User:Shawndouglas/sandbox/sublevel3 - Revision history

Shawndouglas at 21:23, 28 February 2022

2022-02-28T21:23:04Z

← Older revision		Revision as of 21:23, 28 February 2022
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	==The laws themselves===		==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])===		===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])===
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	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].		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].

			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/]

			==Additional information==

			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:
			* [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?]
			* [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]

Shawndouglas at 20:53, 28 February 2022

2022-02-28T20:53:36Z

← Older revision		Revision as of 20:53, 28 February 2022
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	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.		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.

	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>		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>

	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:		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:

Shawndouglas at 20:53, 28 February 2022

2022-02-28T20:53:21Z

← Older revision		Revision as of 20:53, 28 February 2022
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	==The laws themselves===		==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]):		===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])===

	<blockquote>'''(b) Manufacturing'''		<blockquote>'''(b) Manufacturing'''
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	:'''(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>		:'''(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>

	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):		===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)===

	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):		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):
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	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>		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>

			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:

			<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>

			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/]

			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].

Shawndouglas at 20:38, 28 February 2022

2022-02-28T20:38:28Z

← Older revision		Revision as of 20:38, 28 February 2022
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			==The laws themselves===

	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]):		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]):

	<blockquote>'''(b) Manufacturing'''		<blockquote>'''(b) Manufacturing'''
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	'''(c) Telecommunications services'''		'''(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.		A provider of telecommunications service shall ensure that the service is accessible to and usable by individuals with disabilities, if readily achievable.

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	:'''(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		:'''(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>		:'''(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>

			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):

			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):

			<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.

			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.

			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>

Shawndouglas at 20:27, 28 February 2022

2022-02-28T20:27:03Z

← Older revision		Revision as of 20:27, 28 February 2022
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	<blockquote>'''(1) Disability''' The term “disability” means, with respect to an individual—		<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;		:'''(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		:'''(B)''' a record of such an impairment; or

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

			The term '''readily achievable''' is [https://www.law.cornell.edu/uscode/text/42/12181 defined here]. It is defines as:

			<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—

			:'''(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.</blockquote>

Shawndouglas at 20:14, 28 February 2022

2022-02-28T20:14:21Z

← Older revision	Revision as of 20:14, 28 February 2022
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		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]):

		<blockquote>'''(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.</blockquote>

		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:

		<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;

		'''(B)''' a record of such an impairment; or

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

Shawndouglas: Blanked the page

2022-02-21T16:23:20Z

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Shawndouglas at 17:09, 19 February 2022

2022-02-19T17:09:19Z

← Older revision		Revision as of 17:09, 19 February 2022
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	Given the intricacies and costs of being LAAF-accredited, a LAAF-accredited lab will lean on their laboratory informatics solutions to help the lab stay compliant. Established and knowledgeable informatics vendors will already have functionality in place in their solutions—typically a LIMS—to address the requirements of ISO/IEC 17025:2017. However, they will also likely need to make a few tweaks to their solutions to address the needs of a LAAF-accredited lab. For example, tests and workflows will likely require a "flag" to indicate to users whether or not a test or workflow is LAAF-related. The reporting module will need to be robust and flexible, allowing for the automated and manual placement of required information into the reports and other documents required with LAAF. And fully-featured document management, document retention, and version control will also be critical. Ultimately, the solution will ideally assist the LAAF-accredited lab with the rigorous requirements of accreditation through its feature set.		Given the intricacies and costs of being LAAF-accredited, a LAAF-accredited lab will lean on their laboratory informatics solutions to help the lab stay compliant. Established and knowledgeable informatics vendors will already have functionality in place in their solutions—typically a LIMS—to address the requirements of ISO/IEC 17025:2017. However, they will also likely need to make a few tweaks to their solutions to address the needs of a LAAF-accredited lab. For example, tests and workflows will likely require a "flag" to indicate to users whether or not a test or workflow is LAAF-related. The reporting module will need to be robust and flexible, allowing for the automated and manual placement of required information into the reports and other documents required with LAAF. And fully-featured document management, document retention, and version control will also be critical. Ultimately, the solution will ideally assist the LAAF-accredited lab with the rigorous requirements of accreditation through its feature set.


	==Further reading==		==Further reading==

Shawndouglas: /* Closing */

2022-02-19T17:08:58Z

Closing

← Older revision		Revision as of 17:08, 19 February 2022
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	The Laboratory Accreditation for Analyses of Foods or LAAF rule has been a long time coming, as part of a mandate set out in the FDA's Food Safety Modernization Act. The intent with LAAF appears to be the provision of an accreditation program for laboratories participating in the critical role of ensuring the safety of the U.S. food supply. LAAF provides additional structure to the labs wishing to fulfil that role, ensuring they do it accurately and effectively. LAAF accreditation will not impact all food and environmental labs in the U.S., only those that choose to take up the role. Once accrediting bodies set up their LAAF accreditation programs, labs can begin the accreditation process and soon after conduct analyses of samples that fall under the umbrella of LAAF testing. These labs will not only need to be accredited to ISO/IEC 17025:2017 but also follow a number of other procedures, including proficiency testing, a critical component of LAAF. Reporting will also be strict, at least initially, until the lab qualifies for abridged reporting.		The Laboratory Accreditation for Analyses of Foods or LAAF rule has been a long time coming, as part of a mandate set out in the FDA's Food Safety Modernization Act. The intent with LAAF appears to be the provision of an accreditation program for laboratories participating in the critical role of ensuring the safety of the U.S. food supply. LAAF provides additional structure to the labs wishing to fulfil that role, ensuring they do it accurately and effectively. LAAF accreditation will not impact all food and environmental labs in the U.S., only those that choose to take up the role. Once accrediting bodies set up their LAAF accreditation programs, labs can begin the accreditation process and soon after conduct analyses of samples that fall under the umbrella of LAAF testing. These labs will not only need to be accredited to ISO/IEC 17025:2017 but also follow a number of other procedures, including proficiency testing, a critical component of LAAF. Reporting will also be strict, at least initially, until the lab qualifies for abridged reporting.

	Given the intricacies and costs of being LAAF-accredited, a LAAF-accredited lab will lean on their laboratory informatics solutions to help the lab stay compliant. Established and knowledgeable informatics vendors will already have functionality in place in their solutions—typically a LIMS—to address the requirements of ISO/IEC 17025:2017. However, they will also likely need to make a few tweaks to their solutions to address the needs of a LAAF-accredited lab. For example, tests and workflows will likely require a "flag" to indicate to users whether or not a test or workflow is LAAF-related. The reporting module will need to be robust and flexible, allowing for the automated and manual placement of required information into the reports and other documents required with LAAF. And fully-featured document management, document retention, and version control will also be critical.		Given the intricacies and costs of being LAAF-accredited, a LAAF-accredited lab will lean on their laboratory informatics solutions to help the lab stay compliant. Established and knowledgeable informatics vendors will already have functionality in place in their solutions—typically a LIMS—to address the requirements of ISO/IEC 17025:2017. However, they will also likely need to make a few tweaks to their solutions to address the needs of a LAAF-accredited lab. For example, tests and workflows will likely require a "flag" to indicate to users whether or not a test or workflow is LAAF-related. The reporting module will need to be robust and flexible, allowing for the automated and manual placement of required information into the reports and other documents required with LAAF. And fully-featured document management, document retention, and version control will also be critical. Ultimately, the solution will ideally assist the LAAF-accredited lab with the rigorous requirements of accreditation through its feature set.


	==Further reading==		==Further reading==

Shawndouglas: /* Analyses */

2022-02-19T17:07:32Z

Analyses

← Older revision		Revision as of 17:07, 19 February 2022
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	===Analyses===		===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 assigned 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 that runs through the system should be capturing all the necessary details for what the FDA considers a "full analytical report" (see next section).		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 assigned to a LAAF-specific product, sample, or test is qualified to conduct a LAAF analysis (which, by extension, means the system should be able to flag an analyst as LAAF-qualified). Finally, the entire analytical process that runs 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 packet submission===		===Reporting and information packet submission===