LII:The Comprehensive Guide to Physician Office Laboratory Setup and Operation/The clinical environment

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The physician office laboratory (POL) is a clinical laboratory that is owned, operated, and managed by a physician office. Definitions, as noted in The Practical Guide to the U.S. Physician Office Laboratory, vary from state to state, but this is a solid enough definition. Nearly 49 percent of all clinical laboratories in the U.S. were POLs according to Centers for Medicare and Medicaid Services statistics in November 2014.[1]

This first chapter on the topic of the clinical working environment has 11 sections.

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1. The Clinical Environment

The clinical laboratory and its equipment

The POL is a clinical laboratory located in an ambulatory or outpatient care setting, specifically in the physician office. The clinical laboratory is used to test specimens from human patients to assist with the diagnosis, treatment, or monitoring of a patient condition. Testing in the clinical lab generally depends on three common methodologies to meet those goals: comparing the current value of a tested substance to a reference value, examining a specimen with microscopy, and detecting the presence of infection-causing pathogens.[2]

These three methodologies depend on clinical expertise from staff. Managerial staff like laboratory directors and laboratory department supervisors, for example, are responsible for the planning, management, and administration of the lab's operations as well as applying and enforcing quality systems and regulatory requirements. The lab itself is staffed with pathologists, cytotechnologists, histotechnologists, and clinical laboratory assistants, performing and interpreting specimen tests using one or more techniques.[3] Those methodologies and tests also require a wide variety of instruments and equipment. A histotechnologist will require a microtome to prepare a specimen for an anatomical pathology examination, and blood chemistry analyses depend on sample tubes, centrifuges, and blood analyzers. More advanced clinical laboratories performing molecular diagnostics techniques will use specialty tools like fluorescence microscopes and spectrometers. And all that equipment must meet manufacturing, testing, and calibration standards to ensure the utmost accuracy of tests.[4]

However, the clinical environment of the POL is somewhat different than your average reference or diagnostic lab that receives, processes, and reports on specimens en masse. The POL is typically a smaller operation, performing simple laboratory testing that can produce useful diagnostic data cheaply and rapidly. Rather than performing advanced pathology procedures that require specific equipment and expertise, the POL typically focuses on blood chemistry, urinalysis, and other testing domains that don't require significant resources and provide rapid results. This can be seen in Centers for Medicare and Medicaid Services statistics reported in November 2014 that show nearly 61 percent of POLs in the U.S. are certified to provide CLIA-waived tests[1], "simple tests with a low risk for an incorrect result."[5] These "simple tests" don't require advanced equipment and highly-trained physicians. Urinalysis reagent strips, influenza nasal swabs, and whole blood mononucleosis kits are all CLIA-waived testing devices that can be used by well-trained phlebotomists, nurses, or laboratory assistants.[6] Some POLs opt to provide more advanced testing services, however, with 23 percent of all POLs holding provider performed microscopy (PPM) certificates to perform moderate-level CLIA testing.[1] This allows POLs to perform moderate complexity tests like urine sediment analysis and the determination of "the presence or absence of bacteria, fungi, parasites, or cellular elements" in a specimen.[7] However, the majority of POLs remain smaller and simpler than their diagnostic lab counterparts.

Good laboratory practices

As previously stated, the ultimate goal of the clinical laboratory — and by extension, the POL — is to test specimens from human patients to assist with the diagnosis, treatment, or monitoring of a patient condition. This, of course, requires accurate results to ensure the best result. In the 1970s the U.S. Food and Drug Administration noted non-clinical laboratories in many cases conceived experiments poorly, failed to inform laboratory personnel of protocol, and didn't regard strict laboratory procedure to be necessary. This brought about the Good Laboratory Practice regulations in November 1976.[8][9] Clinical laboratories were not left out of improvements, however. Though the Clinical Laboratories Improvement Act of 1967 brought about some reforms to laboratory practices[10], the act wasn't doing enough by the mid-1980s. The regulations were revised and put into effect on October 31, 1988 as the Clinical Laboratory Improvement Amendments of 1988.[11] Known as CLIA, the regulations have helped shape the policy and procedure of clinical laboratories of all types, including how training and experience is gauged and documented, reagents are prepared, and quality control is approached.

Today in the U.S., like any other clinical lab, physician office laboratories must follow good laboratory practices to ensure the best outcomes for its associated patients. These practices must be engaged in at every stage of the laboratory testing process. During the initial test ordering process, for example, lab personnel must review orders for accuracy and seek verification from the physician if there are any questions. Following order entry, staff should complete a requisition and explain all preparation procedures to the patient. When the patient arrives, staff should use appropriate procedures and containers to collect the specimen(s) from the patient. Processing of the specimen should include proper storage, preservation (if required), labeling, and transportation. The POL must run quality control tests prior to testing the patient sample to ensure instruments are properly calibrated and appropriate testing proficiency is met. After test completion, a laboratory report is printed and the physician notified. Patients should also be notified per the policy of the physician practice. Disposal of laboratory waste is also part of good laboratory practice, as is proper documentation in the patient record regarding testing and results.[2]

Laboratory safety

Like any other laboratory, safety in the clinical laboratory is of vital importance. Good safety practices ensure the sample being tested is not contaminated, and they also protect the person doing the testing from infection or other issues resulting from exposure.

Quality control guidelines and standards ensure procedures are followed and equipment is checked, lowering specimen contamination risk and improving the accuracy of test results. Laboratory safety guidelines assist professionals with managing risk from biohazards, chemical hazards, or physical hazards that may be present in the laboratory. The two U.S government agencies that primarily set safety guidelines are the Centers for Disease Control and Prevention (CDC) and the Occupational Safety and Health Administration (OSHA). CDC training involves learning about the chain of infection and standard precautions for infection control, while OSHA biohazard training involves the blood borne pathogen standard (BBPS) as well as the exposure control plans and guidelines that promote staff health and safety. OSHA also requires training to deal with chemical hazards in the laboratory.[12][2]

Laboratories of any size must also deal with physical hazards such as obstructions, electrical equipment, fires, floods, earthquakes. Preparing for these possible hazards in some cases can be as simple as ensuring a box is not placed where someone walking could trip over it. OSHA has numerous guidelines related to the physical hazard training, including how to conduct a fire drill. Other beneficial preparatory activities include organizing and documenting clearly labeled chemical inventories, providing clear access to material safety data sheets (MSDS), enacting a hazard communication program, and providing training on OSHA adherence protocols.[12][2]

The POL is not exempt from these quality control and safety considerations simply because it's smaller and simpler, however. It may not have the chemical stocks and testing hazards of a large diagnostic lab, but specimens must still be kept uncontaminated and procedures for using even the simplest of CLIA-waived test devices must be followed. Biohazards are still generated and must be treated appropriately using work-practice controls, personal protective equipment, and engineering controls. And bleach (sodium hypochlorite), one of the most prevalent chemicals in labs[13], must still be handled properly to ensure human safety and equipment longevity.[12][2]

Regulatory compliance: HIPAA and PPACA

Clinical laboratories must comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Among HIPAAs many goals is the desire to improve privacy and security protections for an individual's personal and identifying health information. As such, laboratories are required to implement measures that prevent unauthorized disclosure of and access to a patient's protected health information (PHI) in the laboratory. In the original implementation of HIPAA, this meant that laboratory staff were discouraged from giving laboratory test results to a patient without physician permission.[2] However, in February 2014, the Department of Health and Human Services wanted to encourage patients to take a more proactive approach to their own health care by giving them a mechanism to learn more about their own health. The HHS put into place an amendment to CLIA that became effective in April 7 2014, allowing patients to request laboratory results directly from a laboratory. Under the change, laboratories (including POLs) are now required to give patients their laboratory results within 30 days of a written request by the patient or authorized agent. Other safeguards related to patient data and HIPAA are still applicable.[14] However, it's still not clear how this change impacts the POL, by definition located in the physician's office. As such, the physician's office-based procedures for acquiring PHI also likely apply to the in-office laboratory.

Another federal statute that impacts laboratory testing is the Patient Protection and Affordable Care Act (PPACA), signed in 2010 by President Barack Obama. This law cut fees paid for laboratory testing and established accountable care organizations (ACOs). Both the cuts to the Medicare Clinical Laboratory Fee Schedule and the creation of ACOs (which may decrease laboratory testing volume[15]) present additional challenges to the laboratory — especially in the physician office — as economic concerns may cause a laboratory to no longer have incentive to offer some forms of testing.

Regulatory compliance: CLIA

In 1988 the Clinical Laboratory Improvement Amendments (CLIA) were passed as an amendment to the original 1967 legislature.[11] CLIA attempts to ensure the accuracy, reliability, and timeliness of test results regardless of where the test was performed. As part of this process, seven different criteria are used to gauge and assign one of three complexity levels to laboratory devices, assays, and examinations: high, moderate, and waived.[5][16] Clinical laboratories handling specimens originating from the U.S. and its territories must apply for a CLIA certificate that is appropriate for the type of testing it performs.

The POL largely conducts CLIA-waived tests, with 60.5 percent of all POLs in the U.S. running on a CLIA certificate of waiver as of November 2014.[1] These tests are recognized as simple to perform with a low risk of erroneous results and include among others urinalysis for pregnancy and drugs of abuse, blood glucose and cholesterol tests, and fertility analysis. Despite the simplicity of a wiaved test, it "needs to be performed correctly, by trained personnel and in an environment where good laboratory practices are followed."[17] As such, the Centers for Medicare and Medicaid Services (CMS) provides additional enforcement of labs with CLIA certificates of waiver, conducting on-site visits to approximately two percent of such labs to verify quality testing, regulatory compliance, and test appropriateness.[18] In some cases a POL may also offer moderate-level provider performed microscopy (PPM) testing (23.3 percent of all POLs as of November 2014[1]), depending on the office specialty.[2] To perform this type of testing in addition to waived testing, a PPM certificate is also required.

Since most POL testing is waived, anyone can be the laboratory director at a POL; however, some states have different requirements, so it is important to check with your local regulatory body when hiring staff for the laboratory. POLs that also incorporate PPM testing have different requirements for directors, who "must meet specific education, training and experience under subpart M of the CLIA requirements."[19] More information can be found regarding the CLIA complexity levels and what is required under each on the FDA's website, the references in this section, and the CLIA waived test list.

Point-of-care testing

The College of American Pathologists (CAP) defines point-of-care testing (POCT) as "any type of laboratory testing that takes place at or near where the patient is located."[20] Historically this sort of testing was mundane due to the nature of the available methods; however, today these tests have advanced to include tests such as glucose testing. POCT can be a nice addition to the POL, as it can allow patients to monitor themselves between visits. Like waived CLIA tests, POCT can also be performed by laboratory personnel. Both personnel and patients (those who use testing devices at home) must be trained on how to use POCT devices in order to get the most accurate results.[21][22]

Some POCT devices are gradually allowing the patient to send data from their instruments directly to the physician office. However, this is not always a straightforward procedure. As the CAP notes in its point-of-view on POCT, "interoperability should be developed or expanded ... to provide better oversight and incorporation of results into the electronic medical record."[20] As Meaningful Use Stage 3 rules for electronic health records (EHRs) — which will require the acceptance of patient generated data — go into effect in 2016, questions still remain about how interoperable POCT devices and EHRs will actually be. (This will be discussed in more detail in the data management section below).

Provider-performed microscopy testing

CLIA has approved some tests for the provider performed microscopy (PPM) level, a subcategory of the moderate complexity level. These tests must be of moderate complexity and require a microscope as the primary analysis tool, and they must be performed by a qualified physician or nurse practitioner in a set period of time with limited handling of the specimen for the utmost accuracy.[23] Eligibility of PPM tests is determined by CMS, and include wet mounted tissue examinations, semen analysis, certain mucous and nasal smears, and certain urinalyses.[24] (For the full list, consult the CMS-updated PDF file.)

These individual tests are useful to many POLs, though they have their own procedures and require the ability to focus and maintain the microscope at optimal performance level. Part of doing so is learning the structures of the microscope and how to use it. Since these procedures are performed by physicians or mid-level practitioners, the provider should be well trained in how to do this. They should be able to identify the parts of the microscope and understand how the lenses work. Knowledge of proper slide preparation is also vital, as improperly prepared slides can ruin an otherwise correctly performed PPMT procedure. In addition to an appropriate microscope, PPMT procedures require several other items, including immersion oil, lens paper, and tissue (lint free, soft).[2] Finally, though PPMT isn't regulated, the provider and laboratory personnel should carefully document quality assurance procedures for PPMT at regular intervals.[23] As noted previously, POLs that incorporate PPM testing have different requirements for laboratory directors than CLIA-waived labs, requiring a higher level of documented training and competence.[19]

CLIA market and industry trends

The third installment of research firm Kalorama Information's Physician Office Laboratory Markets reported the number of POLs performing CLIA-waived in vitro diagnostic (IVD) testing increased an average annual rate of 3.8 percent from 2005 to 2013, though "the number of POLs conducting moderate and high complexity testing under CLIA compliance or accreditation decreased by an annual average rate of 0.8 percent."[25] As for what's being tested, the report noted that "[i]n the past five years, the most performed POL tests have changed little with the exception of some recently CLIA-waived infectious disease tests and vitamin D testing."[25] The report also noted that many of the CLIA waivers granted in 2014 have been for tests in "highly competitive, established POL segments, such as drugs-of-abuse testing, routine clinical chemistries, urinalysis, hormone tests (including pregnancy), and dipstick urinalysis."[26] Many of those IVD tests were likely waived by regulation or cleared for home or over-the-counter use; however, a few of those tests had to go through a more rigorous process to become CLIA-waived.

Addition of the Dual 510(k) and CLIA Waiver by Application process

Originally an IVD test product not CLIA-waived by regulation or not cleared for home or over-the-counter use — even if it had clear advantages as a CLIA-waived product — would have to first be taken through the FDA 510(k) premarketing submission process which would then classify it as moderate or high complexity.[27] Then, if the product was viable as a moderate complexity device, the manufacturer would try to market and make money on their product and then go through the CLIA Waiver by Application process if they thought there were clear benefits and eligibility for CLIA-waived product status. This process would work for many manufacturers but frustrate a few (as of 2014, only 10 to 12 CLIA Waiver by Application requests were arriving to the FDA each year) who deemed their product non-viable to market unless it were CLIA-waived.[28]

Initially driven by the Medical Device User Fee Amendments of 2012 (MDUFA III) — an FDA attempt "to increase the efficiency of regulatory processes in order to reduce the time it takes to bring safe and effective medical devices to the U.S. market"[29] — the FDA sought to overhaul its Administrative Procedures for CLIA Categorization guidance documents, tracking mechanisms, and public CLIA database to improve the IVD and medical equipment regulation process. Among these changes, effective March 21, 2014, was the addition of the Dual 510(k) and CLIA Waiver by Application process specifically for "that small subset of products that are not really viable if they are not waived."[28][30][31] The process is specific, requiring a pre-submission to receive FDA feedback first and be cleared for the Dual strategy. If approved, both the 510(k) and the CLIA Waiver by Application can be submitted at the same time.[28][27][32] On December 17, 2014, rapid diagnostic manufacturer Quidel Corporation announced its Sofia Strep A+ Fluorescent Immunoassay became the first product to be approved through the Dual program[33], opening a potential gateway for other rapid diagnostic companies to fast track their product through FDA and CLIA waiver approval.

More sophisticated CLIA-waived tests appear

More sophisticated tests eligible for labs with a certificate of waiver are appearing as of late, further increasing same-day testing opportunities in POLs. The first ever waived rapid screening test for syphilis was approved in the United States in December 2014, allowing physicians to make a preliminary diagnosis in as soon as 12 minutes. The product came about with the recognition of a the increasing number of primary and secondary syphilis cases in the U.S., nearly 55,000 new cases a year.[34] HIV testing is another growing segment of POL activities. Nearly four percent of all approved CLIA-waived tests are HIV tests, and of labs that offer CLIA-waived testing in general, 36 percent of them include at least one CLIA-waived HIV test.[35] The demand for more accurate and timely test results has driven companies like Trinity Biotech to create more flexible options; in November 2014 the company announced its Uni-Gold Recombigen HIV test "for the detection of antibodies to HIV in human serum, plasma, venous, and finger stick whole blood" was approved for CLIA-waived status, making it at the time the only rapid HIV test to be approved for all sample types.[36]

Several POCT companies have stepped up their CLIA-waived efforts recently, including Alere, Inc. and Cepheid, Inc. In an April 2015 interview with GenomeWeb, Cepheid chairman and CEO John Bishop stated the company would be "adding a sales force specifically for the CLIA market in early May" with expectations that the "market is actually going to step up overall test volumes as you move more broadly-disseminated."[37] Alere has been doing the same, though both companies are arguably heading up the charge towards a new potential trend in the CLIA-waived testing market: molecular and nucleic acid-based testing.

"I think the molecular tests are going to grab market share very rapidly ... and that's going to get even more emphasized with all of the programs now on antibiotic stewardship and more diagnostically directed use of therapeutics."[37] - John Bishop, Cepheid, Inc. chairman and CEO

"[W]e look forward to kind of changing the concept in the marketplace, [and showing] that you can get a highly sensitive, molecular result in minutes."[38] - K.C. McGrath, Alere, Inc. respiratory product manager

"We expect many other simple and accurate tests using nucleic acid-based technology to be developed in the near future. Once cleared by FDA, such tests can allow health care professionals to receive test results more quickly to inform further diagnostic and treatment decisions."[39] - Alberto Gutierrez, FDA director of the Office of In Vitro Diagnostics and Radiological Health

"I think traditional [polymerase chain reaction] assays will get better, faster, their boxes will get smaller, and you'll start to see a lot more point-of-care approved tests."[40] - Christine Ginocchio, BioMérieux vice president of global microbiology affairs

Molecular diagnostic tests have long been the domain of the full-fledged laboratory, even as companies like Cepheid have made progress with sales of its molecular Flu Xpert test[37], rated by CLIA for moderate complexity labs.[41] With only roughly 30 percent of physicians offices running at moderate complexity[38], however, molecular testing has seemed largely out-of-reach for the POL. Yet in January 2015, Alere and the FDA announced that the i Influenza A & B test had become the first ever nucleic acid-based test to receive CLIA-waived status, meaning it could be offered in POLs with a certificate of waiver.[41][39] While it's not clear if molecular point-of-care and and POL-friendly tests will become more prevalent in the coming years, their benefit to the POL are becoming clearer. In the case of the i Influenza A & B test, diagnosing a patient with influenza on a same-day physician visit with easy-to-use molecular tech could potentially reduce antibiotic prescriptions, decrease infection rates, and improve outcomes through early detection.[39]

Other players in the CLIA market

Other entities are beginning to focus on the CLIA market as well. Take AmericanBio, a custom reagent manufacturer that announced in October 2014 that it was implementing a "CLIA Grade product line and CLIA Grade Custom Manufacturing Services," helping device manufacturers sort through "regulatory framework, validation needs, consistency, and quality driven metrics that will support their diagnostic tool," both traditional and molecular.[42] Additionally, seminars and webinars on getting medical devices CLIA-waived are appearing from market research companies like Research and Markets and government agencies like the National Institutes of Health.[43][44] And niche businesses like Precision for Medicine are popping up, offering specialty regulatory, device, and test development services for the CLIA market.[45]

Side-effects of cheap and easy testing

The CLIA market, however, is not without its warts. One of the potential side-effects of cheap and easy testing in the physician office is the occasional desire to monetize it, particularly when Medicare reimbursement for a particular set of tests is quite lucrative. While in the U.S. the profit-driven trend of health care has caused many to debate further changes, in truth, physicians still must be concerned with at least meeting operating costs.[46] However, some physicians have been more opportunistic, particularly in the field of urine drug testing. A 2012 article in the Journal of Pain & Palliative Care Pharmacotherapy titled "Profit-Driven Drug Testing" showed urine drug screens for both waived and non-waived tests reimbursed by Medicare increased by 4,537 percent from 2000 to 2009. Even worse, "the total number of CLIA-waived drug tests (CPT Code 80101QW) paid for by Medicare and conducted at physicians’ offices increased approximately 3,172,910 percent; with 101 tests conducted in 2000 and 3,204,740 in 2009."[47] This sudden increase of reimbursements came in part because physicians could bill Medicare per panel, meaning an 11-panel urine drug screen could be billed 11 times. CMS amended their rules in 2010 to prevent this type of unintended billing behavior, making drug testing less lucrative in general, especially for the POL.[47]

Yet some labs with a CLIA certificate of compliance or accreditation to handle moderate to advanced tests would continue to skirt the issue by moving to advanced mass spectrometry urine drug tests (qualitative) due to Medicare guidelines that encourage doctors to test patients using pain medicines to ensure their proper usage. In late 2014, The Wall Street Journal reported that Medicare was spending $445 million on 22 advanced drugs-of-abuse tests in 2012, up by more than 1,400 percent from 2007. With separate tests for each substance screened, an incentive remained for laboratories and physicians to abuse moderate- to advanced-level urine drug testing.[48]

Economic issues related to the POL

Data management

References

  1. ↑ 1.0 1.1 1.2 1.3 1.4 Centers for Medicare and Medicaid Services, Division of Laboratory Services (November 2014). "Enrollment, CLIA exempt states, and certification of accreditation by organization" (PDF). http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf. Retrieved 18 April 2015. 
  2. ↑ 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 Garrels, Marti; Oatis, Carol S. (2014). Laboratory and Diagnostic Testing in Ambulatory Care: A Guide for Healthcare Professionals (3rd ed.). Elsevier Health Sciences. pp. 368. ISBN 9780323292368. https://books.google.com/books?id=LM9sBQAAQBAJ. Retrieved 18 April 2015. 
  3. ↑ "Careers in Pathology and Medical Laboratory Science" (PDF). American Society for Clinical Pathology. http://www.ascp.org/pdf/CareerBooklet.aspx. Retrieved 18 April 2015. 
  4. ↑ "Laboratory Safety Standards". American National Standards Institute. 2015. http://webstore.ansi.org/laboratory_safety/. Retrieved 18 April 2015. 
  5. ↑ 5.0 5.1 Centers for Disease Control and Prevention (31 May 2013). "Clinical Laboratory Improvement Amendments (CLIA): Test complexities". http://wwwn.cdc.gov/clia/Resources/TestComplexities.aspx. Retrieved 18 April 2015.  Cite error: Invalid <ref> tag; name "CDCTestCom" defined multiple times with different content
  6. ↑ "CLIA - Clinical Laboratory Improvement Amendments - Currently Waived Analytes". U.S. Food and Drug Administration. 13 April 2015. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm. Retrieved 18 April 2015. 
  7. ↑ Kulczycki, Michael (1 April 2014). "Focusing on Provider-Performed Microscopy Procedure Requirements for Ambulatory Health Care". Ambulatory Buzz. The Joint Commission. http://www.jointcommission.org/musingsambulatory_patient_safety/focusing_provider_microscopy_procedure_req_ambulatory_health_care/. Retrieved 18 April 2015. 
  8. ↑ Taylor, Jean M.; Stein, Gary C.; Weinberg, Sandy (2002). "Chapter 1: Historical Perspective". Good Laboratory Practice Regulations (3rd ed.). CRC Press. pp. 1–24. ISBN 9780203911082. https://books.google.com/books?id=50P7CAAAQBAJ&pg=PA1. Retrieved 19 May 2015. 
  9. ↑ Seiler, Jürg P. (2006). "Chapter 1: What Is Good Laboratory Practice All About?". Good Laboratory Practice (2nd ed.). Springer Science & Business Media. pp. 1–58. ISBN 9783540282341. https://books.google.com/books?id=Hhj1sDFIlOYC&pg=PA1. Retrieved 19 May 2015. 
  10. ↑ "Public Law 90-174" (PDF). United States Statutes at Large, Volume 81. 1967. http://www.gpo.gov/fdsys/pkg/STATUTE-81/pdf/STATUTE-81-Pg533.pdf. Retrieved 24 March 2014. 
  11. ↑ 11.0 11.1 "Public Law 100-578" (PDF). United States Statutes at Large, Volume 102. 1988. http://www.gpo.gov/fdsys/pkg/STATUTE-102/pdf/STATUTE-102-Pg2903.pdf. Retrieved 24 March 2014. 
  12. ↑ 12.0 12.1 12.2 Cox, Phyllis; Wilken, Danielle (2010). "Chapter 1: Safety in the Laboratory". Palko's Medical Laboratory Procedures (3rd ed.). McGraw-Hill Education. pp. 1–23. ISBN 9780073401959. https://books.google.com/books?id=6uWWPQAACAAJ. Retrieved 18 April 2015. 
  13. ↑ "Examples of Common Laboratory Chemicals and their Hazard Class". National Institutes of Health, Office of Management. 27 November 2012. http://orf.od.nih.gov/EnvironmentalProtection/WasteDisposal/Pages/Examples+of+Common+Laboratory+ChemicalsandtheirHazardClass.aspx. Retrieved 18 April 2015. 
  14. ↑ "CLIA Program and HIPAA Privacy Rule; Patients' Access to Test Reports" (PDF). Federal Register 79 (25): 7290–7316. 6 February 2014. http://www.gpo.gov/fdsys/pkg/FR-2014-02-06/pdf/2014-02280.pdf. Retrieved 13 April 2015. 
  15. ↑ Hughes, D.; Cammarata, B. (16 January 2014). "Clinical labs under ACA: Challenge and opportunity". Law360. http://www.law360.com/articles/500623/clinical-labs-under-aca-challenge-and-opportunity. Retrieved 18 April 2015. 
  16. ↑ "CLIA Categorization Criteria". U.S. Food and Drug Administration. 6 March 2014. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm124208.htm. Retrieved 23 March 2014. 
  17. ↑ "Clinical Laboratory Improvement Amendments (CLIA) - CLIA Waived Tests". Centers for Disease Control and Prevention. 14 March 2014. http://wwwn.cdc.gov/clia/Resources/WaivedTests/default.aspx. Retrieved 23 March 2014. 
  18. ↑ "Certificate of Waiver Laboratory Project". Centers for Medicare and Medicaid Services. 27 February 2014. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Certificate_of_-Waiver_Laboratory_Project.html. Retrieved 19 May 2015. 
  19. ↑ 19.0 19.1 "How to Apply for a CLIA Certificate, Including International Laboratories". Centers for Medicare and Medicaid Services. 30 April 2012. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/How_to_Apply_for_a_CLIA_Certificate_International_Laboratories.html. Retrieved 19 May 2015. 
  20. ↑ 20.0 20.1 "Point Of Care Testing". College of American Pathologists. September 2013. http://www.cap.org/apps//cap.portal?_nfpb=true&cntvwrPtlt_actionOverride=%2Fportlets%2FcontentViewer%2Fshow&_windowLabel=cntvwrPtlt&cntvwrPtlt{actionForm.contentReference}=policies%2Fpolicy_appII.html. Retrieved 18 April 2015. 
  21. ↑ Kiechle, Frederick L.Main, Rhonda Ingram (2002). The Hitchhiker's Guide to Improving Efficiency in the Clinical Laboratory. American Association for Clinical Chemistry. pp. 132. ISBN 9781890883720. https://books.google.com/books?id=ud55aVHAiTQC. Retrieved 13 April 2015. 
  22. ↑ "Point-of-Care Diagnostic Testing". Research Portfolio Online Reporting Tools. National Institutes of Health. 29 March 2013. http://report.nih.gov/nihfactsheets/ViewFactSheet.aspx?csid=112. Retrieved 18 April 2015. 
  23. ↑ 23.0 23.1 "Waived and Provider Performed Microscopy (PPM) Tests". American Academy of Family Physicians. http://www.aafp.org/practice-management/regulatory/clia/tests.html. Retrieved 19 May 2015. 
  24. ↑ "Provider-performed Microscopy Procedures" (PDF). Centers for Medicare and Medicaid Services. http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/ppmplist.pdf. Retrieved 19 May 2015. 
  25. ↑ 25.0 25.1 Park, Richard (13 October 2014). "Examining the Physician Office Lab Market: Growth and Reimbursement". Medical Design Technology. Advantage Business Media. http://www.mdtmag.com/blogs/2014/10/examining-physician-office-lab-market-growth-and-reimbursement. Retrieved 01 June 2015. 
  26. ↑ Park, Richard (29 September 2014). "Examining the Physician Office Lab Market: CLIA and Technology". Medical Design Technology. Advantage Business Media. http://www.mdtmag.com/blogs/2014/09/examining-physician-office-lab-market-clia-and-technology. Retrieved 01 June 2015. 
  27. ↑ 27.0 27.1 "Administrative Procedures for CLIA Categorization: Guidance for Industry and Food and Drug Administration Staff" (PDF). U.S. Department of Health and Human Services. 12 March 2014. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070889.pdf. Retrieved 01 June 2015. 
  28. ↑ 28.0 28.1 28.2 Wirt, Tammy (24 March 2014). "NWS HHS FDA CRDH" (PDF). U.S. Food and Drug Administration. http://www.fda.gov/downloads/Training/CDRHLearn/UCM390761.pdf. Retrieved 01 June 2015. 
  29. ↑ "Fact Sheet: Medical Device User Fee Amendments of 2012". U.S. Food and Drug Administration. 3 August 2012. http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm313695.htm. Retrieved 01 June 2015. 
  30. ↑ Mullen, Allyson B. (19 March 2014). "FDA Issues Revised Final Guidance Regarding Administrative Procedures for CLIA Categorization". FDA Law Blog. Hyman, Phelps & McNamara, P.C. http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2014/03/fda-issues-revised-final-guidance-regarding-administrative-procedures-for-clia-categorization.html. Retrieved 01 June 2015. 
  31. ↑ Rath, Prakash (5 March 2014). "Administrative Changes to FDA’s CLIA Categorization Program" (PDF). U.S. Food and Drug Administration. http://ftp.cdc.gov/pub/CLIAC_meeting_presentations/pdf/Addenda/cliac0314/04_Rath_Admin%20Changes%20to%20FDA%27s%20CLIA%20Program.pdf. Retrieved 01 June 2015. 
  32. ↑ "CLIA Waiver by Application". U.S. Food and Drug Administration. 26 March 2015. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm393233.htm. Retrieved 01 June 2015. 
  33. ↑ "Quidel Receives Simultaneous FDA Clearance And CLIA Waiver For Its Sofia® Strep A+ Fluorescent Immunoassay (FIA) Via The FDA's New Dual Submission Program". Med Device Online. VertMarkets, Inc. 17 December 2014. http://www.meddeviceonline.com/doc/quidel-receives-simultaneous-fda-clearance-and-clia-waiver-0001. Retrieved 01 June 2015. 
  34. ↑ "Trinity Biotech Announces CLIA Waiver of Rapid Syphilis Test". GlobeNewswire, Inc. 16 December 2014. http://globenewswire.com/news-release/2014/12/16/691813/10112606/en/Trinity-Biotech-Announces-CLIA-Waiver-of-Rapid-Syphilis-Test.html. Retrieved 26 May 2015. 
  35. ↑ "HIV testing - prevalent CLIA waived tests". Percepta Associates, Inc. 12 March 2015. http://www.perceptaassociates.com/hiv-testing-clia-waived-tests/. Retrieved 26 May 2015. 
  36. ↑ "Trinity Biotech Receives CLIA Waiver for Uni-Gold(TM) Recombigen(R) HIV Test". PR Newswire Association LLC. 10 November 2014. http://www.prnewswire.com/news-releases/trinity-biotech-receives-clia-waiver-for-uni-goldtm-recombigenr-hiv-test-75323487.html. Retrieved 26 May 2015. 
  37. ↑ 37.0 37.1 37.2 Johnson, Madeleine (26 April 2015). "Cepheid Sees 'Significant Opportunity' in Menu Expansion, CLIA Market". GenomeWeb. Genomeweb LLC. https://www.genomeweb.com/business-news/cepheid-sees-significant-opportunity-menu-expansion-clia-market. Retrieved 21 May 2015. 
  38. ↑ 38.0 38.1 Johnson, Madeleine (19 June 2014). "With FDA-Cleared Flu Test, Alere Launches Isothermal MDx Platform for US Clinical Market". GenomeWeb. Genomeweb LLC. https://www.genomeweb.com/pcrsample-prep/fda-cleared-flu-test-alere-launches-isothermal-mdx-platform-us-clinical-market. Retrieved 21 May 2015. 
  39. ↑ 39.0 39.1 39.2 Seiffert, Don (12 January 2015). "FDA waiver of Alere's flu test poses threat to market leader Cepheid". Boston Business Journal. American City Business Journals. http://www.bizjournals.com/boston/blog/bioflash/2015/01/fda-waiver-of-aleres-flu-test-poses-threat-to.html. Retrieved 21 May 2015. 
  40. ↑ Johnson, Madeleine (30 April 2015). "Q&A: BioMérieux's Christine Ginocchio Chats About Her Clinical Lab Career Arc, Syndromic PCR Panels". GenomeWeb. Genomeweb LLC. https://www.genomeweb.com/pcr/qa-biom-rieuxs-christine-ginocchio-chats-about-her-clinical-lab-career-arc-syndromic-pcr-panels. Retrieved 26 May 2015. 
  41. ↑ 41.0 41.1 Johnson, Madeleine (12 January 2015). "With CLIA Waiver and Widespread Flu, Alere Ramps Up Molecular Test Production". GenomeWeb. Genomeweb LLC. https://www.genomeweb.com/pcr/clia-waiver-and-widespread-flu-alere-ramps-molecular-test-production. Retrieved 21 May 2015. 
  42. ↑ "AmericanBio expands product offerings, introduces exclusive CLIA Grade product line". AmericanBio, Inc. 17 October 2014. https://www.americanbio.com/news-events/americanbio-expands-product-offerings-introduces-exclusive-clia-grade-product-line1. Retrieved 27 May 2015. 
  43. ↑ "How to get a CLIA Waiver for your Medical Device: One and a Half Day In-person Seminar 2015 (Newark, NJ)". Research and Markets. May 2015. http://www.researchandmarkets.com/reports/3215400/how-to-get-a-clia-waiver-for-your-medical-device. Retrieved 27 May 2015. 
  44. ↑ ""CLIA Waivers: The What, The Why, and The How" Webinar". National Institutes of Health. 15 April 2015. http://www.nibib.nih.gov/news-events/meetings-events/clia-waivers-what-why-and-how-webinar. Retrieved 27 May 2015. 
  45. ↑ "Regulatory Solutions". Precision for Medicine. http://www.precisionformedicine.com/regulatory-solutions/. Retrieved 27 May 2015. 
  46. ↑ Ubel, Peter (12 February 2014). "Is The Profit Motive Ruining American Healthcare?". Forbes.com. Forbes, Inc. http://www.forbes.com/sites/peterubel/2014/02/12/is-the-profit-motive-ruining-american-healthcare/. Retrieved 27 May 2015. 
  47. ↑ 47.0 47.1 Collen, Mark (2012). "Profit-Driven Drug Testing". Journal of Pain & Palliative Care Pharmacotherapy (26): 13–17. doi:10.3109/15360288.2011.650358. http://www.academia.edu/7840929/Profit-driven_drug_testing. Retrieved 27 May 2015. 
  48. ↑ Weaver, Christopher; Matthews, Anna-Wilde (10 November 2014). "Doctors Cash In on Drug Tests for Seniors, and Medicare Pays the Bill". The Wall Street Journal. Dow Jones & Company, Inc. http://www.wsj.com/articles/doctors-cash-in-on-drug-tests-for-seniors-and-medicare-pays-the-bill-1415676782. Retrieved 01 June 2015. 
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