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Based on record review, review of policies, review of procedures, observation, and staff interview, the Hospital failed to protect and promote each patient's rights, by failure to ensure patient rights to receive care in a safe setting (A144)which resulted in a determination of immediate jeopardy on 04/20/16. The facility took appropriate and immediate action and the immediate jeopardy was removed on 04/22/16. The hospital failed to prevent a staff to patient assault (A145). The cumulative effect of these systemic practices resulted in a risk to the health and safety of all 48 patients.

Based on physician credentialing review, policy review, bylaw review, and staff interview the hospital failed to ensure medical staff operated under bylaws approved by the Governing Board for training and competency documentation for moderate sedation and failed to evaluate physician qualifications and demonstrated competencies with re-credentialing (A340), and the medical staff failed to be accountable under the bylaws to ensure quality of care for patients receiving moderate sedation during invasive procedures (A347) . A determination of immediate jeopardy was made for failure to ensure appropriate physician credentialing on 04/22/16. The hospital took immediate and appropriate action and the immediate jeopardy was removed on 04/26/16. The cumulative effect of these systemic practices resulted in a risk to all patients who had or will have an invasive procedure under moderate sedation.

Based on nursing competency review, policy review, and staff interview the hospital failed to ensure nursing services monitored annual nursing competency and (A-0392) failed to ensure an adequate number of registered nurses were trained and qualified to monitor and recover patients who received bedside invasive procedures under moderate sedation. The cumulative effects of these systemic practices resulted in a risk to all patients who had or will have an invasive procedure under moderate sedation.

Based on medical record review, staff interview, job description review, policy and competency training review the hospital failed to ensure a medical bronchoscopy procedure was performed by personnel qualified and designated in writing to perform the procedure (A1161). The cumulative effect of this systemic practice failed to ensure the hospital met the needs of the patients.

Based on policy review, bylaw review, credential review, and staff interview the hospital failed to ensure medical staff operated under bylaws approved by the Governing Board for training and competency for procedures with moderate sedation. This has the potential to affect all patients who undergo an invasive procedure under moderate sedation. The hospital census was 48.

Findings include:

On 04/20/16 hospital policy #H-SIP 02-006, Moderate Sedation Analgesia, revised 02/2014 was reviewed. The policy documented, "The Medical Staff Bylaws require the facility Medical Executive Committee to designate a physician advisor or subcommittee to oversee medical staff performing surgeries and/or invasive procedures where moderate sedation drugs are administered. The scope of this oversight includes but is not limited to types of surgeries/ invasive procedures performed with moderate sedation, moderate sedation physician competency attestation and patient outcomes for those patients undergoing surgeries/invasive procedures where sedation is used".

The policy addressed competency determination whereas, "The facility designated physician advisor to surgery and invasive procedure oversight shall attest to the competency of all non-anesthesiologist physicians who are administering Moderate Sedation/Analgesia. The non-anesthesiologist physician moderate sedation competency testing shall occur with initial privileging and re-appointment privileging."

On 04/20/16 the hospital's Chief Clinical Officer (CCO) provided a list of 11 physicians with credentialing privileges for moderate sedation bedside procedures. The CCO also provided a list of invasive procedures with moderate sedation conducted from 01/01/16 through 04/20/16. The list included 20 EDG/Peg's and seven bronchoscopies.

On 04/20/16 the hospital Bylaws were reviewed including section 9.8, Operative and Other Invasive Procedures Subcommittee/Advisor. The Bylaws lacked documentation related to policy #H-SIP 02-006, Moderate Sedation Analgesia and physician competency for moderate sedation.

On 04/21/16 physician credentialing review revealed none of the hospital's procedure physician had re-appointment privileges or competencies for moderate sedation administration.

Based on record review, review of policies, review of procedures, observation, and staff interview, the Hospital failed to ensure the patient has the right to receive care in a safe setting. This affected one patient (Patient #1) of 42 patient's receiving continuous cardiac monitoring. The hospital census was 48.

Findings include:

Review of Patient #1's medical record revealed the patient was admitted to the hospital on 02/27/16 from an acute care hospital with Severe Sepsis without Septic Shock secondary to C. difficile colitis. Patient #1 had a past surgical history to include Cardiac Defibrillator placement. Patient #1 was receiving continuous cardiac monitoring (Telemetry) during this admission.

Review of Patient #1's Cardiology Report dated 03/11/16 revealed an Echocardiogram was ordered for clinical indications of Endocarditis. The final impression noted an ejection fraction around 40-45%, left atrial enlargement, no obvious valvular abnormalities, no obvious vegetation seen, no pericardial effusion, and would recommend a transesophageal echocardiographic evaluation if clinically indicated to better evaluate vegetation, given oversensitive with transesophageal echocardiographic evaluation.

Review of Internal Medicine Progress Note dated 03/26/16 for Patient #1 revealed vital signs were stable with a heart rate (HR) of 71.

Review of Patient #1 Telemetry rhythm "strip" dated 03/26/16 at 03:00:07 revealed a HR of 69 beats per minute (bpm).
Review of strip dated 03/26/16 at 07:00:07 revealed a HR of 67 bpm.
Review of strip dated 03/26/16 at 11:00:07 revealed a HR of 74 bpm.
Review of strip dated 03/26/16 at 15:00:07 revealed a HR of 60 bpm.
Review of strip dated 03/26/16 at 19:00:07 revealed a HR of 71 bpm.
Review of strip dated 03/26/16 at 23:00:07 revealed a HR of 66 bpm.
Review of strip dated 03/27/16 at 03:00:07 revealed a HR of 77 bpm.
Review of strip dated 03/27/16 at 06:07:24, revealed a HR of 25 bpm.
Review of strip dated 03/27/16 at 06:08:20 revealed a HR of 17 bpm.
Review of strip dated 03/27/16 at 06:09:49 revealed a HR of 00 bpm. (Asystole-no cardiac activity)

Review of Patient #1's Registered Nurse (RN), Respiratory Therapist (RT) and Patient Care Technician (PCT) progress notes/documentation from 03/27/15 at 00:01 until 03/27/16 at 06:52 revealed the progress notes lacked documentation related to cardiac issues/concerns; however, a progress note written by RT at 06:51 revealed "Patient intubated with a #8 ETT and secured at the lip".

Review of Incident Report signed by Staff #C revealed "I called the pod 06:01 the first time about the patient's HR dropping, then ... (PCT) picked up the phone and she said "ok, I'm going in." Then I called again around 06:09 the second time because nothing's change and still ..... was the one who picked the phone up and said "ok!" and hang up. I called the third time 05 to 10 mins. After my second call around 06:15-06:20, .... (RT) picked up my third call and told her about what's happening and to check the patient, then she said, "ok, I'll go get the pct." And hang up. I called again at 06:33 the fourth time, .... the RN taking care of patient and she said, "Oh, I didn't know about that nobody told me anything, but ok, I'll go check on him right now".

Review of Rapid Response Team and Code H Record dated 03/27/16 revealed at 06:34 a code was called to #2016 (Patient #1's room) with an arrival time of 06:35 and the event ended at 06:56.

Review of Code Blue Flow sheet for Patient #1 dated 03/27/16 revealed at 06:35 the heart rhythm was Asystole. The patient was intubated at 06:48. At 06:50 there was pulseless electrical activity, at 06:56 the patient was asystole and time of death was called.

Review of Physician progress note dated 03/27/16 at 06:59 revealed called to Code Blue overhead at 06:35. Monitor Tech (MT) called to say patient was off the monitor. ACLS (advanced cardiac life support) was initiated and continued for 20 minutes. Patient pronounced at 06:56.

Review of Incident Report dated 03/27/16 at 8:30 AM signed by Staff #D revealed the "MT called the POD and reported the Patient #1 in room 2016 was still on the monitor. I told her I didn't know he had been off and I would check it then. I went to the pt's room he was non responsive, no chest movement, no carotid pulse detected. I called the code right then and the team arrived and began to attempt resusitation. I asked PCT if there had been a call he was off monitor. She said yes and when she checked it he was still hooked up but the monitor wasn't working."

Review of Staff #I's Performance Improvement Form dated 03/28/16 and signed by Staff #H revealed employee had been suspended until completion of investigation of the incident on 03/27/16. Moreover, Staff #I was terminated on 04/08/16 due to validation of falsification and documentation.

Review of Event Recording Call #1 being held as a Sub-Committee of Quality Control dated 03/31/16, revealed a brief summary of event details as well as an overview of the event of 03/27/16 between 06:01 AM-06:56 AM. A time line of the event was presented until the time of death. Action taken as a result of the event was removal of the MT from current assignment until more education was provided. The MT was to work as PCT until competency was established. Further review revealed the absence of incident reports or confidential statements of the RN'S, RT, or PCT of their participation in the incident of 03/27/16.

Interview on 04/19/16 at approximately 10:05 AM with Staff #B stated the Event Recording Call is the hospital's internal investigation and stated/confirmed there were no statements requested by Staff #E, Staff #F, or Staff #I.

Interview on 04/20/16 at 11:10 AM with Staff #C, when presented with the Incident Report of 03/27/16, stated he/she was the author and there is nothing to add to or take away from his/her written statement. Staff #C stated/confirmed he/she did not follow hospital policy by making sure Patient #1's primary nurse was notified of the change in telemetry strip, instead he/she called the unit and spoke with the PCT on the first and second call and spoke to the RT on the third call; he/she did not directly speak to the RN until the fourth call to the unit. Moreover, Staff #C stated there was no return call from either the PCT or RT after telling them to check on the patient. Staff #C stated/confirmed that he/she did not place a call on the overhead system when the telemetry monitor indicated Patient #1 was asystole per the Telemetry Monitoring Policy. Further, Staff #C stated he/she was never interviewed by management during the hospital investigation of the incident.

Interview on 04/20/16 at 12:04 PM with Staff #D stated he/she was not aware of the events of the morning of 03/27/16 until approximately 06:20-06:25 when the MT called the unit and asked to check on the patient. Staff #D stated upon entering the room, the patient was un-responsive, had no pulse or chest movement, and a Code Blue was activated. When asked if he/she had on his/her person the unit portable phone during the 7P-7A shift, Staff #D stated no, "it was probably on the desk or on the charger." Staff #D further stated there was no communication related to this incident between him/her and the RT or PCT. Further, Staff #D stated he/she was never interviewed by management during the hospital investigation of the incident.

Observation on 04/20/16 during a tour of all the units in the hospital revealed eight out of nine RNs observed did not have the unit portable phone on their person or readily available.

Interview on 04/21/16 at 9:05 AM with Staff #E stated there is one portable phone for each unit for the RN to carry at all times. Staff #E stated he/she makes random checks on each unit to ensure the RN'S have the phone on their person and if not, he/she counsels them verbally of the need to keep the phone readily available at all times. Pertaining to the event on 03/27/16, Staff #E stated he/she was not aware of the incident until a Code Blue was called at approximately 06:30, at which time he/she responded to Patient #1's room and found the patient pulseless and un-responsive. Further, Staff #E stated he/she was never asked to file an incident report or was interviewed by management during the hospital investigation of the incident.

Review of Kindred Healthcare Policy #H-PC 04-006, Patient Safety/Risk Management, Effective date 08/2006, Continuous Cardiac Monitoring (Telemetry): Page 4:8- The nurse assigned to the patient responds immediately if any of the following occurs:
a. Notice of an alarm at the central monitoring station by a telemetry
b. Any observed change in the patient s cardiac rhythm
c. Loss of telemetry signal
d. Unreadable signal due to artifact
e. Intermittent signal loss
Page 7:14-The monitor technician notifies the patient's nurse if alarm sound; there is any change in patient rhythm, poor signal or loss of signal, or any change in monitoring lead.
i. If the monitoring technician is unable to notify the patient's nurse regarding non-life-threatening rhythm changes (and patient is asymptomatic) the monitor technician will immediately notify the person next in authority i.e. Unit nurse manager, nursing supervisor, etc.
ii. If the monitoring technician is unable to notify the patients nurse regarding identified life-threatening dysrhythmias, the monitor technician will immediately activate the Rapid Response Process.

This citation substantiated substantial allegation OH00083386, OH00083348, and OH00083353.

Based on medical record review, facility policy review, staff and patient interview, the facility failed to prevent the assault of a patient by an employee and failed to ensure staff followed current facility policies related to abuse of a patient and event reporting. This affected one patient (#4) of ten patients sampled. The hospital census was 48.

Findings include:

The medical record of Patient #4 was reviewed on 04/20/16 at 02:00 PM. Patient #4 was admitted to the facility on 03/30/16 at 05:35 PM. According to a physician's history and physical, he had a diagnosis of benzodiazepine abuse and suspicion of alcohol withdrawal. A staff nurse's skin assessment documented the patient had a pressure ulcer to his left buttock and another to his left heel. A fall risk assessment documented the patient was a high risk for falls as the patient was repeatedly described in nursing and physician progress notes as "weak".

An order written by a physician on 04/02/16 at 07:30 PM documented Patient #4's spouse was not permitted to visit until further notice. On the evening of 04/15/16 a nursing note documented the patient became upset when he wanted to bring some clean clothes to the hospital but staff informed him that his spouse was not permitted to come to the hospital. The nursing note documented the patient informed staff he wanted to leave the hospital AMA. A rapid response was called when the patient attempted to get out of bed and stumbled. The note further documented the patient attempted to crawl out of the room as he was too weak to walk. Staff helped the patient to dress. The patient was assisted to a wheel chair and taken out of the hospital to wait for a cab. The note documented the patient was bought back to the hospital by the Nursing Supervisor per the request of Staff A, the CEO. The patient requested to continue his care at the facility.

Staff N, Nurse, was interviewed on 04/30/16 at 10:30 AM. Staff N reported caring for Patient #4 on the evening of 04/15/16. Staff N stated the patient became verbally abusive when he was told his spouse could not come to visit. The patient requested to leave AMA. Staff N reported he assisted the patient to get dressed. When the patient stood up, he stumbled requiring the Staff Nurse and the Nursing Supervisor to assist the patient to a chair. The Nurse further explained that after requesting a wheelchair and being advised that Patient #4 would need to wait until the physician arrived, the patient stated he would crawl in order to leave. When the patient got down on his hands and knees, he was again assisted up to a chair. Staff N reported turning his/her head briefly to see if the physician had arrived when he/she heard a " loud crash". Staff N heard the Nursing Supervisor (Staff M) scream: "You're not going to pull a knife on me!". When Staff N turned to see what was going on, he/she observed the Nursing Supervisor's shoulder to be touching Patient #4's chest. The Nurse wasn't sure if it was the chair or the patient that hit the plastic glove dispenser but he/she noted the dispenser was damaged. Staff N was asked if he/she thought the Nursing Supervisor used excessive force and he/she replied, "Absolutely, I was shocked. It was like he/she had PTSD (post traumatic stress disorder)."

Patient #4 was interviewed on 04/19/16 at 02:00 PM. The patient reported being upset when staff would not let his spouse come to bring him clean clothes. The patient informed staff that he wanted to leave AMA. The patient reported reaching for his phone to call 911, as Staff M stood in front of the door blocking him from leaving, when Staff M slammed his/her shoulder into him sending him slamming into the wall. The patient stated: "I have never been so humiliated in all my life." Patient #4 reported hitting the wall so hard that it damaged the glove dispenser bolted to the wall. The glove dispenser was observed during the interview to be lopsided and hanging with one screw. The patient also reported noticing blood coming from his left hand after the incident. An abrasion the size of a dime was observed on the patient's left hand.

Staff M, the Nursing Supervisor, was interviewed on 04/20/16 at 03:35 PM. According to the Nursing Supervisor, when the patient informed the staff that he was going to call 911, the patient reached in his pocket. The Nursing Supervisor stated: "I thought it was a knife and I wasn't getting ready to let him/her pull a knife on me!". Staff M admitted that the item the patient pulled out of his pocket was a cell phone but stated that he/she wasn't sure what the item was at the time. Staff M further admitted putting his/her shoulder into the patient's chest pushing him.

The personnel record of the Nursing Supervisor, Staff M, was reviewed on 04/20/16 at 04:30 PM. The record documented the Nursing Supervisor was hired as a staff nurse on 03/27/15 and was promoted to a supervisor on 05/17/15. There were no disciplinary actions related to allegations of patient assault noted in the Staff M's personnel record. His/Her general orientation also included education on abuse/neglect/patient rights and responsibilities.

The facility's policy titled Event Reporting System was reviewed on 04/26/16 at 09:45 AM. According to the policy staff are responsible for reporting to their own leadership and to Kindred, in a timely and efficient manner, any event which is unexpected, unintended, or undesirable or which departs from the routine operations through the Event Reporting System.

The facility's policy titled Abuse of Patient, Elder, Child by Staff Identification - Response & Reporting was reviewed on 04/26/16 at 10:00 AM. According to the policy staff are instructed to notify the Chief Clinical Officer, Nursing Supervisor or clinical area Manager immediately in any instance of reported, observed, or suspected patient abuse.

Staff B and Staff R were interviewed on 04/26/16 at 10:35 AM. Staff B stated the Nursing Supervisor was terminated as of 04/26/16. When referring to the events of 04/15/16, Staff B stated: " He/She (Nursing Supervisor) crossed the line. Staff P stated the assault by the Nursing Supervisor on the patient wasn't immediately escalated to Administration as required by facility policies. The event wasn't reported until 04/19/16, four days after it occurred.

This deficiency substantiates substantial allegation OH00083818 and OH00084070.

Based on policy review, bylaw review, credential review, and staff interview the medical staff failed to evaluate qualifications and competencies for moderate sedation use during the physician re-credentialing process. This affected 11 physicians identified by the hospital with privileges for conducting invasive procedures with moderate sedation. This had the potential to affect all patients requiring procedures with moderate sedation use. The hospital census was 48.

Findings include:

On 04/20/16 hospital policy #H-SIP 02-006, Moderate Sedation Analgesia, revised 02/2014 was reviewed. The policy documented, "The Medical Staff Bylaws require the facility Medical Executive Committee to designate a physician advisor or subcommittee to oversee medical staff performing surgeries and/or invasive procedures where moderate sedation drugs are administered. The scope of this oversight includes but is not limited to types of surgeries/ invasive procedures performed with moderate sedation, moderate sedation physician competency attestation and patient outcomes for those patients undergoing surgeries/invasive procedures where sedation is used."

The policy addressed competency determination whereas, "The facility designated physician advisor to surgery and invasive procedure oversight shall attest to the competency of all non-anesthesiologist physicians who are administering Moderate Sedation/Analgesia. The non-anesthesiologist physician moderate sedation competency testing shall occur with initial privileging and re-appointment privileging."

On 04/20/16 the hospital's Chief Clinical Officer (CCO) provided a list of 11 physicians with credentialing privileges for moderate sedation bedside procedures. The CCO also provided a list of invasive procedures with moderate sedation conducted from 01/01/16 through 04/20/16. The list included 20 EDG/Peg's and seven bronchoscopies.

On 04/20/16 the hospital Bylaws were reviewed including section 9.8, Operative and Other Invasive Procedures Subcommittee/Advisor. The Bylaws lacked documentation related to policy #H-SIP 02-006, Moderate Sedation Analgesia and the re-credentialing appraisal of qualifications for physician competency of moderate sedation.

On 04/21/16 physician credentialing review revealed none of the hospital's procedure physician had re-credentialing privileges or competency qualification for moderate sedation administration.

This citation substantiated substantial allegation OH00083827, OH00083386, and OH00083348.

Based on policy review, bylaw review, credential review, and staff interview the medical staff failed to ensure accountability to the governing body for the appraisal of qualification during the physician credentialing and re-credentialing process. This included 11 physicians identified by the hospital as conducting invasive procedures with moderate sedation use. This had the potential to affect all patients requiring procedures with moderate sedation. The hospital census was 48.

Findings include:

On 04/20/16 hospital policy #H-SIP 02-006, Moderate Sedation Analgesia, revised 02/2014 was reviewed. The policy documented, "The Medical Staff Bylaws require the facility Medical Executive Committee to designate a physician advisor or subcommittee to oversee medical staff performing surgeries and/or invasive procedures where moderate sedation drugs are administered. The scope of this oversight includes but is not limited to types of surgeries/ invasive procedures performed with moderate sedation, moderate sedation physician competency attestation and patient outcomes for those patients undergoing surgeries/invasive procedures where sedation is used."

The policy addressed competency determination whereas, "The facility designated physician advisor to surgery and invasive procedure oversight shall attest to the competency of all non-anesthesiologist physicians who are administering Moderate Sedation/Analgesia. The non-anesthesiologist physician moderate sedation competency testing shall occur with initial privileging and re-appointment privileging."

On 04/20/16 the hospital's Chief Clinical Officer (CCO) provided a list of 11 physicians with credentialing privileges for moderate sedation bedside procedures. The CCO also provided a list of invasive procedures with moderate sedation conducted from 01/01/16 through 04/20/16. The list included 20 EDG/Peg's and seven bronchoscopies.

On 04/20/16 the hospital Bylaws were reviewed including section 9.8, Operative and Other Invasive Procedures Subcommittee/Advisor. The bylaws lacked documentation related to policy #H-SIP 02-006, Moderate Sedation Analgesia and/or the accountability of the medical staff for the quality of medical care provided to patients who require an invasive procedure with moderate sedation use.

On 04/21/16 physician credentialing review revealed none of the hospital's procedure physician had re-credentialing privileges or competency qualification for moderate sedation administration.

Based on policy review, nursing training and competency review, and staff interview the hospital failed to ensure an adequate number of registered nurses were trained and qualified through annual competency to care for patients who had an invasive procedure under moderate sedation. This had the potential to affect all patients who undergo an invasive procedure under moderate sedation. The hospital census was 48.

Findings include:

On 04/20/16 hospital policy #H-SIP 02-006 Moderate Sedation Analgesia, released 02/2014 was reviewed. The policy documented all patients who receive moderate sedation regardless of the location of the procedure will be monitored by a competent Registered Nurse whose primary responsibility is to monitor the patient during the procedure. The RN responsible for monitoring the patient receiving moderate sedation would complete training and competency and maintain annual competency in the skill prior to administering and/or monitoring moderate sedation.

The policy documented the registered nurse managing the care of the patient receiving moderate sedation/analgesia shall have no other significant responsibility that would leave the patient unattended or compromise the continuous monitoring.

On 04/20/16 the hospital ' s Chief Clinical Officer (CCO) provided a list of 13 registered nurses trained and competent to administer and monitor moderate sedation patients. The training records were reviewed and revealed eight nurses, including the operating room nurse manager who was tasked with the moderate sedation competency training oversight, lacked the required annual training and competency.

On 04/20/16 at 3:00 PM Staff B confirmed the lack of documented annual competency for registered nurses who monitor and recover patients under moderate sedation.

This citation substantiates substantial allegation OH00083983, OH00083827, OH00083386, and OH00083348.

Based on policy review, medical record review, and staff interview the hospital failed to ensure the medical record contained detailed information of an invasive bronchoscopy procedure. This affected one (Patient #5) of two bronchoscopy procedures reviewed. The hospital census was 48.

Findings include:

On 04/27/16 hospital policy #H-PC 04-001 PRO, Documentation Required for Invasive Procedures with and without Sedation, revised 08/2014 was reviewed. The policy documented standard procedure forms to document for all inpatient and outpatient invasive procedures with and without sedation including (1) Procedure Checklist H-PC-001-000, (2) Invasive Procedures with Moderate Sedation Form for procedures outside of a designated operating room or surgical suite H-PC-002-0000, (3) Post-Anesthesia Nursing Care Record H-PC-004-0000.

On 04/26/16 the medical record for Patient #5 was reviewed for information related to an emergency bronchoscopy performed on 03/27/16 at 2:25 AM. The paper chart provided by the hospital lacked documentation related to the invasive procedure.

The hospital's nurse manager provided a printed copy of electronic progress notes for 03/26/16 and 03/27/16. The electronic progress notes were reviewed and documented a change of shift handoff report on 03/26/16 at 7:34 PM.

A physician progress note on 03/27/16 at 2:56 AM documented a patient with "markedly diminished breath sound throughout and oxygen saturation of 58 percent." The progress note continued, "Will supervise Respiratory Therapist Doug with bronchoscopy as I cannot transfer him until stable."

A physician progress note on 03/27/16 at 3:06 AM documented the patient had a bronchoscopy done emergently and a transfer was lined up to send the patient to Kettering Medical Center.

On 04/27/16 the Chief Executive Officer (CEO) was asked to provide the required documentation forms for the invasive bronchoscopy done on Patient #5 on 03/27/16 at 2:25 AM. The CEO stated the medical record lacked the required procedure forms because staff did not completed the forms.

On 04/28/16 at 7:35 AM an interview was conducted with the Intensive Care Unit (ICU) Registered Nurse (RN) who was assigned to Patient #5 on the night of the bronchoscopy. The RN stated she was present in the room during the procedure, administered medications to the patient, and remained with the patient during the recovery and until transferred to another hospital by emergency medical services (EMS) transportation. The RN stated she completed the Procedure Checklist form, the Invasive Procedures with Moderate Sedation form, and the Post-Anesthesia Nursing Care Record form.

On 04/28/16 at 10:00 AM an interview was conducted with the physician who supervised the bronchoscopy. The physician stated she was present in the patient's room during the procedure. The physician stated she did not recall if the ICU RN was in the room during the procedure or if the required forms were completed. The physician stated she did not fill out the required procedure forms.

This citation substantiates substantial allegation OH00083827 and OH00083386.

Based on tour of the surgical suites, facility policy review, and staff interview, the facility failed to ensure staff followed current facility policy for storing endoscopes used in the performance of invasive procedures such as bronchoscopies and placement of PEG tubes. This had the potential to affect all patients who have required invasive procedures. The hospital census was 48.
Findings include:
The facility's surgical suites were toured on 04/20/16 at 09:40 AM. A supply cabinet was noted in the corner of Operating room #1. A colon scope was noted to be hanging from a hook inside the cabinet. The door was noted to be opened. Staff O, the Infection Control Preventionist, present during the tour, was asked if it was facility policy to store equipment used for surgical procedures in a opened cabinet. Staff O closed the accordion style door. He/She did not respond to the question.
The facility policy titled Endoscope Reprocessing was reviewed on 04/20/16 at 11:00 AM. According to the policy staff are instructed to store clean endoscopes in a closed cabinet with venting that allows air circulation around the flexible endoscopes.
These findings were confirmed with Staff P on 04/20/16 at 11:05 AM.
This deficiency substantiates Substantial Allegation #OH00083397.

Based on medical record review, policy review, job descriptions and staff interviews the facility failed to ensure a medical bronchoscopy procedure was performed by personnel qualified and designated in writing to perform the procedure. This affected one of two medical records reviewed for patients receiving bronchoscopy procedures. (Patient #5) A total of 10 medical records total were reviewed. The hospital census was 48.

Findings include:

Review of Hospital policy H-PC 04-001 PRO, Documentation Requirements for Invasive Procedures with and without Sedation, revised 08/2014 listed three required procedure documents. The required documents included a "procedure checklist" , an "invasive procedure with moderate sedation form for procedures outside of a designated operating room or surgical suite", and a "post-anesthesia nursing care record - phase one".

On 04/27/16 the medical record for Patient #5 was reviewed. A hospital respiratory therapist conducted a bronchoscopy on a severely compromised ventilated patient. The patient was transferred by emergency medical service (EMS) to an acute care hospital equipped for ventilator stabilization immediately following the invasive procedure. The medical record lacked documentation of the 03/27/16 invasive bronchoscopy procedure.

Interview on 04/28/16 at 9:00 AM of the hospital's Chief Clinical Officer stated there was no procedure documentation forms available for review.

On 04/28/16 at 10:00 AM a physician (Staff J) interview revealed the physician confirmed respiratory therapist performed the bronchoscopy.

Interview on 04/28/16 at 3:15 PM with the respiratory therapist (Staff K) confirmed he/she did the bronchoscopy on 03/27/16 and confirmed the lack of documented competency to do a bronchoscopy.

On 04/28/16 the personnel file for the respiratory therapist was reviewed. A job description documented "responsibility for administering safe and competent respiratory care as ordered per physician, monitoring mechanical ventilation, administering medications, patient assessment, understanding ramifications of hemodynamic monitoring, understanding blood work results, monitoring, teaching, and training". The job description lacked documentation of tasks including conducting bronchoscopies.

Review of the respiratory therapist's personnel file contained a "2015 annual competencies for respiratory therapist" form which documented competency in "Bronchoscopy Set-Up". The Bronchoscopy Set-Up competency assessment documented bronchoscopy preparation and bronchoscopy assistance. There was no competency assessment for conducting a bronchoscopy.