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Based on review of hospital documentation, a review of policies and procedures, a review of committee meeting minutes and staff interviews, the hospital failed to ensure anesthesia, pharmacy, laboratory services and other multiple departments developed, implemented and maintained an effective, ongoing, hospital wide, data-driven quality assessment and performance improvement program which resulted in condition level non-compliance.

Please refer to A273, A297, A308, A309

Based on a review of hospital documentation, a review of policies and procedures, a review of committee meeting minutes and interviews, the hospital failed to comprehensively collect and analyze data for the department of anesthesia, laboratory services and multiple other departments to monitor the effectiveness and safety of services and quality of care. The finding included:

Interview and review of the quality committee minute meetings dated October 2016 to August of 2018 with the Director of Quality on 9/28/18 at 11:00am failed to identify that the department of anesthesia, pharmacy, laboratory services and multiple other departments reported to the quality committee.

Review of the reporting schedule for year 2018 for the Medical Quality and Safety Committee failed to identify that each department in the hospital was scheduled to report to the Quality Committee at regular intervals. The hospital failed to have a record of the reporting schedule for 2016 or 2017.

Interview with the Director of Quality on 9/28/18 at 11:00am indicated she was hired in April of 2018 and was not aware that each department was absent from the reporting schedule. Further interview identified that she was not aware that each department would be responsible to identify high risk areas, collect data, analyze the data, take action aimed at performance improvement, track performance to ensure sustainability, and to report the information to the quality committee on a routine basis.

Interview with the Chief Nursing Officer (CNO) and the Chief Medical Officer (CMO) on 9/26/18 at 4:00 PM indicated they were not aware that each department was not on the 2018 reporting schedule and that each department had not attended the quality meeting routinely to discuss high risk areas in each service line, provide data collection, analysis, and implementation of improvement projects to reflect the betterment of health care outcomes in all areas. Further interview with the CNO and CMO identified they were hired in February of 2018 and indicated the failure to ensure that all components of the quality department were inclusive and comprehensive was likely due to the transition in leadership of the hospital.

Review of the Performance Improvement Management Plan dated January 2016 directed in part, a continuous improvement strategy that incorporated the review, measurement, assessment, and improvement activities for organization-wide performance to ensure quality service to patients. The plan included the development and deployment of methods to improve organizational areas based on data specific to the department's scope of care. Performance improvement strategies would also be based on measurement and assessment of process outcomes. The quality committee would ensure that process design facilitates current practice and was clinically sound. Furthermore, the committee would ensure the same level of care to all patients through a cross functional review of patient care activities provided by personnel delivering direct care and support services. The committee would assess the departmental performance information as it related to the scope of care and would be responsible to ensure the development and deployment of all performance improvement strategies.

Based on review of hospital documentation, a review of policies and procedures, a review of committee meeting minutes and staff interviews, the hospital failed to comprehensively focus on high risk, or problem prone areas and take action at performance improvement activities, measure its success and ensure sustainability for the department of anesthesia, pharmacy, laboratory services and multiple other departments. The finding included:

Interview and review of the quality committee minute meetings dated October 2016 to August of 2018 with the Director of Quality on 9/28/18 at 11:00 am failed to identify that the department of anesthesia, laboratory services and multiple other departments reported to the quality committee.

Review of the reporting schedule dated 2018 for the Medical Quality and Safety Committee failed to identify that each department in the hospital was scheduled to report to the Quality Committee at regular intervals. The hospital failed to have record of the reporting schedule for 2016 or 2017.

Further interview with the Director of Quality on 9/28/18 at 11:00am indicated she was hired in April of 2018 and was not aware that each department was absent from the reporting schedule. Moreover, the Director of Quality identified she was not aware that each department would be responsible to identify high risk areas, collect, analyze data, take action aimed at performance improvement, track performance to ensure sustainability and to report the information to quality on a routine basis.

Interview with the Chief Nursing Officer (CNO) and the Chief Medical Officer (CMO) on 9/26/18 at 4:00 PM indicated they were not aware that each department was not on the 2018 reporting schedule and that each department had not attended the quality meeting routinely to discuss high risk areas in each service line, provide data collection, analysis, and implementation of improvement projects to reflect the betterment of health care outcomes. Further interview with the CNO and CMO identified they were hired in February of 2018 and indicated the failure to ensure that all components of the quality department were inclusive and comprehensive was likely due to the transition in leadership of the hospital.

Review of the Performance Improvement Management Plan dated January 2016 directed in part, a continuous improvement strategy that incorporated the review, measurement, assessment, and improvement activities for organization-wide performance to ensure quality service to patients. The plan included the development and deployment of methods to improve organizational areas based on data specific to the department's scope of care. Performance improvement strategies would be based on measurement and assessment of process outcomes. The quality committee would ensure that process design facilitates current practice and was clinically sound. Furthermore, the committee would ensure the same level of care to all patients through a cross functional review of patient care activities provided by personnel delivering direct care and support services. The committee would assess the departmental performance information as it related to the scope of care and would be responsible to ensure the development and deployment of all performance improvement strategies.

Based on review of hospital documentation, review of policies and procedures, review of committee meeting minutes and interviews, the hospital failed to develop annual improvement projects for the departments of anesthesia, pharmacy, laboratory including multiple other departments. The finding included:


Interview and review of the quality committee minute meetings dated October 2016 to August of 2018 with the Director of Quality on 9/28/18 at 11:00 AM failed to identify that the department of anesthesia, pharmacy, laboratory services and multiple other departments reported to the quality committee. Further review of the quality committee minute meeting dated October 2016 to August of 2018 failed to identify annual improvement projects.

Review of the reporting schedule dated 2018 for the Medical Quality and Safety Committee failed to identify that each department in the hospital was scheduled to report to the Quality Committee at regular intervals. The hospital failed to have record of the reporting schedule for 2016 or 2017.

Review of the Performance Improvement Management Plan dated January 2016 failed to identify that annual improvement projects were the responsibility of the quality committee.

Further interview with the Director of Quality indicated she was hired in April of 2018 and was not aware that each department was absent from the reporting schedule. Moreover, the Director of Quality identified she was not aware that annual improvement projects should have been identified and incorporated into the Performance Improvement Management Plan.

Interview with the Chief Nursing Officer (CNO) and the Chief Medical Officer (CMO) on 9/26/18 at 4:00 PM indicated they were not aware that each department was not on the 2018 reporting schedule and had not attended the quality meeting routinely to discuss high risk areas in each service line, provide data collection, analysis, and implementation of improvement projects to reflect the betterment of health care outcomes. Additionally, the CNO and CMO were not aware that the annual improvements had not been identified for 2018. Further interview with the CNO and CMO indicated they were hired in February of 2018 and identified the failure to ensure that all components of the quality department were inclusive and comprehensive was likely due to the transition in leadership.

Based on review of hospital policies, a review of facility documentation, review of hospital meeting minutes and interviews, the hospital failed to ensure anesthesia, pharmacy, laboratory, and multiple other departments were incorporated in the hospital-wide QAPI (Quality Assurance Performance Improvement) Committee.
The finding included:

Interview and review of the quality committee minute meetings dated October 2016 to August of 2018 with the Director of Quality on 9/28/18 at 11:00am failed to identify that the department of anesthesia, pharmacy, laboratory services and multiple other departments reported to the quality committee.

Review of the reporting schedule dated 2018 for the Medical Quality and Safety Committee failed to identify that each department in the hospital was scheduled to report to the Quality Committee at regular intervals. Further review identified that the hospital failed to have record of the reporting schedule for 2016 or 2017.

Further interview with the Director of Quality indicated she was hired in April of 2018 and was not aware that each department was absent from the reporting schedule. Moreover, the Director of Quality identified she was not aware that each department would be responsible to identify high risk areas, collect, analyze data, take action aimed at performance improvement, track performance to ensure sustainability and to report the information to quality on a routine basis.

Interview with the Chief Nursing Officer (CNO) and the Chief Medical Officer (CMO) on 9/26/18 at 4:00 pm indicated they were not aware that each department was not on the 2018 reporting schedule and had not attended the quality meeting routinely to discuss high risk areas in each service line, provide data collection, analysis, and implementation of improvement projects to reflect the betterment of health care outcomes. Further interview with the CNO and CMO identified they were hired in February of 2018 and indicated the failure to ensure that all components of the quality department were inclusive and comprehensive was likely due to the transition in leadership.

Review of the Performance Improvement Management Plan dated January 2016 directed in part, a continuous improvement strategy that incorporated the review, measurement, assessment, and improvement activities for organization-wide performance to ensure quality service to patients. The plan included the development and deployment of methods to improve organizational areas based on data specific to the department's scope of care. Performance improvement strategies would be based on measurement and assessment of process outcomes. The quality committee would ensure that process design facilitates current practice and was clinically sound. Furthermore, the committee would ensure the same level of care to all patients through a cross functional review of patient care activities provided by personnel delivering direct care/support services. The committee would assess the departmental performance information as it related to the scope of care and would be responsible to ensure the development and deployment of all performance improvement strategies.

Further review of the Performance Improvement Management Plan dated January 2016 directed that the Quality and Patient Safety Committee would assist the board in overseeing and ensuring the quality of clinical care and patient safety for the hospital. The Board of Directors would maintain ultimate responsibility for the effectiveness of the performance improvement management system.

Based on review of hospital documentation, review of policies and procedures, review of committee meeting minutes and staff interviews, the hospital failed to comprehensively address priorities for improved quality care and determine the number of distinct improvement projects to be conducted annually. The finding included:


Interview and review of the quality committee minute meetings dated October 2016 to August of 2018 with the Director of Quality on 9/28/18 at 11:00 am failed to identify that the department of anesthesia, pharmacy, laboratory services and multiple other departments reported to the quality committee.

Review of the reporting schedule dated 2018 for the Medical Quality and Safety Committee failed to identify that each department in the hospital was scheduled to report to the Quality Committee at regular intervals.The hospital failed to have record of the reporting schedule for 2016 or 2017. Further review of the quality committee minute meeting dated October 2016 to August of 2018 failed to identify annual improvement projects.

Review of the Performance Improvement Management Plan dated January 2016 failed to identify that annual improvement projects were part of the responsibility of the quality committee.

Further interview with the Director of Quality indicated she was hired in April of 2018 and was not aware that each department was absent from the reporting schedule. Moreover, the Director of Quality identified she was not aware that annual improvement projects should have been identified and incorporated into the Performance Improvement Management Plan.

Interview with the Chief Nursing Officer (CNO) and the Chief Medical Officer (CMO) on 9/26/18 at 4:00 PM indicated they were not aware that each department was not on the 2018 reporting schedule and had not attended the quality meeting routinely to discuss high risk areas in each service line, provide data collection, analysis, and implementation of improvement projects to reflect the betterment of health care outcomes. Additionally, the CNO and CMO were not aware that the annual improvements had not been identified for 2018. Further interview with the CNO and CMO identified they were hired in February of 2018 and indicated the failure to ensure that all components of the quality department were inclusive and comprehensive was likely due to the transition in leadership.

Based on observation, a review of hospital documentation, contractor reports, interviews and policies, it was determined that the hospital failed to meet the Condition of Participation for Pharmaceutical Services as evidenced by:


1. The hospital failed to ensure that the Pharmacy Director effectively supervised the day to day operations of the Pharmacy Department as evidenced by the failure to ensure safe pharmaceutical practices for beyond use dating and/or the failure to develop, implement, and follow policy/procedures, and/or the failure to ensure pharmacy and environmental staff were adequately trained on applicable pharmacological standard operating procedures to maintain compliance with federal and state laws (USP-797).



Please refer to A491, A492 and A501

Based on observation, review of facility documentation, interviews and a review of policies and procedures, the hospital failed to ensure safe pharmaceutical practices for beyond use dating and/or failed to provide evidence of policies and procedures that were consistent with acceptable professional principles and/or failed to conduct training of staff on applicable pharmacological standard operating procedures in accordance with Federal and/or state laws, United States Pharmacopeia, Chapter 797, Pharmaceutical Compounding (USP-797). The findings included:


a. During a tour of the pharmacy on 10/3/18 with the Department of Consumer Protection (DCP), it was noted that multiple compounded medications located in the refrigerator were absent a label that identified beyond use dating (BUD) and/or a multidose vial of Gentamycin was not labeled with the BUD.

Interview with the Director of the Pharmacy on 10/3/18 indicated that the pharmacy staff had been utilizing expiration dates for most sterile compounding preparations that identified a two day expiration date. Subsequent to the surveyor inquiry, the Director of Pharmacy identified that all Compounded Sterile Preparations (CSP's) would be immediately labeled with the appropriate BUD in accordance with USP 797 guidelines.

b. During a tour of the pharmacy on 10/3/18 it was observed that the Pharmaceutical staff and Environmental services failed to wash hands for thirty seconds up to their elbow.

c. During a tour of the pharmacy on 10/3/18 it was observed that the Pharmaceutical staff and Environmental services failed to clean their fingernails with a nail pick during the handwashing process.

d. During a tour of the pharmacy on 10/3/18 it was observed that the Pharmaceutical staff and Environmental services failed to dry their hands with a non-shedding towel.

e. During a tour of the pharmacy on 10/3/18 it was observed that the Pharmacy Techician was wearing makeup.

f. During a tour of the pharmacy on 10/3/18 it was observed that the Pharmacist had exposed skin.

g. During a tour of the pharmacy on 10/3/18 it was observed that the Environmental staff failed to wear a gown that provided appropriate coverage.

h. During a tour of the pharmacy on 10/3/18 it was observed that the Pharmaceutical Technicians failed to dispose of their gowns and could not identify if the gown was reusable per manufacturers recommendation.

i. During a tour of the pharmacy on 10/3/18 it was observed that the Pharmaceutical staff failed to utilize sterile gloves during compounding preparation and failed to don sterile gloves over the isolator gloves.

j. During a tour of the pharmacy on 10/3/18 it was observed that the Pharmaceutical staff failed to use a waterless based alcohol scrub subsequent to leaving the isolator and prior to resuming compounding.

k. During a tour of the pharmacy on 10/3/18 it was observed that Environmental services staff and the Pharmacy Technician placed a shoe cover on their feet and failed to step across the line of demarcation in accordance with USP 797.

l. During a tour of the pharmacy on 10/3/18 it was observed that reusable mop handles were not in original working condition and not labeled.

m. During a tour of the pharmacy on 10/3/18 it was observed that the Pharmaceutical staff and Environmental Services failed to differentiate that mini-mop handles used for the hazardous versus the non-hazardous isolator.

n. During a tour of the pharmacy on 10/3/18 it was observed the Environmental staff failed to document the mixing and diluting of cleaning and sanitizing agents via a log.

o. During a tour of the pharmacy on 10/3/18 it was observed that Pharmacy Technicians failed to appropriately label the sterile isopropyl alcohol when it was opened and/or the expiration date.

p. During a tour of the pharmacy on 10/3/18 it was observed that the Environmental staff failed to document that the the cart utilized in the segregated compounding area was cleaned daily.

q. During a tour of the pharmacy on 10/3/18 it was observed that a fatigue mat was utilized however the documentation failed to identify how it was cleaned and/or appropriate for use.

r. During a tour of the pharmacy on 10/3/18 it was observed that a tacky mat was utilized outside of the segregated compounding area and failed to be located directly in front of the entry door.

s. During a tour of the pharmacy and a review of the manufacturers guidelines for cleaning of the isolators on 10/3/18, it was identified that the dwell time should be ten minutes however, an observation indicated the drying time in parts of the isolator was ninety seconds and the technician failed to rewet the surfaces to ensure the appropriate dwell time.

t. During a tour of the pharmacy on 10/3/18, it was observed the facility failed to have non-permeable surfaces to ensure appropriate cleaning ie. wood doors, particle boards under counters, walls and ceilings.

u. During a tour of the pharmacy on 10/3/18, it was observed in the sterile compounding room, the facility failed to ensure walls were painted with epoxy based paint, additionally bare wood was observed.

v. During a tour of the pharmacy on 10/3/18, it was observed in the sterile compounding room, the facility failed to ensure that light fixtures were sealed.

w. During a tour of the pharmacy on 10/3/18, it was observed that the segregated compounding area was overstocked with unused sharps containers and a large supply of isolator gloves.

x. Review of the hospital documentation failed to identify that agar plates were utilized for fingertip testing and that documentation lacked the results, hand designation, the dates, incubation temperature, signature of observer and that daily checks were conducted.

y. Review of the hospital documentation failed to identify that media fill tests final results were documented as pass or fail. Further review failed to include the incubation time or temperature, and/or the media testing procedures failed to include the fill volume, inspection of filled units, interpretation of results and action levels with the correct actions required.

z. Review of the hospital documentation failed to identify that compounding and environmental service staff have documented competencies for gowning and handwashing.

aa. Review of the hospital documentation failed to identify a risk acknowledgement and/or that compounding personnel had hazardous didactic training and/or that observational assessments were documented.

bb. Review of the hospital documentation failed to identify that the compounding containment isolator failed to have documentation that indicated the room in which it was located maintained a minimum of twelve air exchanges per hour.

cc. Review of the hospital documentation failed to indicate the volume of the primary engineering control (PEC) when obtaining air samples.

dd. Review of the pharmacies standard operating procedures (SOP) identified the hospital failed to comprehensively address SOP's for the clean room regarding cleaning and environmental testing.

ee. Review of the pharmacies standard operating procedures identified the hospital failed to address that all sterile compounds would be identified as hazardous.

ff. Review of the pharmacies standard operating procedures identified the hospital failed to address if gowns utilized in the sterile compounding room were reusable per manufacturers recommendations and if they were not disposable, where and how would they be stored.

gg. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP regarding how frequency the tacky mat would be changed or replaced.

hh. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP that directed how frequent the fatigue matt would be changed or replaced and/or its appropriate location.

ii. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP prohibiting personnel from entering the compounding area and/or clean room if they had a sunburn, weeping sores, conjunctivitis or an active respiratory infection.

jj. Review of the pharmacies standard operating procedures identified the hospital failed to have an SOP that directed all personnel in the compounding area were required to remove all jewelry and makeup.

kk. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP that prohibited all personnel from wearing artificial nails or extenders, and that required staff to keep natural nails neat and trimmed.

ll.Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP regarding how frequency the fatigue mat would be changed or replaced.

mm. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP regarding how every CSP would be visually inspected for the presence of particulate matter, evidence of incompatibility or other issues.

nn. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP that directed single dose containers, bags, bottles, syringes or vials that were opened or punctured in worse than ISO Class 5 air would be used within one hour and the remaining contents discarded and/or how are they identified for expiration.

oo. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP that directed single dose vials exposed to ISO 5 air or cleaner would be used within six hours of the initial puncture and any remaining contents discarded and/or how are they identified for expiration.

pp. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP that directed multiple dose vials assigned a BUD of twenty eight days or the manufacturers specific BUD, (whichever was less) after the initial entry or puncture and/or how are multi-dose vials identified for expiration after they have been opened or punctured.

qq. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP for in process checks performed by a pharmacist and to ensure that procedures were followed.

rr. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP that directed if a CACI (compounding aseptic container isolator) was used, the room in which it was located needed to be certified to a minimum or 12 ACPH (air change per hour).

ss. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP that directed all compounding staff would have passed an initial and subsequent annual competency assessments of aseptic compounding skills including handling hazardous drugs and that all pharmacists and technicians performing compounding using hazardous drugs were appropriately trained in the safe handling, garbing, cleaning, and disinfecting procedures and waste disposal of hazardous drugs and materials.

Interview with the Director of the Pharmacy on 10/4/18 at 2:00 PM indicated although the staff was trained in USP 797 guidelines he was unaware of the garbing procedures as this pharmacy had isolators and not a "clean room". The Director of Pharmacy identified he did not conduct surveillance of garbing, handwashing or cleaning therefore was unaware that the USP 797 were not performed in accordance with the regulations. Further interview identfied that the Director was unaware that the hospital's standard operating procedures were not comprehensive.

Interview with the Infection Control Nurse on 10/4/18 at 2:15 PM identified she was new in the infection control role and although she was aware that aspectic compounding was a high risk area, she had not initiated surveillance rounds to ensure garbing, handwashing and that all infection control practices were maintained in this area of the pharmacy.

Interview with the Director of Environmental Services on 10/4/18 at 1:20pm identified he was not aware that a mixing log was needed to verify the appropriate cleaning solutions and their amounts. Additionally, the Director of Environmental Services indicated the Environmental staff was trained on gowning, handwashing and cleaning of the compounding area by the operations manager however documentation of the training was not available.

An immediate plan of action dated 10/4/18 directed a policy would be created for Beyond Use Dating for all CSP's. Expiration dates would no longer be used. All new CSP's would immediately be labeled with a BUD and all other CSP's with expiration dates would be disposed of. Compounding staff would be trained immediately or prior to the next working shift by the pharmacy manager.

The immediate plan of action directed that a policy would be written for proper hand hygiene for entry into the compounding area including the use of sterile gloves, lint free towels, the use of full gown coverage and garbing in relationship to the line of demarcation. Training would be completed prior to the next working shift by the pharmacy manager and by the infection control nurse. Additionally, the fatigue mat, extra sharp containers and clutter was removed from the compounding area on 10/4/18. Moreover the staff would be immediately trained when cleaning the isolators to ensure a dwell time of ten minutes until an alternate cleaning product could be obtained. This training would be conducted by the pharmacy manager prior to the next working shift.

Based on observation, a review of facility documentation, interviews, and policy review, the hospital failed to provide the necessary supervision of pharmacy services to ensure that policies and procedures were developed and comprehensive related to the preparation of compounding medications, and/or failed to provide evidence of staff training, and/or failed to ensure a process was in place to monitor adherence to the policies and procedures in accordance with Federal and/or state laws, United States Pharmacopeia, Chapter 797, Pharmaceutical Compounding (USP-797). The findings include:

a. During a tour of the pharmacy on 10/3/18 with the Department of Consumer Protection (DCP), it was noted that multiple compounded medications located in the refrigerator were absent a label that identified beyond use dating (BUD) and/or a multidose vial of Gentamycin was not labeled with the BUD.

Interview with the Director of the Pharmacy on 10/3/18 indicated that the pharmacy staff had been utilizing expiration dates for most sterile compounding preparations that identified a two day expiration date. Subsequent to the surveyor inquiry with the Director of Pharmacy identified that all Compounded Sterile Preparations (CSP's) would be immediately labeled with the appropriate BUD in accordance with USP 797 guidelines.

b. During a tour of the pharmacy on 10/3/18 it was observed that the Pharmaceutical staff and Environmental services failed to wash hands for thirty second up to their elbow.

c. During a tour of the pharmacy on 10/3/18 it was observed that the Pharmaceutical staff and Environmental services failed to clean their fingernails with a nail pick.

d. During a tour of the pharmacy on 10/3/18 it was observed that the Pharmaceutical staff and Environmental services failed to dry their hands with a non-shedding towel.

e. During a tour of the pharmacy on 10/3/18 it was observed that the Pharmacy Technician was wearing makeup.

f. During a tour of the pharmacy on 10/3/18 it was observed that the Pharmacist had exposed skin.

g. During a tour of the pharmacy on 10/3/18 it was observed that Environmental staff failed to wear a gown that provided appropriate coverage.

h. During a tour of the pharmacy on 10/3/18 it was observed that the Pharmacy Technician failed to dispose of gowns and could not identify if the gown was reusable per manufacturers recommendation.

i. During a tour of the pharmacy on 10/3/18 it was observed that Pharmaceutical staff failed to utilize sterile gloves during compounding preparation and failed to don sterile gloves over the isolator gloves.

j. During a tour of the pharmacy on 10/3/18 it was observed that the Environmental and Pharmacy Techician failed to use a waterless based alcohol scrub subsequent to leaving the isolator and prior to resuming compounding.

k. During a tour of the pharmacy on 10/3/18 it was observed that Environmental services and the Pharmacy Technician placed a shoe covers on their feet and failed to step across the line of demarcation in accordance with USP 797.

l. During a tour of the pharmacy on 10/3/18 it was observed that reusuable mop handles were not in original working condition and not labeled.

m. During a tour of the pharmacy on 10/3/18 it was observed that the Pharmaceutical staff and Environmental Services failed to differentiate mini-mop handles used for the hazardous versus the non-hazardous isolator.

n. During a tour of the pharmacy on 10/3/18 it was observed the Environmental staff failed to document the mixing and diluting of cleaning and sanitizing agents via a log.

o. During a tour of the pharmacy on 10/3/18 it was observed that all Pharmaceutical Techniciaan's failed to appropriately label the sterile isopropyl alcohol when it was opened or the expiration date.

p. During a tour of the pharmacy on 10/3/18 it was observed that the Environmental staff failed to document that the the cart utilized in the segregated compounding area was cleaned daily.

q. During a tour of the pharmacy on 10/3/18 it was observed that a fatigue mat was utilized however the documentation failed to identify how it was cleaned and/or appropriate for use.

r. During a tour of the pharmacy on 10/3/18 it was observed that a tacky mat was utilized outside of the segregated compounding area and failed to be located directly in front of the entry door.

s. During a tour of the pharmacy and a review of the manufacturers guidelines for cleaning of the isolators on 10/3/18 it was identified that the dwell time should be ten minutes however, an observation indicated the drying time in parts of the isolator was ninety seconds, and the technician failed to rewet the surfaces to ensure the appropriate dwell time.

t. During a tour of the pharmacy on 10/3/18 it was observed the facility failed to have non-permeable surfaces to ensure appropriate cleaning ie. wood doors, particle boards under counters, walls and ceilings.

u. During a tour of the pharmacy on 10/3/18 it was observed in the sterile compounding room that the facility failed to ensure walls were painted with epoxy based paint and bare wood was observed.

v. During a tour of the pharmacy on 10/3/18 it was observe in the sterile compounding room that the facility failed to ensure that light fixtures were sealed.

w. During a tour of the pharmacy on 10/3/18 it was observed that the segregated compounding area was overstocked with unused sharps containers and a large supply of isolator gloves.

x. Review of the hospital documentation failed to identify that agar plates were utilized for fingertip testing and that documentation lacked the results, hand designation, the dates, incubation temperature, signature of observer and that daily checking was conducted.

y. Review of the hospital documentation failed to identify that media fill tests final results were documented as pass or fail. The documentation failed to include the incubation time or temperature, and/or the media testing procedures did not include the fill volume, inspection of filled units, interpretation of results, and action levels with the correct actions required.

z. Review of the hospital documentation failed to identify that compounding and environmental service staff have documented competencies for gowning and handwashing.

aa. Review of the hospital documentation failed to identify a risk acknowledgement and/or that compounding personnel had hazardous didactic training and/or that observational assessments were documented.

bb. Review of the hospital documentation failed to identify that the compounding containment isolator failed to have documentation that indicated the room in which it is located maintained a minimum of twelve air exchanges per hour.

cc. Review of the hospital documentation failed to indicate the volume of the primary engineering control (PEC) when obtaining air samples.

dd. Review of the pharmacies standard operating procedures (SOP) identified the hospital failed to comprehensively address SOP's for the clean room regarding cleaning and environmental testing.

ee. Review of the pharmacies standard operating procedures identified the hospital failed to address that all sterile compounds would be identified as hazardous.

ff. Review of the pharmacies standard operating procedures identified the hospital failed to address if gowns utilized in the sterile compounding room were reusable per manufacturers recommendations and if they were not disposable, where and how would they be stored.

gg. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP regarding how frequency the tacky mat would be changed or replaced.

hh. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP that directed how frequent the tacky matt would be changed or replaced and/or its appropriate location.

ii. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP prohibiting personnel from entering the compounding area and/or clean room if they have a sunburn, weepin sores, conjunctivitis or an active respiratory infection.

jj. Review of the pharmacies standard operating procedures identified the hospital failed to have an SOP that directed all personnel in the compounding area are required to remove all jewelry and makeup.

kk. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP that prohibited all personnel from wearing artificial nails or extenders, and that required staff to keep natural nails neat and trimmed.

ll.Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP regarding how frequency the fatigue mat would be changed or replaced.

mm. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP regarding how every CSP would be visually inspected for the presence of particulate matter, evidence of incompatibility or other issues.

nn. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP that directed single dose containers, bags, bottles, syringes or vials that were opened or punctured in worse than ISO Class 5 air used within one hour and the remaining contents discarded and/or how are they identified for expiration.

oo. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP that directed single dose vials exposed to ISO 5 air or cleaner used within six hours of the initial puncture and any remaining contents discarded and/or how are they identified for expiration.

pp. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP that directed multiple dose vials assigned a BUD of 28 days or the manufacturers specific BUD, (whichever was less) after the initial entry or puncture and/or how are multi-dose vials identified for expiration after they have been opened or punctured.

qq. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP for in process checks performed by a pharmacist and to ensure that procedures were followed.

rr. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP that directed if a CACI (compounding aseptic container isolator) was used, the room in which it was located needed to be certified to a minimum or 12 ACPH (air change per hour).

ss. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP that directed all compounding staff would have passed an initial and subsequent annual competency assessments of aseptic compounding skills including handling hazardous drugs and that all pharmacists and technicians performing compounding using hazardous drugs were appropriately trained in the safe handling, garbing, cleaning, and disinfecting procedures and waste disposal of hazardous drugs and materials.

Interview with the Director of the Pharmacy on 10/4/18 at 2:00 PM indicated although the staff was trained in USP 797 guidelines he was unaware of the garbing procedures as this pharmacy had isolators and not a "clean room". Further interview with the Director of Pharmacy identified he did not conduct surveillance of garbing, handwashing or cleaning therefore was unaware that the USP 797 guidelines were not performed in accordance with the regulations. Furthermore, the Director was unaware that the hospital's standard operating procedures were not comprehensive.

Interview with the Infection Control Nurse on 10/4/18 at 2:15 PM identified she was new in the role of infection control and although she was aware the compounding room was a high risk area she had not initiated surveillance rounds to ensure garbing, handwashing, cleaning and that all infection control practices were maintained in the aseptic area of the pharmacy.

Interview with the Director of Environmental Services on 10/4/18 at 1:20 PM identified he was not aware that a mixing log was needed to verify the appropriate cleaning solutions and their amounts. Additionally, the Director of Environmental Services indicated the Environmental staff was trained on gowning, handwashing and cleaning of the compounding area by the operations manager however documentation of the training was not available.

The job description of the pharmacy director in part identified that he/she would oversee the management of the entire scope of the pharmacy department. The director plans, organizes, staffs, directs, controls, problem-solves, develops staff, reinforces performance and facilitates the work of others. Furthermore, the director of the pharmacy updates departmental polices and procedures, ensures departmental compliance with intravenous compounding and regulatory standards.

An immediate plan of action dated 10/4/18 directed that a policy would be created for Beyond Use Dating for all CSP's. Expiration dates would no longer be used. All new CSP's would immediately be labeled with a BUD and all other CSP's with expiration dates would be disposed of. In addition, compounding staff would be trained immediately and/or prior to the next working shift by the pharmacy manager.

The immediate plan of action directed that a policy would be written for proper hand hygiene for entry into the compounding area including the use of sterile gloves, lint free towels, the use of full gown coverage and garbing in relationship to the line of demarcation. In addition, training would be completed prior to the next working shift by the pharmacy manager and by the infection control nurse. Additionally, the fatigue mat, extra sharp containers, and clutter was removed from the compounding area. Moreover the staff would be immediately trained when cleaning the isolators to ensure a dwell time of ten minutes until an alternate cleaning product could be obtained. This training would be conducted by the pharmacy manager prior to the next working shift.

Based on observation, a review of facility documentation, interviews, and policy review, the hospital, who compounded sterile pharmaceuticals, failed to ensure that standard operating procedures in the segregated compounding area were consistent with USP 797 standards and/or failed to ensure pharmacy and environmental staff were adequately trained. The findings include:

a. During a tour of the pharmacy on 10/3/18 with the Department of Consumer Protection (DCP), it was noted that multiple compounded medications located in the refrigerator were absent a label that identified beyond use dating (BUD) and/or a multidose vial of Gentamycin was not labeled with the BUD.

Interview with the Director of the Pharmacy on 10/3/18 indicated that the pharmacy staff had been utilizing expiration dates for most sterile compounding preparations that identified a two day expiration date. Subsequent to the surveyor inquiry, all Compounded Sterile Preparations (CSP's) would be immediately labeled with the appropriate BUD per USP 797 guidelines.

b. During a tour of the pharmacy on 10/3/18, it was observed that the Pharmaceutical staff and Environmental services failed to wash hands for thirty second up to their elbow.

c. During a tour of the pharmacy on 10/3/18, it was observed that the Pharmaceutical staff and Environmental services failed to clean their fingernails with a nail pick.

d. During a tour of the pharmacy on 10/3/18 it was observed that the Pharmaceutical staff and Environmental services failed to dry their hands with a non-shedding towel.

e. During a tour of the pharmacy on 10/3/18 it was observed that the Pharmaceutical staff was wearing makeup.

f. During a tour of the pharmacy on 10/3/18 it was observed that the Pharmaceutical staff had exposed skin.

g. During a tour of the pharmacy on 10/3/18 it was observed that the Pharmaceutical staff failed to wear a gown that provided appropriate coverage.

h. During a tour of the pharmacy on 10/3/18 it was observed that the Pharmaceutical staff failed to dispose of gowns and could not identify if the gown was reusable per manufacturers recommendation.

i. During a tour of the pharmacy on 10/3/18 it was observed that the Pharmaceutical staff failed to utilize sterile gloves during compounding preparation and failed to don sterile gloves over the isolator gloves.

j. During a tour of the pharmacy on 10/3/18 it was observed that the Pharmaceutical staff failed to used a waterless based alcohol scrub subsequent to leaving the isolator and prior to resuming compounding.

k. During a tour of the pharmacy on 10/3/18 it was observed that Environmental services and the Pharmaceutical staff placed a shoe covers on their feet and failed to step across the line of demarcation in accordance with USP 797.

l. During a tour of the pharmacy on 10/3/18 it was observed that cleaning tools were not in original working condition and not labeled.

m. During a tour of the pharmacy on 10/3/18 it was observed that the Pharmaceutical staff and Environmental Services failed to differentiate cleaning tools used for the hazardous versus the non-hazardous isolator.

n. During a tour of the pharmacy on 10/3/18 it was observed the Environmental staff failed to document the mixing and diluting of cleaning and sanitizing agents via a log.

o. During a tour of the pharmacy on 10/3/18 it was observed that the Pharmaceutical staff failed to appropriately label the sterile isopropyl alcohol when it was opened or the expiration date.

p. During a tour of the pharmacy on 10/3/18 it was observed that the Environmental staff failed to document that the the cart utilized in the segregated compounding area was cleaned daily.

q. During a tour of the pharmacy on 10/3/18 it was observed that a fatigue mat was utilized however the documentation failed to identify how it was cleaned and/or appropriate for use.

r. During a tour of the pharmacy on 10/3/18 it was observed that a tacky mat was utilized outside of the segregated compounding area and failed to be located directly in front of the entry door.

s. During a tour of the pharmacy and a review of the manufacturers guidelines for cleaning of the isolators on 10/3/18 it was identified that the dwell time should be ten minutes however, an observation indicated the drying time in parts of the isolator was ninety seconds, and the technician failed to rewet the surfaces to ensure the appropriate dwell time.

t. During a tour of the pharmacy on 10/3/18 it was observed the facility failed to have non-permeable surfaces to ensure appropriate cleaning ie. wood doors, particle boards under counters, walls and ceilings.

u. During a tour of the pharmacy on 10/3/18 it was observed the facility failed to ensure walls were painted with epoxy based paint and bare wood was observed.

v. During a tour of the pharmacy on 10/3/18 it was observed the facility failed to ensure that light fixtures were sealed.

w. During a tour of the pharmacy on 10/3/18 it was observed that the segregated compounding area was overstocked with unused sharps containers and a large supply of isolator gloves.

x. Review of the hospital documentation failed to identify that agar plates were utilized for fingertip testing and that documentation lacked the results, hand designation, the dates, incubation temperature, signature of observer and that daily checking was conducted.

y. Review of the hospital documentation failed to identify that media fill tests final results were documented as pass or fail. The documentation failed to include the incubation time or temperature, and/or the media testing procedures did not include the fill volume, inspection of filled units, interpretation of results, and action levels with the correct actions required.

z. Review of the hospital documentation failed to identify that compounding and environmental service staff have documented competencies for gowning and handwashing.

aa. Review of the hospital documentation failed to identify a risk acknowledgement and/or that compounding personnel had hazardous didactic training and/or that observational assessments were documented.

bb. Review of the hospital documentation failed to identify that the compounding containment isolator failed to have documentation that indicated the room in which it is located maintained a minimum of twelve air exchanges per hour.

cc. Review of the hospital documentation failed to indicate the volume of the primary engineering control (PEC) when obtaining air samples.

dd. Review of the pharmacies standard operating procedures (SOP) identified the hospital failed to comprehensively address SOP's for the clean room regarding cleaning and environmental testing.

ee. Review of the pharmacies standard operating procedures identified the hospital failed to address that all sterile compounds would be identified as hazardous.

ff. Review of the pharmacies standard operating procedures identified the hospital failed to address if gowns utilized in the sterile compounding room were reusable per manufacturers recommendations and if they were not disposable, where and how would they be stored.

gg. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP regarding how frequency the tacky mat would be changed or replaced.

hh. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP that directed how frequent the tacky matt would be changed or replaced and/or its appropriate location.

ii. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP prohibiting personnel from entering the compounding area and/or clean room if they have a sunburn, weepin sores, conjunctivitis or an active respiratory infection.

jj. Review of the pharmacies standard operating procedures identified the hospital failed to have an SOP that directed all personnel in the compounding area are required to remove all jewelry and makeup.

kk. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP that prohibited all personnel from wearing artificial nails or extenders, and that required staff to keep natural nails neat and trimmed.

ll.Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP regarding how frequency the fatigue mat would be changed or replaced.

mm. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP regarding how every CSP would be visually inspected for the presence of particulate matter, evidence of incompatibility or other issues.

nn. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP that directed single dose containers, bags, bottles, syringes or vials that were opened or punctured in worse than ISO Class 5 air used within one hour and the remaining contents discarded and/or how are they identified for expiration.

oo. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP that directed single dose vials exposed to ISO 5 air or cleaner used within six hours of the initial puncture and any remaining contents discarded and/or how are they identified for expiration.

pp. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP that directed multiple dose vials assigned a BUD of 28 days or the manufacturers specific BUD, (whichever was less) after the initial entry or puncture and/or how are multi-dose vials identified for expiration after they have been opened or punctured.

qq. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP for in process checks performed by a pharmacist and to ensure that procedures were followed.

rr. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP that directed if a CACI was used, the room in which it was located needed to be certified to a minimum or 12 ACPH.

ss. Review of the pharmacies standard operating procedures identified the hospital failed to have a SOP that directed all compounding staff would have passed an initial and subsequent annual competency assessments of aseptic compounding skills including handling hazardous drugs and that all pharmacists and technicians performing compounding using hazardous drugs were appropriately trained in the safe handling, garbing, cleaning and disinfecting procedures and waste disposal of hazardous drugs and materials.

Interview with the Director of the Pharmacy on 10/4/18 at 2:00 pm indicated although the staff was trained in USP 797 guidelines he was unaware of the garbing procedures as this pharmacy had isolators and not a "clean room". Further interview with the Director of Pharmacy identified he did not conduct surveillance of garbing, handwashing or cleaning therefore was unaware that the USP 797 guidelines were not performed in accordance with the regulations. Furthermore, the Director was unaware that the hospital's standard operating procedures were not comprehensive.

Interview with the Infection Control Nurse on 10/4/18 at 2:15 pm identified she was new in the role of infection control and although she was aware the compounding room was a high risk area she had not initiated surveillance rounds to ensure garbing, handwashing, cleaning and that all infection control practices were maintained in the aseptic area of the pharmacy.

Interview with the Director of Environmental Services on 10/4/18 at 1:20pm identified he was not aware that a mixing log was needed to verify the appropriate cleaning solutions and their amounts. Additionally, the Director of Environmental Services indicated the Environmental staff was trained on gowning, handwashing and cleaning of the compounding area by the operations manager however documentation of the training was not available.

An immediate plan of action dated 10/4/18 directed a policy would be created for Beyond Use Dating for all CSP's. Expiration dates would no longer be used. All new CSP's would immediately be labeled with a BUD and all other CSP's with expiration dates would be disposed of. In addition, compounding staff would be trained immediately and/or prior to the next working shift by the pharmacy manager.

The immediate plan of action directed that a policy would be written for proper hand hygiene for entry into the compounding area including the use of sterile gloves, lint free towels, the use of full gown coverage and garbing in relationship to the line of demarcation. In addition, training would be completed prior to the next working shift by the pharmacy manager and by the infection control nurse. Additionally, the fatigue mat, extra sharp containers, and clutter was removed from the compounding area. Moreover, the staff would be immediately trained when cleaning the isolators to ensure a dwell time of ten minutes until an alternate cleaning product could be obtained. This training would be conducted by the pharmacy manager prior to the next working shift.

The Condition of Participation for Laboratory Services has not been met and includes the following:

Based on the hospital's medical record review, facility policies, documentation and staff interviews, the laboratory director failed to ensure proper oversight of testing personnel to ensure laboratory testing personnel report critical value test results according to established policies and procedures and maintain competency to report critical tests results promptly and proficiently in accordance with the Clinical Laboratory Improvement Act (CLIA) requirements.

See A582

Based on the hospital's medical record review, facility policies, documentation and staff interviews, the laboratory director failed to ensure proper oversight of testing personnel to ensure laboratory testing personnel report critical value test results according to established policies and procedures and maintain competency to report critical tests results promptly and proficiently in accordance with the Clinical Laboratory Improvement Act (CLIA) requirements.

The findings include:

Review of hospital root cause analysis and action plan on 9/26/18 for testing performed Sunday 8/5/18 between 3:23PM - 6:57PM, Laboratory Technician#1 (LT) questioned Patient #1's abnormally high potassium (K) result of 9.0 mEq/L( normal range for K is 3.5 - 5.1 mEq/L). The K test was automatically repeated by the chemistry analyzer to auto recheck the validity of the K result. The auto recheck confirmed an abnormally high K result of 9.1 mEq/L. LT #1 cancelled the Basic Metabolic Panel (BMP) order without recording it in the laboratory information system (EPIC) and did not verbally relay the critical result to the unit coordinator (UC), and only requested a redraw. The Surgical Intern realized the first BMP was cancelled at 4:55PM and ordered a 2nd BMP test at 5:12PM which was received in the lab at 5:56PM. At 6:21PM the patient coded and the Registered Nurse (RN) immediately called the lab to inquire about BMP results. LT#1 reported the only available test result, being Sodium at 134(normal range is 136-145mEq/L). The RN heard "K 3.4" with no read back to verify the accuracy of the result, which was reported to the code team. At 6:51PM LT #1 called the UC to report the K result of 9.5. Patient #1 was pronounced dead at 6:55PM.

1. Laboratory Technician #1 (LT) failed to follow laboratory procedures for reporting of critical result values. The laboratory Evaluation of Patient Data policy and procedure (number Chem 22.0) approved on 10/12/17 states a "Fail verify" result that has been determined to be critical will immediately be called to the healthcare provider and to follow the laboratory procedure of documentation.
For an "Absurd Value" an absurd message will be sent when a result is entered that has been defined according to the Min/Max value to be non-compatible. The result must be rerun and verified before being accepted.

2. Laboratory Technician #1 (LT) failed to follow the hospital Quality Assurance Performance Improvement (QAPI) procedures for reporting critical values. The hospital policy "Critical Laboratory Test Results Warranting MD Alerts" effective November 2014 which states "The following test results warrant immediate notification (regardless of the delta checks) to the physician, nurse, or other appropriate health professional within thirty minutes of being completed. After each result has been rechecked by a technologist, he/she will document in the LIS and on the department copy of the report (if applicable) the name of the person(s) notified, date and time called, verification of "read-back" results and the initials of the person making the call. The initials indicate that the person receiving the critical results have read back to the caller the patient's full name and complete results." The above procedure also states that all potassium (K) results over 6.0 mEq/L are critical and the physician, nurse, or other appropriate health professional must be notified.

3. Laboratory Technician #1written statement to the Technical Supervisor (undated) identified Patient #1 was admitted to the emergency room (ER) on 8/5/18. A basic metabolic panel (BMP) along with other tests were ordered and specimen was sent to the lab at 3:59PM on 8/5/18 for testing. A critical 9.1 mEq/L potassium (K) high result value was obtained. Laboratory Technician #1called the ER and directed the Unit Coordinator to recollect the sample due to the sample being questionable and cancelled the BMP test. The critical potassium result value of 9.1 mEq/l was never reported to the Unit Coordinator or entered in the LIS (Laboratory Information System).

4. Review of the patient test report on 9/26/18 for the above specimen sample number X125502 revealed the BMP was deleted with a comment which stated "specimen unsuitable. Please re-order or resubmit. IV fluid contamination." The laboratory information system, (Sunquest), audit system revealed the identification number for the Laboratory Technician who entered the above comment for sample number X125502 was Laboratory Technician #1.

5. Review of the state survey telephone interview with Laboratory Technician #1 on 9/11/18 at 7:55 PM identified the ER was notified on 8/5/18 at 4:56 PM, the test result was questionable and to redraw the patient with no mention of the critical K result. Laboratory Technician #1 further identified he/she wasn't properly trained, was not shown laboratory policies or asked to sign any policies, the critical laboratory procedure was not clear on how to report questionable critical values and that no one had observed Laboratory Technician #1 resulting or reporting critical value results.

6. Review of Laboratory Technician #1 training documentation on 9/26/18 failed to provide evidence of direct observation of reporting critical values however, Laboratory Technician #1 checked the box on the training form that he/she fully understood and felt competent to perform critical Values/Documentation for the Beckman Coulter AU5800 instrument on 5/8/18. The Technical Supervisor signed off Laboratory Technician #1 was fully trained on 5/12/18.

7. Review on 9/26/18 of the state surveyor's interview with the Technical Supervisor on 9/6/18 at 9:45 AM identified Laboratory Technician # 1 failed to follow laboratory procedures for reporting of critical value results. Laboratory Technician # 1 was hired on 3/12/18 and signed training documentation on 5/8/18 indicating he/she was fully competent to perform and report critical value results. Technical Supervisor signed Laboratory Technician #1 training documentation on 5/12/18 and identified once the Technical supervisor signs training documents, staff are considered competent to perform those duties.

8. Interview with the Laboratory Director on 9/26/18 at 4:00PM identified Laboratory Technician #1 failed to follow the hospital QAPI and laboratory policies and procedures for the reporting of critical values and that he/she relies on the Technical Supervisor to train, evaluate and monitor laboratory technicians for pre-analytical, analytical and post-analytical testing in the laboratory.

Based on staff interviews and a review of the hospital's policies and procedures, the hospital failed to have a policy for the administration of anesthesia that was comprehensive and accurate. The finding included:


Review of the clinical record identified Patient #1 was admitted to the hospital on 7/31/18 with cholecystitis and underwent a laparoscopic cholecystectomy under general anesthesia on 8/1/18. Interview and review of the surgical report with (Certified Registered Nurse Anesthetists) CRNA #1 on 9/25/18 at 2:00 PM identified Patient #1 entered the operating room on 8/1/18 at 12:04 PM. CRNA #1 and MD #1 were present. Anesthesia induction commenced at 12:14 PM with medications that included Versed, Propofol, Fentanyl, and Rocuronium. Patient #1 was intubated at 12:16 PM. CRNA #1 indicated the intubation was difficult with tightness identified around the intubation tube that required further assessments and repositioning. After the intubation was completed by MD #1, who was the anesthesiologist, MD #1 left the room. Shortly after MD #1 left the room, elevated peak pressures were noted, the endotracheal tube (ET) was reevaluated and ventilation settings were adjusted. A surgical time out was then conducted. CRNA #1 indicated she stopped what she was doing to participate in the time out and to verify if antibiotics were administered, as she had not reviewed the medical record prior to the initiation of the case. The surgical incision was made at 12:26 PM. Subsequent to the surgical incision, CRNA #1 identified she assessed the patient's airway with a laryngoscope to ensure placement of the ET tube. Patient #1's blood pressure and heartrate were elevated which was thought to be related to sympathetic stimulus, therefore, Propofol and Diludid were administered. CRNA #1 indicated almost immediately thereafter it was identified that Patient #1 was breathing over the ventilator which triggered CRNA #1 to check the vaporizer. CRNA #1 realized the Sevoflourine gas had not been turned on for approximately nineteen minutes from the time of the incision. CRNA #1 immediately administered the Sevoflurane (inhalation anesthetic) for the remainder of the case. Subsequent to the procedure, the patient was able to verbalize explicit details of the case and complained of pain during part of the procedure.

Further interview with CRNA #1 indicated she was not originally scheduled to provide anesthesia in this case. CRNA #1 identified she had not set up the room and did not have time to review the medical record as was her routine practice. CRNA #1 indicated she should have stopped the line prior to the surgical time out and asked for MD #1 to return to the room to assist in troubleshooting the ventilator, ensure the ET tube placement and overall assessment of the patient prior to the surgical incision.

Interview with MD # 1 on 9/25/18 at 3:00 PM identified he was present for the induction and intubation of Patient #1 however, did not ensure that the Sevoflurane was on prior to leaving the room.

Interview with the Chief of Anesthesia on 9/25/18 at 1:00 PM identified although the CRNA's administered the Sevoflurane, it was the responsibility of the physician to ensure the Sevoflurane was turned on prior to leaving the room. Further interview and review of the hospital policy entitled Guidelines for Administration of Anesthesia with the Chief of Anesthesia directed in part that an Anesthesiologist or CRNA would be present at the induction of each anesthetic and that all anesthetics initiated by a member of the Department of Anesthesia required the presence of an attending anesthesiologist throughout the administration of general anesthesia. The Chief of Anesthesia indicated the policy was inaccurate and would be changed to identify that an attending anesthesiologist would be present for the induction of each anesthetic when the case was assigned to a CRNA and that either an anesthesiologist or CRNA would be present throughout the duration of general anesthesia.

Subsequent to the incident education was provided to all attending anesthesiologists that indicated the anesthesiologist would be responsible to ensure that he/she was present for induction, intubation, and to verify the anesthetic gas had been turned on prior to leaving the room. The attestation would be recorded in each clinical record.

Based on a clinical record review, staff interviews and a review of hospital documentation for one of ten patient's (Patient #1), reviewed for the administration of general anesthesia, the hospital failed to ensure that anesthesia policies addressed pre-anesthesia responsibilies for administering inhalational anesthetic throughout the surgical procedure which subsquently rendered intraoperative awareness and discomfort to the patient. The finding included:

Review of the clinical record identified Patient #1 was admitted to the hospital on 7/31/18 with cholecystitis and underwent a laparoscopic cholecystectomy under general anesthesia on 8/1/18. Interview and review of the surgical report with CRNA #1 on 9/25/18 at 2:00 PM identified Patient #1 entered the operating room on 8/1/18 at 12:04 PM. CRNA #1 and MD #1 were present. Anesthesia induction commenced at 12:14 PM with medications that included Versed, Propofol, Fentanyl, and Rocuronium. Patient #1 was intubated at 12:16 PM. CRNA #1 indicated the intubation was difficult with tightness identified around the intubation tube that required further assessments and repositioning. After the intubation was completed MD #1, who was the anesthesiologist, left the room. Shortly after MD #1 left the room elevated peak pressures were noted, the endotracheal tube (ET) was reevaluated and ventilation settings were adjusted. A surgical time out was then conducted. CRNA #1 indicated she stopped what she was doing to participate in the time out and to verify if antibiotics were administered, as she had not reviewed the medical record prior to the initiation of the case. The surgical incision was made at 12:26 PM. Subsequent to the surgical incision CRNA #1 identified she assessed the patient's airway with a laryngoscope to ensure placement of the ET tube. Patient #1's blood pressure and heartrate were elevated which was thought to be a result of sympathetic stimulus, therefore, Propofol and Diludid were administered. CRNA #1 indicated almost immediately thereafter, it was identified that Patient #1 was breathing over the ventilator which triggered CRNA #1 to check the vaporizer. CRNA #1 realized the Sevoflourine gas had not been turned on for approximately nineteen minutes from the time of the incision. CRNA #1 immediately administered the Sevoflurane for the remainder of the case. Subsequent to the procedure the patient was able to verbalize explicit details of the case and complained of pain during part of the procedure.

Further interview with CRNA #1 indicated she was not originally scheduled to provide anesthesia in this case. CRNA #1 identified she had not set up the room, and did not have time to review the medical record as was her rountine practice. CRNA #1 indicated she should have stopped the line prior to the surgical time out and asked for MD #1 to return to the room to assist in troubleshooting the ventilator, ensure the ET tube placement and overall assessment of the patient prior to the surgical incision.

Interview with MD #1 on 9/25/18 at 3:00 PM identified he was present for the induction and intubation of Patient #1 however did not ensure that the Sevoflurane was on prior to leaving the room.

Interview with the Chief of Anesthesia on 9/25/18 at 1:00 PM identified although the CRNA's administered the Sevoflurane it was the responsibility of the physician to ensure the Sevoflurane was turned on prior to leaving the room.

Subsequent to the incident, education was provided to all attending anesthesiologists that indicated that the anesthesiologist would be responsible to ensure that he/she was present for induction, intubation, and to verify the anesthetic gas had been turned on prior to leaving the room. The attestation would be recorded in each clinical record.