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Based on observation, interview, and record review, the hospital failed to ensure medications including compounded (mixed) sterile (germ free) intravenous (IV, directly into a vein) medication (preparations) services, were provided in a safe manner as evidenced by:

1. The hospital failed to ensure compounded sterile IV medications were prepared following USP<797> standards for immediate use CSPs. (USP 797 is the first set of enforceable sterile compounding standards issued by the United States Pharmacopeia (USP). USP 797 describes the guidelines, procedures and compliance requirements for compounding (mixing) sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded). The hospital's staff prepared CSPs for scheduled IV antibiotics following the administration of a first dose. These failures resulted in the potential, during the past year, for 599 patients to be exposed to approximately 650 doses of ceftriaxone (IV antibiotic) and approximately 698 doses of vancomycin (IV antibiotic), that were not prepared following USP<797> standards for immediate use (urgent/emergency IV medication) CSPs.

2. The hospital failed to ensure Radiology Technicians passed the Aseptic Admixture Preparation Competency (ability to prepare IV medications correctly) before preparing sterile IV medications. Radiology Technicians, that have not passed the admixture competency, prepared IV contrast and IV sodium chloride syringes. These syringes were used in CT (computed tomography, x-ray) and MRI (magnetic resonance imaging, for viewing internal body structure) patient studies. These failures resulted in the radiology department patients being exposed to IV medications that were prepared by staff who were not deemed competent.

3. The hospital failed to ensure staff did not prepared medium risk (risk of contamination) level CSPs. The hospital's nurses prepared medium risk level banana bags (intravenous fluid with vitamins). These failures resulted in the potential, over the past year, for 599 patients to be exposed to 18 banana bags, that were not prepared following all USP<797> standards for medium risk level CSPs.

4. a) A used single dose vial (SDV) of Isovue injection (contrast media, a substance introduced into a part of the body in order to improve the visibility of internal structure during radiography/x-ray) was available for use in a warmer (a heating device) in the CT (Computed tomography is a type of imaging. It uses special x-ray equipment to make cross-sectional pictures of your body) trailer. This finding had the potential of exposing patients to infections.

4. b) Isovue injection vials were stored in the warmer in the CT trailer not in accordance with manufacturer requirements.

4. c) No temperature monitoring was done for the warmer containing Isovue injection vials. Findings 4b and 4c had the potential of exposing patients to deteriorated medications or burns from overheated medications.

5. Nurse was able to override (thereby making medication available for patient administration before a safety review by the pharmacist) the automated dispensing cabinet (ADC) and obtain a fentanyl (narcotic for pain) patch not in accordance with facility policy. This failure had the potential of exposing a patient to serious side effects of fentanyl including respiratory depression and death.

6. Unusable medications were available for use when an expired vial of labetalol (for high blood pressure) was stored in the anesthesia cart (containing medications used during surgery) and nitroglycerin (a medication for the management of chest pain of heart origin) intravenous (IV, injected through the vein) solution was not stored in accordance with manufacturer requirements. This had the potential of exposing patients to contaminated or ineffective medications.

7. Contents list posted on the outside of two emergency crash carts (carts that contain medicines and equipment needed for life threatening emergencies) did not match the contents within. This failure had the potential of preventing caregivers from quickly finding and using drugs required for resuscitating patients during a medical emergency.

Findings:

1. During a concurrent tour and interview, on 2/28/17 at 10:40 am, Director of Pharmacy (DOP) identified the pharmacy. Inspection of the pharmacy did not show an IV compounding hood (device to maintain germ free work area) for mixing sterile IV preparations (CSP). DOP was asked to describe how the hospital prepared CSPs. DOP stated the pharmacy did not prepare CSPs. He stated all IV medications were prepared by hospital staff in the patient care areas (nursing units, emergency department, radiology department, and operating suite).

During an interview, in the acute care (nursing unit) medication room, on 2/28/17 at 2:05 pm, Pharmacy Technician (RX Tech) was asked to describe how the nurses used the VIAL-MATE adaptor (device to connect one medication vial with one IV fluid container). RX Tech's description included the adaptor was used by nursing to prepare IV medications. She further stated the adaptor was not used if the neck of the drug vial was incompatible (too small or large) with the VIAL-MATE adaptor.

During a concurrent observation, interview, and record review, on 2/28/17 at 2:10 pm, in the acute care medication room, Registered Nurse (RN 3) was asked to demonstrate the preparation of azithromycin (IV antibiotic) 500 mg (milligram) in 250 ml (milliliter) of normal saline (salt water). Her demonstration included the use of a syringe and needle to reconstitute (add fluid to) a dry powder vial of azithromycin 500 mg. RN 3 stated she would withdraw the liquid contents of the azithromycin vial and inject the dose into a bag of 250 ml normal saline. Further inspection showed an empty plastic bin for storing VIAL-MATE adaptor devices. RN 3 was asked to describe the use of the adaptor device. RN 3's description included that the nurse could choose if he/she used the adaptor device.

During an interview, on 2/28/17 at 3:30 pm, RX Tech was asked to describe the ordering and stocking process for the VIAL-MATE adaptor. RX Tech's description included that VIAL-MATE adaptor was currently out of stock.

1a. During a concurrent interview and medical record review, on 3/1/1 at 10:45 am, Registered Nurse (RN 2) identified the electronic (computer) medical record (EMR) for Patient 13. Review of Patient 13's EMR showed she was admitted to the hospital on 2/27/17 at 1:21 pm. Continued review showed the nurses prepared (mixed medication vials with IV fluid) and administered a first dose and seven scheduled doses of 3 gm (gram) ampicillin-sulbactam (IV antibiotic) 1.5 gm powder vial (two vials) in sodium chloride 0.9% 100 ml IV. Further review showed the nurses prepared, and administered, four doses of vancomycin 1 gm in sodium chloride 250 ml IV.

1b. During a concurrent interview and medical record review, on 3/1/17 at 10:45 am showed:
RN 2 identified the EMR for Patient 14. Review of Patient 14's EMR showed he was admitted on 2/25/17 at 1:30 pm. Continued Review of Patient 14's EMR showed the nurses prepared, and administered, a first dose and two scheduled doses of ceftriaxone 1 gm in sodium chloride 0.9% 50 ml IV.

1c. RN 2 identified the EMR for Patient 15. Review of Patient 15's EMR showed she was admitted on 2/26/17 at 2:59 pm. Continued review of Patient 15's EMR showed the nurses prepared, and administered, a first dose and one scheduled dose of vancomycin 1 gm in sodium chloride 0.9% 250 ml IV. Continued review showed the nurses prepared and administered a first dose and one scheduled dose of ceftriaxone 1 gm in sodium chloride 0.9% 50 ml.

1d. RN 2 identified the EMR for Patient 16. Review of Patient 16's EMR showed he was admitted to the hospital on 2/26/17 at 12:37 pm. Continued review showed the nurses prepared, and administered, a first dose and three scheduled doses of ceftriaxone 1 gm in sodium chloride 0.9% 50 ml IV.

1e. During an EMR review, on 3/1/17 at 4 pm showed:
Patient 17 was admitted on 5/17/16 at 10:50 pm. Review of the EMR showed the nurses prepared and administered a first dose and six scheduled doses of vancomycin 1 gm in sodium chloride 0.9% 250 ml IV.

1f. Patient 18 was admitted on 2/1/16 at 2:10 pm. Review of the EMR showed the nurses prepared and administered a first dose of vancomycin and six scheduled doses of 750 mg (one 500 mg vial and one 250 mg vial) in sodium chloride 0.9% 250 ml IV.

1g. Patient 19 was admitted on 2/6/17 at 12:07 pm. Review of the EMR showed the nurses prepared and administered a first dose and five scheduled doses of vancomycin 1 gm in sodium chloride 0.9% 250 ml IV.

1h. Patient 20 was admitted on 8/15/16 at 9:46 am. Review of the EMR showed the nurses prepared and administered a first dose and three scheduled doses of vancomycin 1 gm in sodium chloride 0.9% 250 ml IV.

1i. Patient 21 was admitted on 2/3/16 at 11:51 am. Review of the EMR showed the nurses prepared and administered a first dose and three scheduled doses of ceftriaxone 1 gm in sodium chloride 0.9% 50 ml IV.

1j. Patient 22 was admitted on 7/2/16 at 2:50 pm. Review of the EMR showed the nurses prepared and administered a first dose and six scheduled doses of ceftriaxone 1 gm in sodium chloride 0.9% 50 ml IV. Continued review showed the nurses prepared and administered a subsequent order for a first dose and one scheduled dose of ceftriaxone 1 gm in sodium chloride 0.9% 50 ml IV.

During a concurrent interview and record review, on 3/2/17 at 10:30 am, DOP and Chief Nursing Officer (CNO) acknowledged the nurses prepared the first dose, and subsequent scheduled (anticipated, not an emergency) doses, of IV medications. DOP identified the hospital's policy and procedure for Pharmacy Oversight of Services Equipment, Supplies, and Quality Control. DOP reviewed the policy and procedure and stated it did not allow for nurses to mix non-emergency (subsequent scheduled) doses of IV medication. DOP stated one of the standards used for developing the policy and procedure was USP<797>. DOP was asked if the hospital adhered to all USP<797> standards for the preparation of CSPs outside of the pharmacy. DOP stated the hospital had not adhered to all USP<797> standards for the preparation of immediate use CSPs as applied to subsequent scheduled doses of IV medication.

An administrative record review, of the Transactions by Item/Procedure, Acute Care and Monitor, CeftriaXONE 1GM Inj (injection), for the past year, showed approximately 650 patient doses prepared from medication removed from two (medical/surgical and acute care) of four storage areas.

An administrative record review, of the Transactions by Item/Procedure, Acute Care and Monitor, Vancomycin Hydrochloride 1 gm, for the past year, showed approximately 698 patient doses, prepared from medication removed from two (medical/surgical and acute care) of four storage areas.

An administrative record review, of the Admission Summary (Date 3/1/17), showed 599 patients were admitted to the hospital over the past year.

An administrative record review, of the hospital's policy and procedure for Pharmacy Oversight of Services Equipment, Supplies, and Quality Control (Effective Date: 10/2016) showed, Policy: "Orchard Hospital Pharmacy Department provides for adequate equipment, supplies, and written quality control procedures for the provision of pharmaceutical services within Orchard Hospital, including intravenous solution additives; ...2) Pharmacy formulary includes premixes in multiple doses of medications and adapters to reduce needle sticks performed by nursing staff ...3) Sterile areas will be used for all urgent (emergency), one time intravenous mixing, except in emergency situations (per USP-NF Chapter 797). These sterile areas are located in the Emergency Department closed and locked pharmacy automated dispensing room with the use of a clean tray; and in the Monitored Bed area closed and locked pharmacy automated dispensing room with the use of a clean tray ..." Continued review showed, Procedures:, 1) "Pharmacy will oversee sterile aseptic validation for nursing staff ...b. Pharmacy will provide and oversee adequate equipment and supplies for nursing staff to perform onetime urgent/emergent preparations for aseptic intravenous admixing ...e. A new, sterile needle and syringe should always be used to access medications. Adapters should also be used when they can to reduce any needle sticks into bags." The hospital mixed, and administered, non-emergency IV medications after the first ordered dose.

The United States Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the quality, purity, identity, and strength of medicines. USP's drug standards are enforceable in the United States by the Food and Drug Administration and are published in the United States Pharmacopeia/National Formulary (USP 35/NF 30). The USP revised general chapter <797> entitled PHARMACEUTICAL COMPOUNDING (mixed)-STERILE (germ free) PREPARATIONS (CSP) documents in the Introduction that "The objective of this chapter is to describe conditions and practices to prevent harm, including death, to patients that could result from (1) microbial contamination (nonsterility), (2) excessive bacterial toxins ..." [Adherence to these practice and quality standards allows the hospital to assign beyond use dates (date beyond which a CSP cannot be started) to CSPs as described in USP <797>.]

An administrative record review, of the 2017 USP Compounding Compendium, Current with USP 40-NF 35 (Nov 2016, Page 45-46) showed, Immediate-Use CSPs, "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 agents, or critical therapy where the preparation of the CSP under conditions described for Low-Risk Level CSPs subjects the patient to additional risk due to delays in therapy." Continued review showed, "Compounding in worse than ISO Class 5 (measurement of air quality) (see Table 1) conditions increases the potential for clinically significant microbial colonization and thus for patient harm, especially in critically ill or immunocompromised patients."

2. During a concurrent tour and interview, on 2/28/17 at 3 pm, in the CT trailer, Radiology Technician (Rad Tech) identified IV contrast (medication used in a CT study). Rad Tech was asked to describe the use of IV contrast. Her description included that the Radiology Technicians prepared IV contrast by withdrawing the dose from a vial into a syringe. Rad Tech also stated that the Radiology Technicians prepared normal saline (salt water, used in a CT study) syringe by withdrawing the dose from an IV bag. Further inspection showed the trailer contained a sink. In the MRI trailer Rad Tech identified a sink. Rad Tech was asked if the sink worked. Rad Tech stated the sink in the CT and MRI trailers did not work.

During an interview on 3/1/17 at 10:10 am, Director of Pharmacy (DOP) was asked to describe the hospital's sterile IV medication competency program. DOP's description included hospital staff were required to pass the Aseptic (prevent contamination by germs) Admixture (mixing) Preparation Competency before preparing IV medications. DOP was asked if the Radiology Technicians passed the competency. DOP stated that none of the Radiology Technicians passed the Aseptic Admixture Preparation Competency.

An administrative record review, of the hospital's policy and procedure for Pharmacy Oversight of Services Equipment, Supplies, and Quality Control (Effective Date: 10/2016) showed, Policy: "Orchard Hospital Pharmacy Department provides for adequate equipment, supplies, and written quality control procedures for the provision of pharmaceutical services within Orchard Hospital, including intravenous solution additives; developing and conducting appropriate in-service training program for professional staff to assure compliance ...1) Pharmacy shall provide oversight of sterile aseptic competency validation for nursing staff in order for nursing staff to safely provide emergency/urgent aseptic intravenous solutions ..."

An administrative record review, of the hospital's policy and procedure for Pharmacy Oversight of Services Equipment, Supplies, and Quality Control (Effective Date: 10/2016) showed, Aseptic Admixture Preparation Competency, This competency must be passed with 100% compliance., "Complete Hand Hygiene and don gloves ...Pass Fail ..."

3. During a concurrent tour and interview, on 2/28/17 at 10:40 am, Director of Pharmacy (DOP) identified the pharmacy. Inspection of the pharmacy did not show an IV compounding hood (device to maintain germ free work area) for mixing sterile IV preparations (CSP). DOP was asked to describe how the hospital prepared CSPs. DOP stated the pharmacy did not prepare CSPs. He stated all IV medications were prepared by hospital staff in the patient care areas (nursing units, emergency department, radiology department, and operating suite).

During an interview, in the acute care (nursing unit) medication room, on 2/28/17 at 2:15 pm, Registered Nurse (RN 3) was asked to describe the IV medications she had prepared. Her description included compounding banana (yellow colored fluid) bags 1 liter (L) normal saline (salt water) with multivitamins, thiamine (vitamin), and folic acid (vitamin). Compounding banana bags required the nurse to add three items to a 1 L bag of normal saline. The hospital was requested to provide the number of banana bags compounded by nurses for the past year.

During a concurrent interview and administrative record review, on 3/2/17 at 10:30 am, DOP and Chief Nursing Officer (CNO) acknowledged the hospital's nurses had compounded banana bags. DOP was asked to describe the USP<797> risk level that applied to the compounding of the banana bags. DOP acknowledged the banana bag, with the nurses adding three additives to a 1 L bag of normal saline, was medium risk (risk of contaminating a CSP when following all USP<797> standards) level compounding. DOP stated the hospital's policy and procedures did not allow nurses to compound medium risk level sterile IV medications.

An administrative record review, of the hospital's policy and procedure for Pharmacy Oversight of Services Equipment, Supplies, and Quality Control (Effective Date: 10/2016) showed, Policy: "Orchard Hospital Pharmacy Department provides for adequate equipment, supplies, and written quality control procedures for the provision of pharmaceutical services within Orchard Hospital, including intravenous solution additives; ...2) Pharmacy formulary includes premixes in multiple doses of medications and adapters to reduce needle sticks performed by nursing staff ...3) Sterile areas will be used for all urgent, one time intravenous mixing, except in emergency situations (per USP-NF Chapter 797). These sterile areas are located in the Emergency Department closed and locked pharmacy automated dispensing room with the use of a clean tray; and in the Monitored Bed area closed and locked pharmacy automated dispensing room with the use of a clean tray ..." Continued review showed, Procedures:, 1) "Pharmacy will oversee sterile aseptic validation for nursing staff ...b. Pharmacy will provide and oversee adequate equipment and supplies for nursing staff to perform onetime urgent/emergent preparations for aseptic intravenous admixing ...e. A new, sterile needle and syringe should always be used to access medications. Adapters should also be used when they can to reduce any needle sticks into bags." The policy does not show a procedure to compound medium risk level IV medications outside of the pharmacy.

An administrative record review, of MRN Admission_ID Order_Item_Title, from 3/2/17 at 9 am, showed 18 banana bags were mixed in the past year.

An administrative record review, of the Admission Summary (Date 3/1/17), showed 599 patients were admitted to the hospital over the past year.

The United States Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the quality, purity, identity, and strength of medicines. USP's drug standards are enforceable in the United States by the Food and Drug Administration and are published in the United States Pharmacopeia/National Formulary (USP 35/NF 30). The USP revised general chapter <797> entitled PHARMACEUTICAL COMPOUNDING (mixed)-STERILE (germ free) PREPARATIONS (CSP) documents in the Introduction that "The objective of this chapter is to describe conditions and practices to prevent harm, including death, to patients that could result from (1) microbial contamination (nonsterility), (2) excessive bacterial toxins ..." [Adherence to these practice and quality standards allows the hospital to assign beyond use dates (date beyond which a CSP cannot be started) to CSPs as described in USP <797>.]

An administrative record review, of the 2017 USP Compounding Compendium, Current with USP 40-NF 35 (Nov 2016, Page 45-46) showed, Immediate-Use CSPs, "The immediate-use provision is intended only for those situations where there is a need for emergency or immediate patient administration of a CSP ....Preparations that are medium-risk level and high-risk level (of microorganism contamination) CSPs shall not be prepared as immediate-use CSPs ..." Continued review showed, "Compounding in worse than ISO Class 5 (measurement of air quality) (see Table 1) conditions increases the potential for clinically significant microbial colonization and thus for patient harm, especially in critically ill or immunocompromised patients."


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4. a) On 2/28/17 at 2:55 pm during a tour of the CT trailer a warmer was observed. (CT stands for computed tomography. The CT scan can reveal anatomic details of internal organs that cannot be seen in conventional X-rays). The contents of the warmer (a cabinet designed for use in hospitals for warming bottles or bags of fluids to body temperature or above) showed an opened single dose vial (SDV) of Isovue with a handwritten date/time of 2/27 at 2:58 pm. (A single dose vial is a vial of liquid medication intended for use in a single patient. Isovue is an intravenous contrast used in CT to help highlight blood vessels and to enhance the tissue structure of various organs such as the brain, spine, liver and kidneys. "Intravenous" means that the contrast is injected into a vein using a small needle). In a concurrent interview the Radiology technician (Rad Tech) stated that the vial was used on 2/27/17 and could be stored in the warmer for up to 24 hours after opening for subsequent use. Rad Tech read the manufacturer label on the Isovue bottle and acknowledged that the label indicated "single dose bottle, discard unused portion."

Review of facility policy, "Disposal of Single Use and Care of Multi-use Patient Items",
dated 7/16, indicated "All partially used medications ...will be disposed of after each patient use."

Review of facility policy, "Medication Inventory Inspection and Maintenance", dated 5/16, indicated "Pharmacist will be responsible for checking pharmacy areas including ...CT ...trailers that contain medications ...Discard any opened single dose vials ..."

During an interview on 2/28/17 at 3:10 pm the Director of Pharmacy (DOP) stated that he was not aware of the warmer in the CT trailer.

The Centers for Medicare and Medicaid services (CMS) issued a survey and certification letter dated June 15, 2012: Ref: S&C: 12-35-ALL indicating "SUBJECT: Safe Use of Single Dose/Single Use Medications to Prevent Healthcare-associated Infections. Administering drugs from one SDV to multiple patients without adhering to USP <797> standards is not acceptable under CMS infection control regulations: Medications in SDVs typically lack antimicrobial preservatives. According to the Centers for Disease Control and Prevention (CDC), ongoing outbreaks provide evidence that medications from SDVs can become contaminated and serve as a source of infection when they are used inappropriately."

4. b) On 2/28/17 at 2:55 p.m. during a tour of the CT trailer, a warmer was observed. The contents of the warmer included nine vials of Isovue injections. There was no date on the vials indicating when they were placed in the warmer or how long they were to be stored in the warmer.

In a concurrent interview the Rad Tech confirmed that the vials of Isovue were undated and Rad Tech was not aware how long and at what temperature they could be stored in the warmer.

During an interview on 3/1/17 at 2 pm DOP stated that the manufacturer for Isovue did not indicate storage in a warmer.

Review of the DOP provided manufacturer insert for Isovue indicated: Store at 68 to 77 degrees Fahrenheit.

Review of facility policy "Medication/Supply Storage" dated 7/16 indicated "All drugs and pharmaceutical supplies are stored in accordance with the national standards and otherwise pursuant to the manufacturer's guidelines."

4. c) On 2/28/17 at 2:55 pm during a tour of the CT trailer, a warmer was observed. The contents of the warmer included nine vials of Isovue injections.

During a concurrent interview the Rad Tech was unable to read the warmer's temperature and indicated that there was no monitoring of the warmer's temperatures.

Review of facility policy "Medication/Supply Storage" dated 7/16 indicated 'Warm Temperature: between 30 degrees Centigrade (86 degrees Fahrenheit) and 40 degrees Centigrade (104 degrees Fahrenheit)."


5. An Automated Dispensing Cabinet (ADC) was observed outside the inpatient pharmacy on 2/28/17 at 10:45 am. (An automated dispensing cabinet is a computerized drug storage cabinet designed for hospitals. ADCs allow medications to be stored and dispensed near the point of care while controlling and tracking drug distribution). In a concurrent interview the DOP stated that the ADC was used by nurses. DOP was asked if fentanyl patches were located in the ADC and he stated that fentanyl patches were in the ADC and nurses were unable to remove them unless the pharmacist had reviewed the order.

On 2/28/17 at 11:12 am emergency department manager (EDM) was asked by the surveyor to remove a fentanyl patch from the ADC. EDM was able to override the ADC prompts and retrieve the fentanyl patch.

Review of facility policy titled, "Fentanyl Patch Prescribing Guidelines" dated 6/16 indicated "Under no circumstances shall nursing override the order in CADU (ADC) to withdraw fentanyl patch without first getting approval from the pharmacist."

Fentanyl patch is a high potency opioid used for pain and has a boxed warning which is the strongest warning the FDA (food and drug administration) can require a pharmaceutical company to place on the labeling of a prescription drug, or in literature describing it. Following is part of the black box warning: "Respiratory depression and death may occur with use of fentanyl transdermal system, even when fentanyl transdermal system has been used as recommended and not misused or abused."

6. a) On 2/28/17 at 2:40 p.m. inspection of the surgery department anesthesia cart showed an expired vial of labetalol 100 milligram injection. (Labetalol is a medication used to treat high blood pressure). The labetalol vial was dated with an expiration date 2/1/17. In a concurrent interview Operating Room Manager, (RN 5) confirmed that the vial of labetalol was expired.

6. b) On 2/28/17 at 11:50 am, an ADC was observed in a medication room on the monitoring unit. The ADC had 4 bottles of nitroglycerin IV solution stored without protective covering. The bottles were exposed to fluorescent light from the room.

Review of the manufacturer's label on the bottle indicated: Protect from light.
In a concurrent interview the DOP confirmed that the bottles of nitroglycerin were not protected from light.

Review of facility policy, "Medication/Supply Storage" dated 7/16 indicated "All drugs and pharmaceutical supplies are stored in accordance with ...manufacturer's guidelines."

7. On 2/28/17 at 11:50 am two emergency crash carts were observed in the MedSurg (Medical Surgery) unit. (Crash carts are a movable collection of emergency equipment and supplies meant to be readily available for resuscitative efforts. It includes medications as well as equipment). The crash carts inventory list indicated fosphenytoin (for seizures) vials were located in the refrigerator.

Inspection of the MedSurg refrigerator indicated there were no fosphenytoin vials. In a concurrent interview the DOP acknowledged that fosphenytoin vials were not available for the emergency crash carts.

Review of facility policy, "Medication Inventory Inspection and Maintenance", dated 5/16, indicated "The emergency cart is locked or kept in a secure area. All required drugs are present and useable."

Based on observation, interview, and record review, the hospital failed to monitor and assess the compounding (mixing) of intravenous (IV, directly into a vein) sterile (germ free) compounded preparations (CSP). The hospital's staff prepared sterile IV medications. The hospital did not monitor and assess compliance with policy and procedure for Pharmacy Oversight of Services Equipment, Supplies, and Quality Control. The hospital did not monitor and assess compliance with USP<797> standards for immediate use CSPs.

These failures resulted in the potential, during the past year, for 599 patients to be exposed to approximately 650 doses of ceftriaxone (IV antibiotic) and approximately 698 doses of vancomycin (IV antibiotic), that were not prepared following USP<797> standards for immediate use CSPs.

Findings:

1. During a concurrent tour and interview, on 2/28/17 at 10:40 am, Director of Pharmacy (DOP) identified the pharmacy. Inspection of the pharmacy did not show an IV compounding hood (device to maintain germ free work area) for mixing sterile IV preparations (CSP). DOP was asked to describe how the hospital prepared CSPs. DOP stated the pharmacy did not prepare CSPs. He stated all IV medications were prepared by hospital staff in the patient care areas (nursing units, emergency department, radiology department, and operating suite).

During an interview, in the acute care (nursing unit) medication room, on 2/28/17 at 2:05 pm, Pharmacy Technician (RX Tech) was asked to describe how the nurses used the VIAL-MATE adaptor (device to connect one medication vial with one IV fluid container). RX Tech's description included the adaptor was used by nursing to prepare IV medications. She further stated the adaptor was not used if the neck of the drug vial was incompatible (too small or large) with the VIAL-MATE adaptor.

During a concurrent observation, interview, and record review, on 2/28/17 at 2:10 pm, in the acute care medication room, Registered Nurse (RN 3) was asked to demonstrate the preparation of azithromycin (IV antibiotic) 500 mg (milligram) in 250 ml (milliliter) of normal saline (salt water). Her demonstration included the use of a syringe and needle to reconstitute (add fluid to) a dry powder vial of azithromycin 500 mg. RN 3 stated she would withdraw the liquid contents of the azithromycin vial and inject the dose into a bag of 250 ml normal saline (low risk compounding). Further inspection showed an empty plastic bin for storing VIAL-MATE adaptor devices. RN 3 was asked to describe the use of the adaptor device. RN 3's description included that the nurse could choose if he/she used the adaptor device.

During an interview, on 2/28/17 at 3:30 pm, RX Tech was asked to describe the ordering and stocking process for the VIAL-MATE adaptor. RX Tech's description included that VIAL-MATE adaptor was currently out of stock.

1a. During a concurrent interview and medical record review, on 3/1/17 at 10:45 am, Registered Nurse (RN 2) identified the electronic (computer) medical record (EMR) for Patient 13. Review of Patient 13's EMR showed she was admitted to the hospital on 2/27/17 at 1:21 pm. Continued review showed the nurses prepared (mixed medication vials with IV fluid) and administered a first dose and seven scheduled doses of 3 gm (gram) ampicillin-sulbactam (IV antibiotic) 1.5 gm powder vial (two vials) in sodium chloride 0.9% 100 ml IV. Further review showed the nurses prepared, and administered, four doses of vancomycin 1 gm in sodium chloride 250 ml IV.

During a concurrent interview and medical record review, on 3/1/17 at 10:45 am showed:

1b. RN 2 identified the EMR for Patient 14. Review of Patient 14's EMR showed he was admitted on 2/25/17 at 1:30 pm. Continued Review of Patient 14's EMR showed the nurses prepared, and administered, a first dose and two scheduled doses of ceftriaxone 1 gm in sodium chloride 0.9% 50 ml IV.

1c. RN 2 identified the EMR for Patient 15. Review of Patient 15's EMR showed she was admitted on 2/26/17 at 2:59 pm. Continued review of Patient 15's EMR showed the nurses prepared, and administered, a first dose and one scheduled dose of vancomycin 1 gm in sodium chloride 0.9% 250 ml IV. Continued review showed the nurses prepared and administered a first dose and one scheduled dose of ceftriaxone 1 gm in sodium chloride 0.9% 50 ml.

1d. RN 2 identified the EMR for Patient 16. Review of Patient 16's EMR showed he was admitted to the hospital on 2/26/17 at 12:37 pm. Continued review showed the nurses prepared, and administered, a first dose and three scheduled doses of ceftriaxone 1 gm in sodium chloride 0.9% 50 ml IV.

1e. During an EMR review, on 3/1/17 at 4 pm showed:
Patient 17 was admitted on 5/17/16 at 10:50 pm. Review of the EMR showed the nurses prepared and administered a first dose and six scheduled doses of vancomycin 1 gm in sodium chloride 0.9% 250 ml IV.

1f. Patient 18 was admitted on 2/1/16 at 2:10 pm. Review of the EMR showed the nurses prepared and administered a first dose of vancomycin and six scheduled doses of 750 mg (one 500 mg vial and one 250 mg vial) in sodium chloride 0.9% 250 ml IV.

1g. Patient 19 was admitted on 2/6/17 at 12:07 pm. Review of the EMR showed the nurses prepared and administered a first dose and five scheduled doses of vancomycin 1 gm in sodium chloride 0.9% 250 ml IV.

1h. Patient 20 was admitted on 8/15/16 at 9:46 am. Review of the EMR showed the nurses prepared and administered a first dose and three scheduled doses of vancomycin 1 gm in sodium chloride 0.9% 250 ml IV.

1i. Patient 21 was admitted on 2/3/16 at 11:51 am. Review of the EMR showed the nurses prepared and administered a first dose and three scheduled doses of ceftriaxone 1 gm in sodium chloride 0.9% 50 ml IV.

1j. Patient 22 was admitted on 7/2/16 at 2:50 pm. Review of the EMR showed the nurses prepared and administered a first dose and six scheduled doses of ceftriaxone 1 gm in sodium chloride 0.9% 50 ml IV. Continued review showed the nurses prepared and administered a subsequent order for a first dose and one scheduled dose of ceftriaxone 1 gm in sodium chloride 0.9% 50 ml IV.

During a concurrent interview and record review, on 3/2/17 at 10:30 am, DOP and Chief Nursing Officer (CNO) acknowledged the nurses prepared the first dose, and subsequent scheduled (anticipated, not an emergency) doses, of IV medications. DOP identified the hospital's policy and procedure for Pharmacy Oversight of Services Equipment, Supplies, and Quality Control. DOP reviewed the policy and procedure and stated it did not allow for nurses to mix non-emergency (subsequent scheduled) doses of IV medication. DOP stated one of the standards used for developing the policy and procedure was USP<797>. DOP was asked if the hospital adhered to all USP<797> standards for the preparation of CSPs outside of the pharmacy. DOP stated the hospital had not adhered to all USP<797> standards for the preparation of immediate use CSPs as applied to subsequent scheduled doses of IV medication.

During an interview, on 3/2/17 at 10:50 am, Infection Control (Inf RN) was asked to describe his role in the hospital's quality assurance (maintain level of quality) process. Inf RN description included that he was a member of the hospitals quality assurance team. Inf RN stated that DOP was also a member of the hospital's quality assurance team. Inf RN was asked if the team, over the past year, reviewed data to monitor and assess nursing compliance with policy and procedures and USP<797> for preparing sterile IV medications. Inf RN stated he was not aware of the team monitoring, or requesting data, to assess nursing compliance with policy and procedures and USP<797> for preparing sterile IV medications.

An administrative record review, of the Transactions by Item/Procedure, Acute Care and Monitor, CeftriaXONE 1GM Inj (injection), for the past year, showed approximately 650 patient doses prepared from medication removed from two (medical/surgical and acute care) of four storage areas.

An administrative record review, of the Transactions by Item/Procedure, Acute Care and Monitor, Vancomycin Hydrochloride 1 gm, for the past year, showed approximately 698 patient doses, prepared from medication removed from two (medical/surgical and acute care) of four storage areas.

An administrative record review, of the Admission Summary (Date 3/1/17), showed 599 patients were admitted to the hospital over the past year.

An administrative record review, of the hospital's policy and procedure for Pharmacy Oversight of Services Equipment, Supplies, and Quality Control (Effective Date: 10/2016) showed, Policy: "Orchard Hospital Pharmacy Department provides for adequate equipment, supplies, and written quality control procedures for the provision of pharmaceutical services within Orchard Hospital, including intravenous solution additives; developing and conducting appropriate in-service training program for professional staff to assure compliance." Further review showed, References: "USP NF 797."

The United States Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the quality, purity, identity, and strength of medicines. USP's drug standards are enforceable in the United States by the Food and Drug Administration and are published in the United States Pharmacopeial/National Formulary (USP 35/NF 30). The USP revised general chapter <797> entitled PHARMACEUTICAL COMPOUNDING (mixed)-STERILE (germ free) PREPARATIONS (CSP) documents in the Introduction that "The objective of this chapter is to describe conditions and practices to prevent harm, including death, to patients that could result from (1) microbial contamination (nonsterility), (2) excessive bacterial toxins ..." [Adherence to these practice and quality standards allows the hospital to assign beyond use dates (date beyond which a CSP cannot be started) to CSPs as described in USP <797>.]

An administrative record review, of the 2017 USP Compounding Compendium, Current with USP 40-NF 35 (Nov 2016, Page 45-46) showed, Immediate-Use CSPs, "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 agents, or critical therapy where the preparation of the CSP under conditions described for Low-Risk Level CSPs subjects the patient to additional risk due to delays in therapy." Continued review showed, "Compounding in worse than ISO Class 5 (measurement of air quality) (see Table 1) conditions increases the potential for clinically significant microbial colonization and thus for patient harm, especially in critically ill or immunocompromised patients."

An administrative record review, of the hospital's policy and procedure for Performance Improvement Plan (Dates of Review/Revision: 12/2016), Performance Improvement (PI) Focus, did not show preparing IV medications in the patient care areas.