Burger, Terry, MBA, BSN, RN, NE-BC, CIC

Fry, Deborah, MT (ASCP), MBA, CIC

Mitman, Cindy L, Pharm D

Tallarita, Gary, MT (ASCP)

English

Lehigh Valley Health Network: LVHN Scholarly Works

Lehigh Valley Health NetworkLVHN Scholarly WorksDepartment of MedicineClosing the Gap: Revising Sterility Testing Policiesand Procedures Based on the United StatesPharmacopeia (USP) 797 Guidelines and a NearMissCindy L. Mitman Pharm DLehigh Valley Health Network, Cindy_L.Mitman@lvhn.orgTerry Burger MBA, BSN, RN, NE-BC, CICLehigh Valley Health Network, Terry_Lynn.Burger@lvhn.orgDeborah Fry MT (ASCP), MBA, CICLehigh Valley Health Network, Deborah.Fry@lvhn.orgGary Tallarita MT (ASCP)Lehigh Valley Health Network, Gary.Tallarita@lvhn.orgFollow this and additional works at: http://scholarlyworks.lvhn.org/medicinePart of the Infectious Disease Commons, Medical Sciences Commons, and the Pharmacy andPharmaceutical Sciences CommonsThis Poster is brought to you for free and open access by LVHN Scholarly Works. It has been accepted for inclusion in LVHN Scholarly Works by anauthorized administrator. For more information, please contact LibraryServices@lvhn.org.Published In/Presented AtMitman, C., Burger, T., Fry, D., & Tallarita, G. (2013. June 1-5). Closing the gap: Revising sterility testing policies and procedures based onthe united states pharmacopeia (USP) 797 guidelines and a near miss. Poster presented at: The 2013 American Society of Health SystemPharmacists (ASHP) Summer Meeting and Exhibition, Minneapolis, MN.•		Response	following	positive	sterility	test	results			 	 –		Notified providers	 	 	 	 •		Disclosed event to patients (5)	 	 	 	 •		Contacted Risk Management	 	 –		Retrieved unused syringes  	 	 –		Sterility tested more syringes from batch	 	 –		Screened patients (blood cultures negative)	 	 –		Risk Management engaged:	 	 	 	 •		Infection Control	 	 	 	 •		Microbiology Lab	 	 	 	 •		Pharmacy	 	 	 	 •		Infectious DiseasesLehigh Valley Health Network, Allentown, PAClosing the Gap: Revising Sterility Testing Policies and Procedures Based on the United States Pharmacopeia (USP) 797 Guidelines and a Near MissCindy Mitman, Pharm D; Terry Burger, MBA, BSN, RN, NE-BC, CIC; Deborah Fry, MT(ASCP), MBA, CIC; Gary Tallarita, MT(ASCP), CIC© 2013 Lehigh Valley Health NetworkDisclosuresAuthors	of	this	presentation	have	the	following	to	disclose	concerning	possible	financial	or	personal	relationships	with	commercial	entities	that	may	have	a	direct	or	indirect	interest	in	the	subject	matter	of	this	presentation.Purpose•		Due	to	a	national	shortage,	a	batch	of	sodium	bicarbonate	syringes	was	compounded	from	vials	into	unit-dosed	syringes		 	 –		Prepared in the pharmacy clean room	 	 –		Given a 9 day beyond use date (BUD)	 	 –		Sterility tested	 	 –		Released to stock	 	 –		Sterility tests came back positive within 24 hours •		Previous	procedure	for	recalling	products	from	positive	sterility	tests	was	not	documented	in	policy	and	procedure	manualConclusions•		Hospital	Pharmacy	Departments	should	collaborate	with	their	Infection	Preventionist	colleagues	to	identify	activity	that	fall	under	the	purview	of	USP	797.			•		On	site	observations	of	personnel	practices	are	imperative	to	insure	proficiency	and	competency	of	the	individuals	responsible	for	sterile	preparations.				•		Definition	of	formal	policies	and	procedures	is	needed	to	safely	prepare	and	recall	sterile	products	for	patient	use.	•		Clear	communication	and	swift	response	to	positive	sterility	test	results	is	critically	important	to	mitigate	patient	harm.			Volumetric Air Sampler Aseptic Technique andProper Garb•	 	Cindy	Mitman:	Nothing	to	disclose•	 	Terry	Burger:	Nothing	to	disclose•	 	Deborah	Fry:	Nothing	to	disclose•	 	Gary	Tallarita:	Nothing	to	discloseResults•		Identified	gaps	in	the	existing	policies	and	procedures	at	initial	meeting	between	departments	•		Created	Action	Plan	(Pharmacy	portion	listed	below)		 	 –		Reviewed USP 797 and USP 71 Guidelines with all stakeholders	 	 –		Re-educated pharmacy staff with infection prevention strategies	 	 	 	 •		Aseptic technique	 	 	 	 •		Personal Protective Equipment	 	 	 	 •		Traffic control	 	 	 	 •		Hand hygiene	 	 	 	 •		Excessive talking 	 	 –		Improved environmental air sampling procedure:	 	 	 	 •		Monthly settling plate sampling → monthly volumetric sampling	 	 –		Documented communication protocol for positive sterility tests in policies and proceduresMethodsPolicy Amendments•		Products	that	get	sterility	tested,	but	do	not	surpass	the	USP	797	BUD	recommendations	for	sterility	testing	 	 –		Released without quarantining	 	 –		Notification to Pharmacy Management, Infection Control and Risk Management if any products that tested positive reached patients  	 	 –		Further dissemination of information to additional stakeholders•		Products	that	get	sterility	tested	based	on	USP	797	guidelines	 	 –		Quarantine period	 	 –		Notification to Pharmacy Management and Infection Control, but not Risk Management if no products dispensed to patients	 	 –		Pharmacy will then consult with Infection Control to investigate possible causes PharmacyManagementInfectionControlRiskManagementInfectiousDiseasesLaboratoryPatientSafetyPhysiciansPatientsNotification

Closing the Gap: Revising Sterility Testing Policies and Procedures Based on the United States Pharmacopeia (USP) 797 Guidelines and a Near Miss

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Closing the Gap: Revising Sterility Testing Policies and Procedures Based on the United States Pharmacopeia (USP) 797 Guidelines and a Near Miss

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