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Based on a review of facility documentation, observation, and employee interviews (EMP), it was determined that the facility failed to establish a policy to ensure that the Pharmacy was administered in accordance with accepted professional principles (A-0491); the facility failed to ensure that all compounding monitoring and testing was performed consistent with State and Federal laws and acceptable standards of practice (A-0501); and the facility failed to ensure that medications that were outdated or inadequately labeled were not made available for patient use in the Pharmacy Department and patient care areas (A-0505).

Findings include:

Review, at approximately 1:00 PM on December 1, 2016, of the "USP <797> Resource Guide," Copyright 2013, American Society of Health-System Pharmacists, revealed, "Section 3: Personnel Monitoring ... Gloved Fingertip Sampling. Gloved fingertip sampling is used to ensure that compounding personnel can successfully complete hand hygiene, gowning, and gloving without contaminating the gloved hands. During a gloved fingertip sampling, an evaluator will collect a gloved fingertip and thumb sample from both hands of the compounding employee by lightly pressing each fingertip into appropriate agar plates. The plates are then incubated. A successful test shows no growth after an incubation period, which is typically 48 to 72 hours. For initial certification, compounding personnel must demonstrate that they can pass the gloved fingertip sampling test three consecutive times with no growth. After successfully completing the initial testing, compounding personnel must successfully retest at least once a year. Media-Fill Testing. A media-fill test is used to evaluate the aseptic technique of compounding personnel and to ensure the procedures used are able to produce sterile compounds without microbial contamination. During the test, a microbiological growth medium is substituted for the drug product to simulate admixture compounding. A successful test shows no growth after incubation. Compounding personnel must complete a media-fill test initially and annually thereafter if they are working with low-risk preparations. ... Surface Sampling. Surface sampling is another type of monitoring that involves the use of plates or swabs containing a growth medium to detect bacteria on surfaces in the compounding area. ... Surface sampling is used to ensure that compounding personnel can successfully clean and disinfect surfaces within the sterile compounding area. After the PEC [Primary Engineering Control] and similar surfaces are properly cleaned and disinfected by the compounding personnel, there should be no bacteria on the surfaces. USP <797> requires surface sampling to be done periodically. A monitoring plan for surface sampling must be developed and identify the point at which further action needs to be taken. You should work with your Infection Control Officer to determine an appropriate plan. ... ."

Review, at approximately 2:00 PM on November 29, 2016, of Policy#ADMX-01, "IV Admixture Service," revision date March 2009, revealed, "... Purpose: To describe the IV admixture program. ... Policy: ... VI. Compounded sterile products will be compounded as necessary in a cleanroom environment using practices consistent with Chapter 797 of the United States Pharmacopeia. Reviewed: ... 5/16 ... ."

1. Review of a document titled "USP 797 Compliance Testing Scorecard- December 1, 2016," revealed a timeline for Gloved Fingertip and Media Fill Testing, for the Greenville and Farrell/Shenango Valley locations. Review of the documentation revealed as of the day of entrance, November 29, 2016, ten of 18 eligible employees had no current Gloved Fingertip or Media Fill Testing.

2. Review of a document titled "USP 797 Compliance Testing Scorecard- December 1, 2016," revealed a timeline for the testing of Viable Air/Surface Sampling for the Greenville and Farrell/Shenango Valley locations. Review of the documentation revealed as of the day of entrance, November 29, 2016, Viable Air/Surface sampling was not current for both, the Greenville and Farrell/Shenango Valley locations.

3. On November 29, 2016, at 9:55 AM, EMP5 stated, "In PA, the Pharmacists believe that oversight is only for patients in the hospital proper [not including others under the hospital CCN]." When asked what the UPMC Pharmacists currently believed, EMP5 stated, "The same, well [pause] not now."

4. On November 30, 2016, at approximately 10:05 AM, when asked to confirm that the failed areas for the Pharmacy inspection at Greenville, included the media fill testing and fingertip testing, EMP1 stated, "Yes. Both." When asked when the testing had been due, EMP1 stated, "Both [tests] several years out ... well in theory."

5. On December 1, 2016, at 12:50 PM, EMP1 confirmed that Viable Air Sampling was not completed for the Farrell/Shenango Valley and Greenville Pharmacies.

6. When asked, at approximately 12:55 PM on December 1, 2016, if the facility had policies regarding how frequently gloved fingertip sampling, media-fill testing, and surface sampling should be done, EMP1 stated, "No. ... No."

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Review, at approximately 9:28 PM on December 5, 2016, of Policy#MED-06, "Guidelines for Single and Multi-Dose Vials and Syringes," reviewed April 2015, revealed, "... Scope: This policy applies to all departments of UPMC Horizon. ... Policy: It is the policy of UPMC Horizon that aseptic technique be utilized with entries into single dose vials, multi-dose vials and sterile bottles of irrigation solution. These products are to be dated at the time of entry with an expiration date that identifies that the vial or solution is to be disposed of and is no longer to be used. ... B. Multiple Dose Vials (MDV) that DO NOT require reconstitution: ... 2. Label the vial with the expiration date 28 days from the date opened and the initials of the person opening the vial. a. If the manufacturer's expiration date occurs before this time, the manufacturer's expiration date must be used. ... 4. Multiple dose vials that have reached their expiration date, as well as vials suspected of being contaminated (cloudiness, particles), or changed in any way, or if the vials has [sic] not been stored according to the manufacturer's recommendations, MUST be discarded. 5. All opened vials MUST be discarded when the medication is discontinued, the patient has been discharged, or the 28 day expiration has been reached. ... C. Multiple dose vials that require reconstitution: 1. Label with the date of reconstitution, the drug concentration, the initials of the person reconstituting, and the expiration date of the final solution as prescribed by the manufacturer but must not exceed 28 days (reconstitution is primarily performed in the Pharmacy). ... 3. The reconstituted vial must be discarded when the expiration date has been reached or if contamination is suspected. ... Outdate Guidelines ... All items are to be labeled with the EXPIRATION date and not the date the container was opened. ... [Item] Multi-dose vials ... [Labeling Procedure] Label 28 days forward from the date opened ... [Outdate Timeframe] 28 days ... [Item] Insulin ... [Labeling Procedure] Label 28 days forward from the date opened. ... [Outdate Timeframe] 28 days ..."

1. On December 2, 2016, at approximately 10:42 AM, a storage area outside of the IV Admixture Clean Room at Greenville Pharmacy Department, contained metal shelving units with blue storage bins. Upon inspection, one of the bins contained two dark-colored storage bags, labeled as "Epi Kits." In addition to a syringe and needle in each bag, the bags also included ampules of Epinephrine 1:1000. One of the ampules was noted to have an expiration date of "1 March 2016," and the other was noted to have an expiration date of "1 January 2015." Upon presenting the supplies to EMP1, EMP1 stated that the supplies belonged to OTH3. Inspection of the storage area did not reveal identification of the supplies as belonging to another entity. EMP1 confirmed that in the event OTH3 would be unable to visit a discharged patient, the facility would utilize the supplies contained in this storage area, to prepare for the patient's first dose, home-use until OTH3 would provide supplies to the patient. Also noted in this area, a shelf that was labelled for "D5 100ml 16 pgk," "NSS 50ml singles," and "NSS 50 ml 16 pgk," was empty, with the exception of a sodium chloride pre-filled syringe, which expired "2015-08."

EMP5 and EMP9, present for the observation, confirmed the above findings.

2. On December 2, 2016, at approximately 10:51 AM, a tour of the Greenville Pharmacy Department Pharmacy Clean Room revealed sterile gloves with an expiration date of February 2016.

EMP1, present at the time of the finding, confirmed the sterile gloves were expired stating, "Yes. There are about 30 of them. They are chemo gloves. Sterile, powder-free." EMP1 added, "Oh, yeah. We must not be using them." EMP1 confirmed that a Pharmacy Technician is responsible for monitoring outdated supplies in the Clean Room area.

3. Inspection of the medication refrigerator in the Nursing Station Medication room on 3 West Greenville, at approximately 11:05 AM on December 2, 2016, revealed an IV admixture of Vancomycin with a due date of December 2, 2016, at "18:35." No beyond use (BUD) or expiration date was identified on the admixture.

EMP13 and EMP9 confirmed that they were both unsure of the beyond use date.

Visualization of a vial of Humalog 3 ml revealed the vial to be uncapped/open and containing a sticker indicating, "Do Not Use After," with a handwritten date of, "1-2-17."

EMP14 confirmed that the date the vial was uncapped/opened was not indicated, and was unknown. EMP9 confirmed that in the event the vial had been opened on December 2, 2016, the handwritten date of January 2, 2017, exceeded the recommendation of 28 days beyond use date after access.

4. Inspection of the "Ortho" Medication Room refrigerator, located on 3 West Greenville on December 2, 2016, at 11:10 AM, revealed a bag of Vancomycin 1 gm. The medication label revealed a due date of December 2, 2016, at 1:59 PM. Further review of the label revealed no expiration or BUD.

EMP15 and EMP9, present at the time of the finding, confirmed the medication had no expiration or BUD identified.

5. On December 2, 2016, at approximately 11:34 AM, observation of the medication refrigerator located in the Medication/Hood Room atGreenville Cancer Center Outpatient Oncology (OPO)) revealed an uncapped vial of Vinblastine Sulfate injection 1 mg/mL. The opened vial revealed no information regarding when it had been opened, who opened it, or an expiration and/or BUD.

EMP16, present at the time of the observation, confirmed there was no marking on the medication corresponding with it being opened/accessed or an expiration/BUD date stating, "No. It's not marked."

When asked, at approximately 12:50 PM on December 2, 2016, why there would have been an uncapped vial of Vinblastine Sulfate at this location if the staff were no longer performing chemotherapeutic admixtures, EMP1 stated, "I'm not sure."

6. On December 2, 2016, from approximately 12:40 PM to 1:05 PM, the following medications (includes number of doses and expiration date) were identified with the stock of medications in the Farrell/Shenango Valley Pharmacy: Metronidazole 250 mg., four doses with an expiration of November 2016; Doxepin 10 mg., 20 doses with an expiration of November 2016; quietiapine fumerate, over 80 doses with an expiration of November 2016; Dexamethasone 0.5 mg., 33 doses with an expiration of November 2016; and one box of Anu-Med suppositories with an expiration of November 2016.

7. On December 2, 2016, from approximately 12:40 PM to 1:05 PM, an additional surveyor identified the following expired medications in the stock medication in the Farrell/Shenango Valley campus Pharmacy: Timolol Maleate Ophthalmic Gel Forming Solution 0.5% 5 ml, box of one, expired November 2016; Tropicamide Opthalmic Solution 1% 2 ml, expired November 2016; Bethanechol 10mg (four tablets), packaging expired November 2016; Trihexyphenidy HCL 2 mg per tab (ten tablets), expired November 2016; and Rifampin 600mg/vial, expired November 2016.

Upon presenting EMP1 with the "Timolol Maleate Ophthalmic Gel Forming Solution 0.5% 5 ml," and identifying the item as expired, EMP1 stated, "Oh, ok."

On December 2, 2016, at 1:05 PM, EMP1, present during the findings, confirmed the aforementioned findings (Pharmacy Department Farrell/Shenango Valley).

8. On December 2, 2016, at approximately 1:20 PM eight 250 ml bags of Dobutamine 5% Dextrose were observed in the Farrell/Shenango Valley Pharmacy with an expiration of October 2016.

EMP1, present at the time of the observation, confirmed the expired bags of Dobutamine 5% Dextrose.

9. On December 2, 2016, at approximately 1:28 PM, an opened, unmarked/unlabeled vial of Humalog was observed in the medication refrigerator located on 2 West (Farrell/Shenango Valley Location).

EMP18, present at the time of the observation, confirmed the Humalog was uncapped and had been opened with no marking on the medication corresponding with it being opened/accessed or an expiration/BUD date. When asked if he/she would administer the medication to a patient, EMP18 stated, "No. Because it does not have a date (open or expiration/BUD)."

10. When asked, at approximately 3:24 PM on December 2, 2016, if there was a policy for distressed, expired, and unlabeled drugs, EMP5 stated, "[We're] Not going to release any policies until the [sic] come under extensive review."

Based on a review of facility documentation, and observation and staff interview (EMP), it was determined that the facility failed to ensure a safe and sanitary environment in the Pharmacy Department and patient care areas.

Findings include:

1. On December 2, 2016, at approximately 10:25 AM, inspection of the medication shelving in the Greenville Pharmacy Department revealed dust that accumulated upon contact with a finger and hand.

EMP1 and EMP9 confirmed the findings at the time of discovery. When asked if the accumulation appeared to be at least a month's worth, EMP1 stated, "It's probably six months." EMP1 added, regarding the frequency of cleaning, "It's every six months and as needed. It looks like that's as needed [indicating it appeared as though the area needed to be cleaned]." EMP9, present at the time, stated, "That's ridiculous."

2. On December 2, 2016, at approximately 10:40 AM inspection of the shelving located in the Greenville Pharmacy Department IV Room work area revealed dust that accumulated upon contact with a finger and hand.

EMP1, present at the time of discovery, confirmed the dust stating, "Oh my."

3. On December 2, 2016, at approximately 10:42 AM, a storage area outside of the IV Admixture Clean Room at Greenville Pharmacy Department, was lacking a protective wall base coved to the floor and tightly sealed to the wall, covering all seams. A void was noted between the base of the wall and the floor along the wall that was shared with the IV Admixture Room. Additionally, in this area, upon removing a blue storage bin from the metal shelving unit, visible dust fell from the bin to the floor. Storage bags contained within the bins on the metal shelving units were noted to have accumulated a layer of dust. Upon presenting the supplies to EMP1, EMP1 stated that the supplies belonged to OTH3. Inspection of the storage area did not reveal identification of the supplies as belonging to another entity. EMP1 confirmed that in the event OTH3 would be unable to visit a discharged patient, the facility would utilize the supplies contained in this storage area, to prepare for the patient's first dose, home use until OTH3 would provide supplies to the patient.

EMP5 and EMP9, present for the observation, confirmed the above findings.

EMP1 denied any recent construction, and further denied knowledge of why there would not have been a protective wall base coved to the floor and tightly sealed to the wall.

4. On December 2, 2016, at approximately 10:55 AM, tour of the Greenville Pharmacy Department Narcotic Room revealed a layer of accumulated dust on the storage shelving.

EMP1, present for the observation, confirmed the above findings.

5. Inspection of the "Ortho" Medication Room, located on 3 West on December 2, 2016, at 11:15 AM, revealed an open hole in the wall, located behind a freezer with exposed plaster.

EMP15 and EMP9, present at the time of the finding, confirmed the existence of the hole and exposed plaster.

6. At approximately 12:55 PM on December 2, 2016, upon exiting the IV Admixture Clean Room, at the Farrell/Shenango Valley Campus, the sink located adjacent the entrance to the Clean Room was noted to have a countertop, which was not fixed to the cabinet below, and had a warped shape, with loose caulking along the rear wall.

EMP13, present for the observation, confirmed the condition of the countertop.

7. At approximately 11:55 AM on December 2, 2016, EMP5 confirmed that the facility did not have a policy specific to the cleaning of the Pharmacy, which would be inclusive of dusting frequency.

8. When asked, at approximately 3:24 PM on December 2, 2016, who is responsible for cleaning the storage shelving in the Pharmacy, EMP5 stated, "[We're] Not going to release any policies until the [sic] come under extensive review."