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Tag No.: A0701
Based on a review of the facility's records and staff and interviews, the facility failed to maintain the environment of the operating room in a manner that assured the safety and well-being of patients. The facility failed to ensure that the cardiovascular operating room (CVOR) #1 was terminally cleaned on 12/18/19 prior to the proposed surgery for Patient #1. Patient #1 observed blood splatter on the ceiling of the OR on 12/19/19. The facility thereafter failed to identify and address and correct the root cause of the failure to terminally clean CVOR #1 on 12/18/19.
Findings:
Review of the facility's January 2020 grievance log revealed a patient grievance dated 1/7/20, that Patient #1 was scheduled for open-heart surgery (date not listed); upon entering the operating room for his surgery, Patient #1 observed there was blood on the operating room (OR) ceiling and equipment. The grievance further revealed that Patient #1 informed the OR staff about the blood on the ceiling and equipment, but the operating room staff continued their work assignments despite Patient # 1's voiced concerns. conditions. The grievance log further revealed that the surgeon, MD #FF postponed the procedure when the blood observed by Patient #1 was brought to MD FF's attention.
A review of Patient #1's medical record revealed that Patient #1 was admitted into the facility on 12/16/19. The physician's notes in the record revealed that Patient #1 was scheduled for open-heart bypass surgery on 12/19/19. A nurse's note dated 12/19/19 at 7:30 a.m. revealed that Patient #1's surgery was aborted due to the Operating Room being contaminated.
A review of an email provided by the Director of Quality Resources (DQ EE) dated 1/9/20 revealed that the DQ EE asked the director of environmental services, DES CC who specifically was assigned to terminally clean the OR at the end of the day. DES CC responded in the email that HS LL was assigned to clean CVORs on 12/18/19 but called out. HS PP was assigned to terminally clean the CVORs on 12/18/19 in place of HS LL after HS LL called out of work. HS MM was assigned to terminally clean CVOR on 12/19/19.
A review of the facility's December 2019 OR Terminal Cleaning log for the week of 12/15/19 through 12/21/19 of CVOR#1 and CVOR#2, revealed no documentation that terminal cleaning occurred on 12/18/19 and 12/19/19. The last terminal cleaning that was signed off as complete for CVOR#1 and CVOR#2 was documented on 12/17/19. On 1/8/20 at 6:30 p.m., the director of surgical services DIR BB acknowledged that there was no documentation that terminal cleaning was conducted on 12/18/19 and 12/19/19 for CVOR #1 and CVOR #2.
During an interview with DIR BB in the executive administration conference room on 1/8/20 at 5:30 p.m., DIR BB stated that on 12/19/19 after he was informed of the incident with Patient #1 regarding reports of blood in the ceiling in CVOR #1, environmental services was immediately brought in the suite to terminally clean the OR, remove instrumentation, and all disposables were disposed of. When asked who was responsible for terminally cleaning CVOR#1, why there was no documentation that terminal cleaning had been conducted on 12/18/19 and 12/19/19 for CVOR #1 and CVOR#2, DIR BB was unable to state who was responsible for cleaning CVOR#1. DR BB did not provide an explanation for the lack of documentation confirming that CVOR#1 and CVOR#2 had been terminally cleaned on 12/18/19. DIR BB further stated that the facility utilized non-punitive measures of correction for staff and had used the 12/19/19 incident as a coaching opportunity for the environmental staff.
During an interview with the Director for Perfusion, DIR II on 1/8/20 at 10:50 a.m., DIR II stated he recalled when Patient #1 was brought into CVOR#1 on 12/19/19. DIR II stated that he observed the anesthesiologist inserting lines into Patient #1. DIR II further stated that one of the nurses informed him that Patient #1 had noticed 'stuff' on the ceiling. DIR II stated that he looked up at the ceiling and noticed there was blood on the ceiling and inquired if the circulating nurse had contacted MD FF to inform him of the findings. DIR II further stated he left the OR to inform management. DIR II stated that MD FF was contacted, and MD FF instructed the surgery team to bring Patient #1 out of the room and to clean the OR room. DIR II stated that the surgery team tore down the surgery set up, and the case was canceled. DIR II described the blood on the ceiling as blood splatter and that the blood splatter could be a result of a four (4) foot catheter, based on how the blood appeared on the ceiling.
During an interview with RN KK on 1/9/20 at 11:30 a.m.in the conference room, RN KK stated that on 12/19/19 she and the surgery team wheeled Patient #1 into the OR. RN KK further stated that Patient #1 looked up from the operating room table and asked what was on the ceiling. RN KK stated she was with RN JJ and saw that there was blood on the ceiling. RN KK described the blood as dots of blood, and the color appeared dried red. RN KK stated that Patient #1's surgery case was the first case in the morning, at approximately 7:00 a.m. RN KK further stated that the physician assistant, PA GG proceeded to place the IVs into Patient #1, and that the surgery team contacted MD FF via phone call. RN KK stated that PA GG gave proceeded to administer medication to Patient #1. RN KK stated that it would not have been safe to proceed with the surgery because of the risk of bodily contamination from the previous surgery case that may have occurred in the OR. RN KK stated that she observed a yellow sign outside the OR that indicated that the room had been terminally cleaned. RN KK further stated whoever arrived in the morning was responsible for going to the OR that they are assigned to determine if the room was cleaned.
During an interview with PA GG on 1/9/20 at 2:17 p.m., he stated that Patient #1 was brought to the OR and Patient #1 was moved to the OR table. PA GG further stated that he provided sedation and inserted arterial lines into Patient #1. PA GG stated he administered the medication, Versed (a sedative used to cause relaxation), Fentanyl (pain medication), and Lidocaine (local anesthetic) to Patient #1. PA GG further stated that surgery staff were pointing at the ceiling. PA GG stated he observed blood on the light lamp, base and arm of the light lamp, and the ceiling. PA GG further described the blood as dried blood splattered on the ceiling and the color as burgundy. PA GG stated that MD FF was called, and MD FF arrived at the OR and told staff to take Patient #1 out of the room and back to the ICU (intensive care unit). PA GG stated that he then removed Patient #1's insertions. PA GG stated that he heard that the EVS housekeeper that was assigned to clean the OR on 12/18/19 got sick and had to go to the Emergency Room.
During an interview with the environment housekeeper, HS PP on 1/9/20 at 3:30 p.m., in the conference room, HS PP stated she sometimes was assigned to terminally clean ORs. HS PP further stated she normally worked the 2:30 p.m.-11:00 p.m. shift, and that terminal cleaning was done after 10:00 p.m. HS PP stated HS LL fell sick the day before the 12/19/19 (12/18/19) incident and that people in the OR realized HS LL would not be coming to work. HS PP stated that HS LL usually cleaned CVOR #1 and CVOR #2. HS PP stated another environment services team did terminal cleaning of the ORs when all the cases were finished for the day; a member of this team would arrive at 5:00 p.m., and another person arrives at 10:00 p.m. HS PP stated it was not her job to terminally clean the rooms on 12/18/19 and 12/19/19. HS PP stated she did not know who was assigned to terminally clean the rooms on 12/18/19 and 12/19/19.
An interview with environmental services supervisor HS UU on 1/9/20 on 1/9/20 and 3:35 p.m. in the conference room revealed that terminal cleaning happened at the end of the surgery case day, that there was no specified time for terminal cleaning. HS UU further clarified that later terminal cleaning occurred after 10:00 pm. HS UU stated that cleaning from surgery case to surgery case included but was not limited to cleaning the floor and removing the linen. HS UU further stated that a terminal clean involved top of the ceiling to the floor clean. HS UU was unable to state who was assigned to terminally cleaning CVOR#1 on 12/18/19.
During an interview with MD FF accompanied by Attorney-WW and Attorney-XX on 1/10/20 at approximately 2:15 p.m., in the conference room, MD FF stated he received the call on 12/19/19, the morning of Patient #1's scheduled surgery that Patient #1 had seen what the patient thought was blood on the ceiling. MD FF stated that he said to cancel the case. MD FF further stated that after the cancellation, he did go to the OR and he saw a splotch of something he assumed was blood. MD FF stated that it was dark, red deoxygenation blood. When asked what action he took thereafter, MD FF stated that he spoke to the acting director of the CVOR talked to the COO. He explained to the staff that surgery could not go on. MD FF stated that he did not know why the OR had not been cleaned on that day. He stated that the cleaning crew was very dedicated and that an unclean OR was not the norm in all his years in this facility. MD FF further stated that apart from the bloodstains on the ceiling, the rest of the room appeared perfectly clean. MD FF stated that the cleaning crew may have terminally cleaned the room and merely 'missed a spot'. MD FF could not confirm if the ceiling is cleaned as part of a terminal cleaning protocol. MD FF further stated that the chance of an adverse outcome from dried bloodstains was infinitesimal had surgery continued as scheduled. MD FF conceded that the presence of blood spots was not ideal and that is why he canceled the case. MD FF stated he was told the cleaning person who was responsible for cleaning CVOR #1 had fallen ill.
During an interview with the Vice President of Quality Improvement, VP DD on 1/9/19 at 11:10 a.m., VP DD stated the EVS housekeeper/tech (HS LL) who was assigned to clean CVOR #1 on the night of 12/19/19 had fallen ill (suffered a heart attack) on the job and had had to go to the Emergency Room.
Tag No.: A0951
Based on a review of the facility's records and staff and interviews, the facility failed to provide surgical services in accordance with acceptable standards of practice. The facility failed to ensure that the cardiovascular operating room (CVOR) #1 was terminally cleaned on 12/18/19 prior to the proposed surgery for Patient #1. Patient #1 observed blood splatter on the ceiling of the OR on 12/19/19. The facility thereafter failed to identify and address and correct the root cause of the failure to terminally clean CVOR #1 on 12/18/19.
Findings:
Review of the facility's January 2020 grievance log revealed a patient grievance dated 1/7/20, that Patient #1 was scheduled for open-heart surgery (date not listed); upon entering the operating room for his surgery, Patient #1 observed there was blood on the operating room (OR) ceiling and equipment. The grievance further revealed that Patient #1 informed the OR staff about the blood on the ceiling and equipment, but the operating room staff continued their work assignments despite Patient # 1's voiced concerns. conditions. The grievance log further revealed that the surgeon, MD #FF postponed the procedure when the blood observed by Patient #1 was brought to MD FF's attention.
A review of Patient #1's medical record revealed that Patient #1 was admitted into the facility on 12/16/19. The physician's notes in the record revealed that Patient #1 was scheduled for open-heart bypass surgery on 12/19/19. A nurse's note dated 12/19/19 at 7:30 a.m. revealed that Patient #1's surgery was aborted due to the Operating Room being contaminated.
A review of an email provided by the Director of Quality Resources (DQ EE) dated 1/9/20 revealed that the DQ EE asked the director of environmental services, DES CC who specifically was assigned to terminally clean the OR at the end of the day. DES CC responded in the email that HS LL was assigned to clean CVORs on 12/18/19 but called out. HS PP was assigned to terminally clean the CVORs on 12/18/19 in place of HS LL after HS LL called out of work. HS MM was assigned to terminally clean CVOR on 12/19/19.
A review of the facility's December 2019 OR Terminal Cleaning log for the week of 12/15/19 through 12/21/19 of CVOR#1 and CVOR#2, revealed no documentation that terminal cleaning occurred on 12/18/19 and 12/19/19. The last terminal cleaning that was signed off as complete for CVOR#1 and CVOR#2 was documented on 12/17/19. On 1/8/20 at 6:30 p.m., the director of surgical services DIR BB acknowledged that there was no documentation that terminal cleaning was conducted on 12/18/19 and 12/19/19 for CVOR #1 and CVOR #2.
During an interview with DIR BB in the executive administration conference room on 1/8/20 at 5:30 p.m., DIR BB stated that on 12/19/19 after he was informed of the incident with Patient #1 regarding reports of blood in the ceiling in CVOR #1, environmental services was immediately brought in the suite to terminally clean the OR, remove instrumentation, and all disposables were disposed of. When asked who was responsible for terminally cleaning CVOR#1, why there was no documentation that terminal cleaning had been conducted on 12/18/19 and 12/19/19 for CVOR #1 and CVOR#2, DIR BB was unable to state who was responsible for cleaning CVOR#1. DR BB did not provide an explanation for the lack of documentation confirming that CVOR#1 and CVOR#2 had been terminally cleaned on 12/18/19. DIR BB further stated that the facility utilized non-punitive measures of correction for staff and had used the 12/19/19 incident as a coaching opportunity for the environmental staff.
During an interview with the Director for Perfusion, DIR II on 1/8/20 at 10:50 a.m., DIR II stated he recalled when Patient #1 was brought into CVOR#1 on 12/19/19. DIR II stated that he observed the anesthesiologist inserting lines into Patient #1. DIR II further stated that one of the nurses informed him that Patient #1 had noticed 'stuff' on the ceiling. DIR II stated that he looked up at the ceiling and noticed there was blood on the ceiling and inquired if the circulating nurse had contacted MD FF to inform him of the findings. DIR II further stated he left the OR to inform management. DIR II stated that MD FF was contacted, and MD FF instructed the surgery team to bring Patient #1 out of the room and to clean the OR room. DIR II stated that the surgery team tore down the surgery set up, and the case was canceled. DIR II described the blood on the ceiling as blood splatter and that the blood splatter could be a result of a four (4) foot catheter, based on how the blood appeared on the ceiling.
During an interview with RN KK on 1/9/20 at 11:30 a.m.in the conference room, RN KK stated that on 12/19/19 she and the surgery team wheeled Patient #1 into the OR. RN KK further stated that Patient #1 looked up from the operating room table and asked what was on the ceiling. RN KK stated she was with RN JJ and saw that there was blood on the ceiling. RN KK described the blood as dots of blood, and the color appeared dried red. RN KK stated that Patient #1's surgery case was the first case in the morning, at approximately 7:00 a.m. RN KK further stated that the physician assistant, PA GG proceeded to place the IVs into Patient #1, and that the surgery team contacted MD FF via phone call. RN KK stated that PA GG gave proceeded to administer medication to Patient #1. RN KK stated that it would not have been safe to proceed with the surgery because of the risk of bodily contamination from the previous surgery case that may have occurred in the OR. RN KK stated that she observed a yellow sign outside the OR that indicated that the room had been terminally cleaned. RN KK further stated whoever arrived in the morning was responsible for going to the OR that they are assigned to determine if the room was cleaned.
During an interview with PA GG on 1/9/20 at 2:17 p.m., he stated that Patient #1 was brought to the OR and Patient #1 was moved to the OR table. PA GG further stated that he provided sedation and inserted arterial lines into Patient #1. PA GG stated he administered the medication, Versed (a sedative used to cause relaxation), Fentanyl (pain medication), and Lidocaine (local anesthetic) to Patient #1. PA GG further stated that surgery staff were pointing at the ceiling. PA GG stated he observed blood on the light lamp, base and arm of the light lamp, and the ceiling. PA GG further described the blood as dried blood splattered on the ceiling and the color as burgundy. PA GG stated that MD FF was called, and MD FF arrived at the OR and told staff to take Patient #1 out of the room and back to the ICU (intensive care unit). PA GG stated that he then removed Patient #1's insertions. PA GG stated that he heard that the EVS housekeeper that was assigned to clean the OR on 12/18/19 got sick and had to go to the Emergency Room.
During an interview with the environment housekeeper, HS PP on 1/9/20 at 3:30 p.m., in the conference room, HS PP stated she sometimes was assigned to terminally clean ORs. HS PP further stated she normally worked the 2:30 p.m.-11:00 p.m. shift, and that terminal cleaning was done after 10:00 p.m. HS PP stated HS LL fell sick the day before the 12/19/19 (12/18/19) incident and that people in the OR realized HS LL would not be coming to work. HS PP stated that HS LL usually cleaned CVOR #1 and CVOR #2. HS PP stated another environment services team did terminal cleaning of the ORs when all the cases were finished for the day; a member of this team would arrive at 5:00 p.m., and another person arrives at 10:00 p.m. HS PP stated it was not her job to terminally clean the rooms on 12/18/19 and 12/19/19. HS PP stated she did not know who was assigned to terminally clean the rooms on 12/18/19 and 12/19/19.
An interview with environmental services supervisor HS UU on 1/9/20 on 1/9/20 and 3:35 p.m. in the conference room revealed that terminal cleaning happened at the end of the surgery case day, that there was no specified time for terminal cleaning. HS UU further clarified that later terminal cleaning occurred after 10:00 pm. HS UU stated that cleaning from surgery case to surgery case included but was not limited to cleaning the floor and removing the linen. HS UU further stated that a terminal clean involved top of the ceiling to the floor clean. HS UU was unable to state who was assigned to terminally cleaning CVOR#1 on 12/18/19.
During an interview with MD FF accompanied by Attorney-WW and Attorney-XX on 1/10/20 at approximately 2:15 p.m., in the conference room, MD FF stated he received the call on 12/19/19, the morning of Patient #1's scheduled surgery that Patient #1 had seen what the patient thought was blood on the ceiling. MD FF stated that he said to cancel the case. MD FF further stated that after the cancellation, he did go to the OR and he saw a splotch of something he assumed was blood. MD FF stated that it was dark, red deoxygenation blood. When asked what action he took thereafter, MD FF stated that he spoke to the acting director of the CVOR talked to the COO. He explained to the staff that surgery could not go on. MD FF stated that he did not know why the OR had not been cleaned on that day. He stated that the cleaning crew was very dedicated and that an unclean OR was not the norm in all his years in this facility. MD FF further stated that apart from the bloodstains on the ceiling, the rest of the room appeared perfectly clean. MD FF stated that the cleaning crew may have terminally cleaned the room and merely 'missed a spot'. MD FF could not confirm if the ceiling is cleaned as part of a terminal cleaning protocol. MD FF further stated that the chance of an adverse outcome from dried bloodstains was infinitesimal had surgery continued as scheduled. MD FF conceded that the presence of blood spots was not ideal and that is why he canceled the case. MD FF stated he was told the cleaning person who was responsible for cleaning CVOR #1 had fallen ill.
During an interview with the Vice President of Quality Improvement, VP DD on 1/9/19 at 11:10 a.m., VP DD stated the EVS housekeeper/tech (HS LL) who was assigned to clean CVOR #1 on the night of 12/19/19 had fallen ill (suffered a heart attack) on the job and had had to go to the Emergency Room.