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5550 UNIVERSITY AVENUE

SAN DIEGO, CA null

RESPIRATORY CARE SERVICES

Tag No.: A1151

Based on interview and document review, the hospital did not have an effective Respiratory Therapy service that maintained, organized and staffed to ensure the health and safety of patients when:

1. Failed to ensure that Respiratory Care Practitioners demonstrated competencies for the emergent airway management procedure of endotracheal intubation were current. ( A tag 1161)

2. Failed to have an effective policy and procedure in place to ensure appropriate staff response to a cardiopulmonary emergency. (A tag 93, 1163)

3. Failed to ensure that interventions during a code blue procedure were consistent with the facility's policies, procedures and established protocols. ( A tag 93)

4. Failed to ensure that code blue interventions were supervised and/or implemented in a manner that met the needs of the patient. ( A tag 93, 1161)

5. Failed to have referral plan that included a policy and procedure to be implemented when the patient's needs exceeded the facility capabilities. ( A tag 93)


The cumulative effect of these systemic problems resulted in the hospital's failure to deliver care in compliance with the Condition of Participation for Respiratory Services and failure to provide a safe and secure environment for patients.

CARE OF PATIENTS - MD/DO ON CALL

Tag No.: A0067

Based on interview and record review the hospital's governing body failed to ensure the participation of an available privileged physician (MD 2) to provide patient services for 1 of 30 sampled patients (29). MD 2 did not participate in Patient 29's emergency cardiac/respiratory resuscitation intervention (code blue), while in the facility and aware of the event, as required by the facility policy. The facility nursing staff and respiratory care staff conducted the resuscitation intervention without the supervision of a physician.

Findings:

Patient 29 was admitted to the hospital on 2/13/15 with diagnoses which included "ARF" (acute respiratory failure) per the hospital Patient Registration Form. Patient 29 died at the hospital on 3/17/15.

A review of the hospital's 24 Hour Care Record assessment form, dated 3/4/15 at 8:00 A.M. and 7:30 P.M., indicated that Patient 29 was "Awake...Alert...Oriented". The same assessment form indicated that the patient's vital signs (measurements of heart, respiration, blood pressure and/or temperature) were within normal limits and that the patient had no change of condition during the night shift. A review of the 24 hour Care Record assessment form, dated 3/5/15 at 7:45 A.M., indicated that the patient was again stable and unchanged. In addition, the assessment indicated that the patient was "Oriented to Person...Place..Calm...Speech: Intelligible". The form's Nursing Progress Note Page indicated that the patient was assisted to reposition in bed at 11:45 A.M. Per the same note at 12:55 P.M., the patient's telemetry (electronic remote heart monitor) indicated a slow heart beat and the patient was found unresponsive. Cardiopulmonary Resuscitation (CPR... code blue life saving interventions for cardiac/respiratory arrest) was initiated.

During an interview and joint record review on 3/10/15 at 9:00 A.M., Patient 29's Resuscitation Record and Post Code Review forms, dated 3/5/15, were reviewed with the Director of Quality Risk Management/Infection Preventionist (DQRM/IP). The Resuscitation Record documented the emergency interventions, assessments and events of the code blue. The Post Code Review form included questions and comments which identified quality indicator improvement concerns. The Post Code form indicated that "MD 2 refused to intubate [insert a tube to assist breathing]...No doctor showed up". The DQRM/IP stated no "house staff physician" had been in the hospital at the time of the code blue and that the hospital had asked MD 2, who was in the hospital, for assistance. The DQRM/IP stated that the hospital had 24 hour physician coverage on weekends, 5:00 P.M. Fridays until 7:00 A.M. on Mondays and overnight coverage Monday through Thursday. The DQRM/IP stated the hospital relied on the hospital's anesthesiology staff, on call speciality physicians or privileged physicians present in the hospital to respond to emergent patient needs during the weekday daytime hours. The DQRM/IP stated that the hospital anesthesiologist's privileges had been suspended at the time of the reviewed blue code occurrence on 3/5/15 at 12:55 P.M. and that MD 2 had been the only physician in the facility.

During an interview on 3/10/15 at 5:00 P.M., Registered Nurse (RN) 17 stated that MD 2 responded to the code blue, was asked to intubate, refused and left the room. RN 15 stated that the nurses and respiratory care staff then continued the code blue per established protocols.

During an interview on 3/11/15 at 12:30 P.M., MD 2 stated that he was present in the facility on 3/5/15 and was asked by hospital staff to respond to the code blue. MD 2 stated that he was not comfortable with intubation because of inexperience with the procedure. MD 2 stated that he had been willing to help, however when told by RN 17 "we got this doc", that he had left the room. MD 2 stated that he thought the hospital had "coverage" for code blue emergencies and had not been informed of his responsibility to respond to code blue announcements when he was at the hospital. In a subsequent interview at 2:30 P.M., MD 2 stated that he had sought clarification more that one year ago from the Chief Executive Officer (CEO) at the time, and had been informed that physicians should respond to code blue procedures "in accordance with their comfort level."

A review of the hospital's policy and procedure entitled Code Blue Event/Cardiopulmonary Arrest, dated 2/7/14, included "8. When the house physician or any physician available in the facility has arrived; they assume responsibly for running the code. The code team members should remain at the bedside."

During a meeting with the hospital Governing Body on 3/18/15 at 12:20 P.M., the Medical Director (MD) stated the expectation that physicians present in the hospital at the time of a code blue "should be required" to respond and supervise the team. The MD and Governing Body participants acknowledged that the hospital had not effectively communicated this expectation to the privileged physicians.

EMERGENCY SERVICES

Tag No.: A0093

Based on interview and record review the hospital failed to implement or have an effective policy and procedure in place to ensure that competent and appropriate staff were available to respond to a cardiopulmonary emergency (cardiac and/or respiratory arrest) for 1 of 30 sampled patients (29). The hospital's interventions during a code blue procedure (a life saving intervention/protocol implemented at the time of a cardiac and/or respiratory arrest) were not consistent with the hospital's policies and procedures. Patient 29's code blue interventions were not supervised by an available physician. A hospital nurse performed an invasive procedure that was not within their scope of practice. The hospital respiratory care staff had not demonstrated current competencies for performance of their job responsibilities. Furthermore, a Registered Nurse performed a procedure that was not within their scope of practice. In addition, the hospital did not have a referral plan that included a policy and procedure to be implemented when the patient's needs exceeded the hospital staff capabilities.

On 3/11/15 at 12:00 P.M., a situation of Immediate Jeopardy was determined to be present due to the findings outlined in A tag 0093. A meeting was held with the Chief Executive Officer; CEO, Chief Clinical Officer; CCO, Director of Finance; DOF, Director of Business Development; DBD, Director of Pharmacy; DOP, Director of Nursing; DON, and the Human Resource Department; HRD. After receipt of an acceptable corrective action plan, the Immediate Jeopardy was abated on 3/18/15 at 10:00 A.M.

Findings:

Patient 29 was admitted to the hospital on 2/13/15 with diagnoses which included "ARF" (acute respiratory failure) per the hospital Patient Registration Form. Patient 29 died at the facility on 3/17/15.

A review of the hospital Discharge Summary, dated 3/25/15 and authenticated by MD 1 (pulmonary specialist physician), included Patient 29's history and hospital course. The summary included the code blue event of 3/5/15. The summary included "I suspect his [Patient 29] primary event was respiratory...He was also hypovalemic (low fluid volume) and in shock; however he was intubated during the resuscitative efforts...The patient was unresponsive, hypotensive (low blood pressure) and acute respiratory acidosis (respiratory condition which involves a life threatening imbalance in oxygen and carbon dioxide levels), severely hypoxic (low oxygen levels)...I suspect patient developed anoxic encephalopathy (brain damage due to low oxygen) following cardiac arrest." The summary indicated that the patient failed to progress and that ventilator life support was discontinued on 3/17/15.

During an interview and joint record review on 3/10/15 at 9:00 A.M., Patient 29's Resuscitation Record and Post Code Review forms, dated 3/5/15, were reviewed with the Director of Quality Risk Management/Infection Preventionist (DQRM/IP). The Resuscitation Record form documented the emergency interventions, assessments and events of the patient's code blue. The Resuscitation Record form indicated that the patient's code blue was initiated at 12:55 P.M. The same record indicated that Respiratory Care Practitioner (RCP) 1 and RCP 2 were in attendance. In addition, the DQRM/IP stated that the Cardiopulmonary Director (CPD) also attended the same code blue. The Resuscitation Record form checkboxes (labeled to describe the patient's), "At Onset Breathing", had been left blank. Columns on the form which indicated measurements/assessments for "BP (blood pressure), pulse (heart rate), resp (respirations), SAO2 (blood oxygen concentration)" had also been left blank. An area on the Resuscitation Record form labeled "Comments/Results/Procedures" did not include any assessment or information regarding the patient's respiratory/breathing status or oxygenation concentration, response to administered medications, communication with a physician for medication orders and laboratory blood specimen collection or results. There was no record or evidence of airway status assessment or airway management interventions from 12:55 P.M. until 1:15 P.M. At that time, the Resuscitation Record form indicated that "Intubation", (the insertion and placement of a tube in the trachea/airway to assist breathing), occurred at 1:15 P.M. The form indicated that the intubation procedure was performed by Registered Nurse (RN) 17. There was not documentation of RCP attempts to intubate the patient. The Post Code Review form included questions and comments which identified quality indicator improvement concerns. The Post Code Review form included "Staff education provided: RT (respiratory therapy/cardiopulmonary staff) unable to intubate...RT initially did not want to intubate". "[MD (medical doctor) 2] refused to intubate. No physician showed up to the code". The DQRM/IP stated the hospital relied on the hospital's "in house" anesthesiology staff, on call speciality physicians or privileged physicians present in the hospital to respond to emergent patient needs during the weekday daytime hours. The DQRM/IP stated that the hospital anesthesiologist had been on suspension from the hospital at the time of the code blue occurrence on 3/5/15. The DQRM/IP stated that a "house staff " physician had not been in the hospital at the time of the code blue, but that MD 2, who was at the hospital to examine another patient, was asked for assistance. The DQRM/IP stated that MD 2 was a privileged physician at the hospital.

A review of the hospital's 24 Hour Care Record assessment form, dated 3/4/15 at 8:00 A.M. and 7:30 P.M., indicated that Patient 29 was "Awake...Alert...Oriented". The same assessment form indicated that the patient's vital signs (measurements of heart, respiration, blood pressure and/or temperature) were within normal limits and that the patient had no change of condition during the night shift. A review of the 24 hour Care Record assessment form, 3/5/15 at 7:45 A.M., indicated that the patient was again stable and unchanged. In addition, the assessment indicated that the patient was "Oriented to Person...Place..Calm...Speech: Intelligible". The form's Nursing Progress Note Page indicated that the patient was assisted to reposition in bed at 11:45 A.M. Per the same note, at 12:55 P.M., the patient's telemetry (a remote electronic heart monitor) indicated a slow heart beat and the patient was found unresponsive. Cardiopulmonary Resuscitation (CPR...life saving interventions for cardiac/respiratory arrest, also referred to as a code blue) was initiated. At 1:40 P.M., the Nursing Progress Note, indicated that the patient was transferred to the Intensive Care Unit (ICU) and was unresponsive except to painful stimuli.

A review of a Physician Progress Note, dated "3/5" and authenticated by MD 3 (physician/facility medical director), included "Pt (patient) intubated by [name] RN (Registered Nurse) CXR (chest x-ray) ET (endotracheal tube) at carina (a ridge at the lower trachea/airway which separates the two openings of the lungs) will reposition". An additional, "Operative Report", dated 3/5/15 at 2:02 P.M. authenticated by MD 3, included "status post code blue, was intubated by [RN 17] the patient was transported to the ICU and chest x-ray was done...This shows ET tube to be at the level of the carina and it will be pulled back 2 cm (centimeters)..."

A review of the hospital policy and procedure entitled Code Blue Event/Cardiopulmonary Arrest, dated 2/7/14 included "Purpose: To provide efficient, quality care and timely intervention in the event of cardiac-pulmonary arrest or medical emergency. To ensure resuscitation services are systematically available through the hospital...Procedure: An ACLS (advanced cardiac life support) certified Registered Nurse may manage the code using ACLS algorithms until the physician arrives...Laboratory staff collects blood specimen for immediate testing..."code blue panel"...ABG (arterial blood gas...a laboratory blood test which indicates proper air exchange in the body)...When the house physician or any physician available in the facility has arrived; they assume responsibility for running the code...In the event the patient is in need of a higher level of care, an order will be written by the physician for the designated level of care and the patient will be discharged and/or transferred to the care level...CODE BLUE TEAM...ICU RN who is ACLS certified...Direct code event until physician arrives...Respiratory Therapist...Manages airway and assist as needed...Physician...Directs code event."

The review of a Specimen Inquiry laboratory report, dated 3/5/15, indicated that blood for an ABG test was collected on "3/5/15-1320 (1:20 P.M.)", which was more than 20 minutes after the code blue was initiated and 5 minutes after Patient 29 had been intubated by RN 17.

A review of the facility policy and procedure entitled Adult Endotracheal Intubation, dated 8/26/13, included "Purpose: To provide adult endotracheal intubation when a physician is unavailable...Policy: Trained Respiratory Care Practitioners (RCP) may perform adult endotracheal intubation in a code blue setting, in the absence of a qualified physician who can intubate, when conditions are impending, actual airway compromise, respiratory failure and for airway protection."

During an interview on 3/10/15 at 12:00 P.M., RN 20 stated that she was the ICU (Intensive Care Unit) nurse assigned to respond the code blue procedures on 3/5/15. RN 20 stated that she "ran the code" using the established American Heart Association algorithm (a sequential list of medication and interventions based on the identified type of cardiopulmonary emergency) for one round of medication and that RN 17 then "took over the code". RN 20 stated that MD 2 responded to the code blue, and stated that he was not able to intubate patients. RN 20 stated that after RCP 1 failed to intubate the patient, RN 17 volunteered to attempt the patient's intubation. RN 20 stated that she was ACLS certified, however, endotracheal intubation was out of her scope of practice. RN 20 stated that she was not aware of a procedure to follow in the event that a physician was unable or unwilling to respond to a code blue. RN 20 stated that there was no discussion of alternative procedures and that the code blue continued until the patient's pulse returned, at 1:30 P.M., and that the patient was then transferred into the ICU.

During an interview on 3/10/15 at 3:30 P.M., RCP 1 stated that her job responsibilities included the management of patients' airways during code blue procedures. RCP 1 stated that she had current ACLS certification (specialized training/protocols for procedures, which include intubation skills, implemented in the treatment cardiac and respiratory arrest with re-certification required every 2 years). RCP 1 stated that she had demonstrated endotracheal intubation on a practice mannequin during her last ACLS training on 2/6/14. RCP 1 stated that she had not practiced endotracheal intubation since that time. RCP 1 stated that she had tried to intubate a patient once since that time and that she had not been successful. RCP 1 stated that she tried to intubate Patient 29 twice during the 3/5/15 code blue and had not been successful. RCP 1 stated that the hospital did not require ongoing demonstration of endotracheal intubation skills other than the every 2 year ACLS recertification.

During an interview on 3/10/15 at 3:50 P.M., the Cardiopulmonary Director (CPD) stated that she had oversight of the hospital's Respiratory Care Practitioner's skills and competencies. The CPD stated that ACLS certification was not a job requirement of the RCP staff, but was "recommended". The CPD stated that she was not ACLS certified and had not attempted endotracheal intubation "for years". The CPD recalled the code blue event of 3/5/15. The CPD stated that the nurses requested the patient's intubation and that when RCP 1 was unsuccessful, RN 17 had volunteered to intubate the patient. The CPD stated that she was not sure if intubation was necessary or was within the Registered Nurse's scope of practice. The CPD stated that the hospital did not require ongoing demonstration of endotracheal intubation skills for the Respiratory Care Practitioners.

A review of RCP 1, RCP 2 and CPD's job descriptions was conducted on 3/13/15 at 3:15 P.M. RCP 1's job description, entitled Lead Respiratory Care Practitioner II, included "Demonstrates competence in performance of special procedures...Assists physicians with special procedures such as... intubation".

RCP 2's job description entitled Respiratory Care Practitioner II included "Position Summary: performs direct and in-direct cardio-pulmonary services...intubation..." and "Demonstrates competence in performance of special procedures...Assists physicians with special procedures...intubation..."

CPD's job description, entitled Cardiopulmonary Director, included "Demonstrates competence in performance of procedures... Provides CPR (cardio-pulmonary resuscitation), intubation... Assists physician with special procedures such as intubation."

Eight of the hospitals Respiratory Care Clinical Performance Evaluation/Intubation Competency forms, indicated that RCP staff received training and demonstrated competency on 2/18/13. No other intubation competency assessments were provided.

During an interview on 3/10/15 at 5:00 P.M., RN 17 stated that MD 2 responded to the code blue, was asked to intubate, refused and then left the patient's room. RN 17 stated that the nurses then continued the code blue per established protocols. RN 17 stated that RCP 1 was prompted by the nursing staff to intubate Patient 29. RN 17 stated that RCP 1 attempted to intubate two times, but was unsuccessful. RN 17 stated that he then volunteered to to attempt intubation and was successful. RN 17 stated that he thought that endotracheal intubation was within his scope of practice because he was ACLS certified. RN 17 stated that phone contact was made with MD 1 (one of Patient 29's physicians) during the code blue and that an additional medication had been ordered. RN 17 recalled that MD 1 had informed him that he was 30-40 minutes away from the hospital. RN 17 stated that he was not aware of a procedure to follow in the event that a physician was unable or unwilling to respond to a code blue. RN 17 stated that there was no discussion of alternative procedures and that the code blue continued until circulation returned, at 1:30 P.M., and the patient was transferred into the ICU.

A review of RN 17's current job description, dated 11/7/14, did not include the specific skill for endotracheal intubation.

A review of the California Department of Consumer Affairs/Board of Registered Nursing explanation of the scope of RN practice included "Scopes of Practice...A knowledge of the respective scopes of practice of registered nurses and physicians is important in determining which activities overlap medical practice and therefore require standardized procedures... Standardized Procedures for Medical Functions, The means designated to authorize performance of a medical function by a registered nurse is a standardized procedure developed through collaboration among registered nurses, physicians and administrator in the organized health care system in which it is to be used."

During an interview on 3/11/15 at 12:15 P.M., the CCO stated that it was his understanding the ACLS certification enabled Registered Nurses to perform endotracheal intubation procedures. The CCO acknowledged that the facility had not developed an approved standardized procedure which enabled facility Registered Nurses to perform endotracheal intubation.

A review of the hospital policy and procedure entitled Code Blue Event/Cardiopulmonary Arrest, dated 2/7/14, included "8. When the house physician or any physician available in the facility has arrived; they assume responsibly for running the code. The code team members should remain at the bedside."

During an interview on 3/11/15 at 12:30 P.M., MD 2 stated that he was present in the facility on 3/5/15 and was asked by hospital staff to respond to the code blue. MD 2 stated that he was not comfortable with intubation because of his inexperience with the procedure. MD 2 stated that he had been willing to help, however when told by RN 17 "we got this doc", that he had left the room. MD 2 stated that he thought the hospital had "coverage" for code blue emergencies and that he had not been informed of his responsibility to respond to code blue procedures when he was in the hospital. In a subsequent interview at 2:30 P.M., MD 2 stated that he had sought clarification more that one year ago from the Chief Executive Officer (CEO) at the time, and had been informed that physicians should respond to code blue procedures "in accordance with their comfort level."

During an interview on 3/12/15 at 3:30 P.M., the MD 3 stated that he was called to respond to the hospital when informed of the need for a physician after Patient 29 was transferred to the ICU. MD 3 stated that the hospital relied on the "house" anesthesiology staff to cover for patient emergent needs during the daytime hours. MD 3 acknowledged that the anesthesiologist was not always available to respond to emergent patient needs and code blue events and stated "we need to train other personnel". MD 3 stated that he "was surprised that [RN 17] had intubated the patient." MD 3 acknowledged that he had oversight of the Cardiopulmonary Department and that the hospital did not have a standardized procedure which allowed Registered Nurses to perform endotracheal intubation procedures. MD 3 stated that any privileged physician who was in the hospital, was expected to respond to code blue events and should "at least try to help".

During an interview on 3/13/15 at 2:45 P.M., RCP 2 stated that his job responsibilities included the management of patients' airways during code blue procedures. RCP 2 stated that his last ACLS certification occurred 9/20/13. RCP 2 stated that he had been employed at this hospital since "December 2014" and had transferred to this hospital from a "sister hospital" in another state. RCP 2 stated that he had intubated patients successfully on average of 1-2 times a month at his last position. RCP 2 stated that he had completed his orientation skills/competencies checklist at this hospital, except for an endotracheal intubation demonstration. RCP 2 stated that the CPD had instructed him not to intubate patients until she had arranged an intubation demonstration with the hospital's ACLS instructor. RCP 2 stated that he had not yet been scheduled to complete the intubation demonstration. RCP 2 stated that the laboratory blood specimen for the patient's ABG test was collected after RN 17 intubated the patient and right before the patient was transferred to the ICU, approximately 1:30 P.M., over 30 minutes after the code blue was initiated.

During an interview on 3/13/15 at 3:30 P.M., the Chief Clinical Officer (CCO) stated that his responsibility included oversight of the CPD and RCP staff. The CCO acknowledged that he was not familiar with the status of individual RCP staff competencies related to endotracheal intubation procedures. The CCO further acknowledged that, although intubation skills were included in the job descriptions, the hospital had not specified requirements for the demonstration of those skills.

During a meeting with the hospitals Governing Body on 3/18/15 at 12:20 P.M., the Medical Director stated the expectation that physicians present in the hospital at the time of a code blue "should be required" to respond and supervise the code blue team. The Governing Body acknowledged that the hospital had not effectively communicated this expectation to the privileged physicians. In addition, the Governing Body acknowledged that the hospital did not have a policy or procedure developed that would meet emergent patient needs in the event that a physician could not or would not respond to a life threatening medical emergency and had not implemented the existing code blue policy and procedure as expected. Furthermore, the Governing Body acknowledged that the hospital did not have a specialized standardized procedure which allowed Registered Nurses to perform endotracheal intubation and that the RCP staff did not have current demonstrated proficiencies for endotracheal intubation.

RESPIRATORY CARE PERSONNEL POLICIES

Tag No.: A1161

Based on interview and record review the hospital failed to identify the required level of skill and monitoring of competencies for the Respiratory Care Practitioner (RCP) staff, related to endotracheal intubation (insertion of a tube into the trachea/airway to assist with breathing). In addition, the hospital failed to maintain clarity and consistency between policy, procedures and the RCP job descriptions. The requirements for RCP staff specific skill competencies, for endotracheal intubation procedures, had not been identified, described or monitored to meet the emergent needs of the hospital's patients. RCP had minimal experience performing and practicing endotracheal intubations.

Findings:

During an interview and joint record review on 3/10/15 at 9:00 A.M., Patient 29's Resuscitation Record and Post Code Review forms, dated 3/5/15, were reviewed with the Director of Quality Risk Management/Infection Preventionist (DQRM/IP). The Resuscitation Record documented the patient assessments, emergency interventions and events of the code blue conducted on 3/5/15. The same record indicated that Respiratory Care Practitioner (RCP) 1 and RCP 2 were in attendance. In addition, the DQRM/IP stated that the the Cardiopulmonary Director (CPD) also attended the same code blue. The Post Code Review form included "Staff education provided: RT (respiratory therapy) unable to intubate...RT initially did not want to intubate".

A review of the hospital's policy and procedure entitled "Code Blue Event/Cardiopulmonary Arrest", dated 2/7/14 included "Purpose: To provide efficient, quality care and timely intervention in the event of cardiac-pulmonary arrest or medical emergency. To ensure resuscitation services are systematically available through the hospital."

A review of the hospital's policy and procedure entitled "Adult Endotracheal Intubation", dated 8/26/13, included "Purpose: To provide adult endotracheal intubation when a physician is unavailable...Policy: Trained Respiratory Care Practitioner's (RCP) may perform adult endotracheal intubation in code blue setting, in the absence of a qualified physician who can intubate, when conditions are impending, actual airway compromise, respiratory failure and for airway protection."

During an interview on 3/10/15 at 3:30 P.M., RCP 1 stated that her job responsibilities included the management of patients' airways during code blue procedures. RCP 1 stated that she had current ACLS (advanced cardiac life support) certification (specialized training/protocols for procedures, implemented in the treatment cardiac and respiratory arrest with a re-certification was required every 2 years). RCP 1 stated that she had demonstrated endotracheal intubation on a practice mannequin during her last ACLS training on 2/6/14. RCP 1 stated that she had not practiced endotracheal intubation since that time. RCP1 stated that she had tried to intubate a patient once since that time and that she had not been successful. RCP 1 stated that she tried to intubate Patient 29 twice during the 3/5/15 code blue and had not been successful.

During an interview on 3/10/15 at 3:50 P.M., the Cardiopulmonary Director (CPD) stated that she had oversight of the hospital's Respiratory Care Practitioners' skills and competencies. The CPD stated that ACLS certification was not a job requirement of the RCP staff, but was "recommended". The CPD stated that she was not ACLS certified and had not attempted endotracheal intubation "for years".

During an interview on 3/13/15 at 2:45 P.M., RCP 2 stated that his job responsibilities included the management of patients' airways during code blue procedures. RCP 2 stated that his last ACLS certification occurred 9/20/13. RCP 2 that he had been employed at this hospital since "December 2014" and had transferred to this hospital from a "sister hospital" in another state. RCP 2 stated that he had intubated patients successfully on average of 1-2 times a month at his last job. RCP 2 stated that he had completed his orientation skills/competencies checklist at this hospital, except for an endotracheal intubation demonstration. RCP 2 stated that the CPD had instructed him not to intubate patients until she had arranged an intubation demonstration with the hospital's ACLS instructor.

A review of RCP 1, RCP 2 and CPD's job descriptions were conducted on 3/13/15 at 3:15 P.M.

A review of RCP 1's job description, entitled Lead Respiratory Care Practitioner II, included "Demonstrates competence in performance of special procedures...Assists physicians with special procedures such as... intubation".

A review of RCP 2's job description entitled Respiratory Care Practitioner II included "Position Summary: performs direct and in-direct cardio-pulmonary services...intubation..." and "Demonstrates competence in performance of special procedures...Assists physicians with special procedures...intubation..."

CPD's job description, entitled Cardiopulmonary Director, included "Demonstrates competence in performance of procedures..Provides CPR (cardio-pulmonary resuscitation), intubation...Assists physician with special procedures such as intubation."

A review of 8 hospital Respiratory Care Clinical Performance Evaluation/Intubation Competency forms, indicated that RCP staff received training and demonstrated competency on 2/18/13. No other intubation competency assessments were provided.

During an interview on 3/13/15 at 3:30 P.M., the Chief Clinical Officer (CCO) stated that his responsibility included oversight of the CPD and cardiopulmonary staff. The CCO acknowledged that he was not familiar with the status of individual cardiopulmonary staff competencies related to endotracheal intubation procedures. The CCO further acknowledged that, although included in the job descriptions, the facility had not specified frequency requirements for the demonstration of competency skills related to endotracheal intubation for the RCP staff.

ORDERS FOR RESPIRATORY SERVICES

Tag No.: A1163

Based on interview and record review the hospital failed to provide respiratory care services by a licensed practitioner who acted within the licensed individual's scope of practice for 1 of 30 sampled patients (29). An endotracheal intubation procedure was performed by a Registered Nurse (RN) 17 when Respiratory Care Practicioner (RCP) staff were unsuccessful and without medical staff oversight.

Findings:

Patient 29 was admitted to the facility on 2/13/15 with diagnoses which included "ARF" (acute respiratory failure) per the facility Patient Registration Form. Patient 29 died at the facility on 3/17/15.

During a joint record review on 3/10/15 at 9:00 A.M., Patient 29's Resuscitation Record and Post Code Review forms, dated 3/5/15, were reviewed with the Director of Quality Risk Management/Infection Preventionist (DQRM/IP). The Resuscitation Record documented the patient assessments, emergency interventions and events of the patient's code blue initiated on 3/5/15 at 12:55 P.M. There was no evidence of airway assessment or airway management interventions from 12:55 P.M. until 1:15 P.M. At that time, the Resuscitation Record form indicated that "Intubation", (the insertion and placement of a tube in the trachea/airway to assist breathing), occurred at 1:15 P.M. The same form indicated that the intubation procedure was performed by RN 17.

During an interview on 3/10/15 at 3:50 P.M., the Cardiopulmonary Director (CPD) stated that she had attended Patient 29's code blue on 3/5/15 and that Respiratory Care Practitioner (RCP) 1 and RCP 2 had also been in attendance. The CPD recalled that MD 2 was at the code blue for a short time, but that she was not sure what role he played. The CPD stated that the RCP staff were administrating oxygen to the patient via a mask. The CPD stated that, upon request from one of the nurses, she had instructed RCP 1 to intubate (insertion of a tube into the trachea/airway to assist breathing). The CPD stated that RCP 1 attempted to intubate the patient twice, but was not successful. The CPD stated that RCP 2 was "new" to the facility and had not yet demonstrated intubation competency. The CPD stated that she had not intubated "for years". The CPD stated that RN 17 then volunteered to intubate the patient.

During an interview on 3/10/15 at 5:00 P.M., RN 17 stated that MD 2 responded to the code blue, was asked to intubate, refused and left the room. RN 17 stated that the nurses and respiratory care staff then continued the code blue procedure. RN 17 stated that RCP 1 attempted to intubate the Patient 29 twice, but was unsuccessful. RN 17 stated that he then intubated the patient himself. RN 17 stated that he was not aware of a facility policy or procedure that enabled Registered Nurses to perform endotracheal intubation nor had he demonstrated a competency since his employment at the facility. RN 17 stated that he that he thought that having a current ACLS (Advanced Cardiac Life Saving ) certification (interventions implemented in a cardiac or respiratory arrest) enabled him to perform endotracheal intubation. RN 17 stated that he was not sure if his state licensure scope of practice included endotracheal intubation.

A review of RN 17's current job description, dated 11/7/14, did not include the specific skill for endotracheal intubation.

A review of the California Department of Consumer Affairs/Board of Registered Nursing explanation of the scope of RN practice included "Scopes of Practice...A knowledged of the respective scopes of practice of registered nurses and physicians is important in determing which activities overlap medical practice and therefore require standardized procedures...Scope of Medical Practice..The Medical Practice Act authorizes physicians to...penetrate the tissues of human beings...As a general guide, the performance of these by a registered requires a standardized procedure..."

During an interview on 3/11/15 at 12:15 P.M., the Chief Clinical Officer acknowledged that the facility had not developed an approved standardized procedure which enabled facility registered nurses to perform endotracheal intubation.