HospitalInspections.org

The Condition of Participation is NOT met as:
Based on observation, interview, and record review, the hospital's Governing Body (GB) failed to assume full legal responsibility for implementing, and monitoring policies governing the hospital's pharmacy operation, and providing the oversight for quality health care, in a safe environment as follows:

Findings:

1. The hospital has failed to have developed, implemented and maintained an effective, ongoing, hospital-wide, data-driven quality assessment, and performance improvement program.
(Cross reference Condition of Participation A-0263).

2..The hospital failed to ensure that safe pharmaceutical services had been provided and meet the needs of each patient (Cross Reference Condition of Participation A-489)

3. The hospital failed to meet the regulatory requirements for the Condition of Participation: CFR 482.42 Infection Prevention and Control and Antibiotic Stewardship Program as evidenced by the following:

a. The facility failed to demonstrate the governing body appointed an infection prevention manager responsible for the infection control program based off the recommendations of the medical staff leadership and nursing leadership.
This facility failure had the potential for an unqualified infection prevention manager to lead the hospitals infection prevention and control program.
(Refer to A-748)

b. The hospital failed to ensure a safe and sanitary environment and implement policy and procedures to minimize the transmission of healthcare acquired infections (HAIs) when: a.Temperature and humidity had been out of range in the operating rooms (ORs), OR sterile supply room, and sterile processing department (SPD).b.Humidity was out of range in the labor and delivery (L&D) OR's (OR #1 and OR #2).cTemperature and humidity were not monitored where sterile instruments were stored in L&D.These facility's failures had the potential for negative patient care outcomes and the potential to spread harmful microorganisms to patients that could result in procedural and surgical site infections. (Refer to A-749)

c.The hospital failed to :properly store patient care equipment when unable to determine if clean or dirty on the medical surgical unit.
d. Ensure dirty equipment was not stored in a clean patient room.
e. Ensure dirty equipment (a bladder scanner) was not stored in the clean storage room.
f. Ensure staff performed hand hygiene on the medical surgical unit when coming out of a patient's room (Patient 101), who was in isolation and on contact precautions (to prevent the transmission of infectious agents and microorganisms which are spread by direct or indirect contact with the patient and or the patient's environment).
g. Ensure staff disposed of Personal Protective Equipment (PPE) appropriately on the medical surgical unit when coming out of a patient's room (Patient 101), who was in isolation and on contact precautions.
h.Ensure staff wore gloves when accessing an IV (intravenous-in the vein) site for one Patient (Patient 100) for medication administration on the medical surgical unit.
i.Ensure staff recorded the date and time on an IV site for one patient (Patient 100) on the medical surgical unit.
j. Ensure staff recorded the date and time on an IV site for one patient (Patient 301) in the Emergency Room (ER).
These failures had the potential to spread infection to patients, staff, and visitors. (See A-750)


4. Based on hospital administrative staff interviews and review of the hospital's Antibiotic Stewardship Program (ASP) policies and procedures, the hospital failed to ensure that the hospital had created and maintained ASP minutes which would have demonstrated the hospital's implementation, success, and sustainability of their antibiotic use activities.This failure had the potential to result in the hospital's inability to provide effective antibiotic therapy for their patients. (Refer to A-770)

5. Based on interview with the hospital's Infection Preventionist (IP), the IP was unable to provide any documented evidence that he had any communication and collaboration with the hospital's ASP. This failure had the potential to result in the hospital's inability to provide effective antibiotic therapy for their patients. (Refer to A-777)

6. Based on hospital administrative staff interview (Infection Control Preventionist) [IP] and review of the hospital's Antibiotic Stewardship Program (ASP) policies and procedures, the hospital failed to ensure that the hospital had created and maintained ASP minutes which would have demonstrated the hospital's implementation, success, and sustainability of their antibiotic use activities. This failure had the potential to result in the hospital's inability to provide effective antibiotic therapy for their patients. (Refer to A-778)

7. Based on interview with the hospital's administrative staff the hospital failed to provide evidence that the hospital's ASP had been communicating and collaborating with the hospital's medical staff, nursing, pharmacy leadership, the hospital infection preventionist, and the QAPI programs regarding antibiotic use issues within the hospital. 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 A-780)

8. Based on hospital administrative staff interviews and policy and procedure 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 A-781)

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.

The Condition of Participation is NOT met as:
Based on staff interview and document review, the hospital's Governing Body (GB) failed to ensure the hospital had developed, implemented and maintained an effective, ongoing, hospital-wide, data-driven quality assessment, and performance improvement program, when:

1. The governing body (GB) failed to specify frequency and detail of data collection to ensure all identified hospital services, which accurately reflected the depth and scope of departmental operations and the services furnished were evaluated on a routine basis to identify quality and performance problems, implement appropriate corrective or improvement activities, and to ensure the monitoring and sustainability of those corrective or improvement activities.
(Cross Reference A-0273).

2. The QAPI department failed to developed a plan that required monitoring of the effectiveness, safety of services, and quality of care provided to their patients. The QAPI plan had a process to determine areas of concern, but did not include pharmacy and therapeutics committee oversight of medication errors and did not initiate a methodology for reassessing the performance improvement plan developed for concerns. As a result, there was no way to determine if the plan for an identified issue was effective or needed to be revised.
(Cross reference A-0286).

3. The governing board (GB) did not ensure documentation that the hospital conducted performance improvement projects reflected of the scope and complexity of the hospital, when QAPI program failed to focus on known high-risk, high volume and problem prone areas within the pharmacy medication errors. This failure resulted to missed opportunities for improvement with possibility of adverse patient outcomes.
(Cross Reference A-0297)

4. The governing body (GB) failed to ensure the quality assurance and performance improvement (QAPI) program reflected the complexity of the hospital's services and involved all hospital departments and services This failure had the potential for non implementation of needed quality programs due to lack of data to support, monitor, follow up on potential hospital services that required improvement for the rendition of quality health care.
(Cross Reference A-0308 )

5. The hospital's governing body (GB) failed to ensure the quality assurance and performance improvement (QAPI) program reflected the complexity of the hospital's services and involved all hospital departments and services.
The GB failed to ensure the QAPI department developed a plan that required monitoring of the effectiveness, safety of services, and quality of care provided to their patients. The GB failed to determine the number of distinct improvement projects that are conducted annually and evaluated for improved quality of care, patient safety. The QAPI plan had a process to determine areas of concern, but did not initiate it's governing body approved performance improvement plan methodology to include pharmacy and therapeutics committee oversight of medication errors and did not initiate a methodology for reassessing a performance improvement plan developed for concerns.
(Cross Reference A-0309)

These failures, put patients at potential risk for substandard care, adverse events, and negative outcomes. The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Quality Assessment and Performance Improvement.

Based on administrative staff interview, and document review, the hospital failed to have governing body (GB) specify frequency and detail of data collection to ensure all identified hospital services, which accurately reflected the depth and scope of departmental operations and the services furnished, were evaluated on a routine basis to identify quality and performance problems, implement appropriate corrective or improvement activities, and to ensure the monitoring and sustainability of those corrective or improvement activities.

This failure resulted in a lack of developed comprehensive program that identified opportunities for improvement, that may result in compromised patient outcomes in relationship to the patience care services provided.


Findings:

During a review of facility document titled, "Performance Improvement Plan," dated, "4/8/2021," document indicated in part.... "VII Performance Improvement Plan Approvals Adoption. 7.7.1 This Organizational Performance Improvement Plan approved and adopted by the Governing Board, the Medical Staff acting through its Medical Executive Committee and by the organizational leaders
A. Governing board: The governing board is responsible for establishing and maintaining the organization performance improvement program. The Governing Board has delegated to the medical staff and Chief Executive Officer the responsibility for implementation of the program.... The Chief of Staff and the Chief Executive Officer have delegated oversight of performance improvement functions to the Quality Council. The Governing Board requires the medical and hospital staff to implement and report on activities for identifying and evaluating opportunities to improve patient care and services through out the organization. The effectiveness of the performance improvement activities will be evaluated and reported to the Governing Board."

During a concurrent interview and record review on 11/01/23 at 2:45 p.m., with chief quality officer (CQO), CQO acknowledged that governing board meetings and medical executive meetings agendas and minutes from December 2022 through October 2023 did not reflect GB specification of frequency and detail of data collection. CQO stated, "No, that's not been happening."

Based on interview and record review, the hospital failed to ensure the Quality Assessment Performance Improvement (QAPI) department developed a plan that required monitoring of the effectiveness, safety of services, and quality of care provided to their patients. The QAPI plan had a process to determine areas of concern, but did not initiate it's governing body approved performance improvement plan methodology to include pharmacy and therapeutics committee oversight of medication errors and did not initiate a methodology for reassessing a performance improvement plan developed for concerns.

This failure resulted in the hospital's inability in determining if the plan for an identified issue was effective or needed to be revised, and thereby reduce the incidence of medication errors and potential adverse events .

Findings:

Review of hospital's policy and procedure titled, " Performance Improvement Plan," most recent revised and governing body approval date, "4/8/2021," "pg. 3 of 6," indicated in part...
III. Performance Improvement Methodology
The Organization Leaders have adopted the methodology of focus PDCA (plan, do, check, act) . The focus PDCA cycle will be used as the model for (name of hospital) performance improvement process..."
"Start the PDCA cycle
Plan the process improvement and design pilot project
Do the improvement (implement pilot project) analysis and data collection.
Check the results and lessons learned.
Act by adopting, adjusting or abandoning the change. Re-enter PDCA cycle continually to improve..."

During a interview on 11/2/23, starting at 9:25 a.m., with the director of pharmacy (DOP), DOP acknowledged that the " Performance Improvement Plan (PIP)" is the policy that would be utilized for PIP for medication errors.

During a review of hospitals entire calendar year to date 01/19/23, 04/13/23 and 10/12//23, "Pharmacy and Therapeutics Committee," minutes and agendas the documents did not reflect performance improvement activities for medication errors and lacked demonstrated process improvement and design pilot activities for grouped errors, lacked lessons learned or results and "act" of adopting or adjusting change." Minutes did not reflect specific activities for interventions, no time lines and no follow up for checking results.

During a concurrent interview and facility documents review on 11/02/2023, starting at 9:25 a.m., with DOP, review of Pharmacy and Therapeutics Committee meeting minutes for calendar year 2023, the 01/19/23, 04/13/23 and 10/12//23 were reviewed for performance improvement activities. DOP acknowledged there were no other pharmacy and therapeutic committee meeting minutes that utilized and or reflected the hospital policy for use of PDCA methodology. DOP stated, "No, we have been doing this informally but not tracking anywhere or checking to see if anything has changed." DOP acknowledged that hospital is not using the PIP (performance improvement project) methodology." .

Based on interview and document review, the hospital governing board (GB) did not ensure documentation that the hospital conducted performance improvement projects reflected of the scope and complexity of the hospital, when QAPI program failed to focus on known high-risk, high volume and problem prone areas within the pharmacy medication errors.

This failure resulted to missed opportunities for improvement with possibility of adverse patient outcomes.


Findings:

Review of facility document titled, "Medication Safety Quality Improvement Program," last Governing Board approval date, "2/10/22, " indicated in part...
I. (name of hospital) Pharmacy Department will work with the Department of Quality Improvement to maintain a Medication Quality Improvement Program that documents and assesses medication errors to determine causes and appropriate responses..."
V. Procedure...B. On a ongoing basis, (name of hospital) will identify targets for improving safety of the medication use process and implement process improvements and communication strategies as a multi-disciplinary strategy to enhance communication safety..."
Appendix A; (name of hospital) monitors medication safety through the pharmacy, medical staff, Quality Improvement, risk management, the hospital Governing Board...
Pharmacy and Therapeutics Committee.. reports to Quality Council quarterly,
Quality Council reports to Medical Executive Committee -Bimonthly,
Medical Executive Committee reports to Governing Board -monthly."

During a concurrent interview and concurrent record review on 11/01.2023, starting at 2:45 p.m., with chief quality manage(CQM), CQM acknowledged, a review of hospital submitted "Patient Safety Review Q3, 2022" power point dated "Q3 2022" without attendance or minutes documented or able to be retrieved by QAPI staff, power point indicated in part, "Medication related events" were top safety events.

A request and review of Quality Council meeting(s) for year to date 2023, revealed only one quarter power point (first quarter 2023) without date, attendance or minutes and no included information regarding medication errors.

A review of Medical Executive agendas and meeting minutes from November 2022 through September of 2023 did not reveal any QAPI /and or medication errors information. Review of Governing Board meeting agendas and minutes from March 2023 through October 2023 did not reveal any QAPI and or medication error information.
CQM acknowledging confirmed performance improvement activity projects are not reported through QAPI Clinical council and that GB has not been involved in the numbers and types of projects based on complexity and scopes of services provided by the hospital, CQM stated, "No that's been happening."

Based on interview and record review the hospital's governing body (GB) failed to ensure the quality assurance and performance improvement (QAPI) program reflected the complexity of the hospital's services and involved all hospital departments and services

This failure had the potential for non implementation of needed quality programs due to lack of data to support, monitor, follow up on potential hospital services that required improvement for the rendition of quality health care .

Findings:

During a review of facility document titled, "Performance Improvement Plan," dated, "4/8/2021," document indicated in part....
A. Governing board: The governing board is responsible for establishing and maintaining the organization performance improvement program. The Governing Board has delegated to the medical staff and Chief Executive Officer the responsibility for implementation of the program.... The Chief of Staff and the Chief Executive Officer have delegated oversight of performance improvement functions to the Quality Council. The Governing Board requires the medical and hospital staff to implement and report on activities for identifying and evaluating opportunities to improve patient care and services through out the organization. The effectiveness of the performance improvement activities will be evaluated and reported to the Governing Board."

During a interview on 11/02/2023, starting at 2:45 p.m., with chief quality officer (CQO) confirmed that there were no QAPI activities occurring through the QAPI program for 5 of 8 hospital licensed services, including intensive care newborn services, perinatal services, pediatric services, basic emergency services and out-patients services. CQO indicated there are QAPI activities for physical therapies, but CQO unable to produce any documentation for calendar year 2023.

A request and review of Quality Council meeting(s) for year to date 2023, revealed only one quarter power point (first quarter 2023) without date, attendance or minutes. A review of Medical Executive agendas and meeting minutes from November 2022 through September of 2023 did not reveal any QAPI information. Review of Governing Board meeting agendas and minutes from March 2023 through October 2023 did not reveal any QAPI information.

CQO acknowledging confirmed performance improvement activity projects are not reported through QAPI Clinical Council and that GB has not been involved in the numbers and types of projects based on complexity and scopes of services provided by the hospital, CQO stated, "No that's been happening."

Based on interview and record review the hospital's governing body (GB) failed to ensure the quality assurance and performance improvement (QAPI) program reflected the complexity of the hospital's services and involved all hospital departments and services.

The GB failed to ensure the QAPI department developed a plan that required monitoring of the effectiveness, safety of services, and quality of care provided to their patients. The GB failed to determine the number of distinct improvement projects that are conducted annually and evauated for improved quality of care, patient safety. The QAPI plan had a process to determine areas of concern, but did not initiate it's governing body approved performance improvement plan methodology to include pharmacy and therapeutics committee oversight of medication errors and did not initiate a methodology for reassessing a performance improvement plan developed for concerns.

These failures had the potential for non implementation of needed quality programs due to lack of data to support, monitor, or follow up on potential hospital services that required improvement for the rendition of quality health care .

Findings:

During a review of facility document titled, "Performance Improvement Plan," dated, "4/8/2021," document indicated in part....
A. Governing board: The governing board is responsible for establishing and maintaining the organization performance improvement program. The Governing Board has delegated to the medical staff and Chief Executive Officer the responsibility for implementation of the program.... The Chief of Staff and the Chief Executive Officer have delegated oversight of performance improvement functions to the Quality Council. The Governing Board requires the medical and hospital staff to implement and report on activities for identifying and evaluating opportunities to improve patient care and services through out the organization. The effectiveness of the performance improvement activities will be evaluated and reported to the Governing Board."

During a interview on 11/02/2023, starting at 2:45 p.m., with chief quality officer (CQO) confirmed that there were no QAPI activities occurring through the QAPI program for 5 of 8 hospital licensed services, including intensive care newborn services, perinatal services, pediatric services, basic emergency services and out-patients services. CQO indicated there are QAPI activities for physical therapies, but CQO unable to produce any documentation for calendar year 2023.

A request and review of Quality Council meeting(s) for year to date 2023, revealed only one quarter power point (first quarter 2023) without date, attendance or minutes. A review of Medical Executive agendas and meeting minutes from November 2022 through September of 2023 did not reveal any QAPI information. Review of Governing Board meeting agendas and minutes from March 2023 through October 2023 did not reveal any QAPI information.
CQO acknowledging confirmed performance improvement activity projects are not reported through QAPI Clinical Council and that GB has not been involved in the numbers and types of projects based on complexity and scopes of services provided by the hospital, CQO stated, "No that's been happening."

Review of hospital's policy and procedure titled, " Performance Improvement Plan," most recent revised and governing body approval date, "4/8/2021," "pg. 3 of 6," indicated in part...
III. Performance Improvement Methodology
The Organization Leaders have adopted the methodology of focus PDCA (plan, do, check, act) . The focus PDCA cycle will be used as the model for (name of hospital) performance improvement process..."
"Start the PDCA cycle
Plan the process improvement and design pilot project
Do the improvement (implement pilot project) analysis and data collection.
Check the results and lessons learned.
Act by adopting, adjusting or abandoning the change. Re-enter PDCA cycle continually to improve..."

During a interview on 11/2/23, starting at 9:25 a.m., with the director of pharmacy (DOP), DOP acknowledged that the " Performance Improvement Plan (PIP)" is the policy that would be utilized for PIP for medication errors.

During a review of hospitals entire calendar year to date 01/19/23, 04/13/23 and 10/12//23, "Pharmacy and Therapeutics Committee," minutes and agendas, the documents did not reflect performance improvement activities for medication errors and lacked demonstrated process improvement and design pilot activities for grouped errors, lacked lessons learned or results and "act" of adopting or adjusting change. Minutes did not reflect specific activities for interventions, no time lines and no follow up for checking results.

During a concurrent interview and facility documents review on 11/02/2023, starting at 9:25 a.m., with director of pharmacy (DOP), a review of Pharmacy and Therapeutics Committee meeting minutes for calendar year 2023, the 01/19/23, 04/13/23 and 10/12//23 were reviewed for performance improvement activities. DOP acknowledged there were no other pharmacy and therapeutic committee meeting minutes that utilized and or reflected the hospital policy for use of PDCA methodology. DOP stated, "No, we have been doing this informally but not tracking anywhere or checking to see if anything has changed." DOP acknowledged that hospital is not using the PIP (performance improvement project) methodology." .

Based on observation, interview, and record review, the facility failed to:
1. Ensure care plans were initiated for two of three sampled neonates (new borns) (Patient 209 and 211) in the neonatal intensive care unit (NICU), per their policy and procedure (P & P). A care plan documents the process of identifying a patient's needs as well as the nursing interventions (or implementations) planned to meet these needs. The care plan is used to establish continuity of care and facilitates holistic care and ensures collaboration among nurses, patients, and other healthcare providers.
2. Ensure pain assessment was conducted per their P & P and standard of practice for one of three sampled patients (Patient 208) in the intensive care unit (ICU).
3. Ensure one of two sampled patient (Patient 206) restraints (devices that limit a patient's movement) were monitored and implemented in the intensive care unit per their P & P.
4. Ensure two of three sampled patients (Patient 201 and 203) pre-op documents were checked per their P & P in the same day surgery unit.
5. Ensure care plans were initiated for 5 out of 10 sampled patients (Patient 100,101,102,104,106) per their policy and procedure.
6. Ensure pain assessments were conducted for 2 out of 10 sampled patients (Patient 100 and 102) per their policy and procedure.
7. Ensure one sampled patient (Patient 101) had a physicians order for restraints per their policy and procedure.
8. Ensure pain assessments were conducted for 1 out of 5 sampled patient (Patient 301) per their policy and procedure.

These facility's failures place patients, at risk of not receiving the required care, at risks of harm due to restraints usage, and potential for suffering with pain due to the lack of assessment.

Findings:

1. A review of the facility's policy and procedure (P &P) titled "Plan of Care, Interdisciplinary", dated 8/4/16, in the PROCEDURE part indicated "The RN initiates the interdisciplinary plan of care after completion of the initial assessment in collaboration with the patient and family, to ensure that direct and indirect nursing care services provided for the patient's safety, comfort, hygiene and protection and for disease prevention and restorative measures."

a) A review of the clinical record for Patient 209 was conducted on 10/31/23. The record indicated patient was admitted to the NICU on 10/30/23 at 11:28 p.m., diagnosis included respiratory distress-newborn. Patient require intensive cardiac and respiratory monitoring, continuous and/or frequent vital signs monitoring.

The patient's initial assessment was conducted on 10/31/23 at 12:29 a.m.

The care plan titled "Respiratory Compromise" was initiated on 10/31/23 at 6:33 a.m.

During a concurrent record review, care plan, P & P, and interview with the director of perinatal services (DPNS) on 10/31/23 at 3:50 p.m., the DPNS acknowledged and agreed the respiratory care plan was not initiated after the initial assessment was conducted. The care plan was initiated six to seven hours after the assessment.

b). A review of the clinical record for Patient 211was conducted on 10/31/23. The record indicated patient was admitted to the NICU on 10/20/23 at 1:23 p.m., diagnosis included respiratory distress syndrome, At risk for Apnea (stop breathing), Premature, and At risk for Hyperbilirubinemia (high bilirubin levels). Patient require intensive cardiac and respiratory monitoring, continuous and/or frequent vital signs monitoring.

The patient's initial assessment was conducted on 10/20/23 at 2:30 p.m.

The care plan titled "Respiratory Compromise", was initiated on 10/20/23 at 6:48 p.m.

The care plan titled "Newborn", was initiated on 10/20/23 at 6:44 p.m.

During a concurrent record review, care plan, P & P, and interview with the DPNS on 10/31/23 at 5:04 p.m., the DPNS acknowledged and agreed the care plans were not initiated right after the initial assessment was conducted. Furthermore, the DPNS agreed the care plan P & P indicates care plans will be initiated after the initial assessment. Perhaps the time frame of one-half hour between initial assessment and care plan initiate on is okay. However, these care plans were initiated four plus hours after the initial assessment.

2. A review of the facility's policy and procedure (P &P) titled "AACN Procedure Manual for Critical Care", dated 11/10/22, indicated "It is the policy that [facility's name] will use the following reference for nursing care and procedures located in the AACN Procedural Manual for High Acuity, Progressive and Critical Care ..."

In the AACN Procedural Manual for High Acuity, Progressive and Critical Care, Chapter 1, pg. 16, indicated "Ongoing assessments become more focused, and the frequency is driven by the stability of the patient; however, routine periodic assessments are the norm. For example, ongoing assessments may occur every few minutes for extremely unstable patients, unit protocols may require that stable patients are assessed every two to four hours."

During a concurrent record review of Patient 208 and interview with the DPNS on 11/1/23 at 12:30 p.m., the record revealed there was no pain assessments from 10/25/22 at 8:00 p.m., until 10/26/23 at 7:00 a.m., for a total of 11 hours. Then from 10/31/23 midnight until 7:00 a.m., for a total of 7 hours. The DPNS confirmed pain assessment are conducted every two hours in the ICU. Furthermore, confirmed this patient was not assess for pain every two hours.

3. A review of the facility's P &P titled "Restraints & Seclusion", dated 6/10/22, in the PROCEDURE part indicated "RN assessments of the need to continue or discontinue restraints are documented and are restrained flow sheet. Restraint is initiated or continued only upon the order of a physician or LIP ... the order must be obtained either during the emergency application of the restraint or immediately after the restraint has been applied ... Restraint orders must be renewed and a daily basis."

During a concurrent record review of Patient 206 and interview with the DPNS on 11/1/23 at 11:51 a.m., the record revealed patient was placed on bilateral soft wrist restraints starting on 10/6/23 at 8:00 a.m. Restraints continued daily until discontinued on 10/26/23 at 8:00 p.m.

On 10/21/23 there was no restraint nursing assessment conducted from midnight until 8:00 a.m.

There was no physician restraint order on 10/6/23 for this patient upon initiation of the restraints. There was no physician restraint order on 10/16/23 however restraint remained applied.

The DPNS acknowledged and confirmed restraints were not assessed on 10/21/23 and restraint physician orders were missing for 10/6/23 and 10/16/23.

4. A review of the facility's P &P titled "Admitting Patients to the Operating Room", dated 5/11/23, in the PURPOSE part indicated "To provide guidelines for the circulating register nurse RN to efficiently review the patient's record and interview the patient prior to the operative procedure ... Review history and physical (H & P) to ensure it is current to within 30 days of surgery. After physician marks the correct side/site, ensure the surgeon completes the H & P update before any medication is given by an anesthesia provider or RN. The H & P update documenting any changes in the patient's condition is completed within 24 hours after registration or inpatient admission, but prior to surgery or a procedure requiring anesthesia services.

A) During a concurrent review of Patient 201's Physician Assessment for Diagnostic/Interventional Procedure (H & P update) form and interview with the peri-op manager (POM) and peri-op director (POD) on 11/1/23 at 4:53 p.m., the POM and POD reported it is the responsibility of the circulating RN to check the H & P update form for completeness before procedure.

The form consisted of three sections where physician signature, date, and time were required. First section was for anesthesia assessment. Second section was for vital signs, ekg, and level of consciousness assessment. Third section was for post-procedure assessment.

The H &P update form for this patient was noted to be blank on the second section. The form was missing the patient's name or patient's name sticker on the right bottom area of the form.

The POM acknowledged and agreed the form was not complete and stated, "I agree the physician did not sign the second section and the patient's name sticker is missing."

B) During a concurrent review of Patient 203's Physician Assessment for Diagnostic/Interventional Procedure (H & P update) form and interview with the POM on 11/1/23 at 4:32 p.m., the H &P update form for this patient was noted to be blank on the first and second section. The form was missing the physician's signature, date, and time on the first and second sections of the form. In addition, the date and time was missing on the third section of the form.

The POM acknowledged and agreed the form was not fully complete and stated, "I agree the physician did not sign, date and time the sections of the form."




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5. During a review of the facility's policy and procedure (P&P) titled "Plan of Care, Interdisciplinary ", dated 8/4/2016, indicated in part ... "Planning for care, treatment and services is individualized to meet the patient's unique needs ...Assessment, planning and evaluation are interdisciplinary and based upon actual or potential problems, anticipated length of stay, assessed needs, policies, patient care standards, cultural issues, available resources, and will be consistent with other therapies/and or disciplines ...the RN (registered nurse) initiates the Interdisciplinary Plan of Care after completion of the initial assessment, in collaboration with the patient and family, to ensure that direct and indirect nursing care services provide for patient's safety, comfort, hygiene, and protection and for disease prevention and restorative measures ..."

During a concurrent interview and record review on 11/1/23, at 11:10 a.m., with the clinical informatics nurse (CI), Patient 100's "Plan of Care Summary" and Interdisciplinary Plan of Care" were reviewed. The plan of care summary indicated Patient 100's reason for visit, on 10/29/23, was for acute renal insufficiency (a condition in which the kidneys suddenly can't filter waste from the blood) and low back pain radiating to the right lower extremity. The Interdisciplinary Care Plans that were initiated for Patient 100, was a pain care plan and a procedure care plan. There was no care plan initiated for renal insufficiency, for Patient 100. CI acknowledged the care plan for renal insufficiency should have been initiated for Patient 100.

During a concurrent interview and record review on 11/1/23, at 11:45 a.m., with the clinical informatics nurse (CI), Patient 101's "Emergency Room Consult Note", "Fall Risk Assessment", "Labs", "Physician Orders" and "Interdisciplinary Plan of Care" were reviewed. The emergency room note indicated Patient 101's reason for visit, on 10/16/23, was for left hip fracture and right foot fracture from a fall, pain, and diarrhea. Patient 101's fall risk assessment score was 60, and indicated that a score of 45 and higher, puts the patient as a high risk for fall. Patient 101's labs for diarrhea indicated Patient 101 was positive for C-difficile (a bacterial infection of the intestinal tract and is highly contagious). Patient 101's physician orders indicated Patient 101 was to be put in isolation, and to use enteric precautions (contact precautions for preventing infections transmitted primarily by direct or indirect contact with fecal material). The Interdisciplinary Care Plans that were initiated for Patient 101, was a cognition care plan and a pain care plan. There was no care plan for falls and no care plan for isolation/infection, for Patient 101. CI acknowledged the care plan for falls, and the care plan for contact precautions/isolation, and infection, should have been initiated for Patient 101.

During a concurrent interview and record review on 11/1/23, at 12:20 p.m., with the clinical informatics nurse (CI), Patient 102's "Emergency Room Consult Note" and "Interdisciplinary Plan of Care" were reviewed. The emergency room note indicated Patient 102's reason for visit, on 10/27/23, was for a fall, a broken right shoulder, pain, and hyperglycemia (high blood sugar). The Interdisciplinary Care Plans that were initiated for Patient 102, was a fall care plan and a diabetic (high blood sugar) care plan. There was no care plan for pain, for Patient 102. CI acknowledged the care plan for pain should have been initiated for Patient 102.

During a concurrent interview and record review on 11/1/23, at 4:04 p.m., with the clinical informatics nurse (CI), Patient 104's "Plan of Care Summary", "Fall risk Assessment", and "Interdisciplinary Plan of Care" were reviewed. The plan of care summary indicated Patient 104's reason for visit, on 10/31/23, was for an Abnormal CT (imaging scan to detect disease and injuries) of the head (from a fall), heart failure, and generalized weakness. Patient 104's fall risk assessment score was 80, and indicated that a score of 45 and higher, puts the patient as a high risk for fall. The Interdisciplinary Care Plans that were initiated for Patient 104, was a pain care plan, heart failure care plan, and infection care plan. There was no care plan initiated for fall, for Patient 104. CI acknowledged the care plan for falls should have been initiated for Patient 104.

During a concurrent interview and record review on 11/1/23, at 4:38 p.m., with the clinical informatics nurse (CI), Patient 106's "Emergency Room Consult Note" and "Interdisciplinary Plan of Care" were reviewed. The emergency room note indicated Patient 106's reason for visit, on 10/28/23, was for a repeat allergic reaction, with vomiting, throat clearing, and worsening rash (hives), and further indicated being treated for anaphylaxis (a severe, potentially life-threatening allergic reaction). The Interdisciplinary Care Plans that were initiated for Patient 106, was a pain care plan. There was no care plan for respiratory compromise or anaphylaxis, for Patient 106. CI acknowledged the care plan for anaphylaxis (respiratory compromise) should have been initiated for Patient 106.

6. During a review of the facility's policy and procedure (P&P) titled "Pain Management", dated 10/2022 indicated in part ... " All patients have a right to appropriate assessment and management of pain ...B. The pain intensity and pain relief, as reported by the patient will be assessed and documented: 1. On admission ... 2. After any known pain-producing event ... 3. With each new report of pain ... 4. With vital signs ...5. A reassessment within one hour of intervention or less as appropriate ...6. When medications are administered ...7. Assess the patient's level of sedation before and after administering narcotic medication that could be potentially sedating ..."

During a concurrent interview and record review on 11/1/23 at 10:51 a.m., with the clinical informatics nurse (CI), Patient 100's "Pain Assessment Flowsheet" and "Medication Administration Record" (MAR) dated 10/31/23 was reviewed. The pain assessment flowsheet indicated Patient 100 was requesting pain medication at 8:20 a.m. and his pain level was 8/10. The MAR indicated Patient 100 was given Dilaudid (a narcotic to treat moderate to severe pain) 0.5 mg (milligrams) IVP (intravenous [in the vein] push) at 8:20 a.m. Further review of the pain assessment flowsheet indicated there was no other documentation of a pain assessment and or pain level until 11:15 a.m. CI was asked when do you reassess a patients pain level, CI verbalized within one hour after pain medication administration. CI acknowledged Patient 100's pain reassessment was late (was not reassessed until 3 hours later) and should have been reassessed within an hour after pain medication administration.

During a concurrent interview and record review on 11/1/23 at 12:19 p.m., with the clinical informatics nurse (CI), Patient 102's "Medication Administration Record" (MAR) and "Pain Assessment Flowsheet" dated 10/30/23 were reviewed. The MAR indicated Patient 102 was given one Norco 325mg-5mg oral tablet (a narcotic to treat moderate to severe pain) at 8:25 a.m. The pain assessment flowsheet indicated there was no documentation of a pain assessment and or Patient 102's pain level prior to giving the pain medication (Norco). CI acknowledged Patient 102's pain assessment was not done and should have been documented prior to Patient 102 receiving the pain medication.

7. During a review of the facility's policy and procedure (P&P) titled "Restraint & Seclusion", dated 6/10/2022 indicated in part ... "Based on an individual patient assessment, the use of Restraint and Seclusion is limited to those situations where it is necessary to ensure the immediate physical safety of the patient, staff members, or others ...A. Methodology: 4. Obtain order from a physician or other Licensed Independent Practioner (LIP) ...B. Authorizing and Ordering of Restraints: 1. Restraint is initiated or continued only upon the order of a physician or LIP, following the procedural guidelines in Exhibit A ...Exhibit A: A. Ordering and Renewal: 1. In an emergent situation, and when a physician or LIP is not readily available, a registered nurse competent in restraint usage may initiate restraint use based on an appropriate assessment of patient needs ...2. The order must be obtained either during the emergency application of the restraint or immediately (defined as without time interval) after the restraint has been
applied ..."

During a review of Patient 101's "Emergency Room Progress Note" dated 10/16/23, The progress note indicated Patient 101 was refusing a blood draw and oral medications including vancomycin (antibiotic to treat infection) ...Patient 101 does not have decision making capacity at this time ...Patient 101 was diagnosed with C-difficile (a bacterial infection of the intestinal tract and is highly contagious) ...given high risk of worsening illness and decompensation, bilateral wrist restraints were ordered to facilitate care.

During a review of Patient 101's "Restraint Assessment Flowsheet" dated 10/16/23, The assessment indicated restraints were initiated at 9:00 p.m. and discontinued at 10:30 p.m. Total restraint time was 90 minutes.

During a concurrent interview and record review on 11/1/23 at 11:21 a.m., with the clinical informatics nurse (CI), Patient 101's "Restraint Assessment Flowsheet" dated 10/16/23, and "Physician Orders" were reviewed. CI acknowledged the restraints were initiated on 10/16/23 at 9:00 p.m. and discontinued at 10:30 p.m. When asked to see the physician orders for the application of the restraints, CI reviewed the physician orders and indicated the order date for the restraints was put in on 10/17/23 at 2:12 a.m. The CI acknowledged the order was put in late (5 hours later) after the restraints had already been discontinued and further verbalized the orders should have been put in before or right after the restraints were applied.



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8. During a review of the facility's policy and procedure (P&P) titled "Pain Management", dated 10/2022 indicated in part ... " All patients have a right to appropriate assessment and management of pain ...B. The pain intensity and pain relief, as reported by the patient will be assessed and documented: 1. On admission ... 2. After any known pain-producing event ... 3. With each new report of pain ... 4. With vital signs ...5. A reassessment within one hour of intervention or less as appropriate ...6. When medications are administered ...7. Assess the patient's level of sedation before and after administering narcotic medication that could be potentially sedating ..."

During a concurrent interview and record review on 11/1/23 at 4:41 p.m., with the emergency room manager (ERM), Patient 301's "Pain Assessment Flowsheet" and "Medication Administration Record" (MAR) dated 10/30/23, 10/31/23, and 11/1/23 was reviewed. The MAR dated 10/30/23 indicated Patient 301 was given one Norco 325mg-5mg oral tablet (a narcotic to treat moderate to severe pain) at 2:33 a.m. and her pain level was 6/10. Further review of the pain assessment flowsheet dated 10/30/23 indicated there was no other documentation of a pain assessment and or pain level until 10/31/23 at 12:06 a.m. Additionally, the MAR dated 10/31/23 indicated Patient 301was given Morphine (a narcotic to treat severe pain) 2 mg (milligrams) IVP (intravenous [in the vein] push) at 8:28 p.m. and her pain level was 7/10. Further review of the pain assessment flowsheet dated 10/31/23 and 11/1/23 indicated there was no other documentation of a pain assessment and or pain level until 11/1/23 at 6:13 a.m. Also, the MAR dated 11/1/23 indicated Patient 301was given Morphine 2 mg IVP at 2:15 a.m. and her pain level was not assessed. Lastly, review of the pain assessment flowsheet dated 11/1/23 indicated there was no other documentation of a pain assessment and or pain level until 11/1/23 at 6:13 a.m. ERM was asked, when do you reassess, a patients pain level ERM verbalized within one hour after oral pain medication administration and 15 to 30 minutes after IVP pain medication administration. ERM acknowledged Patient 301's pain reassessment was not done within an hour after oral pain medication administration or within 15 to 30 minutes for IVP pain medication administration.

Based on interview and record review the facility failed to:
1. Ensure nursing staff administered and titrated Norepinephrine (used to increase and maintain blood pressure in limited, short-term serious health situations) and Phenyleprine (vasoconstrictor to raise the blood pressure), medication drips for one of two sampled patients (Patient 207), as per physician's orders.
2. Ensure nursing staff administered and titrated Precedex (an alpha2-adrenergic agonist with sedative properties used for short-term intravenous sedation) medication drip for one of two sampled patients (Patient 206) as per physician's order.
3. Ensure nursing staff administered and titrated Propofol (a sedating and hypnotic agent administered intravenously to induce and maintain anesthesia or sedation) medication drip for one of two sampled patients (Patient 204), as per physician's order.

The facility's failures place patients at risk of significantly decreasing the blood pressure and/or sedating them resulting in harm to the patients.

Findings:

1.A) A review of the clinical record for Patient 207 was conducted on 11/1/23. A physician's order for Norepinephrine medication drip was to start medication at 4 micrograms (mcg) per minute (min). Titrate by 1 mcg/min. Every one minute. For a goal mean arterial pressure (MAP) 65 mmHg. Maximum dose 40mcg/min.

The electronic medication administration record (eMAR), dated 10/27/23, indicated medication drip was started at 8:55 p.m., at 4mcg/min. At 9:15 p.m., rate was increased to 12 mcg/min. At 9:30 p.m., rate was increased to 14mcg/min. At 10:00 p.m., rate was increased to 16 mcg/min.

During a concurrent record review and interview with the inpatient care manager (IPCM) on 11/1/23 at 12:19 p.m., the IPCM acknowledged and confirmed the Norepinephrine medication drip was not administered as per the physician's order.

B). Further review of Patient 207's clinical record indicated a physician's order for Phenylephrine medication drip was to start medication at 40 mcg/min. Increase by 20 mcg/min and decrease by 5mcg/min. Every five minutes. For MAP >= 65 mmHg. Maximum dose 360mcg/min.

The e-MAR dated 10/28/23, indicated medication drip was started at 9:00 a.m., at 35mcg/min. At 9:30 a.m., medication was increased to 40mcg/min. At 10:15 a.m., medication was increased to 50mcg/min. At 12:30 p.m., medication was increased to 55mcg/min. At 4:30 p.m., medication was increased to 60mcg/min.

During a concurrent record review and interview with the inpatient care manager (IPCM) on 11/1/23 at 11:37 a.m., the IPCM acknowledged and confirmed the Phenylephrine medication drip was not administered as per the physician's order.

2. A review of the clinical record for Patient 206 was conducted on 11/1/23. A physician's order, dated 10/28/23 for Precedex medication drip was to start medication at 0.2 mcg/kg/hr. Titrate by 0.2 mcg/kg/hr. Every 10 minutes. For a goal RASS 0 to -2. Maximum dose 1.4mcg/kg/hr. The Richmond Agitation Sedation Scale (RASS) is an instrument designed to assess the level of alertness and agitated behavior in critically-ill patients.

The e-MAR dated 10/28/23 indicated Precedex medication drip was started at 4:35 p.m., at 0.2mcg/kg/hr. At 4:45 p.m., medication was increased to 0.4mcg/kg/hr. At 6:45 p.m., medication was increased to 1.4mcg/kg/hr. At 7:45 p.m., medication was decreased to 1.2mcg/kg/hr.

On 10/28/23 from 5:00 p.m., until 10/29/23 at 1:30 a.m., the patient's RASS score was -2.

During a concurrent record review and interview with the inpatient care manager (IPCM) on 11/1/23 at 10:20 a.m., the IPCM acknowledged and confirmed the Precedex medication drip was not administered as per the physician's order. Unclear the reason the Precedex medication was increased if the RASS score was at target goal (0 to -2).

3. A review of the clinical record for Patient 204 was conducted on 11/1/23. A physician's order, dated 10/27/23 at 3:40 p.m., for Propofol medication drip was to start medication at 5 mcg/kg/min. Titrate by 5 mcg/kg/min. Every 5 minutes. For a goal RASS -2 to -3. Maximum dose 50 mcg/kg/min.

The e-MAR dated 10/27/23 indicated Propofol medication drip was started at 4:26 p.m., at 30 mcg/kg/min.

During a concurrent record review and interview with the inpatient care manager (IPCM) on 11/1/23 at 3:25 p.m., the IPCM acknowledged and confirmed the Propofol medication drip was not administered as per the physician's order.

Based on observation, interview, and record review the hospital failed to ensure that safe pharmaceutical services had been provided and meet the needs of each patient as evidenced by:


1. The hospital failed to identify and label the Lovenox (a fragment of heparin of low molecular weight that is administered by subcutaneous injection to prevent and treat deep vein thrombosis and pulmonary embolism) medication as a High Alert medication as per the identified Institute for Safe Medication Practices ISMP pharmacy guidelines or Standards of Practice and they failed to label Heparin intravenous medication vials with a High Alert label as per the hospital's practice. (Refer to A-500)

2. The hospital failed to keep medications secure as normal saline 0.9% IV (intravenous) syringe flushes had been found inside of an unlocked isolation cart. (Refer to A-502)

3. The hospital failed to ensure chilled normal saline used for the treatment of Malignant Hyperthermia (a severe reaction to certain drugs used for anesthesia) had not expired inside the intensive care unit ICU refrigerator and that expired medications were not available for patient use. (Refer to A-505)

4. The hospital failed to ensure that all medications had stop order dates and that these dates had been implemented by the hospital based on the drug manufacturer's requirements and the Food and Drug Administration (FDA) to protect patients from medication errors and overdoses which had the potential to contribute to a patient's death, while under care of the hospital, during each patient's stay. . (Refer to A-507).

5. The hospital failed to ensure incidents of suspected Adverse Drug Events (ADR) were reviewed to identify areas of improvement and to ensure that medication administration errors were not occuring in the hospital. (Refer to A-508)

6. The hospital failed to follow its policy with established controls for Controlled Substance security and monitoring to prevent and detect Diversion by staff members. (Refer to A-509)

7. The hospital failed to ensure that the hospital's current drug formulary contained only medications with the safest patient profiles had been kept or maintained on the hospital's current drug formulary. (Refer to A-511)

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 Pharmaceutical Services.

Based on observation, interview, and record review, the facility failed to:
1. Identify and labeled the Lovenox (a fragment of heparin of low molecular weight that is administered by subcutaneous injection to prevent and treat deep vein thrombosis and pulmonary embolism) medication as a High Alert medication as per the identified Institute for Safe Medication Practices ISMP pharmacy guidelines or Standards of Practice.
2. Labeled Heparin intravenous medication vials with a High Alert label as per their practice.

The facility's failures place patients at risk of being administered a high alert medication without the nursing staff implementing the high alert medication independent double check process prior to the medication administration and at risk of medication error due to the lack of High Alert labeling.

Findings:

1.During a tour of the cardiovascular intensive care unit (CVICU) on 10/30/23 at 3:40 p.m., inside the automatic dispensing cabinets (ADC) machine the Lovenox subcutaneous (SQ) medication was observed without any labeling indicating this was a High Alert medication.

During a concurrent tour of the Step-Down unit and interview with a registered nurse (RN1), inside the ADC machine, the Lovenox medication was observed without any labeling indicating this was a High Alert medication. RN 1 confirmed the Lovenox medication did not and has not had a High Alert labeling affixed to the product or on the storage location. The Lovenox administration does not require for a second RN to witness the medication administration (Independent Double Check).

A review of the policy titled "Independent Double Check- High Alert Medication Administration", dated 5/3/18, indicated "The hospital's policy is to promote patient safety by avoiding preventable injuries associated with "high-risk" drugs based on...ISMP evaluation of actual Sentinel events. As an added safeguard, when a nurse is initiating administration of High Alert medications, a second nurse will perform an Independent Double Check." Review of the policy Attachment B, attachment lists the medications considered as High Alert thus requiring an independent double check. The Lovenox medication was not on the list.

A review of the document titled "ISMP List of High-Alert Medications in Acute Care Settings", dated 2018, the document indicated "Anticoagulants (e.g., warfarin, low molecular weight heparin (Lovenox), unfractionated heparin) were considered High Alert medications.

During a concurrent review of the ISMP document (2018), Independent Double Check- High Alert Medication Administration policy and interview with the director of pharmacy (DOP) on 11/2/23 at 9:44 a.m., the DOP confirmed the facility follows the ISPM guidelines or standard or practice regarding the High Alert medications. The DOP furthermore acknowledged and agreed the Lovenox should be included in the policy's attachment B list and the medication administration should require an independent double check.

2. During a tour of the CVICU and Step-Down unit on 10/30/23 from 12:35 p.m., to 1:10 p.m., the Heparin 5000 units/milliliter (ml) and Heparin 10,000/10 ml intravenous (IV) medication vials were observed inside the ADC machine cubicles without any type of labeling indicating this was a High Alert medication. However, the Insulin medication was observed with a red sticker affixed to the insulin vial with the words "HIGH ALERT".

A review of the policy titled "Independent Double Check- High Alert Medication Administration", dated 5/3/18, Attachment B, the attachment lists the medications considered as High Alert. The list included the insulin and heparin medications.

During a concurrent review of the High- Alert medication administration policy and interview with the DOP on 11/2/23 at 9:40 a.m., the DOP was asked the difference between the High Alert labeling of insulin and heparin medications. The DOP indicated the facility labels all their high alert medications i.e., insulin labeling. The DOP acknowledged and agreed the heparin vial were not labeled and they all should be labeled.

Based on observation interview and record review the facility failed to ensure Patient's 204 a multi -dose eye ointment mediation was labeled as per their policy and procedure once medication was opened.

The facility's failure place patient at risk of being administer a medication that was expired.

Finding:

A review of the policy titled "Drug Distribution; Multi Dose Containers", dated 5/5/16, indicated "A. All multi-dose containers used within the Pharmacy, a Nursing Unit, or Ancillary area must be dated and initialed at the time of original puncturing. A sticker is placed on the vial "EXPIRES ON ..." for the nursing units. B. These containers must be discarded 28 days from this date or sooner if the container so states or the expiration time is less than 28 days."

During a concurrent tour of the cardiovascular intensive care unit (CVICU) and interview with the inpatient care manager (IPCM) on 10/30/23 at 4:33 p.m., inside the medication room, Patient's 204 multidose eye medication was observed without any labeling as to when the medication was opened. The IPCM acknowledged and agreed the medication container should be labeled with the opening date.

Based on observation, interview, and review of the facility policy and procedure for Medication Storage, the facility failed to keep medications secure when normal saline 0.9% IV (intravenous) syringe flushes were found in an unlocked isolation cart.

This failure had the potential for unauthorized personnel, patients, and or visitors to have access to these syringes.

Findings:

During a concurrent observation and interview on 10/31/23, at 4:43 p.m., with the medical surgical nursing supervisor (MSS), an isolation cart outside of room 250 was observed. The isolation cart is an unlocked cart, and in the top drawer the contents observed were supplies and 2 normal saline 0.9% IV syringe flushes. When asked if the normal saline 0.9% IV syringe flushes should be kept in an unlocked isolation cart, the MSS stated, "No, the normal saline syringes should not be kept in here, they should be in the medication room."

During a review of the facility's policy and procedure (P&P) titled "Medication Storage", dated 6/9/2022 indicated in part ... "It is the policy of (name of facility) to assure the security of medications stored in all locations, while allowing safe and appropriate access to necessary medications at all times ...access to medication storage areas is restricted to authorized personnel only ...storage of medication outside the pharmacy: 1. Every hospital unit warranting medication storage will have medication storage devices on the ward ...2. All medications stored outside of the automated dispensing cabinets will be stored in a secure location (i.e., locked medication room, locked cabinet, or cart) ..."

Based on observation and interview, and record review the facility failed to ensure:


1.Chilled normal saline used for the treatment of Malignant Hyperthermia (a severe reaction to certain drugs used for anesthesia) was not expired inside the intensive care unit ICU refrigerator.

This failure had the potential of not having any chilled normal saline available when needed.


2. Medications with different routes were separated, all unusable or expired medications were not available for patient use in accordance with manufacturer's recommendations, and facility policies and procedures, in the pharmacy, as evidenced by:

1. 2 bottles of otic (ear) suspensions and 10 bottles of ophthalmic (eye) solutions were found stored in the same bin
2. 1- 60 ml (milliliter- unit of measure) Sodium Chloride 2 meq (milliequivalents- unit of measure)/ ml solution was found to be expired
3. 2- 30 ml partially used bottles of reconstituted (addition of water to powder) Azithromycin (antibiotic) 200 mg (milligram- unit of measure)/5 ml, were found to be expired
4. 1- 60 ml partially used bottle of reconstituted Cefdinir (antibiotic) 125 mg/5 ml was found to be expired
5. 1 partially used bottle of 4 mg Perphenazine (antipsychotic- used to treat mental illness) was found to be expired

These failures had the potential to result in patient harm due to wrong medication being administered, and exposure to potentially subtherapeutic (ineffective) medications.


Findings:


1.During a concurrent tour of the intensive care unit (ICU) and interview with the clinical supervisor (CS) on 10/30/23 at 4:52 p.m., one liter of normal saline with expiration date of 7/2023 was observed stored inside the medication refrigerator. The CS reported the chilled normal saline was for the treatment of malignant hyperthermia. The CS acknowledged and confirmed the normal saline was expired and should not be inside the refrigerator.



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2. During a concurrent inspection of the pharmacy area and interview on 11/1/23 at 10:58 a.m. with Pharm 1, 2- 10 ml bottles of Neomycin/Polymyxin B/Hydrocortisone otic suspension were found stored in the same bin with 10 bottles of ophthalmic solutions. Pharm 1 acknowledged otic and ophthalmic medications should be separately stored. Pharm 1 stated, "Otic and ophthalmic solutions should be stored separately, so correct product is dispensed for correct route and administration, it's a safety issue."

During a concurrent inspection of the pharmacy area and interview on 11/1/23 at 11:22 a.m. with Pharm 1, 1- 60 ml Sodium Chloride 2 meq/ml solution for NICU (neonatal intensive care unit) patients with an expiration date of 10/30/23 , 2- 30 ml partially used bottles of Azithromycin 200 mg/5 ml with an expiration date of 10/28/23, 1- 60 ml partially used bottle of Cefdinir 125 mg/5 ml with an expiration date of 10/24/23, and 1 partially used bottle of 4 mg Perphenazine with an expiration date of 10/23/23 were found on the pharmacy shelves available for patient use. Pharm 1 acknowledged the expired medications should not be available for patient use. Pharm 1 stated, "Yes [Sodium Chloride solution] compounded for NICU, very fragile population with zero room for error, would have been discarded on 10/30/23 morning ... yes, expired medications should be discarded."

During an interview on 11/2/23 at 11:17 a.m., with Director of Pharmacy (DOP), DOP stated the expectation was for otic and ophthalmic medications to be stored separately. DOP stated, "can use ophthalmic in ears, but not otic in eyes ... they are formulated for specific use ..." Regarding expiration medications being available for patient use, DOP acknowledged expired medications should not be available for patient use and stated, "Potential for expired medications to be given to a patient, they can get subtherapeutic dose, could be sub potent."

During a review of Lexicomp, a nationally recognized drug reference, the manufacturer for Azithromycin indicated, "Suspension: Store dry powder below 30°C [centigrade-temperature measurement] (86°F [Fahrenheit- temperature measurement]). Store reconstituted suspension at 5°C to 30°C (41°F to 86°F) and use within 10 days.
During a review of Lexicomp, a nationally recognized drug reference, the manufacturer for Cefdinir indicated, "Store at 20°C to 25°C (68°F to 77°F). Store reconstituted suspension at room temperature 20°C to 25°C (68°F to 77°F) for 10 days."

During a review of the hospital's policy and procedure (P&P), titled "Medication Storage", dated 6/9/22, the P&P indicated, "The pharmacy staff will maintain an ongoing process to monitor all stored medications to ensure: 1. Detection, segregation, and proper disposal of outdated, deteriorated, recalled, obsolete, or hazardous drugs 2. Medications are stored under proper conditions of sanitation, temperature, light, humidity, ventilation, regulation, and security."

Based on interview and record review, the hospital failed to ensure the duration for use of medications was in accordance with manufacturer's specification. The facility policy for automatic stop orders did not reflect the manufacturer's guidelines for the use of Protonix IV (intravenous- into the vein).

This failure placed patients at risk for adverse consequences from administration of unnecessary medications.

Findings:

During a concurrent record review and interview on 11/2/23 at 9:54 a.m., with Critical Care Educator (CCE), Resident N206's clinical record was reviewed. Resident N206's clinical record indicated a physician order for Protonix (medication for gastro-intestinal bleed and reflux) 40 mg (milligrams- unit of measure) IV every 12 hours, start 10/8/23 indefinitely. Resident N206's clinical record indicated that on 10/6/23, Resident N206 received an orogastric (OG) tube insertion (placement of tube into stomach through mouth). A note by hospital pharmacist, dated 10/28/23 at 12:51 p.m., indicated, "Pantoprazole 40 mg injection ... intervention type route change IV/PO [by mouth] ... pt [patient] NPO [nothing by mouth] IV to PO not appropriate." A review of Resident N206's medication administration record (MAR) indicated Resident N206 was administered Lipitor (medication for high blood cholesterol) 10 mg daily via OG from 10/5/23 to present, and Protonix 40 mg every 12 hours via IV from 10/8/23 to present. CCE acknowledged Protonix was available as a suspension and could be administered via OG tube. CCE stated, "We don't make determination from IV to PO, that's a question for pharmacy. Pharmacy said IV to PO not appropriate because patient NPO .... yes, they were getting medication through OG at that time."

During a concurrent record review and interview on 11/2/23 at 10:21 a.m. with CCE, Resident N204's clinical record was reviewed. Resident N204's clinical record indicated that on 10/27/23, Resident N204 received a nasogastric (NG) tube insertion (placement of tube into stomach through the nose). A review of Resident N204's clinical record indicated a physician order for Protonix 40 mg IV daily for gastro-intestinal prophylaxis (prevention), start 10/28/23 and a stop date of 11/26/23. CCE acknowledged that Resident N204 was being administered Protonix 40 mg daily via IV, while also being administered other medications via NG tube.

During a concurrent record review and interview on 11/2/23 at 11:24 a.m. with DOP, DOP acknowledged Resident N206 and N204 were currently on Protonix IV and had been administered Protonix IV since 10/8/23 and 10/28/23 respectively. DOP acknowledged Protonix IV could have been switched to a suspension and stated, "Protonix IV, it's never been on stop order policy ... [Important to administer Protonix IV as specified by manufacturer because] medication might not be required any longer, some medications might cause more adverse effects when used IV."

During a review of the manufacturer package insert (information about the drug) for Protonix IV, the manufacturer indicated, "The recommended adult dosage of Protonix IV is 40 mg given once daily by intravenous infusion for 7 to 10 days ... discontinue treatment of Protonix IV as soon as the patient is able to receive treatment with Protonix Delayed -Release tablets or oral suspension."

During a review of the hospital's policy and procedure (P&P), titled "Automatic Stop Orders", dated 9/22/21, the P&P indicated, "The facility will ensure safe administration of medications through the Automatic Stop Process. Medications that should be included, at a minimum, as part of the Automatic Stop Process are included .... Acetaminophen (injectable), Albumin, Alvimopam, Calcitonin, Fidaxomicin, Ketorolac, Meperidine, Methocarbamol (injectable), Tedizolid." The hospital P&P did not include Protonix IV.

Based on interview, and policy review, the hospital failed to ensure incidents of suspected Adverse Drug Events (ADR) were reviewed to identify areas of improvement. The hospital also failed to ensure that medication errors were not occuring with the hospital's nursing staff.

This failure prevented the hospital from using the information for performance improvement and insuring that all patients remained free from nursing medication administration errors, which could have been prevented.

Findings:

1. During a review of the hospital's policies and procedures (P&P) titled, Adverse Drug Reaction and Medication Error Reporting", dated 5/11/23, the P&P indicated, "ADRs shall be reviewed at least quarterly, and findings reported at the P&T Committee meeting for review & initiation of safety strategies to use whenever possible."
During an interview on 11/2/23 at 12:21 p.m., with Director of Pharmacy (DOP), DOP was unable to provide documentation that incidents of suspected ADRs were being reviewed as per hospital's P&P. DOP stated, " ...can't provide evidence that we're reviewing incidents of suspected ADR."



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2. Clinical record review with the hospital's IPCM of patient N-110's record on 11/2/2023 at 8:35 am revealed a medication order had been written on 9/7/2023 at 4:51 am, for Gentamycin (an antibiotic) 4mg/kg (16.94 mg) to be infused over 30 minutes and to be given every 24 hours to this neonatal patient. The first dose of this antibiotic had been given on 9/7/2023, but the next dose of this medication (which was to be given on 9/8/2023) had not been given as ordered by the patient's physician. Review of the clinical record on 11/2/2023 revealed that no one had documented in this patient's medical why this medication had not been given. The hospital's IPCM was unable to find any nursing notes or other documentation to clarify why this medication had not been given to patient N-110, as ordered by the patient's physician.

3. Clinical record review with the hospital's Clinical Informaticist (CI) of patient N-402's record on 11/2/2023 at 8:15 am revealed a medication order had been written on 9/10/2023 at 11:31 pm, for a Fentanyl (a potent synthetic opioid) drip. The order read: "Fentanyl 1000 micrograms (mcg) in 100 ml of Sodium Chloride, start at 50 mcg per hour (mcg/hr). Review of patient N-402's medication administration record (MAR) on 11/2/2023 at 8:20 am revealed that the patient's Fentanyl drip had been started at 9/11/2023 at 12:06 am at 100 mcg/hr contrary to the physician's order. The entire patient's chart was reviewed with the hospital's CI and the group was unable to find any information which would explain why the nurse started this drip at 100 mcg/hr rather than the 50 mcg/hr which had been ordered by the patient's physician. During the clinical record review of patient N-402's chart, the CI stated: "I was unable to any documentation as to why the nurse started this infusion at a rate of 100 mcg/hr instead of the 50 mcg/hr which had been ordered by the doctor".

4. Clinical record review with the hospital's IPCM of patient N-110's record on 11/2/2023 at 8:50 am revealed a medication order had been written on 9/7/2023 at 4:51 am, for TPN (Total Parenteral Nutrition) in 250 milliliter (ml) bag to be infused at a rate of 14 ml/hr to be given continuously to this neonatal patient. The nurse taking care of this patient started this patient's TPN at 5 ml/hr on 9/7/2023 at 7:59 am contrary to the patient's physician order for 14 ml/hr. Review of the clinical record on 11/2/2023 revealed that no one had documented in this patient's medical why this medication had not been started at 14 ml/hr as ordered by the patient's physician. The hospital's IPCM was unable to find any nursing notes or other documentation to clarify why this medication had not been started at the 14 ml/hr for patient N-110, as ordered by the patient's physician.

Based on record review and interview, and policy and procedure, the facility failed to follow its policy with established controls for Controlled Substance security and monitoring to prevent and detect Diversion for staff members (Registered Nurse (RN) 3 and, RN 4) when:

1. Review of Omnicell ( an automated medication dispensing system) documents titled "Detailed Risk Score Analysis" (solution that captures data from Omnicell) dated from 6/1/2023 to 10/8/23 revealed RN 3 diverted medications such as Hydromorphone, Morphine, and Acetaminophen-Hydrocodone (controlled prescription drugs to treat pain regulated by a government) meant for other patients for his own personal use from the Omnicell.

2. Review of RN 4 Detailed Risk Score Analysis from the Omnicell dated from 7/1/23 - 9/30/23 had unresolved discrepancies with significant loss.

These facility failures placed the patients at increased risk for inadequate disease management.

Findings:

1. During an interview on 10/30/23 at 12:23 p.m. with chief quality officer (CQO), CQO indicated the facility conducted an interview with RN 3 after an incident whereby, RN 3 was seen exiting a medication room with Omnicell without reason to be in the room on 10/12/23 by nurses and RN 3 admitted to have been taking narcotic medications from the hospital for several months for self-use.

During a record review titled of "Detailed Risk Score Analysis" dated 8/1/23 - 10/9/23 indicated, a Variance Trends, (difference between what was expected to happen and what actually happened) for RN 3 showed a highly unusual number of variances that included 44 variances with a status of "Open." Med Trends, RN 3 exhibits highly unusual medication activity patterns when: Administering and Dispensing Hydromorphone injection, Dispensing and Administering Morphine Injection., Dispensing Lorazepam injection, Dispensing and Administering Acetaminophen-Hydrocodone oral.

During a concurrent interview and record review on 10/30/23 at 4:09 p.m. with director of pharmacy (DOP), "Omnicell Dispensing Practices Report (ODPR)" dated 7/1/23 - 9/30/23 was reviewed. DOP stated, RN 3 had unusually high amounts of narcotics pulled from the Omnicell. DOP further stated, the Omnicell system sends anomalous (deviating from what is standard, normal, or expected) usage reports to management on a monthly and quarterly basis for review. However, DOP confirmed the reports were never reviewed.

During an interview on 10/30/23 4:26 p.m. with chief operating officer (COO), COO stated that the diversion of controlled substances by RN 3 affected over 316 patients.

During an interview with COO on 10/31/23 at 8:48 a.m., COO confirmed that the reports were going out however, no one could understand them so the reports weren't being reviewed.

2. Review of an email from CQO dated 10/16/23 indicated, Data reviewed validated RN 4 activity was not in accordance with policy. So, RN 4 was placed on investigatory suspension. Further reviews showed, email from CQO dated 10/18/23 indicated, the plan was for RN 4 to be interviewed by nursing/HR (human resources) leadership on 10/19/23.

During a concurrent interview and record review on 10/30/23 at 4:09 p.m. with director of pharmacy (DOP), the "Omnicell Dispensing Practices Report (ODPR)" ( A securely store controlled substances in the automated dispensing cabinet, releasing each dose into special drawers for easy access and accountability) with names of nurses on the report dated from 7/1/23 - 9/30/23 reviewed. The ODPR indicated RN 4, total doses 869, within 35 transaction days. DOP stated, RN 4 had unusually high amounts of narcotics pulled from the Omnicell. DOP further stated, that however, the Omnicell system sends anomalous (deviating from what is standard) usage reports to managements on a monthly and quarterly basis and confirmed the reports were never reviewed.

During an interview with COO on 10/31/23 at 8:48 a.m., COO stated, "I'm responsible and I'm gonna own that. At the end of the day these reports were going out but no one could understand them. The reports weren't being reviewed. I'm gonna own the mistake."

During a concurrent interview and record review on 11/1/23 at 3:15 p.m. with DOP, unresolved discrepancies for RN 4 reviewed. DOP indicated 34 controlled substances pulled from the Omnicell by RN 4 are unaccounted for. DOP acknowledged the missing controlled substances are a significant loss. DOP stated the loss was not reported and should have been investigated. DOP confirmed, Omnicell Discrepancy Practices Reports should have been reviewed in the Diversion Committee Meetings, but they were not.

During a concurrent interview and record review on 11/1/23 at 3:25 p.m. with DOP confirmed that there were 89 unresolved discrepancies for controlled substances pulled from the Omnicell by RN 3. DOP revealed the loss was not reported and should have been investigated. DOP also confirmed, Omnicell Discrepancy Practices Reports should have been reviewed in the Diversion Committee Meetings, but they were not.

During a concurrent interview and record review on 11/1/23 at 4:08 p.m. with DOP, "Detailed Risk Score Analysis" dated 8/1/23 - 10/16/23 was reviewed. The report indicated, RN 4 exhibits highly unusual medication activity patterns when: Administering Acetaminophen-Hydrocodone Oral, Administering Oxycodone oral, Administering Acetaminophen-Oxycodone Oral. DOP confirmed an investigation into the highly unusual medication activity patterns exited in June 2023, but the reports were never reviewed. DOP stated he was instructed by corporate to only look at September. RN 4 "was taken off the list." DOP confirmed RN 4 had a high rate of anomalous usage, compared to peers. And DOP confirmed and stated, "it should have been investigated."

Review of the facility's policy and procedure titled, "Controlled Substance Diversion Prevention and Detection", dated 9/2022, indicated, (Page 1 of 10) 1. Purpose: The purpose of this policy is to establish controls for Controlled Substance security and monitoring to prevent and detect Diversion.

Further review of the facility's policy and procedure titled, "Controlled Substance Diversion Prevention and Detection, Appendix A - Controlled Substance Report Reviews", Page 9, dated 9/2022, indicated, Review: Anomalous Usage/Trending, Review Frequency: Monthly and Quarterly, Report Review Responsibility: Pharmacy Monthly, Diversion Prevention Committee Quarterly. Review User Watch List - Anomalous Usage, Review Frequency: Monthly and Quarterly. Report Review Responsibility: Pharmacy Monthly, Diversion Prevention Committee Quarterly.

Based on interview with the hospital's Pharmacy Director of Pharmacy and review of the hospital's current drug formulary the hospital failed to ensure that only medications with the safest patient profiles had been kept or maintained on the hospital's current drug formulary.

Findings:

During an interview with Director of Pharmacy (DOP) on 5/12/2023 at 2:45 pm, she stated that the hospital had developed a local drug formulary specific for this hospital, but that this drug formulary had not been reviewed in "quite some time". The hospital had failed to look at the current drug formulary based on the following criteria: medication effectiveness in treatment, potential risk for harm to patients, and the costs for the use of any medications (including duplication in therapy).

Review of the hospital's current drug formulary included drugs like Cocaine solution and powder, Droperidol, and Flecainide all of which are very old drugs and newer drugs are available which can be substituted, with safer drug profiles and with fewer side effects, or these drugs carry a Black Box Warning. For example, Cocaine has a very strong profile for "potential abuse", and other less abusive drugs are available and able to be used with similar results.
Flecainide is an antiarrhythmic drug used to treat patients with irregular heart rhythms. From the drug's manufacturer (Roxane Laboratories, Inc.), package insert dated September 2014, Flecainide (TAMBOCOR (Trademark)) has the following Black Box Warning: "FLECAINIDE IS NOT RECOMMENDED FOR USE IN PATIENTS WITH CHRONIC ATRIAL FIBRILLATION. Case reports of ventricular proarrhythmic effects in patients treated with flecainide for atrial fibrillation/flutter have included increased PVCs, VT, ventricular fibrillation (VF), and death." There are safer alternative medications for the use and/or treatment for the treatment of these disease states.


Droperidol, is a sedative, tranquilizer, and anti-nausea medication used to reduce nausea and vomiting. From the drug's manufacturer (Hospira, Inc.) package insert for Droperidol (Inapsine) dated March 2021, Droperidol has the following Black Box Warning: Cases of QT prolongation and/or torsade de pointes have been reported in patients receiving droperidol at doses at or below recommended doses. Some cases have occurred in patients with no known risk factors for QT prolongation and some cases have been fatal.
Due to its potential for serious proarrhythmic effects and death, droperidol should be reserved for use in the treatment of patients who fail to show an acceptable response to other adequate treatments, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs (see Warnings, Adverse Reactions, Contraindications, and Precautions).
Cases of QT prolongation and serious arrhythmias (e.g., torsade de pointes) have been reported in patients treated with droperidol. Based on these reports, all patients should undergo a 12-lead ECG prior to administration of droperidol to determine if a prolonged QT interval (i.e., QTc greater than 440 msec for males or 450 msec for females) is present. If there is a prolonged QT interval, droperidol should NOT be administered. For patients in whom the potential benefit of droperidol treatment is felt to outweigh the risks of potentially serious arrhythmias, ECG monitoring should be performed prior to treatment and continued for 2-3 hours after completing treatment to monitor for arrhythmias.

Droperidol is contraindicated in patients with known or suspected QT prolongation, including patients with congenital long QT syndrome. There are safer alternative medications for the use and/or treatment for the treatment of these disease states. During an interview with the hospital's Director of Pharmacy (DOP) on 11/2/2023 at 12:20 pm, the DOP stated: "this drug should not have been on our hospital's drug formulary".


ASHP Guidelines on Preventing Medication Errors in Hospitals who also provides guidance on the National Standards for drug formularies, states, under their Formulary Assessment and Management section:
"A well-designed formulary system will guide clinicians to prescribe the safest and most cost-effective agent for treating a particular disease state or medical issue. Formularies limit the selection of medications available so that clinicians become proficient with the dosing, preparation, and administration practices of a selected number of medications. A streamlined formulary can also help to standardize the content of EHRs, pharmacy information systems, and infusion pump settings/medication libraries ... The "ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System" provide detailed guidance on formularies and medication evaluation documents (i.e., monographs) and should be consulted for more information. In particular, when preparing an evidence-based formulary review document for a medication, a section should be devoted to medication safety assessment and recommendations. In short, the pharmacist/pharmacy should consider whether the medication being reviewed for addition to the formulary has potential safety issues ....".

The hospital failed to meet the regulatory requirements for the Condition of Participation: CFR 482.42 Infection Prevention and Control and Antibiotic Stewardship Program as evidenced by the following:

1. Based on interview, and record review, the facility failed to demonstrate the governing body appointed an infection prevention manager responsible for the infection control program based off the recommendations of the medical staff leadership and nursing leadership.
This facility failure had the potential for an unqualified infection prevention manager to lead the hospitals infection prevention and control program.
(Refer to A-748)

2. Based on observation, interview and record review, the hospital failed to ensure a safe and sanitary environment and implement policy and procedures to minimize the transmission of healthcare acquired infections (HAIs) when:

A. Temperature and humidity had been out of range in the operating rooms (ORs), OR sterile supply room, and sterile processing department (SPD).
B. Humidity was out of range in the labor and delivery (L&D) OR's (OR #1 and OR #2).
C. Temperature and humidity were not monitored where sterile instruments were stored in L&D.

These facility's failures had the potential for negative patient care outcomes and the potential to spread harmful microorganisms to patients that could result in procedural and surgical site infections. (Refer to A-749)


3. Based on observation, interview, and record review, the facility failed to:

A. Properly store patient care equipment when unable to determine if clean or dirty on the medical surgical unit.
B. (a) Ensure dirty equipment was not stored in a clean patient room.

(b) Ensure dirty equipment (a bladder scanner) was not stored in the clean storage room.

C. Ensure staff performed hand hygiene on the medical surgical unit when coming out of a patient's room (Patient 101), who was in isolation and on contact precautions (to prevent the transmission of infectious agents and microorganisms which are spread by direct or indirect contact with the patient and or the patient's environment).
D. Ensure staff disposed of Personal Protective Equipment (PPE) appropriately on the medical surgical unit when coming out of a patient's room (Patient 101), who was in isolation and on contact precautions.
E. Ensure staff wore gloves when accessing an IV (intravenous-in the vein) site for one Patient (Patient 100) for medication administration on the medical surgical unit.
F. Ensure staff recorded the date and time on an IV site for one patient (Patient 100) on the medical surgical unit.
G. Ensure staff recorded the date and time on an IV site for one patient (Patient 301) in the Emergency Room (ER).

These failures had the potential to spread infection to patients, staff, and visitors. (See A-750)


4. Based on hospital administrative staff interviews and review of the hospital's Antibiotic Stewardship Program (ASP) policies and procedures, the hospital failed to ensure that the hospital had created and maintained ASP minutes which would have demonstrated the hospital's implementation, success, and sustainability of their antibiotic use activities.This failure had the potential to result in the hospital's inability to provide effective antibiotic therapy for their patients. (Refer to A-770)

5. Based on interview with the hospital's Infection Preventionist (IP), the IP was unable to provide any documented evidence that he had any communication and collaboration with the hospital's ASP. This failure had the potential to result in the hospital's inability to provide effective antibiotic therapy for their patients. (Refer to A-777)

6. Based on hospital administrative staff interview (Infection Control Preventionist) [IP] and review of the hospital's Antibiotic Stewardship Program (ASP) policies and procedures, the hospital failed to ensure that the hospital had created and maintained ASP minutes which would have demonstrated the hospital's implementation, success, and sustainability of their antibiotic use activities. This failure had the potential to result in the hospital's inability to provide effective antibiotic therapy for their patients. (Refer to A-778)

7. Based on interview with the hospital's administrative staff the hospital failed to provide evidence that the hospital's ASP had been communicating and collaborating with the hospital's medical staff, nursing, pharmacy leadership, the hospital infection preventionist, and the QAPI programs regarding antibiotic use issues within the hospital. 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 A-780)

8. Based on hospital administrative staff interviews and policy and procedure 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 A-781)

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.



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On 10/31/23 at 1:00 p.m., an Immediate Jeopardy (IJ), a situation in which the facility's noncompliance had placed the health and safety of patients in its care at risk for serious injury, serious harm, serious impairment, or death, was declared when:

The hospital failed to ensure a safe and sanitary environment and implement policy and procedures to minimize the transmission of healthcare acquired infections (HAIs) when temperature and humidity were out of range in the operating room (OR #2-used only as storage) where sterile supplies are stored and the sterile processing department (SPD-the area where the cleaning and sterilization of devices and instruments used in medical and surgical procedures, takes place) as per the hospital's adopted professional American Society of Heating, Refrigerating and Air Conditioning Engineers (ASHRAE) Standard 170, 2008, Ventilation of Health Care Facilities. According to this standard the Temperature and Relative Humidity (RH) Ranges: for Sterile Storage and Sterile Processing Clean side 72-78 deg F and RH 60% maximum, and Sterile Processing Decontamination (dirty) side 72-78 deg F and RH 30-60%. The risk was observed on 10/31/23 starting at 9:30 a.m. during a tour of Sterile Storage and continued through 10:35 a.m. during tour of SPD. Sterile supplies and surgical instruments were being stored in unacceptable temperature ranges. Further investigation of the temperature logs, in Sterile Storage, revealed the temperature was out of range for the month of October 2023. In SPD temperature and humidity were out of range for month of October 2023. This placed surgical patients at high risk of acquiring an infection when using possible compromised/contaminated sterile supplies, instruments, and medical devices. (Refer to A-749)

The hospital's Chief Operating Officer, Chief Nurse Officer, Quality Chief Officer, Peri-Operative Surgical Manager, Infection Preventionist, Director of Peri-natal Services, and Emergency Room Manager were informed of the Immediate Jeopardy on 10/31/23 at 1:00 p.m.

On 11/1/23 at 9:42 a.m., the hospital submitted a plan of correction (POC) which included the hospital adopting the American Society of Heating, Refrigerating and Air Conditioning Engineers (ASHRAE) Standard 170, 2017, Ventilation of Health Care Facilities for maintaining temperature, humidity, and air pressure relationships in critical areas. The hospital updated temperature and humidity logs to reflect the most current ASHRAE Standard 170, 2017 requirements. Temperature and humidity will be logged daily in the critical areas. Employee education and training on the new expectations and ranges which are to be met per the new temperature and humidity policy. The POC was discussed with the Department. The POC was accepted.

The Immediate Jeopardy was removed after a corrective action plan was accepted on 11/1/23 at 9:42 a.m. in the presence of the Chief Nursing Officer and Quality Chief Officer.

Based on interview, and record review, the facility failed to demonstrate the governing body appointed an infection prevention manager responsible for the infection control program based off the recommendations of the medical staff leadership and nursing leadership.

This facility failure had the potential for an unqualified infection prevention manager to lead the hospitals infection prevention and control program.

Findings:

During a interview on 11/01/23, starting at 8:30 a.m., with corporate executive officer (CEO) of facility, when asked if facility infection preventionist (IP) manager had been appointed by the governing body based on medical staff and nursing leadership, CEO stated, "I don't think so." CEO directed executive assistant (EA1) to review governing body agendas from 2019 (IP start date) until most recent 2023 governing body meeting, for governing body appointment of the infection control manager.

During an interview on 11/01/23, starting at 10:30 a.m., with executive assistant (EA1), EA1 indicated she had reviewed all the governing body minutes as directed and was unable to locate any documentation of governing body appointment of IP. EA1 stated, "No we reviewed all the months and could not find any anything, I also checked with (name of CEO) and he said he didn't think it occurred."

Based on observation, interview and record review, the hospital failed to ensure a safe and sanitary environment and implement policy and procedures to minimize the transmission of healthcare acquired infections (HAIs) when:

1.Temperature and humidity was out of range in the operating rooms (ORs), OR sterile supply room, and sterile processing department (SPD)

2. Humidity was out of range in the labor and delivery (L&D) OR's (OR #1 and OR #2).

3. Temperature and humidity were not monitored where sterile instruments were stored in L&D.

These facility's failures had the potential for negative patient care outcomes and the potential to spread harmful microorganisms to patients that could result in procedural and surgical site infections.

Findings:

1. During a review of the facility's policy and procedure (P&P) titled "Temperature, Humidity and Air Pressure Relationship Management", dated 9/8/2022 indicated in part ... " The temperature and humidity of items and areas not monitored by an automated system shall require human surveillance to ensure these factors remain within safe parameters ...the temperature and/or humidity of any refrigerators holding patient items, storage rooms holding sterile equipment, operating rooms, and any other items and areas as necessary will be monitored and recorded at least daily using a log format ...in Operating rooms, the temperature and humidity will be checked daily before any procedures are begun for the day ...Unless a department follows a more stringent set of parameters, logs will be based on ASHRAE requirements ...Operating Rooms 1-7: Temperature Range 68-75 deg F ...Relative Humidity % range 30-60%... Sterile Storage Areas and Sterile Processing-Clean: Temperature Range 72-78 deg F ...Relative Humidity % range 60% maximum ... Sterile Processing-Decontamination: Temperature Range 72-78 deg F ...Relative Humidity % range 30-60%... In the event that the temperature or humidity is found to be out of range, immediate action must be taken to mitigate risk ..."

During a concurrent observation, interview, and record review on 10/31/23, at 9:30 a.m., with the peri-op manager (POM) and the infection control preventionist (IP), OR 2 was observed. POM stated we store all our sterile trays and supplies in OR 2, we monitor it daily for temperature and humidity, using a hand-held device, and document it daily on a log. OR 2's temperature and humidity were checked by POM using the hand-held device and the temperature was 66.6 deg F and 26.1% H (humidity). The facility document titled, "Daily Humidity/Temperature Log - Operating Rooms/Recovery Rooms," dated October 2023 and location: OR 2, indicated the temperature was out of range everyday of the month. POM and IP acknowledged that the temperature of OR 2 was out of range during the observation and everyday it was recorded on the October log. Additionally, the IP verbalized the facility policy and procedure uses AORN and ASHRAE guidelines for temperature and humidity in OR rooms and sterile storage.

During a concurrent observation and interview on 10/31/23, at 9:33 a.m., with the peri-op manager (POM) and the infection control preventionist (IP), OR 1 was observed. POM stated we monitor our ORs daily for temperature and humidity, using a hand-held device. OR 1's temperature and humidity were checked by POM using the hand-held device and the temperature was 68.5 deg F and 22.3% H (humidity). POM and IP acknowledged that the humidity of OR 1 is out of range. Additionally, the IP verbalized the facility policy and procedure uses AORN and ASHRAE guidelines for temperature and humidity in OR rooms.

During a concurrent observation and interview on 10/31/23, at 9:35 a.m., with the peri-op manager (POM) and the infection control preventionist (IP), OR 3 was observed. POM stated we monitor our ORs daily for temperature and humidity, using a hand-held device. OR 3's temperature and humidity were checked by POM using the hand-held device and the temperature was 67.6 deg F and 23.7% H (humidity). POM and IP acknowledged that the temperature and humidity of OR 3 is out of range. Additionally, POM stated they are currently doing a total knee in OR 3. Also, IP stated, "I wouldn't want to be doing a total knee right now when this is the humidity, it is a fire risk." Lastly, the IP verbalized the facility policy and procedure uses AORN and ASHRAE guidelines for temperature and humidity in OR rooms.

During a concurrent observation and interview on 10/31/23, at 9:38 a.m., with the peri-op manager (POM) and the infection control preventionist (IP), OR 4 was observed. POM stated we monitor our ORs daily for temperature and humidity, using a hand-held device. OR 4's temperature and humidity were checked by POM using the hand-held device and the temperature was 67.6 deg F and 22.9% H (humidity). POM and IP acknowledged that the temperature and humidity of OR 4 is out of range. Additionally, the IP verbalized the facility policy and procedure uses AORN and ASHRAE guidelines for temperature and humidity in OR rooms.

During a concurrent observation and interview on 10/31/23, at 9:40 a.m., with the peri-op manager (POM) and the infection control preventionist (IP), OR 4 was observed. POM stated we monitor our ORs daily for temperature and humidity, using a hand-held device. OR 5's temperature and humidity were checked by POM using the hand-held device and the temperature was 69.3 deg F and 22.7% H (humidity). POM and IP acknowledged that the humidity of OR 5 is out of range. Additionally, the IP verbalized the facility policy and procedure uses AORN and ASHRAE guidelines for temperature and humidity in OR rooms.

During a concurrent observation and interview on 10/31/23, at 9:42 a.m., with the peri-op manager (POM) and the infection control preventionist (IP), OR 6 was observed. POM stated we monitor our ORs daily for temperature and humidity, using a hand-held device. OR 6's temperature and humidity were checked by POM using the hand-held device and the temperature was 68.8 deg F and 24.0% H (humidity). POM and IP acknowledged that the humidity of OR 6 is out of range. Additionally, the IP verbalized the facility policy and procedure uses AORN and ASHRAE guidelines for temperature and humidity in OR rooms.

During a concurrent observation and interview on 10/31/23, at 9:47 a.m., with the peri-op manager (POM) and the infection control preventionist (IP), OR 7 was observed. POM stated we monitor our ORs daily for temperature and humidity, using a hand-held device. OR 7's temperature and humidity were checked by POM using the hand-held device and the temperature was 67.3 deg F and 24.0% H (humidity). POM and IP acknowledged that the temperature and humidity of OR 7 is out of range. Additionally, the IP verbalized the facility policy and procedure uses AORN and ASHRAE guidelines for temperature and humidity in OR rooms.

During a concurrent observation and interview on 10/31/23, at 10:35 a.m., with the sterile processing department supervisor (SPDS), POM and the IP, sterile processing-clean was observed. SPDS stated we monitor sterile processing-clean daily for temperature and humidity, using a hand-held device. Sterile processing-clean's temperature and humidity were checked by SPDS using the hand-held device and the temperature was 71.3 deg F and 20.5% H (humidity). The facility document titled, "Daily Humidity/Temperature Log - Sterile Processing (Clean Side)," dated October 2023 and location: Prep & Pack, indicated the temperature was out of range every day of the month. SPDS and IP acknowledged that the temperature of sterile processing- clean was out of range during the observation and everyday it was recorded on the October log. Additionally, the IP verbalized the facility policy and procedure uses AORN and ASHRAE guidelines for temperature and humidity in SPD.

During a concurrent observation and interview on 10/31/23, at 10:37 a.m., with the SPDS, POM and the IP, sterile processing-decontamination side was observed. SPDS stated we monitor our sterile processing-decontamination daily for temperature, using a hand-held device. Sterile processing-decontamination temperature and humidity were checked by SPDS using the hand-held device and the temperature was 72.0 deg F and 22.8% H (humidity). The facility document titled, "Daily Humidity/Temperature Log - Sterile Processing (Decontamination-Side)," dated October 2023 and location: Decon, indicated the temperature was out of range every day of the month. SPDS and IP acknowledged that the temperature of sterile processing- decontamination side was out of range everyday it was recorded on the October log, the humidity was out of range during observation, and they have not been monitoring the humidity daily and recording on the log. Additionally, the IP verbalized the facility policy and procedure uses AORN and ASHRAE guidelines for temperature and humidity in SPD.



According to the AORN Guidelines titled, ""Design and Maintenance", dated 2012-2019, the guidelines indicated in part, "Personnel who identify an unintentional variance in the predetermined HVAC system parameters should report the variance according to the health care organization's policy and procedures...a small variance for a short period of time may not be of clinical concern, whereas a large variance for a longer period may have clinical significance...based on the risk assessment, corrective measures may include: rescheduling procedures to the areas of the surgical suite where the HVAC system is functioning with in normal parameters, delaying elective procedures, limiting surgical procedures to emergency procedures only, closing the affected ORs...based on a risk assessment, corrective measures taken to restore the surgical suite to full functionality after the HVAC system variance has been corrected may include...terminally cleaning when there is evidence of contamination on surfaces...reprocessing or disgarding any supplies with packaging that may have been compromised."



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2. During a review of the facility's policy and procedure (P&P) titled "Temperature, Humidity and Air Pressure Relationship Management", dated 9/8/2022 indicated in part ... " The temperature and humidity of items and areas not monitored by an automated system shall require human surveillance to ensure these factors remain within safe parameters ...the temperature and/or humidity of any refrigerators holding patient items, storage rooms holding sterile equipment, operating rooms, and any other items and areas as necessary will be monitored and recorded at least daily using a log format ...in Operating rooms, the temperature and humidity will be checked daily before any procedures are begun for the day ...Unless a department follows a more stringent set of parameters, logs will be based on ASHRAE requirements ...OB Operating Rooms 1-2: Temperature Range 68-75 deg F ...Relative Humidity % range 30-60%... In the event that the temperature or humidity is found to be out of range, immediate action must be taken to mitigate risk ..."

During a concurrent observation and interview on 10/30/23, at 4:35 p.m., with the director of perinatal services (DPNS) and the labor and delivery scrub technician (ST 1), the labor and delivery operating room (OR) #1 was observed. The digital wall thermometer indicated the temperature of the operating room was 67.5 deg F and 28% H (humidity). DPNS was asked if the humidity was out of range, DPNS verbalized we do not use the reading on the wall thermometer because it is not accurate. DPNS verbalized that the temperature and humidity are taken with a hand-held wand (probe), every morning and readings are marked onto a graph, on a log, before any cesarean section starts. DPNS verbalized if the temperature and or humidity are out of range, plant operations is notified, and a work order number is received. The DPNS verbalized the work order number is documented at the bottom of the log. DPNS verbalized the facility policy and procedure uses AORN and ASHRAE guidelines, and the humidity range of 30-60%. ST 1 used the hand-held wand and read 68.3 deg F and 28.7% H. DPNS acknowledged the humidity was out of range and further verbalized would need to notify plant operations.

During a concurrent observation and interview on 10/30/23, at 4:45 p.m., with the DPNS and ST 1, the labor and delivery OR #2 was observed. The digital wall thermometer indicated the temperature of the operating room was 72.5 deg F and 24% H (humidity). ST 1 used the hand-held wand and was reading 23.6 % H. DPNS acknowledged the humidity was out of range for OR #2 and would inform plant operations.

According to the AORN Guidelines titled, ""Design and Maintenance", dated 2012-2019, the guidelines indicated in part, "Personnel who identify an unintentional variance in the predetermined HVAC system parameters should report the variance according to the health care organization's policy and procedures...a small variance for a short period of time may not be of clinical concern, whereas a large variance for a longer period may have clinical significance...based on the risk assessment, corrective measures may include: rescheduling procedures to the areas of the surgical suite where the HVAC system is functioning with in normal parameters, delaying elective procedures, limiting surgical procedures to emergency procedures only, closing the affected ORs...based on a risk assessment, corrective measures taken to restore the surgical suite to full functionality after the HVAC system variance has been corrected may include...terminally cleaning when there is evidence of contamination on surfaces...reprocessing or disgarding any supplies with packaging that may have been compromised."

3. During a concurrent observation and interview on 10/30/23, at 1:00 p.m., with the director of perinatal services (DPNS), a labor and delivery room was observed. In the labor and delivery room, a delivery table and its contents were observed. The contents inside the delivery table consisted of a sterile vaginal instrument tray, sterile vaginal delivery pack, and a clean red container to put dirty instruments in after a delivery. When asked if temperature and humidity are being monitored in the labor rooms, DPNS stated, "No, temperature and humidity are not being monitored in the labor rooms." Informed DPNS that AORN and ASHRAE guidelines indicate to monitor temperature and humidity where sterile instruments and supplies are being stored. DPNS acknowledged the sterile vaginal instruments trays and sterile supplies, should be monitored for temperature and humidity.

During a review of the facility's policy and procedure (P&P) titled "Temperature, Humidity and Air Pressure Relationship Management", dated 9/8/2022 indicated in part ... " The temperature and humidity of items and areas not monitored by an automated system shall require human surveillance to ensure these factors remain within safe parameters ...the temperature and/or humidity of any refrigerators holding patient items, storage rooms holding sterile equipment, operating rooms, and any other items and areas as necessary will be monitored and recorded at least daily using a log format ...in Operating rooms, the temperature and humidity will be checked daily before any procedures are begun for the day ...Unless a department follows a more stringent set of parameters, logs will be based on ASHRAE requirements ...Sterile Storage Areas: Temperature Range 72-78 deg F ...Relative Humidity % range 60% maximum... In the event that the temperature or humidity is found to be out of range, immediate action must be taken to mitigate risk ..."

The hospital's Chief Operating Officer, Chief Nurse Officer, Quality Chief Officer, Peri-Operative Surgical Manager, Infection Preventionist, Director of Peri-natal Services, and Emergency Room Manager were informed of the Immediate Jeopardy on 10/31/23 at 1:00 p.m. (Refer to the IJ).

Based on observation, interview, and record review, the facility failed to:

1. Properly store patient care equipment when unable to determine if clean or dirty on the medical surgical unit.

2 (a) Ensure dirty equipment was not stored in a clean patient room.

(b) Ensure dirty equipment (a bladder scanner) was not stored in the clean storage room.

3. Ensure staff performed hand hygiene on the medical surgical unit when coming out of a patient's room (Patient 101), who was in isolation and on contact precautions (to prevent the transmission of infectious agents and microorganisms which are spread by direct or indirect contact with the patient and or the patient's environment).

4. Ensure staff disposed of Personal Protective Equipment (PPE) appropriately on the medical surgical unit when coming out of a patient's room (Patient 101), who was in isolation and on contact precautions.

5. Ensure staff wore gloves when accessing an IV (intravenous-in the vein) site for one Patient (Patient 100) for medication administration on the medical surgical unit.

6. Ensure staff recorded the date and time on an IV site for one patient (Patient 100) on the medical surgical unit.

7. Ensure staff recorded the date and time on an IV site for one patient (Patient 301) in the Emergency Room (ER).

These failures had the potential to spread infection to patients, staff, and visitors.


Findings:


1. During a review of the facility's policy and procedure (P&P) titled "Cleaning and Storage of Patient Care Items", dated 3/10/2022 indicated in part ... "All patient care items must be cleaned between patient uses ...Patient care equipment managed by patient care units or services must be wiped with a hospital-approved disinfectant daily and when visibly soiled ...After cleaning, the item will be tagged and placed in the clean area, charged if necessary and properly labeled ...the tag will be removed or adjusted when item is placed into care ...All clean patient care equipment will be identified as clean by use of a removable tag which indicates that the item is clean ...a three part tag will be used to easily identify the status of the equipment ...that tag is divided into three sections (Clean, In Use, and Dirty) and perforated for easy use ...when equipment is used on a patient, the bottom portion of the tag which reads "Clean" is to be torn off. The bottom now reads "In Use". This alerts others that the equipment is being used for a patient ...once the equipment is no longer needed for the patient, the portion of the tag that reads "In Use" is to be torn off. The tag now reads "Dirty". This alerts others that the equipment needs to be cleaned ... Clean items may also be protected by plastic covers ..."


During a concurrent observation and interview on 10/31/23, at 3:44 p.m., with the medical surgical nursing supervisor (MSS), in an empty patient room, room 151, two IV pumps, were observed. The two IV pumps did not have an equipment tag to indicate if the pumps were clean or dirty. MSS acknowledged the IV pumps did not have an equipment tag and should have one to indicate if the pumps are clean or dirty. MSS verbalized the room is a clean patient room and sometimes equipment is moved in and out of patient rooms. When asked if the IV pumps were clean or dirty, MSS verbalized did not know if the pumps were clean or dirty and would inform EVS (environmental services) staff to clean the IV pumps.


2 (a) During a review of the facility's policy and procedure (P&P) titled "Cleaning and Storage of Patient Care Items", dated 3/10/2022 indicated in part ... "All patient care items must be cleaned between patient uses ...Patient care equipment managed by patient care units or services must be wiped with a hospital-approved disinfectant daily and when visibly soiled ...After cleaning, the item will be tagged and placed in the clean area, charged if necessary and properly labeled ..."


During a concurrent observation and interview on 10/31/23, at 3:46 p.m., with the medical surgical nursing supervisor (MSS), in an empty patient room, room 151, a MetaNeb machine (a machine that can help you breathe easier by helping the lungs expand, move secretions, and prevent lung failure) was observed. The MetaNeb machine had connection tubing, a breathing tube, and mouth piece still connected to the machine and appeared to be dirty. The equipment tag that was attached to the MetaNeb machine indicated still "In Use". MSS verbalized the room is a clean patient room and acknowledged the MetaNeb machine was not "In Use" and was dirty. MSS further verbalized the MetaNeb machine needed to be cleaned.


(b) During a concurrent observation and interview on 10/31/23, at 4:09 p.m., with the medical surgical nursing supervisor (MSS), the clean storage room was observed. The clean storage room contained shelves of clean supplies. A bladder scanner was also observed being stored in the room. The bladder scanner had a used washcloth and an opened bottle of gel on the machine. The equipment tag indicated the scanner was dirty. MSS acknowledged the bladder scanner was dirty. MSS was asked if a dirty bladder scanner should be stored in the clean storage room, MSS stated, "No, the bladder scanner should be placed into the dirty utility room until it has been cleaned."



3. During a review of the facility's policy and procedure (P&P) titled "Standard Precautions", dated 2/10/2022 indicated in part ... "To outline the evidence-based Standard Precautions guidelines that (name of facility) follows to prevent transmission of microorganisms to patients and workers ...Perform hand hygiene in the following circumstances: after risk of exposure to blood, body fluids, secretions, and excretions; after touching a patient surroundings and equipment; immediately after removing gloves; before and after touching a patient, including before entering clean or empty rooms ...Perform hand hygiene with soap and water or alcohol-based hand sanitizer ...a. Wash hands for 20 seconds with soap and water when hands are visibly soiled or for care of patients with C-difficile (a bacterial infection of the intestinal tract and is highly contagious) confirmed or suspected, after going to the bathroom, and before and after eating ...b. Follow manufacturer's instructions for use (IFU) for alcohol based hand sanitizer, covering the entire surface area of both hands and allowing to dry fully before providing care or donning gloves ..."



During a concurrent observation and interview on 10/31/23, at 4:42 p.m., with the medical surgical nursing supervisor (MSS) and a nursing assistant (CNA 1), CNA 1 was observed putting on a gown, gloves, and a face shield to enter Patient 101's Room (Room 250). MSS verbalized Patient 101 was on contact isolation precautions. CNA 1 was then observed removing the gown, gloves, and face shield and exited the room, without performing hand hygiene. When asked CNA 1 if he performed hand hygiene after removing his gloves, and exiting the room, CNA 1 stated, "No, I forgot". MSS acknowledged CNA 1 should have performed hand hygiene after removing the gloves and when exiting Patient 101's room.



During a review of Patient 101's medical record indicated Patient 101 was positive for C-difficile. Patient 101's physician orders indicated Patient 101 was to be put in isolation, and to use enteric precautions (contact precautions for preventing infections transmitted primarily by direct or indirect contact with fecal material).



4. During a review of the facility's policy and procedure (P&P) titled "Standard Precautions", dated 2/10/2022 indicated in part ... "To outline the evidence-based Standard Precautions guidelines that (name of facility) follows to prevent transmission of microorganisms to patients and workers ...Doff (remove) and discard all PPE except respirator prior to exiting room: first remove gloves, then gown, then eye protection, then mask ..."



During a concurrent observation and interview on 10/31/23, at 4:42 p.m., with the medical surgical nursing supervisor (MSS) and a nursing assistant (CNA 1), CNA 1 was observed putting on a gown, gloves, and a face shield to enter Patient 101's Room (Room 250). MSS verbalized Patient 101 was on contact isolation precautions. CNA 1 was then observed removing the gown, gloves, and face shield. CNA 1 disposed of the gown and gloves in Patient 101's room, then exited the room while holding on to the face shield. CNA 1 then hung the face shield on the isolation cart that was on the outside of Patient 101's room. When asked if the face shield should be hanging on the outside of the isolation cart, MSS stated, "No, the face shield should be thrown away. MSS verbalized during Covid-19 when PPE was scarce, face shields would be saved during the shift and put in a brown paper bag so the same CNA or nurse could reuse for the whole shift. MSS further verbalized it is not the practice now, and we have enough disposable face shields and PPE; and should be discarded after use.


5. Review of the nursing textbook titled, "Fundamentals of Nursing, Ninth Edition," by Potter et al., published by Elsevier, © 2017, indicated, "ADMINISTERING MEDICATIONS BY INTRAVENOUS BOLUS ... Apply clean gloves ... During IV bolus administration there is risk of blood exposure ... ADMINISTERING INTRAVENOUS MEDICATIONS BY PIGGYBACK ... Apply clean gloves ... During IV administration there is a risk of blood exposure."



During an observation on 10/31/23, at 4:56 p.m., in Patient 100's room (Room 251), a registered nurse (RN 2) was observed administering Dilaudid (a narcotic to treat moderate to severe pain) 0.5 mg (milligrams) IVP (intravenous [in the vein] push) at 4:56 p.m., without wearing gloves.



During an interview on 10/31/23, at 5:00 p.m., with the medical surgical nursing supervisor (MSS), MSS was informed of RN 2 was not wearing gloves when accessing the IV to give the Dilaudid. MSS verbalized was unaware that gloves needed to be worn when accessing an IV if there was no blood contact expected.



Review of the Centers for Disease Control and Prevention (CDC) website, https://www.cdc.gov/infectioncontrol/guidelines/isolation/recommendations.html#iv, accessed 11/1/23, the CDC recommendations indicated "IV. Standard Precautions. Assume that every person is potentially infected ... with an organism that could be transmitted in a healthcare setting and apply the following infection control practices during the delivery of health care ... IV.B.2.a. Wear gloves when it can be reasonably anticipated that contact with blood or other potentially infectious materials... could occur."



6. During a concurrent observation and interview on 10/31/23, at 4:56 p.m., with Patient 100, in Patient 100's room (Room 251), a registered nurse (RN 2) was observed administering Dilaudid (a narcotic to treat moderate to severe pain) 0.5 mg (milligrams) IVP (intravenous [in the vein] push). When asked Patient 100 about his IV, he stated, "I have had this IV in for three days." The IV site was observed and had no date or time when the IV was started.



During an interview on 10/31/23, at 5:00 p.m., with the medical surgical nursing supervisor (MSS), MSS was informed of Patient 100's IV site was missing a date and a time. MSS reviewed Patient 100's medical record and verified Patient 100's IV had been started on 10/28/23 and further verbalized The IV should have been dated and timed by the nurse who started the IV.



During a review of the facility's policy and procedure (P&P) titled "Intravenous Therapy", dated 6/5/2014 indicated in part ... "Assessment & Documentation: a. Document date and time of insertion, patient's response, number and location of attempts, type and size of catheter, stabilization method and dressing along with the signature of the nurse inserting the catheter ..."















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7. During a concurrent observation and interview on 10/30/23, at 4:53 p.m., with Patient 301, in the emergency room, a registered nurse (RN 5) was observed starting an IV (in the vein), RN 5 left the room and started other tasks. The IV site was observed and had no date or time when the IV was started.

During an interview on 10/30/23, at 5:00 p.m., with the Emergency Room Manager medical (ERM), ERM was informed of Patient 301's IV site was missing a date and a time. ERM verbalized the IV should have been dated and timed by the nurse who started the IV.

During a review of the facility's policy and procedure (P&P) titled "Intravenous Therapy", dated 6/5/2014 indicated in part ... "Assessment & Documentation: a. Document date and time of insertion, patient's response, number and location of attempts, type and size of catheter, stabilization method and dressing along with the signature of the nurse inserting the catheter ..."

Based on hospital administrative staff interviews and review of the hospital's Antibiotic Stewardship Program (ASP) policies and procedures, the hospital failed to ensure that the hospital had created and maintained ASP minutes which would have demonstrated the hospital's implementation, success, and sustainability of their antibiotic use activities.

Findings:

During an interview with both the hospital's Chief Operating Officer (COO) and the hospital's Director of Pharmacy (DOP) on 11/1/2023 at 3:45 pm and after previously asking multiple administrative hospital staff for the hospital's ASP minutes, the hospital's COO stated: "the hospital does not have any ASP minutes after January of 2023."

During the interview, the COO was asked to if he could provide any evidence that the hospital's ASP had taken any of the data regarding ASP and implemented any changes for success and sustainability around their raw data. The COO indicated during the interview that he would not be able to show how the hospital had used the raw data to make changes and/or improvement with patient care along with the hospital's use and management of antibiotic therapy.

Review of the hospital's Antibiotic Stewardship Program (ASP) policies and procedures entitled: "Antimicrobial Stewardship Program", dated 4/4/2019 reads: "The ASP is an intensive surveillance program dedicated to providing optimal antibiotic usage. It allows for protocol driven antibiotic interventions and encompasses core elements of antibiotic stewardship which align with The Joint Commission standards: leadership, accountability, drug expertise, action, tracking, reporting and education." The only element that the hospital was able to show that they were completing was the "reporting", the hospital was unable to show that any of the other elements outlined in this policy and procedure had been implemented.

Review of the hospital's Antibiotic Stewardship Program (ASP) policies and procedures entitled: "Antimicrobial Stewardship Program", dated 4/4/2019 reads: "Antibiotic prescribing and resistance patterns will be tracked, along with restricted antibiotic use ..."
The hospital was unable to provide any documented evidence that antibiotic prescribing and resistance patterns had been tracked by the hospital as outline in the hospital's policies and procedures above.

Based on interview with the hospital's Infection Preventionist (IP), the IP was unable to provide any documented evidence that he had any communication and collaboration with the hospital's ASP.

Findings:

During an interview with the hospital's IP on 11/2/2023 at Noon, the hospital's IP was asked if he could provide any evidence/documentation demonstrating that he had collaborated and/or communicated with the hospital's ASP. The IP indicated during the interview that he did not have any documentation of his attendance at the ASP meetings and he also indicated that he did not have any evidence that he had any collaboration or communication with the hospital's ASP. The IP also indicated during the interview that he was aware that the hospital had no ASP meeting minutes, which would have provided evidence of the IP's participation with/in ASP.

Based on hospital administrative staff interview (Infection Control Preventionist) [IP] and review of the hospital's Antibiotic Stewardship Program (ASP) policies and procedures, the hospital failed to ensure that the hospital had created and maintained ASP minutes which would have demonstrated the hospital's implementation, success, and sustainability of their antibiotic use activities.

Findings:


Review of the hospital's Antibiotic Stewardship Program (ASP) policies and procedures entitled: "Antimicrobial Stewardship Program", dated 4/4/2019 reads: "The ASP is an intensive surveillance program dedicated to providing optimal antibiotic usage. It allows for protocol driven antibiotic interventions and encompasses core elements of antibiotic stewardship which align with The Joint Commission standards: leadership, accountability, drug expertise, action, tracking, reporting and education." The only element that the hospital was able to show that they were completing was the "reporting" aspect from the hospital's policy and procedure, but the hospital was unable to show that any of the other elements which were outlined in the hospital's policy and procedure had been implemented or acted upon. The hospital was unable to provide evidence (e.g. meeting minutes) that the hospital had actually been monitoring and improving the hospital's use of antibiotics within the hospital. The hospital failed to provide an current antibiogram which included resistance to the hospital's Pharmacy as the Pharmacy was using the 2021 version of a partial antibiogram, based on interview with hospital Pharmacy staff

Based on interview with the hospital's administrative staff the hospital failed to provide evidence that the hospital's ASP had been communicating and collaborating with the hospital's medical staff, nursing, pharmacy leadership, the hospital infection preventionist, and the QAPI programs regarding antibiotic use issues within the hospital.

Findings:

During an interview with both the hospital's Chief Operating Officer (COO) and the hospital's CNO on 11/1/2023 at 4:07 pm and after previously asking multiple administrative hospital staff for the hospital's ASP minutes, the hospital's COO stated: "the hospital does not have any ASP minutes after January of 2023." During the interview, the COO was asked to if he could provide any evidence that the hospital's ASP had taken any of the data regarding ASP and implemented any changes for success and sustainability around their raw data. The COO indicated during the interview that he would not be able to show how the hospital had used the raw data to make changes and/or improvement with patient care along with the hospital's use and management of antibiotic therapy. The COO also indicated during the interview that he could not provide any evidence that the hospital's ASP had been communicating and collaborating with the hospital's medical staff, nursing, pharmacy leadership, the hospital infection preventionist, and the QAPI programs regarding antibiotic use issues within the hospital, as a result of the hospital not having any ASP minutes since January of 2023.

Based on interview with the hospital's administrative staff the hospital failed to provide evidence that the hospital's ASP had been communicating and collaborating with the hospital's medical staff, nursing, pharmacy leadership, the hospital infection preventionist, and the QAPI programs regarding antibiotic use issues within the hospital.

Findings:

During an interview with both the hospital's Chief Operating Officer (COO) and the hospital's CNO on 11/1/2023 at 4:07 pm and after previously asking multiple administrative hospital staff for the hospital's ASP minutes, the hospital's COO stated: "the hospital does not have any ASP minutes after January of 2023." During the interview, the COO was asked to if he could provide any evidence that the hospital's ASP had taken any of the data regarding ASP and implemented any changes for success and sustainability around their raw data. The COO indicated during the interview that he would not be able to show how the hospital had used the raw data to make changes and/or improvement with patient care along with the hospital's use and management of antibiotic therapy. The COO also indicated during the interview that he could not provide any evidence that the hospital's ASP had been communicating and collaborating with the hospital's medical staff, nursing, pharmacy leadership, the hospital infection preventionist, and the QAPI programs regarding antibiotic use issues within the hospital, as a result of the hospital not having any ASP minutes since January of 2023.