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Based on interview and record review, the hospital failed to ensure the temperature in the Pharmacy remained in compliance with the hospital's medication temperature policy and procedure. This failure had the potential for the medications to lose its potency and effectiveness.

Findings:

During a concurrent interview and record review on 11/2/21, at 11:55 AM, with the Maintenance Plant Manager (MPM), the Pharmacy Smart Temperature logs indicated the following:

1) On 10/10/21, between 8:33 AM and 6:03 PM, the temperature in the Pharmacy never rose above 67 degrees Fahrenheit (F) during this 9-hour period.
2) On 10/12/21, between 6:33 AM and 4:33 PM, the temperature in the Pharmacy never rose above 67 degrees Fahrenheit during this 10-hour period.
3) On 10/13/21, between 6:03 AM and 6:33 PM, the temperature in the Pharmacy never rose above 67 degrees Fahrenheit during this 10-hour period.
4) On 10/16/21, between 10:32 AM and 4:02 PM, the temperature in the Pharmacy never rose above 67 degrees Fahrenheit on during this 5-hour period.
5) On 10/17/21, between 11:02 AM and 4:02 PM, the temperature in the Pharmacy never rose above 67 degrees Fahrenheit during this 5-hour period.
6) On 10/19/21, between 6:32 AM and 7:32 PM, the temperature in the Pharmacy never rose above 67 degrees Fahrenheit during this 13-hour period.
7) On 10/20/21, between 6:32 AM and 6:02 PM, the temperature in the Pharmacy never rose above 67 degrees Fahrenheit during this 11-hour period.
8) On 10/26/21, between 2:31 AM and 7:31 PM, the temperature in the Pharmacy never rose above 67 degrees Fahrenheit during this 17-hour period.

MPM verified the findings.

During a review of the hospital's policy and procedure titled "Sterile Compounding- Temperature Monitoring", dated 7/20/2020, indicated "Controlled room temperature shall be maintained 20 to 25 degrees Celsius (68 to 77 degrees Fahrenheit)".

The hospital failed to meet the regulatory requirements for the Condition of Participation: CFR 485.635 Provision of Services as evidenced by the following:

1. Based on interview and record review, the hospital failed to eliminate and/or remediate mold growth in the hospital's Pharmacy Sterile Compounding Area (SCA), based on two reports from M-bioLabs (provides environmental testing for health care facilities and Pharmacies) dated 3/2021 and 9/2021. This failure had the potential for all of the hospital's sterile compounded products to be contaminated which could have resulted in patient harm or illness. (Refer to C-1016, item 1)

2. Based on interview and record review, the hospital failed to ensure "banana bag" (an intravenous [IV- goes into the veins] medication containing thiamine, folic acid, multivitamins, and magnesium sulfate [vitamins and minerals]) compounding was done by a pharmacist for five of five sampled emergency room patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5) per policy and procedure. These failures had the potential for banana bags becoming contaminated and result in patient infection. (Refer to C-1016, item 2)

On 11/4/21 at 1:40 PM, an Immediate Jeopardy situation (a situation in which the facility's noncompliance has placed the health and safety of patients in its care at risk for serious injury, serious harm, serious impairment, or death) was identified and called with regards to the hospital's noncompliance with highly pathogenic microbial and fungal growth in the Pharmacy's Sterile Compounding Area (SCA). The Immediate Jeopardy was called in the presence of the hospital's Administrator, Pharmacist (Pharm) 1, Pharmacist in Charge (PIC), Medical Director (MD) for Acute Care, and the hospital's Executive Assistant (EA).

On 11/10/21 at 11:50 AM, the hospital's Administrator provided a Plan of Action which included the following summarized actions:

a. The hospital terminated compounding of medications which did not meet the hospital's definition of immediate use medications for emergent use. A contract was developed between Hospital 2 and this hospital for the sterile compounding of all other compounded medications.
b. Housekeeping conducted a terminal cleaning of the hospital's SCA using Peridox (RTU) ready to use cleaning agent and this terminal cleaning was to be completed by the hospital and this cleaning will continue each month. The hospital's Infection Control Professional (ICP) will be involved in training Housekeeping staff in the terminal cleaning process. Draft policies and procedures were developed for the terminal cleaning process.
c. Medical staff, along with Nursing staff and Pharmacy staff were notified of the sterile drug compounding changes and staff education was provided.
d. A HEPA-filter (Highly-efficiency particulate absorbing filter which helps remove viruses and bacteria) was borrowed from a local hospital on 11/9/2021 for use in the Pharmacy to assist in purifying the air in the Pharmacy's SCA.
e. Filters in the hospital's air handlers were inspected and replaced and these filters will be replaced every month moving forward.
f. Environmental retesting of the Pharmacy's SCA will be completed by ENV services (an outside environmental testing company).
g. Staff Development will be involved in any staff training.

On 11/10/21 at 12:52 PM, while onsite and after confirming the facility's implementation of the immediate corrective Plan of Action, the Immediate Jeopardy situation was removed in the presence of the Hospital's Administrator, Pharm 1, PIC, MD for Acute Care, and the Hospital's EA.

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care, in compliance with the Condition of Participation for Provision of Services.

Based on interview and record review, the hospital failed to follow the hospital policies and procedures and USP 797 (guidelines and sets of standards for compounding sterile preparations) when the hospital failed to:

1. Eliminate and/or remediate mold growth in the hospital's Pharmacy Sterile Compounding Area (SCA), based on two reports from M-bioLabs dated 3/2021 and 9/2021. This failure had the potential for all of the hospital's sterile compounded products to be contaminated which could have resulted in patient harm or illness.

M-bioLabs provides environmental testing for health care facilities and Pharmacies.

2. Ensure "banana bag" (an intravenous [IV- goes into the veins] medication containing thiamine, folic acid, multivitamins, and magnesium sulfate [vitamins and minerals]) compounding was done by a pharmacist for five of five sampled emergency room patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5) per policy and procedure. These failures had the potential for banana bags becoming contaminated and result in patient infection.

On 11/4/21 at 1:40 PM, an Immediate Jeopardy situation (a situation in which the facility's noncompliance has placed the health and safety of patients in its care at risk for serious injury, serious harm, serious impairment, or death) was identified and called with regards to the hospital's non-compliance with highly pathogenic microbial and fungal growth in the Pharmacy's Sterile Compounding Area (SCA). The Immediate Jeopardy was called in the presence of the hospital's Administrator, Pharmacist (Pharm) 1, Pharmacist in Charge (PIC), Medical Director (MD) for Acute Care, and the hospital's Executive Assistant (EA).

On 11/10/21 at 11:50 AM, the hospital's Administrator provided a Plan of Action which included the following summarized actions:

a. The hospital terminated compounding of medications which did not meet the hospital's definition of immediate use medications for emergent use. A contract was developed between Hospital 2 and this hospital for the sterile compounding of all other compounded medications.
b. Housekeeping conducted a terminal cleaning of the hospital's SCA using Peridox (RTU) ready to use cleaning agent and this terminal cleaning was to be completed by the hospital and this cleaning will continue each month. The hospital's Infection Control Professional (ICP) will be involved in training Housekeeping staff in the terminal cleaning process. Draft policies and procedures were developed for the terminal cleaning process.
c. Medical staff, along with Nursing staff and Pharmacy staff were notified of the sterile drug compounding changes and staff education was provided.
d. A HEPA-filter (Highly-efficiency particulate absorbing filter which helps remove viruses and bacteria) was borrowed from a local hospital on 11/9/2021 for use in the Pharmacy to assist in purifying the air in the Pharmacy's SCA.
e. Filters in the hospital's air handlers were inspected and replaced and these filters will be replaced every month moving forward.
f. Environmental retesting of the Pharmacy's SCA will be completed by ENV services (an outside environmental testing company).
g. Staff Development will be involved in any staff training.

On 11/10/21 at 12:52 PM, while onsite and after confirming the facility's implementation of the immediate corrective Plan of Action, the Immediate Jeopardy situation was removed in the presence of the Hospital's Administrator, Pharm 1, PIC, MD for Acute Care, and the Hospital's EA.

Findings:

1. During an interview on 11/3/21, at 9:55 AM, ICP, ICP stated PIC had not consulted with her since 2019 (more than 2 years ago).

During a concurrent interview and review of the hospital's Environmental Sampling Report from "M-bioLabs," dated 3/2021, on 11/4/21, at 10:45 AM, with PIC, the report indicated the presence of highly pathogenic (which are defined as biological agents that can cause severe human disease and present a serious hazard to health care workers) mold/fungus (Aspergillus niger), which can cause opportunistic infections (infections which occur with individuals with weakened immune systems) for humans. The hospital's PIC was unable to provide any evidence that this Aspergillus mold had been eliminated/remediated from the Pharmacy's SCA. PIC confirmed he had not taken any corrective action to remediate the growing molds which had been found in the Pharmacy's SCA in 3/2021 and 9/2021. PIC acknowledged he had been aware of the fungal/mold growth in the SCA since 4/2021. PIC also stated he had not consulted with the hospital's ICP, since 2019 (more than 2 years ago), which was confirmed in an earlier interview on 11/3/2021 at 9:55 AM, with the ICP. He acknowledged he had not implemented any system (in coordination with a competent microbiologist, infection control professional, or industrial hygienist), to remediate the fungus/mold which had been found in the pharmacy's SCA.

During a concurrent interview and review of the hospital's Environmental Sampling Report dated 9/2021, on 11/4/21 at 10:45 AM, with PIC, the report indicated the presence of highly pathogenic mold/fungus (Aspergillus niger and Curvularia), which can cause opportunistic infections for humans. The hospital's PIC was unable to provide any evidence that this Aspergillus mold and Curvularia mold had been eliminated/remediated from the Pharmacy's SCA.

During a review of the hospital's policy and procedure (P&P) titled: "Compounded Sterile Products (CSPs) Policies and Procedures", dated 9/2017, the P&P indicated, "All compounding policies and will follow . . .USP general chapter <797> will greatly influence these policies . . ."

During a review the hospital's P&P titled, "Sterile Compounding -Cleaning and Maintenance of ISO (International Organization for Standardization) Environment and SCA, dated 3/2021, the P&P indicated, "Cleaning and maintenance of ISO Environment and SCA shall adhere to USP <797> standards." USP 797, was written by the U.S. Pharmacopeia is the current national standard of practice for Sterile Compounding.

During a review of the guidance under CMS's State Operations Manual under section 485.635 (a)(3)(iv) the guidance indicates, "Compounded medications, whether non-sterile or sterile, may be subject to physical and chemical contamination and unintended variations in strength. Microbial contamination and bacterial endotoxins are particularly hazardous with respect to compounded medications that are intended to be sterile.

A CAH pharmacy must be administered in accordance with accepted professional principles, and therefore must be able to demonstrate how it assures that all sterile and non-sterile compounded preparations dispensed and/or administered to the CAH's patients are being compounded consistent with accepted professional standards to ensure safety. The CAH must be able to provide evidence that the CAH's standard operating procedures for compounding, if performed in-house, and for quality oversight of compounding, regardless of source, are consistent with accepted professional principles.

Compounding may take place in the CAH's pharmacy on-site and/or the CAH may obtain some or all of its compounded medications from external sources. Regardless of the source, if accepted standards for safe compounding are not met, compounded medications may contain less or more than the intended dose and/or may be chemically or microbiologically contaminated, with potentially serious adverse consequences for the patients who receive them.

During a review of USP 797 the following was noted under the section labeled, "Action Levels, Documentation, and Data Evaluation" reads: ". . . Regardless of the number of cfu (colony forming units) identified in the pharmacy, further corrective actions will be dictated by the identification of microorganisms recovered (at least the genus level) by an appropriate credentialed laboratory of any microbial bioburden captured as cfu . . . Highly pathogenic microorganisms (e.g . . . molds . . .) can be potentially fatal to patients receiving CSPs (Compound Sterile Prepations) and must be immediately remedied, regardless of cfu count, with the assistance of a competent microbiologist, infection control professional, or industrial hygienist."

During a review of the hospital's Pharmacy and Therapeutics meeting minutes dated 10/18/19, the minutes indicated, " . . . Infection Control Nurse professional noted that copies of the various test results will need to be sent to Infection Control and asked if this would be addressed in this policy. Per [PIC], USP 797 does not require test results to be submitted except when there is a problem, so it was not addressed in this policy. He [PIC] will, however add these items to his existing testing policy." As indicated above, even when there were problems with the environmental testing results, these results had not been shared with the Infection Control Nurse professional since the date of this meeting (10/18/19).


42744

2. During an interview on 11/2/21, at 3:51 PM, with Registered Nurse (RN) 1, RN 1 stated, "Frequently at night we [RNs] do mix banana bags." RN 1 stated, there is a pharmacist on call at night to mix "banana bags," so mixing by RNs varies.

During an interview on 11/4/21, at 6:47 AM, with House Supervisor (HS), HS stated, "Yeah, we mix our own banana bags."

During a concurrent interview and record review on 11/4/21, at 9:19 AM, with Director of Staff Development (DSD), the "RN ER [Emergency Room] Department Orientation and Competency Record" (RN ER Orientation) was reviewed. The RN ER Orientation Record did not include any training for ER RNs to mix banana bags. DSD stated there is no training for RNs to mix banana bags because they are not allowed to mix banana bags. DSD stated, mixing banana bags is considered compounding and "nursing staff are not allowed to do compounding." DSD stated, pharmacy mixes banana bags.

During a concurrent interview and record review on 11/4/21, at 9:39 AM, with Pharm 1, Patient 1, Patient 2, Patient 3, Patient 4, and Patient 5's ER "Order Sheet (OS)," multiple dates, were compared against the pharmacy's "Master Compounding Log," multiple dates. The following banana bags were mixed and given by the RNs:
1. Patient 1's "OS" indicated, "Banana Bag IV. . ." was to have thiamine 100 mg/L (milligrams per liter- units of measurement), folic acid 1 mg/L, and multiple vitamins 1 amp/L (ampule per liter- units of measurement) mixed into NS (Normal Saline- 9 percent sodium solution, frequently used as IV liquid), and was given by RN 1 on 10/1/21, at 8:11 PM.
2. Patient 2's "OS" indicated, "Banana Bag IV . . ." was to have thiamine, folic acid, and multiple vitamins mixed into NS, and was given by RN 2 on 10/21/21, at 12:33 AM.
3. Patient 3's "OS" indicated, "Banana Bag IV . . ." was to have magnesium, thiamine, folic acid, and multiple vitamins mixed into NS, and was given by RN 1 on 8/6/21, at 9:40 PM.
4. Patient 4's "OS" indicated, "Banana Bag IV . . ." was to have magnesium, thiamine, folic acid, and multiple vitamins mixed into NS, and was given by RN 2 on 10/4/21, at 11:34 PM.
5. Patient 5's "OS" indicated, "Banana Bag IV . . ." was to have magnesium, thiamine, folic acid, and multiple vitamins mixed into NS, and was given by RN 3 on 9/28/21, at 1:53 AM.
Pharm 1 compared the pharmacy's "Master Compounding Log" and stated there were no records indicating a pharmacist had compounded Patient 1, Patient 2, Patient 3, Patient 4, or Patient 5's banana bags. Pharm 1 stated, "They didn't call us to make it" or it would be in the log [referring to the Master Compounding Log]. Pharm 1 stated, all of those banana bags were not made in the pharmacy. Pharm 1 stated, there are no P&Ps, training, or skills validation for RNs to compound banana bags in the ER.

"During a review of the facility's P&P titled, "STERILE COMPOUNDING- "BANANA BAG" MANAGEMENT BY PHARMACY," dated 8/5/20, the P&P indicated, "POLICY: Pharmacist shall manage "Banana Bag" compounding to meet current compounding requirements and appropriate/correct components. . . JUSTIFICATION: To meet the request of hospitalists, the California Board of Pharmacy requirements, and to reduce nursing burden. . . B. Emergency Department. . . 3. Once pharmacy is notified of a "Banana Bag" order, pharmacy will prepare a "Banana Bag" as follows: . . ."

The hospital failed to meet the regulatory requirements for the Condition of Participation: CFR 485.640 Infection Prevention and Control and Antibiotic Stewardship Program as evidenced by the following:

1. Based on interview and record review, the hospital failed to ensure an effective infection control program was implemented when the Infection Control Professional failed to conduct surveillance, prevention and control activities. This had the potential to result in infections to go undetected and not acted upon. This also resulted in identified pathogenic mold/fungus in the Pharmacy's Sterile Compounding Area (SCA) to go unidentified and acted upon which could result in hospital acquired opportunistic infections (infections which occur with individuals with weakened immune systems) of the hospital's patients. (Refer to C-1208)

2. Based on interview and record review, the hospital Infection Control Professional failed to provide documented evidence of an effective antibiotic stewardship program. This has the potential to result in the overuse of antibiotics. (Refer to C-1221)

3. Based on interview and record review, the hospital Infection Control Professional failed to ensure the antibiotic stewardship program was current and in place. This failure had the potential to result in the hospital's inability to provide effective antibiotic therapy for their patients. (Refer to C-1242)

4. Based on interview and record review, the hospital failed to implement a hospital wide antibiotic stewardship program which showed current monitoring and improvement of the hospital's antibiotic usage. This failure had the potential to result in the hospital's inability to provide effective antibiotic therapy for their patients. (Refer to C-1244)

5. Based on interview and record review, the hospital failed to implement an antibiotic stewardship program which maintained documentation of any antimicrobial stewardship program activities. This failure had the potential to result in the hospital's inability to provide effective antibiotic therapy for their patients. (Refer to C-1246)

6. Based on interview and record review, the hospital failed to implement an antibiotic stewardship program which provided communication and collaboration with the hospital's medical staff, nursing, and pharmacy leadership, along with the Infection Control Professional and Quality Assurance Performance Improvement on the hospital's use of antibiotics. This failure resulted in the hospital's medical, nursing, and pharmacy staff, being unable to provide antibiotic therapy to their patients in a safe and effective manner. (Refer to C-1248)

7. Based on interview and record review, the hospital failed to implement an antibiotic stewardship program which provided competency-based training and education to the hospital's medical staff, nursing, pharmacy staff, and personnel who provided contracted services. This failure had the potential to result in the hospital staff and contracted staff providing the hospital's patients with subtherapeutic antibiotic therapy. (Refer to C-1250)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure an effective system-wide infection control program thus resulting in the hospital's inability to provide an environment which was free from the transmission of infections and communicable diseases.

Based on interview and record review, the hospital failed to ensure an effective infection control program was implemented when the Infection Control Professional (ICP) failed to conduct surveillance, prevention and control activities. This had the potential to result in infections to go undetected and not acted upon. This also resulted in identified pathogenic mold/fungus in the Pharmacy's Sterile Compounding Area (SCA) to go unidentified and acted upon which could result in hospital acquired opportunistic infections (infections which occur with individuals with weakened immune systems) of the hospital's patients.

Findings:

During a review of the hospital "Biological Sampling Report from "M-bioLabs," dated 3/9/2021, and 9/8/2021, the report indicated the presence of a highly pathogenic (which are defined as biological agents that can cause severe human disease and present a serious hazard to health care workers) mold/fungus (Aspergillus niger) in the Pharmacy's Sterile Compounding Area (SCA).

During an interview on 11/10/21, at 2:21 PM, with ICP, she stated she has not participated in the infection prevention and control program meeting.

During an interview on 11/16/21. at 9:44 AM, with ICP, she stated she has not conducted any surveillance of infections. ICP reviewed the two biological sampling reports. She stated she had not been provided copies of the reports and was not aware there was an issue in pharmacy. She stated she has not conducted any infection control activities other than COVID related infection control activities.

During an interview on 11/16/21, at 10:17 AM, with the ICP, she stated she had not attended the IPPC meeting in several months. She stated, "I think I skipped a couple of the meeting because I didn't have anything to report." Requested a policy and procedure for infection control and prevention program and none provided.

During a review of the infection prevention and control program meeting minutes for Pharmacy and Therapeutics Infection Prevention Program Committee Meeting," dated 10/11/21 and 9/20/21, there was no documented evidence ICP attended.

During a review of the hospital document titled "Pharmacy and Therapeutics IPPC [Infection Prevention Program Committee] Committee Meeting" attendance roster, dated 11/11/2021 and 9/20/2021. There was no documentation evidence ICP attended either meeting.

During a review of the hospital's "Position Description/Performance Evaluation" job description "Infection Preventionist: dated 5/21/2019, the job description indicated, "The Infection Preventionist (IP) [ICP] is responsible for the overall direction of the infection Prevention and Control Program (IPIC). This includes planning, developing, directing, implementing and evaluation infection prevention with the healthcare district and it's associated facilities. The IP is responsible for the effective direction, management and operation of the infection prevention and control department, including education of hospital personnel, Consults with the Centers for Disease Control (CDC), Association of Professionals in Infection Control (APIC), and the county and state departments. The responsibilities encompass compliance with Centers for Medicare and Medicaid Services (CMS), OSHA [Occupational Safety and Health Administration] and state regulations and outbreak investigations."

Based on interview and record review, the hospital's Infection Control Professional (ICP) failed to provide documented evidence of an effective antibiotic stewardship program which followed nationally recognized guidelines. This has the potential to result in the overuse of antibiotics.

Findings:

During an interview on 11/16/21, at 2:20 PM, with the ICP, she stated she has not participated in the hospital antibiotic stewardship program meeting for several months. At 3:32 PM, ICP stated the antibiotic stewardship meeting usually is conducted once a quarter. ICP stated the committee "has met zero times this year in 2021."
ICP stated the guidelines the hospital uses for the development of the antibiotic stewardship program is the "CDPH [California Department of Public Health] Antimicrobial Stewardship Program Toolkit Examples for Program Implementation 2015". A hospital policy and procedure for antibiotic stewardship was requested and none was provided.

During a review of the hospital documents titled "Attendance for Antibiotic Stewardship 101 undated, no documentation was provided to indicate the ICP had attended the meetings.

During a review of the hospital policy and procedure titled, Antimicrobial Stewardship Program (ASP)," dated 9/25/2017, indicated, "The role of the Antimicrobial Stewardship Program (ASP) is to promote and evaluate the judicious use of antimicrobial agents at [hospital] and the initiate quality improvement activities that increase responsible and effective use of antimicrobial through a multidisciplinary approach. . . D. Core ASP members include: . .3. Infection Control Nurse [ICP]."

During a review of "CDPH Antimicrobial Stewardship Program Toolkit Examples for Program Implementation 2015", the toolkit indicated, "Basic . . . An institution-specific antimicrobial stewardship policy and/or procedure has been adopted . . . the physician-supervised multidisciplinary antimicrobial stewardship program (ASP committee oversees organization-wide efforts to promote and evaluate the appropriate use of antimicrobial agents . . . ASP committees generally include the following core members . . . Infection preventionist [ICP] . . ."

During a review of the hospital's "Position Description/Performance Evaluation" job description "Infection Preventionist" dated 5/21/2019, it indicated, "The Infection Preventionist (IP) [ICP] is responsible for the overall direction of the infection Prevention and Control Program (IPIC). This includes planning, developing, directing, implementing and evaluation infection prevention with the healthcare district and it's associated facilities. The IP is responsible for the effective direction, management and operation of the infection prevention and control department, including education of hospital personnel, Consults with the Centers for Disease Control (CDC), Association of Professionals in Infection Control (APIC), and the county and state departments. The responsibilities encompass compliance with Centers for Medicare and Medicaid Services (CMS), OSHA [Occupational Safety and Health Administration] and state regulations and outbreak investigations."

Based on interview and record review, the hospital Infection Control Professional (ICP) failed to ensure the antibiotic stewardship program was current and in place. This failure had the potential to result in the hospital's inability to provide effective antibiotic therapy for their patients.

Findings:

During an interview on 11/16/21, at 2:20 PM, with the ICP, she stated she has not participated in the hospital antibiotic stewardship program meeting for several months. At 3:32 PM, ICP stated the antibiotic stewardship meeting usually is conducted once a quarter. ICP stated the committee "has met zero times this year in 2021."

During an interview and record review on 11/16/21, at 3:30 PM, with the Pharmacist in Charge (PIC), the hospital's last Antimicrobial Stewardship Committee (ASC) minutes was dated 9/18/19. PIC stated the hospital's ASC had not met for more than two years.

During a review of the hospital documents titled "Attendance for Antibiotic Stewardship 101 undated, no documentation was provided to indicate the ICP had participated in the meetings.

During a review of the hospital policy and procedure titled, Antimicrobial Stewardship Program (ASP)," dated 9/25/2017, indicated, "The role of the Antimicrobial Stewardship Program (ASP) is to promote and evaluate the judicious use of antimicrobial agents at [hospital] and the initiate quality improvement activities that increase responsible and effective use of antimicrobial through a multidisciplinary approach. . . D. Core ASP members include: . .3. Infection Control Nurse [ICP]."

Based on interview and record review, the hospital failed to implement a hospital wide antibiotic stewardship program which showed current monitoring and improvement of the hospital's antibiotic usage. This failure had the potential to result in the hospital's inability to provide effective antibiotic therapy for their patients.

Findings:

During an interview and record review on 11/16/21 at 3:30 PM, with the Pharmacist in Charge (PIC), the hospital's last Antimicrobial Stewardship Committee (ASC) minutes was dated 9/18/19. PIC stated the ASC had not met for more than two years. PIC was unable to provide any evidence of monitoring or improvement for the use of antibiotics throughout the hospital since the ASC's last meeting on 9/18/19.

During a review of the hospital policy and procedure titled, Antimicrobial Stewardship Program (ASP)," dated 9/25/2017, indicated, "The role of the Antimicrobial Stewardship Program (ASP) is to promote and evaluate the judicious use of antimicrobial agents at [hospital] and the initiate quality improvement activities that increase responsible and effective use of antimicrobial through a multidisciplinary approach. . . D. Core ASP members include: . .3. Infection Control Nurse [ICP]."

Based on interview and record review, the hospital failed to implement an antibiotic stewardship program which maintained documentation of any antimicrobial stewardship program activities. This failure had the potential to result in the hospital's inability to provide effective antibiotic therapy for their patients.

Findings:

During an interview and record review, on 11/16/21, at 3:30 PM, with the Pharmacist in Charge (PIC), the hospital's last Antimicrobial Stewardship Committee (ASC) minutes was dated 9/18/19. PIC stated the ASC had not met for more than two years. PIC was unable to provide evidence of any ASC activities, since 9/18/19.

During a review of the hospital policy and procedure titled, Antimicrobial Stewardship Program (ASP)," dated 9/25/2017, indicated, "The role of the Antimicrobial Stewardship Program (ASP) is to promote and evaluate the judicious use of antimicrobial agents at [hospital] and the initiate quality improvement activities that increase responsible and effective use of antimicrobial through a multidisciplinary approach. . . D. Core ASP members include: . .3. Infection Control Nurse [ICP]."

Based on interview and record review, the hospital failed to implement an antibiotic stewardship program which provided communication and collaboration with the hospital's medical staff, nursing, and pharmacy leadership, along with the Infection Control Professional (ICP) and Quality Assurance Performance Improvevement (QAPI) on the hospital's use of antibiotics. This failure resulted in the hospital's medical, nursing, and pharmacy staff, being unable to provide antibiotic therapy to their patients in a safe and effective manner.

Findings:

During a concurrent interview and record review, on 11/16/21, at 3:30 PM, with the Pharmacist in Charge (PIC), the last hospital's Antimicrobial Stewardship Committee (ASC) minutes was dated 9/18/19. PIC stated the hospital's ASC had not met for more than two years. PIC was asked if he had any evidence of communication and collaboration with the hospital's medical staff, nursing, and pharmacy leadership since the ASC's last meeting on 9/18/19. PIC stated he did not have any evidence of communication or collaboration. PIC stated he had not had any collaboration or communication with the ICP or QAPI since the ASC's last meeting on 9/18/19.

During a review of the hospital policy and procedure titled, Antimicrobial Stewardship Program (ASP)," dated 9/25/2017, indicated, "The role of the Antimicrobial Stewardship Program (ASP) is to promote and evaluate the judicious use of antimicrobial agents at [hospital] and the initiate quality improvement activities that increase responsible and effective use of antimicrobial through a multidisciplinary approach. . . D. Core ASP members include: . .3. Infection Control Nurse [ICP]."

Based on interview and record review, the hospital failed to implement an antibiotic stewardship program which provided competency-based training and education to the hospital's medical staff, nursing, pharmacy staff, and personnel who provided contracted services. This failure had the potential to result in the hospital staff and contracted staff providing the hospital's patients with subtherapeutic antibiotic therapy.

Findings:

During a concurrent interview and record review on 11/16/21, at 3:30 PM, with the Pharmacist in Charge (PIC), the hospital's last Antimicrobial Stewardship Committee (ASC) minutes was dated 9/18/19. PIC stated the hospital's ASC had not met for more than two years. PIC was asked if he had any evidence of competency-based training and education for the hospital's medical staff, nursing, pharmacy staff, and personnel who provided contracted services. PIC stated the last time the ASC provided education to the hospital's staff was in 2018, and no other education had been provided to the hospital's nursing staff, since then.

During a review of the hospital policy and procedure titled, Antimicrobial Stewardship Program (ASP)," dated 9/25/2017, indicated, "The role of the Antimicrobial Stewardship Program (ASP) is to promote and evaluate the judicious use of antimicrobial agents at [hospital] and the initiate quality improvement activities that increase responsible and effective use of antimicrobial through a multidisciplinary approach. . . D. Core ASP members include: . .3. Infection Control Nurse [ICP]."