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Based on observation, interview, and record review, the facility failed to ensure an intravenous [(IV)- in the vein] compounded medications (two or three medications mixed together) were administered at the correct time for five of 33 sampled patients (Patient 1, 6, 12, 13, and 19).
This deficient practice resulted in the administration of expired and potentially contaminated IV compounded medication to Patient 1 and 19, placing patients at high risk for acquiring an infection.

Findings:

During an interview on 2/02/2021 at 2:03 pm, the Director of Pharmacy (DOP) stated that on 1/3/2021, the room used for sterile IV compounding medications was flooded and currently inoperable. The DOP stated the facility's pharmacists were using a different location to prepare to compound IV medications intended for immediate-use. The DOP stated some of the immediate use compounded medications included Remdesivir (an antiviral drug used to treat COVID - 19 [coronavirus disease 2019, a new virus that can spread from person to person, causing respiratory illness]). The DOP stated that the compounded medications should be administered within one hour of the medication start preparation time. The DOP stated the medication's sterility may be compromised and may cause infections to patients if administered after one hour from the start of the medication preparation time.

On 2/02/2021 at 2:03 pm, in the pharmacy, observed an IV bag labeled with Patient 1's name. The label indicated the bag contained Remdesivir 100 milligrams (mg) in 250 milliliters (ml) of 0.9 percent (%) Sodium Chloride (Normal Saline [NS], a mixture of salt and water) solution. The label indicated this medication was compounded on 2/02/2021 at 1:30 pm and indicated not to start administering the medication after 2:30 pm on 2/02/2021. The label also indicated to contact the pharmacy immediately to remake the IV bag if it expired.

On 2/2/2021 at 2:45 pm, during a concurrent interview and review of Patient 1's Medication Administration Record (MAR), the pharmacy technician (PhT 2) stated the pharmacy kept track of the administration times of IV compounded medications to ensure the medications were administered within one hour after the medication was prepared. PhT 2 stated the administration time was checked in the patient's MAR and documented on the compounding log. PhT 2 reviewed Patient 1's MAR and stated that Remdesivir 100 mg in 250 ml of NS was administered 2/2/2021 at 2:39 pm and should have been administered before 2:30 pm.

On 2/2/2021 at 4:41 pm, during an interview and review of Patient 1's MAR, the registered nurse (RN 2) stated she received Patient 1's dose of IV Remdesivir and administered it to Patient 1 right away at 2:39 pm on 2/2/2021. RN 2 stated she did not check the label for the date and time of medication expiration. RN 2 stated Remdesivir was an IV compounded medication, and she knew it needed to be administered within an hour of its' start preparation time.

A review of Patient 1's medical record indicated the patient was admitted to the facility on 1/21/2021, with diagnoses including back pain and COVID-19.

A review of Patient 1's MAR, dated 2/02/2021, indicated Remdesivir 100 mg IV was administered on 2/02/2021 at 2:39 pm.

A review of the pharmacy's "Compounding Log", dated 2/02/2021, indicated Remdesivir was a compounded medication. The Compounding Log had affixed Patient 1's medication label indicating Remdesivir 100 mg IV was prepared at 1:30 pm on 2/02/21. The beyond-use date [(BUD)- or expiration date, the date and time after which the administration of a compounded drug preparation shall not be dispensed or stored) documented on the label indicated a time of 2:30 pm on 2/02/2021.

A review of Patient 6's medical record indicated the patient was admitted to the facility on 1/06/2021 with diagnoses including COVID - 19.

A review of Patient 6's MAR, dated 1/09/2021, indicated Remdesivir 100 mg IV to administer daily at 2 pm. The MAR indicated that the medication was administered at 3:15 pm on 1/09/2021.
A review of Patient 12's medical record indicated the patient was admitted to the facility on 1/05/2021 with diagnoses including COVID - 19.

A review of Patient 12's MAR dated 1/09/2021 indicated Remdesivir 100 mg IV to administer daily at 2 pm. The MAR indicated that medication was administered at 3:08 pm on 1/09/2021.
A review of Patient 13's medical record indicated the patient was admitted to the facility on 12/27/2020 with the diagnoses including COVID - 19.

A review of Patient 13's MAR dated 1/09/2021 indicated Remdesivir 100 mg IV to administer daily at 2 pm. The MAR indicated that the medication was administered at 4:24 pm on 1/09/2021.

A review of Patient 19's medical record indicated the patient was admitted to the facility on 1/06/2021with diagnoses including shortness of breath and COVID - 19.

On 2/4/2021 at 8:40 am, during a concurrent interview and review of the pharmacy's "Compounding Log", dated 1/18/2021, the DOP stated that Remdesivir IV was one of the medications compounded in the pharmacy and should be administered within one hour of the start of the medication preparation time. The DOP confirmed that the preparation time and the expiration date and time were not documented on the log. The DOP confirmed the Compounding Log had affixed Patient 19's medication label indicating daily administration at 2 pm and stated that it should not be given after 3 pm.

A review of Patient 19's MAR, dated 1/18/2021, indicated Remdesivir 100 mg to administer via IVPB (intravenous piggyback [a secondary infusion given through a primary IV line]) daily at 2 pm. The MAR indicated Remdesivir was administered at 3:09 pm on 1/18/2021.

A review of the facility's policy and procedure titled "Sterile Compounding," dated 9/2018, indicated for any sterile compounded drug preparation compounded outside an ISO (International Organization for Standardization) class 5 PEC (Primary Engineering Control), the sterile compounded drug shall be labeled for "immediate use only." The administration shall begin no later than one hour following the start of the compounding process.

Based on observation, interview, and record review, the facility failed to meet the Condition of Participation for Pharmaceutical Services. The facility failed to:

1. Ensure forty-seven of fifty (47 of 50) pharmacy staff had current skills competency evaluations since 2019. (Refer to A 493, A 501)

2. Ensure all intravenous [(IV) - into the patient's vein) sterile (germ-free) compounding (mixing) preparations (CSPs) were performed under the supervision of a registered pharmacist. On 1/3/2021, the hospital's pharmacy IV compounding sterile area (CSA) became unusable due to a busted water pipe and flooding and caused the closure of the IV CSA at 2:30 p.m. (Refer A501)

3. Ensure patients were not subjected to a high risk of infection, potential contaminants, or expired medications throughout the facility between 1/3/2021 through 2/5/2021 due to 2,154 IV medications compounded in the pharmacy outside of a sterile environment. (Refer A501)

4. To follow the facility's policy to ensure sterile compounded medication preparation labeled 'for immediate use only' and administration began no later than one hour following the compounding process's start. Five of 33 sampled patients (Patient 1, 6, 12, 13, and 19) were administered expired IV compounded medications prepared in the facility's pharmacy for immediate use. (Refer A501)

5. Ensure the label of an IV compounded medication was not intentionally changed to reflect a new beyond-use-date (BUD- the date or time after which a compounded sterile preparation [CSP] may not be stored or transported and is calculated from the date or time of compounding). BUD defined by United States Pharmacopeia [USP - establishes quality standards for drug compounding] chapter <797>. The facility's pharmacy provided the compounded IV medication with intentionally changed time to nursing staff to administer to one of 33 sampled patients (Patient 1). (Refer to A 501)

6. Ensure an expired controlled II (narcotic medication to treat pain, high risk for addiction and dependence) medication, Fentanyl Drip IV, prepared under Immediate-Use provision, did not remain available for 24 hours after its preparation on the Intensive Care Unit for one of 33 sampled patients (Patient 2). (Refer A501, A505)

7. Ensure expired or mislabeled medications were not available for use for two of 33 sampled patients (Patient 1 and 2). (Refer to A 505)

These systemic failures' cumulative effect jeopardized patients' health and safety throughout the hospital, with 2,154 compounded IV medications intended for immediate-use. Patients admitted to the facility from 1/3/2021 to 2/5/2021 were placed at high risk for medication errors, infection, administration of potentially contaminated IV medications, and other related adverse health outcomes.

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

1. The pharmacy was staffed with a sufficient number of personnel to provide quality pharmaceutical services to meet the patients' needs, who were requiring administration of intravenous ([IV] - in the patient vein) medication, throughout the hospital and the staff providing care.

2. The pharmacy had adequate staffing to monitor and provide the appropriate controls to deliver IV compounded sterile products (CSPs) throughout the facility for administration to patients within one hour of preparation, including for patients (Patient 1, 6, 12, 13, and 19) that were administered expired medications.

3. The facility conducted IV compounding competency annually for pharmacy staff and the pharmacy staff had current IV compounding competency when compounded IV medications. Forty-seven of 50 pharmacy staff did not receive training and annual IV compounding competency since 2019.

4. A bag of an intravenous Remdesivir (an antiviral medication used to treat COVID - 19 [coronavirus disease 2019, a new virus that can spread from person to person, causing respiratory illness]) was not mislabeled to reflect an extended expiration time and was given to nursing staff for administration to Patient 1.


5. The facility had a system in place to deliver the IV compounded medications to the facility's units within one hour. The facility's dumbwaiter (pneumatic tube systems - used to transport materials safely and efficiently between two or more points) was broken and not functional.

The failure to provide sufficient pharmacy staff to provide accurate and timely order processing and medication delivery placed patients, who were requiring administration of IV medication, throughout the hospital at risk for potential harm due to expired medication and potential medication errors, including Patient 1, 6, 12, 13, and 19, who were administered an expired medication.

On February 4, 2021 at 3:50 pm, the survey team called an immediate jeopardy ([IJ] - identified non-compliance that makes serious injury, harm, impairment or death likely to occur to one or more recipients if the non-compliance is not corrected) situation in the presence of the Quality Manager/ Chief Nursing Officer (CNO), the Chief Executive Officer (CEO), the Clinical Operations Officer (COO), and the Director of Pharmacy (DOP) due to the facility's failure to:

A. Ensure 47 of 50 pharmacy staff (pharmacist, technician, and intern) had current skills competency evaluation, specifically after 1/3/2021, when the compounding (mixing) sterile (germ-free) area (CSA) flooded and was unavailable for use. As a result, IV medications were compounded for immediate-use (to be administered within one hour) outside of a compounding sterile area.

B. Ensure pharmacy was sufficiently staff to provide delivery of IV medication for immediate-use prior to expiration for five of 33 sampled patients (Patient 1, 6, 12, 13, and 19). Creating an environment for pharmacist (Pharm 1) and technician (PhT 3) intentionally changing an expired IV compounding medication expiration time on a label to make it appear as if the medication was not expired, and then provide it a Registered Nurse (RN 2) who unaware administer an expired compounded medication to Patient 1.

On February 5, 2021 at 11:57 am, after verifying an acceptable plan of action (POA) onsite, the IJ was lifted. The POA indicated pharmacy staff received an immediate education and competency validations regarding sterile medication compounding, completion of compounding logs and clarification on the immediate-use procedure. Pharmacy staff counseled in regards to employee conduct and education on sterile compounding. The DOP and Quality Leadership will have an oversight and will conduct audits of the corrections.

Findings:

a. On 2/2/2021 at 2:09 p.m., during an interview with CNO and DOP, the DOP stated that on 1/3/2021, the hospital's pharmacy IV compounding sterile area (CSA) became unusable due to a broken water pipe flooding the area. The DOP stated the IV CSA closed on 1/3/2021 at 2:30 pm, requiring the pharmacy to relocate to a clean space and prepare IV compound medication for immediate-use. DOP stated the IV compounded medication for immediate-use must be administered to patients within one hour from the time the IV medication compounding started.

During an interview and document review on 2/5/2021 at 4:55 pm, CNO provided a breakdown of the total number of IV compounded sterile products (CSP) in December 2020 that totaled 1,503 IV CSPs. The CNO confirmed the number of IV CSPs prepared in January 2021 totaled 2,154, a 43 percent increase. The CNO stated the pharmacy did not have adequate staffing to monitor and provide the appropriate controls to deliver IV CSPs throughout the facility for administration to patients within one hour of preparation, including for patients (Patient 1, 6, 12, 13, and 19) that were administered expired medications.

b. During an interview on 2/4/2021, at 8:41 am, DOP stated they were not doing annual IV compounding competency for pharmacy staff. DOP stated pharmacy staff were compounding IV medications in the pharmacy without current IV competency. DOP acknowledged that 47 of 50 pharmacy staff had not received training and annual IV compounding competency since 2019.
During an interview with the DOP on 2/3/2021, at 10:20 am, the DOP stated the facility's policy is to follow "USP <797> [United States Pharmacopeia - establishes quality standards for drug compounding]" standards of practice for sterile compounding.
A review of the facility's policy and procedure titled "Sterile Compounding," dated September 2018, indicated "Personnel who prepare compounded sterile compounds: Pharmacist, technicians, and interns who have satisfactorily completed the (hospital) Sterile Compounding Training Program ...is comprised of the following and is reassessed at least every 12 months. Training with the IV Pharmacist or Technician (observation and demonstration), hand hygiene and garbing, cleaning and disinfection of the controlled compounding area, and documentation of sterile compounding ..." The policy indicated, "Reference ...USP<797>"

c. During an interview and with pharmacist 1 (Pharm 1) and pharmacist technician 3 (PhT 3) on 2/4/2021 at 3:31 pm, PhT 3 stated they were overwhelmed in the pharmacy on 2/2/2021. The PhT 3 stated no new IV compound for Remdesivir (Veklury - an antiviral medication approved to treat COVID-19) was made for Patient 1 on 2/2/2021. PhT 3 stated on 2/2/2021 at 2:30 pm she asked Pharm 1 to change the expiration time on the label. Pharm 1 confirmed he placed the new label on top of the old label on Patient 1's IV bag of Remdesivir and that the handwriting on the new label was his. Pharm 1 confirmed that Patient 1's IV bag of Remdesivir was given to RN 2, who waited at the pharmacy to pick up Patient 1's medication. Pharm 1 stated a new IV bag was not prepared and that he extended the expiration time of the IV Remdesivir compounded medication by 10 minutes on 2/2/2021 from a preparation time of 1:30 p.m. with an expiration time of 2:30 p.m. to preparation time of 1:40 p.m., expiration time of 2:40 p.m. on the same day. Pharm 1 and PhT 3 stated they had not received any IV compounding training or competency in over two years. (Refer A501)

During an interview and record review of Patient 1 medication administration record (MAR) on 2/2/2021 at 4:24 pm with CNO, Charge Nurse (CN 1) and RN 2, RN 2 stated once she received Patient 1's IV medication Remdesivir from the pharmacy on 2/2/2021 she administered the medication to Patient 1 right away. RN 2 reviewed Patient 1's MAR and confirmed Patient 1 was administered the Remdesivir on 2/2/2021 at 2:39 pm. RN 2 was unaware an expired medication was administered to Patient 1, which had the potential for drug instability, exposure to contaminants, and increased the risk of infection for Patient 1. (Refer A501)
d. During an interview with CNO and DOP on 2/2/2021 at 2:25 pm, the DOP stated that starting 1/3/2021, the facility did not have a working CSA to make IV CSPs. DOP stated the facility's dumbwaiter (pneumatic tube systems - used to transport materials safely and efficiently between two or more points) was broken for a couple of weeks. DOP stated he did not have the human resources needed to deliver the IV compounded medications to the facility's units within one hour. DOP stated the medications do not always make it to the patients to meet the one-hour immediate use requirement. (Refer A501)

e. During an interview on 2/2/2021 at 2:46 pm, in the presence of PhT 3, the PhT 2 stated she just returned to work from leave to a new immediate-use process for compounding IV medications. PhT 2 stated she had not received training or had an IV compounding annual competency. The PhT 3 stated all pharmacy technicians are responsible for checking the medication administration time of the immediate-use IV compounded medication to patients. The PhT 3 stated she found a few IV medications not administered to patients within one hour. (Refer A501)

f. During an interview on 2/2/2021, at 4:24 pm with the Charge Nurse (CN 1) on the Medical-Surgical Unit, she stated she was aware the IV compounded medication from the pharmacy must be administered to the patient within one-hour or to notify the pharmacy to make a new IV compound if the medication expired. CN 1 stated the pharmacy calls the nursing station when the IV compound is ready for pickup. CN 1 stated any nursing staff could pick up compounding medication from the pharmacy, and only RNs must pick up controlled drugs.

g. During an interview on 2/4/2021, at 3:04 pm with PhT 3 and Pharm 1, the PhT 3 stated, "Before, when a nurse on a unit would miss a medication, we would put it into the dumbwaiter and send to them. Now that the dumbwaiter has broken, the nurses have to come to the pharmacy to pick up the medications. Nurses do not pick up the medications timely after we call several times. It is overwhelming in the pharmacy. Adding things to do, but not adding new people." Pharm 1 stated, "The distribution system has a lot to be desired. No Pyxis (automated medication delivery system), dumbwaiter (pneumatic tube) broken, remodeling the pharmacy. We do not have the staff to deliver medications to the units. Nurses are busy and do not have time to keep running to the pharmacy for medication pickup. They should have a messenger at night. There are only two people in the pharmacy, one pharmacist and one technician, and the same for the graveyard shift."

h. During an interview on 2/3/2021 at 10:20 am, DOP stated, "We need extra help in the Intensive Care Unit to check the administration of the compounded IV drips to patients (patients administered immediate-use IV CSPs). Will reassign a pharmacy staff to focus on the IV drip administration starting today (2/3/2021). Late administration of IV medications flagged. Have not had a chance to follow-up."

During an interview and record review on 4/4/2021, at 8:02 am, DOP provided the pharmacy staff schedule for the months of December 2020, January 2021, February 2021 and stated five pharmacists are working during the day. One pharmacist and one technician are working during the evening and one pharmacist and one technician work during night shift. DOP stated there was no designated pharmacist per shift to oversee IV compounding. The DOP stated there was not enough staff to provide timely delivery of immediate-use IV CSP, verify administration to the patient within one hour of preparation, and audit for expired medications to ensure patients including (Patient 1, 6, 12, 13, and 16) would not be administered expired medications.

Based on observation, interview and record review, the facility failed to ensure nine of 33 sample patients whom received intravenous (IV - into the patient's vein) compounded (mixing) sterile (germ-free) preparations (CSPs) were performed under the supervision of Registered Pharmacist in accordance with standard of practice.

On 1/3/2021 at 2:30 p.m., the facility's pharmacy IV compounding sterile area (CSA) became unusable due to a broken water pipe flooding the area and caused closure to the IV CSA.


The facility failed to:

1. Ensure facility written policies and procedures titled, "Sterile Compounding" dated September 2018 and indicated "Reference ... United States Pharmacopeia (USP - establishes quality standards for drug compounding that are free from contaminants and are consistent in intended identity, strength and potency. It describes a number of requirements, including responsibilities of compounding personnel, training, environmental monitoring, storage...) chapter <797> were implemented for pharmacy staff compounding IV drugs.


2. Ensure to demonstrate that pharmacy staff were trained and had evidence of competency assessment before preparing IV drug compounding. Forty-seven of 50 pharmacy staff (pharmacist [Pharm], technicians [PhT], and interns) did not have current skills competency evaluations, specifically after 1/3/2021, CSA flooded and was unavailable for use, resulting in IV medications for immediate-use (to be administered within one hour) to be compounded at another location, failing to maintain a sterile compounding area.


3. Follow chapter <797> of a current USP for the "Immediate-Use" provision (criteria) that required administration (direct application of a sterile medication to a single patient by injection, infusing, or otherwise providing a sterile medication in its final form) to patient within one hour from the start of the IV compounding for five of 33 sampled patients (Patient 1, 6, 12, 13, and 19). The "Immediate-Use" provision is intended only for those situations where there is a need for emergency or immediate patient administration of a compounded sterile preparation (CSP), such as cardiopulmonary resuscitation (CPR - emergency procedure) or emergency room (area of the hospital to treat severe medical conditions immediately) treatment.


4. Ensure the "Immediate-Use" provision was followed to ensure registered pharmacist supervised pharmacist technicians who compounded IV CSP for three of 33 sampled patients (Patient 27, 31, and 32). Facility failed to ensure the pharmacist (Pharm 2) performed compounding pre-check and post-check of all IV CSP before medications administered to patients, and failed to ensure medication's label accuracy and accuracy of the addition of all drug products or ingredients used to prepare the finished sterile product and their volumes or quantities.

5. Ensure an expired controlled II (narcotic medication to treat pain, with high risk for addiction and dependence) medication, IV Fentanyl Drip prepared under Immediate-Use provision did not remain available for use 24 hours after preparation on the Intensive Care Unit for patient use, for one of 33 sampled patients (Patient 2).


These failures jeopardized patients' health and safety throughout the hospital admitted between 1/3/2021 through 2/5/2021 and placed patients at high risk for medication errors, administration of potentially contaminated IV medications prepared in the pharmacy, and increased patients' risk of adverse health outcomes, including infections.

On February 4, 2021 at 3:50 pm, the survey team called an immediate jeopardy (IJ, identified non-compliance that makes serious injury, harm, impairment or death likely to occur to one or more recipients if the non-compliance is not corrected) situation in the presence of the quality manager/chief nursing officer (QM/CNO), the chief executive officer (CEO), clinical operating officer (COO), and the director of pharmacy (DOP).

a. Ensure 47 of 50 pharmacy staff had current skills competency evaluation, specifically after 1/3/2021, when the compounding (mixing) sterile (germ-free) area (CSA) flooded and was unavailable for use. As a result intravenous (IV, in the vein) medications were compounded for immediate-use (to be administered within one hour) outside of a compounding sterile area.

b. Ensure pharmacy staff would not intentionally change the expired IV compounding medication expiration time on a label to make it appear as if the medication was not expired, and then provide the nursing staff to administer an expired compounded medication to Patient 1.

On February 5, 2021 at 11:57 am, after verifying an acceptable plan of action (POA), the IJ was lifted in the presence of QM/CNO, CEO, and COO. The POA indicated pharmacy staff received an immediate education and competency validation regarding sterile medication compounding, completion of compounding logs, and clarification on the immediate-use procedure. Pharmacy staff were counseled in regards to employee conduct and education on sterile compounding. The DOP and Quality Leadership will have an oversight and will conduct audits of the corrections.

Findings:

1. During an interview with the Director of Pharmacy (DOP) on 2/2/2021, at 2:09 pm., stated there was a "flood in the hospital's pharmacy compounding area, and the hospital stopped using the CSA on 1/3/2021 at 2:30 pm.

During an interview with the DOP and Chief Nursing Officer/Risk Manager (CNO) on 2/2/2021 at 2:25 pm, they stated pharmacist and technicians were making IV compounds for immediate-use since 1/3/2021 in an unclassified space (a space not required to meet any air cleanliness classification based on International Organization for Standardized [ISO]).


During an interview with the DOP and CNO on 2/2/2021 at 2:25 pm, the DOP stated the hospital did not develop and did not implement a policy and procedure to guide the process for pharmacist and technicians who prepared the sterile IV compounding for immediate use.

On 2/2/2021 at 2:25 pm, during an interview, the CNO stated the pharmacy provide IV compounds for immediate-use to multiple departments that include but not limit to Emergency Room (ER), Intensive Care Unit (ICU), Neonatal (very young or premature babies) ICU, Labor and Delivery, and Medical-Surgical [(Med/Surg) - care for primarily adult patients before and after surgical procedures].

On 2/2/2021 at 4:24 pm, during an interview on Med/Surg Unit with CNO on February 2, 2021, at 4:24 pm, stated nursing staff notified of new IV administration time during a daily huddle (a short meeting). CNO stated the hospital had not developed and implemented a policy and procedure to guide the process for sterile IV compounding for immediate use.


During an interview on 2/3/2021, at 10:20 am, the DOP stated the facility's policy was to follow "USP chapter <797> [United States Pharmacopeia - establishes quality standards for drug compounding]" standards of practice for sterile compounding.

During an interview on 2/5/2021 at 4:55 pm, CNO provided documentation indicating there were compounded 2,154 IVs in the hospital pharmacy intended for immediate-use, from 1/3/ 2021 through 1/31/2021.

A review of the facility provided policy and procedure titled "Sterile Compounding" dated September 2018 indicated, "Policy ... All admixtures compounded by Pharmacy Department personnel will be performed in the laminar flow hood using aseptic techniques ... Policy and procedures shall be reviewed annually by the pharmacist-in-charge. Documentation of review included above. Staff (Pharmacist and technicians) assigned to compounding duties will be notified of any changes in policy and procedures through receipt of updated policy/procedure ...Reference ...USP <797>." The facility failed to update and implement their policy and procedure for IV sterile compounds prepared by facility's pharmacist and technicians when the facility CSA became unavailable on 1/3/2021 in accordance with facility referenced USP <797>.


A review of the currently official versions of General Chapter <797> (last revised in 2008) remain official, the section titled, "INTRODUCTION" indicated, "The objective of this chapter is to describe conditions and practices to prevent harm, including death, to patients that could result from (1) microbial [germ] contamination (nonsterile) ...The standards in this chapter are intended to apply to all persons who prepare CSPs and all places where CSPs are prepared (e.g., hospitals and other healthcare institutions, patient treatment clinics, pharmacies, physicians' practice facilities, and other locations and facilities in which CSPs are prepared, stored, and transported). Persons who perform sterile compounding include pharmacists, nurses, pharmacy technicians, and physicians. These terms recognize that most sterile compounding is performed by or under the supervision of pharmacists in pharmacies. This chapter also applies to all healthcare personnel who prepare, store, and transport CSPs." The facility failed to implement their policy and procedure for IV sterile compounds prepared by facility's pharmacist and technicians when the facility CSA became unavailable on 1/3/2021 in accordance with facility referenced USP <797>.


A review of the currently official versions of General Chapter <797> (last revised in 2008) remain official, the section titled, "IMMEDIATE-USE CSPs," indicated, "The immediate-use provision is intended only for those situations where there is a need for emergency or immediate patient administration of a CSP. Such situations may include cardiopulmonary resuscitation, emergency room treatment, preparation of diagnostic [to determine disease] agents, or critical therapy where the preparation of the CSP under conditions described Low-Risk Level CSPs (risk-level [LOW, MEDIUM, or HIGH] is assigned according to the corresponding probability of contaminating a CSP) subjects the patient to additional risk due to delays in therapy. Immediate-use CSPs are not intended for storage for anticipated needs or batch compounding (compounding two or more finished sterile preparation units at the same time, for administration to more than one patient)." The facility failed to update and implement their policy and procedure for immediate-use IV sterile compounds prepared by facility's pharmacist and technicians when the facility CSA became unavailable on 1/3/2021 in accordance with facility referenced USP <797>.


A review of the currently official versions of General Chapter <797> (last revised in 2008) remain official, the section titled, "Personnel Training and Competency Evaluation of Garbing [attire], Aseptic [clean] Work Practices, and Cleaning/Disinfection Procedures" indicated, "Personnel who prepare CSPs shall be trained conscientiously and skillfully by expert personnel ...This training shall be completed and documented before any compounding personnel begins to prepare CSPs." The facility failed to implement their policy on personnel training and competency before preparing IV sterile compounds by facility's pharmacist and technicians in accordance with facility referenced USP <797>.


A review of the currently official versions of General Chapter <797> (last revised in 2008) remain official, the section titled, "Maintaining, Sterility, Purity, and Stability of Dispensing and Distributed CSPs," indicated, "This section summarizes the responsibilities of compounding facilities for maintaining quality and control of CSPs that are dispensed and administered within their parent healthcare organizations ...In fulfilling this general responsibility, the compounding facility is responsible for ...the appropriate education, training, and supervision of compounding personnel assigned to these functions ...Establishing, maintaining, and ensuring compliance with comprehensive written policies and procedures encompassing these responsibilities is a further responsibility of the compounding facility." The subsection titled "Education and Training" indicated, "Compounding personnel shall design, implement, and maintain a formal education, training, and competency assessment program."

A review of the currently official versions of General Chapter <797> (last revised in 2008) remain official, the section titled, "Quality Assurance (QA) Program" indicated, "Characteristics of a QA program include the following ...Formalization (to make official) in writing."


2. During an interview on 2/2/2021, at 3:05 pm, the DOP stated the hospital pharmacy is compounding IV for "Immediate-Use." DOP stated IV compounding conducted in an unclassified space inside the pharmacy that was outside of an International Organization for Standardization (ISO) Class 5 sterile compounding area [(ISO Class 5)-is a controlled environment that complies with the proper air cleanliness, room pressures, and air changes per hour to prevent IV contamination].

On 2/4/2021, at 8:01 am, during an interview and record review, DOP provided records of Sterile Product Preparation competencies conducted with pharmacy staff in 2019 and 2020. These records indicated four (four pharmacist and zero pharmacy technicians and zero pharmacy interns) of 50 pharmacy staff received annual IV compounding training and competency review in 2019, and three of 50 pharmacy staff (one pharmacist, two pharmacy technicians, and zero pharmacy interns) documented to have received training and annual IV compounding competency in 2020.

During an interview on February 4, 2021, at 8:41 am, DOP stated they did not conduct annual IV compounding competency for pharmacy staff. DOP stated pharmacy staff are involved in compounding IV medications in the pharmacy without current IV competency. DOP acknowledged 47 of 50 pharmacy staff had not received training and annual IV compounding competency in 2020.

On 2/4/2021 at 1:17 pm, during an interview and record review of quality assessment and improvement (QAPI) minutes dated 2/1/2020, Pharmacy and Therapeutics (P&T) minutes dated 2/25/2020, 7/14/2020, and 11/17/2020, and medical executive committee (MEC) minutes dated 1/27/2021 related to IV compounding and competency with CNO and Director of Medical Staff (DMS), CNO stated that the QAPI committee last met 2/1/2020. CNO stated there was no discussion or documentation in the QAPI or P&T minutes addressing the CSA disruption for IV preparation, relocation for Immediate-Use IV compounding, training, or competency. DMS stated MEC last met on 1/27/2021 and there was no documentation in the MEC minutes that addressed the IV CSA room's flooding or change in IV compounding of CSP for Immediate-Use. DMS reviewed the P&T committee minutes and stated there was no documentation the P&T discussed or addressed the IV flooding in the pharmacy. DMS stated the P&T committee next meeting scheduled for 2/19/2021.

Concurrently, the DOP, CNO, Chief Operating Officer (COO), Chief Executive Officer (CEO), were requested to provide documentation to demonstrate training and dated competencies on each pharmacy staff IV compounding. DOP stated he could not produce documentation to demonstrate each pharmacy staff involved with IV compounding was trained and competent before compounding IV medications.

During an interview with the DOP on 2/3/2021, at 10:20 am, the DOP stated the facility's policy was to follow "USP <797> [United States Pharmacopeia - establishes quality standards for drug compounding]" standards of practice for sterile compounding.

A review of the facility's policy and procedure titled "Sterile Compounding" dated September 2018, indicated "Personnel who prepare compounded sterile compounds: Pharmacist, technicians, and interns who have satisfactorily completed the (hospital) Sterile Compounding Training Program ...is comprised of the following and is reassessed at least every 12 months. Training with the IV Pharmacist or Technician (Observation and demonstration), Hand hygiene and garbing, Cleaning and disinfection of the controlled compounding area, and Documentation of sterile compounding ..." The Policy indicated, "Reference ...USP<797>"


3a. During an interview on 2/2/2021, at 2:09 pm, the DOP stated there was a "flood in the facility's pharmacy compounding area, and the hospital stopped using the CSA on 1/3/2021 at 2:30 pm. DOP stated the hospital pharmacy is using a temporary clean space for immediate-use IV compounding only.

During an observation of the compounding pharmacy area on 2/2/2021 at 2:09 pm in the presence of DOP, there was an IV bag filled with medication and labeled for Patient 1 observed on a cart.

During an interview on 2/2/2021 at 2:20 pm, in the presence of DOP, CNO, and pharmacist technician 1 (PhT 1), the PhT 1 stated the observed IV bag medication was a completed compounded IV medication labeled for Patient 1. The PhT 1 stated that the IV compounding log's preparation time is the time after IV compound preparation is complete and then given an expiration time of one hour for immediate use.

A review of the IV compounding log, dated 2/2/2021, indicated a "Prep Time" of 13:30 (1:30 pm). The beyond-use-date (BUD as defined by USP <797> as the date or time after which a compounded sterile preparation [CSP] may not be stored or transported and is calculated from the date or time of compounding) of 2/2/2021 at 14:30 (2:30 pm). The IV bag was labeled for Patient 1 and contained Remdesivir (Veklury - is an antiviral medication approved to treat COVID-19) 100 milligrams (mg) diluted in Sodium Chloride (salt) 0.9% (concentration) 250 milliliters (ml).

During an interview on 2/2/2021 at 2:25 pm, DOP stated the preparation time should be the time at the start of compounding and not the compound's completed time under the provision for immediate use for IV compounding.

During record review and concurrent interview with CNO, Charge Nurse (CN 1), and Registered Nurse (RN 2) on 2/2/2021 at 4:23 pm, Patient 1's Medication Administration Record (MAR) was reviewed and indicated Remdesivir 100 mg administration started at 2:39 pm (nine minutes after the BUD). RN 2 stated she pick-up the IV compounded medication from the pharmacy at 2:30 pm and administered the medication right away. Nothing stood out to her on the IV bag that would alert her the medication had expired.

On 2/3/2021 at 8:47 am, CNO provided a picture of a labeled IV bag with Patient 1's name and stated administered to the patient the day before on 2/2/2021. After comparing the compounding log records, a copy of the label prepared by PhT 1 with the picture provided by CNO, CNO stated the label on the IV bag of Remdesivir for Patient 1 had different handwriting. It did not match the prep time and the BUD time of the original label. CNO stated he would have to investigate.

During an interview with the DOP on 2/3/2021, at 10:20 am, DOP stated the facility's policy was to follow "USP <797> [United States Pharmacopeia - establishes quality standards for drug compounding]" standards of practice for sterile compounding.

During an interview with CNO and DOP on 2/4/2021 at 8:54 a.m., stated the IV compounded Remdesivir for Patient 1was administered later than one-hour after compounded on 2/2/2021. DOP stated there was no new compounding log to indicate a new Remdesivir IV bag was made for Patient 1 before administering the medication to the patient. CNO confirmed there was no new compounding log for Patient 1's Remdesivir medication. The "Immediate-Use" provision (criteria) described in the current USP chapter <797> was not followed to administer IV compounded medication within one hour from the start of IV compounding.

During an interview with Registered Pharmacist (Pharm 1) and PhT 3 on 2/4/2021 at 3:31 pm, PhT 3 stated they were overwhelmed in the pharmacy on 2/2/2021. The PhT 3 stated a new IV compound for Remdesivir was not made for Patient 1 on 2/2/2021. PhT 3 stated she asked Pharm 1 on 2/20/201 at 2:30 p.m. to change the expiration time on the label. Pharm 1 confirmed he placed the new label on top of the old label on Patient 1's IV bag of Remdesivir and that the handwriting on the new label was his. Pharm 1 confirmed that Patient 1's IV bag of Remdesivir dated 2/2/2021 was given to RN 2, who waited at the pharmacy to pick up Patient 1's medication. Pharm 1 stated a new IV bag was not prepared and that he extended the expiration time of the IV Remdesivir compounded medication by 10 minutes on 2/2/2021 from a preparation time of 1:30 p.m. with an expiration time of 2:30 p.m. to preparation time of 1:40 p.m., expiration time of 2:40 p.m. on the same day. Pharm 1 and PhT 3 stated they had not received any IV compounding training or competency in over two years.

During an interview and record review of Patient 1 medication administration record (MAR) on 2/2/2021 at 4:24 pm with CNO, Charge Nurse (CN 1) and RN 2, RN 2 stated once she received Patient 1's IV medication Remdesivir from the pharmacy on 2/2/2021 she administered the medication to Patient 1 right away. RN 2 reviewed Patient 1's MAR and confirmed Patient 1 was administered the Remdesivir on 2/2/2021 at 2:39 pm. RN 2 was unaware an expired medication was administered to Patient 1, which had the potential for drug instability, exposure to contaminants, and increased the risk of infection for Patient 1.

A review of the facility's policy and procedure titled "Sterile Compounding" dated September 2018 indicated, "For any sterile compounded drug preparation compounded outside of an ISO Class 5 ... the sterile compounded drug preparation shall be labeled 'for immediate use only' and administration shall begin no later than one hour following the start of the compounding process."

A review of the facility's policy and procedure titled "Sterile Compounding" dated September 2018 indicated "Reference ...USP <797>."

A review of the currently official versions of General Chapter <797> (last revised in 2008) remain official, the section titled, "Personnel Training and Competency Evaluation of Garbing [attire], Aseptic [clean] Work Practices, and Cleaning/Disinfection Procedures" indicated, "Personnel who prepare CSPs shall be trained conscientiously and skillfully by expert personnel ...This training shall be completed and documented before any compounding personnel begin to prepare CSPs."


3b. On 2/3/2021 at 12:30 pm, Patients 6, 12, and 13's IV compounding logs were reviewed. The compounding log dated 1/9/2021 indicated that IV Remdesivir 100 mg diluted in Sodium Chloride 0.9% 250 ml solution was compounded for Patient 6, 12, and 13. Compounding labels had an administration time of "daily at 2 pm" for each patient. The compounding log was missing IV compounding preparation time and BUD (expiration) time.

During an interview and review of compounding logs with the DOP on 2/4/2021, at 8:41 am, DOP confirmed compounding logs were incomplete. DOP stated pharmacist should verify the compounding log to ensure it is complete with the start time of IV compounding, beyond-use-date (expiration date and time) and initials documented on the log to confirm the product meets standard.

A review of the Medication Administration Record (MAR) dated 1/9/2021 indicated the following:

a. Patient 6's physician order indicated to administer Remdesivir IV daily at 2 pm. According to MAR, documented administration time was 3:14 pm.

b. Patient12's physician order indicated to administer Remdesivir IV daily at 2 pm. According to MAR, documented administration time was 3:08 pm.

c. Patient13's physician order indicated to administer Remdesivir IV daily at 2 pm. According to MAR, documented administration time was 4:24 pm.

On 2/3/2021 at 12:30 pm, IV compounding logs were reviewed for Patient 19. The compounding log dated 1/18/2021 indicated that Remdesivir 100 mg IV diluted in Sodium Chloride 0.9% 250 ml solution compounded for Patient 19. Patient 19's compounding label had documented administration time of at 2:00 pm daily. The compounding log was missing IV compounding preparation time and BUD (expiration) time.

A review of the Medication Administration Record (MAR) dated 1/18/2021 indicated the following:

d. Patient 19's physician order indicated to administer Remdesivir IV daily at 2 pm. According to MAR, documented administration time was 3:09 pm.

During an interview with DOP on 2/2/2021 at 2:25 pm, DOP stated the pharmacy was not notified when IV compound medication intended for immediate use was not administered within one hour for patients (Patient 6, 12, 13, and 19). DOP stated the pharmacist should check the IV compounding ingredients before starting to compound and the pharmacy technician should document preparation time at the start of IV compounding. DOP stated the facility had no process in place to review or track late IV compounded medication administration to patients, or a process to monitor potential adverse reactions to patients due to administration of expired or contaminated IV medication, which could increase the risk of infection for Patients 6, 12, 13, and 19.

A review of the facility's policy and procedure titled "Sterile Compounding" dated September 2018 indicated, "For any sterile compounded drug preparation compounded outside of an ISO Class 5 ... the sterile compounded drug preparation shall be labeled 'for immediate use only and administration shall begin no later than one hour following the start of the compounding process".


4. During observation and concurrent interview on 2/5/2021 at 2:03 pm, with CNO, DOP, and Pharm 2, there was seven prepared IV bag of medication observed on a cart inside the pharmacy with the corresponding compounding logs for Patient 27, 31, and 32. Pharm 2 stated they were completed compounded IV medications for him to check them. Pharm 2 stated he did not initial under 'Pre-check" on the compounding logs. Pharm 2 stated, "I did not have a chance to sign off before the technician compounded the medication." Pharm 2 stated he could not determine the accuracy of the completed IV compounded bags without conducting a pre-check of ingredients and quantity. Pharm 2 stated he checked 30 IV compounded medication today, 2/5/2021. Pharm 2 stated, "I have not had IV compounding training at this job."

During a concurrent interview with CNO and DOP, DOP stated, Pharm 2 was covering during lunch and does not usually work with IV compounding. DOP confirmed that Pharm 2 had not completed an IV compounding competency upon hire last year.

During an interview on 2/4/2021 at 8:41 am, DOP stated a pharmacist should verify the ingredients, strength, and calculations before compounding begins, initial compounding Log, and perform a final check of the completed compound to verify the product meets the standard.

A review of the facility's policy and procedure titled "Sterile Compounding" dated September 2018 indicated, "Ingredients and compounding process approved by the supervising pharmacist for each preparation before compounding begins."

5. During an interview, 2/2/2021 at 3:54 pm, with CNO, Director of ICU (DICU), and Registered Nurse (RN 1), RN 1 stated IV compounded medications prepared at the hospital pharmacy was for immediate-use and must be administered to the patient within one hour of the start of preparation time.

During a concurrent observation and interview with CNO, DICU, and RN 1 on 2/2/2021 at 3:54 pm, RN 1 opened a locked cabinet inside the ICU main medication room and removed an unused IV bag medication. RN 1 stated IV compound labeled for Patient 2. The label listed the main ingredient as IV injectable Fentanyl. RN 1 stated Patient 2's IV Fentanyl Drip observed in the ICU medication room on 2/2/2021 had expired on 2/1/2021 at 1400 (2 pm) and not administered to Patient 2. RN 1 said she should have notified the pharmacist when the medication expired and returned the expired narcotic medication as soon as possible the same day it expired to the pharmacy.

During an interview with CNO, DICU, and ICU Pharmacist (Pharm 2) on 2/2/2021 at 3:50 pm, Pharm 2 stated responsibilities include reviewing ICU patient medications administration records, antibiotic therapy, verifying IV compounded medication orders, and sending physician orders to the pharmacy. Pharm 2 stated provides notification to ICU RNs when the IV compounded medication for patients are ready for pick-up from the pharmacy. Pharm 2 was asked if he reviews the administration time for immediate-use compounded IV, Pharm 2 stated, "Do not look at time IV compounded medication is administered. Just make sure it is given to the patient."

During an interview with DOP on 2/2/2021 at 2:25 pm, DOP stated the pharmacy/pharmacist are not notified when IV compound medication intended for immediate use was not administered in one hour and should document preparation time at the start of IV compounding. DOP stated there was no process for late medication administration. The patient's impact could be the administration of expired or contaminated IV medication and increasing patients' risk of infection.

A review of the facility's policy and procedure titled "Sterile Compounding" dated September 2018 indicated, "If the medication administration has not begun within one hour following the start of the compounding process, the compounded sterile preparation shall be promptly, properly, entirely, and safely discarded."

Based on observation, interview, and record review, the facility failed to ensure expired and mislabeled medications were not available for use for two of 33 sampled patients (Patient 1 and 2). The facility failed to:

1. Ensure Patient 1's, intravenous [(IV)-given in the vein] Remdesivir (an antiviral medication used to treat COVID - 19 [coronavirus disease 2019, a new virus that can spread from person to person, causing respiratory illness]) bag was not mislabeled to reflect an extended expiration time and was given to nursing staff for administration to Patient 1.

2. Ensure Patient 2's Fentanyl (a narcotic used to treat severe pain and considered a type of controlled substance [A drug or other substance that the government tightly controls because it may be abused or cause addiction] dose was returned to the pharmacy after it expired.

These deficient practices resulted in Patient 1 receiving an expired medication and placed Patient 2 at high risk to receive an expired medication with associated outcomes, including
infection.

On February 4, 2021 at 3:50 pm, the survey team called an immediate jeopardy [(IJ)- identified non-compliance that makes serious injury, harm, impairment or death likely to occur to one or more recipients if the non-compliance is not corrected] situation in the presence of the Quality Manager/Chief Nursing Officer (QM/CNO), the Chief Executive Officer (CEO), the Clinical Operations Officer (COO), and the Director of Pharmacy (DOP) due to the facility's failed to:

1. Ensure 47 of 50 pharmacy staff had current skills competency evaluations, specifically after 1/3/2021, when the compounding (mixing) sterile (germ-free) area (CSA) flooded and was unavailable for use. As a result intravenous [(IV)- in the vein] medications were compounded for immediate-use (to be administered within one hour) at another location.

2. Ensure the pharmacy staff intentionally would not changed the expired IV compounding medication expiration time on a label to make it appear as if the medication was not expired, and then provide the nursing staff to administer an expired compounded medication to Patient

On February 5, 2021 at 11:57 am, after verifying an acceptable plan of action (POA), the IJ was lifted. The POA indicated pharmacy staff received an immediate education and competency validations regarding sterile medications compounding, completion of compounding logs, and clarification on the immediate-use procedure. Pharmacy staff was counseled in regards to employee conduct and education on sterile compounding. The DOP and the Quality Leadership will have an oversight and will conduct audits of the corrections.

Findings:

During an interview on 2/02/2021 at 2:03 pm, the Director of Pharmacy (DOP) stated that on 1/3/2021, the room was used for sterile IV compounding (mixing two or more medications to be given in the vein) of drugs was flooded and currently inoperable. The DOP stated they were using a different location for the compounding of IV medications. The IV compounded medications were for immediate-use. The DOP stated some of the immediate use compounded medications included Remdesivir and Fentanyl. The compounded medication should be used or administered within one hour of the start of the preparation time.

On 2/2/2021, at 3:08 pm, during an interview, the DOP stated the medication's sterility may be compromised and may cause infections to patients if administered after an hour of its' start preparation time.

1. On 2/2/2021 at 2:03 pm, in the pharmacy, observed an IV bag labeled with Patient 1's name. The label indicated the bag contained Remdesivir (an antiviral medication used to treat COVID - 19 [coronavirus disease 2019, a new virus that can spread from person to person, causing respiratory illness]) 100 milligrams (mg) in 250 milliliters (ml) of 0.9 percent (%) Normal Saline [(NS), a mixture of salt and water]. The label indicated the medication was compounded (mixed) on 2/02/2021 at 1:30 pm and indicated not to start administering the medication after 2/02/2021 at 2:30 pm. The label also indicated to contact the pharmacy immediately to remake the IV bag if it expired. The facility provided a copy of the medication along with medication labels.

During an observation of the medical-surgical (M/S) unit and interview with the registered nurse (RN 2), on 2/02/2020 at 4:38 pm, Patient 1's room door was closed. RN 2 stated Patient 1 was discharged today at 4:06 pm. The door was closed for 30 minutes after discharge for terminal cleaning (cleaning method used in healthcare environments to control infection spread).

During an concurrent interview and review of Patient 1's medication administration record (MAR), on 2/2/2021 at 2:45 pm, the pharmacy technician (Pharm tech 2) stated the pharmacy kept track of the administration times of IV compounded medications to ensure the medications were administered within one hour after the medication was prepared. Pharm tech 2 stated the time of administration was checked in the patient's MAR and documented on the compounding log. Pharm tech 2 checked Patient 1's MAR and stated that Remdesivir 100 MG with 250 ml of NS was administered at 2:39 pm and should have been administered before 2:30 pm.

During a concurrent interview and review of Patient 1's medication administration record (MAR) on 2/02/2021 at 4:41 pm, RN 2 stated she was aware that Patient 1's medication Remdesivir had to be given within one from the time it was prepared. RN 1 stated she administered Patient 1's medication as soon as she received it. RN 2 reviewed the MAR and stated she administered the Remdesivir at 2:39 pm on 2/02/2021. RN 2 stated she did not check the expiration date and time on Patient 1's medication label and administered it right away. RN 2 said she had not realized the medication was given after the expiration time, of 2:30 pm.


During an interview, on 2/03/2021 at 9:49 am, the associate chief nursing officer (CNO) provided a photograph of the Remdesivir bag administered to Patient 1 on 2/2/20 at 2:39 pm. The CNO stated the charge nurse (CN 1) and RN 2 had taken a photograph. The CNO compared the copy of the Pharmacy label and the picture provided by CN 1 and RN 2 and stated that the writing on the labels looked different. The label on the photograph indicated the medication was prepared on 2/2/2021 at 1:40 pm and contained the instruction not to start administering the medication after 2/02/2021 at 2:40 pm. The CNO stated there was no documented evidence in the pharmacy's "Compounding Log", dated 2/02/2021, to account for the preparation of the second bag of Remdesivir at 1:40 pm for Patient 1. The CNO stated that only one bag of Remdesivir was prepared for Patient 1, and there was only one Log to account for it. The CNO stated a second bag of Remdesivir should have been prepared because the medication administered to Patient 1 expired at 2:30 pm on 2/2/2021.

During an interview on 2/04/2021 at 3:04 pm, the pharmacy technician (PhT 3) stated that on 2/02/2021, she was aware that Patient 1's Remdesivir expired at 2:30 pm. PhT 3 stated nursing staff arrived to pick up Patient 1's medication at 2:35 pm. PhT 3 asked the pharmacist (Pharm 1) to change the label on Patient 1's medication to add additional 10 minutes to the expiration time and change the time to 2:40 pm. PhT3 stated she provided Pharm 1 with a new label, and he changed the preparation date and time to 2/02/2021 at 2:40 pm with the instruction not to administer after 2/02/2021 at 2:40 pm. PhT3 stated Pharm 1 placed the new label on top of the previous label on Patient 1's Remdesivir bag and then gave it to nursing staff for patient's administration.

During a concurrent interview, on 2/4/2021 at 3:21 pm, Pharm 1 observed the photograph of Patient 1's Remdesivir bag with the new label indicating a new preparation time of 1:40 pm and expiration time of 2:40 pm. Pharm 1 stated he made the new label for Patient 1 and verified it was his handwriting. Pharm 1 said PhT3 asked him to add ten more minutes to the expiration time. Pharm 1 stated it was just 10 minutes more. Pharm 1 confirmed it was the same bag with a new label placed on top of the previous label.

A review of Patient 19's medical record indicated the patient was admitted to the facility on 1/06/2021 with diagnoses including shortness of breath and COVID - 19.

A review of the Policy and procedure titled "Sterile Compounding', dated 9/2018, indicated for any sterile compounded drug preparations compounded outside an ISO (International Organization for Standardization) class 5 PEC (Primary Engineering Control), the sterile compounded drug shall be labeled for "immediate use only' and administration shall begin no later than one hour following the start of the compounding process.

2. On 2/2/2021 at 3:54 pm, during a concurrent interview and observation of the medication room in the Main Intensive Care Unit (ICU), in the presence of the Director of ICU (DICU), the registered nurse (RN 1) stated IV compounded medications (two or more combined drugs) prepared at the facility's pharmacy were for immediate-use and must be administered to the patient within one hour of the preparation start time. RN 1 stated only RNs could pick-up IV compounded narcotics (a type of pain medication that can have a severe side effect, such as addiction) from the pharmacy. RN 1 opened a locked cabinet inside the Main ICU medication room and removed an unused IV bag of medication. The medication was labeled for Patient 2 and indicated it contained an injectable IV Fentanyl Drip (a narcotic used to treat severe pain given continuously through the vein) with a preparation date and time of 2/1/2021 at 2 pm and expiration date and time of 2/1/2021 at 3 pm. RN 1 stated Patient 2's IV Fentanyl Drip observed in the ICU medication room on 2/2/2021 at 3:54 pm was expired and not administered to Patient 2. RN 1 said she should have notified the pharmacy and returned the expired narcotic medication.

A review of Patient 2's medical record indicated the patient was admitted to the facility on 1/26/2021 with diagnoses including COVID - 19.

A review of the facility's policy and procedure titled "Medication Management: Controlled Substances", dated 7/2019, indicated when a controlled substance is no longer needed, it should be returned to the pharmacy.

Based on interviews and record review, the facility failed to ensure intravenous [(IV) - into the patient's vein] sterile (germ-free) compounding (mixing) preparations start time (CSPs) or medications were administered within one hour of its preparation time for five of 33 sampled patients (Patients 1, 6, 12, 13, and 19).

This deficient practice resulted in the administration of expired and potentially contaminated IV compounded medication to Patient 1, 6, 12, 13, and 19, placing patients at high risk for acquiring an infection and other associated outcomes.

Findings:

During an interview, on 2/02/2021 at 2:03 pm, the Director of Pharmacy (DOP) stated that on 1/03/2021 at 2:30 pm there was flooding in the facility's pharmacy compounding sterile area (CSA), and it was currently not in use. The DOP stated they were using a different location for the compounding of IV medications. The IV compounded medications were for immediate-use. The DOP stated some of the immediate use compounded medications included Remdesivir (an antiviral drug used to treat COVID - 19 [coronavirus disease 2019, a new virus that can spread from person to person, causing respiratory illness]). The compounded medications should be used or administered within one hour of the start of the preparation time. Also, at 3:08 pm, the DOP stated the medication's sterility may be compromised and may cause infections to patients if administered after one hour of its' preparation start time.

During an observation on 2/02/2021 at 2:03 pm, there was an IV bag labeled with Patient 1's name in the pharmacy. The label indicated the bag contained Rremdesivir 100 milligrams (mg) in 250 milliliters (ml) of 0.9 percent (%) s Normal Saline [(NS)- a mixture of salt and water]. The label indicated the medication was compounded (mixed) on 2/02/2021 at 1:30 pm and indicated administer after 2/02/2021 at 2:30 pm. The label also indicated to contact the pharmacy immediately to remake the IV bag if it expired.

During a concurrent interview and review of Patient 1's medication administration record (MAR), on 2/2/2021 at 2:45 pm, the pharmacy technician (PhT 2) stated the pharmacy kept track of the administration times of IV compounded medications to ensure the medications were administered within one hour after the medication was prepared. PhT 2 stated the administration time was checked in the patient's MAR and documented on the compounding Log. PhT 2 reviewed Patient 1's MAR and stated that Remdesivir 100 mg in 250 ml of NS was administered at 2:39 pm and should have been administered before 2:30 pm.

During an interview and review of Patient 1's MAR, on 2/2/2021 at 4:41 pm, the registered nurse (RN 2) stated she received Patient 1's dose of IV Remdesivir and administered it to Patient 1 right away at 2:39 pm on 2/2/2021. RN 2 stated she did not check the label for the date and time of expiration. RN 2 stated Remdesivir was an IV compounded medication, and she knew it needed to be administered within one hour of its' preparation start time.

A review of Patient 1's medical record indicated the patient was admitted to the facility on 1/21/2021 with diagnoses including back pain and COVID - 19.

A review of Patient 1's MAR, dated 2/02/2021, indicated Remdesivir 100 mg in NS 250 ml administered on 2/02/2021 at 2:39 pm.

A review of the pharmacy's "Compounding Log", dated 2/02/2021, indicated Remedesivir was a compounded medication. The Log contained Patient 1's medication labeled indicating Remedesivir 100 mg was prepared at 1:30 pm. The beyond-use date [(BUD)- an expired date, or date and time after which the administration of a compounded drug preparation shall not begin or dispensed, or stored) indicated a time of 2:30 pm on 2/02/2021.

A review of Patient 6's medical record indicated the patient was admitted to the facility on 1/06/2021 with diagnoses including COVID - 19.

A review of Patient 6's MAR, dated 1/09/2021, indicated Remdesivir 100 mg in NS 250 ml to administer daily at 2 pm. According to MAR, the medication was administered at 3:15 pm.

A review of Patient 12's medical record indicated Patient 12 was admitted to the facility on 1/05/2021 for COVID - 19.

A review of Patient 12's MAR dated 1/09/2021 indicated Remdesivir 100 mg in NS 250 ml to administer daily at 2 pm. According to MAR, the medication was administered at 3:08 pm.

A review of Patient 13's medical record indicated the patient was admitted to the facility on 12/27/2020 with diagnoses including COVID - 19.

A review of Patient 13's MAR dated 1/09/2021 indicated Remdesivir 100 mg in NS 250 ml to administer daily at 2 pm. According to MAR, the medication was administered at 4:24 pm.

A review of Patient 19's medical record indicated the patient was admitted to the facility on 1/06/2021 with diagnoses including shortness of breath and COVID - 19.

During a concurrent interview and review of the pharmacy's "Compounding Log", dated 1/18/2021, the DOP stated that Remdesivir was one of the medications compounded in the pharmacy and should be administered within one hour of the start of the preparation time. The DOP verified that the preparation time and the expiration date and time were not documented on the Log. The DOP stated Log contained a medication label for Patient 19 indicating that the medication should be given daily at 2 pm and should not be given after 3 pm.

A review of Patient 19's MAR, dated 1/18/2021, indicated Remdesivir 100 mg in 250 ml NS to administer IVPB (intravenously piggyback [a secondary infusion given through a primary IV line]) daily at 2 pm. The MAR indicated Remdesivir was administered at 3:09 pm on 1/18/2021.

A review of the facility's policy and procedure titled, "Sterile Compounding', dated 9/2018, indicated for any sterile compounded drug preparations compounded outside an ISO (International Organization for Standardization) class 5 PEC (Primary Engineering Control), the sterile compounded drug shall be labeled for "immediate use only' and administration shall begin no later than one hour following the start of the compounding process.