Food and Drug Administration: Laboratory Analysis of Product Samples Needs To Be More Timely

Highlights

GAO reviewed the Food and Drug Administration's (FDA) field laboratories, focusing on: (1) their timeliness in processing product samples to determine if they were violative; and (2) measures FDA could implement to improve this process.

Recommendations

Recommendations for Executive Action

Agency Affected	Recommendation	Status
Department of Health and Human Services	The Secretary of Health and Human Services should direct the Commissioner, FDA, to establish time-frame guidelines for field laboratories' processing of all samples, consistent with the four sample processing priority designators used by the laboratories.	Closed – Implemented A draft sample processing time-frame guideline was circulated to FDA Regional Food and Drug Directors for their review and comment. On March 9, 1987, the sample processing time frames were finalized and sent to all of the district offices for implementation.
Department of Health and Human Services	The Secretary of Health and Human Services should direct the Commissioner, FDA, to establish procedures that require district offices' investigations and laboratory branches to coordinate and schedule the collection of surveillance samples.	Closed – Implemented FDA incorporated PMRS elements and standards in district-level staff performance plans to ensure coordination between investigations and laboratory branches.
Department of Health and Human Services	The Secretary of Health and Human Services should direct the Commissioner, FDA, to establish procedures that require the investigations branch to collect surveillance samples in accordance with the collection schedule developed with the laboratory branch, unless an emergency should arise.	Closed – Implemented FDA emphasized increased coordination between investigations and laboratory branches in a November 1986 district manager's conference and will incorporate coordination in district PMRS.
Department of Health and Human Services	The Secretary of Health and Human Services should direct the Commissioner, FDA, to establish procedures that require laboratory directors to continue to prepare schedules for receipt of surveillance samples tested for other districts, and require these districts to follow the prepared schedules, unless agreements on deviations from the schedules are reached with the laboratory.	Closed – Implemented FDA instructed its district directors to monitor and manage the flow of surveillance samples from other districts and prepare work schedules to determine when samples may be accepted. Action was accomplished at a district managers' conference. Follow-up over time is needed to ensure that oral instructions are sufficient to accomplish the purpose of this recommendation.
Department of Health and Human Services	The Secretary of Health and Human Services should direct the Commissioner, FDA, to establish procedures that require laboratory directors to determine an approximate inventory size that will permit the processing of samples within the time-frame guidelines established by FDA.	Closed – Implemented District directors were directed to implement this recommendation. Additional work is needed to determine whether such a directive is effective.
Department of Health and Human Services	The Secretary of Health and Human Services should direct the Commissioner, FDA, to establish a policy that prohibits the dumping of product samples into the laboratory's inventory.	Closed – Implemented FDA action consisted of oral instructions at a November 1986 district managers' conference. Further follow-up over time is needed to ensure that oral instructions are sufficient to accomplish the purpose of this recommendation.
Department of Health and Human Services	The Secretary of Health and Human Services should direct the Commissioner, FDA, to assess the simplified analytical documentation practices used by various FDA laboratories, including eliminating detailed step-by-step descriptions of the analyses performed on nonviolative samples, and determine their applicability to all FDA laboratories.	Closed – Implemented After assessing the different practices, FDA selected one to be used by all field laboratories. FDA issued a directive on use of the single simplified practice.
Department of Health and Human Services	The Secretary of Health and Human Services should direct the Commissioner, FDA, to define the universe of samples that should be covered by abbreviated reporting.	Closed – Implemented After assessing the different practices at various laboratories, FDA issued directives which define the universe of samples that may use abbreviated reporting.
Department of Health and Human Services	The Secretary of Health and Human Services should direct the Commissioner, FDA, to develop a standardized abbreviated form and implement its use as FDA policy on a laboratorywide basis.	Closed – Implemented After assessing the different practices at various laboratories, FDA issued a directive which includes the appropriate forms all laboratories should use with analytical processes.
Department of Health and Human Services	The Secretary of Health and Human Services should direct the Commissioner, FDA, to change the laboratory management system sample priority classifications to those used by the laboratories in setting processing priorities to: (1) enable laboratory managers to better schedule the testing of samples; and (2) give laboratory managers greater monitoring capability over laboratory performance.	Closed – Implemented The laboratory management system was modified to accept and track the sample processing time frames. Software was designed to permit better management of samples and monitoring of schedules.
Department of Health and Human Services	The Secretary of Health and Human Services should direct the Commissioner, FDA, to evaluate field laboratory performance in meeting the time-frame guidelines.	Closed – Implemented FDA modified its laboratory management system to provide better analysis capabilities. Implementation was completed in December 1987.

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