AIHA Laboratory Accreditation Programs (AIHA-LAP, LLC) is a group of laboratory accreditation programs. The primary mission of AIHA-LAP, LLC is to establish high standards of performance for laboratories that promote the production of quality data for use in evaluating exposures that impact public health, the environment and natural resources. These programs are administered in a non-discriminatory manner and are open to all laboratories wishing to participate. Access to AIHA-LAP, LLC programs is not conditional upon the size of the laboratory or organization seeking accreditation, nor are there undue financial conditions to restrict participation. Accreditation is granted to any laboratory satisfying AIHA-LAP, LLC requirements for accreditation.
AIHA-LAP, LLC is managed to conform to the requirements of the ISO/IEC 17011:2004, Conformity Assessment – General Requirements for Accreditation Bodies Accrediting Conformance Assessment Bodies. Laboratories seeking accreditation must conform to the requirements of the ISO/IEC Standard 17025:2005, General Requirements for the Competence of Testing and Calibration Laboratories, in addition to program-specific requirements as detailed in the latest revision of the AIHA Laboratory Accreditation Programs, LLC Policies.
AIHA-LAP, LLC currently operates five accreditation programs:
- The Industrial Hygiene Laboratory Accreditation Program (IHLAP) is designed specifically for laboratories involved in testing samples to evaluate workplace exposures.
- The Environmental Lead Laboratory Accreditation Program (ELLAP) accredits laboratories performing analysis of lead in environmental samples including paint, soil, dust wipes and air. The ELLAP is recognized by the Environmental Protection Agency (EPA) through a Memorandum of Agreement and this program has been designed to comply with the requirements of the EPA National Lead Laboratory Accreditation Program (NLLAP). It is standard practice for AIHA-LAP staff to meet regularly with representatives of EPA NLLAP, to collaborate on means of continuously improving the AIHA-LAP, LLC accreditation programs and the relationship between the signatory parties.
- The Environmental Microbiology Laboratory Accreditation Program (EMLAP), is specifically for labs identifying microorganisms commonly detected in air, fluids, and bulk samples during indoor air quality studies.
- The Food Laboratory Accreditation Program (FoodLAP) is specifically for laboratories testing food products (including raw agricultural commodities), finished food products, and food ingredients.
- The Unique Scope Laboratory Accreditation Program is in essence ISO/IEC 17025:2005 only accreditation. This program was established to accommodate consumer product testing accreditation and accreditation for other types of testing not typlicallty part of the inductial hyiene, lead, microbiology and food programs.
The IHLAP, ELLAP, EMLAP, FoodLAP and UniqueScope LAP programs are fully recognized by the Inter-American Laboratory Accreditation Cooperation (IAAC), the Asia Pacific Laboratory Accreditation Cooperation (APLAC), and the International Laboratory Accreditation Cooperation (ILAC).
Duties and Rights
As an accreditation body, AIHA-LAP, LLC has a duty to:
- Operate laboratory accreditation programs in accordance with requirements in ISO/IEC 17011 and other applicable national and international requirements;
- Uphold the ISO/IEC 17025 standard and the AIHA-LAP, LLC Policies;
- Offer a range of laboratory accreditation services that promote the reporting of quality data to address occupational and environmental exposure;
- Disseminate real time information to participant laboratories;
- Address feedback and pursue “continuous improvement”;
- Establish, maintain, periodically review and make publicly available AIHA-LAP, LLC volunteer governance; and,
- Enhance its accreditation programs to better serve the participant laboratories and ensure programs meet international and national requirements.
AIHA-LAP, LLC also has the right(s) to:
- Implement critical Policy changes with input from stakeholders;
- Specify additional requirements for accreditation beyond ISO/IEC 17025 such as personnel qualifications, quality system requirements, program-specific technical requirements, and proficiency testing requirements as outlined in AIHA-LAP, LLC Policies;
- Grant, suspend, deny or withdraw accreditation based on AIHA-LAP, LLC Policies;
- Appoint volunteers using criteria outlined in its governance document;
- Improve its efficiency and effectiveness for its laboratories, volunteers, contractors, and staff through organizational re-structuring and process improvement initiatives;
- Identify and selectively pursue opportunities for partnerships, liaisons and coalitions with interested parties on public policy issues of mutual interest and with clearly identified outcomes
AIHA-LAP, LLC is financed entirely by its fee-based accreditation services The LLC receives revenue in the way of the annual fees, site assessment fees and other fees for accreditation applications, re-accreditations, field of testing (FoT) additions, and monthly payment plans. This revenue covers the expenses of AIHA-LAP, LLC staffing and business operations that are obtained through a contractual Agreement made with AIHA (its sole Member.)
AIHA-LAP, LLC’s organization, structure and relationship with AIHA and other Related Bodies
As stated in ISO/IEC 17011:2004, clause 4.3.7, Note 1, a related body is a separate legal entity that is linked by common ownership or contractual arrangements to the accreditation body. The American Industrial Hygiene Association (AIHA), a not-for-profit corporation organized under the laws of the State of Illinois, is the sole owner of AIHA-LAP, LLC, as detailed under Legal Responsibility. However, there are no requirements for AIHA-LAP, LLC customers to be members of AIHA to be accredited or for individuals to be AIHA members to volunteer or serve on AIHA-LAP, LLC committees. The LLC’s accreditation program open to all eligible laboratories. AIHA-LAP, LLC does not offer discounts to AIHA members and AIHA doesn’t offer membership discounts to AIHA-LAP, LLC customers.
AIHA-LAP, LLC was organized in November 2008 as a limited liability company, a registered and distinct legal entity, under the laws of the Commonwealth of Virginia in the United States. AIHA also is the sole owner of two separately organized and operated Virginia limited liability companies, AIHA Proficiency Analytical Testing, LLC (AIHA-PAT, LLC) and AIHA Registry Programs, LLC. These LLCs are considered AIHA’s Affiliated Laboratory Programs.
a) Distinctly different Names, Logos, Symbols and Top Management of the Affiliated Laboratory Programs
The names, logos and symbols of AIHA, AIHA-LAP, LLC, AIHA-PAT, LLC and AIHA Registry Programs, LLC are distinctly different. AIHA-LAP, LLC’s name includes AIHA’s acronym in its name since AIHA accreditation is cited in several state and federal regulatory requirements.
AIHA-PAT, LLC and AIHA Registry Programs, LLC are separate legal entities created in November/December 2008 under the laws of the Commonwealth of Virginia. The top manager for AIHA-PAT, LLC and the AIHA Registry Programs, LLC is different from the top management of AIHA-LAP, LLC and is the AIHA Director of Operations. Proficiency testing decisions are being made by a separate AIHA-PAT, LLC board that is completely independent of the accreditation decision makers. Laboratories are free to use another approved provider for proficiency testing. Employees and office space of AIHA-PAT, LLC and AIHA Registry Programs, LLC are contractually leased from AIHA. The Data Management System is a resource shared with AIHA-LAP, LLC. AIHA-PAT, LLC provides proficiency testing (PT) reports to AIHA-LAP, LLC. PT data is only accessible to AIHA-PAT, LLC. The staffs of AIHA-PAT, LLC and AIHA Registry Programs, LLC do not have access to accredited laboratory information.
Laboratories accredited by AIHA-LAP, LLC may participate in AIHA-PAT, LLC proficiency testing programs, but they also are free to use other approved proficiency testing programs or to demonstrate competency independently.
Each of AIHA-LAP, LLC, AIHA-PAT, LLC and AIHA Registry Programs, LLC has a:
- Distinct name that includes the AIHA acronym since AIHA is cited in several states and federal regulatory requirements
- Established and distinct legal identity and tax ID number
- Separate technical board (decision makers)
- Group of separate dedicated volunteers and strategic advisors
- Separate governance and operating agreements
- Separate set of policy documents outlining program requirements
- Separate fee schedules
- Separate budget and separately managed finances
- Separate vendor contracts
- Separate Web site
b) Different top management for those activities
The Managing Director of AIHA-LAP, LLC and has the authority for supervision of the finances for AIHA-LAP, LLC, contractual arrangements, and supervision of the implementation of the policies and procedures, and delegation of authority for certain activities on her behalf. The Director’s position description provides further details on these and other responsibilities. The Director of AIHA-LAP, LLC does not serve in a similar capacity with any of AIHA, AIHA-PAT, LLC or AIHA Registry Programs, LLC. The Managing Director of AIHA-LAP, LLC reports to the AIHA CEO. The AIHA CEO is not involved with the day-to-day operations or the accreditation process, but is kept informed of the status of the accreditation programs by the AIHA-LAP, LLC Managing Director.
The AIHA Board of Directors has fiscal responsibility and oversight of AIHA-LAP, LLC, and approves the AIHA-LAP, LLC budget. The AIHA Board of Directors also interfaces with the AIHA CEO, who hires the Managing Director of AIHA-LAP, LLC. There is a Professional and Administrative Service Agreement between AIHA and AIHA-LAP, LLC for technical staff, office space, and support/professional services. AIHA-LAP, LLC provides annual payments through a License Agreement with AIHA to use the AIHA name and brand. AIHA-LAP, LLC has liability insurance for its staff, volunteers and site assessors.
c) Personnel different from those involved in the accreditation decision-making process
Accreditation decisions are made by AIHA-LAP, LLC’s Analytical Accreditation Board (AAB). In the past, AAB members were elected through balloting, but that process was changed to an appointment process in 2009. The staff of AIHA-LAP, LLC does not make accreditation decisions, nor does the AIHA CEO. In addition, the AIHA Board of Directors is not involved in the accreditation decisions. The members of AIHA-LAP, LLC’s AAB do not serve in any position of AIHA, AIHA-PAT, LLC or AIHA Registry Programs, LLC.
d) No possibility to influence the outcome of an accreditation assessment
All AIHA-LAP, LLC site assessors are required to sign Site Assessor Contracts (SAC) with AIHA-LAP, LLC that include language regarding conflict of interest and confidentiality. Assessors cannot serve on the AAB, making accreditation decisions. The reports of site assessment submitted by the site assessors are considered by the AAB in accreditation decisions, but the assessors cannot influence the final accreditation decision. As discussed in the previous section, all accreditation decisions are made by the AIHA-LAP, LLC AAB. The members of AIHA-LAP, LLC’s related bodies (AIHA, AIHA-PAT, LLC. and AIHA Registry Programs) do not serve in any position within AIHA-LAP, LLC that has a possibility to influence the outcome of an assessment for accreditation.
Laboratory Rights and Duties
AIHA-LAP, LLC requires accredited laboratories (CABs) to conform to the following duties:
a) The CAB commits to fulfill continually the requirements for accreditation set by the AIHA-LAP, LLC for the areas where accreditation is sought or granted. AIHA-LAP, LLC gives due notice of any changes to its requirements for accreditation (Policies). It takes account of views expressed by interested parties before deciding on the precise form and effective date of the changes. Following a decision on, and publication of, the changed requirements, the CAB carries out any necessary adjustments. This includes agreement to adapt to changes in the requirements for accreditation, to be verified at next assessment by AIHA-LAP, LLC.
b) When requested, the CAB affords such accommodation and cooperation as is necessary to enable AIHA-LAP, LLC to verify fulfillment of requirements for accreditation. This applies to all premises where the conformity assessment services take place.
c) The CAB provides access to information, documents and records as necessary for the assessment and maintenance of the accreditation. The On-Site Documents and Records Review List informs the CAB of a subset of information that must be readily available.
d) The CAB provides access to those documents that provide insight into the level of independence and impartiality of the CAB from its related bodies, where applicable.
e) CAB arranges the witnessing of CAB services when requested by AIHA-LAP, LLC.
f) The CAB claims accreditation only with respect to the scope for which it has been granted accreditation, per Policy Module 7.
g) The CAB does not use its accreditation in such a manner as to bring AIHA-LAP, LLC into disrepute.
h) The CAB pays fees as shall be determined by AIHA-LAP, LLC (Fee Schedule available upon request).
i) The CAB adheres to the requirements in Policy Module 3, Accreditation, Maintenance and Reaccreditation Process, which requires the accredited CAB that it informs the AIHA-LAP, LLC by, without delay, of significant changes relevant to its accreditation, in any aspect of its status or operation relating to its legal, commercial, ownership or organizational status, the organization, top management and key personnel, main policies, resources and premises, scope of accreditation, and other such matters that may affect the ability of the CAB to fulfill requirements for accreditation.
Accredited laboratories (CABs) have the right to:
a) an efficient and timely accreditation process and granting of accreditation, including a request for a pre-assessment.
b) have its accreditation information and current status posted to the AIHA-LAP, LLC website for its customers’ use, including name and address, term of accreditation, certificate and scope of accreditation.c) information from AIHA-LAP, LLC on suitable ways to obtain traceability of measurement results in relation to the scope for which accreditation is provided. AIHA-LAP, LLC has published policies and guidance on traceability of measurement in Appendix H of the Policy Modules.
d) information on the AIHA-LAP, LLC website and other communication regarding domestic and international arrangements in which it is involved, such as the ILAC MRA and the IAAC MLA.
e) provide stakeholder input through direct communication and feedback forms (available on the AIHA-LAP website).
f) file a complaint and have it processed in a timely manner per Policy Module 8.
g) timely processing and resolution of reconsideration of any adverse decision made by the accreditation body elated to its desired accreditation status, including refusal to accept an application, refusal to proceed with an assessment, corrective action requests, changes in accreditation scope, decisions to deny, suspend or withdraw accreditation, and/ or any other action that impedes the attainment of accreditation.
h) due notice from AIHA-LAP, LLC of any changes to its requirements for accreditation, the opportunity to express views before AIHA-LAP decides on the precise form and effective date of the changes per Policy Module 8.
i) AIHA-LAP, LLC impartiality and confidentiality regarding the CAB in accreditation decisions, including confidentiality of records.