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Based on medical record review and staff interview it was determined the facility failed to ensure the physician chosen by the patient was notified of the patient's admission for one (Patient #3) of 41 sampled patients.

Findings included:

The Face Sheet indicated Patient #3 was admitted on 6/24/19 at 6:33 p.m. The Initial Nursing Patient History dated 6/25/19 at 1:11 a.m. and signed by the Registered Nurse (RN) included an area to indicate if the patient wanted their physician notified of their admission. There were designated areas to indicate the physician's name and telephone number if the physician was not in the hospital data base of medical staff members. The review of the document revealed Patient #3 answered "yes" to the question asking if the patient wanted their physician notified. No additional information regarding the physician's name, or telephone number was entered. The detailed review of the medical record failed to reveal any evidence the staff complied with the patient's request to notify their physician.

The finding was confirmed by the Quality Coordinator present at the time of the record review conducted on 6/28/19 at 1:30 p.m.

Based on document review and staff interview the facility did not ensure that one patient (Patient #1) of 41 patients reviewed was protected from abuse or harassment.

Findings included:

Review of the Professional Conduct Event report dated 5-25-19 was revealed that on 5-25-19 at 14:00 an emergency department (ED) trauma patient who was alert and oriented had been undressed and then covered by a blanket. The document indicated the trauma surgeon arrived in the room and did not introduce himself to the patient. The trauma team rolled the patient onto his right side to evaluate his backside. The trauma surgeon checked for rectal tone by inserting a gloved finger without lubrication into the patient's rectum and did not inform the patient prior to doing so. The patient verbalized he felt upset and violated. Additional documentation from an email communication to the Medical Director of Trauma dated 5/25/19, indicating the trauma surgeon made Patient #1 very uncomfortable and the patient did not want the surgeon anywhere near him. The patient began crying, and was adamant that the surgeon no longer follow his case. The surgeon then asked the patient where he lives, and the patient responded, "You don't need to know where I live you pervert, get away from me".

On 6/25/19 at 11:45 a.m., the Registered Nurse (RN) who wrote the Professional Conduct Event report came to the facility to be interviewed concerning the event. The RN indicated she was the nurse assigned to the care of Patient #1 in the ED on 5/25/19. She was provided a copy of the report being reviewed for her reference. She confirmed she personally witnessed everything stated in the report and confirmed the report was a complete and accurate description of events. She indicated the physician returned to the patient's room three times after the patient clearly told the physician he wanted no further care from him. The RN indicated after the surgeon returned to the patient's room a third time, she told the surgeon that the patient had asked that he stay away from him, and did not want him as his physician during his stay in the hospital. The surgeon indicated he had no plans to follow up further with the patient, and left. The nurse confirmed that the rectal exam to check for rectal muscle tone was a standard examination for a trauma patient, but indicated the other ED physicians tell the patients in advance of their intention to do a rectal exam, use lubricant, and give the patient an opportunity to give or decline consent. The nurse indicated if the patient declines, the physician asks the patient to "squeeze their butt cheeks".

There was no evidence presented by the facility that this event had been investigated or actions taken to prevent abuse/harassment of patients in the future prior to June 25, 2019. In addition, there was no evidence presented that there was follow-up with the patient regarding his voiced concerns.

Based on document review and staff interview, it was determined the facility failed to collect, analyze, and implement corrective actions related to patient infections and sterilizer equipment failures to ensure safe quality care was provided.

Findings included:

On 06/25/19 at 9:07 a.m., an interview was performed with the facility Infection Preventionist (IP) Manager regarding Governing Board (GB) agenda item related to Aspergillus fumigatus mold and bronchoscope patients on 03/18/19. The IP stated the facility had identified three patients that had bronchoscopies performed on 03/18/19 with positive bronchial washings with Aspergillus fumigatus mold. The IP stated none of the patients showed symptoms of infection and were not treated for the mold. The IP stated the cultures were likely a contamination.

A review of the list of patients with positive respiratory Aspergillus fumigatus mold cultures from 01/01/19 through 06/28/19, showed a total of eleven patients. Six of the patients had bronchoscopies performed and five were inpatients with positive respiratory secretions. There was no evidence provided that indicated the other seven positive cases had been analyzed to see if those patients cultures had been contaminated or if they were hospital acquired infections.

On 06/25/19 at 2:00 p.m., a tour of the bronchoscope department was performed, accompanied by the IP Manager and the Registered Nurse (RN) processing bronchoscopes. While on tour, a review of the three Steris 1E Sterilization Records dated 03/18/19, the date of three positive Aspergillus fumigates mold cultures, showed there were 21 loads sterilized and 13 (62 %) of the loads failed sterilization parameters. Continued review of the sterilization logs from 03/09/19 through 03/23/19 showed numerous failures of all three sterilizers. While on tour, a request for evidence of maintenance addressing the Steris 1E sterilizer failures was requested.

On 06/2819 at 9:45 a.m., a group interview was performed with Vice President (VP) of Infrastructure, Associate Vice President (AVP) of Surgical Services, Director of Engineering, Director of Informative Technology (IT), Manager of Biomed Services, IP staff member and the IP Manager regarding the Steris 1E sterilizer failures. The Director of Engineering stated the sterilizer started failing due to construction expansions and impact of these expansions on the facility water pressure. The VP of Infrastructure stated the water pressure issues and sterilizer failures started in June of 2018, which the team thought was the cause of the Sterilizer 1E failures. The VP of Infrastructure and the Director of Engineering stated the plan to fix the water pressure issues effecting the sterilizers was to install a buffer tank and additional water tank to increase water pressure to the sterilizers. Both stated the installation was performed in April 2019. The surveyor asked if the sterilizers failures stopped after the installation. The AVP of Surgical Services stated they had not. A total number of failures for each of the three Steris 1E sterilizers from 04/09/19 through 06/27/19 was requested.

A review of the sterilizer failures after the 04/09/19 buffer and water tank installation to fix suspected low water pressure, showed 53 sterilizer load failures occurred from 04/09//19 through 06/27/19. The specific code failures generated by the sterilizer showed:
Chamber level low - 4
UV intensity timeout - 2
Operator canceled - 1
Drain check - 20
Power failure - 1
Indicator - 9
Concentration low - 1
Load time - 1
Filter - 4
Temperature - 4
Fill - 4
Load time - 1

On 06/28/19 at 11:45 a.m., an interview with the VP of Infrastructure confirmed the finding the facility had not tracked, trended or analyzed the ongoing sterilizer failures.

On 06/28/19 at 3:00 p.m., an interview with the VP Regulatory & Infection Control confirmed the finding that seven of the eleven patient Aspergillus fumigatus mold positive respiratory cultures had not been tracked, trended, or analyzed.

Based on document review and staff interview it was determined the Medical Executive Committee failed to ensure one (#A), of 9 sampled members of the medical staff, of a total of 868 actively credentialed members of the medical staff, met the criteria for requested privileges that the Medical Executive Committee recommended for approval to the Governing Body.

Findings included:

The Medical Staff Bylaws, approved by the Board of Directors November 2015, indicated the responsibility of the Medical Executive Committee included the delineation of clinical privileges for each eligible individual.

The review of the credentialing file for Physician #A revealed the reappointment application to the medical staff included a requested for privileges in deep sedation. The application indicated Physician #A was currently granted privileges in deep sedation for the period 2/1/16 through 1/31/18. The application indicated the criteria for the maintenance of privileges in deep sedation included the performance of at least 10 procedures in the previous 24 months with acceptable quality and sedation review. The criteria required the Approval of the Chair of Anesthesia Services Department.

The credentialing file revealed the Anesthesiology Chair reviewed the file of Physician #A and recommended approval for the requested privileges on 12/31/18. The Emergency Medicine Department ex-officio Chair reviewed the file and recommended approval on 12/31/18. The Credentials Committee reviewed the file and recommended approval of the privileges requested by Physician #A on 1/3/19. The Medical Executive Committee reviewed the file and recommended the approval of the privileges requested by Physician #A on 1/3/19, for submission to the Board of Directors for final approval.

The detailed review of the information submitted to each of the above-named reviewers failed to reveal any evidence that the volume of deep sedation cases performed by Physician #A over the previous 24 month period was available for review. The facility was unable to demonstrate that a report listing the volume of deep sedation cases performed by Physician #A existed in the credentialing file at the time the physician's reappointment or at the time of the survey.

At the surveyor's request, the facility produced a report listing the volume of sedation cases performed by Physician #A during the 24 month period prior to his request for reappointment to the medical staff. The report listed a total of 6 cases involving Physician #A providing sedation to patients between November 2017 and October 2018. Of the six cases, four indicated moderate sedation was provided and two cases involved deep sedation provided by Physician #A.

In an interview conducted on 6/26/19 at 2:00 p.m., the Director of Medical Staff Services confirmed the finding the Anesthesiology Chair, the Emergency Department ex-officio Chair, the Credentials Committee, and the Medical Staff Committee all recommended to the Governing Body that Physician #A be approved for privileges for which there was no evidence the physician met the established criteria.

Based on policy review, medical record review, and staff interview it was determined the facility failed to ensure nursing staff provided care and services to meet the needs of the patient relating to the administration of drugs prescribed on an as needed basis (PRN) and the pain assessments for five (patient #11, 12, 14, 20, & 21) out of 41 patients sampled.

Findings included:

According to a facility policy titled "Medication: General Principles-CL.0169" dated 03/2020, all medications require an order from a physician or APP (advanced practice practitioner) and licensed staff administering the medication are responsible for knowing basic information about the medications they administer. The policy states medications are administered based on the seven rights of medication administration:
Right patient
Right dosage
Right route
Right time
Right drug
Right reason
Right documentation

Review of the medical record for patient #20 revealed a physician order, dated 6/20/2019 at 7:05 p.m., for Tylenol 650 mg (milligrams) by mouth every 4 hours as needed for a temperature greater than 38.3 degrees Celsius. Review of the MAR (Medication Administration Record) revealed the patient received Tylenol 650 mg by mouth on 6/20/2019 at 10:04 p.m., 6/21/2019 at 06:36 a.m., and 6/21/2019 at 12:13 p.m. Review of the patient's temperature for 6/20/2019 and 6/21/2019 revealed no evidence that the patient's temperature was 38.3 degrees Celsius or greater at the time of the medication administration. An interview with Clinical Informatics Analyst on 6/26/2019 at 10:45 a.m. confirmed the findings.

Review of facility policy titled "Pain Management-CL.0016", dated 04/2019, revealed inpatients shall receive treatment for any active pain issue (acute or chronic), when intensity exceeds their acceptable level. After pain medication administration, a reassessment is recommended to occur within 15-60 minutes following treatment. The response to intervention must be assessed, whether the intervention was pharmacological or non-pharmacological.

Review of the medical record for patient #21 revealed a physician order, dated 6/21/2019 at 7:43 a.m., for Fentanyl 25 mcg (micrograms) by intravenous (IV) push every 4 hours as needed for moderate pain of 7-10 on the pain scale. Review of the MAR (Medication Administration Record) revealed the patient received Fentanyl 25 mcg IV on 6/21/2019 at 12:17 p.m., and on 6/22/2019 at 2:56 p.m. Review of the RN (Registered Nurse) assessments for 6/21/2019 and 6/22/2019 revealed no evidence the patient was assessed for pain intensity, a pain goal, or the location of the pain at or about the time of administration. Review of the RN assessments following administration of the pain medication revealed no evidence the patient was assessed for effectiveness of the pain medication within 1 hour of administration. Interview with the Associate Chief Officer of Clinical Informatics on 6/26/2019 at 1:00 p.m. confirmed the findings.

Review of the medical record for patient #11 revealed a physician order, dated 6/21/2019 at 9:31 p.m., for Tramadol 50 mg (milligrams) by mouth every 4 hours as needed for moderate pain of 4-6 on the pain scale. Review of the MAR (Medication Administration Record) revealed the patient received Tramadol 50 mg by mouth on 6/26/2019 at 4:48 a.m. Review of the RN (Registered Nurse) assessments for 6/26/2019 revealed no evidence the patient was assessed for pain at or about the time of administration. Review of the RN assessments following administration of the pain medication revealed no evidence the patient was assessed for effectiveness of the pain medication within 1 hour of administration. An interview with RN Clinical Informatics on 6/26/2019 at 2:30 p.m., confirmed the findings.

Review of the medical record for patient #12 revealed a physician order, dated 6/14/2019 at 11:33 a.m., for Oxycodone/Acetaminophen 5/325 mg, 1 tablet, by mouth every 4 hours as needed for moderate pain of 4-6 on the pain scale or Oxycodone/Acetaminophen 5/325 mg, 2 tablets, by mouth every 4 hours as needed for severe pain of 7-10 on the pain scale. Review of the MAR revealed the patient received Oxycodone/Acetaminophen 5/325 mg, 2 tablets, by mouth on 6/25/2019 at 8:53 a.m. Review of the RN (Registered Nurse) assessments for 6/26/2019 at 8:00 a.m., revealed the patient's pain level was assessed as a 6 on the pain scale. Review of the RN assessment and notes revealed no evidence of the rationale for administration of 2 tablets instead of 1 tablet as ordered by the physician. Review of the RN assessment within 1 hour of administration of the pain medication revealed no evidence the patient was assessed for effectiveness of the pain medication. Interview with RN Clinical Informatics on 6/26/2019 at 2:45 p.m., confirmed the findings.

Review of the medical record for patient #14 revealed a physician order, dated 6/21/2019 at 3:29 p.m., for Oxycodone/Acetaminophen 10/325 mg, 2 tablets, by mouth every 4 hours as needed for severe pain of 7-10 on the pain scale. Review of the MAR revealed the patient received Oxycodone/Acetaminophen 10/325 mg, 2 tablets, by mouth on 6/25/2019 at 2:18 p.m. Review of the RN (Registered Nurse) assessments for 6/26/2019 at 2:00 p.m. revealed the patient's pain level was assessed as a 10 on the pain scale. Review of the RN assessment revealed no evidence the patient was assessed for effectiveness of the pain medication within 1 hour of administration. Review of the MAR revealed the patient received Oxycodone/Acetaminophen 10/325 mg, 2 tablets, by mouth on 6/25/2019 at 6:04 p.m. Review of the RN (Registered Nurse) assessments for 6/26/2019 at 6:04 p.m., revealed the patient's pain level was assessed as a 10 on the pain scale. Review of the RN assessment revealed no evidence the patient was assessed for effectiveness of the pain medication within 1 hour of administration. Interview with Manager of Performance and Quality on 6/26/2019 at 4:00 p.m., confirmed the findings.

Based on policy and procedure reviews, document reviews, personnel file reviews, observations and staff interviews it was determined the facility failed to follow acceptable standards of practice related to sterilization and disinfection of surgical/endoscope instruments and maintenance of an infection control program that minimizes risk of infections associated with surgical procedures performed by the facility (refer to A 0749).

Based on facility policies and procedures, document review, personnel file reviews, observations and staff interviews, it was determined the facility failed to follow acceptable standards of practice related to sterilization and disinfection of surgical and endoscope instruments. The facility failed to develop and maintain an infection control program that minimizes risk of infections associated with surgical procedures performed by the facility.

Findings included:

1. Failure to maintain sterilizer equipment in the Sterile Processing Department (SPD).

A review of the policy entitled, "Sterilization and Disinfection of Surgical Instruments," #CL.0054, effective 01/2019, showed:
- The purpose is to provide guidance for sterilization and disinfection of instruments used in surgical procedures, and or invasive procedures to reduce the risk of
a surgical wound infection.
- Manufacturer's directions and facility policies and procedures for reprocessing instruments, including directions for use of the reprocessing equipment (i.e.,
sterilizers).
- Personnel must have proper training on processing instruments with competency testing on orientation to their jobs. Documentation of training should be
maintained in the employees personnel file. Continuing education, including training for all new instrumentation, devices, and equipment is conducted at
regular intervals.
- Documentation of each sterilizer load so that all sterilized items can be traced back to the patient should include the following:
- Sterilizer identification
- Type of sterilizer and cycle used
- Lot control number
- Superficial load contents
- Critical parameters met...1E
- Results of sterilization process monitors
- Operator's name, initials, or identification

On 06/26/19 at 9:45 AM a tour was conducted of the SPD, accompanied by the Infection Prevention (IP) Manager and SPD Manager. While on tour, the sterilization instrument tracking log was requested from the sterilization technician (ST). The ST confirmed the facility did not have a log or evidence of the ability to determine what instruments were used on patients in the advent of a recall or communicable disease exposure requiring patient notification.

An interview on 06/26/19 at 1:45 PM with the Associate Vice President (AVP) of Surgical Services confirmed the above findings.

2. Failure to maintain sterilizer equipment for bronchoscopes in the Sterile Processing Department (SPD). Failure to track, trend, and analyze pathogens with known association with construction - Aspergillus fumigatus mold .

A review of the policy entitled. "Medical Equipment Management Plan," #PL.0007, effective 03/2019, showed sterilizer equipment users are responsible for...performance verification of all sterilizers, which is reported to the Clinical Engineering Equipment Control Officer...records of load testing are retained in the SPD. Clinical Engineering is responsible for overseeing the inspections, tests, and maintenance of all sterilizers...through outside contractor.

Upon request for a policy for sterilization of bronchoscopes, the facility provided a policy entitled, "High Level Disinfection: Metricide OPA (Orthophthalaldehyde Solution," #IC.0046, reviewed 09/2019. The policy showed sterilization of bronchoscopes using Metricide. The facility had three Steris 1E sterilizers. The disinfectant used by the facility was peracetic acid and not Orthophthalaldehyde. The facility was unable to respond with a policy using the high level disinfectant paracetic acid.

On 06/25/19 at 9:07 a.m., an interview was performed with the facility Infection Preventionist (IP) Manager regarding Governing Board (GB) agenda item related to Aspergillus fumigatus mold and bronchoscope patients on 03/18/19. The IP stated the facility had identified three patients that had bronchoscopies performed on 03/18/19 with positive bronchial washings with Aspergillus fumigatus mold. The IP stated none of the patients showed symptoms of infection and were not treated for the mold. The IP stated the cultures were likely a contamination. The IP performed an investigation and stated there was a ceiling tile inside a supply room that was connected to the bronchoscope room that was suspected to have mold. The IP stated the ceiling tile was removed but not cultured for suspected mold. The IP was asked if an assessment of the bronchoscope processing had been performed to ensure compliance with policies and proper processing of the scopes. The IP stated she had not.

A review of the CDC's (Centers for Disease Control) website showed pulmonary aspergillosis is acquired by inhalation of airborne spores in the environment. Hospital-acquired aspergillosis is usually associated with airborne fungal contamination of the hospital environment, especially after building construction events. https://wwwnc.cdc.gov/eid/article/24/8/17-1865_article

On 06/25/19 at 2:00 p.m., a tour of the bronchoscope department was performed, accompanied by the IP Manager and the RN processing bronchoscopes. An interview with the RN and ST in the bronchoscopy room revealed the ceiling tile had a black hand print from a worker. Both stated they could clearly see the outline of a hand. While on tour, a review of the the three Steris 1E Sterilization Records dated 03/18/19, the date of three positive Aspergillus fumigates mold cultures, showed there were 21 loads sterilized and 14 (66%) of the loads failed sterilization parameters. Continued review of these records from 03/09/19 through 03/23/19, showed numerous failures of all three sterilizers. Additionally, the records indicated the staff were processing 21 anesthesia blades (laryngoscopes) in a load using the Steris 1E sterilizer, a specialized piece of equipment manufactured specifically for sterilizing bronchoscopes.

The VP of Regulatory & Infection Control was unable to provide requested evidence of maintenance addressing the Steris 1E sterilizer failures. The VP of Regulatory & Infection Control was unable to provide requested evidence of the manufacturer Instructions for Use (IFU's) validating anesthesia blades could be sterilized in the Steris 1E.

Ensuring consistency of sterilization practices requires a comprehensive program that ensures operator competence and proper methods of cleaning and wrapping instruments, loading the sterilizer, operating the sterilizer, and monitoring of the entire process. Furthermore, care must be consistent from an infection prevention standpoint in all patient-care settings, such as hospital and outpatient facilities. https://www.cdc.gov/infectioncontrol/guidelines/disinfection/sterilization/sterilizing-practices.html

On 06/25/19 at approximately 2:30 p.m., a request for a policy for sterilization of bronchoscopes for each of the three sterilizers used was requested. The facility provided the following three policies and procedures for bronchus processing:

1.A respiratory department standard of operation procedure/policy entitled, "Respiratory Care Reprocessing Immersible Flexible Endoscopy/Storage/Loaners," no #, effective 11/15/2018, showed:
- Endoscope reprocessing should be performed by staff members who are fully aware of endoscope design and the dangers associated with inadequate cleaning and disinfection.
- Reprocessing immersible flexible endoscopes with the Steris AER is performed according to the following procedure.
- Performed by: Licensed Respiratory Therapist/Practitioner or Registered Nurse, who has demonstrated competency...
- Refer to Guidelines for Operation for Safety and Warning Statements for Steris AER.

2. A document entitled, "BF-UC180F, "showed bronchoscope processing for one of the Steris 1E sterilizers. The directions for use varied from the above policy.

3. A document entitled, "BF-H190/BF-Q180/FGQ-IT180/LF-TP," showed a different set of bronchoscope processing for one of the three Steris 1E sterilizers. The directions for use varied from the above policy and protocol.

On 06/28/19 at 10:55 a.m., an interview with the Respiratory Therapy (RT) Team Leader, revealed a fourth bronchoscope process/competency for one of the three Steris 1E sterilizer models. The directions for use varied from the previous policies and procedures provided on 06/25/19. The team leader confirmed this document was the official Bronchoscopy Scope Reprocessing Competency for staff. A review of the competency failed to reveal manufacturer required steps for each of the three sterilizer models in use.

A review of the policy entitled, "Orientation and Employee Competence," #TA.0060, effective 09/2018, showed a mission carried out by staff properly oriented and educated on...safety practices and policies, and competent to perform their job duties. Continued review of the policy showed department specific orientation should be provided to each employee using job-specific orientation plan...the plan is based on specific job roles and tasks...validation of competence in daily practice is achieved through trainer/preceptor/supervisor observations, demonstration on hands of skills, completion of skills checklist and documentation of monitoring.

A review of the list of staff authorized to perform sterilization and disinfection of bronchoscopes included a list of Registered Respiratory Therapists(RRT's) and Registered Nurses (RN's) totaling 18 employees (16 RRT's and 2 RN's). A review of the Registered Respiratory Therapist (RRT), Bronchoscopy Lab RN - Respiratory Services, the IC Manager, Main OR & SPD Manager, Director of Surgical & Procedural Services, and Associate Vice President (AVP) - Preoperative & Surgical Services - Medical Center Administrator job descriptions failed to show the presence of the critical process of sterilizing scopes. None of the above staff had competencies for sterilization of bronchoscopes used on patients.

On 06/2819 at 9:45 a.m., a group interview was performed with the Vice President (VP) of Infrastructure, AVP of Surgical Services, Director of Engineering, Director of Informative Technology (IT), Manager of Biomed Services, IP staff member and the IP Manager regarding the Steris 1E sterilizer failures. The Director of Engineering stated the sterilizer started failing due to construction expansions and impact of these expansions of the facility water pressure. The VP of Infrastructure stated the water pressure issues and sterilizer failures started in June of 2018 and was thought to be the cause of the Sterilizer 1E failures. The VP on Infrastructure and the Director of Engineering stated the plan to fix the water pressure issues effecting the sterilizers, was to install a buffer tank and additional water tank to increase water pressure to the sterilizers. Both stated the installation was performed in April 2019. The surveyor asked if the sterilizer failures stopped after the installation. The AVP of Surgical Services stated they had not. A total number of failures for each of the three Steris 1E sterilizers from 04/09/19 through 06/27/19 was requested.

A review of the sterilizer failures after the 04/09/19 buffer and water tank installation to fix suspected low water pressure, showed 53 sterilizer load failures occurred from 04/09/19 through 06/27/19. The specific codes generated by the sterilizer showed:
Chamber level low - 4
UV intensity timeout - 2
Operator canceled - 1
Drain check - 20
Power failure - 1
Indicator - 9
Concentration low - 1
Load time - 1
Filter - 4
Temperature - 4
Fill - 4
Load time - 1

An interview with the VP of Infrastructure, Director of Engineering, and AVP of Surgical Services on 06/28/19 at 9:45 a.m., confirmed there had not been an investigation into the ongoing sterilizer failures occurring from 06/01/18 to 06/27/19. Additionally, the facility was unable to provide evidence the facility or the contracted Steris representative had been on site to investigate or attempt to resolve the ongoing sterilizer failures that started approximately one year ago.

On 06/28/19 at 2:20 p.m., the IP manager was asked for a list of all bronchoscopy positive Aspergillus fumigatus mold cultures from 01/01/19 to 06/28/19.

A review of the list of patients with positive respiratory Aspergillus fumigatus mold cultures from 01/01/19 through 06/28/19, showed a total of eleven patients. Six of the patients had bronchoscopies performed and five were inpatients with positive respiratory secretions. There was no evidence provided that indicated the other seven positive cases had been analyzed to see if those patient's cultures had been contaminated or if they were hospital acquired infections.

On 06/28/19 at 3:00 p.m., an interview with the VP Regulatory & Infection Control confirmed the above findings.

3. Failure to ensure a safe environment in the operating room during construction.

On 06/27/19 at 11:00 a.m., a tour of the OR was performed, accompanied by the Vice President (VP) of Infrastructure, AVP of Surgical Services, Director of Engineering, IP staff member and the IP Manager. The facility was noted to have 30 operating rooms in the department. Upon entry into the OR, the surveyor was made aware the facility shut down the construction project in OR #14 and OR #6 that morning to ensure the construction barrier and staff were following the Infection Control Risk Assessment (ICRA) for the project. A tour of OR #14 showed contractors reinforcing the ICRA barrier exterior, interior and ventilation vents on the ceiling with tape. The contractor's ladder was noted to have excessive dirt and dust of unknown origin that was carried through the sterile OR to OR#14. All tour members present confirmed these findings. An interview with the Director of Engineering revealed the contractors wear bunny suits to protect their clothes from construction dust. The tour members confirmed the contractors exit the ICRA barrier with the bunny suit on, and they travel down the sterile OR hallway to exit the department. The members agreed this was not an appropriate process. OR #6 was observed to have a ICRA barrier but no contractors.

A review of the Infection Control Construction/Maintenance Permit, while on tour of the or, revealed a start date of June 01, 2019 with an estimated duration until July 31, 2019. The permit showed the construction activity was a Type B; small scale, short duration, moderate to high levels. The risk group was Group 4: highest risk.

The permit showed a Class III for the construction project in the OR. The permit was signed by the IP Manager on 05/31/19. According to the permit, this would make a Class IV an option as well. The difference between the Class III and IV, is the requirement for an anteroom where all personnel are required to pass through, so they can be Hepa vacuumed prior to leaving the barrier, or they can wear cloth overalls that are removed each time they leave the work area / inside the ICRA barrier.

An interview with IP Manager on 06/27/19, while on tour of the OR, revealed the project was not actually of short duration (Type B). The IP Manager confirmed a Type C would have been more appropriate. Type C's include any activity which cannot be completed with a single work shift. The IP manager confirmed the finding the ICRA should have been a Class IV.