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Based on observation, interview, and record review, the facility's Governing Body (GB) failed to ensure the hospital's operation was conducted in an effective, safe, and organized manner by failing:

1. To ensure the medical staff was accountable to the GB for the quality of patient care provided at the facility (Refer to A338, A340, A347, A353, and A363); and

2. To ensure the radiological services were provided in a safe and effective manner that would meet the patients' needs. (Refer to A338, A340, A347, A353, A363, and A538).

The cumulative effect of these systemic problems resulted in failure of the Governing Body to ensure patients were receiving quality care in a safe and effective manner.

Based on interview and record review, the facility failed to ensure an unusual occurrence was reported as defined in their policy, for one sampled patient (Patient 1). Patient 1 sustained a traumatic liver injury due to a biliary drain placement, developed complications requiring an unplanned admission to the Intensive Care Unit (ICU), and expired three days later. As a result the facility was unable to analyze the cause and implement preventive actions following the incident.

Findings:

On May 5, 2014, a visit to the facility was made to investigate a complaint regarding a patient death (Patient 1) related to complications of an Interventional Radiology (IR) procedure. During the initial investigation it was determined that the Director of Quality and Risk Management (DQRM) was not aware of the incident.

The record for Patient 1 was reviewed. Patient 1 was admitted to the facility on November 24, 2013, with complaints of chest and abdominal pain. Patient 1 was diagnosed with acute Cholecystitis (inflammation of the gall bladder) and a procedure was ordered for a percutaneous cholecystostomy (the insertion of a catheter into the gallbladder under radiologic guidance for drainage or the removal of gallstones), and drain placement.

The procedure was completed on November 29, 2013, in the IR special procedures area. Physician 1 completed the procedure, with no immediate complications noted. The procedure was completed at 9:10 a.m., and the patient returned to his bed on the Medical/Surgical Unit at 9:15 a.m.

According to the Nurses Notes, at 9:20 a.m., Patient 1 was complaining of pain to the right side, 5/10 (moderate pain) on a scale of 1-10 (10 = severe pain).

At 10:10 a.m., Patient 1 complained of increased pain to the right side, now 8/10, and had a blood pressure of 186/89. The Physician Assistant (PA 1), was at the bedside and ordered to medicate the patient with Dilaudid 1.5 milligrams (mg) for pain.

A "Rapid Response Team Record," dated November 29, 2013, was reviewed. The report indicated a rapid response was called for Patient 1, at 11:02 a.m. for the following event. "Pt (patient) is s/p (status post) biliary drain placement with onset severe 10/10 upper abd (abdomen) / epigastric chest pain..." Patient 1 was treated in his room with medications, intravenous (IV) fluids, and oxygen. An EKG showed normal rhythm.

At 2:20 p.m., Patient 1's blood pressure dropped to 83/50, while he continued to complain of pain and was diaphoretic (sweaty). Patient 1 was transferred to the ICU.

The "Cardiopulmonary Resuscitation Record," for Patient 1, dated November 29, 2013, was reviewed. The record indicated patient 1 was intubated at 8 p.m.

A physician progress note (Physician 2), for Patient 1, dated December 2, 2013, was reviewed. The progress note indicated, "This is an 80 year-old male who was admitted for acute cholecystitis due to gallstones. The patient had a biliary drain placed to decompress the gallbladder and the patient sustained traumatic liver injury during the procedure. The patient went into hemorrhagic shock, requiring intubation and placed on a ventilator..."

The Death Summary, for Patient 1, dated December 26, 2013 was reviewed. The summary indicated, "This is an 80 year old male with a history of hypertension, CAD (coronary artery disease), CHF (congestive heart failure), abdominal hernia and ileostomy, came in with acute cholecystitis... and the patient was also found to be in acute renal failure..." Hospital course included, "The patient was admitted to medical floor and the patient was started on IV fluids and provided supportive care... The patient continued to have abdominal pain... The patient did not want to have cholecystectomy (removal of the gallbladder) and the surgeon (Physician 3) agreed with the plan of monitoring... (Physician 3) recommended a biliary drain placement. The patient was evaluated by intervention radiology and a biliary drain was placed, but during the process of biliary drain placement, the patient sustained liver injury and that caused the patient to go into hypovolemic shock due to hemorrhage. The patient was moved to ICU... CT abdomen showed a large hematoma in the abdomen... the patient was intubated... On December 2nd, daughter made a decision to take the patient off the life support as the prognosis was poor... The patient expired on December 2nd..."

On December 13, 2013, at 3:25 p.m. the DQRM was interviewed. The DQRM stated the incident/occurrence should have been reported through the facility occurrence reporting system as soon as the injury became apparent. The DQRM stated all staff had access to the system, and any one or all of the staff involved could have and should have reported the occurrence, so that an investigation and peer review could have been done timely.

The policy and procedure titled, "Occurrence Notification Process," dated December 2010, was reviewed. The policy indicated, "Purpose: to provide guidelines to improve patient care, ensure safe healthcare facility practices through concurrent identification of serious injuries, and conducting timely peer review, evaluation of patient care, and intervention to reduce occurrences..." The policy further indicated complications of procedures performed in the radiology department resulting in unexpected or unplanned admission to ICU should be reported through the facility reporting system.

Based on interview and record review, the facility failed to ensure performance improvement activities were conducted for the Interventional Radiology (IR) service where invasive procedures were performed by interdisciplinary team members on a daily basis. This failed practice resulted in the inability to identify opportunities to improve patient outcomes, and the potential for preventable complications or death.

Findings:

On May 5, 2014, a visit was made to the facility to investigate a complaint regarding a patient death (Patient 1) related to complications of an IR procedure. During the initial investigation it was determined that the Director of Quality and Risk Management (DQRM) was not aware of the incident.

The record for Patient 1 was reviewed. Patient 1 was admitted to the facility on November 24, 2013, with complaints of chest and abdominal pain. Patient 1 was diagnosed with acute cholecystitis (inflammation of the gallbladder) and a procedure was ordered for a cholecystostomy (creating an opening in the gall bladder) and drain placement.

The procedure was completed on November 29, 2013, in the IR special procedures area. Physician 1 completed the procedure, with no immediate complications noted. The procedure was completed at 9:10 a.m., and the patient returned to his bed on the Medical/Surgical Unit at 9:15 a.m.

According to the Nurses Notes, at 9:20 a.m., Patient 1 complained of pain to the right quadrant that measure 5/10 (moderate pain on a scale of 1-10).

At 10:10 a.m., Patient 1 complained of increased pain to the right side, now 8/10, and had a blood pressure of 186/89. The Physician Assistant (PA 1), was at the bedside and ordered to medicate the patient for pain with Dilaudid 1.5 milligrams (mg).

A "Rapid Response Team Record," dated November 29, 2013, was reviewed. The report indicated a rapid response was called for Patient 1, at 11:02 a.m. for the following event. "Pt (patient) is s/p (status post) biliary drain placement with onset severe 10/10 upper abd (abdomen) / epigastric chest pain..." Patient 1 was treated in his room with medications, intravenous (IV) fluids, and oxygen. An EKG showed normal rhythm.

At 2:20 p.m., Patient 1's blood pressure dropped to 83/50, while he continued to complain of pain and was diaphoretic (sweating profusely). Patient 1 was transferred to the ICU.

The "Cardiopulmonary Resuscitation Record," for Patient 1, dated November 29, 2013, was reviewed. The record indicated patient 1 was intubated at 8 p.m.

A physician progress note (Physician 2), for Patient 1, dated December 2, 2013, was reviewed. The progress note indicated, "This is an 80 year-old male who was admitted for acute cholecystitis due to gallstones. The patient had a biliary drain placed to decompress the gallbladder and the patient sustained traumatic liver injury during the procedure. The patient went into hemorrhagic shock, requiring intubation and placed on a ventilator..."

The Death Summary, for Patient 1, dated December 26, 2013 was reviewed. The summary indicated, "This is an 80 year old male with a history of hypertension, CAD (coronary artery disease), CHF (congestive heart failure), abdominal hernia and ileostomy, came in with acute cholecystitis... and the patient was also found to be in acute renal failure..." Hospital course included, "The patient was admitted to medical floor and the patient was started on IV fluids and provided supportive care... The patient continued to have abdominal pain... The patient did not want to have cholecystectomy and the surgeon (Physician 3) agreed with the plan of monitoring... (Physician 3) recommended a biliary drain placement. The patient was evaluated by intervention radiology and a biliary drain was placed, but during the process of biliary drain placement, the patient sustained liver injury and that caused the patient to go into hypovolemic shock due to hemorrhage. The patient was moved to ICU... CT abdomen showed a large hematoma in the abdomen... the patient was intubated... On December 2nd, daughter made a decision to take the patient off the life support as the prognosis was poor... The patient expired on December 2nd..."

A review of the Cath Lab Log indicated IR procedures were performed on a daily basis during the week, and occasionally on weekends.

A review of the facility 2014 Quality Improvement Plan was conducted on October 15, 2014. The plan did not include indicators for the IR service.

During an interview with the DQRM on October 15, 2014, at 10 a.m., the DQRM stated there were no quality indicators specific to the IR service, and the complication from the IR procedure performed on Patient 1 was not identified through the quality process.

Based on interview and record review, the facility failed to ensure that the medical staff operated under the facility medical staff bylaws as approved by the governing body. This was evidenced by:

For physician 1, there was no documented evidence of current competence for a privilege granted at the time of his reappointment (See A-340);

An adverse patient event was not reviewed by the Medical Staff Peer Review Committee in a timely manner (See A- 347);

Medical Staff Bylaws were not enforced when Physician privileges were not based on current demonstrated competence, and physicians performed procedures they were not privileged to perform. (See A-353); and

An invasive procedure was performed by Physician 6 without documented evidence that he had been granted that privilege by the Governing Body (See A-363).

The cumulative effect of these systemic problems resulted in failure of the Medical Staff to ensure patients were receiving quality care in a safe and effective manner.

Based on interview and record review, the facility failed to ensure there was documented evidence of current competence for a privilege granted at time of reappointment to a member of the radiology staff (Physician 1). This practice increased the risk of a poor health outcome.

Findings:

During a review of the credential file for Physician 1, the facility "Imaging Department Request for Clinical Privileges" form, dated October 9, 2012, indicated "Percutaneous Cholecystotomy" (an invasive procedure performed under imaging guidance to place a tube through the skin into the gallbladder), the box across from this privilege was checked "Approved." However, Physician 1's credential file did not contain documented evidence of demonstrated experience/competence in this procedure during the last reappointment period.

During a review of a list of Percutaneous Aspiration of Gallbladder procedures (percutaneous cholecystotomy), performed at the facility between 2004 and 2014, the list indicated there were 10 procedures performed in the last ten years. The list indicated that Physician 1 performed this procedure in 2007. At the time of reappointment (2012/2013), Physician 1 was granted the privilege, even though he had not performed the procedure for five years. Since his reappointment, Physician 1 had performed the procedure two more times.

During a concurrent interview with the Director of Medical Staff Services, on October 15, 2014, at 2:50 p.m., she acknowledged that Physician 1 did not have documented evidence of current experience/competence in that procedure.

The facility "Imaging Department Rules and Regulations," revised 2/2010, indicated "Clinical Privileges. The department Chair recommends delineated clinical privileges for each individual seeking privileges in the Imaging Department and privileges are granted in accordance with the Medical Staff Bylaws. Delineated privileges shall be based on the individual's documented training and/or experience, demonstrated abilities, current competence, judgment and character, and current licensure. Additional privileges may be recommended when the member can show that additional training and/or experience so warrants."

The facility "Medical Staff Bylaws 2012," approved by the Board of Governors on July 26, 2012, indicated "Requests for clinical privileges shall be evaluated on the basis of the member's education, training, experience, current demonstrated professional competence and judgment, clinical performance, current health status, and the documented results of patient care ... "

Based on interview and record review, the facility failed to ensure that an adverse patient event, involving Patient 1, was reviewed by the Medical Staff Peer Review Committee in a timely manner. This practice increased the risk of a similar adverse patient event occurring in the future.

Findings:

On May 5, 2014, a visit to the facility was made to investigate a complaint regarding a patient death (Patient 1) related to complications of an Interventional Radiology (IR) procedure. During the initial investigation it was determined that the Director of Quality and Risk Management (DQRM) was not aware of the incident.

The record for Patient 1 was reviewed. Patient 1 was admitted to the facility on November 24, 2013, with complaints of chest and abdominal pain. Patient 1 was diagnosed with acute cholecystitis (inflammation of the gall bladder) and a procedure was ordered for a percutaneous cholecystostomy (the insertion of a catheter into the gallbladder under radiologic guidance for drainage or the removal of gallstones), and drain placement.

The procedure was completed on November 29, 2013, in the IR special procedures area. Physician 1 completed the procedure, with no immediate complications noted. The procedure was completed at 9:10 a.m., and the patient returned to his bed on the Medical/Surgical Unit at 9:15 a.m.

According to the Nurses Notes, at 9:20 a.m., Patient 1 was complaining of pain to the right side of 5/10 (moderate pain) on a scale of 1-10 (10 = severe pain).

At 10:10 a.m., Patient 1 complained of increased pain to the right side, now 8/10, and had a blood pressure of 186/89. The Physician Assistant (PA 1), was at the bedside and ordered to medicate the patient with Dilaudid 1.5 milligrams (mg) for pain.

A "Rapid Response Team Record," dated November 29, 2013, was reviewed. The report indicated a rapid response was called for Patient 1, at 11:02 a.m., for the following event. "Pt (patient) is s/p (status post) biliary drain placement with onset severe 10/10 upper abd (abdomen) / epigastric chest pain..." Patient 1 was treated in his room with medications, intravenous (IV) fluids, and oxygen. An EKG showed normal rhythm.

At 2:20 p.m., Patient 1's blood pressure dropped to 83/50, while he continued to complain of pain and was diaphoretic (sweaty). Patient 1 was transferred to the ICU.

The "Cardiopulmonary Resuscitation Record," for Patient 1, dated November 29, 2013, was reviewed. The record indicated patient 1 was intubated at 8 p.m.

A physician progress note (Physician 2), for Patient 1, dated December 2, 2013, was reviewed. The progress note indicated, "This is an 80 year-old male who was admitted for acute cholecystitis due to gallstones. The patient had a biliary drain placed to decompress the gallbladder and the patient sustained traumatic liver injury during the procedure. The patient went into hemorrhagic shock, requiring intubation and placed on a ventilator..."

The Death Summary, for Patient 1, dated December 26, 2013 was reviewed. The summary indicated, "This is an 80 year old male with a history of hypertension, CAD (coronary artery disease), CHF (congestive heart failure), abdominal hernia and ileostomy, came in with acute cholecystitis... and the patient was also found to be in acute renal failure..." Hospital course included, "The patient was admitted to medical floor and the patient was started on IV fluids and provided supportive care... The patient continued to have abdominal pain... The patient did not want to have cholecystectomy (removal of the gallbladder) and the surgeon (Physician 3) agreed with the plan of monitoring... (Physician 3) recommended a biliary drain placement. The patient was evaluated by intervention radiology and a biliary drain was placed, but during the process of biliary drain placement, the patient sustained liver injury and that caused the patient to go into hypovolemic shock due to hemorrhage. The patient was moved to ICU... CT abdomen showed a large hematoma in the abdomen... the patient was intubated... On December 2nd, daughter made a decision to take the patient off the life support as the prognosis was poor... The patient expired on December 2nd..."

On December 13, 2013, at 3:25 p.m., the DQRM was interviewed. The DQRM stated the incident/occurrence should have been reported through the facility occurrence reporting system as soon as the injury became apparent. The DQRM stated all staff had access to the system, and any one or all of the staff involved could have and should have reported the occurrence, so that an investigation and peer review could have been done timely.

During an interview with the Chair of Radiology (Physician 5), on October 13, 2014, at 2:30 p.m., he was asked if a physician should have to report an adverse event. He stated that the physician could report the event if he/she chose to. Physician 5 stated there was an "HPR form which was filled out like an incident report."

During an interview on October 13, 2014, at 3:05 p.m., the Radiology Department Manager was asked what quality data from Interventional Radiology (IR) was sent to the Quality Assurance Committee. She stated Interventional Radiology was not currently reporting to the Quality Assurance Committee. When the Radiology Department Manager was asked who should report an adverse patient event, she stated the person who discovered the adverse event or the treating physician should report the adverse event.

During an interview with Physician 1, on October 14, 2014, at 9:20 a.m., Physician 1 was asked what adverse patient event information did the Radiology Department send to the Quality Assurance Committee? He stated that specific adverse patient events "trigger" a report sent to the Peer Review and Quality Assurance Committees. Physician 1 gave the example "if a patient was sent to a higher level of care." MD 1 was asked if he could report an adverse patient event if he wanted to, he stated he could through the "HP" system. He added that "Anyone can do that. I don't."

The policy and procedure titled, "Occurrence Notification Process," dated December 2010, was reviewed. The policy indicated, "Purpose: to provide guidelines to improve patient care, ensure safe healthcare facility practices through concurrent identification of serious injuries, and conducting timely peer review, evaluation of patient care, and intervention to reduce occurrences..." The policy further indicated complications of procedures performed in the radiology department resulting in unexpected or unplanned admission to ICU should be reported through the facility reporting system.

During an interview with the DQRM on October 15, 2014, at 8 a.m., she stated the occurrence involving Patient 1, on November 29, 2013, was reviewed during the June 23, 2014 Medical Staff Quality Review Committee (MSQRC) meeting. She acknowledged that this was not a timely review of the adverse patient event.

The facility "Imaging Department Rules and Regulations," revised 2/2010, indicated "The department Chair shall have the following authority and responsibilities ... Generally monitor the quality and appropriateness of patient care and professional performance provided by members with clinical privileges in the department through a planned and systematic process and oversee the effective conduct of patient care, evaluation and monitoring functions delegated to the department by the Medical Executive Committee ...Provide for continuous assessment and improvement of the quality of care and services provided."

Based on interview and record review, the facility failed to ensure that the medical staff enforced the bylaws adopted by the facility as evidenced by:

1. Physician privileges were not based on current demonstrated competence (Physician 1).

2. A physician performed procedures they were not privileged to perform (Physician 6).

This practice had the potential to increase the risks of poor health outcomes for facility patients.

Findings:

1.During a review of the credential file for Physician 1, the facility "Imaging Department Request for Clinical Privileges" form, dated October 9, 2012, indicated "Percutaneous Cholecystotomy" (an invasive procedure performed under imaging guidance to place a tube through the skin into the gallbladder), the box across from this privilege was checked "Approved." However, Physician 1's credential file did not contain documented evidence of demonstrated experience/ competence in this procedure during the last reappointment period.

During an interview with the Director of Medical Staff Services, on October 15, 2014, at 2:50 p.m., she acknowledged that Physician 1 did not have documented evidence of current experience/competence in that procedure.

2. The clinical record for Patient 14 was reviewed on October 15, 2014, at 2:50 p.m. The "Final Report," dated June 26, 2014, at 5:41 p.m., indicated that the procedure was performed by Physician 6 on June 26, 2014.

During a concurrent interview with the Director of Medical Staff Services, she confirmed that the report indicated Physician 6 had performed the procedure.

During a review of the credential file for Physician 6, the facility "Imaging Department Request for Clinical Privileges" form, dated June 14, 2013, indicated under "Percutaneous Cholecystotomy" the approval check box was left blank. This indicated that Physician 6 was not granted the privilege to perform a percutaneous cholecystotomy by the facility Governing Body. Furthermore, there was no evidence that Physician 6 had requested the privilege at the time of his initial appointment on September 26, 2013.

During a concurrent interview with the Director of Medical Staff Services, on October 15, 2014, at 2:50 p.m., she acknowledged that Physician 6 did not have the privilege to perform that procedure. She stated "he shouldn't be doing that."

The facility "Imaging Department Rules and Regulations," revised 2/2010, indicated "Clinical Privileges. The department Chair recommends delineated clinical privileges for each individual seeking privileges in the Imaging Department and privileges are granted in accordance with the Medical Staff Bylaws. Delineated privileges shall be based on the individual's documented training and/or experience, demonstrated abilities, current competence, judgment and character, and current licensure. Additional privileges may be recommended when the member can show that additional training and/or experience so warrants."

The facility "Medical Staff Bylaws 2012," approved by the Board of Governors on July 26, 2012, indicated "Requests for clinical privileges shall be evaluated on the basis of the member's education, training, experience, current demonstrated professional competence and judgment, clinical performance, current health status, and the documented results of patient care ..."

Based on interview and record review, there was no documented evidence one physician (Physician 6) had been granted the privilege to perform a "percutaneous cholecystotomy " (an invasive procedure under imaging guidance to place a tube through the skin into the gallbladder), at the time he performed the procedure in June of 2014. This failure had the potential to increase the risk of substandard quality of care for hospital patients.

Findings:

During a review of a list of Percutaneous Aspiration of Gallbladder procedures (percutaneous cholecystotomy), performed at the facility between 2004 and 2014, the list indicated that there were 10 procedures performed in the last ten years. The list indicated that all of the procedures were performed by either Physician 1 or Physician 7. A random selection of clinical records from the list were pulled for further review.

The clinical record for Patient 14 was reviewed on October 15, 2014, at 2:50 p.m. The "Final Report," dated June 26, 2014, at 5:41 p.m., indicated that the procedure was performed by Physician 6 on June 26, 2014.

During a concurrent interview with the Director of Medical Staff Services, she confirmed that the report indicated that Physician 6 had performed the procedure.

During a review of the credential file for Physician 6, the facility "Imaging Department Request for Clinical Privileges" form, dated June 14, 2013, indicated under "Percutaneous Cholecystotomy" the approval check box was left blank. This indicated that Physician 6 was not granted the privilege to perform a percutaneous cholecystotomy by the facility Governing Body. There was no evidence that Physician 6 had requested the privilege at the time of his initial appointment on September 26, 2013.

During a concurrent interview with the Director of Medical Staff Services, on October 15, 2014, at 2:50 p.m., she acknowledged that Physician 6 did not have the privilege to perform that procedure. She stated "he shouldn't be doing that."

During a telephone interview with Physician 6, on October 15, 2014, at 3:15 p.m., he was asked if he performed the percutaneous cholecystotomy, for Patient 14, as the record indicated. He acknowledged that he had performed the "Percutaneous Cholecystotomy", for Patient 14, on June 26, 2014. When questioned if he had been granted the privilege to perform that procedure, he answered " for us, it's the same as any other image guided drain placement, such as a percutaneous nephrostomy (placing a tube through the skin into the kidney under imaging guidance)." He further stated that he would not perform this procedure routinely, but would perform the procedure as a "life- saving procedure." He stated that he had been on call for Interventional Radiology (IR), on June 26, 2014, and was asked to perform the procedure on a sick patient who was not a candidate for surgery, and needed the drain placed.

The facility "Imaging Department Rules and Regulations," revised 2/2010, indicated "Clinical Privileges. The department Chair recommends delineated clinical privileges for each individual seeking privileges in the Imaging Department and privileges are granted in accordance with the Medical Staff Bylaws. Delineated privileges shall be based on the individual's documented training and/or experience, demonstrated abilities, current competence, judgment and character, and current licensure. Additional privileges may be recommended when the member can show that additional training and/or experience so warrants."

The facility "Medical Staff Bylaws 2012," approved by the Board of Governors on July 26, 2012, indicated,
"Requests for clinical privileges shall be evaluated on the basis of the member's education, training, experience, current demonstrated professional competence and judgment, clinical performance, current health status, and the documented results of patient care..."

Based on observation, interview, and record review, the facility failed, for patients undergoing procedures in the Interventional Radiology (IR) department:

1. To ensure post procedure Aldrete scores were assessed to determine recovery from sedation for five sampled patients (Patients 1, 14, 23, 30, and 31);

2. To ensure Aldrete scores were assessed prior to administration of sedation for two sampled patient (Patient 30 and 31);

3. To ensure vital signs were monitored for 30 minutes following procedural sedation for two sampled patients (Patients 23 and 31);

4. To ensure vital signs were taken upon arrival to the floor and 15 minutes later, by the receiving unit nurse, for four sampled patients (Patients 1, 14, 23, and 30);

5. To ensure post procedure site assessments were completed according to facility policy and physician orders for three sampled patients (Patients 14, 23, and 31); and

6. To ensure a pain assessment was completed post procedure, on arrival back to the unit, according to the facility policy for two sampled patient (Patients 30 and 31).

Failure to assess and monitor patients before and after receiving procedural sedation and undergoing invasive procedures in the IR Department, had the potential to place these patients at risk for injury due to procedural complications, including bleeding, respiratory insufficiency (lack of)/arrest, and death.

Findings:

The policy and procedure titled, "Procedural Sedation," dated March 2012, was reviewed. The policy indicated, "Procedural sedation involves the use of sedatives and analgesic agents to reduce anxiety and pain suffered by patients during procedures... the purpose of this policy is to provide guidelines for the management of intravenous procedural sedation administered to patients undergoing short term, therapeutic, diagnostic or surgical procedures..."

1a. A signed informed consent, dated November 29, 2013, for Patient 1 was reviewed. The consent was for a procedure, "Percutaneous cholecystostomy with ultrasound or computerized tomography guidance with possible moderate sedation."

The "Monitoring Record of Procedural Sedation," for Patient 1, dated November 29, 2013, was reviewed. The record indicated Patient 1 arrived to the procedure room at 8:30 a.m. The pre-sedation modified Aldrete score was assessed as a 10. Sedation was administered at 8:47 a.m., the procedure ended at 9:10 a.m., and Patient 1 left the procedure room at 9:15 a.m., to return to his inpatient room on a medical/surgical unit. There was no documentation of a modified Aldrete score assessed for patient 1 prior to being transferred back to his inpatient room.

On October 15, 2014, at 10:55 a.m., Registered Nurse (RN) 1 was interviewed. RN 1 stated she was the special procedures nurse for Patient 1 on November 29, 2013. She stated the post procedure Aldrete score should be done on all patients that received moderate sedation upon discharge from the special procedures room, and prior to returning to their in-patient room. This would ensure the patient returned to their pre-procedure score. RN 1 was unable to find documentation of a post procedure Aldrete score for Patient 1.

1b. The record for Patient 14 was reviewed on October 15, 2014. Patient 14, an 83 year old female, was admitted to the facility on June 21, 2014, with obstructive jaundice (yellowish pigmentation of the skin due to obstruction of the bile ducts).

The record indicated the patient went to the interventional radiology procedure room on June 26, 2014, where she underwent placement of a cholecystostomy (an invasive procedure performed under imaging guidance to place a tube through the skin into the gallbladder) tube under moderate sedation.

A review of the "Monitoring Record of Procedural Sedation," dated June 26, 2014, indicated Patient 14 received Versed (used for sedation during procedures that do not require general anesthesia, but do require the patient to remain calm and relaxed) 1 milligram (mg) and Fentanyl (a opioid [analgesic] medication often used for patients undergoing procedural sedation) 50 micrograms, with the last dose given at 4:45 p.m. According to documentation on the form, the patient was transferred back to the medical/surgical unit at 5:20 p.m. There was no evidence the radiology nurse assessed the post procedure Aldrete score to determine whether the patient was recovered from the sedation prior to taking him back to his room.

1c. The record for Patient 23 was reviewed on October 15, 2014. Patient 23, a 67 year old male, was admitted to the facility on August 19, 2014, with kidney and bladder stones.

(i) The record indicated the patient went to the interventional radiology procedure room on August 20, 2014, where he underwent placement of a ureteral stent (a tube to help drain urine from the kidney into the bladder) under moderate sedation.

According to the "Monitoring Record of Procedural Sedation" form, the procedure started at 9: 30 a.m., the radiology nurse administered Versed 0.5 mg and Fentanyl 25 mcg IV (intravenous) at 9:32 a.m., the procedure ended at 9:40 a.m., and Patient 23 was taken out of the procedure room and back to his hospital room at 9:45 a.m. (13 minutes after the sedation was given and five minutes after the procedure ended). There was no evidence the radiology nurse assessed the post procedure Aldrete score to determine whether the patient was recovered from the sedation prior to taking him back to his room.

(ii) The record indicated the patient returned to the interventional radiology procedure room on August 21, 2014, where he underwent placement of a nephrostomy tube(a tube placed through the skin and into the kidney to drain urine) under moderate sedation.

According to the "Monitoring Record of Procedural Sedation" form, the procedure started at 3:15 p.m., the radiology nurse administered Versed 1 mg and Fentanyl 50 mcg IV (intravenous - twice as much as the previous day) at 3:20 p.m., the procedure ended at 3:35 p.m., and Patient 23 was taken out of the procedure room and back to his hospital room at 3:45 p.m. (25 minutes after the sedation was given and 10 minutes after the procedure ended). There was no evidence the radiology nurse assessed the post procedure Aldrete score to determine whether the patient was recovered from the sedation prior to taking him back to his room.

1d. A record review was conducted on Patient 30 on October 15, 2014. The record indicated Patient 30 had two interventional radiology procedures performed during his hospital stay. On May 19, 2014, Patient 30 had a "CT (computerize axial tomography-type of high density x-ray) guided abdominal drain" placed. On May 27, 2014, Patient 30 had an "Abdominal drain placed." A review was conducted of the forms titled, "Monitoring Record of Procedural Sedation."

(i) On May 19, 2014, Patient 30 had the following intravenous (by vein) sedation medications:

Versed 0.5 milligrams (mg)- 9 p.m. (sedation medication)
Fentanyl 25 micrograms (mcg)-9 p.m. (opiod pain medication)
Versed 0.5 mg-9:07 p.m.
Fentanyl 25 mcg-9:07 p.m.

The record did not indicate the radiology nurse assessed the post procedure Aldrete score to determine whether Patient 30 was recovered from sedation prior to being transferred to the unit.

(ii) On May 27, 2014, Patient 30 had the following intravenous sedation medications during a procedure:

Versed 1 mg-12:50 p.m.
Fentanyl 25 mcg-12:50 p.m.
Fentanyl 25 mcg-13:05 p.m.

The record did not indicate the radiology nurse assessed the post procedure Aldrete score to determine whether Patient 30 had recovered from sedation prior to transfer to the unit.

1e. A record review was conducted on October 15, 2014, on Patient 31. The record indicated Patient 31 had "CT guided renal pelvis drain, abscess drain," on May 8, 2014. A review was conducted of the form "Monitoring Record of Procedural Sedation."

Patient 31 had the following sedation medications:

Versed 0.5 mg-10:30 a.m.
Fentanyl 25 mcg-10:39 a.m.
Versed 0.5 mg-10:46 a.m.
Fentanyl 25 mcg 10:49 a.m.

The record did not indicate the radiology nurse assessed the post procedure Aldrete score to determine whether Patient 31 was recovered from receiving sedation prior to transfer to the unit.

An interview was conducted with the Intensive Care Unit/Post Anesthesthia Care Unit Manager (IPNM) on October 15, 2014, at 11:30 a.m. The IPNM stated," A post procedure Aldrete score should have been completed on both patients (Patients 30 and 31)."

The policy and procedure titled, dated March 2012, "Procedural Sedation," was reviewed. The policy indicated, "Post-procedure/ Recovery phase... The RN is to identify and document post procedure modified Aldrete Score every 15 minutes minutes and obtain and record the patient's vital signs every fifteen (15) minutes for a minimum of thirty (30) minutes following the last dose of IV medication... Recovery Area Criteria for Inpatients... Modified Aldrete score of 8 or greater than, or equal to patient's modified Aldrete score prior to administration of moderate sedation..."

2a. A record review was conducted on Patient 30 on October 15, 2014. The record indicated Patient 30 had two interventional radiology procedures performed during his hospital stay. On May 19, 2014, Patient 30 had a "CT (computerize axial topography-type of high density x-ray) guided abdominal drain. On May 27, 2014, Patient 30 had an "Abdominal drain placed." A review was conducted of the forms titled, "Monitoring Record of Procedural Sedation."

(i) On May 19, 2014, Patient 30 had the following intravenous (by vein) sedation medications:

Versed 0.5 milligrams (mg)- 9 p.m. (sedation medication)
Fentanyl 25 micrograms (mcg)-9 p.m. (opioid pain medication)
Versed 0.5 mg-9:07 p.m.
Fentanyl 25 mcg-9:07 p.m.

Patient 30 did not have a pre-sedation Aldrete score in the record.

(ii) On May 27, 2014, Patient 30 had the following intravenous sedation medications during a procedure:

Versed 1 mg-12:50 p.m.
Fentanyl 25 mcg-12:50 p.m.
Fentanyl 25 mcg-13:05 p.m.

Patient 30 did not have a pre-sedation Aldrete score in the record.

2b. A record review was conducted on Patient 31's "Monitoring Record of Procedural Sedation." Patient 31 had the following medications administered during her procedure:

Versed 0.5 mg-10:30 a.m.
Fentanyl 25 mcg-10:39 a.m.
Versed 0.5 mg-10:46 a.m.
Fentanyl 25 mcg 10:49 a.m.

Patient 31 had an entry under the "Pre-sedation Modified Aldrete Score as "08:30 (time as 8:30 a.m.)."

An interview was conducted with the Intensive Care Unit/Post Anesthesthia Care Unit Manager (IPNM) on October 15, 2014, at 11:30 a.m. The IPNM acknowledged Patient 30 should have had a pre-procedure Aldrete score for both procedures. The IPNM stated concerning Patient 31, "The nurse in-put the time instead of the actual score."

The policy and procedure titled, "Procedural Sedation," dated March 2012, was reviewed. The policy indicated, "Assess each patient prior to the administration of moderate sedation identifying a modified Aldrete Score... The Registered Nurse is responsible for the documentation of the assessment immediately before moderate sedation is administered, during the procedure, and through to discharge."

3a. The record for Patient 23 was reviewed on October 15, 2014. Patient 23, a 67 year old male, was admitted to the facility on August 19, 2014, with kidney and bladder stones.

(i). The record indicated the patient went to the interventional radiology procedure room on August 20, 2014, where he underwent placement of a ureteral stent (a tube to help drain urine from the kidney into the bladder) under moderate sedation.

According to the "Monitoring Record of Procedural Sedation" form, the procedure started at 9:30 a.m., the radiology nurse administered Versed 0.5 mg and Fentanyl 25 mcg IV (intravenous) at 9:32 a.m., the procedure ended at 9:40 a.m., and Patient 23 was taken out of the procedure room and back to his hospital room at 9:45 a.m. (13 minutes after the sedation was given and five minutes after the procedure ended). The radiology nurse did not monitor the patient for 30 minutes following procedural sedation before taking him to the medical surgical floor.

(ii). The record indicated the patient returned to the interventional radiology procedure room on August 21, 2014, where he underwent placement of a nephrostomy tube(a tube placed through the skin and into the kidney to drain urine) under moderate sedation.

According to the "Monitoring Record of Procedural Sedation" form, the procedure started at 3:15 p.m., the radiology nurse administered Versed 1 mg and Fentanyl 50 mcg IV (intravenous - twice as much as the previous day) at 3:20 p.m., the procedure ended at 3:35 p.m., and Patient 23 was taken out of the procedure room and back to his hospital room at 3:45 p.m. (25 minutes after the sedation was given and 10 minutes after the procedure ended). The radiology nurse did not monitor the patient for 30 minutes following procedural sedation before taking him to the medical surgical floor.

3b. Record review conducted on Patient 31 indicated she had "CT guided renal pelvis drain, abscess drain," on May 8, 2014.

Patient 31 had the following sedation medications:

Versed 0.5 mg-10:30 a.m.
Fentanyl 25 mcg-10:39 a.m.
Versed 0.5 mg-10:46 a.m.
Fentanyl 25 mcg 10:49 a.m.

According to the facility policy on "Procedural Sedation," vital signs were to continue for a minimum of 30 minutes from the time of the last dose of intravenous sedation given. Patient 31's last dose of sedation was at 10:49 a.m., with an out of room time of 11:10 a.m. According to policy, Patient 31 should have had vitals signs taken till 11:19 a.m.., thirty minutes after her last dose of sedation. Patient 30's vital signs were not completed in the procedure room for thirty minutes prior to transferring to the unit.

The policy and procedure titled, "Procedural Sedation," dated March 2012, was reviewed. The policy indicated, "The RN is to document post procedure vital signs every fifteen (15) minutes for a minimum of thirty (30) minutes following the last dose of IV (intravenous) sedation..."

4a. The record for Patient 1 was reviewed with RN 2. A signed informed consent, dated November 29, 2013, for Patient 1 was reviewed. The consent was for a procedure, "Percutaneous cholecystostomy with ultrasound or computerized tomography guidance with possible moderate sedation."

The "Monitoring Record of Procedural Sedation," for Patient 1, dated November 29, 2013, was reviewed. The record indicated Patient 1 arrived to the procedure room at 8:30 a.m., and vital signs were obtained. Sedation was administered at 8:45 a.m. The procedure started at 8:47 a.m. and ended at 9:10 a.m. Vital signs were monitored throughout the procedure. Patient 1 left the procedure room at 9:15 a.m. (five minutes after the end of the procedure), to return to his inpatient room on a medical/surgical unit.

Nursing notes for Patient 1, dated November 29, 2013, at 9:20 a.m., indicated, "Patient back to room pain 5/10 to right quad..." There were no vital signs documented on this nurses note.

The vital sign flowsheet indicated the first set of vital signs were taken at 9:45 a.m., 25 minutes after the patient was transferred back to his room.

Nursing Notes for Patient 1, dated November 29, 2013, at 10:10 a.m., indicated, "patient complaining of increased pain to right side 8/10 blood pressure 186/89." No other vital signs were obtained.

On October 13, 2014, RN 1 was interviewed. RN 1 stated she took vital signs before a procedure/sedation and every 5 minutes throughout the procedure. RN 1 stated the patient can return to the inpatient room as soon as the procedure was over as long as it had been at least 30 minutes since the last dose of sedation was given. RN 1 stated she was the sedation nurse, and recovered the patient from the sedation. RN 1 stated she reported off to the patient's primary nurse, who assumed care of the patient at that time.

On October 14, 2014, at 2:30 p.m. RN 2 was interviewed. RN 2 reviewed the medical record for Patient 1 and stated there should have been vital signs done as soon as Patient 1 arrived back to his room at 9:20 a.m., and 15 minutes later at a minimum.

4b. On October 13, 2014, at 10:15 a.m., during an interview with the Clinical Supervisor (CS) of the medical/surgical unit, the CS stated when patients return from Interventional Radiology (IR), the nurse will assess the patient's vital signs, pain level and puncture site as ordered by the physician.

During an interview with medical/surgical Registered Nurse (RN) 4, on October 13, 2014, at 10:45 a.m., RN 4 stated she would check a patient's vital signs upon a patient's return to the floor from Interventional Radiology (IR).

On October 15, 2014, Patient 14's record was reviewed. Patient 14, was admitted to the facility on June 21, 2014, for treatment of weakness and hypotension (low blood pressure). According to the History and Physical, Patient 14 had obstructive jaundice (yellowish pigmentation of the skin due to obstruction of the bile ducts) and a history of pancreatic cancer. On June 25, 2014, the physician documented, "Will have Radiology evaluate for transcutaneous biliary drainage."

Patient 14's consent dated June 26, 2014, indicated the patient was to undergo an "Image guided cholecystostomy tube placement with sedation."

A review of the "Monitoring Record of Procedural Sedation," dated June 26, 2014, indicated Patient 14 received Versed (used for sedation during procedures that do not require general anesthesia, but do require the patient to remain calm and relaxed) 1 milligram (mg) and Fentanyl (a opioid [analgesic] medication often used for patients undergoing procedural sedation) 50 micrograms, with the last dose given at 4:45 p.m. According to documentation on the form, the patient was transferred back to the medical/surgical unit at 5:20 p.m.

Patient 14's record was reviewed with Registered Nurse (RN) 2 on October 15, 2014, at 12 p.m. There was no documentation in the record that indicated what time the patient returned to the medical/surgical unit. There were no initial vital signs documented upon the patient's return to the medical surgical unit. The first set of vital signs taken by the assigned medical/surgical nurse, were taken at 6:37 p.m., approximately one hour after the patient was documented as being transferred from IR back to the medical surgical unit. Additional vital signs were not taken until 9:50 p.m.

4c. The record for Patient 23 was reviewed on October 15, 2014. Patient 23, a 67 year old male, was admitted to the facility on August 19, 2014, with kidney and bladder stones.

(i). The record indicated the patient went to the interventional radiology procedure room on August 20, 2014, where he underwent placement of a ureteral stent (a tube to help drain urine from the kidney into the bladder) under moderate sedation.

According to the "Monitoring Record of Procedural Sedation" form, the procedure started at 9: 30 a.m., the radiology nurse administered Versed 0.5 mg and Fentanyl 25 mcg IV (intravenous) at 9:32 a.m., the procedure ended at 9:40 a.m., and Patient 23 was taken out of the procedure room and back to his hospital room at 9:45 a.m.

The medical surgical nurse's notes indicated Patient 23 arrived back in his room at 10:10 a.m., and vital signs were taken at 10:15 a.m. The notes indicated the vital signs were then taken every hour. There was no evidence the second set of vital signs were taken 15 minutes after arriving to the medical surgical floor.

(ii). The record indicated the patient returned to the interventional radiology procedure room on August 21, 2014, where he underwent placement of a nephrostomy tube(a tube placed through the skin and into the kidney to drain urine) under moderate sedation.

According to the "Monitoring Record of Procedural Sedation" form, the procedure started at 3:15 p.m., the radiology nurse administered Versed 1 mg and Fentanyl 50 mcg IV (intravenous - twice as much as the previous day) at 3:20 p.m., the procedure ended at 3:35 p.m., and Patient 23 was taken out of the procedure room and back to his hospital room at 3:45 p.m.

The medical surgical nurse's notes indicated Patient 23's vital signs were taken at 4:08 p.m. (on arrival to the medical surgical floor), and then hourly. There was no evidence the second set of vital signs was taken 15 minutes after arriving to the medical surgical floor.

4d. A record review was conducted of Patient 30's chart on October 15, 2014. The record indicated Patient 30 had a drain placed in the abdomen three times during his hospital stay:

(ii) May 15, 2014- Ultrasound guided drain was placed into the abdomen. Time out of room 6:10 p.m.

Review of Patient 30's record indicated vital signs were taken on the unit May 15, 2014, at 6:30 p.m. with the next vital sign entry made at 8:52 p.m., more than two hours later.

(ii) May 19, 2014-CT (computed Axial Tomography or CAT scan) guided abdominal drain was placed. Time out of room 9:35 p.m.

On May 19, 2014, Patient 30's record indicated vital signs were taken on the unit at 10 p.m. with the next vital sign entry as 2 a.m., four hours later.

(iii) May 27, 2014-Abdominal drain placement. Time out of room 1:25 p.m.

On May 27, 2014, post procedure vital signs were taken at 2 p.m. with the next vital sign entry at 6 p.m., four hours later.

An interview was conducted with the Nurse Manager of the Medical/Surgical Telemetry Unit (NMMS 1) on May 15, 2014, at 11:30 a.m. The NMMS 1 stated, "After an interventional radiology procedure a patient is brought back to the unit. The nurse is to take immediate vitals then repeat the vitals in fifteen minutes or sooner if the patient is unstable. If stable then the vital signs are reverted back to every four hours or per unit policy."

The policy titled, "Procedural Sedation," dated March 2012, was reviewed." The policy indicated, "Patient's transferred to in-house care shall have vital signs documented on arrival to the patient's room, 15 minutes later, and then per that unit's standard or per physician order."

On October 16, 2014, at 2:20 p.m., the Chief Nursing Officer (CNO) was interviewed. The CNO stated a patient should remain in the special procedure area or the recovery room after any invasive procedure for a minimum of 30 minutes from the end of the procedure, not 30 minutes from the last sedation dose. She stated they need to be monitored for both sedation as well as procedure related complications. The CNO stated she realized there was also some inconsistencies on post procedure monitoring for some patients, dependant on if the patient was an in-patient or an out-patient. The CNO stated the policy needed to be reviewed and revised.

5a. On October 15, 2014, Patient 14's record was reviewed. Patient 14, was admitted to the facility on June 21, 2014, for treatment of weakness and hypotension (low blood pressure). According to the History and Physical, Patient 14 had obstructive jaundice (yellowish pigmentation of the skin due to obstruction of the bile ducts) and a history of pancreatic cancer. On June 25, 2014, the physician documented, "Will have Radiology evaluate for transcutaneous biliary drainage."

The record indicated the patient went to the interventional radiology procedure room on June 26, 2014, where she underwent placement of a cholecystostomy (an invasive procedure performed under imaging guidance to place a tube through the skin into the gallbladder) tube under moderate sedation.

Patient 14's record was reviewed with Registered Nurse (RN) 2 on October 15, 2014, at 12 p.m. There was no documentation related to Patient 14's drain or dressing until 8:25 p.m., on June 26, 2014.

5b. The record for Patient 23 was reviewed on October 15, 2014. Patient 23, a 67 year old male, was admitted to the facility on August 19, 2014, with kidney and bladder stones.

(i). The record indicated the patient went to the interventional radiology procedure room on August 20, 2014, where he underwent placement of a ureteral stent (a tube to help drain urine from the kidney into the bladder) under moderate sedation.

According to the "Monitoring Record of Procedural Sedation", the procedure started at 9: 30 a.m., the radiology nurse administered Versed 0.5 mg and Fentanyl 25 mcg IV (intravenous) at 9:32 a.m., the procedure ended at 9:40 a.m., and Patient 23 was taken out of the procedure room and back to his hospital room at 9:45 a.m.

The post procedure physician's orders indicated when Patient 23 arrived back to the medical surgical floor, the medical surgical nurse was to check the procedure site every 15 minutes for one hour, then every 30 minutes for one hour, and notify the radiologist if the patient had bleeding or swelling at the procedure site.

The medical surgical nurse's notes indicated Patient 23 arrived back in his room at 10:10 a.m., and vital signs and the procedure site were checked at 10:15 a.m. The notes indicated the vital signs were then checked every hour, not as ordered by the physician. There was no evidence the procedure site was reassessed.

(ii). The record indicated the patient returned to the interventional radiology procedure room on August 21, 2014, where he underwent placement of a nephrostomy tube(a tube placed through the skin and into the kidney to drain urine) under moderate sedation.

According to the "Monitoring Record of Procedural Sedation" the procedure started at 3:15 p.m., the radiology nurse administered Versed 1 mg and Fentanyl 50 mcg IV (intravenous) at 3:20 p.m., the procedure ended at 3:35 p.m., and Patient 23 was taken out of the procedure room and back to his hospital room at 3:45 p.m.

The post procedure physician's orders (obtained by phone after Patient 23 arrived back to the medical surgical floor), indicated the medical surgical nurse was to check the procedure site every 15 minutes for one hour, then every 30 minutes for one hour, and notify the radiologist if the patient had bleeding or swelling at the procedure site.

The medical surgical nurse's notes indicated Patient 23's vital signs were checked at 4:08 p.m., and then hourly. There was no evidence the procedure site was assessed by the medical surgical nurse.

5c. Patient 31 was admitted to the facility on May 7, 2014, with the diagnosis of abdominal pain and diverticular abscess (draining area of the bowel tissue).

Record review of Patient 31's chart indicated Patient 31 had a physician's order dated May 8, 2014, at 11:09 a.m. The order indicated, "Check puncture site for bleeding, hematoma, or swelling. Call M.D. if bleeding. Check and record at 15 minute intervals for one hour, then 30 minute intervals for 3 hours."

A review of the facility's form titled, "Monitoring Record of Procedural Sedation," dated May 8, 2014, indicated Patient 31 had a "CT (computerized axiomal tomography or CAT scan) guided renal pelvis drain, drain (of) abscess." The procedure end time was listed as 11 a.m. with the time out of room as 11:10 a.m. Review of the receiving unit's drain assessment was documented as 12 noon, 3 p.m., 7:47 p.m. The nurse did not follow the 15 minute interval assessment order by the physician for one hour and continue for 30 minute assessments for 3 hours.

An interview was conducted with the Nurse Manager of the Medical/Surgical Telemetry Unit 2 (NMMS 2-of the related facility) on May 16, 2014, at 11:15 a.m. The NMMS 2 acknowledged the unit nurse did not follow the physician's post procedural orders.

A review of the facility policy and procedure titled,"Physician's Orders," dated with revision May 2012, indicated,"...Physician's orders will be accurately processed and promptly followed." The policy further indicated, "If there is any difficulty in reading and/or understanding a physician's written order, the licensed employee shall personally (or via phone) contact the physician for clarification."

The facility policy and procedure titled, "Assessment/Reassessment of Patient," with a last revised date of February 2009, was reviewed. The policy indicated it's purpose was to establish guidelines delineating responsibility of all healthcare team members in the data gathering process to establish individual plan of care and establish treatment plan. The policy indicated the implementation of the nursing process will be consistent with the plan for medical care and each patient was re-assessed every shift, or more often, as indicated by patient's needs. The policy further indicated, "A reassessment must be documented at the time of transfer by the accepting nurse. This reassessment must include, but is not limited to, a general impression of the patient with a focused system specific assessment of those problems identified on the care plan and/or identified problems on the patient's presentation to the accepting nurse."


6a. Patient 30 was admitted to the facility on May 13, 2014, with the diagnosis of retro peritoneal abscess, benign neoplasm (noncancerous tumor located near the kidney pelvis). On May 19, 2014, Patient 30 had a "CT guided abdominal drain" placed (computerize axial topography-type of high density x-ray).

A record review was conducted of the form titled, "Monitoring Record of Procedural Sedation," dated, May 8, 2014. Patient 30 was medicated with fentanyl 25 micrograms at 9:07 p.m., with an out of room time of 9:35 p.m. Patient 30's pain was not assessed upon return to the unit. Patient 30's pain was not assessed until 10:27 p.m., fifty-two minutes after leaving the procedure room.

6b. Patient 31 was admitted to the facility on May 7, 2014, with the diagnosis of abdominal pain and diverticular abscess (draining area of the bowel tissue).

A record review was conducted of the form titled, "Monitoring Record of Procedural Sedation," dated, May 8, 2014, with an out of room time of 11:10 a.m. The form indicated Patient 31 had a "CT (computed Axial Tomography or CAT scan) guided renal pelvis drain, abscess drain (performed)."

Further review of the post procedure assessment, including pain assessment, was conducted on October 15, 2014. The record indicated Patient 31 was medicated at 10:49 a.m. with Fentanyl 25 micrograms by intravenous route. Patient 31's pain assessment was not completed on arrival back to the unit. Patient 31's first documented post procedure unit vital sign was at 12 noon. A pain assessment was not documented until 7:48 p.m., more than seven hours after Patient 31's procedure was performed.

An interview was conducted with the Nurse Manager of the Medical/Surgical Telemetry Unit 2 (NMMS 2-of the related facility) on October 16, 2014, at 11:15 a.m. The NMMS 2 acknowledged pain assessment was not completed per pain assessment protocol of the unit(Patients 30 and 31).

A review of the facility policy and procedure titled,"Pain Management," dated with revision June 2012, indicated, "Patients who are in a special procedure or in another department who need narcotic pain medication must be monitored for 30 minutes post narcotic administration by a Registered Nurse (RN). Monitoring includes re-assessment for pain control..."

Based on observation, interview, and record review, the facility failed to ensure:

1. The Interventional Radiologist assigned ASA (American Society of Anesthesiologists) scores and, when indicated according to the facility policy, request anesthesia consultation, prior to providing procedural sedation for three sampled patients (Patients 1, 14, and 30);

2. The Interventional Radiologist performed a re-evaluation of two patients immediately prior to the administration of medication for procedural sedation (Patients 12 and 14);

3. The Interventional Radiologist ordered and provided follow up monitoring and management for five patients who underwent invasive Interventional Radiology (IR) procedures (Patients 1, 12, 13, 14, and 23);

4. There was documented evidence of current competence for a privilege granted at the time of reappointment to a member of the radiology staff (Physician 1) (A340);

5. An adverse patient event involving one patient who suffered complications from a procedure performed by an Interventional Radiologist (Patient 1), was reviewed by the Medical Staff Peer Review Committee in a timely manner (A347);

6. Privileges for one Interventional Radiologist (MD 1) were based on current demonstrated competence (A353); and,

7. One Interventional Radiologist (MD 6) performed only those procedures he had privileges to perform (A353)(A363).

The cumulative effect of these systemic problems resulted in failure to ensure radiology services were provided in a safe and effective manner.

Findings:

According to the facility's policy and procedure titled "Procedural Sedation," with a last revised date of March 2012, the physician performing procedural sedation was to ensure the policy was followed. The policy indicated the physician was responsible for assigning an ASA (American Society of Anesthesiologists) score for each patient and completing the Sedation Evaluation Form. The policy recommended the Division of Anesthesia be consulted for patients with a ASA Class IV. The policy defines ASA Classifications as a pre-procedure assessment to determine anesthesia risk. ASA Classifications range from ASA I (normal healthy patient) to ASA VI (patient declared brain dead).

1a. The record for Patient 1 was reviewed. Patient 1, an 80 year old male, was admitted to the facility on November 24, 2013. Patient 1 had multiple diagnoses including history of hypertension (high blood pressure), coronary artery disease, aortic valve replacement, uncontrolled diabetes, and status post heart bypass surgery and colostomy. Patient 1 also was diagnosed with acute cholecystitis (inflammation of the gallbladder). A surgical consult was done, and Patient 1 was considered a poor surgical candidate for a cholecystectomy (removal of the gall bladder), therefore the surgeon recommended a cholecystostomy tube placed (the insertion of a catheter into the gallbladder under radiological guidance for drainage or the removal of gallstones).

The "Physician Record of Sedation," for Patient 1, dated November 29, 2013, indicated a planned procedure of Cholecystostomy under moderate sedation. The ASA classification assigned was "2 (II) Mid-Mod Systemic Disease - No functional limitation."

On October 16, 2014, at 12:10 p.m., Physician 4 was interviewed. Physician 4 (an anesthesiologist) stated a patient with multiple co-morbidities who was considered a poor surgical candidate, such as Patient 1, should be classified as an ASA IV. He stated a class IV would trigger an anesthesiologist consult prior to the procedure/sedation.

1b. On October 15, 2014, Patient 14's record was reviewed. Patient 14 was admitted to the facility on June 21, 2014, for treatment of weakness and hypotension (low blood pressure). According to the History and Physical, Patient 14 had obstructive jaundice (yellowish pigmentation of the skin due to obstruction of the bile ducts).

Patient 14's record contained a consent dated June 26, 2014, for an "Image guided cholecystostomy (an invasive procedure performed under imaging guidance to place a tube through the skin into the gallbladder) tube placement with sedation."

There was no "Physician Record of Sedation," form in Patient 14's record. The form was used to document pre-sedation evaluation, anesthesia risk (ASA Classification), plan for sedation, informed consent, re-evaluation just prior to sedation and post-procedure evaluation. There was no evidence in the record that Patient 14's ASA Classification was documented elsewhere in the record.

A review of the "Monitoring Record of Procedural Sedation," indicated Patient 14 received Versed (used for sedation during procedures that do not require general anesthesia, but do require the patient to remain calm and relaxed) 1 milligram (mg) and Fentanyl (a opioid [analgesic] medication often used for patients undergoing procedural sedation) 50 micrograms, with the last dose given at 4:45 p.m.

1c. The record for Patient 30 was reviewed. Patient 30 was admitted to the facility on May 13, 2014, with the diagnosis of abdominal pain and sepsis (infection). Patient 30 underwent two Interventional Radiology (IR) procedures (an invasive procedure requiring sedation and live x-ray during the procedure) during his stay at the facility.

(i) On May 19, 2014, Patient 30 had a procedure performed in the interventional radiology department and was given procedural sedation.

A record review was conducted of Patient 30's "Monitoring Record of Procedural Sedation" for May 19, 2014, which indicated Patient 30 received the following intravenous (by vein) sedation medications:

Versed 0.5 milligrams (mg)- 9 p.m.
Fentanyl 25 micrograms (mcg)-9 p.m.
Versed 0.5 mg-9:07 p.m.
Fentanyl 25 mcg-9:07 p.m.

A record review was conducted of Patient 30's pre-sedation assessment. There was no record in Patient 30's chart which indicated an airway assessment was completed for Patient 30 prior to receiving procedural sedation on May 19, 2014.

(ii) On May 27, 2014, Patient 30 had the following intravenous sedation medications during a procedure:

Versed 1 mg-12:50 p.m.
Fentanyl 25 mcg-12:50 p.m.
Fentanyl 25 mcg-13:05 p.m.

A record review was conducted of Patient 30's pre-sedation assessment. There was no record in Patient 30's chart to indicated an airway assessment was completed for Patient 30 prior to receiving procedural sedation on May 27, 2014.

An interview was conducted on October 15, 2014, at 11:30 a.m., with the Nurse Manager of the Post Anesthesia Care Unit (NMPACU) . The NMPACU stated, "There were no documented ASA classification for both of Patient 30's IR procedures."

The policy titled, "Procedural Sedation," dated March 2012, was reviewed. The policy indicated it was recommended the Division of Anesthesia staff be consulted for patient evaluation for the administration of intravenous sedation in the patient populations as stated, "ASA Class IV patients..." The policy further defined, "ASA Classifications: To determine anesthesia risk (pre-procedure assessment)... ASA II: Patient with mild to moderate systemic disease. (i.e. well controlled hypertension or diabetes)... ASA IV: Patient with severe systemic disease that is incapacitating, and life threatening. (i.e. Severe cardiopulmonary, renal, hepatic, or endocrine dysfunction)... "

2a. On October 14, 2014, Patient 12's record was reviewed. Patient 12 was admitted to Facility A on September 16, 2014, for treatment of a biliary obstruction (a blockage of the bile ducts with accumulation of bile in the liver). According to the progress note dated September 16, 2014, Patient 12 had a history of advanced obstructive esophageal (tube that runs between the throat and the stomach) cancer. Patient 12 was experiencing a new onset of painless jaundice (yellowing of the skin). The physician recommended percutaneous transhepatic cholangiogram (PTC) (a procedure performed by an Interventional Radiologist in the radiology department, to relieve blockage in the bile ducts without having to perform surgery) drainage and decompression.

A review of Patient 12's record revealed the patient was transferred via ambulance to Facility B, on September 17, 2014. At Facility B, Patient 12 underwent PTC for biliary obstruction.

Patient 12's "Physician Record of Sedation," form was reviewed. The form was used to document pre-sedation evaluation, anesthesia risk, plan for sedation, informed consent, re-evaluation just prior to sedation and post procedure evaluation. According to documentation on the form, Patient 12 was to undergo "moderate IV (intravenous) sedation." There was no documentation in the area titled "Re-evaluation Just Prior to Sedation."

During the procedure, the patient received Versed (used for sedation during procedures that do not require general anesthesia, but do require the patient to remain calm and relaxed) 1 milligram (mg) and Fentanyl (a opioid [analgesic] medication often used for patients undergoing procedural sedation) 25 micrograms, with the last dose given at 11:31 a.m. At 11:53 a.m., it was documented, "All wires removed and drain sutured in to place." Patient 12's vital signs were taken every five minutes between 11:30 a.m., and 11:55 a.m. At 12 noon, Patient 12 was picked up by the ambulance attendants for the return trip to Facility A, five minutes following the conclusion of the procedure.

2b. On October 15, 2014, Patient 14's record was reviewed. Patient 14 was admitted to the facility on June 21, 2014, for treatment of weakness and hypotension (low blood pressure). According to the History and Physical, Patient 14 had obstructive jaundice (yellowish pigmentation of the skin due to obstruction of the bile ducts).

Patient 14's record contained a consent dated June 26, 2014, for an "Image guided cholecystostomy tube placement with sedation."

There was no "Physician Record of Sedation," form in Patient 14's record. The form was used to document pre-sedation evaluation, anesthesia risk, plan for sedation, informed consent, re-evaluation just prior to sedation and post-procedure evaluation. There was no evidence in the record that Patient 14's re-evaluation just prior to sedation was documented elsewhere in the record.

A review of the "Monitoring Record of Procedural Sedation," indicated Patient 14 received Versed (used for sedation during procedures that do not require general anesthesia, but do require the patient to remain calm and relaxed) 1 milligram (mg) and Fentanyl (a opioid [analgesic] medication often used for patients undergoing procedural sedation) 50 micrograms, with the last dose given at 4:45 p.m. According to documentation on the form, the patient was transferred back to the medical/surgical unit at 5:20 p.m.

The facility policy and procedure titled, "Procedural Sedation," with a last revised date of March 2012, was reviewed. The policy indicated, "Procedural sedation involves the use of sedatives and analgesics to reduce anxiety and pain suffered by patients during procedures."According to the policy procedural sedation was performed in the "Radiology/Diagnostic Imaging," department. The policy indicated the physician was responsible for the safety and well being of the patient having moderate sedation and shall ensure the policy was observed. The policy indicated physician responsibilities included: "...completing the Sedation Evaluation Form...Assessing the patient immediately prior to administration of procedural sedation..."

3a. The record for Patient 1 was reviewed. Patient 1, an 80 year old male, was admitted to the facility on November 24, 2013. Patient 1 had multiple diagnoses including history of hypertension (high blood pressure), coronary artery disease, aortic valve replacement, uncontrolled diabetes, and status post heart bypass surgery and colostomy. Patient 1 also was diagnosed with acute cholecystitis (inflammation of the gallbladder). A surgical consult was completed, and Patient 1 was considered a poor surgical candidate for a cholecystectony (removal of the gall bladder), therefore the surgeon recommended the placement of a cholecystostomy tube (the insertion of a catheter into the gallbladder under radiological guidance for drainage or the removal of gallstones).

Patient 1 had an order for IR (Interventional Radiology) Cholecystostomy Percutaneous, dated November 28, 2013.

The "Monitoring Record of Procedural Sedation," dated November 29, 2013, and signed by Physician 1, indicated the procedure start time was 8:45 a.m., and the procedure end time was 9:10 a.m. Patient 1 left the procedure room at 9:15 a.m., and was returned to his inpatient room.

The "Physician Record of Sedation," dated November 29, 2013, and signed by Physician 1, indicated a post-procedure evaluation was completed at 9:10 a.m. (immediately at the end of the procedure).

The "Radiology Post Procedure Note," by Physician 1, dated November 29, 2013, at 9:16 a.m., indicated no complications. There were no other post-procedure progress notes by Physician 1 to indicate any follow-up made with Patient 1 following the procedure.

On October 14, 2014, at 9:15 a.m., Physician 1 was interviewed. Physician 1 stated he was a Diagnostic Radiologist for the facility. Physician 1 stated he remembered Patient 1. He stated he was also working at another hospital on November 29, 2013, and came to this facility to perform the procedure. He stated as soon as the procedure was over he returned to the other hospital. Physician 1 stated he wrote orders for nursing to notify him if there were any changes in the patient's condition following the procedure. Physician 1 stated he did not recall if nursing notified him when Patient 1 began complaining of increased pain, experienced unstable vital signs, and eventually had a rapid response team called to evaluate the patient. Physician 1 further stated he did not follow up with Patient 1 following the percutaneous cholecystostomy drain placement. Physician 1 stated he would expect the surgeon and/or primary physician to be involved in the follow up care.

3b. On October 14, 2014, Patient 12's record was reviewed. Patient 12 was admitted to Facility A on September 16, 2014, for treatment of a biliary obstruction (a blockage of the bile ducts with accumulation of bile in the liver). According to the progress note dated September 16, 2014, Patient 12 had a history of advanced obstructive esophageal (tube that runs between the throat and the stomach) cancer. Patient 12 was experiencing a new onset of painless jaundice (yellowing of the skin). The physician recommended percutaneous transhepatic cholangiogram (PTC) (a procedure performed by an Interventional Radiologist in the radiology department, to relieve blockage in the bile ducts without having to perform surgery) drainage and decompression.

A review of Patient 12's record revealed the patient was transferred via ambulance to Facility B, on September 17, 2014. At Facility B, Patient 12 underwent PTC for biliary obstruction.

Patient 12's "Physician Record of Sedation," form was reviewed. The form was used to document pre-sedation evaluation, anesthesia risk, plan for sedation, informed consent, re-evaluation just prior to sedation and post procedure evaluation. According to documentation on the form, Patient 12 was to undergo "moderate IV (intravenous) sedation." There was no documentation in the area titled "post -procedure evaluation."

During the procedure, the patient received Versed (used for sedation during procedures that do not require general anesthesia, but do require the patient to remain calm and relaxed) 1 milligram (mg) and Fentanyl (a opioid [analgesic] medication often used for patients undergoing procedural sedation) 25 micrograms, with the last dose given at 11:31 a.m. At 11:53 a.m., it was documented, "All wires removed and drain sutured in to place." Patient 12's vital signs were taken every five minutes between 11:30 a.m., and 11:55 a.m. At 12 noon Patient 12 was picked up by the ambulance attendants for the return trip to Facility A, five minutes following the conclusion of the procedure.

There was no documentation, by the physician in the section for "Post-Procedural Evaluation," on the "Physician Record of Sedation" form. There were no physician orders specific to the post procedural time period or Patient 12's newly placed drainage tube.

A review of the ambulance run sheet indicated the patient's vital signs were taken when the patient was picked up (there was no documentation of time for this entry) and again at 12:30 p.m.

During a review of Patient 12's record on October 14, 2014, with Registered Nurse (RN) 2, the RN stated she was unable to find post procedural orders for Patient 12.

During an interview with Physician 5, the Chair of the Radiology Physicians, on October 16, 2014, at 1:40 p.m., Physician 5 was asked if the IR physician should write post procedure orders. Physician 5 stated post procedures orders were required.

3c. On October 14, 2014, at 9:15 a.m., Physician 1 was interviewed. Physician 1 stated he was a Diagnostic Radiologist, but he also performed Interventional Radiology (IR). Physician 1 described IR as performing biopsies, placing drains or central lines, and performing angiograms, in conjunction with a radiological device such as ultrasound or Computerized Tomography (CT). Physician 1 stated imaging was done to show what needed to be drained or where the needle was to be placed. The physician stated when he performed this type of procedure, he wrote post procedure orders and would expect the patient's staff to call him with immediate post procedure issues.

On October 15, 2014, at 10 a.m., the Interventional Radiology (IR) room at Facility A was observed. Patient 13 was observed lying on a procedure bed in the middle of the room. Registered Nurse (RN) 1 was observed sitting at the patient's bedside monitoring the patient. Certified Radiology Technician (CRT) was observed changing fluid collection containers as they filled. The room contained the required equipment and space to perform IR.

During an interview with the Imaging Director (ID), on October 15, 2014, at 10 a.m., the ID stated Patient 13 was undergoing a paracentesis (procedure using a needle to remove fluid from the abdomen), as an outpatient. The ID stated the patient would be sent to the Post Anesthesia Care Unit (PACU-unit where patients were monitored following surgical procedures) before transfer or discharge.

On October 15, 2014, at 10:25 a.m., Patient 13 was transferred to the PACU, where RN 3 completed an assessment and applied devices to monitor the patient's condition. During a concurrent interview, RN 3 stated the Radiologists were "good about writing post procedure orders." Patient 13's record was reviewed with RN 3, and post procedural orders were not in the patient's electronic record. RN 3 stated she would need to contact the IR for orders.

3d. On October 15, 2014, Patient 14's record was reviewed. Patient 14 was admitted to the facility on June 21, 2014, for treatment of weakness and hypotension (low blood pressure). According to the History and Physical, Patient 14 had obstructive jaundice (yellowish pigmentation of the skin due to obstruction of the bile ducts). On June 25, 2014, the physician documented, "Will have Radiology evaluate for transcutaneous biliary drainage."

Patient 14's record contained a consent dated June 26, 2014, for an "Image guided cholecystostomy tube placement with sedation."

There was no "Physician Record of Sedation," form in Patient 14's record. The form was used to document pre-sedation evaluation, anesthesia risk, plan for sedation, informed consent, re-evaluation just prior to sedation and post-procedure evaluation.

A review of the "Monitoring Record of Procedural Sedation," indicated Patient 14 received Versed (used for sedation during procedures that do not require general anesthesia, but do require the patient to remain calm and relaxed) 1 milligram (mg) and Fentanyl (a opioid [analgesic] medication often used for patients undergoing procedural sedation) 50 micrograms, with the last dose given at 4:45 p.m. According to documentation on the form, the patient was transferred back to the medical/surgical unit at 5:20 p.m.

Patient 14's record was reviewed with Registered Nurse (RN) 2 on October 15, 2014, at 12 p.m. RN 2 found the only orders written by the physician who performed the IR procedure, were written at June 25, 2014, 7:09 p.m. RN 2 indicated there were no post procedure orders stipulating how often vital signs should be taken, when the puncture site and dressing should be monitored, and who to call for immediate post procedure issues.

The IR physician orders dated June 26, 2014, at 7:09 p.m. (90 minutes after the patient returned to the floor) indicated "Flush line every 8 hours with 10 cc (cubic centimeter) of Normal Saline Solution. Change bag as needed. Call physician on call for bright red blood in the bag, puncture site bleeding, hematoma, or swelling. Check puncture site with vital signs."

3e. The record for Patient 23 was reviewed on October 15, 2014. Patient 23, a 67 year old male, was admitted to the facility on August 19, 2014, with kidney and bladder stones.

(i). The record indicated the patient went to the interventional radiology procedure room on August 20, 2014, where he underwent placement of a ureteral stent (a tube to help drain urine from the kidney into the bladder) under moderate sedation.

According to the record, the procedure was completed and Patient 23 was taken back to his hospital room at 10:10 a.m. There was no evidence in the record the radiologist who performed the procedure made a follow up visit to assess the patient's condition or response to the procedure.

(ii). The record indicated the patient returned to the interventional radiology procedure room on August 21, 2014, where he underwent placement of a nephrostomy tube(a tube placed through the skin and into the kidney to drain urine) under moderate sedation.

According to the record, the procedure was completed and Patient 23 was taken back to his hospital room at 3:45 p.m. There was no evidence in the record the radiologist who performed the procedure made a follow up visit to assess the patient's condition or response to the procedure.

The facility policy and procedure titled, "Procedural Sedation," with a last revised date of March 2012, was reviewed. The policy indicated, "Procedural sedation involves the use of sedatives and analgesics to reduce anxiety and pain suffered by patients during procedures."According to the policy procedural sedation was performed in the "Radiology/Diagnostic Imaging," department. The policy indicated the physician was responsible for the safety and well being of the patient having moderate sedation and shall ensure the policy was observed. The policy indicated physician responsibilities included: "...Assessing the patient immediately prior to administration of procedural sedation... Assigning the ASA score for each patient and completing the Sedation Evaluation Form..." In the Post-Procedure/Recovery phase: "The physician is to note the outcome of the procedure and indicate how the patient tolerated the sedation..."

The policy and procedure titled, "Cath Lab and Special Procedures Scope of Service 2014," was reviewed. The policy indicated the Special Procedure Service was performed by Radiologists or Vascular Surgeons. The goals and objectives included delivering quality care. According to the policy, the Special Procedure Room and Cardiac Cath Lab were under the direction of the Medical Director of the Department of Imaging for invasive/interventional radiology. The medical director was responsible and accountable to ensure that procedures were comprehensive.

According to the clinical practice guidelines of the Society of Interventional Radiology, "Participation by radiologist in patient follow up is an integral part of percutaneous transhepatic cholangiography, biliary drainage, and cholecystostomy and will increase the success rare of the procedure. Close follow up, with monitoring and management of patients who have undergone percutaneous transheptic cholangiography, biliary drainage, and cholecystostomy, is appropriate for the radiologist."