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==The FDA Food Safety Modernization Act (FSMA) final rule on Laboratory Accreditation for Analyses of Foods (LAAF)==
==The laws themselves==


===1. Federal Telecommunications Act of 1996, Section 255 ([https://www.law.cornell.edu/uscode/text/47/255 47 U.S.C. § 255 - Access by persons with disabilities])===


===What is the Food Safety Modernization ACT (FSMA)?===
<blockquote>'''(b) Manufacturing'''
The FSMA is U.S. legislation that was signed into law in January 2011, giving the U.S. [[Food and Drug Administration]] (FDA) broader authority to regulate how the country's food supply is grown, harvested, and processed. The FSMA gives the FDA additional powers towards the prevention of food-borne risks, the inspection of food-related facilities, the enforcement of compliance controls and violations, the response to food supply threats, and the imposition of stricter controls on imported goods. The FSMA was largely born out of "high-profile outbreaks related to various foods" in the 2000s<ref name="FDAFoodBill10Arch">{{cite web |url=https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm237758.htm |archiveurl=https://web.archive.org/web/20101226031457/https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm237758.htm |title=Food Bill Aims to Improve Safety |author=U.S. Food and Drug Administration |publisher=U.S. Food and Drug Administration |date=23 December 2010 |archivedate=26 December 2010 |accessdate=18 February 2022}}</ref> and recognition that "a breakdown at any point on the farm-to-table spectrum can cause catastrophic harm to the health of consumers and great disruption and economic loss to the food industry."<ref name="HamburgFood11Arch">{{cite web |url=http://www.foodsafety.gov/news/fsma.html |archiveurl=https://web.archive.org/web/20110107124402/http://www.foodsafety.gov/news/fsma.html |title=Food Safety Modernization Act: Putting the Focus on Prevention |author=Hamburg, M.A. |work=FoodSafety.gov |date=January 2011 |archivedate=07 January 2011 |accessdate=18 February 2022}}</ref>
A manufacturer of telecommunications equipment or customer premises equipment shall ensure that the equipment is designed, developed, and fabricated to be accessible to and usable by individuals with disabilities, if readily achievable.


'''(c) Telecommunications services'''


===What is the Laboratory Accreditation for Analyses of Foods (LAAF) rule?===
A provider of telecommunications service shall ensure that the service is accessible to and usable by individuals with disabilities, if readily achievable.
The LAAF rule is an amendment to the FSMA, as originally required by FSMA's Section 202 (a)<ref name="FDAFullText17Arch">{{cite web |url=https://www.fda.gov/food/food-safety-modernization-act-fsma/full-text-food-safety-modernization-act-fsma |archiveurl=https://web.archive.org/web/20190701000423/https://www.fda.gov/food/food-safety-modernization-act-fsma/full-text-food-safety-modernization-act-fsma |title=Full Text of the Food Safety Modernization Act (FSMA) |publisher=U.S. Food and Drug Administration |date=13 December 2017 |archivedate=01 July 2019 |accessdate=18 February 2022}}</ref>, that mandates [[laboratory]] "testing of food in certain circumstances" (more specifically, "certain tests that are already occurring"<ref name="FRLab21">{{cite web |url=https://www.federalregister.gov/documents/2021/12/03/2021-25716/laboratory-accreditation-for-analyses-of-foods |title=Laboratory Accreditation for Analyses of Foods |work=Federal Register |date=03 December 2021 |accessdate=18 February 2022}}</ref>) be performed by LAAF-accredited laboratories<ref name="FDALabAccred21">{{cite web |url=https://www.fda.gov/about-fda/economic-impact-analyses-fda-regulations/laboratory-accreditation-analyses-foods-final-regulatory-impact-analysis |title=Laboratory Accreditation for Analyses of Foods, Final Regulatory Impact Analysis |publisher=U.S. Food and Drug Administration |date=03 December 2021 |accessdate=18 February 2022}}</ref>, as part of the overarching goals of the FSMA. The rule emphasizes that testing of food includes "the analysis of human or animal food, as well as testing of the food growing or manufacturing environment (i.e., 'environmental testing')."<ref name="FRLab21" />


As currently written, "owners and consignees" of food products or environments subject to FSMA-driven food testing are directly affected. The "certain circumstances" of testing include when<ref name="FRLab21" />:
'''(d) Compatibility'''
Whenever the requirements of subsections (b) and (c) are not readily achievable, such a manufacturer or provider shall ensure that the equipment or service is compatible with existing peripheral devices or specialized customer premises equipment commonly used by individuals with disabilities to achieve access, if readily achievable.</blockquote>


* growing, harvesting, packing, or holding environments for sprouts test positive for ''Listeria'' species or ''L. monocytogenes'' as part of normal mandated environmental testing;
The term '''disability''' is [https://www.law.cornell.edu/uscode/text/42/12102 defined here]. You can read the full entry, but the basics are:
* egg producers of 3,000 or more laying hens, who have have already mandated tests on molting and non-molting pullets and hens, reveal ''Salmonella enteritidis'' during environmental testing;
* bottled drinking water facilities reveal ''Escherichia coli'' in their approved product and operations water sources as part of mandated environmental testing;
* the FDA issues a directed food laboratory order to any owner or consignee, specifying a particular food product or environment be tested for an identified or suspected food safety problem;
* the FDA conducts evidence-based hearings prior to a mandatory food recall order;
* the FDA reviews the corrective action plan for a registered food facility ordered to be suspended;
* the FDA examines submitted evidence as part of an administrative detention appeal process;
* a food article (that has arrived to the U.S., or has had an FDA-approved representative sample submitted prior to arrival) is submitted for admission of import or being offered for import into the U.S., to better ensure that the food article meets or exceeds the applicable requirements; and
* a food article impacted by an import alert (that has arrived to the U.S., or has had an FDA-approved representative sample submitted prior to arrival) requires successful consecutive testing in order to be removed from the import alert.


Accreditation bodies and laboratories that have been or are seeking to be be recognized by the FDA as able to LAAF-accredit or be LAAF-accredited, respectively, are also affected by this rule. Accreditation bodies seeking to accredit labs to the LAAF rule must be able to demonstrate compliance with ISO/IEC 17011:2017 and the membership and signatory requirements of the International Laboratory Accreditation Cooperative (ILAC) and its Mutual Recognition Arrangement (MRA), as well as other obligations laid out by LAAF (e.g., conflict of interest requirements, laboratory assessment and corrective action requirements, records and reporting requirements, etc.).<ref name="FRLab21" />
<blockquote>'''(1) Disability''' The term “disability” means, with respect to an individual—
:'''(A)''' a physical or mental impairment that substantially limits one or more major life activities of such individual;


For each method of food testing that is or will be LAAF-accredited, laboratories seeking LAAF accreditation must be able to demonstrate compliance with [[ISO/IEC 17025|ISO/IEC 17025:2017]] and show that each method has also successfully passed a proficiency test or comparable program with the last 12 month. It must also show that it uses appropriate reference materials or quality control samples for each sample batch tested under the LAAF rule. Of course, the lab must also comply with other obligations laid out by LAAF (e.g., conflict of interest requirements, documentation of qualifications and conformance, analytical requirements, records and reporting requirements, etc.).<ref name="FRLab21" />
:'''(B)''' a record of such an impairment; or


:'''(C)''' being regarded as having such an impairment (as described in paragraph (3)).</blockquote>


===How does LAAF affect laboratories who are or want to become LAAF-accredited?===
The term '''readily achievable''' is [https://www.law.cornell.edu/uscode/text/42/12181 defined here]. It is defines as:
Broadly speaking, most competitive and well-established food and environmental testing laboratories will already be ISO/IEC 17025:2017 certified. However, those labs who are or want to be LAAF-accredited will need to ensure or re-verify that "each method of food testing for which it is or will be LAAF-accredited" meets the section seven method selection, verification, and validation requirements set out in ISO/IEC 17025:2017.<ref name="FRLab21" /> LAAF also mandates proficiency testing for each of the lab's LAAF-intended methods, with the proficiency test needing to have occurred within the last 12 months and results needing to have been submitted to the FDA within 30 calendar days of receipt.<ref name="FRLab21" /> Most accreditation bodies that certify a lab to ISO/IEC 17025:2017 either make strong recommendations for or requirements of proficiency testing once or twice a year<ref name="GustDevelop04">{{cite web |url=https://www.nist.gov/system/files/documents/pml/wmd/labmetrology/dev-prof-test-gust.pdf |format=PDF |title=Developing a Proficiency Testing Plan for your Laboratory |author=Gust, J.C. |work=Measurement Science Conference 2004 |date=January 2004 |accessdate=18 February 2022}}</ref><ref name="APHLLab18">{{cite web |url=https://www.aphl.org/aboutAPHL/publications/Documents/FS-2018Feb-ISO-IEC-Accreditation-Costs-Survey-Report.pdf |format=PDF |title=Proficiency Testing Due to Accreditation |work=Laboratory Costs of ISO/IEC 17025 Accreditation: A 2017 Survey Report |author=Association of Public Health Laboratories |pages=10–11 |date=February 2018 |accessdate=18 February 2022}}</ref>, but not all labs interested in LAAF accreditation may participate in proficiency testing. Non-certified labs interested in food safety testing will have to weigh the costs of ISO/IEC 17025:2017 accreditation and any proficiency testing associated with it against the LAAF-mandated circumstances of testing and how common they will be, as the costs are typically not trivial.<ref name="APHLLab18" /> This process may be more challenging for those labs with non-standard methods that don't readily fall under an existing proficiency testing program, requiring a comparable and approved comparison program.


The lab will also need to take into consideration sampling, analysis, and reporting requirements.
<blockquote>'''(9) Readily achievable''' The term “readily achievable” means easily accomplishable and able to be carried out without much difficulty or expense. In determining whether an action is readily achievable, factors to be considered include—


====LAAF sampling requirements====
:'''(A)''' the nature and cost of the action needed under this chapter;
The lab will also need to capture and submit the necessary LAAF-specified sample information with results reporting, including the<ref name="FRLab21" />:
:'''(B)''' the overall financial resources of the facility or facilities involved in the action; the number of persons employed at such facility; the effect on expenses and resources, or the impact otherwise of such action upon the operation of the facility;
:'''(C)''' the overall financial resources of the covered entity; the overall size of the business of a covered entity with respect to the number of its employees; the number, type, and location of its facilities; and
:'''(D)''' the type of operation or operations of the covered entity, including the composition, structure, and functions of the workforce of such entity; the geographic separateness, administrative or fiscal relationship of the facility or facilities in question to the covered entity.</blockquote>


* sampler's qualifications (first time only; reference previously submitted qualifications in subsequent submissions);
===2. Rehabilitation Act of 1973, Section 508, amended ([https://www.law.cornell.edu/uscode/text/29/794d 29 U.S.C. 794d] - Electronic and information technology)===
* documented sampling plan, including name of the sampler and sampling firm;
* sample collection reports for each sample, including product code, sample environment, date of sampling, lot number, sample size, sample identity, sample quantity, sample collection procedures and preparations, chain of custody, and methods used to ensure validity of analysis; and
* in the case of FDA-determined variances or deviations from sampling plans and documentation, advanced notice of sampling ("48 hours before each of the next 10 occasions") with unique identification and necessary identifying, demographic, explanatory, and chronology information.


====LAAF analysis requirements====
There's a government website dedicated to Section 508: [https://www.section508.gov/ https://www.section508.gov/] The related laws and polices can be [https://www.section508.gov/manage/laws-and-policies/ found here]. The intro states (italics emphasis mine):
For analyses, the LAAF-accredited lab will also be required to ensure the<ref name="FRLab21" />:


* analyses are conducted solely on the sample or representative sample received from the sampling firm;
<blockquote>In 1998, Congress amended the Rehabilitation Act of 1973 to require Federal agencies to make their electronic and information technology (EIT) accessible to people with disabilities. The law (29 U.S.C § 794 (d)) ''applies to all Federal agencies when they develop, procure, maintain, or use electronic and information technology''. Under Section 508, agencies must give ''disabled employees and members of the public'' access to information comparable to the access available to others.
* analyst is qualified to conduct the analysis on the sample, including having demonstrable experience with the LAAF-accredited test method, and complies with conflict of interest requirements (i.e., no gifts, gratuity, or other items of value in receipt for the analysis);
* appropriate LAAF-accredited test method (the method must be properly verified) or FDA-approved method outside the scope of LAAF-accreditation associated with the sample is used; and
* testing process and results are documented "to account for all information that is required to be included in a full analytical report" (see the next section).


====LAAF reporting and submissions requirements====
The [https://www.access-board.gov/ U.S. Access Board] is responsible for developing Information and Communication Technology (ICT) accessibility ''standards'' to ''incorporate into regulations that govern Federal procurement practices.'' On January 18, 2017, the Access Board issued a final rule that updated accessibility requirements covered by Section 508, and refreshed guidelines for telecommunications equipment subject to Section 255 of the Communications Act. The final rule went into effect on January 18, 2018.
Sections § 1.1152 and § 1.1153 of LAAF makes it clear a comprehensive package of analytical reports and other documentation is required for submission to the FDA after a LAAF-accredited analysis takes place at the lab. This includes test results, notifications, reports, studies, and required documentation, based off several scenarios. Broadly speaking, each component of the submitted package should include the name and physical address of the LAAF-accredited lab, an appropriate laboratory contact with email and phone number, and "an identification unique to the test results, report, notification, or study."<ref name="FRLab21" />


The LAAF program places additional requirements on portions of the submission package. Regarding test results, the lab must include the name and street address of the test client (the owner or consignee) and any appropriate U.S. Customs and Border Protection entry and line numbers. As previously mentioned, sampling and analysis documents will also need to be submitted, including sampling plans, sample collection reports, sampler's qualifications, validation study details, verification study details, method modification and deviation justifications, and certification of the results, complete with name, title, and signature of the certifier. If any non-standard methods were used, the lab may also be asked to provide further details.<ref name="FRLab21" />
The rule updated and reorganized the Section 508 Standards and Section 255 Guidelines ''in response to market trends and innovations in technology.'' The refresh also harmonized these requirements with other guidelines and standards both in the U.S. and abroad, including standards issued by the European Commission, ''and with the World Wide Web Consortium (W3C) Web Content Accessibility Guidelines (WCAG 2.0), a globally recognized voluntary consensus standard for web content and ICT.''</blockquote>


For the actual full analytical report, which must be submitted with the above mentioned items, the lab must include<ref name="FRLab21" />:
In discussing ICT, the U.S. Access Board [https://www.access-board.gov/ict/#b-summary-of-key-provisions summarized the key provisions] as such:


* all components referenced in sections 7.8.2.1 and 7.8.3.1 of ISO/IEC 17025:2017
<blockquote>The Revised 508 Standards and 255 Guidelines replace the current product-based regulatory approach with an approach based on ICT functions. The revised technical requirements, which are organized along the lines of ICT functionality, provide requirements to ensure that covered hardware, software, electronic content, and support documentation and services are accessible to people with disabilities. In addition, the revised requirements include functional performance criteria, which are outcome-based provisions that apply in two limited instances: when the technical requirements do not address one or more features of ICT or when evaluation of an alternative design or technology is needed under equivalent facilitation.</blockquote>
* documentation of references for the analytical method used
* name and signature of the analyst who completed each analytical, validation, and verification step, along with date
* calculations made
* additional references, in color where available, such as chromatograms, charts, graphs, photographs, etc.
* complete identification of the reference standards used, addressing source and purity, while noting concentration, units used, preparation conditions, storage conditions, reference standard preparer, date of preparation, expiration date, chemical balance, solvent used, etc.
* copies of labels from sample container used or any other labeling required as part of the evaluation process
* ''all'' original raw data acquired during the course of the analysis
* relevant supporting information such as storage location, instrument printout, and photocopies of original labels and documentation that came with the sample/product
* identification of software used
* associated certificates of analysis for standards and software
* an information packet of qualifications for each analyst involved, including curriculum vitae, training records for the methods used, and other documentation demonstrating the analyst's ability to perform the method used


Finally, labs may qualify to submit abridged analytical reports rather than full analytical reports, particularly after they've managed to submit five error-free full analytical reports in a row and are in good standing with the FDA's LAAF program. In addition to the previously mentioned documentation that must be sent with test results, the abridged analytical report will only require the components referenced in sections 7.8.2.1 and 7.8.3.1 of ISO/IEC 17025:2017, as well as the quality control results, "including the expected result and whether it is acceptable."<ref name="FRLab21" />
The full (lengthy) information about the ICT Accessibility 508 Standards and 255 Guidelines is found here: [https://www.access-board.gov/ict/ https://www.access-board.gov/ict/]


As of February 2022, it's not clear exactly how reports will need to be submitted. Section § 1.1110 states, "All applications, reports, notifications, and records submitted to FDA under this subpart must be submitted electronically and in English unless otherwise specified." Section § 1.1152 adds that "the results of all testing required to be conducted under this subpart directly to FDA via the location specified by the website described in § 1.1109, unless another location is specified by FDA."<ref name="FRLab21" /> Presumably details of the submission process will become clearer once sufficient laboratories are LAAF-accredited.
The specific software requirements that LabLynx will likely need to consider under Section 508 appear to be found in [https://www.access-board.gov/ict/#chapter-5-software Chapter 5: Software] and [https://www.access-board.gov/ict/#chapter-6-support-documentation-and-services Chapter 6: Support Documentation and Services]. (If for some reason LLX is in the hardware domain, they'll want to also consider[https://www.access-board.gov/ict/#chapter-4-hardware Chapter 4: Hardware] If you're curious about the underlying standards, you can find them in [https://www.access-board.gov/ict/#chapter-7-%C2%A0-referenced-standards Chapter 7: Referenced Standards].


====LAAF records requirements====
Finally, the Section 508 government website has a full Design & Develop section that may be applicable to development process: [https://www.section508.gov/develop/ https://www.section508.gov/develop/]
The LAAF-accredited lab has a few additional records requirements placed on them. All "records created and received while [the laboratory] is LAAF-accredited that relate to compliance" with LAAF will need to be retained for five years after their date of creation. Such documents include:


* accreditation, proficiency test, and comparison program results and related documentation;
==Additional information==
* documentation of food testing performed under LAAF;
* all the components of FDA submission packets;
* communications with the FDA and clients (owner or consignee) regarding food testing, including initial requests;
* documentation of internal investigations, audits, and corrective actions related to LAAF testing;
* documentation of suspension, probation, scope reduction, disqualification, or withdraw of LAAF accreditation


Additionally, those records must be accessible in a timely fashion for review and copying by the FDA. The rule also notes that they should be available "for electronic submission upon written request of an authorized officer or employee of FDA," noting if an electronic format is requested, the files should be submitted with 10 business days of request.<ref name="FRLab21" /> Finally, "significant amendments" to these records need to be tracked to their previous or original versions. This version control requirement means lab must retain all necessary versions, including the original. Any version control scheme should include the date of an amendment, the personnel responsible for the amendment, and a "conspicuous" notice on the original document indicating a change has been made and where to view that change.
1. The Section 508 website and its glossary mention LIMS under "[https://www.section508.gov/art/glossary/#S scientific instrument]," though only secondarily. At the end: "If a scientific instrument is integrated with a computer or a monitor, the computer (and associated operating system) and the monitor would be separate EIT deliverables, requiring their own Government Product Accessibility Templates (GPAT). If the computer included application software, this software would be another EIT deliverable requiring its own GPAT."
2. It appears some software can qualify for "a legally-defined Exception (Back Office)," as found in this example with STARLIMS and the VA: [https://www.oit.va.gov/Services/TRM/ToolPage.aspx?tid=7502 https://www.oit.va.gov/Services/TRM/ToolPage.aspx?tid=7502]


 
3. Some additional posts and guides that may be revealing:
===What considerations should laboratory informatics software developers have with their solutions in regards to LAAF?===
* [https://www.levelaccess.com/how-do-i-determine-if-my-web-site-or-application-is-section-508-compliant/ How do I determine if my website or application is Section 508 compliant?]
Whether a [[laboratory information management system]] (LIMS) or some other informatics solution, the [[laboratory informatics]] software developer can ensure its solution better meets the needs of a LAAF-accredited laboratory in several ways. A quality solution should already address most of the following requirements, but the vendor may need to make a few minor adjustments to ensure better support for the LAAF-accredited lab.
* [https://ftp.cdc.gov/pub/Software/RegistryPlus/508%20Compliance/508softwareandos.doc GSA Guide For Making Software Applications and Operating Systems Accessible] (.doc file; NOTE: No date, so not sure if incorporates amended material, so be careful)
 
* [https://www.dhs.gov/publication/dhs-section-508-compliance-test-processes DHS Section 508 Compliance Test Processes]
'''Sample acquisition and client management'''
 
Product and/or sample registration should be able to accurately capture submitted information and product state. Assuming the product is submitted for sampling, this includes product identifier(s), lot number, shipping container, client name and street address, and observations about the status of the received product. Whether the lab samples the product or a third party does the sampling, reception should also include sampling time and date, sample size, sample identifier(s), sample quantity, sample collection procedures and preparations, and chain of custody. Some of these details may be captured as part a client management module of the system, though most will be documented at registration. However, LAAF also requires additional sampling documentation to be captured and sent by the lab. Can the informatics solution attach qualifications documents to a client record? Can sampling plans, sample collection reports, and advance notice of sampling documentation be captured, stored, and linked to registered product, scheduled analyses, or analytical reports? Can a received product and/or sample be designated as LAAF-related in the system?
 
'''Analyses'''
 
As the LAAF rule notes, analyses can be either food-related or environmental in nature. As such, the informatics solution should be flexible enough to address the subtleties of these types of analyses and the sample matrices associated with them. The well-designed system will likely come preconfigured with multiple test types for food and environmental testing. However, the system will need to be configurable in its tests and workflow management to allow for the addition of new and customized tests and method-related workflows. This prompts a few questions. Can an existing or new test or workflow be flagged as being LAAF-specific and marked as validated for LAAF? Or is there some other means to ensure a LAAF-related sample can only be connected with a LAAF-accredited test method or workflow? Can a custom, FDA-approved method outside the scope of LAAF-accreditation be entered into the system and marked as being LAAF-useable? The system also should ensure an analyst assignment to a LAAF-specific product, sample, or test is qualified to conduct a LAFF analysis (which, by extension, means the system should be able to flag an analyst as LAAF-qualified). Finally, the entire analytical process ran through the system should be capturing all the necessary details for what the FDA considers a "full analytical report" (see next section).
 
'''Reporting and information submission'''
 
The informatics vendor will want to ensure or re-verify their solution's reporting module is able to address the needs of ISO/IEC 17025:2017. For reference, the report components addressed in sections 7.8.2.1 and 7.8.3.1 of ISO/IEC 17025:2017 include:
 
* report title
* name and address of the laboratory
* location of activity performed (even at a mobile or third-party location)
* unique identification or report components as being part of a complete report
* clear identification of the end of the report
* customer name and contact information
* method used
* unique identification, description, and condition of a sample and container
* sampling date and reception date
* dates of laboratory performance activities
* date report is issued
* reference to a sampling plan, methods, or other sources relevant to the validity and application of the results
* statement of exclusive relation between the items tested, sampled, or calibrated and the actual results
* results, with units of measurement
* deviations from, additions to, or exclusions from the method
* identification of the individual authorizing or finalizing the report
* identification of results from external providers
* specific test conditions (e.g., environmental conditions)
* statement of conformity with requirements or specifications
* measurement uncertainty presented in a same unit as or in a term relative to the measurand
* opinions and interpretations of the results
 
 
==Further reading==
* {{cite web |url=https://www.aphl.org/aboutAPHL/publications/Documents/FS-2018Feb-ISO-IEC-Accreditation-Costs-Survey-Report.pdf |format=PDF |title=Laboratory Costs of ISO/IEC 17025 Accreditation: A 2017 Survey Report |author=Association of Public Health Laboratories |pages=16 |date=February 2018}}
 
==References==
{{Reflist|colwidth=30em}}

Latest revision as of 21:23, 28 February 2022

The laws themselves

1. Federal Telecommunications Act of 1996, Section 255 (47 U.S.C. § 255 - Access by persons with disabilities)

(b) Manufacturing

A manufacturer of telecommunications equipment or customer premises equipment shall ensure that the equipment is designed, developed, and fabricated to be accessible to and usable by individuals with disabilities, if readily achievable.

(c) Telecommunications services

A provider of telecommunications service shall ensure that the service is accessible to and usable by individuals with disabilities, if readily achievable.

(d) Compatibility

Whenever the requirements of subsections (b) and (c) are not readily achievable, such a manufacturer or provider shall ensure that the equipment or service is compatible with existing peripheral devices or specialized customer premises equipment commonly used by individuals with disabilities to achieve access, if readily achievable.

The term disability is defined here. You can read the full entry, but the basics are:

(1) Disability The term “disability” means, with respect to an individual—

(A) a physical or mental impairment that substantially limits one or more major life activities of such individual;
(B) a record of such an impairment; or
(C) being regarded as having such an impairment (as described in paragraph (3)).

The term readily achievable is defined here. It is defines as:

(9) Readily achievable The term “readily achievable” means easily accomplishable and able to be carried out without much difficulty or expense. In determining whether an action is readily achievable, factors to be considered include—

(A) the nature and cost of the action needed under this chapter;
(B) the overall financial resources of the facility or facilities involved in the action; the number of persons employed at such facility; the effect on expenses and resources, or the impact otherwise of such action upon the operation of the facility;
(C) the overall financial resources of the covered entity; the overall size of the business of a covered entity with respect to the number of its employees; the number, type, and location of its facilities; and
(D) the type of operation or operations of the covered entity, including the composition, structure, and functions of the workforce of such entity; the geographic separateness, administrative or fiscal relationship of the facility or facilities in question to the covered entity.

2. Rehabilitation Act of 1973, Section 508, amended (29 U.S.C. 794d - Electronic and information technology)

There's a government website dedicated to Section 508: https://www.section508.gov/ The related laws and polices can be found here. The intro states (italics emphasis mine):

In 1998, Congress amended the Rehabilitation Act of 1973 to require Federal agencies to make their electronic and information technology (EIT) accessible to people with disabilities. The law (29 U.S.C § 794 (d)) applies to all Federal agencies when they develop, procure, maintain, or use electronic and information technology. Under Section 508, agencies must give disabled employees and members of the public access to information comparable to the access available to others.

The U.S. Access Board is responsible for developing Information and Communication Technology (ICT) accessibility standards to incorporate into regulations that govern Federal procurement practices. On January 18, 2017, the Access Board issued a final rule that updated accessibility requirements covered by Section 508, and refreshed guidelines for telecommunications equipment subject to Section 255 of the Communications Act. The final rule went into effect on January 18, 2018.

The rule updated and reorganized the Section 508 Standards and Section 255 Guidelines in response to market trends and innovations in technology. The refresh also harmonized these requirements with other guidelines and standards both in the U.S. and abroad, including standards issued by the European Commission, and with the World Wide Web Consortium (W3C) Web Content Accessibility Guidelines (WCAG 2.0), a globally recognized voluntary consensus standard for web content and ICT.

In discussing ICT, the U.S. Access Board summarized the key provisions as such:

The Revised 508 Standards and 255 Guidelines replace the current product-based regulatory approach with an approach based on ICT functions. The revised technical requirements, which are organized along the lines of ICT functionality, provide requirements to ensure that covered hardware, software, electronic content, and support documentation and services are accessible to people with disabilities. In addition, the revised requirements include functional performance criteria, which are outcome-based provisions that apply in two limited instances: when the technical requirements do not address one or more features of ICT or when evaluation of an alternative design or technology is needed under equivalent facilitation.

The full (lengthy) information about the ICT Accessibility 508 Standards and 255 Guidelines is found here: https://www.access-board.gov/ict/

The specific software requirements that LabLynx will likely need to consider under Section 508 appear to be found in Chapter 5: Software and Chapter 6: Support Documentation and Services. (If for some reason LLX is in the hardware domain, they'll want to also considerChapter 4: Hardware If you're curious about the underlying standards, you can find them in Chapter 7: Referenced Standards.

Finally, the Section 508 government website has a full Design & Develop section that may be applicable to development process: https://www.section508.gov/develop/

Additional information

1. The Section 508 website and its glossary mention LIMS under "scientific instrument," though only secondarily. At the end: "If a scientific instrument is integrated with a computer or a monitor, the computer (and associated operating system) and the monitor would be separate EIT deliverables, requiring their own Government Product Accessibility Templates (GPAT). If the computer included application software, this software would be another EIT deliverable requiring its own GPAT."

2. It appears some software can qualify for "a legally-defined Exception (Back Office)," as found in this example with STARLIMS and the VA: https://www.oit.va.gov/Services/TRM/ToolPage.aspx?tid=7502

3. Some additional posts and guides that may be revealing:

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