Industrial hygienists and occupational and environmental health and safety professionals make important decisions based on the results they get back from the laboratories they trust to analyze their samples. Many factors can affect the quality of these results. For example, practitioners endeavor to develop robust sampling strategies, use properly calibrated instruments and equipment, and select appropriate sampling methods. But when it comes time to send samples off for analysis, what should IHs and OEHS professionals know about laboratories to help make sure they’ll get good data in return? Laboratories can participate in a variety of programs to help ensure that they are regularly providing their customers with quality sampling results. Accreditation and proficiency testing are two examples of third-party recognition that laboratories can pursue to demonstrate competency in sample analysis. Even individuals who work in laboratories, like asbestos fiber-counting analysts, can seek recognition of their knowledge and skills through registry programs, which recognize those who demonstrate competency in specific areas of industrial hygiene, environmental health, or safety practice.
The Synergist
spoke with Cheryl O. Morton, managing director of AIHA Laboratory Accreditation Programs, LLC, and Angela Oler, ASQ CQA, who directs operations for both AIHA Proficiency Analytical Testing Programs, LLC, and AIHA Registry Programs, LLC, about the differences between accreditation, proficiency testing, and registry programs. Morton and Oler provide an overview of their programs and discuss what each offer laboratories and their customers alike.
To hear Morton tell it, accreditation is the most rigorous third-party review that laboratories can undergo. From application to accreditation, the process of getting a laboratory program accredited can take approximately nine months to complete. AIHA-LAP is managed to conform to the requirements of ISO/IEC 17011,
Conformity assessment—Requirements for accreditation bodies accrediting conformity assessment bodies
. ISO/IEC 17011, which was most recently updated in 2017, specifies requirements for the competence, consistent operation, and impartiality of accreditation bodies that assess and accredit conformity assessment bodies, including laboratories. Laboratories seeking accreditation by AIHA-LAP must conform to the requirements of ISO/IEC 17025,
General requirements for the competence of testing and calibration laboratories
, a standard that was also revised last year. (See the article on page 22 to learn more about the changes to ISO standards 17011 and 17025.) Would-be accredited laboratories must also adhere to program-specific requirements outlined in AIHA-LAP’s policies.
Laboratories that wish to become accredited by AIHA-LAP must first demonstrate their ability to correctly analyze samples of contaminants before they can even apply for accreditation. AIHA-LAP requires that laboratories successfully pass at least one round of proficiency testing prior to applying to become accredited. Once a laboratory has successfully proved its proficiency and submitted a complete application, AIHA-LAP staff will send a site assessor for an on-site visit to the laboratory facility. For three to five days, the assessor will review the laboratory’s procedures and assess the measures that the facility has in place to produce quality results. Site assessors evaluate laboratories’ proficiency, records, processes, and methods to produce a report. Laboratories are allowed up to three attempts to correct any issues identified by the site assessor. AIHA-LAP has a Technical Advisory Panel that provides expertise for each of AIHA-LAP’s accreditation programs and is responsible for checking the quality of the site assessment reports. A separate group, the Analy- tical Accreditation Board, or AAB, makes all decisions on accreditation applications and comprises 16 members who have extensive technical and analytical laboratory experience. AAB members include individuals who work for NIOSH, OSHA, private entities, universities, and laboratories. Morton stresses that AIHA-LAP has established checks and balances to ensure that board members do not have any conflicts with laboratories on which the AAB will be deliberating. For example, an individual from a competing laboratory or someone who previously worked for a laboratory applying for accreditation would not vote on that laboratory’s application.  Laboratories can apply for accreditation specific to the type of testing they do under one or more of AIHA-LAP’s five programs: the Environmental Lead Laboratory Accreditation Program (ELLAP), which is for laboratories that analyze lead in environmental samples such as paint, soil, dust, and air; the Environmental Microbiology Laboratory Accreditation Program (EMLAP), for laboratories that specialize in the analysis of microorganisms commonly detected in air, fluids, and bulk samples as part of indoor air quality studies; the Food Laboratory Accreditation Program (FoodLAP), for laboratories that perform tests on food products and ingredients; the Industrial Hygiene Laboratory Accreditation Program (IHLAP)​, for laboratories that analyze samples to evaluate occupational exposures to chemical hazards; and the Unique Scopes Laboratory Accreditation Program​, which covers laboratories that perform testing that is not addressed under AIHA-LAP’s other programs. Forensic methods, phthalates, and some consumer products are examples of areas that fall under the unique scopes program. A laboratory that has been approved for accreditation by AIHA-LAP receives a certificate/scope page and is listed on AIHA-LAP’s website. Each accredited laboratory receives a unique identification number that is tied to its location, the program under which it is accredited, and the analyses it performs. AIHA-LAP accredited laboratories also have the option to use accreditation symbols that are specific to each of the five programs. These accreditation symbols are intended to help customers select laboratories to meet their testing needs. Customers should confirm that a laboratory is accredited for the fields of testing they need for their exposure assessment. Checking a laboratory’s ID number on AIHA-LAP’s website allows customers to see exactly which tests it is accredited to perform. Information about accredited laboratories’ specific scopes of accreditation and fields of testing is available
. AIHA-LAP’s website will also indicate if a laboratory has been suspended for a particular scope or test. Accredited laboratories undergo assessment by AIHA-LAP every two years.
AIHA-LAP is recognized internationally by the International Laboratory Accreditation Cooperation, an international cooperation of laboratory and inspection accreditation bodies. AIHA-LAP is also a signatory of the ILAC Mutual Recognition Arrangement, which is signed by accreditation bodies that have been evaluated by ILAC peers and deemed competent and equivalent. Two regional bodies—the Inter American Laboratory Accreditation Cooperation and the Asia Pacific Laboratory Accreditation Cooperation—have also recognized AIHA-LAP. “These are the bodies that make sure that we follow ISO/IEC 17011 in addition to other requirements,” Morton explains. “The ILAC MRA represents the recognition that we have with our international counterparts who have come here, reviewed us, and deemed us equivalent to themselves.” Laboratories accredited by AIHA-LAP meet high standards of performance that promote the production of quality data. “Although accreditation doesn’t guarantee good data, it indicates that the laboratory’s quality system and technical expertise have been evaluated by an outside, independent third party,” Laura Parker, IH consulting scientist and manager at Maxxam Analytics, explained in a
2016 Synergist article
on improving collaboration between field IHs and laboratory professionals. “An assessment for accreditation includes a review of the procedures and quality assurance that the lab uses to generate reproducible and defensible results.”
Participating in proficiency testing helps laboratories ensure that they’re giving their customers good data, that the analysis they’re doing falls within an expected range, and that they’re “getting the right answer,” Oler says. AIHA PAT Programs provides external quality control program assessment for laboratories, allowing participants to demonstrate that they’re able to correctly analyze both workplace and environmental samples. AIHA PAT is an accredited provider of proficiency testing under ISO/IEC 17043,
Conformity assessment—General requirements for proficiency testing
, which sets requirements for the competence of providers of proficiency testing schemes and for the development and operation of proficiency testing schemes. AIHA PAT’s five programs—the Bulk Asbestos Proficiency Analytical Testing (BAPAT) Program, Beryllium Proficiency Analytical Testing (B​ePAT) Program, Environmental Lead Proficiency ​Analytical Testing (ELPAT) Program, Environmental Microbiology​ Proficiency Analytical Testing (EMPAT) Program, and the Industrial Hygiene Proficiency Analytical Testing (IHPAT) Program—align closely with AIHA-LAP’s accreditation programs, and many accredited laboratories use AIHA PAT for their proficiency testing needs. AIHA PAT Programs ships samples for analysis to participating laboratories on a quarterly or tri-annual basis, depending on the program. Participants enter their results in PAT’s online portal so that PAT can determine laboratories’ proficiency. The Proficiency Analytical Testing Programs Board, which comprises qualified technical experts who provide technical advice and assistance to the AIHA PAT Programs, reviews and approves all summary data for each round before scores are finalized and results are distributed to PAT Programs participants.  “Proficiency testing should be used as a tool in a laboratory’s quality system,” Oler says. “We offer proficiency testing because important decisions are made based on the data that laboratories return to their customers. We help ensure those values are reliable.” AIHA PAT Programs is open to all interested laboratories and does not lay out specific requirements for a laboratory’s quality system, for example. This limits the scope of proficiency testing. According to Oler, PT’s role is more narrowly defined than that of a laboratory accreditation program. Where accreditation covers all the processes and components that go into a laboratory’s end result, proficiency testing focuses only on the accuracy of that result: can a laboratory get the right answer when AIHA PAT Programs gives it a blind sample? Oler notes that many AIHA PAT participants are not accredited. “PT serves a role for those who do not wish to seek accreditation, but still want to have that third-party assessment of their analytical capabilities,” she says. AIHA PAT Programs also helps participants improve and refine the analytical skills of their staff, test new methods, and train analysts. A current list of PAT participants is available
The main focus of the AIHA Registry Programs, LLC, which was formed in 2009 to separate credentialing from AIHA’s membership and education activities to better ensure impartiality, is to promote recognition of individuals who have a certain level of competence in a specific area of expertise. AIHA Registry Programs meets the laboratory realm with the Asbestos Analysts Registry, which recognizes organizations and their affiliated analysts involved in fiber counting of air samples outside of established laboratory locations. Customers who require qualified fiber counters to analyze asbestos samples in the field can use AAR to find registered organizations and analysts. “I describe the AAR program as a middle ground between what full-fledged accreditation gives you and what PT gives you,” Oler says. “The AAR program requires a review of organizations’ personnel qualifications and training, microscope maintenance, internal audits, final reporting, corrective action, and things of that nature.” One of the primary differences between AAR and accreditation through AIHA-LAP is that AAR does not require laboratories to go through a site assessment since applicant organizations are not evaluated against ISO/IEC 17025 or any other ISO standard. Organizations undergo technical review by program reviewers for AAR, and affiliated analysts must also submit an application that demonstrates their quality control work with their current organization. In addition, each analyst is required to maintain proficiency in the Asbestos Analysts Testing program, AAR’s statistically valid airborne fiber-counting quality control program, to keep their registered analyst status.
Laboratories can participate in a variety of programs to help ensure that they are regularly providing their customers with quality sampling results.
Figure 1. Comparing AIHA-LAP, AIHA PAT, and AAR.
Tap on the figure to open a larger version in your browser.
Another key difference between AAR registration and AIHA-LAP accreditation is that AAR focuses on asbestos analysis that happens primarily on job sites or in the field whereas AIHA-LAP and AIHA PAT emphasize more traditional laboratory analysis. However, the AAR program may be used by laboratories that do not need to be accredited, but desire documentation of their ability to do quality work in asbestos fiber counting. AAR-registered analysts and registered organizations are listed on the AIHA Registry Programs website. AIHA Registry Programs encourages laboratory customers to contact organizations directly to view their most recent AAT performance results report and to verify their current registration status and proficiency performance. Customers should also ensure that organizations have the proper state and local licensure to perform the laboratory work in question. More information on what AAR offers laboratories and individual analysts is available on the AIHA Registry Programs
AIHA-LAP, AIHA PAT, and the AIHA Registry Programs are independent organizations, and laboratories can participate in more than one program. For example, a laboratory that specializes in analyzing asbestos samples could participate in all three LLC programs. Each program has unique requirements and provides customers with different means of choosing a laboratory to meet their testing needs. Figure 1 is intended to help industrial hygienists and OEHS professionals understand the differences between the programs’ offerings. It’s up to laboratory customers to take these differences, as well as regulatory requirements, into consideration when choosing a laboratory to work with. Morton and Oler stress that IHs and other end users should feel comfortable asking for documentation that proves that a laboratory is recognized by one or more of these third-party programs. Consumers can ask for appropriate documentation such as a laboratory’s accreditation certificate, proficiency report, identification number, or its AAR listing information regarding the registration of the organization and its analysts. Laboratories should freely share such information with consumers.    
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AIHA’s Additional Registries
AIHA Registry Programs offers registries that address specialized areas of practice such as hazard communication and exposure assessment. For example, the SDS and Label Authoring Registry recognizes professionals who specialize in authoring safety data sheets and labels. The Exposure Decision Analysis Registry recognizes professionals who have acquired the skills and knowledge to effectively manage workplace exposure and monitoring data; OEHS professionals who must make critical exposure assessment decisions based on smaller data sets might consider participating in this registry. These two programs are based on bodies of knowledge developed by AIHA Registry Programs. Individuals must pass a test-based competency assessment that is used to determine whether they meet a minimum level of competency. The AIHA Registry Programs hopes to launch a new Occupational Health and Safety Management System Auditor Registry later this year. This new registry is intended to help organizations implement the new ISO 45001 standard (the key elements of the new OHSMS standard are described in the
cover article
of the June/July Synergist.  Learn more about the
AIHA Registry Programs
Laboratory Accreditation, Proficiency Testing, and Registries Explained