Defining Event Reporting In The Cell Processing Facility (CPF) (2010)

Background:Laboratory "events" go by different names, such as Error, Accident, Incident, Occurrence or Deviation to name a few. Reporting of events in the hospital setting is generally well defined but those occurring in CPF are as yet not classified, though some of these are mandatory FDA-reportable.FACT Standards offer definitions for four events: Biological Product Deviation (BPD) relates to product contamination; Errors and Accidents relate to product safety, purity and potency; Variance refers to planned deviation from operating procedure; and Adverse Event refers to any event related to an intervention.FDA on the other hand has only one broad concern: Prevention of introduction, transmission, and spread of communicable disease through a distributed HCT/P; resulting in HCT/P deviation or an Adverse Reaction (and both are listed together under Complaint).However in the CPF daily routine, we come across a number of events which are not covered by FACT or FDA regulatory standards, but which must be addressed if our goal is to improve the quality, efficiency and safety of the laboratory, its patient, product and personnel.Thus far no work has been published referring to events in the CPF. We at NMH are defining a system for Event Management which may be worth looking at.Event Classification:See Table 1.Discussion:Published data on errors occurring hospital-wide concur that, Errors are much more frequent than reported Adverse Events (and may be as many as 100:1)1,2; At most times, Management is unaware of the magnitude of the problem2; Event-reporting systems may be able to produce valuable information1,2; Humans are fallible and errors are to be expected3,4,5; and Errors result from system failures, not people failures2,3, and 5.In all likelihood CPF has many events which go unidentified and unreported in the absence of a standardized system for documenting events1,2. Further, events go unreported out of fear of embarrassment, punishment or litigation6 or of reprisal, loss of reputation, job or extra work7 and from lack of belief that reporting will lead to improvement8.Conclusion:Tabled 1Event Classification1. HCT/P Deviation:1.1BPD: (Distributed, Contaminated, Recall, Adverse Reaction etc)1.2Improper Product Release (UMN, Without Review or Signature etc)1.3Product Label related1.4Product Bag related1.5Patient-Donor Information related1.6Other: (Improper Processing, Storage etc)2. SOP Deviation:2.1Not Per Procedure, or No Procedure2.2Wrong Procedure or Form2.3In-process Label related: 2.3 AWrong or No Label 2.3 BWrong, No or Incomplete2.4Data Related: 2.4 AWrongor No Data or Calculation 2.4 BNo or Poor Verification 2.4 CNo or Poor Primary or Secondary Review 2.4 DPoor Data Correction 2.4 EOther Data related2.5Poor Notification (Physician, Tech, Participating Program, Vendor etc)2.6Other (Missed Review, No Review, Inappropriate Release of PHI, Data etc)3. Planned Deviation:3.1HCT/P Related: 3.1 ANon-Conforming Product, as Received 3.1 BNon-Conforming to CPF Release Criteria 3.1 COther3.2SOP related4. Equipment or Supply related:4.1Recall or Notice4.2Calibration, Qualification or Maintenance related4.3Alarm or Monitor System related4.4Other (Expired Lot, Out of Order or Service, Inappropriate Use, etc)5. Complaint:5.1Internal5.2External6. Other:6.1Billing related6.2All Other Open table in a new tab Background:Laboratory "events" go by different names, such as Error, Accident, Incident, Occurrence or Deviation to name a few. Reporting of events in the hospital setting is generally well defined but those occurring in CPF are as yet not classified, though some of these are mandatory FDA-reportable.FACT Standards offer definitions for four events: Biological Product Deviation (BPD) relates to product contamination; Errors and Accidents relate to product safety, purity and potency; Variance refers to planned deviation from operating procedure; and Adverse Event refers to any event related to an intervention.FDA on the other hand has only one broad concern: Prevention of introduction, transmission, and spread of communicable disease through a distributed HCT/P; resulting in HCT/P deviation or an Adverse Reaction (and both are listed together under Complaint).However in the CPF daily routine, we come across a number of events which are not covered by FACT or FDA regulatory standards, but which must be addressed if our goal is to improve the quality, efficiency and safety of the laboratory, its patient, product and personnel.Thus far no work has been published referring to events in the CPF. We at NMH are defining a system for Event Management which may be worth looking at. Laboratory "events" go by different names, such as Error, Accident, Incident, Occurrence or Deviation to name a few. Reporting of events in the hospital setting is generally well defined but those occurring in CPF are as yet not classified, though some of these are mandatory FDA-reportable. FACT Standards offer definitions for four events: Biological Product Deviation (BPD) relates to product contamination; Errors and Accidents relate to product safety, purity and potency; Variance refers to planned deviation from operating procedure; and Adverse Event refers to any event related to an intervention. FDA on the other hand has only one broad concern: Prevention of introduction, transmission, and spread of communicable disease through a distributed HCT/P; resulting in HCT/P deviation or an Adverse Reaction (and both are listed together under Complaint). However in the CPF daily routine, we come across a number of events which are not covered by FACT or FDA regulatory standards, but which must be addressed if our goal is to improve the quality, efficiency and safety of the laboratory, its patient, product and personnel. Thus far no work has been published referring to events in the CPF. We at NMH are defining a system for Event Management which may be worth looking at. Event Classification:See Table 1. See Table 1. Discussion:Published data on errors occurring hospital-wide concur that, Errors are much more frequent than reported Adverse Events (and may be as many as 100:1)1,2; At most times, Management is unaware of the magnitude of the problem2; Event-reporting systems may be able to produce valuable information1,2; Humans are fallible and errors are to be expected3,4,5; and Errors result from system failures, not people failures2,3, and 5.In all likelihood CPF has many events which go unidentified and unreported in the absence of a standardized system for documenting events1,2. Further, events go unreported out of fear of embarrassment, punishment or litigation6 or of reprisal, loss of reputation, job or extra work7 and from lack of belief that reporting will lead to improvement8. Published data on errors occurring hospital-wide concur that, Errors are much more frequent than reported Adverse Events (and may be as many as 100:1)1,2; At most times, Management is unaware of the magnitude of the problem2; Event-reporting systems may be able to produce valuable information1,2; Humans are fallible and errors are to be expected3,4,5; and Errors result from system failures, not people failures2,3, and 5. In all likelihood CPF has many events which go unidentified and unreported in the absence of a standardized system for documenting events1,2. Further, events go unreported out of fear of embarrassment, punishment or litigation6 or of reprisal, loss of reputation, job or extra work7 and from lack of belief that reporting will lead to improvement8. Conclusion:Tabled 1Event Classification1. HCT/P Deviation:1.1BPD: (Distributed, Contaminated, Recall, Adverse Reaction etc)1.2Improper Product Release (UMN, Without Review or Signature etc)1.3Product Label related1.4Product Bag related1.5Patient-Donor Information related1.6Other: (Improper Processing, Storage etc)2. SOP Deviation:2.1Not Per Procedure, or No Procedure2.2Wrong Procedure or Form2.3In-process Label related: 2.3 AWrong or No Label 2.3 BWrong, No or Incomplete2.4Data Related: 2.4 AWrongor No Data or Calculation 2.4 BNo or Poor Verification 2.4 CNo or Poor Primary or Secondary Review 2.4 DPoor Data Correction 2.4 EOther Data related2.5Poor Notification (Physician, Tech, Participating Program, Vendor etc)2.6Other (Missed Review, No Review, Inappropriate Release of PHI, Data etc)3. Planned Deviation:3.1HCT/P Related: 3.1 ANon-Conforming Product, as Received 3.1 BNon-Conforming to CPF Release Criteria 3.1 COther3.2SOP related4. Equipment or Supply related:4.1Recall or Notice4.2Calibration, Qualification or Maintenance related4.3Alarm or Monitor System related4.4Other (Expired Lot, Out of Order or Service, Inappropriate Use, etc)5. Complaint:5.1Internal5.2External6. Other:6.1Billing related6.2All Other Open table in a new tab