The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.
|ST JOSEPH HOSPITAL||2901 SQUALICUM PARKWAY BELLINGHAM, WA 98225||Aug. 16, 2016|
|VIOLATION: GOVERNING BODY||Tag No: A0043|
Based on evidence by examples identified throughout the body of this report and the findings below, the cumulative effects demonstrated that the governing body failed to ensure patient safety by mitigating risk and/or implementing timely corrections in pharmacy operations.
Failure to do so creates risk to patient safety and risk to protection from harm.
Reference: A501, A505 and A508
1. In review of documentation from the state Pharmacy Inspection Report from February 10-12 2015 and March 6, 2015, the hospital was made aware of deficiencies in the physical standards required to adhere to USP 797 standards including, but not limited to, HEPA filters, proper airflow and physical configuration. Remodeling was planned per the facility's report to commence in the Spring of 2015.
2. On 8/12/2016 at 9:10 AM the surveyor interviewed the facility's interim Chief Financial Officer (CFO) (Staff Member #12). S/he was unable to identify whether the capital items for the pharmacy remodels had been approved. S/he was able to identify that there were unfulfilled capital requests (pharmacy remodel) from fiscal year 2016 listed with the 2017 items. Subsequently s/he stated that the budget for the pharmacy re-modeling was approved in May or June of 2016. However, s/he was unable to provide meeting minutes or documentation of approval.
S/he provided documenation that between March 11, 2015 and July 11, 2016 , the facility spent in excess of $40,000 on architect and engineering costs and city and state fees in preparation for the pharmacy remodeling.
In follow-up discussion on 8/12/2016 at 3:30 PM, the interim CFO reported via an email communication with the System CFO (Staff Member #15), that the remodel budgets were approved. It was communicated that "once final budgets were completed . . . funding of the project can begin."
On 8/16/2016 at 3:30 PM during an interview with the Chief Executive Officer (CEO) s/he stated that the pharmacy remodels (including the Cancer Center) were approved "last week". S/he also stated that the facility had been actively engaged in planning for the pharmacy remodeling since March 2015.
|VIOLATION: PHARMACEUTICAL SERVICES||Tag No: A0490|
Based on observation, interview and document review, the hospital failed to ensure patient safety related to the quality of pharmaceutical services,
Failure to do so creates risk to patient safety and risk to protection from harm.
As evidenced by deficiencies identified in A0501, A0505 and A0508 in this report, the cumulative effects demonstrated that the hospital failed to ensure patient safety by mitigating risk and/or implementating timely corrections in pharmacy operations.
Due to the scope and severity of deficiencies cited under 42 CFR 482.25, the Condition of Participation for Pharmaceutical Services are NOT MET.
|VIOLATION: PHARMACIST SUPERVISION OF SERVICES||Tag No: A0501|
Based on observation, review of policy and procedure and interview, the facility failed to ensure safe sterile compounding practices and related activities in the preparation and/or use of sterile solutions.
Failure to do so creates risk for patient harm including, but not limited to, illness and death.
Reference: United States Pharmacopoeia [USP], 39 NF 34-General Chapter 797, Pharmaceutical Compounding - Sterile Preparation, Official from 05/01/2016.
A. Antiseptic Hand Hygiene and Protective Wear for Sterile Compounding Activities
1. Per facility policy titled, "Sterile Compounding for Cancer Center" (Policy 303.333.72; Effective 1/20/2014) item 1.1.7. stated, "Compounding personnel are adequately skilled, educated, instructed and trained to adequately perform and document the following activities: Perform antiseptic hand cleansing, Perform disinfection of non-sterile compounding surfaces, Select and don protective garb, Maintain and achieve sterility of compounded sterile preparations in ISO 5 environments, Protect personnel and compounding environments from contamination by . . . cytotoxic and chemotoxic drugs. . . Label and inspect sterile preparations."
2. The following observations of pharmacy staff were noted by the surveyor and technical advisor in the Cancer Center Pharmacy unless otherwise noted:
a. Nail cleaning: On 8/10/2016 between 10:00 AM and 11:00 AM they observed that nail picks were not located at the sink area outside of the segregated compounding area of the Main Pharmacy and therefore were unavailable for use by a pharmacy technician (Staff Member #8) prior to performing sterile compounding activities. At the Cancer Center another pharmacy technician (Staff Member #4) performed hand hygiene at the sink. However, s/he neglected to clean her/his nails first. Unpackaged nail cleaners were noted to be located at the head of the sink in a water proof container in countertop standing water, available for use.
b. Location of sterile gloves for hazardous drug (HD) compounding: On 8/10/2016 between 1:00-1:30 PM they observed that sterile gloves required for compounding of HDs were not located in the hazardous drug compounding area. The gloves for this purpose were located outside of the HD area (requiring interim contact with door handles, etc.).
c. Location of personal protective equipment (PPE): On 8/10/2016 between 1:00-1:30 PM they observed that PPE for non-hazardous drugs (NHD) and HD compounding was located in the pharmacy (office) area (not an ante room). A separate area for donning PPE specific to HD activities was not available.
d. Hand hygiene: On 8/11/2016 between 10:30-11:30 AM they noted that a pharmacy technician (Staff Member #4) did not use an alcohol-based product with persistent antimicrobial activity prior to donning sterile gloves in the sterile compounding areas (HD and NHD). Said product was not available for staff use. S/he used an alcohol hand cleaning product (Avagard-D) with 61% alcohol. The facility policy identified Prevacare as the product to be used.
e. Adequacy in Donning/Doffing PPE: On 8/11/2016 between 10:30-11:30 AM they observed that a pharmacist (Staff Member #7) did not ensure that her/his hair (a long ponytail) was secured under her/his hair cover prior to entry into the HD sterile compounding area and checking medication. That staff member's waist ties were not secured leaving the back of the gown open to the HD environment. Also pharmacy technician's (Staff Member #9) protective gown was donned in the NHD compounding area with the waist straps untied and touching the floor while walking in and out of the area.
Another pharmacy technician (Staff Member #4) engaged in HD sterile compounding and did not have protective eye protection in place. Additionally, the technician was observed exiting the HD compounding area and traversing the non-HD compounding area for supplies (contact with casework) without doffing the HD PPE first.
f. Maintaining Sterility of Donned Gloves: On 8/11/2016 from 10:30-11:30 AM a pharmacy technician (Staff Member #7) did not ensure glove sterility with the interim use of alcohol after contact with the physical contact with the non-ISO Class 5 environment (door handles, printers, cabinetry, supplies), thereby potentially cross-contaminating the gloves for use in sterile preparation.
g. Use of HD PPE outside of the HD compounding area: On 8/11/2016 from 10:30-11:30 AM a pharmacist (Staff Member #7) was observed wearing shoe covers previously worn in the HD environment in the pharmacy office. Upon discussion with the surveyor, s/he stated that s/he wore the same shoes covers throughout the workday in various locations inside and outside of the Cancer Center pharmacy.
Additionally a pharmacy technician (Staff Member #4) was observed wearing HD PPE in the NHD environment thereby potentially contaminating the NHD environment and products. There was not designated area for donning and doffing HD PPE prior to entering the non-HD compounding area.
h. Chemotherapy-rated PPE: Chemotherapy rated sterile gloves were not available for staff use; 2 pairs of chemotherapy-rated sterile gloves are required for HD drug compounding. Instead staff used a pair chemotherapy-rated clean gloves covered by non-chemotherapy rated sterile gloves (Protexis PI Classic, surgical gloves). Additionally, chemotherapy-rated masks were not available for staff use. Instead staff used masks (Insta-Gard Procedure Mask, Blue) designed for standard sterile procedures.
i. Lint free towels: On 8/10/2016 between 1:00-1:30 PM a pharmacy technician (Staff Member #4) was observed using regular hand towels after hand hygiene. Lint free towels for use immediately (at the sink) subsequent to hand hygiene were not available. Packaged towels (Kimberly Clark Wypall x60) were present but they were not designated as "lint-free".
3. On 8/11/2016 at 1:45 PM during an interview with the Pharmacy Director (Staff Member #2) and the Pharmacy Manager (Staff Member #1), they acknowledged the lack of overall USP compliance in the Cancer Center. They also reported that they had determined that the physical space needed to be completely remodeled to be able to ensure the proper environment for full adherence to USP 797.
B. Cleaning and Disinfection of Injection Ports and Vials
1. In review of facility policy titled, "Sterile Compounding" (Policy # 303.333.69; Effective 3/2/2015) under "Transfer of a Parenteral Solution from Vial" item 1.2 stated, "Wipe the entire rubber stopper of a vial container with sterile 70% isopropyl alcohol wipes in the . . . hood". Item 1.3 stated, "Allow sufficient time (approximately 30 seconds) for drying before use to sterilize the surface of the vial."
2. On 8/11/2016 between 10:00 - 11:00 AM, the technical advisor observed a pharmacy technician (Staff Member #4) access injection ports and/or vials without the use of alcohol. Also when alcohol was used, adequate contact time for disinfection was not provided prior to accessing contents.
C. Ensuring Critical Site Access to HEPA Filtered Air within the Hood
1. In review of facility policy titled, "Sterile Compounding: (Policy # 303.333.69; effective 3/2/2015) item 14.8 stated, "Position hands so that they do not block the airflow to the syringe, especially the plunger and syringe tip." The policy made reference to other hand placement requirements but did not address placement of supply items and wrappings in reference to airflow.
2. On 8/11/2016 between 10:30-11:30 AM, the surveyor and the technical advisor observed a pharmacy technician (Staff Member #4) engaged in sterile compounding activities. It was noted that technician's hand positioning and a large amount wrappers and medical supplies were located such that first air (unidirectional airflow) was blocked.
D. Medication Storage in the Cancer Center
Reference: USP 797 "Hazardous Drugs as CSPs"
1. In review of facility policy titled, "Sterile Compounding for Cancer Center" (Policy # 303.333.72; Effective 1/20/2014) under item 3 "Drug and Materials Storage" it did not address separate (refrigerated) storage for HD and NHD drugs.
2. On 8/11/2016 between 10:30 -11:30 AM, the technical advisor noted that a refrigerator located in the NHD compounding area, was used to store both HD and NHD drugs.
E. Labeling Accuracy of Compounded Medications
Reference: USP 797, "Compounding Accuracy Checks" and "Responsibility of Compounding Personnel"
1. Per facility policy titled, "Sterile Compounding for Cancer Center" (Policy # 303.333.75; Effective 1/20/2014) item 4.4 referred staff policy # 333.50. That policy titled, "Labeling of Inpatient Medications" (Effective 09/15/2014) contained item 4 which stated, "A pharmacist must check the label against the original container when transferring medications from one container to another."
There was no mention of a double check system, including labeling accuracy, of all drug products and ingredients used to prepare the finished product and their volumes or quantities. There also was no mention of double-checking during preparation and immediately prior to release.
2. On 8/11/2016 between 10:30-11:30 AM, the technical advisor observed a pharmacy technician (Staff Member #4) set up multiple different medications (at times for multiple patients) in the hood prior to compounding. A pharmacist (Staff Member #7) checked the set-up (volume and identity of ingredients) against the unattached label. Then the pharmacist exited the room. No other pharmacist checks of accuracy during and after the compounding process were observed.
F. Inspecting Compounded Sterile Solutions
1. Per facility policy titled, "Sterile Compounding for Cancer Center" (Policy 303.333.72; Effective 1/20/2014) item 1.1.7. stated, "Compounding personnel are adequately skilled, educated, instructed and trained to adequately perform and document the following activities: . . .inspect sterile preparations." Item 6 under "Preparing chemotherapy for delivery" it stated to insert bag into two yellow chemotherapy zipped bags for delivery and then "Give to pharmacist for final delivery." Item 4.1 stated, "All sterile compounded preparations will be visually inspected for particulates/contaminants." However, the policy did not address how, when and by whom this was to be performed.
2. On 8/10/2016 between 1:00 - 2:00 PM in the Cancer Center pharmacy, the surveyor and technical advisor observed the pharmacy technician (Staff Member #4) deliver recently compounded medications to the Pharmacy office from a segregated compounding area. A pharmacist (Staff Member #5) handled the medications and subsequently handed them to a nurse at the pharmacy window for future administration. The pharmacist did not visually inspect the product (for integrity; particulate matter; verification of contents) prior to handing them to the nurse.
G. Maintenance of Clean and Disinfected Sterile Compounding Surfaces in the Cancer Center
1. Per facility policy titled, "Sterile Compounding" (Policy 303.333.69; Effective 3/2/2015) under "Laminar flow hood" item 188.8.131.52.3 stated, "To remove deposits, use lint free wipes with sterile water . . . Item 184.108.40.206.4 stated, "Prior to starting a shift in the IV room the technician will wipe down the inside and outside surfaces of the hood with sterile 70% isopropyl alcohol using lint free wipes." It also addressed a weekly (Wednesdays) cleaning regimen.
Under 2.1.2 "Biological Safety cabinet" section it provided similar information however it did not address cleaning specific to chemical deactivation of HDs as a part of process.
According to 2016 USP 797 Official (8/1/16 - 11/30/16), under "Cleaning and Disinfecting the Compounding Area" and under Table 3 it provided a frequency for cleaning compounding surfaces which included; "At the beginning of each shift, before each batch, not longer than 30 minutes following previous surface infection when ongoing compounding activities are occurring, after spills, and when surface contamination is known or suspected. "
2. On 8/10/2016 between 1:00-2:00 PM during an interview with technical adviser, a pharmacy technician (Staff Member #4) stated that s/he used a cleaning product called Super Sani-Cloth germicidal disposable wipes to clean the hood surface area. Additionally, s/he stated that for the HD compounding area s/he did not use the 2 step cleaning product (with the chemical neutralizer for HDs). A 2-step product (Safetec) was located (not used) in the area. Also, sterile water and lint free wipes were not available for use.
3. On 8/10/2016 between 1:00-2:00 PM, the surveyor and technical advisor observed a pharmacy technician (Staff Member #4) return from lunch break. S/he cleaned the hood area with a Super Sani-Cloth prior to initiating NHD compounding activities rather than using isopropyl alcohol.
4. a. On 8/11/2016 at 11:15 AM, the surveyor interviewed a pharmacy technician (Staff Member #4) about the use of Covidien preparation pads for hazardous drugs (used routinely in HD compounding environments in the event of a spill). S/he stated that s/he changed the pads every morning or more frequently if there was a spill of HDs.
b. In review of the facility's HD sterile compounding policy, it did not address use/discarding of the preparation pads. In review of a document provided by the hospital from the American Society of Health-System Pharmacists on page 4 it stated, "Preparation pads must be replaced and discarded after preparation of each batch and frequently during extended batch compounding."
H. Environmental Cleaning of Sterile Compounding Areas
1. On 8/10/2016 at 10:00 AM during an interview with the surveyor, the Pharmacy Technician Supervisor (Staff Member #3) stated that since January 2016 the pharmacy staff had been responsible for daily and monthly housekeeping functions in sterile compounding areas (instead of Environmental Services). Monthly cleaning was done with Peridox RTU.
"Monthly Cleaning Schedule" checklists were available and described cleaning process which were recorded as completed. The checklist did not include instructions to clean the ceiling and the walls behind the hoods.
2.a. On 8/11/2016 at 11:30 AM during a tour of the Cancer Center hazardous drug compounding area, the surveyor and technical advisor noted that the ceiling lighting mounts were not flush with the ceiling and were not sealed (not cleanable). Additionally, the air intake was not sealed (not cleanable). The placement of the hood did not allow adequate space for cleaning the wall behind it.
b. In the main pharmacy, the placement of the hood did not allow adequate space for cleaning the wall behind it.
3.a. On 8/10/2016 between 10:00 AM and 11:00 AM, the surveyor interviewed the Pharmacy Technician Supervisor (Staff Member #3) about pharmacy cleaning procedures. S/he stated that since January 2016 the pharmacy staff assumed (from environmental services staff) responsibility for cleaning the sterile compounding area. When asked if there was a procedure accordingly, s/he stated that it had not yet been developed.
b. On that day between 1:00-2:00 PM in the Cancer Center the surveyor noticed a transport box located on top of the non-HD compounding hood near the front edge. The pharmacy technician (Staff Member #4) explained that the box was used to transport medications compounded in the Cancer Center to other locations, usually to the hospital. When asked if there was a cleaning procedure for the inside and outside of the box before and/or after use, s/he replied that there was not one.
I. Staff Consent for Reproductive Health Risk Related to Compounding of Hazardous Drugs
Reference: USP 797, under "Hazardous Drugs As CSPs . . . Compounding personnel of reproductive capability shall confirm in writing that they understand the risks of handling hazardous drugs."
On 8/10/2016 at 2:00 PM during a surveyor and technical adviser interview with the Pharmacy Director (Staff Member #5), s/he indicated that eligible compounding staff had not confirmed in writing that they understood the risks of handling hazardous drugs.
J. Batch Preparation of Sterile Compounded Medication in the Main Pharmacy
1. On 8/10/2016 between 10:00 AM and 11:00 AM, the technical advisor reviewed pharmacy records documenting batching activity of intracoronary-nitroglycerin for patients who would receive interventions in the Cardiac Catheterization Lab. The products were not compounded for specific patients.
At that same time the pharmacy technician (Staff Member #8) disclosed that an average of 16 sterile preparation of this type were compounded and delivered daily to the cardiac cath lab.
2. On 8/11/2016 at 10:00 AM the Manager of Pharmacy (Staff Member #1) acknowledged that area was the only "outlier" in terms of batching medications (inadequate environment). All other compounded sterile preparations were designed to be patient-specific.
K. Room Design for HD and NHD Sterile Compounding
Reference: USP 797 under "Facility Design and Environmental Controls", "Additional Personnel Requirements", "Hazardous Drugs as CSPs", "ISO Class 5 Air Sources, Buffer Areas, and Ante Areas" and "CSP Microbial Contamination Risk Levels"
1 .In review of the Cleanroom Certification and Biological Sampling Report (test # ENV CF) dated 6/17/2014 for the Cancer Center, it stated that the HEPA Leak test was "N/A" [not applicable] in the Ante Room and Chemo Room.
Additionally it stated that the "Ante Room" (also a location for non-hazardous drug compounding room) was rated ISO Class 8 (should be 7) and the Chemo room was rated as Class 8 (should be 7).
2. On 8/11/2016 between 10:00 and 11:00 AM, surveyor and technical advisor visited the Cancer Center pharmacy sterile compounding area and observed that the area did not have an air supply with HEPA filtration. It was also noted that the HD compounding room had a pressure indicator but it could not measure a negative pressure environment because the space was not designed for negative pressure.
3. On 8/10/2016 between 1:00-2:00 PM, the surveyor and technical advisor observed that there was a handwashing sink in close proximity to the ISO Class 5 hood. Sinks should be separated from the immediate compounding environment to prevent cross-contamination.
4. On 8/11/2016 between 1:30 and 2:00 PM, the surveyor and technical advisor interviewed the Lead Project Manager (Staff Member #11) about the compounding area in the Cancer Center. S/he verified that s/he was aware that the space was USP 797 non-compliant. Documentation from building construction that occurred within the past 5 years identified it as not designed to be compliant. S/he advised that the hospital had carefully studied the area and were aware of what was needed to make it compliant. Among other items to be addressed were HEPA filters, revised air flow/ventilation, room pressure monitoring, cleanable surfaces, sinks and eyewash stations.
In a follow-up interview with the Pharmacy Director (Staff Member #2) s/he stated that s/he was not aware that the air supply in the HD compounding area of the Cancer Center was not HEPA filtered, among other items.
L. Frequency of Environmental Sampling
1. Review of USP 797 under "Viable and Non-Viable Environmental Sampling" it stated that environmental sampling shall occur "as a part of the re-certification of facilities and equipment" and that certification procedures shall be performed by a qualified individual no less than every 6 months."
2. Review of a facility document titled "Cleanroom Certification and Biological Sampling Report" (June 17, 2014) for the main pharmacy and Cancer Center, the surveyor and technical advisor noted areas of non-conformity for ISO classification, particle counts and environmental/biological sampling.
3. a.On 8/11/2016 at 3:00 PM during an interview with Pharmacy Manager (Staff Member #1) and the Pharmacy Director (Staff Member #2), they indicated that room certifications were not conducted in calendar year 2015 and 2016 to date (greater than 24 months) due to knowledge of inability to attain compliance due to structural barriers. However, sterile compounding activity was performed in these rooms on a regular basis.
b.On 8/16/2016 at 12:30 PM, during an interview with two Infection Preventionists (Staff Members #13 and 14) they stated that they were not aware of abnormal findings from biological samplings in the sterile compounding rooms. Therefore, they were unable to determine the pathogenicity of the organisms identified or provide consultation to improve the environment.
M. NHD Drug Located in HD Compounding Area
On 8/10/2016 between 1:00 and 2:00 PM, the technical advisor observed an accessed vial of Venofer (NHD) located in the HD compounding space, creating a potential for HD cross-contamination of NHD item.
|VIOLATION: UNUSABLE DRUGS NOT USED||Tag No: A0505|
|**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**
1. a. In review of facility policy titled, "Injectables: Handling of Multidose Vials, Single Dose Vials and Ampules" (Policy # ANC-2661; effective 11/17/15) item 3 stated, "Excess drug remaining in (SDV) [single dose vials] or ampules must be discarded immediately after initial use."
b. On 8/10/2016 between 1:00 and 1:30 PM, the technical advisor and surveyor observed the following vials in the Cancer Center compounding areas spiked with a closed transfer device and available for use:
-a single dose vial of cyclophosphamide with residual medication labelled to expire on " 8-14 " ; Velcade dated 8/13;
-single dose vials with residual solution unlabeled and available for use; sterile water (100 milliliters [mls]), Erbitux (50 ml); Abraxane (50ml) and Venofer
At that time the pharmacy technician reported her/his standard practice was to use the medications throughout the day, when needed.
2. a. In review of facility policy titled, "Injectables: Handling of Multidose Vials, Single Dose Vials and Ampules" (Policy # ANC-2661; effective 11/17/15) item 4 stated, "MDV [multidose vial] may be used for only 28 days. . .When the vials is accessed, the date must be written on the vial along with the expiration date and time."
b.On 8/10/2016 at 1:00 PM in the Cancer Center a multidose vial of Ondanstron was opened and dated as "8/10"; a vial of doxorubicin was labelled for expiration on "8/20"; a vial of Herceptin was unlabeled; a vial of Cisplatin was dated "8/17"; Etoposide was dated as "8/10".
c. On 8/11/2016 at 3:00 PM during a tour of the emergency room , the surveyor and technical advisor observed a 50 milliliter multidose vial of xylocaine 1% with epinephrine opened and unlabeled (unsecured) on a cart outside of a patient room.
d. On 8/11/2016 at 11:15 AM, the technical advisor and surveyor noted a document posted in the HD compounding room. It listed 19 chemotherapy drugs in one column and expirations dates in the other column, listed for room temperature or refrigeration. There was no notation of where the document came from or if it was approved for use. At that time the pharmacy technician (Staff Member #4) stated that s/he did not know where it came from but used it as a daily reference.
The Pharmacy Manager (Staff Member #1) acknowledged the findings at that time.
In subsequent review of first 10 of 19 chemotherapy agent listed on the unofficial document, 7 were single dose medication (i.e. should not have been listed for future use).
3.a. On 8/11/2016 between 3:00 to 4:00 PM the following expired items were found: 2 liters of refrigerated normal saline (needed in a [DIAGNOSES REDACTED] emergency) expired in May 2016 and July 2016 in a refrigerator located outside of an operating room suite; 1 vacutainer located in a crash cart on the medical care unit; and 1 bag of Dextrose 10 in the ED North crash cart.
b. In review of a document titled,"Code Carts, Verifying, Main Campus" (Policy # WR.387.67; Approved 07/07/2011) item 3 stated that the Central Supply department maintained the crash carts monthly. In subsequent review of a form located in Central Supply several units had no documented 2016 monthly checks as follows:
Cardiovascular intensive care unit: April-July; ICU: July; Surgical 3: July; Surgical 2/Pediatrics: June-July; Birth Center: June-July; Short Stay Unit: April-July; ED North: January -July; ED South: January-July; ED Trauma Room: January-July; Endoscopy: May-June.
c. In a follow-up interview on 8/12/2016 at 3:00 PM with a central supply technician (Staff Member #10) s/he acknowledged the lack of documentation of monthly checks of crash cart supplies, including supplies for administration of medications.
4. The following observations were noted by the surveyor and the technical advisor:
-In the Cancer Center on 8/12/2016, two bags of compounded dexamethasone for infusion were located in the NHD compounding room and were labeled as "Dex 12mg". The label was initialed, as reviewed by a pharmacist.
-On 8/10/2016 between 1:00-2:00 PM CADD pump (electronic pump used for automatic infusion of medication outside of the facility) was noted to not be labelled with the pharmacy address, phone number or the name of the prescriber.
|VIOLATION: REPORTING ADVERSE EVENTS||Tag No: A0508|
Based on interview, review of policy and procedure and facility records, the facility failed to demonstrate that it reported medication errors on a quarterly basis to the Pharmacy and Therapeutics Committee.
Failure to do so creates risk that errors and substandard outcomes will not be addressed systematically and therefore may result in ongoing patient harm.
1. In review of facility policy titled, "Adverse Drug Event (ADE) Reporting Program" (Policy #303.333.14; Effective 09/06/2012) on page 4 of 6, item 5 discussed "Cumulative Review". Item 5.1 stated "ADR [adverse drug reaction] data will be summarized . . . Report to the P&T [Committee] for review at least quarterly." The procedure later discussed coding and information about rate-based statistics.
2. In review of the Pharmacy and Therapeutics Committee Meeting minutes it was determined that medication error information had not been included as an agenda item in calendar year 2016 to date (August 12, 2016).