Strengths	Weaknesses	Needed Improvements	Future Actions
Collaboration	Previously established	Regionalized impact if current partners cannot help	Establish other partnerships	Hold regular meetings Invite and engage other newborn screening (NBS) programs
Continuity of operations (COOP) plan	Previously established	Access to plan limited Contacts changed No secondary contacts Limited informatics/information technology (IT) coverage	Develop a comprehensive plan to cover all aspects of NBS Incorporate IT and other agencies in the plan Develop internal standard operating procedure (SOP) Develop plan for specimen rerouting to the backup laboratory	Continue to refine the plan Hire dedicated NBS IT staff; invite IT and other agencies to meetings with partners Work with lab and follow-up staff to write SOP Work with hospitals and providers on protocols
Memorandum of agreement (MOA)	Previously established and in date	MOA lost	Ensure MOA is accessible Develop MOA with additional partners	Widely distribute to staff and revise early Actively seek additional partners
Simulated exercises	One had been carried out	Whole process not evaluated Multiple agencies needed	Exercises should test the entire NBS system	Schedule an exercise annually Design exercise to mimic an actual incident Include all who would likely be involved in an incident
Staffing	Committed lab and follow-up staff	Longer workdays No overtime pay Short-staffed	Prevent staff stress and burnout Find alternate compensation	Cross-train non-NBS staff Discuss possibilities with human resources
Specimen delivery	Specimens transported as quickly as possible	Courier closed Unfamiliarity with shipping options Short notice for procurement approvals	Use the fastest mode to transport specimens	Have the contact information for a backup courier Explore different procurement options for specimen transport
Dependency on technology	Laboratory efficiency is enhanced	Laboratory information management system not accessible No data entry No testing	Need an offline process	Develop and test offline operations at least annually Make offline SOP available to staff
Data entry	Demographic entry was as timely as possible	Hospital and provider databases were not shared Specimen control number (SCN) could not be keyed Form copies lacked clarity Multiple keying errors Multiple corrections Speed and cadence slow	Share provider library reciprocally Standardize NBS collection device Send original forms	Obtain exact field layouts for provider information export and update annually Reformat SCN, field placement, and naming convention Explore state-specific data entry screens
Specimen processing	Accession numbers assigned Impacted laboratory’s unsatisfactory codes added to the NBS form	Not testing unsatisfactory specimens	Follow backup laboratory’s protocol for unsatisfactory specimens	Share unsatisfactory protocol and coding in advance Write the backup laboratory’s unsatisfactory code on the NBS form
Specimen volumes	Backup laboratories managed the specimen surges	Ability to handle extremely large volumes	Be realistic as to capacity	Assess capabilities periodically and share information with partners
NBS panels	Deferred to the backup laboratory’s panel	Panels do not match Test additional disorders Provider inquiries	Promptly return residual specimens Promptly communicate with providers that the COOP is activated	Update and share panel changes annually Explore a perforated specimen card Explore ways to communicate in real time
Retests and reference ranges	No infants were lost to follow-up	Handling recollections and retests	Complete rescreening at the backup laboratory Follow the backup laboratory screening algorithm for supplemental testing	Share updated references ranges and laboratory algorithms at least annually
Mailer format	All specimens had a corresponding mailer	Different mailer formats Difficulty in distinguishing results	Mailer standardization Presumed positive results and actions should stand out	Explore standardization Reformat existing mailers to highlight results
Access to results	Secure remote viewer (SRV) granted access to results	Inability to download multiple results at once Limited log-in capability Not all labs have remote access Difficulty finding results Long-term result storage	Need the ability to download multiple files simultaneously Need remote access for all states in a reciprocal partnership LIMS should have a field to capture the impacted laboratory’s accession number Develop a plan for long-term storage/retrieval of results	Increase bandwidth to allow for larger file downloads Work with IT to grant partners remote access to the LIMS Work to add a field for state accession number Develop a way to link results to specimens in the LIMS
Communication	Improved with each incident	Differences in follow-up algorithms Time differences Results were held	Update follow-up algorithms Consider time zones Treat all positive results as time-critical	Share algorithms annually with partners Do not hold any positive results