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 total operation, and providing the oversight for quality health care, in a safe environment as follows:

1. The contracted services provided in the hospital out-patient services were not evaluated to ensure compliance with the Centers for Medicare & Medicaid Services (CMS) Conditions of Participation (COP) requirements and the evaluation(s) was/were documented.
(Cross reference A-0083)

2. The contracted services provided in the hospital were not evaluated for safety, and effectiveness with documentation in place for follow up or improvement.
(Cross reference A-0084)

3. The hospital have not developed, implemented and maintained an effective, ongoing, hospital-wide, data-driven quality assessment, and performance improvement program.
(Cross reference Condition of Participation A-0263).

4. The 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).

5. The hospital's QAPI program failed to focus on high-risk, high volume and problem prone areas within the pharmacy compounding environment, and did not take actions aimed at performance improvement activities areas in the pharmacy department within the hospital.
(Cross Reference A-0283).

6. The Quality Assessment Performance Improvement (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).

7. The GB did not ensure documentation that the hospital conducted performance improvement projects, reflected the scope and complexity of the hospital, when the QAPI program failed to focus on known high-risk, high volume and problem prone areas within the pharmacy compounding environment. As a result, opportunities for improvement were potentially missed and could result in adverse patient outcomes.
(Cross Reference A-0297).

8. The GB failed to be responsible for the implementation of the quality program. The GB failed to ensure that quality and safety data was correctly gathered and reported, including events monitoring medication errors interventions and unsafe environmental controls within the compounding area of the pharmacy. These high priorities, could affect the safety of the hospital patients and were not reviewed and/or discussed within the Quality Committee of the Governing Board, creating the risk of persistent poor practices and an unsafe environment.
(Cross Reference A-0309).

9. The hospital failed to ensure nursing services were provided in a safe manner, when hospital policies and procedures (P&P) and standards of practice were not followed when:(Cross Reference A-0385)

10. Care plans were not developed for 5 out of 42 sampled Patients (Patient 204, Patient 205, Patient 602, Patient 605, and Patient 609). (Cross Reference A-0396).

11. Adult, Pediatric, and Infant Crash Carts (a cart stocked with emergency medical equipment, supplies, and drugs for use by medical personnel during efforts to resuscitate a patient experiencing cardiac arrest) in ICU (intensive care unit), DOU (direct observation unit), OSU (outpatient surgical unit), postoperative unit (post-op), L&D (labor and delivery), and medical surgical units, were not checked to safeguard there were no expired supplies and equipment, and to ensure proper defibrillator (device that send an electric pulse or shock to the heart to restore a normal heartbeat) function, so as to be ready for use by registered nurses (RNs) during an emergency. (Cross Reference A-0398).

12. Wrist restraints (physical device that immobilizes or reduces the ability of a patient to move) were not monitored for 1 out of 42 sampled patients (Patient 200). (Cross Reference A-0398).

13. Procedure consent forms were incomplete for 3 out of 42 sampled patients (Patient 200, Patient 201, and Patient 202). (Cross Reference A-0398).

14. Heparin medication (used to prevent blood clots from forming) was not administered according to high alert medication policy and procedure.
(Cross Reference A-0398).

15. Seizure (sudden, uncontrolled body movements and changes in behavior that occur because of abnormal electrical activity in the brain) precautions care plan was not implemented by the ICU staff for 1 out of 42 sampled patients (Patient 206). (Cross Reference A-0398).

16. Equipment (Glucometers-blood glucose meter, Mayo stand-portable instrument tray, and air pump-to filter air) were not cleaned and maintained per policy and procedure in different areas of the hospital. (Cross Reference A-0398).

17. Blood specimens were not collected properly. (Cross Reference A-0398).

18. IV (intravenous-in the vein) sites were not labeled with the start dates per policy and procedure for 5 out of 42 sampled patients (Patient 604, Patient 607, Patient 615, Patient 616, and Patient 617). (Cross Reference A-0398).

19. Medications were left at the bedside for 2 out of 42 sampled patients (Patient 612 and Patient 616). (Cross Reference A-0398).

20. Pain assessment not performed per policy and procedure for one out of 42 sampled patients (Patient 604). (Cross Reference A-0398).

21. Sharps (needles and syringes) and supply carts containing sharps were not locked and secure in the emergency department (ED) and labor and delivery (L&D). (Cross Reference A-0398).

22. Physician orders were not followed for medication administration for two out of 42 sampled patients (Patient 1 and Patient 200). Patient 1 received 450 mEq (milliequivalents) of sodium bicarbonate (a medication used to treat metabolic acidosis [when too much acid accumulates in the body]) mixed in 3 liters of sterile water for irrigation (not for IV infusion or injection- the solution is hemolytic [the destruction of red blood cells which can cause serious harm and death]) through the IV, instead of the intended 150 mEq of sodium bicarbonate mixed in 1 liter of sterile water for IV infusion (an isotonic solution-neutral for cells in the body). Patient 1 went into cardiac arrest within 10 hours of receiving the sodium bicarbonate mixed in sterile water for irrigation, and died. Patient 200 received IV Precedex (a medication to manage pain and sedation in the ICU) which was not titrated according to the physician order and may have adversely affected Patient 200 by failing to properly sedate the patient. (Cross Reference A-0405).

13. Clinical Institute Withdrawal Assessment for Alcohol (CIWA) assessments were not performed per protocol for one out of 42 sampled patients (Patient 204). (Cross Reference A-0406).

14.Pharmaceutical services have not safely provided and meet the needs of each patient as evidenced by:(Cross Reference A-0489).

15. The hospital failed to implement all of its policies and procedures regarding the labeling of high alert medications, for 40 out of 40 sampled patients in the hospital's care systems (Cross Reference A-0491).

16. The hospital failed to have an adequate number of pharmacy staff to ensure that all of the tasks and work which had been required in order for the hospital to provide Pharmaceutical Services, had been put into place. This deficiency had the potential to affect 40 out of 40 sampled patients. (Cross Reference to A-0493).

17. The hospital failed to ensure that the hospital was following their policies and procedures for documenting expiration dates for medications (which had been prepared as intravenous drips and infusions). This deficiency had the potential to affect 40 out of 40 sampled patients. (Cross Reference to A-0501).

18. All drugs (any substance that is used to prevent, diagnose, treat, or relieve symptoms of a disease or abnormal condition) and biological's (a class of drugs that are produced using a living system, such as a microorganism, plant cell, or animal cell) were not securely stored and locked when lidocaine (a drug injected into the skin to reduce pain), epinephrine (a biological injected into the skin to reduce bleeding), and bupivacaine (a drug injected into the skin to reduce pain) were stored in an unlocked suture cart (a container on wheels) in the emergency department (ED). This failure had the potential to result in unauthorized staff, patients and visitors having unmonitored access to the drugs and biological's. (Cross Reference A-0502)


19. Expired medications were not available for patient administration. This deficiency had the potential to affect 40 out of 40 sampled patients. (Cross Reference to A-0505).

20 . The hospital failed to update and implement the hospital's policies and procedures for medications with hard stop dates that need to be reassessed periodically by the provider and as per ISPM High alert medication list.
This failure had the potential for patients to receive medications (which could be unsafe) for periods of time which were outside of the drug manufacturer's specifications. (Cross Reference A-0507)


21. The hospital failed to ensure that patients had been protected from medication errors and that these medication errors did not contribute to a patient's death, while under care of the hospital, during the course of each patient's stay. This deficiency had the potential to affect 40 out of 40 sampled patients. (Cross Reference to A -0508).

22. The hospital failed to ensure that the hospital had a local drug formulary (a drug formulary is a list of drugs covered under a hospital's health plan for the care and management of its patients), had been evaluated for each medication's effectiveness, risk, and the costs of the medications, which had been used by the hospital, for patient care. This included evaluating the risks, effectiveness, and costs of medications. The hospital also failed to follow their own policies and procedures regarding their drug formulary. This deficiency had the potential to affect 40 out of 40 sampled patients. (Cross Reference to A-0511).

The cumulative outcome of these failings meant the Governing Body did not ensure the safety and quality of care services were provided in the hospital.

Based on interview and record review, the Governing Body (GB) failed to ensure that 2 out of 2 contracted services provided in the hospital out-patient services were evaluated to ensure compliance with the Centers for Medicare & Medicaid Services (CMS) Conditions of Participation (COP) requirements and the evaluation(s) was/were documented.

This failure created the increased risk of substandard services being provided with no follow up and evaluation.

Findings:

During a review of facility document titled, "Actions by Written Consent of the Sole Director of (Name of hospital)" facility identified as Governing Board Bylaws, dated, "11/13/19", Further review of document, included on "pg 11 of 16,".... The Governing Board shall require the Medical Staff and staffs of the Hospital departments/services to implement and report on the activities and mechanisms for monitoring and evaluating the quality of patient care for identifying opportunities to improve patient care, and for identifying and resolving problems..."

During a review of facility State License dated, "6/1/22", indicated, "License to operate and maintain, Outpatient Services-Orthopedic Clinic, Outpatient Service - Wound Care."

During an interview on 5/23/23, starting at 10:45 a.m., QAPI (Quality Assurance Performance Improvement) Director (QAPI 1), while reviewing QAPI hospital activities, QAPI 1 was asked about out patient services, QAPI 1 stated, "We don't have any, this has not been happening, no activities." QAPI 1, confirmed out-patient services, identified on hospital license have not taken part in any assessment to identify quality or performance problems, and no on-going monitoring .

Based on interview and record review, the Governing Body (GB) failed to ensure that 15 out of 15 contracted services provided in the hospital were evaluated for safety, and effectiveness with documentation in place for follow up or improvement.


This failure had the potential for unsafe and ineffective services to continue with no monitoring and accountability placing patients at risk for poor quality and unsafe care.


Findings:


During a review of facility document titled, "Actions by Written Consent of the Sole Director of (Name of hospital)" facility identified as Governing Board Bylaws, dated, "11/13/19", pg. 14/16," included... "The Governing Board shall review at least annually (i) the quality of service rendered by hospital-based physicians and other professional service contractors, and (ii) the need for and selection of such hospital based physicians and professional service contractors."

During a concurrent interview and record review, on 5/25/23, starting at 12:27 p.m., with QAPI (Quality Assurance Performance Improvement) associate director (QAPI 2) , the facilities document titled, "Clinical Contract Services 2019 Evaluation, 2020 Report," "Purpose: To comply with (name of deeming organization) and Centers of Medicare and Medicaid (CMS) s 482. tag 83-85" was reviewed. Document contained 4 pages and a list of 15 contracted services/providers. QAPI 2 acknowledged that list has not been updated since 2020, that there are no quality performance measures being collected since 2020 report and the need to have GB to annually review, QAPI 2 stated, " Yes, I know I checked with (name of COO) and the last evaluation was in 2019."

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 Quality Assessment Performance Improvement QAPI program failed to focus on high-risk, high volume and problem prone areas within the pharmacy compounding environment and did not take actions aimed at performance improvement activities areas in the pharmacy within the hospital.
(Cross Reference A-0283).

3. 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).

4. The GB did not ensure documentation that the hospital conducted performance improvement projects, reflected of the scope and complexity of the hospital, when the QAPI program failed to focus on known high-risk, high volume and problem prone areas within the pharmacy compounding environment. As a result, opportunities for improvement were potentially missed and could result in adverse patient outcomes.
(Cross Reference A-0297)

5. The GB failed to be responsible for the implementation of the quality program. The GB failed to ensure that quality and safety data was correctly gathered and reported, including events monitoring medication errors interventions and unsafe environmental controls within the compounding area of the pharmacy. These high priorities, could affect the safety of the hospital patients and were not reviewed and discussed within the Quality Committee of the Governing Board, creating the risk of persistent poor practices and an unsafe environment.
(Cross Reference A-0309).


These failures, put patients at 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 to no developed comprehensive program that identified opportunities for improvement, 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, "3/16/22," indicated in part.... "7.7 Performance Improvement Plan Approvals Adoption. 7.7.1 This Organizational Performance Improvement Plan shall be annually reviewed, approved and adopted by the Governing Board, the Medical Staff acting through the Medical Executive Committee and organizational leaders."

During an interview on 5/23/23, starting at 10:45 a.m., with Quality Assurance and Performance Improvement Director (QAPI 1), while concurrently reviewing 2023 QAPI plans, measurements and data, QAPI 1 indicated the QAPI plan is a calendar year plan, and the department started annual QAPI activities and data collection in January 2023. When asked when the Governing Body (GB) or Medical Executive Committee had any input into the frequency and detail of data collection, QAPI 1 stated, "They have not". When asked about timing, in that QAPI Plan data indicated it had already been initiated and that these activities are already half way through the calendar year, QAPI 1 stated, " I understand, and we have plans to go to the next Medical Executive Committee to share."

Based on interviews and record reviews, the hospitals' Quality Assurance Performance Improvement- QAPI) program failed to:

1. Focus on "high-risk, high volume and problem prone," areas within the pharmacy compounding environment and did not take actions aimed at performance improvement .

2. When the hospital failed to ensure that sterile compounded intravenous (IV) medications (product made by the pharmacist is completely free of potentially hazadous contaminats, be they physical, chemical or microbiological) had been compounded consistent with USP 797 (United States Pharmacopeia standards in place governing the sterile preparation of compounding pharmaceuticals) standards. These standards which regulatory agencies, public health and board of pharmacy, review pharmacies for safe compounding (the process of combining, mixing, or altering ingredients to create medication tailored to the needs of an individual patient) practices. The chapter of USP 797 was developed to prevent: Patient harm and fatality from microbial contamination.

3.Review of the hospital's QAPI program, did not reveal the development or implementation of performance improvement activities that addressed these hospital known high risk, high -volume, and problem-prone areas in the pharmacy within the hospital.

These failures placed all patients requiring compounding medications at risk for poor quality care and possible harm with no systems/activities in place for analysis and monitoring.


Findings:

Review of the hospital's policy and procedure, dated 10/4/2018 , entitled: "Compounding RN (registered nurse) IV Piggyback or Infusion (a small bag of solution attached to a primary infusion line) Medication Admixture", reads: "USP 797 is a set of regulations issued by the US Pharmacopeia that governs any pharmacy that prepares admixture sterile products (ASPs). For the purposes of this policy, ASPs include intravenous medications prepared and given as piggybacks or infusions ...These regulations require ASPs be prepared in special clean-room (ISO class-5), ( a greater level of filtration to achieve cleanliness)."

Review of USP 797 states the following regarding environmental control: "Achieving and maintaining sterility and overall freedom from contamination of a Compounded Sterile Product (CSP) is dependent on the quality ...the process utilized ...and environmental conditions under which the process is performed ...The quality and control of environmental conditions for each risk level of operation are explained ...." Environmental condition for sterile compounding includes at least three elements: pressure, temperature, and humidity.

During a review of the hospital's intravenous (IV) compounding logs on 05/22/2023, at 11:15 am and interview with Pharmacist 1, he indicated that the Pharmacy adhere' s to USP 797.

Review of the hospital's Ante room area (pre-compounding area) and the hospital's non-hazardous [non-HD] area (a compounding area where non- dangerous drugs are made) revealed the following concerns:
a)The Ante room pressure was 0.0160 which was below the (0.020 to 0.050) pressure range which has been set by USP 797. The pressure gauge was lighted in red (which indicated that the alarm should have been making an audible sound), but the alarms had been set on silent and the director of pharmacy (DOP) was not aware that this feature (for an audible alarm) had been turned off. Pharmacy staff were unaware that this room had been alarming and no one from engineering had been notified and no work order had been submitted.
b)The Non-HD room pressure was 0.0523 which was above the (0.020 to 0.050) pressure range which has been set by USP 797. The pressure gauge was lighted in red (which indicated that the alarm should have been making an audible sound, but somehow the alarms had been set on silent and the DOP was not aware that this feature (for an audible alarm) had been turned off. Pharmacy staff were unaware that this room had been alarming and no one from engineering had been notified and no work order had been submitted.
c) Inspection of the Pharmacy's sterile compounding area Temperature (Temp) and Pressure logs revealed that both of these clean room areas had been out of compliance (with the hospital's policy and USP 797 standards) for quite some time.

Review of these logs and interview with the Pharmacist 2 on 5/22/2023 at 1:25 pm revealed that the Pharmacy staff have never been recording the room's humidity on a paper log for the sterile compounding areas rooms, in a subsequent interview with the DOP, he too confirmed that a humidity log had not been maintained by the Pharmacy for these clean room areas.

As outlined in USP 797: "Compounding facilities are physically designed and environmentally controlled to minimize airborne contamination from contacting critical sites. These facilities shall also provide comfortable and well-lighted working environment, which typically includes a temperature of 20 degrees Celsius (68 degrees Fahrenheit) or cooler ...For rooms providing a physical separation through the use of walls, doors, and pass-through's, a minimum differential positive pressure of 0.02 to 0.05 inch water column is required."

Review of the hospital's electronic humidity level records on 5/24/2023 at 12:00 pm revealed that from 5/13/2023 to 5/24/2023 the humidity in the Pharmacy's sterile compounding rooms had exceeded 60% Relative Humidity (RH- the amount of water vapor present in air expressed as percentage)) allowed by USP 797, despite this, the hospital's Pharmacy continued to compound patient IV medications without taking room's humidity (which must be taken into account), when evaluating the clean room's environment, when determining the Beyond Use Date (BUD) for these IV compounded medications.

Review of the hospital's electronic pressure level records on 5/24/2023 at 12:00 pm revealed that from 2/4/2023 to 5/24/2023 the pressure in the Pharmacy's sterile compounding rooms had regularly exceeded and fell below the 0.020 to 0.050 inch water column range outlined in USP 797.
Review of the hospital's electronic temperature level records on 5/24/2023 at 12:00 pm revealed that from 2/4/2023 to 5/24/2023 the temperature in the Pharmacy's sterile compounding rooms had regularly exceeded the 68 degrees Fahrenheit temperature outlined in USP 797.

During a interview on 5/24/23, starting at 5:30 p.m. with the director of pharmacy (DOP), DOP acknowledged compounding activities, with environmental controls for pressures, temperatures and humidity have not been "optimal" since "November (2022). Due to weather changes in January (2023), they have been especially problematic." DOP acknowledged that "compounding activities" could be high risk and high volume, and offered that facility carries out prescribed compounding activities, "about 10 times a day with a hospital census of 50-60 that would be considered high volume." DOP also acknowledged that problems with compounding activities have not been brought forward or discussed in Infection control /Pharmacy and Therapeutics Committee, Medical Executive Committee, QAPI Committee or Governing Board Committee.

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 include pharmacy and therapeutics committee oversight of medication errors and did not initiate a methodology for reassessing the performance improvement plan developed for concerns.

This failure resulted to no way of 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:


During a review of facility policy and procedure titled, "Medication Administration and Documentation," dated "4/27/23, revised", "page 31 of 32" indicated in part, "7.11 Medication Error Quality Assurance..."The Director of Pharmacy will review the individual errors and trends including analysis and corrective action plans with patient safety committee on a quarterly basis..."

During a concurrent pharmacy and therapeutic committee (P & T) review and interview with pharmacy director, on 5/24/23, starting at 5:05 p.m., committee minutes for September 2022, November 2022, and Febuary 2023, revealed total medication errors for that month plus total for last quarter segregated by sub categories of "administration, order communication, use, distribution and prescribing." Director of pharmacy while reviewing report acknowledged that data was collected without any plan or evidence of formal or informal implemented changes, director pharmacy stated, "No but I can see we should be doing this, I will work with (name of QAPI director) on this".

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 compounding environment.


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


Findings:


Review of facility document titled, "Performance Improvement Plan," dated, "3/16/22," "page 4/6," indicated in part... "Prioritization of performance improvement initiatives will be based upon the following criteria:
7.2.1 Patient safety
7.2.4 low/high volume of occurrence
7.2.5 High Risk
7.2.6 Problem prone occurrences
7.2.8 Regulatory implications..."

Review of the hospital's policy and procedure, dated 10/4/2018 , entitled: "Compounding RN IV Piggyback or Infusion Medication Admixture", reads: "USP 797 is a set of regulations issued by the US Pharmacopeia that governs any pharmacy that prepares admixture sterile products (ASPs). For the purposes of this policy, ASPs include intravenous medications prepared and given as piggybacks or infusions ...These regulations require ASPs be prepared in special clean-room (ISO class-5)."

USP 797 states the following regarding environmental control: "Achieving and maintaining sterility and overall freedom from contamination of a Compounded Sterile Product (CSP) is dependent on the quality ...the process utilized ...and environmental conditions under which the process is performed ...The quality and control of environmental conditions for each risk level of operation are explained ...." Environmental condition for sterile compounding includes at least three elements: pressure, temperature, and humidity.

Review of the hospital's electronic humidity level records on 5/24/2023 at 12:00 pm revealed that from 5/13/2023 to 5/24/2023 the humidity in the Pharmacy's sterile compounding rooms had exceeded 60% Relative Humidity (RH) allowed by USP 797, despite this, the hospital's Pharmacy continued to compound patient IV medications without taking room's humidity (which must be taken into account), when evaluating the clean room's environment, when determining the Beyond Use Date (BUD) for these IV compounded medications.
Review of the hospital's electronic pressure level records on 5/24/2023 at 12:00 pm revealed that from 2/4/2023 to 5/24/2023 the pressure in the Pharmacy's sterile compounding rooms had regularly exceeded and fell below the 0.020 to 0.050 inch water column range outlined in USP 797.
Review of the hospital's electronic temperature level records on 5/24/2023 at 12:00 pm revealed that from 2/4/2023 to 5/24/2023 the temperature in the Pharmacy's sterile compounding rooms had regularly exceeded the 68 degrees Fahrenheit temperature outlined in USP 797.

During a interview on 5/24/23, starting at 5:30 p.m. with the director of pharmacy (DOP), DOP acknowledged compounding activities with environmental controls for pressures, temperatures and humidity have not been "optimal" since "November (2022), and due to weather changes in January (2023) have been especially problematic." DOP acknowledged that "compounding activities" could be high risk and high volume, and offered that facility carries out prescribed compounding activities, "About 10 times a day, and with a hospital census of 50-60 that would be considered high volume." DOP also acknowledged that problems with compounding activities have not been brought forward or discussed in Infection control /Pharmacy and Therapeutics Committee, Medical Executive Committee, QAPI Committee or Governing Board Committee.

Based on interview and record review, the Governing Body (GB) failed to be responsible for the implementation of the quality program. The GB failed to ensure that quality and safety data was correctly gathered and reported, including events monitoring medication errors interventions and unsafe environmental controls within the compounding area of the pharmacy.

This failure could affect the safety of the hospital patients and were not reviewed and discussed within the Quality Committee of the Governing Board, creating the risk of persistent poor practices and an unsafe environment.


Findings:


Review of facility document titled, "Actions by Written Consent of the Sole Director of (Name of hospital)" facility identified as Governing Board Bylaws, dated, "11/13/19", "page 1-16," indicated in part... "The purpose of the Governing Board is to recommend and implement Hospital policy, promote patient safety and performance improvement, provide quality patient care, and provide for organizational management and planning of the hospital. The Governing Board has ultimate responsibility and legal authority for safety and quality of care."


Review of facility document titled, "Performance Improvement Plan," dated, "3/16/22," indicated in part.... "7.7 Performance Improvement Plan Approvals Adoption. 7.7.1 This Organizational Performance Improvement Plan shall be annually reviewed, approved and adopted by the Governing Board, the Medical Staff acting through the Medical Executive Committee and organizational leaders."

During a interview on 5/23/23, starting at 10:45 a.m., with QAPI Director (QAPI 1), while reviewing 2023 QAPI measurements and data, QAPI 1 indicated QAPI plan is a calendar year plan and the department started annual QAPI activities and data collection in January 2023. When asked when the Governing Body (GB) or Medical Executive Committee had any input into frequency and detail of data collection, QAPI 1 stated, "They have not". When asked about timing, in that QAPI Plan data indicated it had already been initiated and that these activities are already half way through the calendar year, QAPI 1 stated, " I understand, and we have plans to go to the next Medical Executive Committee to share."

Review of facility policy and procedure titled, "Medication Administration and Documentation", dated "4/27/23, revised, pg 31 of 32" indicated in part, "7.11 Medication Error Quality Assurance..."The Director of Pharmacy will review the individual errors and trends including analysis and corrective action plans with patient safety committee on a quarterly basis..."

During a concurrent pharmacy and therapeutic committee (P&T) minutes review and interview with pharmacy director (DOP), on 5/24/23, starting at 5:05 p.m., committee minutes for 9/22, 11/22 and 2/23 revealed total medication errors for that month plus total for last quarter segregated by sub categories of "administration, order communication, use, distribution and prescribing." DOP, while reviewing report acknowledged that data was collected without any plan or evidence of formal or informal implemented changes, pharmacy director stated, "No, but I can see we should be doing this, I will work with (name of QAPI director) on this".

Continued review of facility document titled "Performance Improvement plan," dated, "3/16/22,: indicated in part..."6.1 The Governing Board is responsible for establishing organizational Performance Improvement Program
6.1.1 The Governing Board has delegated to the Medical staff and Chief Executive Officer the responsibility for implementation of the program.
6.1.2 It is their duty to assure patient care is safely delivered within guidelines by medical staff and hospital leadership while meeting all hospital standards and regulations..."
6.1.4 The Governing Board requires the medical and organizational staff to implement and report on activities for identifying and evaluating opportunities to improve patient care and services throughout the organization.
6.3 The Organizational Leadership is responsible for creating an environment that promotes performance improvement through safe delivery of patient care, quality outcomes and high customer satisfaction..."

During a interview on 5/24/23, starting at 5:30 p.m. with the director of pharmacy (DOP), DOP acknowledged compounding activities with environmental controls for pressures, temperatures and humidity have not been "optimal" since "November (2022), and due to weather changes in January (2023) have been especially problematic." DOP acknowledged that "compounding activities (environmental controls)" could be high risk and high volume, and offered that facility carries out prescribed compounding activities, "about 10 times a day with a hospital census of 50-60 that would be considered high volume." DOP also acknowledged that problems with compounding activities have not been brought forward or discussed in Infection control /Pharmacy and Therapeutics Committee, Medical Executive Committee, QAPI Committee or Governing Board Committee.

During a interview on 5/23/23, starting at 3:30 p.m., with corporate operating officer (COO) and corporate executive officer (CEO), COO acknowledged awareness of compounding issues/problems, stated, " We were aware of the compounding issues and the problems with heat, humidity and pressure not being within range, not sure how long but have been working on the project for awhile." COO added that, "Working with corporate to get engineers to fix this, we have maybe been working with the wrong engineer, so I put a call into (name of State with corporate headquarter) and expect a call back at 4 p.m." CEO stated, "Yesterday is when I first became aware of this (compounding environmental non optimal controls)." CEO acknowledged outline of quality/safety committee oversight, that Governing Board delegates quality and pharmacy and therapeutics (P&T) activities to Medical Executive committees. Committee reports on a annual and quarterly move through committees up to Governing Board. CEO acknowledged that compounding environmental safety problems were never brought forward into P&T committee, Medical Executive Committee and that the Governing Board was not made aware.

The Condition of Participation is not met as:

Based on observation, interview, and record review, the hospital failed to ensure nursing services were provided in a safe manner, when hospital policies and procedures (P&P) and standards of practice were not followed when:

1.Care plans were not developed for 5 out of 42 sampled Patients (Patient 204, Patient 205, Patient 602, Patient 605, and Patient 609). (Cross Reference A-396).

2.Adult, Pediatric, and Infant Crash Carts (a cart stocked with emergency medical equipment, supplies, and drugs for use by medical personnel during efforts to resuscitate a patient experiencing cardiac arrest) in ICU (intensive care unit), DOU (direct observation unit), OSU (outpatient surgical unit), postoperative unit (post-op), L&D (labor and delivery), and medical surgical units, were checked to safeguard there were no expired supplies and equipment, and to ensure proper defibrillator (device that send an electric pulse or shock to the heart to restore a normal heartbeat) function, so as to be ready for use by registered nurses (RNs) during an emergency. (Cross Reference A-398).

3.Wrist restraints (physical device that immobilizes or reduces the ability of a patient to move) were not monitored for 1 out of 42 sampled patients (Patient 200). (Cross Reference A-398).

4.Procedure consent forms were incomplete for 3 out of 42 sampled patients (Patient 200, Patient 201, and Patient 202). (Cross Reference A-398).

5. Heparin medication (used to prevent blood clots from forming) was not administered according to high alert medication policy and procedure.
(Cross Reference A-398).

6. Seizure (sudden, uncontrolled body movements and changes in behavior that occur because of abnormal electrical activity in the brain) precautions care plan was not implemented by the ICU staff for 1 out of 42 sampled patients (Patient 206). (Cross Reference A-398).

7. Equipment (Glucometers-blood glucose meter, Mayo stand-portable instrument tray, and air pump-to filter air) were not cleaned and maintained per policy and procedure in different areas of the hospital. (Cross Reference A-398).

8. When blood specimens were not collected properly. (Cross Reference A-398).

9. When IV (intravenous-in the vein) sites were not labeled with the start dates per policy and procedure for 5 out of 42 sampled patients (Patient 604, Patient 607, Patient 615, Patient 616, and Patient 617). (Cross Reference A-398).

10. Medications were left at the bedside for 2 out of 42 sampled patients (Patient 612 and Patient 616). (Cross Reference A-398).

11. Pain assessment not performed per policy and procedure for one out of 42 sampled patients (Patient 604). (Cross Reference A-398).

12. Sharps (needles and syringes) and supply carts containing sharps were not locked and secure in the emergency department (ED) and labor and delivery (L&D). (Cross Reference A-398).

13. Physician orders were not followed for medication administration for two out of 42 sampled patients (Patient 1 and Patient 200). Patient 1 received 450 mEq (milliequivalents) of sodium bicarbonate (a medication used to treat metabolic acidosis [when too much acid accumulates in the body]) mixed in 3 liters of sterile water for irrigation (not for IV infusion or injection- the solution is hemolytic [the destruction of red blood cells which can cause serious harm and death]) through the IV, instead of the intended 150 mEq of sodium bicarbonate mixed in 1 liter of sterile water for IV infusion (an isotonic solution-neutral for cells in the body). Patient 1 went into cardiac arrest within 10 hours of receiving the sodium bicarbonate mixed in sterile water for irrigation, and died. Patient 200 received IV Precedex (a medication to manage pain and sedation in the ICU) which was not titrated according to the physician order and may have adversely affected Patient 200 by failing to properly sedate the patient. (Cross Reference A-405).

14. Clinical Institute Withdrawal Assessment for Alcohol (CIWA) assessments were performed per protocol for one out of 42 sampled patients (Patient 204). (Cross Reference A-406).

The cumulative effects of the hospital's systematic failure to follow policy and procedures, protocols, standards of practice, and physician orders for medication administration, resulted in the hospital's inability to ensure safe medication administration practices and the provision of safe patient care.

Based on interview and record review, the hospital failed to develop and update individualized, person-centered care for 5 patients out of 30 sampled patients when:

1.Care plan was not developed for pain for Patient 602 and Patient 605.

2.A patient centered care plan was not developed for Patient 609 at the time of admission.

3.No patient centered care plan was developed for Patient 204 after initial assessment.

4.Care plan for irregular heart beat problem was not developed for Patient 205.


These failures had the potential for unmet care needs for pain, patient centered care and irregular heart beat.


Findings:

1. During a concurrent record review and interview with the charge nurse (CN) of Medical/Surgical unit (Med/Surg) on 5/22/23 at 3:35 pm. Patient 602 had an order for Tylenol 650 milligrams by mouth every 4 hours for pain as necessary. Care plan for pain was not located. The CN acknowledged pain care plan was not initiated.

During a concurrent record review and interview with the charge nurse (CN) of Medical/Surgical unit (Med/Surg) on 5/23/23 at 9:30 am. Patient 605 had an order for Tramadol (medication use to treat pain) 50 milligrams by mouth every 4 hours as necessary for pain. Care plan for pain was not located. The CN acknowledged pain care plan was not initiated.

The facility polity and procedure titled "Plan Of Care, Interdisciplinary" dated 9/5/2019 indicated "Planning of care, treatments and services is individualized to meet the patient's unique needs.

2. During a concurrent record review and interview with the CN of Med/Surg on 5/23/23 at 11:15 am indicated, Patient 609 was admitted on 5/22/23 at 11:52 pm. An individualized care plan was not developed at the time of admission. The CN acknowledged that the care plan should have been initiated at the time of admission.

The facility policy and procedure title "Plan of Care, Interdisciplinary", dated 9/5/19, in the Procedures part 7.1 indicated "The registered nurse 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 provide for the patient's safety, comfort, hygiene and protection and for disease prevention and restorative measures."



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3. The facility policy and procedure title "Plan of Care, Interdisciplinary", dated 9/5/19, in the Procedures part 7.1 indicated "The registered nurse 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 provide for the patient's safety, comfort, hygiene and protection and for disease prevention and restorative measures."

During a concurrent review of Patient 204 clinical record and interview with quality risk coordinator (QRC) who was navigating the electronic record on 5/24/23 at 10:40 a.m., the record indicated patient was admitted on 5/23/23 at 4:41 a.m. The QRC indicated no care plans had been developed for this patient. No care plans were in the record. The initial assessment had been completed.

During a concurrent review of Patient 204 clinical record and interview with quality assurance performance improvement QAPI 2 on 5/24/23 at 11:00 a.m., QAPI 2 reached out to an informatics (computer expert) person to double check to ensure there were no care plans developed for this patient at all. After QAPI 2 communicating with the informatics person QAPI stated "Yes, the care plans should have been initiated or developed by the night RN and they were not done."

4. The facility policy and procedure title "Plan of Care, Interdisciplinary", dated 9/5/19, indicated "Purpose is to ensure that care, treatment ... are planned and appropriate to the patient's needs and severity of illness. Planning for care, treatment and services is individualized to meet the patient's unique needs. The interdisciplinary plan of care, treatment and services is based on needs identified by the patient's assessment, reassessment and results of diagnostic testing. The RN initiates the interdisciplinary plan of care after completion of the initial assessment ..."

During a concurrent review of Patient 205 clinical record and interview with QAPI 2 on 5/24/23 at 10:33 a.m., the admission history and physical, dated 5/21/23 at 5:23 p.m., indicated patient was found to have some bradycardia (low heart beat) with heart rate (HR) decreasing down as low as 27 (normal HR 60-100 beats per minute). History of atrial fibrillation (irregular heartbeat) taking digoxin medication at home. Digoxin used to treat abnormal heart rhythms (arrhythmias), including atrial fibrillation, as part of a treatment plan to slow the heart rate. Patient's digoxin level was 4.4. Therapeutic levels of digoxin are 0.8-2.0 nanograms (ng) per milliliter (mL). The toxic level is greater >2.4 ng/mL. No cardiac monitoring/treatment care plan was developed for this patient. The QAPI 2 acknowledged and agreed a care plan to address this cardiac (heart) problem should be developed for RNs to monitor possible negative side effects of digoxin toxicity. QAPI stated "I agree the RN should have develop a care plan to address the cardiac problem."

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

1.The intensive care unit (ICU) pediatrics crash cart (a cart stocked with emergency medical equipment, supplies, and drugs for use by medical personnel during efforts to resuscitate a patient experiencing cardiac arrest) was checked to safeguard there was no expired supplies ready to be used by registered nurses (RNs) during an emergency.

2.Patient 200 wrist restraints (physical device that immobilizes or reduces the ability of a patient to move) were monitor as per their policy and procedure.

3. Staff completed the procedure consent forms for three of three sampled patients (Patient 200, 201 and 202).

4.Direct observation unit (DOU) crash cart was checked to safeguard there was no expired defibrillator pads ready to be use.

5. Patient 206 seizures (sudden, uncontrolled body movements and changes in behavior that occur because of abnormal electrical activity in the brain) precautions care plan was implemented by the ICU staff.

6. The crash cart defibrillator (device that send an electric pulse or shock to the heart to restore a normal heartbeat) functioning was checked as per policy and procedure in the ICU and DOU.

7. Glucometer (blood glucose meter) was cleaned as per their policy and procedure.

8. Staff collected blood specimen tube appropriately.

9. The crash cart defibrillator functioning was checked as per policy and procedure in the Postoperative (Post-op) and the Outpatient Surgical Unit (OSU).

10. Intravenous IV sites for Patients 615, 607, 604, 616 and 617 were labeled with the start date as per policy and procedure.

11. Staff did not leave Patient 616 medications at bedside.

12. Staff performed pain assessment as per policy and procedure for Patient 604.

13. The crash cart defibrillator functioning was checked as per policy and procedure in the Medical surgical unit.

14. Staff adhered to standard precautions (infection control practices) while administering intravenous ((IV) into a vein) medication to a patient in the Emergency Department (ED).

15. Staff kept the ED Triage (the sorting of and allocation of treatment to patients) room clean between patients.

16. Staff removed expired supplies from the ED Clean Storage room. -

17. Staff checked the nursery crash cart on the labor and delivery (L&D) unit to safeguard there was no expired supplies ready to be used by RNs during an emergency.

18. Staff checked the supply cart was locked on L&D, in the (after) post-anesthesia care unit (PACU).

These failures placed patients at risk of not receiving the appropriate care as per care plans, assessments, monitoring of restraints and the lack of completed consents, checking the emergency carts and equipment has the potential of resulting in injury, harm and possible death thus jeopardizing the quality of patient care.

Findings:

1.During a concurrent observation of the ICU pediatric crash cart and interview with charge nurse (CN 1) on 5/22/23 at 4:00 p.m., the CN indicated this cart contains supplies that are ready to be used during a pediatric code blue (event requiring immediate resuscitation). The charge nurse is responsible to check this crash cart. Furthermore, the CN 1 indicated RNs do not check for expiration dates on supplies during an emergent event like a code blue.

The cart's drawers were opened one by one, and the following supplies were noted to be expired, package opened or unsanitized:
a) Seven (7) laryngeal mask airways (LMA) used as a temporary method to maintain an open airway during immediate life-saving measure in a patient with a difficult or failed airway. Most LMAs expiration year was 2017.
b) Eight (8) endotracheal tube (ETT) a tube that is placed between the vocal cords through the trachea (windpipe) to provide oxygen and inhaled gases to the lungs. All ETTs expired in 2017.
c) Fourteen (14) intravenous start kits (IV-kit). Single-use sterile IV Start Kit includes supplies for IV catheter site preparation and dressing change: Tegaderm (transparent medical dressing) Dressing, ChloraPrep (skin disinfectant), latex-free tourniquet, gauze dressing, medical tape, and site label. IV kits expired in 2017.
d) Four (4) foley catheters -soft, plastic or rubber tube that is inserted into the bladder to drain the urine. Foleys expired in 2019.
e) Four (4) Trocars - used to access and drain collections of fluid from the body. Trocars expired in 2018.
f) Six (6) peripheral IV angio catheters- a thin plastic tube inserted into a vein using a needle for administration of medications or fluids. IV angiocaths expired in 2017.
g) Eight (8) butterfly peripheral IV angio-catheters- a thin plastic tube inserted into a vein using a needle for administration of medications or fluids. Butterfly angiocaths expired in 2017 and 2018.
h) Two (2) Carbon Dioxide (colorless, odorless gas) CO2 detectors- used as an important indicator to confirm the correct placement of an endotracheal tube (ETT) after intubation. Detectors expired in 5/11/23.
i) One (1) intubation stylet- small, malleable plastic-coated metal rod most used in endotracheal (ETT) devices for intubation. Expired in 2021.
j) Four (4) lubricating jelly- non-irritating, non-sensitizing and unscented lubricant used for a wide variety of routine medical procedures. Lubricants expired on 2/23/22.
k) Two (2) opened packages with oropharyngeal airways -oral airway to maintain or open the airway by stopping the tongue from covering the epiglottis (a flap of cartilage at the root of the tongue).
l) Four (4) oral airways (airway adjunct used in airway management to maintain or open a patient's airway) uncovered or packaged thus unsanitized.
During a concurrent observation of the supplies inside the crash cart and interview with QAPI 2 on 5/22/23 at 4:35 p.m., the QAPI 2 acknowledged and agreed the crash cart should not contain expired, opened package and unsanitized supplies which were ready to be used in case of an emergency or a code blue. Furthermore, acknowledged this is no good for patients or patient care.

The facility policy procedure titled "Bulk Stores-General Organization" dated 7/7/97 indicated "All supply items are to be stored so as to ensure that the oldest items are used first. All supply items should be reviewed weekly and upon issuance in respect to expiration dates. All expired items will be immediately removed from the storage location and place in a holding area until proper disposition can be made."


2.The facility policy and procedure titled "Restraint and Seclusion", dated 6/10/22 indicated "The order must be obtained either during the emergency application of restraints or immediately after the restraint has been applied. Restraints orders must be renewed on a daily basis. Non-violent or medical support restraint consider 2-point restraints (wrist tied with soft cloth straps) first. RN assessments are documented under restraint flowsheet following the observation and monitoring guidelines. a) a description of the patients' behavior and intervention used. b) alternatives or other less restrictive interventions attempted. d) the patient's response to the interventions used, including the rationale for continued use of restraints. i) behavior. j) mental status. k) cognitive functioning. l) elimination needs ..."

During a tour of the ICU on 5/22/23 at 4:15 p.m., patient 200 was observed with bilateral soft wrist restraints. During a follow up observation of patient 200 on 5/23/23 at 11:00 a.m., patient was observed with wrist restraints again.

During a concurrent Patient 200 record review and interview with QAPI 2 on 5/3/23 at 11:34 a.m. the following was noted in the record:
a) There was no physician's order for the use of restraints for 5/2/23, 5/5/23, 5/14/23, 5/15/23, 5/18/23 however
patient's restraints documentation flow sheet indicated patient was restrained on these days.
b) There was no documentation for the reason for the restraint and alternatives attempted on the restraint flow sheet for 42 hours from 5/2/23 midnight to 5/4/23 at 6:00 p.m.
c) There was no documentation on the flow sheet for the type of restraints used on 5/4/23 for 8 hours from 10:00 a.m., to 6:00 p.m., And no documentation for the use of the restraints for 16 hours from 5/4/23 at 8:00 a.m., to 5/5/23 midnight.
d) There was no documentation on the restraint flowsheet for behavior for 16 hours from 5/4/23 at 10:00 a.m., to 5/5/23 at 2:00 a.m.
e) There was no documentation on the restraint flowsheet for the type of restraints used and the reason for the restraints for 38 hours from 5/5/23 at 6:00 a.m., to 5/6/23 at 8:00 p.m. On 5/16/23 for 8 hours from midnight to 8:00 a.m. On 5/18/23 for 8 hours from 10:00 a.m., to 6:00 p.m.
f) There was no documentation on the restraints flow sheet for the reason to use the restraint for 18 hours on 5/8/23 from 2:00 a.m., to 8: p.m. on 5/10/23 for 10 hours from 8:00 a.m., to 6:00 p.m. On 5/12/23 for 14 hours from 6:00 p.m., to 8:00 a.m. On 5/22/23 for 8 hours from 4:00 p.m., to midnight.
g) There was no documentation on the restraint flow sheet for hydration and elimination for 8 hours on 5/22/23 from 10:00 p.m., to 5/23/23 at 6:00 a.m.
The QAPI 2 acknowledged the restraints lack of documentation in the clinical record, confirmed there was no physician order for the restraints on these dates (5/2/23, 5/5/23, 5/14/23, 5/15/23, 5/18/23) and agreed the restraints on this patient was not monitor as per the policy and procedure.

3. a) A review of the facility policy and procedure titled "Inform Consent", dated 9/29/20 indicated "Informed consent should be obtained for all invasive procedures including: All surgical procedures ... Bedside invasive procedures ... Any diagnostic or therapeutic treatment with some risk involved. Complete the consent forms "Consent to Surgery/Special procedures" with respective providers (name)."

During a concurrent review of patient 200 medical record an interview with QAPI 2 on 5/23/23 at 8:56 a.m., the consent form for the procedure tracheostomy (tube inserted into trachea to push air into lungs), dated 5/16/23 and arterial line insertion (plastic catheter into artery to monitor arterial pressures), dated 5/9/23 were noted to be missing the name of the physician performing the procedure. The QAPI 2 acknowledged and agreed the consent forms must have the name of the physician performing the procedure and on these 2 consents the name of the physician was missing.

b) A review of the facility policy and procedure titled "Inform Consent", dated 9/29/20 indicated "Informed consent should be obtained for all invasive procedures including: All surgical procedures ... Bedside invasive procedures ... Any diagnostic or therapeutic treatment with some risk involved. The time and date on the form should be written and the date the form is signed by the patient ..."

During a concurrent review of patient 201 medical record an interview with registered nurse LN 2 on 5/23/23 at 11:24 a.m., the consent form for chest tube placement (tube placed into lungs to drain fluid out), dated 5/22/23 was noted to be missing the date and time the consent form was signed. LN 2 stated "I forgot to write the date and time this consent form was signed."

c) A review of the facility policy and procedure titled "Inform Consent", dated 9/29/20 indicated "Informed consent should be obtained for all invasive procedures including: All surgical procedures ... Bedside invasive procedures ... Any diagnostic or therapeutic treatment with some risk involved. The planned procedure ... and type of anesthesia (loss of feeling or awareness caused by drugs or other substances) should be written on the respective consent form ..."

During a concurrent review of patient 202 medical record an interview with QAPI 2 on 5/23/23 at 11:00 a.m., the consent form for anesthesia services dated 5/21/23 was noted to be missing the type of anesthesia that will be use. The QAPI acknowledged and confirmed the consent form must indicate the type of anesthesia that will be used, and this consent form is missing the type of anesthesia the anesthesiologist (doctor who has special training in giving drugs or other agents to prevent or relieve pain during surgery or other procedures) will be using.

4. A review of facility policy and procedure titled "Emergency Crash Cart Contents and Integrity", titled 2/4/16 indicated "It is the policy ... that contents of emergency crash cart should be maintained in a manner so that they are immediately available for response in a life-threatening emergency.

During a concurrent inspection of the DOU crash cart and interview with QAPI 2 on 5/22/23 at 4:38 p.m., two defibrillator pads (an essential part of an automated external defibrillator to treat a sudden cardiac arrest emergency) with the expiration date of 4/29/23 were observed on top of the crash cart ready to be use. The QAPI acknowledge the observation and agreed that expired defibrillator pads should not be on top of the crash cart.

5. The facility policy and procedure titled "Plan of Care, Interdisciplinary", dated 9/5/19, indicated "Purpose is to ensure that care, treatment ... are planned and appropriate to the patient's needs and severity of illness. To identify individualized patient care goals and interventions to achieve those goals in a collaborative interdisciplinary manner." In the Procedures part indicated "If the identified problem is not printed on the Interdisciplinary Plan of Care, then the individualized problem/intervention/outcome will be entered under the correct heading in the blank spaces provided (i.e., case management, mobility, nutrition, etc.)

During a concurrent observation, review of Patient 206 record and interview with QAPI 2 on 5/24/23 at 10:04 a.m. the record indicated patient was diagnosed with a brain bleed and had seizures. Patient was observed with no seizure precautions i.e., padded side rails, cushions etc. QAPI 2 was asked what were the seizure interventions that were implemented for this patient to prevent physical harm if the patient has a seizure because none were observed. QAPI acknowledged and agreed there are no seizure interventions implemented on this patient. The seizure care plan, dated 5/19/23 at 11:19 p.m., was review however the care plan lacked interventions to prevent patient harm in case of a seizure occurred.

During a concurrent observation of Patient 206 and interview with registered nurse (LN 4) caring for patient on 5/24/23 at 10:20 a.m., LN 4 was asked what were the seizure interventions that were being applied for this patient to prevent physical harm in case a seizure occurred. LN 4 was not able to verbalize and/or demonstrate the seizure interventions for this patient. Furthermore, LN 4 stated "There is no area in the computer to document the specific seizure interventions on the Seizure care plan. I am not aware of any policy indicating that specific interventions for seizures need to be implemented."

6. A review of facility policy and procedure titled "Emergency Crash Cart Contents and Integrity", titled 2/4/16 indicated "It is the policy ... emergency crash cart should be maintained in a manner so that they are immediately available for response in a life-threatening emergency ... The assigned staff member, using the correct power setting per the manufacturer's recommendations, shall test the defibrillator once every 24 hours. The assigned staff member, using a rate of 70, should verify the presence of pacer spikes (vertical signals that represent the electrical activity of the pacemaker) once every 24 hours and document on the crash cart checklist ... Check the defibrillator for proper operation ..."

During a concurrent inspection of the crash carts for the ICU and DOU and interview with the charge nurse (CN) on 5/22/23 at 3:40 p.m., the CN reported the crash cart defibrillator is only manually tested weekly on Wednesdays. The ICU and DOU daily crash cart check documents for April and May 2023 indicated the defibrillator was tested for functionality only on Wednesdays.

During a concurrent review of ICU and DOU daily crash cart checklist documents for April and May 2023 and interview with QAPI 2 on 5/23/23 at 10:07 a.m., QAPI 2 was made aware that their policy and procedure indicated the defibrillator will be tested every 24 hours for functionality and this is not occurring in the ICU and DOU. QAPI stated "Yes, we must check that the defibrillator is tested every 24 hours."

During a concurrent review of the crash cart policy and interview with the chief nurse officer CNO on 5/23/23 at 5:41 p.m., the CNO was made aware the crash cart check practice does not reflect their current policy. CNO stated "No, we do not have a policy indicating the new defibrillator does its own internal check and that RNs can only do a manual defibrillator check/test every Wednesday."





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7. During an interview on 5/22/23, at 3:40 p.m., with the licensed nurse (LN 5), in postoperative (Post-op), area, LN 5 stated I use the purple top Sani wipes (Super Sani-Cloth Germicidal Disposable Wipes) to clean and disinfect the glucometer and stated I just let it dry for 1 minute. LN 5 could not verbalize the 2-minute contact time of the wipes.

During an interview on 5/22/23, at 3:45 p.m., with LN 6, in Post-op, LN 6 stated I use the purple top Sani wipes to clean and disinfect the glucometer. LN 6 also stated, it dry's in 14 seconds. LN 6 could not verbalize the 2-minute contact time of the wipes.

During a review of the manufacturer's (MIFU's) for the Accu-Chek Inform II Glucometer indicated in part ... "Approved cleaning and disinfecting products: We recommend Super Sani-Cloth Germicidal Disposable Wipes..."

During a review of the product label for Super Sani-Cloth Germicidal Disposable Wipes indicated in part ... "Cleaning procedure: All blood and other body fluids must be thoroughly cleaned from surfaces ... before disinfection by the germicidal wipe ... Contact time: Use second germicidal wipe to thoroughly wet surface. Allow surface to remain wet two (2) minutes, let air dry."

During an interview on 5/22/23, at 4:00 p.m., with the director of peri-op (DPO), DPO acknowledged. the glucometer was not being cleaned and disinfected according to the MIFU's and wipes directions and it should be. DPO further acknowledged, Super Sani-Cloth Germicidal Disposable Wipes have a contact time of 2 minutes.

8. During a review of the facility's policy and procedure (P&P) titled, "Phlebotomy Procedure," revised 2/2023, the P&P indicated, "Specimen Collection ... Fill all tubes to the manufacturer's fill line. Gently invert all tubes 5-10 times after filling."

During an observation and concurrent interview, on 5/23/23, at 10 a.m., with licensed nurse (LN 9) and the Director Peri-op (DPO), LN 9 did not invert tube after blood draw form Patient (N406) in preoperative (Pre-op) area. DPO confirmed LN9 did not invert tube.

9.. During a review of the facility's policy and procedure (P&P) titled " Emergency Crash Cart Contents and Integrity," dated 2/4/2016 indicated, "the assigned staff member using the correct power setting per the manufacturer's recommendations, shall test the defibrillator once every 24 hours. The assigned staff member, using a rate of 70, shall verify the presence of pacer spikes once every 24 hours and document on crash cart checklist.

During a concurrent observation and interview, on 5/22/23, at 3:45 p.m., in Preoperative (post-op) area, with licensed nurse (LN 5), LN 5 stated manual testing is done every Wednesday not every day.

During a concurrent observation and interview, on 5/22/23, at 4:25 p.m., in Outpatient Surgical Unit (OSU), with LN 6, LN 6 stated manual testing is done every Wednesday not every day.

During a concurrent interview and record review, on 5/23/23, at 8:45 a.m., with the Director Peri-op (DPO), DPO confirmed the defibrillator is manually tested every Wednesday not every day. Additionally, DPO stated staff are not following the crash cart policy.







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10. During a tour of the Medical and Surgical (Med/Surg) unit with the director of inpatient services (DIS) on 5/22/23 at 11:15 am, Patient 615 was observed to have an intravenous (IV) site (a port used to deliver medication) on the right forearm, no start date label was on the IV site. The DIS acknowledged there was no date on the IV site.

During a tour of the Medical and Surgical (Med/Surg) unit with the director of inpatient services (DIS) on 5/22/23 at 11:25 am, Patient 607 was observed to have an intravenous (IV) site (a port use to deliver medication) on the left forearm, no start date label was on the IV site. The DIS acknowledged there was no date on the IV site.

During a tour of the Medical and Surgical (Med/Surg) unit with the director of inpatient services (DIS) on 5/22/23 at 11:30 am, Patient 604 was observed to have an intravenous (IV) site (a port use to deliver medication) on the right forearm, no start date label was on the IV site. The DIS acknowledged there was no date on the IV site.

During a tour of the Medical and Surgical (Med/Surg) unit with the director of inpatient services (DIS) on 5/22/23 at 11:33 am, Patient 616 was observed to have an intravenous (IV) site (a port use to deliver medication) on the left forearm, no start date label was on the IV site. The DIS acknowledged there was no date on the IV site.

During a tour of the Medical and Surgical (Med/Surg) unit with the director of inpatient services (DIS) on 5/22/23 at 12:15 pm, Patient 617 was observed to have an intravenous (IV) site (a port use to deliver medication) on the left forearm, no start date label was on the IV site. The DIS acknowledged there was no date on the IV site.

The facility policy and procedure titled " Clinical Guidelines: Venous Access Device ( a tube or port used to deliver mediction): Prevention, Insertion And Maintenance" dated 6/2020 indicates "check for system integrity, infusion accuracy, and expiration dates (infusion dressing and administration set) at least every shift.

11. During a tour of the Medical and Surgical (Med/Surg) unit with the director of inpatient services (DIS) on 5/22/23 at 11:30 am, an ethanol nasal swab ( used to disinfect the nose) was observed left on the Patient 616's bedside table. The DIS acknowledged and indicated no medications should be left in the patient's room.

During a tour of the Medical and Surgical (Med/Surg) unit with the director of inpatient services (DIS) on 5/22/23 at 11:50 am, a tube of open nystatin cream (an antifungal) was observed left on the Patient 616's shelf. The DIS acknowledged and indicated no medications should be left in the patient's room.

The facility policy and procedure titled "Medication Storage and Security" dated 10/10/2018 indicated, "all drugs and biologicals are kept in a secure area and locked when necessary."

12. the facility policy and procedure titled "Pain management" dated 10/2022 indicates "A comprehensive pain assessment is conducted as appropriate to the patient's condition and the scope of care, treatment and services provided.

During a concurrent review of Patient 604's electronic medication records and interview on 5/22/23 at 4 pm. The patient was given Percocet (an pain medication) 1 tablet by mouth without a premedication pain assessment on 5/20/23 at 6:35 pm. The charge nurse (CN2) acknowledged pain assessment was not recorded.

13. the facility policy and procedure titled " Emergency Crash Cart Contents and Integrity" dated 2/4/2016 indicates "the assigned staff member using the correct power setting per the manufacturer's recommendations, shall test the defibrillator once every 24 hours. The assigned staff member, using a rate of 70, shall verify the presence of pacer spikes once every 24 hours and document on crash cart checklist.

During a concurrent review and interview with the charge nurse (CN2) and the director of inpatient services (DIS) on 5/23/23 at 8:57 am. Review of the crash cart daily check log indicates manual testing is done every Wednesday. The CN indicates they don't do manual checking every day. The DIS indicated the whole hospital is doing manual checks every Wednesday.


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14. During a concurrent observation and interview on 5/24/23, starting at 9:45 a.m., with LN7, in ED patient room 3, LN10 was observed to administer Magnesium Sulfate (asthma medication) by IV piggyback (type of infusion) and Toradol (pain medication) by IV bolus (type of infusion) without wearing gloves. LN7 verified no gloves were worn by LN10 and stated gloves were not needed if there was no blood contact expected.

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."

Review of the Centers for Disease Control and Prevention (CDC) website, https://www.cdc.gov/infectioncontrol/guidelines/isolation/recommendations.html#iv, accessed 6/2/23, 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."

15. During a concurrent observation and interview on 5/22/23, starting at 11 a.m., with LN7, in the ED Triage room 2:
a) Mayo stand (a small portable table that can be positioned close to the patient during procedures) had a reddish-brown stain on the table portion of the stand. LN7 stated, "Looks like dried blood." LN7 further stated it's not clean.
b) Air purifier next to the patient chair had built up fluffy grey matter covering the air intake grill. LN7 stated, "Looks like dust." LN7 further stated it's not clean.

During a review of the facility's policy and procedure (P&P) titled, "Triage," dated 10/1/20, the P&P indicated, "Triage Room Cleaning ... The triage room will be cleaned daily by Environment of Care Services ... Patient care surfaces will be cleaned between each patient using a hospital approved germicidal agent."

16. During a concurrent observation and interview on 5/22/23, starting at 3:22 p.m., with LN7, in the ED Clean Storage room, Sterile Water for inhalation marked with an expiration date of 2/3/23 was available for patient use. LN7 stated, "Expired." LN7 further stated it should have been removed from the area.

During a review of the facility's P&P titled, "Bulk Stores - General Organization," dated 2/16/05, the P&P indicated, "All expired items will be immediately removed from the storage location and placed in a holding area until proper disposition can be made."


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17. During a review of the facility's policy and procedure titled, "Bulk Stores-General Organization," revised date 2/16/05 indicated in part ... "It is the responsibility of the Director of Material Management and the department's personnel staff to ensure that the proper rotation of all supply items is maintained ...all supply items are to be stored so as to ensure that the oldest items are used first ...all expired items will be immediately removed from the storage location and placed in a holding area until proper disposition can be made ..."

During a concurrent observation and interview on 5/22/23, at 3:42 p.m., with the director of the perinatal services (PSD), during a tour of the nursery on the labor and delivery unit (L&D), the following supplies were expired in the infant crash cart:

A. One 3.0 mm (millimeter) endotracheal tube (ETT) (a device placed into the lung to assist breathing) expired on 2/28/22
B. One 3.5 mm ETT expired on 6/28/22
C. One 4.0 mm ETT expired on 4/28/22
D. One CO2 detector (a device that measures carbon dioxide and ensures correct ETT tube placement) expired on 1/28/21
E. One Miller 00 laryngoscope and blade (a device used to see into your throat and vocal cords for ETT placement) expired on 3/21
F. One Miller 0 laryngoscope and blade expired on 11/22
G. One Miller 1 laryngoscope and blade expired on 7/22
H. One 8f (french size measures diameter of the tube) feeding tube expired on 11/22
I. One 10 ml (milliliter) feeding tube syringe expired on 5/21
J. One blood culture collection bottle expired on 3/31/23
K. One bulb syringe expired on 7/1/22
L. One duoderm dressing expired on 6/21
M. One laryngeal mask air way (LMA) (a device that keeps the airway open) and One bag valve mask (Ambu bag) (a hand-held manual resuscitator device to provide ventilation to patients who are not breathing) were also expired.

The PSD acknowledged that the supplies in the crash cart were expired and should not be, and further acknowledged the supplies were not ready for use.

During a review of the facility's policy and procedure titled, "Disposable Items," revised date 5/19 indicated in part ... "It is the policy to follow manufacturer guidelines for the storage, handling, and use of disposable items ...items must not have reached expiration date ...if items have reached the expiration date, it is not to be used and returned to materials Management for proper disposal ..."

18. During a review of the facility's policy and procedure titled, "Bulk Stores-General Organization," revised date 2/16/05 indicated in part ... "It is the responsibility of the Director of Material Management and the department's personnel staff to ensure that the materials stored in the bulk stores' area are properly organized, secured, and maintained ... It is the responsibility of the Director of Material Management and the department's personnel staff to ensure that proper security procedures are established and enforced ... "

During a concurrent observation and interview on 5/22/23, at 1:05 p.m., with the director of the perinatal services (PSD), during a tour of the post-anesthesia care unit (PACU) on labor and delivery (L&D), a supply cart which contained needles, syringes, and various other supplies, was observed to be unlocked. The PSD acknowledged the PACU supply cart should be locked and verbalized it is the operating room (OR) nurse's responsibility to keep the supply cart locked.

During a review of the facility's policy and procedure titled, "Disposable Items," revised date 5/19 indicated in part ... "It is the policy to follow manufacturer guidelines for the storage, handling, and use of disposable items ...disposable items are to be stored in Materials management until stocked in the individual departments, separate from contaminated supplies ...disposable items are handled so that the integrity of the packaging and the product itself is not damaged before being used ..."

Based on interview and record review, the facility failed to follow policy and procedures and standards of practice for medication administration for 2 out of 42 sampled patients (Patient 1 and Patient 200) when:

1. Patient 1 received 450 mEq (milliequivalents) of sodium bicarbonate (a medication used to treat metabolic acidosis when too much acid accumulates in the body) in 3 liters of sterile water for irrigation (not for IV infusion or injection- the solution is hemolytic which causes destruction of red blood cells which can cause serious harm and death) instead of the intended 150 mEq of sodium bicarbonate mixed in 1 liter of sterile water for IV infusion (an isotonic solution-neutral for cells in the body) per physician order.

2. Physician orders were not followed for the titration of the IV (intravenous-in the vein) medication Precedex (a medication to manage pain and sedation in the ICU) for Patient 200.

These facility failures resulted in nurses not following physician orders. This resulted in a medication administration error for Patient 1. The medication error may have contributed to Patient 1 going into cardiac arrest within 10 hours of receiving the sodium bicarbonate in sterile water for irrigation, and died. These failures may have adversely affected Patient 200 by failing to properly sedate the patient.

Findings:

1. During a review of Patient 1's "ED (emergency department) Physician Notes," dated 3/25/2023, the physician notes indicated, Patient 1, a 57-year-old, was brought into the ED by ambulance who had been complaining of buttock and back pain after falling to the ground at work 5 days ago. The buttock and lower back pain were worsening, and Patient 1 was having increased weakness in the lower legs. Patient 1 sustained another fall that evening. The ambulance was called to bring Patient 1 to the ED. Upon arrival to the ED Patient 1 had a blood sugar of greater than 600 with uncontrolled diabetes (a disease that results in too much sugar in the blood) was alert and talking. The ED physician (MD 1) ordered a CT (computerized tomography scan takes a series of x-rays to diagnose a problem) scan of Patient 1's back to see if any injury after the fall. During the CT scan, Patient 1 had altered mental status and became nonresponsive, and a rapid response was called. Patient 1 still had a pulse with decreased respiratory drive and was brought back to the ED and was intubated (a tube inserted into the lungs to help with breathing). The ED Physician Notes further indicated Patient 1 had severe hyperglycemia (high blood sugar) with the labs showing a blood sugar of 946, acidemia (too much acid in the blood), and was in hyperosmolar nonketotic state (a dangerous condition resulting from very high blood sugar levels). Patient 1 was critically ill and was to be admitted to the ICU.

During an interview on 5/24/23, at 9:08 a.m., with the quality director (QAPI 1), QAPI 1 verbalized Patient 1 came to the ED on 3/25/23 at 1:45 a.m. QAPI 1 verbalized when Patient 1 was in the CT, Patient 1 became unresponsive and had difficulty breathing. A rapid response was called, and Patient 1 was taken back to the ED and was intubated. QAPI 1 verbalized the house supervisor (HS 1) had come to help in the ED and was assisting with the rapid response. QAPI 1 verbalized the ED physician needed help writing orders for the sodium bicarbonate IV solution. QAPI 1 verbalized a second physician, a hospitalist (MD 2) was also in the ED and wrote the order for the sodium bicarbonate solution. QAPI 1 verbalized HS 1 overheard the sodium bicarbonate order and would need to call the on-call pharmacist to come in and prepare the IV solution. QAPI 1 verbalized the pharmacy closes at night and a pharmacist is on-call for the hospital. QAPI 1 verbalized HS 1 called the on-call pharmacist (PH 1) twice and had no response. QAPI 1 verbalized HS 1 took it upon herself to prepare the IV solution. QAPI 1 verbalized HS 1 should have followed the chain of command when not being able to get a hold of the on-call pharmacist. QAPI 1 verbalized the next step would have been for HS 1 to call the director of pharmacy and the administrator on call, and further verbalized they were not notified.

During an interview on 5/24/23, at 4:26 p.m., with the pharmacist (PH 1), PH 1 verbalized being the pharmacist on-call on 3/25/23. PH 1 verbalized remembering the Omnicell being down and not on override and further verbalized if not on override, medications need to be verified. When asked if remembered getting a phone call from HS 1 that night, PH 1 verbalized did not remember. PH 1 was informed HS 1 called twice and sent a text message. PH 1 stated, "I don't know why she could not get a hold of me." PH 1 verbalized seeing a missed call from HS 1 the next morning and a missed text the next morning. PH 1 verbalized his wife's number is also on the call list and is listed as a second phone number to call. PH 1 verbalized she did not get a phone call that night. PH 1 stated, "If HS 1 could not get a hold of me then I would assume she would call the director of pharmacy (DOP) or another pharmacist." PH 1 verbalized typically if on-call, and an order for an IV solution is to be made, then would need to come to the facility to make it.

During a review of the facility's policy and procedure (P&P) titled, "Chain of Command: Medical Staff and Hospital Employees", revised 4/28/21, the P&P indicated in part, ... "The purpose of this policy is to promote quality patient care when conflicts between disciplines arise ...Call MD: place call to the physician, document in medical record, if no answer, go to next step ...verify concern with charge nurse or house supervisor, if physician has not responded, go to next step ...call MD again: place second call to the physician, document in the medical record, if no answer, go to next step ...house supervisor to call MD: review concern with the house supervisor or department director and call the MD, document in the medical record, if no response, go to next step ...house supervisor to call department chair and medical director: supervisor/department director to place call to department chair of notify chief of staff if department chair and medical director are unavailable, if not resolved, go to next step ...house supervisor to call chief of staff: review concern with the administrator on call or Chief Nursing officer, house supervisor or department director to call chief of staff ...final authority lies with the chief of staff ..."

During a review of Patient 1's "ED Physician Orders," dated 3/25/23, the orders indicated, to give 150 mEq of sodium bicarbonate (used to treated acidosis) mixed in 1 liter of sterile water solution.

During an interview on 5/24/23, at 9:20 a.m., with QAPI 1, QAPI 1 verbalized typically ED nurses do not mix medications. QAPI 1 verbalized nurses with IV compounding competency are allowed to prepare the IV solutions but typically the pharmacist is supposed to do this. QAPI 1 verbalized HS 1 went looking for the sterile water. The ED did not have the sterile water and the pharmacy was locked. QAPI 1 verbalized HS 1 went down to materials management and found sterile water in 3-liter bags. QAPI 1 verbalized the 3-liter bag of sterile water was for irrigation and not for IV use. HS 1 grabbed the wrong kind of sterile water. QAPI 1 verbalized the order was for 150 mEq of sodium bicarbonate in 1 liter of sterile water for IV. QAPI 1 verbalized HS 1 mixed 450 mEq of sodium bicarbonate, tripled the dose, instead of 150 mEq, because she was using a 3-liter bag, instead of a 1-liter bag. QAPI 1 verbalized HS 1 did not follow the physician's order and used the wrong sterile water solution and further verbalized this was a medication error. QAPI 1 verbalized HS 1 then proceeded to administer the 450 mEq of sodium bicarbonate in the sterile water irrigation solution through the IV, to Patient 1.

During a review of the facility's policy and procedure (P&P) titled, "Medication Administration and Documentation", revised 4/23, the P&P indicated in part, ... "The purpose of this policy is to ensure the safe administration of medication in the hospital setting and applies to all medications dispensed upon written, telephone or verbal order ...medication administration will follow the five rights: right patient, right medication, right dose, right time of administration, right route of administration ...all medications require a physician's order or protocol approved by the Medical Staff before dispensing and administration ...a pharmacist is on call when the pharmacy is closed in order to respond to requests for emergent drug information, protocol starts and supply emergent medication needs unavailable from the automated dispensing cabinets (ADC-Omnicell) ...ensure that the right medication is being given in the right dose, via the right route, and at the right time for the right reason ...double check the order when using more than one vial, or ampule or when removing multiple tablets for dose...recheck with the pharmacist, nursing supervisor or nursing director ..."

During an interview on 5/24/23, at 9:49 a.m. with the Director of Pharmacy (DOP), the DOP verbalized nurses who have been trained in IV compounding (medication preparation that will be administered IV) may under certain circumstances prepare and make IV medication and solutions. The DOP verbalized it is still preferred that pharmacy does the IV compounding. The DOP verbalized nurses are trained that they may make a low risk (no more than 3 drug ingredients should be combined which includes the IV solution) IV preparation for immediate use. The DOP verbalized "risk" means how many times a drug ingredient is injected into the IV solution bag. The more times you inject (the number of spikes) medication into the IV bag it increases the risk of bacteria and contaminants. When asked about HS 1 making the sodium bicarbonate in the sterile water solution, the DOP verbalized the order for 150 mEq sodium bicarbonate in 1 Liter of sterile water is considered a medium risk IV compound solution. The intended order meant the nurse would have injected 3 ampules (50 mEq each) of sodium bicarbonate into 1 Liter of sterile water. The DOP verbalized HS 1 however, made an IV compounded at high risk when she injected 450 mEq of sodium bicarbonate, 9 ampules (50 mEq each) into 3 Liters of sterile water. The DOP acknowledged HS 1 did not follow policy and procedure for IV compounding and further acknowledged HS 1 used the wrong kind of sterile water to make the IV solution (sterile water for irrigation was used) which should not have been given through the IV.

During a review of the facility's policy and procedure (P&P) titled, "Compounding RN IV Piggyback or Infusion Medication Admixture", revised 10/4/18, the P&P indicated in part... "The purpose of this policy is to define the circumstances under which a trained nurse may prepare an IV medication ...USP 797 (United States Pharmacopeia) is a set of regulations that governs any pharmacy that prepares admixture sterile products (ASPs). For the purpose of this policy, ASPs include intravenous medications prepared and given as piggybacks or infusions ...at this facility, the pharmacy staff will prepare most ASPs per USP 797 regulations. It is only under the following conditions that nursing personnel may prepare ASPs ...a nurse may make an ASP following the procedures listed below in an emergency or life-threatening situation ...a nurse may make an ASP if the pharmacy is closed and the patient needs the medication before the pharmacy will open ...ASPs prepared outside of an ISO class-5 environment (clean room) are deemed immediate use ASPs and must meet the following criteria ...no more than 3 sterile commercial drug ingredients may be combined (that includes the infusion solution) ...Procedure: 7.5. Check solution, additives, and diluents against transcription of order ..."

During an interview on 5/25/23, at 10:00 a.m., the ED physician (MD 1), MD 1 verbalized taking care of patient 1 in the ED on 3/25/23 early in the am. MD 1 verbalized Patient 1 was very sick with high blood sugars, was acidotic, dehydrated, and septic (infection throughout the body). MD 1 verbalized Patient 1 had fallen and was having back pain so sent her to get a CT. MD 1 verbalized during the CT, Patient 1 became nonresponsive, a rapid response was called and further verbalized intubating Patient 1. MD 1 verbalized needing to write an order for sodium bicarbonate infusion drip and asked another hospitalist (MD 2) in the ED at the time, to write the order. MD 1 verbalized MD 2 put in the order for 150 mEq of sodium bicarbonate in 1 Liter of sterile water solution. When asked if he knew about the sodium bicarbonate being mixed with irrigation solution, MD 1 verbalized he did not know. When asked if he knew the on-call pharmacist (PH 1) did not respond to HS 1 phone call, MD 1 verbalized he did not know that. MD 1 verbalized does not usually verify IV solutions when they are hung. MD 1 stated, "I don't remember the nurse (HS 1) asking me to verify the bag." MD 1 verbalized not double checking or looking at the IV bag. When informed of HS 1 using a 3 Liter bag of irrigation, MD 1 verbalized using 3 Liters is odd because IV solutions usually come in 1 Liter bags. When informed of HS 1 using 9 ampules of sodium bicarbonate, which were pulled from the Omnicell and several crash carts, MD 1 verbalized this was also strange because the standard dose if sodium bicarbonate is 3 ampules. MD 1 stated, "I wish I would have known all this was going on and would have rechecked what HS 1 was doing." MD 1 acknowledged this was a system failure.

During an interview on 5/25/23, at 12:00 p.m., with the house supervisor (HS 1), HS 1 verbalized assisting with the care of Patient 1 on 3/25/23 in the ED. HS 1 verbalized the ED was very busy that night all the rooms were full, ED was short staffed, and the Charge nurse had patients. Patient 1 was deteriorating quickly, and a rapid response was called. HS 1 verbalized the ED physician (MD 1) was intubating Patient 1. HS 1 verbalized hearing MD 1 ask the hospitalist (MD 2) to write an order for the sodium bicarbonate drip. HS 1 verbalized needing to call the pharmacist on-call (PH 1) to make the IV solution of sodium bicarbonate because the pharmacy was closed during the night. HS 1 verbalized calling the on-call pharmacist (PH 1) twice and texted once with no response. When asked about trying to call the director of pharmacy (DOP), HS 1 verbalized not wanting to bother him because he had already been there that evening trying to fix the Omnicell which was not working properly. When asked about calling the second phone number listed for PH 1 (the wife phone number), HS 1 verbalized she should have tried the wife's phone and indicated has done so in the past. HS 1 verbalized this was the first time that this pharmacist on call (PH 1) had not responded to a phone call. HS 1 verbalized should have called the DOP and the second phone number for PH 1. HS 1 verbalized wanting to be proactive and helping Patient 1. HS 1 verbalized not finding sterile water in the Omnicell or on any other units. HS 1 verbalized going to pharmacy but the doors were locked. HS 1 went to purchasing and saw boxes of sterile water. HS 1 verbalized these were 3 Liter sterile water irrigation bags and realized they were not for IV use and further verbalized using it anyway. HS 1 verbalized the standard dose for the sodium bicarbonate was 150 mEq (3 ampules) mixed in 1 Liter of IV solution and further verbalized using 9 ampules (450 mEq) in the 3 Liters of sterile water for irrigation. HS 1 verbalized pulling 6 ampules from the Omnicell and 3 ampules from the crash carts. When asked if she had thought it was odd to pull all these ampules, HS 1 stated "I was thinking this solution would last a longtime" and further stated, "No one stopped me to say hey that looks funny." HS 1 verbalized wishing she would have asked someone to double check her. HS 1 verbalized administering the sodium bicarbonate solution around 4:30 a.m. to Patient 1.

During a review of Patient 1's "Medication Administration Record (MAR)," dated 3/25/23, the MAR indicated the 150 mEq of sodium bicarbonate in 1 Liter of sterile water was administered in the IV, at 4:24 a.m. In actuality, 450 mEq of sodium bicarbonate in 3 Liter of sterile water for irrigation was administered in the IV at 4:24 a.m.

During a review of Patient 1's "Admission History and Physical (H&P)," dated 3/25/23 at 6:45 a.m., the H&P indicated Patient 1 was in acute respiratory failure and a hyperosmolar coma. H&P indicated due to the severe acidosis and hyperglycemia there was an order to start a sodium bicarbonate drip from previous physicians. The H&P indicated the ICU intensivist (MD 3) saw that the sodium bicarbonate drip was mixed with irrigation sterile water and was running while seeing Patient 1. The H&P indicated MD 3 immediately stopped the infusion and informed administration. The H&P indicated MD 3 was treating Patient 1 with aggressive fluid resuscitation and an insulin protocol.

During a review of Patient 1's "Admission History and Physical (H&P)," dated 3/25/23 at 2:30 p.m., the H&P indicated Patient 1 was having EKG (electrocardiogram that records electrical signals from the heart to check different heart conditions) changes, went into sinus bradycardia (a heart rate slower than expected fewer than 60 beats per minute) then to asystole (when the heart stops beating-cardiac arrest). ACLS (Advanced Cardiovascular Life Support) was in progress with the family at bedside. There was a mutual decision to stop resuscitation measures. Patient 1 died at 2:48 p.m.





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2. During a concurrent review of Patient 200 record and interview with QAPI 2 on 5/24/23 at 12:30 p.m. The physician's order for Precedex medication (to manage pain and sedation in the ICU), dated 5/17/23 at 4:40 p.m., indicated "Start at 0.2 mcg/kg/hr. Titrate by 0.2 mcg/kg/hr. every 5 minutes for goal RASS of -1. Maximum dose 2 mcg/kg/hr. The Richmond Agitation Sedation Scale (RASS) determines the sedation level, and it measures the severity of agitation and sedation with a score of +4 to +5: +4: combative, +3: very agitated, +2: agitated, +1: restless, 0: alert and calm, -1: drowsy, -2: light sedation, -3: moderate sedation, -4: deep sedation ...

The following was noted:
a) A review of the titration rate changes documentation in the electronic medication administration record (e-MAR) indicated Precedex medication continuous infusion (drip) was started on 5/17/23 at 4:31 p.m., at the rate of 2mcg/kg/hr. instead of 0.2mcg/kg/hr. The same rate continued until 5/21/23 at 1:00 p.m.
b) Precedex titration rate changes ranging from 0.3 mcg/kg/hr. to 0.6 mcg/kg/hr. occurred randomly.
c) On 5/23/23 at 7:42 a.m., Precedex drip was being infuse at 1.4 mcg/kg/hr. until 5/24/23 at 7:04 a.m., RASS scores documented ranged from +1 to +3 and there was no medication titration of Precedex noted.
d) Review of the RASS scores documentation indicated on 5/17/23 from 4:30 p.m., (drip started) to midnight for 8 hours there was no documentation of RASS scores however Precedex drip was being administer. On 5/19/23 at 8:00 p.m., to 5/20/23 at 6:00 a.m., for 10 hours there was no documentation of RASS scores however medication drip continued. On 5/20/23 at 8:00 p.m., to 5/21/23 at 4:00 a.m., for 8 hours there was no RASS scores documentation, but Predecex drip continued. On 5/22/23 from 6:00 a.m., to 8:00 p.m., for 14 hours there was no RASS score documented however Precedex drip was being infuse.

The QAPI 2 acknowledged and confirmed the record review findings and agreed the physician's order was not implemented by the ICU nurses when the Precedex medication drip was administered on this patient.

During an interview with registered nurse (LN4) on 5/24/23 at 5:35 p.m., LN 4 reported RASS score assessment is performed every 15 minutes when Precedex drip is started until patient is stable then RASS score assessments are performed every hour.

During an interview with QAPI 1 on 5/24/23 at 5:40 p.m., QAPI 1 confirmed the practice is to perform and document RASS assessments every 15 minutes until patient is stable then every hour.

Based on record review and interview the facility failed to ensure registered nurses (RNs) performed Clinical Institute Withdrawal Assessment (CIWA) assessments after Patient 204 was administered benzodiazepine (CNS depressants which induce feelings of calm, drowsiness and sleep) medications as indicated in the CIWA protocol.

The facility failure placed patient at risk of being overmedicated resulting in physical harm for the patient.

Finding:

The facility Clinical Institute Withdrawal Assessment for Alcohol (CIWA) protocol, dated 9/6/11 indicated "CIWA score 8-15 and CIWA 16-25, vital signs and CIWA assessment every 4 hours and one hour after each oral dose, 15 minutes after each parenteral dose benzodiazepine ..."

During a concurrent record review of Patient 204 and interview with quality assurance performance improvement (QAPI) 2 on 5/24/23 at 3:51 p.m., record indicated patient was placed on the CIWA protocol to treat his alcohol intake abuse. CIWA protocol is the most common method of treating alcohol withdrawal. CIWA scores of less than 8 to 10 indicate minimal to mild withdrawal. Scores of 8 to 15 indicate moderate withdrawal (marked autonomic arousal); and scores of 15 or more indicate severe withdrawal (impending delirium tremors). Admission history and physical, dated 5/23/23 at 4:41 a.m., indicated patient quit drinking alcohol four days ago "cold turkey" after drinking heavily for years. Patient is hallucinating and is very tremulous (physical tremers).

A review of the CIWA assessments and electronic medication administration record e-MAR was conducted. The e-MAR indicated on 5/23/23 at 7:38 a.m., Librium 25 milligram (mg) was administered however there was no CIWA assessment perform at 8:38 a.m., one hour after the medication administration. Librium (sedative) 25 mg was repeated at1:35 p.m., however no CIWA assessment was performed at 2:35 p.m. Librium 25 mg was administered again at 9:42 p.m., however no CIWA assessment was performed at 10:42 p.m. Ativan (sedative) 4 mg was administered at 7:51 a.m., however no CIWA assessment was performed at 8:51 a.m. Ativan 4 mg was repeated at 9:34 a.m., and no CIWA assessment was performed at 10:34 a.m. Ativan 4 mg was administered again at 4:29 p.m., and again CIWA assessment was performed at 5:29 p.m.

The QAPI 2 confirmed 5/24/23 at 3:51 p.m., the findings and agreed there was no CIWA assessments performed one hour after each medication administration as indicated by the CIWA protocol which place the patient at risk of being overmedicated and/or over sedated if the assessments are not performed.

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 ensure that the hospital had implemented all of its policies and procedures regarding the labeling of high alert medications, for 40 out of 40 sampled patients in the hospital's care systems (Refer to A 491).

2.The hospital failed to have an adequate number of pharmacy staff to ensure that all of the tasks and work which had been required in order for the hospital to provide Pharmaceutical Services, had been put into place. This deficiency had the potential to affect 40 out of 40 sampled patients. (Refer to A 493).

3.The hospital failed to ensure that the hospital was following their policies and procedures for documenting expiration dates for medications (which had been prepared as intravenous drips and infusions). This deficiency had the potential to affect 40 out of 40 sampled patients. (Refer to A 501).

4. The hospital failed to ensure that expired medications were not available for patient administration. This deficiency had the potential to affect 40 out of 40 sampled patients. (Refer to A 505).

5. The hospital failed to ensure that patients had been protected from medication errors and that these medication errors did not contribute to a patient's death, while under care of the hospital, during the course of each patient's stay. This deficiency had the potential to affect 40 out of 40 sampled patients. (Refer to A 508).

6. The hospital failed to ensure that the hospital had a local drug formulary (a drug formulary is a list of drugs covered under a hospital's health plan for the care and management of its patients), had been evaluated for each medication's effectiveness, risk, and the costs of the medications, which had been used by the hospital, for patient care. This included evaluating the risks, effectiveness, and costs of medications. The hospital also failed to follow their own policies and procedures regarding their drug formulary. This deficiency had the potential to affect 40 out of 40 sampled patients. (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 ensure the preventive maintenance (PMs) were being performed on a medication refrigerator and medication digital thermometers according to facility policy and procedure (P&P) when:

1. The digital thermometers in Post-Anesthesia Care Unit (PACU) and Outpatient Surgical Unit (OSU) had stickers on them that indicated the PMs were due on 4/27/20.

2. The medication refrigerator in labor and delivery (L&D), in the operating room hallway, had a sticker on it indicating the PMs were due on 8/22 and the digital thermometer on the medication refrigerator did not have a PM sticker on it.

3. The digital thermometers in Intensive Care Unit (ICU) and Direct Observation Unit (DOU) had sticker on them that indicated the PMs were due on 4/27/20.

4. The digital thermometer in medical surgical unit did not have a PM sticker on it.

These failures put the temperature monitoring system at risk of not being maintained to function properly and put the medication refrigerators at risk of not being maintined to function properly.

Findings:

1.During a review of the facility's P&P titled, " Maintenance Procedures", revised 4/7/2016, the P&P indicated, in part... "Purpose: To establish and define the maintenance procedure for the Department of Pharmacy Services and the responsibilities of all departments in relationship to pharmacy maintenance and operation ... Responsibilities: It is the responsibility of the Director of Pharmacy Services to ensure compliance to this policy ... Duties performed by Pharmacy personnel ... The alarm system of the refrigerator will be checked daily along with a visual check of the temperature graphic chart."

During a review of the facility's P&P titled, " Medical Equipment Maintenance and Management", dated 5/7/21 the P&P indicated, in part... "The need for regular maintenance will be determined using field experience, manufacturer recommendations and requirements of accrediting bodies as a guide."

During a concurrent observation and interview on 5/23/23, at 8:45 a.m., with the director of peri-op (DPO), in the PACU, DPO verbalized, the PM was due on 4/27/20, it is past due.

During a concurrent observation and interview on 5/23/23, at 8:55 a.m., with the DPO, in the OSU, DPO verbalized, the PM was due on 4/27/20, it is past due.






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2. During a review of the facility's policy and procedure titled, "Mission/Responsibilities," revised 4/15 indicated in part ... "The hospital shall maintain safe and functional electrical systems, environment, and equipment ...the Bio-Medical Department shall be responsible for the implementing, maintaining and managing a program to assure the hospital's electrical environment and medical instrumentation are free from fire and shock hazards, are accurate, reliable, and in good state of repair ...establish test schedules, procedures and report forms for BME (Bio-medical Equipment) and the electrical environment ...perform safety, functional and performance checks on all BME as required ..."

During a concurrent observation and interview on 5/22/23, at 4:07 p.m., with the director of perinatal services (PSD), during a tour of the operating room hallway, on the labor and delivery unit (L&D), the medication refrigerator, which contained methergine and hemabate (medications to treat bleeding postpartum-after childbirth), was observed. The refrigerator had a preventive maintenance (PM) sticker on it indicating the PM was due on 8/22. The digital thermometer monitoring the temperature of the medication refrigerator did not have a PM sticker on it. The PSD acknowledged the PM was overdue and verbalized needed to ask the bio medical engineer (BME) about the PM's and the digital thermometer.

The facility policy and procedure titled "Drug Procurement, Distribution and Administration", dated 10/10/18 indicated "All medications should be stored in a manner complying with any special storage requirements (i.e., under refrigeration, protected from light, etc.)

The facility policy and procedure titled "Medical Equipment Maintenance Frequency" dated 5/7/21 indicated "Annual prevented maintenance requirements for devices that require less extensive testing or performance. (Digital thermometers)" will be conducted by the Bio-Med department.

During an interview on 5/22/23, at 4:40 p.m., with the biomedical engineer (BME), the BME acknowledged the medication refrigerator in the operating room hallway on the L&D unit was overdue. The BME verbalized not having any work orders or any paperwork information on this medication refrigerator. The BME verbalized the medication refrigerators come from the pharmacy and had not been registered in the biomedical department to be placed on a PM schedule. The BME verbalized the medication refrigerator, and the digital thermometer should be checked annually for functionality.

During a review of the facility's P&P titled, " Medical Equipment Maintenance and Management", dated 5/7/21 the P&P indicated, in part... "The need for regular maintenance will be determined using field experience, manufacturer recommendations and requirements of accrediting bodies as a guide."




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3. During a concurrent observation of the intensive care unit ICU and direct observation unit DOU Omnicell refrigerator preventive maintenance PM sticker and interview with the bio-medical engineer (BME) on 5/23/23 at 11:20 a.m., the BME explain the sticker indicated the PM for the digital thermometer was due on 4/27/20 which was not done because the refrigerator thermometer had not been registered in the biomedical department to be placed on an annual PM schedule.

During another concurrent observation of the ICU and DOU Omnicell refrigerator digital thermometer and interview with the pharmacy manager (PM) on 5/24/23 at 9:50 a.m., the PM confirm medications that need refrigeration are being stored inside this refrigerator i.e., Ativan injectable. The pharmacy staff is responsible to check and monitor the temperatures for this refrigerator using the digital thermometer. It was shared with the PM that these refrigerators prevented maintenance had not occurred since 4/27/20 therefore the accuracy of the temperature inside the refrigerators were questionable. The staff responsible to check the temperature inside these refrigerators perhaps need to ensure the thermometer has had its preventive maintenance to guarantee the temperature readings are accurate. The PM agreed that the staff reading the digital thermometer must ensure preventive maintenance have occurred to guarantee the thermometer temperature readings are accurate for a safe storage of medications.

The facility policy and procedure titled "Drug Procurement, Distribution and Administration", dated 10/10/18 indicated "All medications should be stored in a manner complying with any special storage requirements (i.e., under refrigeration, protected from light, etc.)

The facility policy and procedure titled "Medical Equipment Maintenance Frequency" dated 5/7/21 indicated "Annual prevented maintenance requirements for devices that require less extensive testing or performance. (Digital thermometers)" will be conducted by the Bio-Med department.



39912


During a review of the facility's P&P titled, " Medical Equipment Maintenance and Management", dated 5/7/21 the P&P indicated, in part... "The need for regular maintenance will be determined using field experience, manufacturer recommendations and requirements of accrediting bodies as a guide."

During the tour of the Medical Surgical (Med/Surg) medication room on 5/23/23 at 12:20 pm with the director of inpatient services (DIS). The refrigerator and the thermometer was observed not having a preventive maintenance (PM) sticker. The DIS acknowledged the refrigerator and thermometer does not have PM stickers.

During an interview with the bio medical engineer (BME) on 5/24/23 at 3:45 pm, the BME indicated when the new automated dispensing machines were installed, many of the refrigerators were moved and could not say why this refrigerator and thermometer was missed for preventive maintenance. The BME indicated this equipment should be checked every year.

Based on interview, inspection of the pharmacy, and review of the hospital pharmacy work schedules the pharmacy failed to have sufficient staff to provide quality pharmaceutical services.

Findings:

During an interview with Pharmacy Technician 1 (Pharm Tech 1) on 5/22/2023 at 11:15 am after inspection of the pharmacy's medication storage area, the surveyor asked Pharmacy Tech 1 why there were so many expired drugs being found in the pharmacy and what the pharmacy's process was regarding expired medications? The Pharmacy Technician proceeded to explain that the pharmacy has been short of staff and that the Pharmacy Technicians and the Pharmacists no longer have the time to look for expired drugs in previously assigned areas. Interview with Pharmacy Technician 2 (Pharm Tech 2) revealed that staffing had been a problem for the pharmacy since COVID and the pharmacy staff who have left the pharmacy have not been replaced since they had left the hospital. Interview with the DOP on 5/24/2023 at 4:00 pm revealed that the hospital's pharmacy has been short of pharmacy staff for quite some time, and they are now down to 4 full-time Pharmacist on one Peridium (as needed) Pharmacist who rarely works at the hospital. Interview with Pharmacist 1 on 5/24/2023 at 4:30 pm revealed that pharmacy staff had been unable to do their assigned job functions because they had been assigned to participate in the hospital's antibiotic stewardship program on top of their regular duties, making it almost impossible for the Pharmacists to get all of their work done. Further review of the Pharmacists work schedule revealed the following dates when there was not a pharmacist available to cover the following "middle" shifts: 5/1/2023, 5/3/2023, 5/8/2023, 5/17/2023, 3/27/2023,3/28/2023, 4/4/2023, 4/5/2023,4/11/2023, and 4/21/2023, just for the last 2 months. As for review of the Pharmacy Technician's schedule, the second Pharm Tech shift was not covered on the following dates: 5/18/2023, 5/19/2023, 5/22/2023, 5/24//2023, and 5/26/2023. Pharmacy staff indicated that they had been unable to complete all of their job duties and provide quality pharmaceutical services as a result of these staffing shortages. Staff also indicated that the hospital does not have a dedicated pharmacy drug buyer, so this responsibility is also shared among the hospital's pharmacy staff on top of their other assigned duties, which makes it difficult for the pharmacy to keep current with the medication supplies that are needed in the hospital for patient care.

Based on observation, interview and record review, the facility failed to ensure that sterile compounded intravenous (IV) medications had been compounded consistent with USP 797 and the hospital's Sterile compounding policies and procedures. The hospital also failed to apply the correct Beyond Use Date (BUD) for the IV medications which had been compounded for 40 out of 40 sampled patients placing them at risk for receiving ineffective, incorrectly prepared, or outdated medications.

Findings:

Review of the hospital's policy and procedure, dated 10/4/2018, entitled: "Compounding RN IV Piggyback or Infusion Medication Admixture", reads: "USP 797 is a set of regulations issued by the US Pharmacopeia that governs any pharmacy that prepares admixture sterile products (ASPs). For the purposes of this policy, ASPs include intravenous medications prepared and given as piggybacks or infusions ...These regulations require ASPs be prepared in special clean-room (ISO class-5)."
USP 797 provides the standards under which regulatory agencies, particularly the state-level department of public health and board of pharmacy, can pursue pharmacies for unsafe compounding practices. The chapter was developed to prevent patient harm and fatality from microbial contamination.
USP 797 states the following regarding environmental control: "Achieving and maintaining sterility and overall freedom from contamination of a Compounded Sterile Product (CSP) is dependent on the quality ...the process utilized ...and environmental conditions under which the process is performed ...The quality and control of environmental conditions for each risk level of operation are explained ...." Environmental condition for sterile compounding includes at least three elements: pressure, temperature, and humidity.

During a review of the hospital's intravenous (IV) compounding logs on 05/22/2023, at 11:15 am and interview with Pharmacist 1, he indicated that the Pharmacy adhere' s to USP 797. Review of the hospital's Ante room area (pre-compounding area) and the hospital's non-hazardous [non-HD] area (a compounding area where non- dangerous drugs are made) revealed the following concerns:

a)The Ante room pressure was 0.0160 which was below the (0.020 to 0.050) pressure range which has been set by USP 797. The pressure gauge was lighted in red (which indicated that the alarm should have been making an audible sound, but somehow the alarms had been set on silent and the DOP was not aware that this feature (for an audible alarm) had been turned off. Pharmacy staff were unaware that this room had been alarming and no one from engineering had been notified and no work order had been submitted.
b)The Non-HD room pressure was 0.0523 which was above the (0.020 to 0.050) pressure range which has been set by USP 797. The pressure gauge was lighted in red (which indicated that the alarm should have been making an audible sound, but somehow the alarms had been set on silent and the DOP was not aware that this feature (for an audible alarm) had been turned off. Pharmacy staff were unaware that this room had been alarming and no one from engineering had been notified and no work order had been submitted.
c) Inspection of the Pharmacy's sterile compounding area Temperature (Temp) and Pressure logs revealed that both of these clean room areas had been out of compliance (with the hospital's policy and USP 797 standards) for quite some time. Review of these logs and interview with the Pharmacist 2 on 5/22/2023 at 1:25 pm revealed that the Pharmacy staff have never been recording the room's humidity on a paper log for the sterile compounding areas rooms, in a subsequent interview with the DOP, he too confirmed that a humidity log had not been maintained by the Pharmacy for these clean room areas. As outlined below, a Clean room's humidity will have an affect on the IV product which has been compounded. Clean rooms are monitored and controlled for seemingly every environmental condition, but one that is very, very relevant, to pharmaceutical compounding is . . .Controlling the humidity of a clean room, this is important to pharmacies not because of a single problem that extreme high or low humidity causes, but rather because of its influence on many factors that could degrade a clean room's environment, and thus its certification on the ISO class scale.
Those factors include the following:
1. Static Charge: You'd think that low levels of humidity would be the preferred option every time, but static electricity shows that a happy medium is ideal. When humidity levels in an environment get to low, static electricity builds up.
2. Condensation: The conversion of water from a gas state to a liquid state is bad news for your clean room. The effect of Kelvin condensation specifically, becomes very problematic when humidity reaches the 70% threshold.
3. Personnel Comfort: The last thing your personnel, with their E.T. like contamination suits and astronaut-looking helmets on want to be is hot and sticky. Keep humidity levels low enough as to not make them uncomfortable.
4. Bacterial Growth: Bacteria and mold like moisture. Once your clean room climbs above the 60% Relative Humidity threshold, bacteria, viruses, fungi, and more will start to multiply. Very literally, your clean room will cease being clean.
As outlined in USP 797: "Compounding facilities are physically designed and environmentally controlled to minimize airborne contamination from contacting critical sites. These facilities shall also provide comfortable and well-lighted working environment, which typically includes a temperature of 20 degrees Celsius (68 degrees Fahrenheit) or cooler ...For rooms providing a physical separation through the use of walls, doors, and pass-throughs, a minimum differential positive pressure of 0.02 to 0.05 inch water column is required."
Review of the hospital's electronic humidity level records on 5/24/2023 at 12:00 pm revealed that from 5/13/2023 to 5/24/2023 the humidity in the Pharmacy's sterile compounding rooms had exceeded 60% Relative Humidity (RH) allowed by USP 797, despite this, the hospital's Pharmacy continued to compound patient IV medications without taking room's humidity (which must be taken into account), when evaluating the clean room's environment, when determining the Beyond Use Date (BUD) for these IV compounded medications.
Review of the hospital's electronic pressure level records on 5/24/2023 at 12:00 pm revealed that from 2/4/2023 to 5/24/2023 the pressure in the Pharmacy's sterile compounding rooms had regularly exceeded and fell below the 0.020 to 0.050 inch water column range outlined in USP 797. Yet, the Pharmacy continued to compound patient IV medications without altering the BUD for these compounded IV medications.
Review of the hospital's electronic temperature level records on 5/24/2023 at 12:00 pm revealed that from 2/4/2023 to 5/24/2023 the temperature in the Pharmacy's sterile compounding rooms had regularly exceeded the 68 degrees Fahrenheit temperature outlined in USP 797. Yet, the Pharmacy continued to compound patient IV medications without altering the BUD for these compounded IV medications.
Review of the Pharmacy's IV compounding log which also contained the compounding recipe for each drug, revealed that the Pharmacy had been compounding Thiamine 200 mg/2ml in Normal Saline 100 milliliter bags. The compounded Thiamine bags had been given an expiration date of 24 hours after being made, but interview with the DOP on 5/22/2023 at 5:15 pm revealed that the Pharmacy did not have any literature or references to support the 24-hour Beyond Use Date (BUD), which the Pharmacy had been assigning to these medications.
A total of three Thiamine IV bags had been compounded between 5/16/2023 and 5/22/2023. All three of these bags had been given 24-hour beyond use dates yet the hospital had no evidence or literature to support the rationale for applying a 24-hour BUD to these compounded IVs.
Pharmacy on 5/21/2023 compounded a drug called Precedex (Dexmedetomidine) [which is used for sleep during surgery] 4 mcq/ml in a 250 milliliter (ml) bag of Normal Saline. Two bags were given 24-hour BUD dates, but during an interview with the DOP on 5/23/2023 at 11:15 am, the DOP acknowledged that this medication should have been given a 12-hour BUD rather than the 24-hour BUD that it had been given because the compounding environment had not been in compliance with USP 797 and the hospital's policies and procedures.
Pharmacy on 5/20/2023 compounded a drug called Potassium Phosphate Riders in a 250 milliliter (ml) bag of Normal Saline. Two bags were given 24-hour BUD dates, but during an interview with the DOP on 5/23/2023 at 11:15 am, the DOP acknowledged that this medication should have been given a 12-hour BUD rather than the 24-hour BUD that it had been given because the compounding environment had not been in compliance with USP 797 and the hospital's policies and procedures. Precedex had also been made on 5/20/2023 and it too had been given a 24-hour BUD. The same incorrect assigning of BUD for various IV infusion medications went on for at least one week while the Pharmacy's compounding area had been outside of USP 797 compliance.


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During a concurrent inspection of the ICU patients' medication cassettes and concurrent interview with QAPI 2 on 5/23/23 at 9:41 a.m., Patient 206 ocular lubricant ophthalmic eye ointment medication label was observed without the initials of the staff who prepared and/or labeled this medication. QAPI 2 acknowledge the observation and agreed the label should have the initials of the staff who prepared or labeled this medication.



39520

During a review of the facility's policy and procedure titled, "Medication Storage and Security," reviewed date 10/18 indicated in part ... "To ensure that storage of all drugs throughout the hospital comply with state, federal and regulatory conditions ...Safe and secure storage of medication occurs throughout the hospital ...drugs shall be stored in an orderly manner with adequate lighting ..."

During a concurrent observation and interview on 5/22/23, at 11:50 a.m. with the director of perinatal services (PSD) and the labor and delivery charge nurse (CN 3), during a tour of the medication room, on labor and delivery (L&D), the medication refrigerator was observed. When asked to retrieve the emergency medications Methergine and Hemabate (medications to treat bleeding after childbirth) from the refrigerator, CN 3 verbalized need to put in the request into the Omnicell (automated drug dispenser), then Omnicell will unlock the refrigerator, to get the medications. CN 3 put in the request and the Omnicell unlocked the medication refrigerator. The Omnicell indicated to pull these medications from bin #9. When observing the medication cassette drawers in the refrigerator, the cassettes were not numbered and or labeled with any medication names. CN 3 and PSD both verbalized the medications used to be stored in a labeled bin so we can see them and retrieve the medications quickly. CN 3 began opening all the cassette drawers looking for the Methergine and Hemabate. CN 3 finally found the Methergine and Hemabate. CN 3 acknowledged in an emergent situation, fumbling through drawers to look for the medications takes too long, and further verbalized these cassette drawers should be labeled.

During an interview on 5/24/23, at 9:49 a.m., with the director of pharmacy (DOP), the DOP verbalized pharmacy technicians restock the Omnicell and the medication refrigerators. The DOP verbalized there is a refrigerator matrix number in the Omnicell to tell you which cassette to pull the medication from. When informed the medication refrigerator cassettes in labor and delivery were not labeled, and the nurses were having a hard time finding medications, the DOP verbalized the cassettes should be numbered or labeled with the name of the medication.

Based on observation, interview, and record review, the facility failed to ensure all drugs (any substance that is used to prevent, diagnose, treat, or relieve symptoms of a disease or abnormal condition) and biologicals (a class of drugs that are produced using a living system, such as a microorganism, plant cell, or animal cell) were securely stored and locked when lidocaine (a drug injected into the skin to reduce pain), epinephrine (a biological injected into the skin to reduce bleeding), and bupivacaine (a drug injected into the skin to reduce pain) were stored in an unlocked suture cart (a container on wheels) in the emergency department (ED). This failure had the potential to result in unauthorized staff, patients and visitors having unmonitored access to the drugs and biologicals.

Findings:

During a review of the facility's policy and procedure (P&P) titled, "Medication Storage and Security," dated 10/10/2018, the P&P indicated, "Medications are to be stored in either locked cabinet, medication cart, or inside a room which may be locked ... These areas are to be kept locked at all times when not in use and inaccessible to patients and visitors."

During a concurrent observation and interview on 5/22/23, at 3:50 p.m., with a licensed nurse (LN7), in the ED, there was an unattended, unlocked suture cart. The suture cart contained one ampule (a glass container for liquid medicine) of lidocaine 1% (strength) 50 mg (milligram)/(per) 5 ml (milliliter), one ampule of epinephrine 1mg/ml, and one vial (glass container) of bupivacaine 0.5% 50mg/10 ml. LN7 stated, "If locked, it would be okay."

Based on observations, interviews, and record reviews, the facility failed to ensure outdated and unusable drugs (any substance that is used to prevent, diagnose, treat, or relieve symptoms of a disease or abnormal condition) and biologicals (a class of drugs that are produced using a living system, such as a microorganism, plant cell, or animal cell) were not available for patient use when:

1. Expired drugs in the crash cart on the Emergency Department (ED) unit.
2. Expired drugs in the crash cart (a container holding drugs and equipment for use in an emergency) on the Outpatient Surgical Unit (OSU).
3. Expired drugs in crash cart on the Labor and Delivery (L&D) unit.
4. Discharged patient's drugs were still on the L&D unit.
5. Expired drugs in the Pharmacy.
6. Discharged patient's drug in the refrigerator on the direct observation unit.
7. Expired etomadate drug inside the ICU/DOU refrigerator.
8. The hospital's Pharmacy failed to ensure that outdated and unusable medications were not available for patient administration.

Findings:


These failures had the potential to result in ineffective or dangerous drugs being used on patients.

Findings:

1. During a review of the facility's policy and procedure (P&P) titled, "Emergency Crash Cart Contents and Integrity," dated 10/10/2018, the P&P indicated, "Medication container/tray shall be checked at least once each 30 days by the Pharmacy department to assure no expiration of drugs. Medications will be replaced when necessary."

During a concurrent observation and interview on 5/22/23, at 6:05 p.m., with a licensed nurse (LN8), in the ED Trauma Room 1:
· Pediatric crash cart contained two prepackaged syringes of 8.4% Sodium Bicarbonate (a lifesaving drug) with a labeled expiration date "1MAY2023." LN8 stated, "Expired."
· Adult crash cart contained two prepackaged syringes of 8.4% Sodium Bicarbonate with a labeled expiration date "1MAY2023." LN8 stated, "Expired."





40678

2. During a review of the facility's policy and procedure (P&P) titled, "Emergency Crash Cart Contents and Integrity," dated 10/10/2018, the P&P indicated, "Medication container/tray shall be checked at least once each 30 days by the Pharmacy department to assure no expiration of drugs. Medications will be replaced when necessary."

During a concurrent interview and observation on 5/22/23, at 4:25 p.m., with licensed nurse (LN6) and the Director Peri-op (DPO), in the OSU, the crash cart contained three vials of Atropine Sulfate (a drug used in emergencies where the heart is beating too slowly) 1mg/10ml with an expiration date of 2/23 and two vials of 8.4% Sodium Bicarbonate (a lifesaving drug) with an expiration date of 5/1/23. DPO confirmed expired medications should not be in the crash cart.


39520

3. During a review of the facility's policy and procedure titled, "Emergency Crash Cart Contents and Integrity" revised 2/16 indicated in part ... "It is the policy that contents of the Emergency Crash carts shall be maintained in a manner so that they are immediately available for response in a life-threatening emergency and to ensure that accurately stocked emergency crash carts are maintained throughout the patient care areas ...crash carts are located in each patient treatment area ...crash carts are checked at least once in a 24-hour period ...check expiration date of drugs label on front drawers 2, 4, & 6 ...medications shall be stocked in the emergency carts in sealed container/trays furnished by the Pharmacy Department ...the contents of the medication containers/trays shall be listed on the outside of the cart and on accompanying drug list in the medication container/tray ...the expiration date of all medications shall be placed on these lists, both inside and outside the cart ...the medication container/tray shall be checked at least once each 30 days by the Pharmacy Department to assure no expiration of drugs ..."

During a concurrent observation and interview on 5/22/23, at 1:10 p.m., with the director of perinatal services (PSD) and the labor and delivery charge nurse (CN 3), during a tour of the post-anesthesia care unit (PACU) on labor and delivery (L&D), an adult emergency crash cart was observed. The medication drug list on the outside of the cart, on the bottom drawer, indicated 2 Succinylcholine (a medication used to paralize and relax muscles for intubation [a tube inserted into the lungs to assist with breathing] during surgical procedures) 100 mg per 5 ml vials expired on 5/18/23. PSD and CN 3 acknowledged the medications were expired according to the list on the outside of the crash cart drawer. The emergency crash cart was then opened, and the medication container/tray was observed. The PSD and CN 3 both confirmed that 2 Succinylcholine 100mg per 5ml vials expired on 5/18/23.

4. During a concurrent observation and interview on 5/22/23, at 12:00 p.m., with the director of perinatal services (PSD) and the labor and delivery charge nurse (CN 3) during a tour of the medication room, on the labor and delivery unit (L&D), the medication cabinet was observed. In the medication cabinet were individual patient cassette drawers and a return to pharmacy box. CN 3 verbalized sometimes patient medications are stored in the cassettes when not in the Omnicell (automated drug dispenser). CN 3 acknowledged there were 3 medications (Betamethasone-medication used in pregnancy to speed up fetal lung maturity in women at risk for premature delivery, Labetalol-medication to treat high blood pressure, and Oxytocin- medication to begin or improve contractions in labor and reduce bleeding after childbirth) with patient names on them in the return to pharmacy box. CN 3 verbalized these patients had been discharged home. CN 3 verbalized pharmacy makes rounds on the unit and pick up medications that need to be returned to pharmacy after the patient is discharged.

During a concurrent observation and interview on 5/23/23, at 3:50 p.m., with a pharmacy technician (PT 1), the medication cabinet in the medication room on the L&D unit was observed. When asked about partially used and unused medications for patients who have been discharged home, PT 1 verbalized the pharmacy techs make daily rounds to the units and should be returning the medications back to the pharmacy. PT 1 acknowledged the 3 medications with patient names on them in the return to pharmacy box and was informed these medications were observed in the return to pharmacy box yesterday on 5/22/23. PT 1 verbalized he would return the 3 medications back to pharmacy and took them from the medication cabinet.

During a review of the medical record of the patient assigned to the Betamethasone medication and the Labetalol medication, the patient had been admitted on 5/10/23 and discharged on 5/14/23. These medications were in the return to pharmacy box for 9 days.

During a review of the medical record of the patient assigned to the Oxytocin medication, the patient had been admitted on 5/19/23 and discharged on 5/21/23. This medication was in the return to pharmacy box for 2 days.

During a review of the facility's policy and procedure titled, "Medication Storage and Security," reviewed date 10/18 indicated in part ... "To ensure that storage of all drugs throughout the hospital comply with state, federal and regulatory conditions ...Safe and secure storage of medication occurs throughout the hospital ...previously dispensed but unused, expired, or returned medications in the hospital must be accounted for, controlled, and disposed of in order to keep patients safe and prevent diversion ...discontinued drugs will be returned to the pharmacy for proper disposition ..."


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6. During a concurrent observation of the Thiamine (prevents vitamin B1 deficiency) medication and interview with charge nurse (CN 1) on 5/23/23 at 9:54 a.m. A thiamine 250 mg/100 ml piggyback bag which belong to Patient 208 in the DOU was observed inside the Omnicell medication refrigerator. The label and this piggyback bag indicated it was due on 3/25/23 at 3:00 p.m. The CN 1 reported this patient had been discharged home on 3/29/23 at 12:10 p.m. Once the patient is discharged pharmacy comes to pick up the medications.

The facility policy and procedure titled "Medication Storage and Security" dated 10/10/18 indicated "Previously dispensed but unused... medications in the hospital must be accounted for, controlled, and disposed of in order to keep patients safe ... Discontinued drugs will be returned to the pharmacy for proper disposition. Medication storage areas should be inspected at least monthly by a pharmacist or pharmacy tech."

7. During a concurrent observation of the Etomidate medication an interview with QAPI 2 on 5/23/23 at 9:20 a.m., a vial of etomidate (short-acting intravenous anesthetic agent used for the induction of general anesthesia and sedation for short procedures) medication was observed with a label indicating expiration date May 2023 inside the ICU/DOU Omnicell refrigerator. Other medications inside the refrigerator were labeled with the expiration month/day/year. The QAPI acknowledge the observation and stated, "I have to check on the expiration date."

During a follow up interview with QAPI 2 on 5/24/23 at11:05 a.m., QAPI 2 Stated "[pharmacy manager name] agrees they (pharmacy staff) should write the month/day/year on all the labels to show the specific date the medication expires. This medication (Etomidate) is expired."

The facility policy and procedure titled "Medication Storage and Security" dated 10/10/18 indicated "The hospital removes all expired, damaged, and/or contaminated medications and stores them separately from medications available for administration. Drugs will not be kept in stock after the expiration date on the label ..."



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8. Inspection of the hospital's pharmacy on 5/22/2023 revealed the following outdated and unusable medications: one cup of Guaifenesin with Dextromethorphan syrup 10 milliliter (ml) with an expiration date 1/2023, one vial of Hepatitis B Immune Globulin for intramuscular injection with an expiration date of 9/2022, two-unit dose tablets of Phytonadione 5mg with an expiration date of 2/27/2023, and two bags of Mannitol 20% 500 ml with an expiration date of 3/2023.

Based on interview with facility hospital Pharmacy staff and review of the hospital's policy and procedures, the hospital failed to update and implement the hospital's policies and procedures for medications with hard stop dates that need to be reassessed periodically by the provider and as per ISPM High alert medication list.

This failure had the potential for patients to receive medications (which could be unsafe) for periods of time which were outside of the drug manufacturer's specifications.

Findings:

A review of the facility policy procedure titled "Automatic Stop Orders", dated 10/10/18 indicated "The purposes of this policy are to ensure that there is a means by which all medications are reevaluated and reviewed on a consistent basis ... the following medications will be automatically stopped by the Pharmacy Department after initial use has begun: Ketorolac Hard Stop in Cerner = 5 days, Nesiritide=2 days, Alvimopan= Hard Stop in Cerner for 15 doses, Meperidine= Hard stop in Cerner for 2 days. All other medications must be renewed and reorder by the physician every 30 days."

The Institute for Safe Medication Practices (ISMP's) List of High Alert Medication in Acute Care Setting indicates drugs need to be reassessed periodically by the provider. Furthermore, indicated that based on error reports submitted to the ISMP, reports of harmful errors in the literature, studies that identify the drugs most often involved in harmful errors, and input from practitioners and safety experts, ISMP created and periodically updates a list of potential high alert medications .... This list of medications included warfarin, enoxaparin etc.

During a concurrent review of the facility's policy an interview with the director of pharmacy (DOP) and pharmacy manager (PM) on 5/25/23 at 11:20 a.m., the DOP and PM were asked if these four medications (ketorolac, nesiritide, alvimopan, meperidine) were the only medications that had "hard stop date alerts" in Cerner, their computer system. The DOP stated "Yes, these are the only medications within the [organization's name] with a hard stop date alert." PM stated, "All other medications must be reviewed and reorder by the physician every 30 days."

During a follow up interview with the PM on 5/25/23 at 11:30 a.m., the PM confirmed warfarin (blood thinner) is a medication that does not have a hard stop date alert in their computer system.

During a concurrent review of the enoxaparin 40 mg injectable administration report and interview with the PM on 5/25/23 at 10:25 a.m., 3 of 3 sample patients record review indicated there was a stop date alert of 30 days.

The FDA recommended dose of Lovenox is 40 mg injection once a day administered by subcutaneous injection for medical patients at risk for thromboembolic complications due to severely restricted mobility during acute illness. The usual duration of administration is 6 to 10 days. The PM confirmed there was no hard stop date alert for 7 to 10 days for this medication in their computer system for any of the patients. April 2023 report consisted of 50 patients.

During a concurrent review of the pantoprazole 40 mg intravenous IV for May 2023 and interview with PM on 5/25/23 at 10:45 a.m., one sampled patient medical record indicated there was a stop date alert for of 30 days for the pantoprazole medication. The PM confirmed there was no hard stop date alert for 7 to 10 days for this medication in their computer system for any of the patients. May report consisted of 74 patients.

The FDA recommended adult dose is pantoprazole 40 mg IV daily by infusion for 7 to 10 days.

During a concurrent review of the ceftazidime I gram (antibiotic) IV administration report for May 2023 and interview with the PM on 5/25/23 at 10:20 a.m., the report indicated two of two sampled patients receiving this antibiotic had a 30 day stop date alert. The PM stated, "All the antibiotics have a 30 day stop date alert."

The FDA-approved dosage is 30 mg/kg/dose IV every 12 hours. 50 mg/kg/dose IV every 12 hours as part of combination therapy for 7 to 10 days.

It was communicated to the PM that standards of practice were to adhere to the ISMP high alert medication list, FDA approved medication therapy time frames and to develop, update and implement policies and procedures surrounding the high alert medication drugs that bear a heightened risk of causing significant patient harm when they are used in error. PM acknowledged and agreed the pharmacy department needs to update their policies and procedures regarding the hard stop date alerts according to that ISMP high alert medications list and FDA approved therapy time frames. The PM furthermore agreed that patients can not be administered medications for 30 days without having the provider reassess and/or review the therapy treatment and reorder the medication if appropriately indicated.

Based on interview and record review, the hospital failed to ensure that a preventable medication error did not occur with one of 40 sampled patients (Patient 1). Patient 1 received Sterile Water for Irrigation (which had been labeled by the drugs manufacturer as do not administer via an Intravenous (IV) route). This medication had been given, contrary to this drug manufacturer's package insert. This hospital medication error may have led/contributed to Patient 1's death, which may have been averted.

Findings:

During record review of Patient 1's medical record, Patient 1 had been seen in the hospital's Emergency Room (ER) on 3/25/2023, at 1:45 am, she had been brought into the hospital by the Paramedics, with her chief complaint being buttock soreness after getting knocked into at work. This patient's blood sugar had been greater than 600, as her Diabetes had been uncontrolled at home while she had been taking her husband's blood sugar medication (Metformin). On arrival patient was alert and responding to questions. No reported nausea, vomiting, diarrhea or abdominal pain. She was subsequently admitted to the hospital and discharged (passed away) on 3/25/2023, at 2:48 pm (less than 24 hours after admission to the hospital), under a Physician's care.

During a review of Patient 1's medical record, dated 5/24/2023, at 9:00 am, the medical record indicated that this patient's physician, (MD 1) had asked (MD 2) to order at 3/25/2023 2:43 am 1000 milliliters (ml) of Sterile Water for injection with 150 milliequivalents (meq) of Sodium Bicarbonate 8.4%. Unfortunately, the hospital's on-call Pharmacist did not respond when the hospital's house supervisor called him twice and she had also text messaged him, but the house supervisor never received any response from the on-call Pharmacist regarding her phone calls or the text message. The house supervisor proceeded down to the hospital's Materials Management location and retrieved a Baxter 3 Liter (3000 milliliter, ml) bag of Sterile Water for irrigation. The house supervisor proceeded to add three times the amount of the ordered Sodium Bicarbonate which had been ordered by MD 2 to this bag of Sterile Water for irrigation. The house supervisor then proceeded to administer this 3-liter bag of Sterile Water for irrigation to this patient via Intravenous (IV) injection. Interview with the Pharmacy Director (DOP) on5/24/2023 at 9:30 am and concurrent chart review revealed that a Tele pharmacy located in San Ramon California (not within the hospital), just under 200 miles away had been responsible for reviewing the order for Sterile Water with Bicarbonate. Further review of the clinical record revealed that even though this bag of Sterile Water for Irrigation had been administered by the house supervisor at 4:24 am, but this physician's order had not been reviewed by a Pharmacist until 6:30 am (more than 2 hours after this medication had been administered to Patient 1).
ASHP guidelines for remote Pharmacy use after hour: "To ensure the safety of the RMOP service, the client and the remote site must establish effective communication channels between personnel at the two sites. Communication among prescriber, pharmacist, and nurse will be critical to assessing the patient's response to drug therapy and achieving desired therapeutic outcomes. The remote pharmacist must have the ability to immediately contact the prescriber or client site's nursing staff to discuss any concerns identified during review of the patient's information. The client must provide its nursing supervisor with a 24-hour telephone number to contact the remote site or remote pharmacist and encourage nurses to communicate with the remote pharmacist. In the event the nursing supervisor is unable to resolve a problem or concern, the client pharmacist on call is available for consultation and problem resolution if the problem cannot wait until the client pharmacist is on duty again. Patient profile information, including laboratory results, should be communicated to the remote site electronically; oral communication of laboratory results should be limited to exceptional circumstances, and such oral communications should be documented in the patient medical record as soon as possible." No communication was made between the Nurse and the Pharmacist who approved IV drip above.

The following information was taken directly from the drug's manufacturer Baxter International Inc.'s package insert: "Sterile Water for Irrigation, USP is not isotonic and is hemolytic. Warnings For irrigation only. Not for injection or infusion by usual parenteral routes. Sterile Water for Irrigation, USP is hypotonic with an osmolarity of zero (mOsmol/L). If used for continuous irrigation or allowed to dwell inside body cavities, absorption into the blood stream may occur resulting in hemolysis, therefore use under such conditions is not recommended. Absorption of water for irrigation (e.g., through perforations, open wounds or body cavities) has resulted in fatal complications or permanent morbidity and use under these conditions is not recommended. Immediate intervention may be required to prevent these outcomes. o Absorption can result in hyponatremia, hypoosmolality, as well as fluid overload. o Possible complications include, but are not limited, to cerebral edema, encephalopathy, pulmonary edema, massive hemolysis, rhabdomyolysis, renal failure, and hyperkalemia and their secondary manifestations and complications. These complications can manifest after irrigation has ended. o The development of these complications is dependent on factors such as rate, volume, pressure, and duration of irrigation. o If absorption of clinically relevant amounts of fluid is suspected, administration should be interrupted, and the patient evaluated for signs of fluid absorption .... In cases where significant absorption may occur (e.g., transurethral resection of prostate), Sterile Water for Irrigation, USP must, if at all, only be used with extreme caution: o Very close monitoring is required during and for an appropriate period after the procedure to allow for timely intervention. Sterile Water for Irrigation, USP must be used only by physicians familiar with the treatment of possible complications ... Sterile Water for Irrigation, USP must not be administered intravenously or by other, usual parenteral routes ....Additives may be incompatible with Sterile Water for Irrigation, USP. Compatibility of additives with Sterile Water for Irrigation, USP must be assessed before addition, by checking for, e.g., a possible color change and/or the appearance of precipitates, insoluble complexes, or crystals. Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of Sterile Water for Irrigation, USP is appropriate. The instructions for use of the medication to be added and other relevant in the event of clinically relevant absorption of Sterile Water for Irrigation, USP, patients must be evaluated, and corrective measures instituted as indicated. Immediate intervention may be required to prevent fatal outcomes or permanent morbidity..."

The National Coordinating Council Medication Error Reporting and Prevention (NCCMERP) is a nationally recognized organization which sets the standards for the definition of medication errors. NCCMERP defines a medication error as: "Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer ..."drug administration error", is limited to those errors in administration that actually reach the patient, i.e. (for example), a medication actually is administered to a patient when it should not be ...".

Based on interview with facility hospital staff and review of the hospital's drug formulary policy and procedure, the hospital failed to implement the hospital's policy and procedure, regarding the hospital's drug formulary (a drug formulary is a list of drugs covered under a hospital's health plan for the care and management of its patients).

Findings:

During an interview with Director of Pharmacy (DOP) on 5/25/2023 at 2:40 pm, he stated that the hospital had not been following the hospital's Drug Formulary policy and procedure. The policy and procedure read: "Drugs currently in stock will be reviewed for inclusion in the TCCH (Twin Cities Community Hospital) formulary.. this policy goes on to read: "this review will occur annually".

During a concurrent interview with the DOP, he indicated that the hospital had not been reviewing the drugs that were in stock at the hospital for their inclusion into the hospital's drug formulary. The DOP also confirmed during that this review of the hospital's in stock medications had not occurred on an annual basis as outlined in the hospital's policy and procedure above.

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 ....".