procedures (Patients 1, 2, 3, 4, 5, 7, and 8).

This failure put patients at risk for delays to recognize, prevent, or rescue patients from adverse effects of general anesthetic agents.

Findings:

Review of patient records indicated that Patients 1, 2, 3, 4, 5, 7, and 8 were administered a general anesthetic agent (propofol) during invasive intestinal procedures. Post-anesthesia assessments for Patients 1, 2, 3, 4, 5, 7, and 8 were documented by Physician G, who concurrently performed the procedure and supervised the monitoring of propofol by a registered nurse (RN). Neither Physician G nor the RN were anesthesia professionals.

Review of the American Society of Anesthesiologists (ASA) Statement on Safe Use of Propofol, last amended 10/15/14 documented, "Due to the potential for rapid, profound changes in sedative/anesthetic depth and the lack of antagonist (rescue) medications, agents such as propofol require special attention. Even if moderate sedation is intended, patients receiving propofol should receive care consistent with that require for deep sedation." The physician should be proficient in airway management and trained to identify and manage the airway and cardiovascular changes which occur in a patient who enters a state of general anesthesia. The trained practitioner should be completely dedicated to the monitoring task.

Concurrent review of physician files with the Medical Staff Coordinator (MSC) on 7/24/17 at 10:45 a.m. indicated that Physician G was granted privileges for moderate sedation, and not for deep sedation or general anesthesia. Physician G's file contained no documented evidence of experience in managing patients under the effects of general anesthesia or of airway management proficiency. There was no documented evidence of preceptorship or proctoring (direct observation) for deep sedation skills by a similarly qualified peer to verify demonstrated competence for the skills.

Review of the ASA Advisory on Granting Privileges for Deep Sedation to Non-Anesthesiologist Sedation Practitioners, approved 10/20/10, noted the potential for general anesthetic agents to quickly move a patient into a state of deep sedation or general anesthesia. Therefore, non-anesthesiology practitioners must demonstrate ability to recognize such states, and maintain the patient's vital functions until the patient has been returned to an appropriate level of sedation. The qualifications for such providers included completion of a formal training program in safe administration of the drugs and rescue from a deeper than intended level of sedation. If the training was not achieved in recent graduate medical education, it may be provided by a separate deep sedation educational program approved by an accrediting organization for medical education. The curriculum should include assessment skills to recognize patients whose condition required sedation by an anesthesia professional, such as morbidly obese patients, elderly patients, patients with severe systemic disease, sleep apnea or delayed stomach emptying. The training should be hands-on in order for the student to demonstrate competency in managing airways of patients during deep sedation and airway management using airway models and simulators. Clinical experience minimum was managing 35 patients or equivalent simulator volume, or more as advised by the facility Director of Anesthesia Services. The non-anesthesiologist who administered and monitored deep sedation must be different from the individual performing the diagnostic or therapeutic procedure. Performance evaluation of the non-anesthesiologist provider should be conducted either by department heads or supervisors at an institution where privileges are previously held, or by proctoring or supervision by a currently privileged provider of deep sedation.

Physician G's file did not document the qualifications and competencies recommended by the ASA to administer/monitor and/or supervise use of propofol or deep sedation care. Therefore, Physician G was not qualified to perform post-anesthesia assessments for patients receiving propofol.

The hospital presented no anesthesia policy that defined who was qualified to perform a post-anesthesia assessment within 48 hours of administration of an anesthetic agent.