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Based on record review, interview and observation, the Hospital failed for one of 11 patients (Patient #1) to ensure Patient #1's safety.

Findings included:

The Admission Note, dated 8/23/16, indicated the Hospital admitted Patient #1 for surgery to correct his/her hip dysplasia (abnormality). The note indicated an anesthesia complication.

The Anesthesia Record, dated 8/23/16, indicated a cardiovascular (heart) collapse event after an intravenous catheter was placed, the fluid warming intravenous tubing was attached and air was observed in the tubing as the fluid began to run and the tubing was disconnected.

The Surveyor observed, at 11:30 A.M. on 9/9/16, a demonstration of the fluid warming machine presented by Anesthesiologist #1. The Surveyor observed that Anesthesiologist #1 connected an air filter device to the fluid warming machine intravenous tubing.

The Surveyor interviewed Anesthesiologist #1, at 11:30 A.M. on 9/9/16. Anesthesiologist #1 said an air filter was used unless the patient was allergic to latex.

The Surveyor interviewed the Executive Director of Quality Improvement for the Anesthesia Department at 12:50 on 9/9/16. The Executive Director of Quality Improvement said that it was the Anesthesiology Department's standard practice to use an air filter unless the use of the air filter was contraindicated.

The Surveyor interviewed the Resident Anesthesiologist at 12:20 P.M. on 9/14/16. The Resident Anesthesiologist said that an air filter was not used in the set-up of the fluid warming machine intravenous tubing.

The Hospital policy titled Use of Intravenous Filters, dated 6/12/14, did not indicate an anesthesiologist was to use an air filter in the setup of the fluid warming machine intravenous tubing.

Based on observation, records reviewed, and interviews the Quality Assessment and Performance Improvement (QAPI) Program Condition of Participation was not met.

Findings included:

The Hospital's Governing Body failed to ensure an effective QAPI Program that analyzed Anesthesia Services performance following Patient #1's adverse patient event at 8:15 A.M. on 9/23/16. Patient #1 suffered an air embolism (air bubble) to the heart, bradycardia (slow heartbeat) and hypotension (low blood pressure) that required the administration of resuscitation (emergency) medications to return Patient #1's heartbeat and blood pressure to baseline (normal) after a Resident Anesthesiologist incorrectly prepared fluid warming machine intravenous tubing.

Refer to TAG: A-0273

The Hospital's Governing Body failed to ensure that Anesthesia Services implemented immediate corrective action(s) and measured the success of corrective actions to ensure that Anesthesia Services sustained improvements.

Refer to TAG: A-0283

The Hospital's Governing Body failed to ensure that Anesthesia Services implemented corrective action(s) mechanisms that included feedback and learning throughout the Hospital.

Refer to TAG: A-0286

The Hospital's Governing Body failed to ensure that Anesthesia Services were responsible and accountable for quality improvement activities, including the reduction of medical errors, and that they were implemented and monitored after Patient #1's adverse patient event.

Refer to TAG: A-0809

Based on record review, interview and observation for one of 11 patients (Patient #1) the Hospital's Governing Body failed to ensure an effective QAPI Program that thoroughly analyzed Anesthesia Services performance following Patient #1's adverse patient event at 8:15 A.M. on 8/23/16. Patient #1 suffered an air embolism (air bubble) to the heart, bradycardia (slow heartbeat) and hypotension (low blood pressure) requiring administration of resuscitation (emergency) medications to return Patient #1's heartbeat and blood pressure to baseline (normal) after a Resident Anesthesiologist incorrectly prepared fluid warming machine intravenous tubing.

Findings included:

The Admission Note, dated 8/23/16, indicated the Hospital admitted Patient #1 for surgery to correct his/her hip dysplasia (abnormality). The note indicated an anesthesia complication.

The Anesthesia Record, dated 9/23/16, indicated a cardiovascular (heart) collapse event after an intravenous catheter was placed, the fluid warming intravenous tubing was attached and air was observed in the tubing as the fluid began to run and the tubing was disconnected. The Anesthesia Record indicated a decrease in Patient #1's end tidal carbon dioxide level (decrease lung blood flow), bradycardia and hypotension. The Anesthesia Record indicated personnel administered Atropine and Epinephrine (resuscitation medications). The Anesthesia Record indicated an echocardiogram (heart ultrasound) showed that the air resolved in Patient #1's right ventricle (heart) over five (5) minutes. The Anesthesia Record indicated surgeons performed a hip closed reduction (restored the hip to the correct alignment) and Spica (over hip and waist) casting versus open hip reduction (surgery) because Patient #1's hip was now reducible under anesthesia.

The document titled Quality Assessment and Performance Improvement Program, dated 2016, indicated if a Root Cause Analysis (Hospital internal investigation) resulted in recommendations to correct or prevent similar adverse events that lead to changes in patient practices these changes must be disseminated to those areas that required education. The document indicated after the education was conducted the organization must ensure that the effectiveness of the changes was sufficient and that any changes in practice were adhered to. The document indicated that, when disseminating recommended practice changes, the organization must: (1) identify the audience to receive education, (2) identify the mode of education, (3) identify methods to audit change implementation and (4) follow up to close the loop and ensure that practice change has been sustained.

The Surveyor interviewed the Vice President for Surgery and Director of Patient Safety & Compliance at 9:00 A.M. on 9/9/16. The Vice President for Surgery and Director of Patient Safety & Compliance said that the Anesthesia Department was responsible for the Hospital internal investigation and corrective action plan.

The Surveyor interviewed the Chief of Perioperative Anesthesia Operating Rooms Medical Director and the Executive Director of the Quality Improvement Program for the Anesthesia Department at 9:30 A.M. on 9/9/16. The Chief of Perioperative Anesthesia Operating Rooms Medical Director and the Executive Director of the Quality Improvement Program for the Anesthesia Department said that the Anesthesia Department conducted the Hospital internal investigation and discovered that Patient #1 had an air embolism because a Resident Anesthesiologist believed that the fluid warming machine intravenous tubing was prepared, primed (intravenous fluid passed through the intravenous tubing) and ready for use by the Anesthesia Technicians. The Chief of Perioperative Anesthesia Operating Rooms Medical Director and the Executive Director of the Quality Improvement Program for the Anesthesia Department said that the fluid warming machine intravenous tubing was not primed and ready for use because Anesthesia Technicians were not required to prepare the fluid warming machine intravenous tubing. The Chief of Perioperative Anesthesia Operating Rooms Medical Director and the Executive Director of the Quality Improvement Program for the Anesthesia Department said that the fluid warming machine was left in Patient #1's operating room from the previous patient operation the day before and the fluid warming machine was not removed from Patient #1's operating room because the Hospital did not have an Anesthesiology Technician working on the shift prior to Patient #1's operation due to approved scheduled time off for the Technician. The Chief of Perioperative Anesthesia Operating Rooms Medical Director and the Executive Director of the Quality Improvement Program for the Anesthesia Department said that the Hospital's fluid warming machines were approximately 15 years old and did not have air filtration capability and the Hospital was trialing a new fluid warming system on Monday 9/12/16 (event date was 8/23/16).

The document titled Hospital Internal Investigation, dated 8/30/16, indicated that inexperience, knowledge and time pressure were all factors in Patient #1's adverse event. The document indicated discussion regarding the fact that the fluid warming machines do not safeguard against air in the tubing and new machines would be purchased. The document indicated to refer to another document for the formal report. (The Hospital did not provide follow-up information when requested by the Surveyor, on 9/15/16 & 9/16/16.)

The Surveyor interviewed Anesthesiologist #1 and observed, at 11:30 A.M. on 9/9/16, a demonstration of the fluid warming machine presented by Anesthesiologist #1. The Surveyor observed that Anesthesiologist #1 connected an air filter device to the fluid warming machine intravenous tubing. Anesthesiologist #1 said that Anesthesiologists used the air filter unless there was a reason not to use the air filter, for example if the patient had a latex allergy.

The Surveyor interviewed the Executive Director of the Quality Improvement Program for the Anesthesia Department at 12:50 on 9/9/16. The Executive Director of the Quality Improvement Program for the Anesthesia Department said that the Resident Anesthesiologist did not use an air filter on the fluid warming machine intravenous tubing that was used for Patient #1. The Executive Director of the Quality Improvement Program for the Anesthesia Department said that guidelines for using the air filter was not included in the email Practice Alert, distributed on 9/1/16, because it was the Anesthesiology Department's standard practice to use an air filter unless contraindicated. The Executive Director of the Quality Improvement Program for the Anesthesia Department said that it was the Attending Anesthesiologist's responsibility to assure proper preparation of fluid warming intravenous tubing and use of an air filter.

The document titled Practice Alert distributed by e-mail, dated 9/1/16, did not indicate guidelines for using an air filter. The Practice Alert indicated the following recommendations: (1) The fluid warming machine intravenous tubing should be set up by the anesthesiologist prior to administration and the tubing must be appropriately primed (filled with fluid) immediately prior to administration and (2) Tubing or equipment not set by someone immediately involved with the case and does not have proper labeling (to include date, time, initials) should not be used and be discarded as soon as possible.

The Surveyor interviewed the Resident Anesthesiologist at 12:20 P.M. on 9/14/16. The Resident Anesthesiologist said that he believed that the Anesthesia Technicians prepared the fluid warming machine intravenous tubing. The Resident Anesthesiologist said that an air filter was not used in the setup of the fluid warming machine intravenous tubing. The Resident Anesthesiologist said that he did not receive the Practice Alert concerning the use of filters and it was not discussed during the Anesthesia Department preparation meeting (for the next day surgeries) and an Attending Anesthesiologist did not talk about the Practice Alert.

The Surveyor interviewed Attending Anesthesiologist #5, at 1:15 P.M. on 9/16/16. Attending Anesthesiologist #5 said that she did not set-up the fluid warming machine intravenous tubing for Patient #1 and she did not review with the Resident Anesthesiologist the procedure to prepare the fluid warming intravenous tubing because Resident Anesthesiologists know how to prepare the tubing. Anesthesiologist #5 said there was no reason to believe that the Resident Anesthesiologist needed education on preparing the fluid warming intravenous tubing.

Quality Assessment and Performance Improvement (QAPI) activities failed to identify that staff practices related to use of an air filter was not consistent.

The document titled Anesthesia Technician I (job description), dated 4/8/15, indicated that Anesthesia Technicians prepared all patient intravenous fluids and intravenous equipment as requested by the Anesthesiologist.

The Surveyor interviewed Anesthesia Technician #1 at 10:20 A.M. on 9/14/16. Anesthesia Technician #1 said he prepared fluid warming machine intravenous tubing by spiking the bag of fluid and priming the tubing with the fluid.

The Surveyor interviewed Anesthesia Technician #2 at 10:30 A.M. on 9/14/16. Anesthesia Technician #2 said he would set up the fluid warming machine intravenous tubing by spiking the bag and priming the tubing if asked by the Anesthesiologist.

The Surveyor interviewed the Patient Safety Manager at 2:55 P.M. on 9/9/16. The Patient Safety Manager said that the Hospital had an Intravenous Therapy Policy and a Use of Intravenous Filters Policy and that the Use of Intravenous Filters Policy did not indicate use of a filter when using a fluid warming machine.

The Hospital policy titled Use of Intravenous Filters, dated 6/12/14, did not indicate the use of an air filter with the setup of the fluid warming machine intravenous tubing.

The Hospital policy titled Peripheral Intravenous Therapy, dated 12/17/13, indicated all clinicians in procedure areas (operating rooms) would label all intravenous tubing with the minimum information of fluid expiration date and time.

The Surveyor interviewed the Patient Safety Manager at 2:55 P.M. on 9/9/16. The Patient Safety Manager said that the Intensive Care Units used fluid warming machines and that the ICU's did not use an air filter.

The Surveyor interviewed the Vice President of Surgery at 9:30 A.M. on 9/14/15. The Vice President of Surgery said the Hospital had fluid warming machines located in operating rooms at two (2) off-site locations (Campus L and Campus W).

The Surveyor interviewed the Executive Director of the Quality Improvement Program for the Anesthesia Department at 11:00 A.M. on 9/14/16. The Executive Director of the Quality Improvement Program for the Anesthesia Department said that each of the Hospital's two (2) off-site Operating Rooms had one (1) fluid warming machine.

The Surveyor interviewed the Operating Room (OR) Nurse Manager for the Hospital off-site Operating Room at Campus W at 9:30 A.M. on 9/15/16. The OR Nurse Manager said that the Operating Room at Campus W had one (1) fluid warming machine. The OR Nurse Manager said that Campus W followed the same policies and procedures as the Hospital.

The Anesthesia Services internal investigation did not thoroughly analyze: (1) Anesthesia Technologists' practice in preparing the fluid warming machine intravenous tubing, (2) Anesthesia Technologists' job description for their responsibility in preparing the fluid warming machine intravenous tubing, (3) Resident Anesthesiologists knowledge about Anesthesia Technologist responsibilities regarding the fluid warming machine and intravenous tubing preparation, (4) the need for Resident Anesthesiologist education or re-education, (5) the Resident Anesthesiologists inexperience, knowledge and time pressure factors in Patient #1's adverse event, (6) if a policy or procedure was needed regarding preparing the fluid warming machine and intravenous tubing for patient use, (7) consistency in practice between the Anesthesiology Department use of an air filter and the Hospital's policy titled Use of Intravenous Filters, (8) the Peripheral Intravenous Therapy policy, (9) other areas in the Hospital (Intensive Care Units) and off-site operating rooms that used the fluid warming machine,
(10) corrective action plans regarding staffing patterns for scheduled time off for Anesthesia Technicians, (11) cleaning procedures (turn-over) between the surgical case prior to Patient #1 and Patient #1's surgical case,
(12) data collection procedures to monitor the effectiveness and compliance with operating room turn-over procedure and (13) data collection procedures to monitor the effectiveness and compliance of the Practice Alert distributed on 9/1/16.

Refer to TAG: 283 (Implementation & Monitoring)

Based on record review, interview and observation of four patients (Patients #1, #5, #6 & #9) in a total sample of 11, the Hospital's Governing Body failed to ensure that Anesthesia Services implemented immediate preventative corrective actions to reduce patient adverse events of a like nature as Patient #1. The Hospital's Governing Body failed to ensure that Anesthesia Services measured compliance with corrective actions following Patient #1's adverse patient event. Patient #1 suffered an air embolism (air bubble) to the heart, bradycardia (slow heartbeat), hypotension (low blood pressure) and the administration of resuscitation (emergency) medications to return Patient #1's heartbeat and blood pressure to baseline (normal) after a Resident Anesthesiologist incorrectly prepared fluid warming machine intravenous tubing.

Findings included:

The document titled Quality Assessment and Performance Improvement Program, dated 2016, indicated if a Root Cause Analysis (Hospital internal investigation) resulted in recommendations to correct or prevent similar adverse events that lead to changes in patient practices. The document indicated that, when disseminating recommended practice changes, the organization must: (1) identify methods to audit change implementation and (2) follow-up to close the loop and ensure that practice change had been sustained.

The document titled Department of Anesthesiology Quality Management Plan, dated 2015, indicated that the Anesthesia Department aligned with the Hospital's quality plan and compliance with regulatory standards.

The Surveyor interviewed the Chief of Perioperative Anesthesia Operating Rooms Medical Director and the Executive Director of the Quality Improvement Program for the Anesthesia Department at 9:30 A.M. on 9/9/16. The Chief of Perioperative Anesthesia Operating Rooms Medical Director and the Executive Director of the Quality Improvement Program for the Anesthesia Department said that the corrective actions included:
(1) a Practice Alert distributed via electronic mail (e-mail, dated 9/1/16),
(2) evaluation of new fluid warming machines,
(3) re-education of the Anesthesia Technicians about removing the fluid warmer machine from the operating room at the end of the operation and (4) a presentation for physician case review scheduled for 9/19/16. The Chief of Perioperative Anesthesia Operating Rooms Medical Director and the Executive Director of the Quality Improvement Program for the Anesthesia Department said that they did not know if the intended recipients of the email read the email.

The document titled Hospital Internal Investigation, dated 8/30/16, did not indicate immediate effective corrective actions. The document indicated to refer to another document for the formal report.

The document titled Hospital Internal Investigation Final Version, undated, did not indicate immediate effective corrective actions.

The Surveyor interviewed the Executive Director of Quality Improvement Program for the Anesthesia Department at 12:50 on 9/9/16. The Executive Director of Quality Improvement Program for the Anesthesia Department said an email Practice Alert was distributed on 9/1/16 to the Anesthesiology Department. The Executive Director of Quality Improvement Program for the Anesthesia Department said the Anesthesia Department did not have documentation to validate that Attending Anesthesiologists received (read and implemented into practice) the Practice Alert recommendations. The Executive Director of Quality Improvement Program for the Anesthesia Department said that it was the Anesthesiology Department's standard practice to use an air filter unless the use of the air filter was contraindicated. The Executive Director of Quality Improvement Program for the Anesthesia Department said that it was the Attending Anesthesiologist's responsibility to assure proper preparation of fluid warming intravenous tubing, use of an air filter and documentation.

The Surveyor observed Anesthesia Services provided, at 1:15 P.M. on 9/9/16, to two (2) patients (Patients #5 & #6) that were identified to have a fluid warming machine but did not have an air filter during their surgery.

The Surveyor interviewed the Executive Director of the Quality Improvement Program for the Anesthesia Department at 11:00 A.M. on 9/14/16. The Executive Director of the Quality Improvement Program for the Anesthesia Department said that the Anesthesia Department distributed a Practice Alert on 9/13/16 regarding preparing the fluid warming machine intravenous tubing. The Executive Director of the Quality Improvement Program for the Anesthesia Department said that 100% of the Anesthesia Department acknowledged the Practice Alert. The Executive Director of the Quality Improvement Program for the Anesthesia Department said the Anesthesia Department implemented a Hotline Sign-Out Log.

The document titled SBAR: Hotline Equipment (Practice Alert), dated 9/13/16, distributed during the Survey, indicated that an air filter may be placed in the tubing proximal (close) to the patient (intravenous catheter) prior to starting the infusion whenever a fluid warming machine was in use. The Practice Alert indicated when an Anesthesiologist should not use an air filter. The document titled Attending Hotline Documentation Alert, dated 9/13/16, indicated the Attending Anesthesiologist must document that the fluid warming machine was used, if the air filter was used and that the tubing was primed and visually inspected for air prior to reaching the patient.

The document titled Hotline Sign-Out Log, undated, indicated the sign-out for the fluid warming machine with the patient's name, Attending Anesthesiologist's name, date, time of the sign-out and the operating room number.

The document titled Hotline Sign-Out Log, dated 9/13/16, indicated a fluid warming machine signed out for use to Patients #7, #8, and #9.

An Anesthesia Note, dated 9/13/16 for Patient #9, did not indicate documentation that the fluid warming machine was used and did not indicate the use of an air filter.

The Surveyor observed, on 9/14/16, a fluid warming machine at one (1), Campus W, of the two (2) Hospital off-site Operating Rooms.

The Surveyor interviewed Anesthesia Technicians #5 & #7, at 9:00 A.M. and 11:30 A.M. respectively on 9/15/16. Anesthesia Technician #5, located at Campus W and #7 located at Campus L, both said that the Hospital had not implemented or educated them regarding the Hotline Sign-Out Log at their respective off-site operating rooms.

The Surveyor interviewed the Patient Safety Manager at 8:30 A.M. on 9/16/16. The Patient Safety Manager said that the Hospital did not have a policy or procedure for Operating Room Turn Over (operating room procedures and personnel responsibilities for cleaning and removing equipment between the end of one operation and the beginning of the next operation).

The document titled Anesthesia Technician Meeting, dated 9/8/16, indicated two (2) Anesthesia Technicians did not attend the meeting that re-educated staff about the fluid warmer machines and Anesthesia Technologist responsibilities.

The Surveyor interviewed the Director of Patient Safety & Compliance at 12:00 P.M. on 9/26/16. The Director of Patient Safety and Compliance said an administrative triad, represented by the Chief Nursing Officer, Chief Quality Officer and Chief legal Counsel, approved the Anesthesia Department Plan of Correction.
The Surveyor interviewed the Patient Safety and Quality Vice President at 9:45 A.M. on 9/27/16. The Vice President said that although it was the Hospital's expectation that the Hospital QAPI processes integrated the Anesthesia Department QAPI processes and that the Hospital QAPI Plan described its integration, the Anesthesia Department Plan of Correction was not well integrated into the Hospital QAPI processes. The Vice President said that three (3) senior Hospital leaders, the administrative triad, approved the Anesthesia Department's Plan of Correction.

Based on review of 4 (Patients #1 , #5, #6 & #9) of 11 patients in a total sample of 11 clinical records, documents reviewed, observations and interviews, the Hospital's Governing Body failed to ensure that Anesthesia Services implemented preventive actions that included feedback and learning to the Intensive Care Units and the two (2) off-site operating rooms, Campus L and Campus W.

Findings included:

The Surveyor interviewed the Vice President of Surgery at 9:30 A.M. on 9/14/15. The Vice President of Surgery said that the fluid warming machines were used in the Intensive Care Units (ICU) and there were fluid warming machines located in operating rooms at two (2) off-site operating room locations, Campus L and Campus W.

The Surveyor interviewed the Patient Safety Manager at 2:55 P.M. on 9/9/16. The Patient Safety Manager said that the Intensive Care Units use fluid warming machines and that the ICU's did not use an air filter.

The Surveyor observed, on 9/14/16, a fluid warming machine at one (1), Campus W, of the two (2) Hospital off-site Operating Rooms.

The Surveyor interviewed Anesthesia Technicians #5 & #7, at 9:00 A.M and 11:30 A.M. respectively on 9/15/16. Anesthesia Technician #5, located at Campus W and Anesthesia Technician #7 located at Campus L, both said that the Hospital had not implemented or re-educated them regarding the Hotline Sign-Out Log at their respective off-site operating rooms.

Based on record reviewed, interview and observation for four (Patients
#1, #5, #6 & #9) of 11 patients, the Hospital's Governing Body failed to ensure that Anesthesia Services were responsible and accountable for quality improvement activites, including the reduction of medical errors, and that they were implemented and monitored after Patient #1's adverse event.

Findings included:

The Surveyor interviewed the Chief of Perioperative Anesthesia Operating Rooms Medical Director and the Executive Director of the Quality Improvement Program for the Anesthesia Department at 9:30 A.M. on 9/9/16. The Chief of Perioperative Anesthesia Operating Rooms Medical Director and the Executive Director of the Quality Improvement Program for the Anesthesia Department said that the Anesthesia Department conducted the Hospital internal investigation and the corrective actions included: (1) a Practice Alert distributed via electronic mail (e-mail, dated 9/1/16), (2) evaluation of new fluid warming machines, (3) re-education of the Anesthesia Technicians about removing the fluid warmer machine from the operating room at the end of the operation and (4) presentation for physician case review scheduled for 9/19/16.

The Chief of Perioperative Anesthesia Operating Rooms Medical Director and the Executive Director of the Quality Improvement Program for the Anesthesia Department said they did not know if the intended recipients of the email read the Practice Alert email. The Chief of Perioperative Anesthesia Operating Rooms Medical Director and the Executive Director of the Quality Improvement Program for the Anesthesia Department said that the Hospital's fluid warming machines were approximately 15 years old and did not have air filtration capability and that the Hospital was trialing a new fluid warming system on 9/12/16 (event date 8/23/16).

The Anesthesia Services internal investigation did not thoroughly analyze:
(1) Anesthesia Technologists' practice in preparing the fluid warming machine intravenous tubing, (2) Anesthesia Technologists' job description for their responsibility in preparing the fluid warming machine intravenous tubing, (3) Resident Anesthesiologists knowledge about Anesthesia Technologist responsibilities regarding the fluid warming machine and intravenous tubing preparation, (4) the need for Resident Anesthesiologist education or re-education, (5) the Resident Anesthesiologists inexperience, knowledge and time pressure factors in Patient #1's adverse event, (6) if a policy or procedure was needed regarding preparing the fluid warming machine and intravenous tubing for patient use, (7) consistency in practice between the Anesthesiology Department use of an air filter and the Hospital's policy titled Use of Intravenous Filters, (8) the Peripheral Intravenous Therapy policy, (9) other areas in the Hospital (Intensive Care Units) and off-site operating rooms that used the fluid warming machine,
(10) corrective action plans regarding staffing patterns for scheduled time off for Anesthesia Technicians, (11) cleaning procedures (turn-over) between the surgical case prior to Patient #1 and Patient #1's surgical case, (12) data collection procedures to monitor the effectiveness and compliance with operating room turn-over procedure and (13) data collection procedures to monitor the effectiveness and compliance of the Practice Alert distributed on 9/1/16.

The Anesthesia Services internal investigation did not implement data collection procedures to monitor the effectiveness and compliance with operating room turn-over procedure and data collection procedures to monitor the effectiveness and compliance of the Practice Alert distributed on 9/1/16.

The Condition of Participation for Anesthesia Services was not met based on review of four (Patients #1, #5, #6 & #9) of 11 patients in a total sample of 11 clinical records, documents reviewed, observations and interviews the Hospital failed to ensure Anesthesia Services: (1) provided anesthesia services in a well-organized manner, (2) thoroughly analyzed Patient #1's adverse patient event, (3) immediately implemented corrective (prevention) action(s), and (4) collected data to monitor identified corrective action(s) effectiveness, safety of Anesthesia Services, quality of care and performance improvement.

Findings include:

The Hospital failed to provide Anesthesia Services in a safe and well-organized manner when a Resident Anesthesiologist incorrectly prepared fluid warming machine intravenous tubing resulting in Patient #1 receiving an air embolism (air bubble) to the heart, bradycardia (slow heartbeat), hypotension (low blood pressure) and the administration of resuscitation (emergency) medications to return Patient #1's heartbeat and blood pressure to baseline.

Refer to TAG: A-1001

The Hospital failed to provide Anesthesia Services consistent with recognized standards for anesthesia care when a Resident Anesthesiologist incorrectly prepared fluid warming machine intravenous tubing resulting in Patient #1 receiving an air embolism to the heart, bradycardia, hypotension and the administration of resuscitation medications to treat Patient #1's bradycardia and hypotension.

Refer to TAG: A-1002

Based on record reviewed, interviews and observation for four (Patients
#1, #5, #6 & #9) of 11 patients, the Hospital failed to provide care governing Anesthesia Services in a safe and well-organized manner when a Resident Anesthesiologist incorrectly prepared fluid warming machine intravenous tubing resulting in Patient #1 receiving an air embolism (air bubble) to the heart, bradycardia (slow heart beat), hypotension (low blood pressure) and the administration of resuscitation (emergency) medications to treat Patient #1's bradycardia and hypotension.

Findings included:

The Admission Note, dated 8/23/16, indicated the Hospital admitted Patient #1 for surgery to correct his/her hip dysplasia (abnormality). The note indicated an anesthesia complication.

The Anesthesia Record, dated 9/23/16, indicated a cardiovascular (heart) collapse event after an intravenous catheter was placed, the fluid warming intravenous tubing was attached and air was observed in the tubing as the fluid began to run and the tubing was disconnected. The Anesthesia Record indicated a decrease in Patient #1's end tidal carbon dioxide level (decrease lung blood flow), bradycardia and hypotension. The Anesthesia Record indicated personnel administered Atropine and Epinephrine (resuscitation medications). The Anesthesia Record indicated an echocardiogram (heart ultrasound) showed that the air resolved in Patient #1's right ventricle (heart) over five (5) minutes. The Anesthesia Record indicated surgeons performed a hip closed reduction (restored the hip to the correct alignment) and Spica (over hip and waist) casting versus open hip reduction (surgery) because Patient #1's hip was now reducible under anesthesia.

Discharge Documentation, dated 8/24/16, indicated physicians discharged Patient #1 to home, doing well, without a fever and with stable (normal) vital signs and a cardiology (heart doctor) follow-up appointment scheduled.

The document titled Department of Anesthesiology Quality Management Plan, dated 2015, indicated that the Anesthesia Department included data collection, quality analysis and monitoring to improve systems and improve patient care.

The document titled Perioperative System Improvement Anesthesia, Perioperative and Pain Medicine Process and Procedures, dated 9/26/16, indicated the committee responsibility was to investigate, provide recommendations (improvement actions) and monitor adverse events with the intent of reducing adverse events to the lowest possible level in incidence and severity.

The Surveyor interviewed the Chief of Perioperative Anesthesia Operating Rooms Medical Director and the Executive Director of the Quality Improvement Program for the Anesthesia Department at 9:30 A.M. on 9/9/16. The Chief of Perioperative Anesthesia Operating Rooms Medical Director and the Executive Director of the Quality Improvement Program for the Anesthesia Department said that the Anesthesia Department conducted the Hospital internal investigation and discovered that Patient #1 had an air embolism because the Resident Anesthesiologist believed that the fluid warming machine intravenous tubing was prepared, primed (intravenous fluid passed through the intravenous tubing) and ready for use by the Anesthesia Technicians. The Chief of Perioperative Anesthesia Operating Rooms Medical Director and the Executive Director of the Quality Improvement Program for the Anesthesia Department said that the fluid warming machine intravenous tubing was not primed and ready for use because Anesthesia Technicians were not required to prepare the fluid warming machine intravenous tubing and that the fluid warming machine was left in Patient #1's operating room from the previous patient operation the day before and was not removed from Patient #1's operating room. The Chief of Perioperative Anesthesia Operating Rooms Medical Director and the Executive Director of the Quality Improvement Program for the Anesthesia Department said that the fluid warming machine was not removed from Patient #1's room because the Hospital did not have an Anesthesiology Technician working on the shift prior to Patient #1's operation because the Hospital had approved a scheduled time off for the Anesthesia Technician. The Chief of Perioperative Anesthesia Operating Rooms Medical Director and the Executive Director of the Quality Improvement Program for the Anesthesia Department said that the Hospital's fluid warming machines were approximately 15 years old and did not have air filtration capability and the Hospital was trialing a new fluid warming system on 9/12/16 (event date was 8/23/16).

The Chief of Perioperative Anesthesia, Operating Rooms Medical Director and the Executive Director of Quality Improvement Program for the Anesthesia Department said that the corrective actions included: (1) a Practice Alert distributed via electronic mail, (2) evaluation of new fluid warming machines, (3) re-education of the Anesthesia Technicians about removing the fluid warmer machine from the operating room at the end of the operation and (4) presentation for physician case review, scheduled for 9/19/16. The Chief of Perioperative Anesthesia Operating Rooms Medical Director and the Executive Director of the Quality Improvement Program for the Anesthesia Department said that they did not know if the intended recipients of the email read the email.

The Surveyor interviewed and observed, at 11:30 A.M. on 9/9/16, a demonstration of the fluid warming machine presented by Anesthesiologist #1. The Surveyor observed that Anesthesiologist #1 connected an air filter device to the fluid warming machine intravenous tubing. Anesthesiologist #1 said that Anesthesiologists used the air filter unless there was a reason not to use the air filter (for example if the Patient had a latex allergy).

The Surveyor interviewed the Executive Director of Quality Improvement Program for the Anesthesia Department at 12:50 on 9/9/16. The Executive Director of Quality Improvement Program for the Anesthesia Department said that the Resident Anesthesiologist did not use an air filter on the fluid warming machine intravenous tubing used for Patient #1. The Executive Director of Quality Improvement Program for the Anesthesia Department said that guidelines for using the air filter was not included in the email Practice Alert distributed on 9/1/16 because it was the Anesthesiology Department's standard of practice to use an air filter unless the use of the air filter was contraindicated. The Executive Director of Quality Improvement Program for the Anesthesia Department said that it was the Attending Anesthesiologist's responsibility to assure that an air filter was used and that the Anesthesia Department did not have documentation to validate that the Attending Anesthesiologist assured that the air filter was used.

The Surveyor observed Anesthesia Services provided, at 1:15 P.M. on 9/9/16, 2 patients (Patients #5 & #6) of 2 Patients, identified to have a fluid warming machine and did not have an air filter during their surgery.

The Practice Alert distributed by e-mail, dated 9/1/16, did not indicate guidelines for using an air filter.

The document titled Anesthesia Technician I, dated 4/8/15, indicated that Anesthesia Technicians prepared all patient intravenous fluids and intravenous equipment as requested by the Anesthesiologist.

The Surveyor interviewed Anesthesia Technician #1 at 10:20 A.M. on 9/14/16. Anesthesia Technician #1 said he prepared fluid warming machine intravenous tubing by spiking the bag priming the tubing with the fluid.

The Surveyor interviewed Anesthesia Technician #2 at 10:30 A.M. on 9/14/16. Anesthesia Technician #2 said he would set up the fluid warming machine intravenous tubing by spiking the bag and priming the tubing if asked by the Anesthesiologist.

The document titled SBAR: Hotline Equipment (Practice Alert), dated 9/13/16 and distributed during the Survey, indicated that an air filter may be placed in the tubing proximal (close) to the patient (intravenous catheter) prior to starting the infusion whenever a fluid warming machine was in use. The Practice Alert indicated when an Anesthesiologist should not use an air filter.

The document titled Attending Hotline Documentation Alert, dated 9/13/16, indicated the Attending Anesthesiologist must document that the fluid warming machine was used, if the air filter was used and that the tubing was primed and visually inspected for air prior to reaching the patient.

The document titled Hotline Sign-Out Log, dated 9/13/16, indicated a fluid warming machine signed out for use with Patients #7, #8, and #9.

An Anesthesia Note, dated 9/13/16 for Patient #9, did not indicate documentation that the fluid warming machine was used and did not indicate the use of an air filter.

The document titled Anesthesia Technician Meeting, dated 9/8/16, indicated two (2) Anesthesia Technicians did not attend the meeting that provided re-education about the fluid warmer machines and Anesthesia Technologist responsibilities.

The Hospital policy titled Use of Intravenous Filters, dated 6/12/14, did not indicate the use of a filter when using a fluid warming machine.

The Surveyor interviewed the Vice President of Surgery at 9:30 A.M. on 9/14/15. The Vice President of Surgery said that the fluid warming machines were used in the Intensive Care Units (ICU) and there were fluid warming machines located in operating rooms at two (2) off-site operating room locations (Campus L and Campus W).

The document titled Hotline Sign-Out Log, undated, indicated the sign-out for the fluid warming machine with the patient's name, attending anesthesiologist's name, date, time of the sign-out and the operating room number.

The Surveyor interviewed Anesthesia Technicians #5 & #7, at 9:00 A. M and 11:30 A.M. respectively on 9/15/16. Anesthesia Technician #5, located at Campus W and Anesthesia Technician #7, located at Campus L, both said that the Hospital had not implemented or re-educated them regarding the Hotline Sign-Out Log at their respective off-site operating rooms.

The policy titled Circulating Nurse Role, dated 2/5/15, indicated the Circulating Nurse coordinated and provided intra-operative patient care outside the sterile field and organized and arranged the surgical suite for planned procedure(s).

Three (3) policies titled: Surgical, Invasive Areas and Delivery Rooms, Between Cases, dated © Sodexo 2010, Surgical, Invasive Areas and Delivery Rooms, Terminal Cleaning at the end of each day, dated © Sodexo 2010, and Surgical, Invasive Areas and Delivery Rooms, Weekly Cycle Cleaning, dated © Sodexo 2010, indicated procedures for cleaning. The three (3) policies did not indicate Hospital staff responsibility for the removal of a fluid warming machine from the operating room.

The Hospital policy titled Cleaning, Disinfection and Sterilization of Patient Care Equipment, dated 11/0/15, indicated all contaminated (soiled) items waiting reprocessing (cleaning), staff labeled as soiled and stored in a soiled utility room. The policy indicated the Hospital stored all clean items in a clean area labeled with a Clean Equipment tag.

The Anesthesia Services internal investigation did not address corrective action plans for the analysis of: (1) Other areas in the Hospital and off-site operating rooms that use the fluid warming machine, (2) Resident knowledge about Anesthesia Technologist responsibilities regarding the fluid warming machine, (3) Resident education or re-education. The Anesthesia Services internal investigation did not analyze: (4) if a policy or procedure was needed regarding using the fluid warming machine and (5) corrective action plans regarding staffing patterns for scheduled time off for Anesthesia Technicians and did not implement data collection to monitor the effectiveness and compliance of the Practice Alert distributed on 9/1/16.

Based on review of 1 (Patient #1) of 11 in a total of 11 clinical records, interviews and documents reviewed the Hospital failed to provide Anesthesia Services consistent with recognized standards for anesthesia care, when a resident anesthesiologist incorrectly prepared a fluid warming machine, resulting in Patient #1 receiving an air embolism (bubble) to the heart, bradycardia (slow heart beat), hypotension (low blood pressure) and resuscitation (emergency) medications to treat the bradycardia and hypotension.

Findings included:

The Admission Note, dated 8/23/16, indicated the Hospital admitted Patient #1 for surgery to correct his/her hip dysplasia (abnormality). The note indicated an anesthesia complication. Anesthesia Record, dated 9/23/16, indicated a cardiovascular (heart) collapse event after an intravenous catheter was placed, the fluid warming intravenous tubing was attached, air was observed in the tubing as the fluid began to run and the tubing was disconnected. The Anesthesia Record indicated an echocardiogram (heart ultrasound) showed that the air resolved in Patient #1's right ventricle (heart) over five (5) minutes.

The Surveyor interviewed the Executive Director of Quality Improvement Program for the Anesthesia Department at 12:50 on 9/9/16. The Executive Director of Quality Improvement Program for the Anesthesia Department said it was the Anesthesiology Department's standard practice to use an air filter unless the use of the air filter was contraindicated and that it was the Attending Anesthesiologist's responsibility to assure proper preparation of fluid warming intravenous tubing and use of an air filter. The Executive Director of Quality Improvement Program for the Anesthesia Department asaid that the Resident Anesthesiologist did not use an air filter on the fluid warming machine intravenous tubing used for Patient #1.

The document titled L-70 Hotline Fluid Warming Set (manufacturer package insert information), undated, indicated to connect the distal end of the Hotline Fluid Warming Set to the patient's intravenous access site without entrapping air.