Difference between revisions of "Physician office laboratory"

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[[File:Johannes Cordua Arzt in seinem Studierzimmer.jpg||thumb|300px|right|The early physician's laboratory was certainly more modest than the 21st-century POL.]]
A '''physician office laboratory''' ('''POL''') is a physician-, partnership-, or group-maintained [[laboratory]] that performs diagnostic tests or examines specimens in order to diagnose, prevent, and/or treat a disease or impairment in a patient as part of the physician practice.<ref name="CMSPOLDef">{{cite web |url=http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c16.pdf |format=PDF |title=Chapter 16 - Laboratory Services |work=Medicare Claims Processing Manual |publisher=Centers for Medicare and Medicaid Services |date=20 June 2013 |accessdate=3 April 2014}}</ref><ref name="WasPOLEP">{{cite web |url=http://www.wadsworth.org/labcert/polep/ |title=Physician Office Laboratory Evaluation Program (POLEP) |publisher=Wadsworth Center New York State Department of Health |accessdate=3 April 2014}}</ref> The POL shows up in primary care physician offices as well as the offices of specialists like urologists, hematologists, gynecologists, and endocrinologists. In many countries like the United States, the physician office laboratory is considered a [[clinical laboratory]] and is thus regulated by federal, state, and/or local laws affecting such laboratories.<ref name="WasPOLEP" /><ref name="CDPHLabs">{{cite web |url=http://www.cdph.ca.gov/programs/lfs/Documents/POL-FAQ.pdf |format=PDF |title=Physician Office Laboratories or Clinics - Frequently Asked Questions about Clinical Laboratory Licensing and Registration |publisher=California Department of Public Health |date=May 2008 |accessdate=3 April 2014}}</ref>
A '''physician office laboratory''' ('''POL''') is a physician-, partnership-, or group-maintained [[laboratory]] that performs diagnostic tests or examines specimens in order to diagnose, prevent, and/or treat a disease or impairment in a patient as part of the physician practice.<ref name="CMSPOLDef">{{cite web |url=http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c16.pdf |format=PDF |title=Chapter 16 - Laboratory Services |work=Medicare Claims Processing Manual |publisher=Centers for Medicare and Medicaid Services |date=20 June 2013 |accessdate=3 April 2014}}</ref><ref name="WasPOLEP">{{cite web |url=http://www.wadsworth.org/labcert/polep/ |title=Physician Office Laboratory Evaluation Program (POLEP) |publisher=Wadsworth Center New York State Department of Health |accessdate=3 April 2014}}</ref> The POL shows up in primary care physician offices as well as the offices of specialists like urologists, hematologists, gynecologists, and endocrinologists. In many countries like the United States, the physician office laboratory is considered a [[clinical laboratory]] and is thus regulated by federal, state, and/or local laws affecting such laboratories.<ref name="WasPOLEP" /><ref name="CDPHLabs">{{cite web |url=http://www.cdph.ca.gov/programs/lfs/Documents/POL-FAQ.pdf |format=PDF |title=Physician Office Laboratories or Clinics - Frequently Asked Questions about Clinical Laboratory Licensing and Registration |publisher=California Department of Public Health |date=May 2008 |accessdate=3 April 2014}}</ref>


Revision as of 16:16, 15 April 2014

The early physician's laboratory was certainly more modest than the 21st-century POL.

A physician office laboratory (POL) is a physician-, partnership-, or group-maintained laboratory that performs diagnostic tests or examines specimens in order to diagnose, prevent, and/or treat a disease or impairment in a patient as part of the physician practice.[1][2] The POL shows up in primary care physician offices as well as the offices of specialists like urologists, hematologists, gynecologists, and endocrinologists. In many countries like the United States, the physician office laboratory is considered a clinical laboratory and is thus regulated by federal, state, and/or local laws affecting such laboratories.[2][3]

POLs in the United States

History

1800s

Throughout the mid- to late 1800s, both the university and hospital laboratory played an important role in helping physicians diagnose disease[4][5][6], followed by the bedside care and analysis of the physician. However, the physician office laboratory also contributed to diagnoses, especially in the latter decades of the century.[6][7][8]

Whether at the hospital lab, the bedside, or the physician office, the urinalysis was a common and important test utilized in diagnosing illness.[9] For the POL in particular, however, the 1890s brought more accessible tests like water examination, poisonous metals analysis, and tests for hypersecretion of hydrochloric acid in the stomach.[7][8][10] Equipment like a water incubating oven, microtome, sterilizer, pipettes, reagents, evaporating dish, centrifuge, and microscope were also more readily available to the physician running their own laboratory.[10][11][12][13]

1900 to 1979

The promotion and success of the physician office laboratory continued on into the first decade of the twentieth century, with most urban physicians able to perform analysis of urine, blood, sputum, and feces.[14][15] Yet the first two decades of the 1900s also saw the slow rise of the "commercial laboratory," a privately- or group-held clinical pathology, chemical, or radiological lab that processed laboratory tests or chemical compounds ordered by a referring physician.[16][17] (Though the same idea, the term "referral lab" didn't begin to appear in medical literature regularly until the early 1950s and "independent laboratory" until the mid-1960s.[18][19][20] ) While some physicians — especially those in thriving urban areas — had a large enough clientele to invest in laboratory equipment and supplies for their own office, others in rural areas were less likely to be able to afford such luxuries. In the latter case, physicians were not able to as effectively provide a clinical diagnosis to their patients. These physicians had to either hope for connections at community regional hospitals to utilize the hospital laboratory (if they were even in reasonable distance or had the testing tools) or find some other means of sample testing.[21] Practitioners and businesspeople alike saw an opportunity for the commercial laboratory to fill those gaps.

However, around the early 1920s, the push for or against the increasingly popular commercial laboratory became more noticeably vocal. Some physicians, specialists, and dentists complained heavily of the lack of quality standards, regulations, and ethics inherent in for-profit clinical, chemical, and radiological laboratories.[22][23][24][25] An alternative was at times proposed in the form of a state or local diagnostic lab or a referral-only "clinic" that could be well-equipped with professional tools, staff, and procedures, critical for rural areas and usable for more than just public health care diagnoses.[16][26] However, other medical professionals, while recognizing the need for more professional laboratory environments and more ethical advertising, dismissed those declaring the commercial laboratory as "evil,"[27] content to state those types of labs were needed and then fully entrenched in the health care environment.[16][24]

The for-profit clinical laboratory, however, would only garner minor prominence until the '70s and '80s. In the meantime, organizations like the American Society of Clinical Pathologists' (ASCP's) Board of Registry (1928) and the American Society of Medical Technologists (1932) began appearing to help promote higher standards in clinical laboratory standards, whether it be in the commercial laboratory, the hospital laboratory, or the physician's office.[28] [29] And with the ever-increasing variety of tests and associated equipment (as well as the demand for it), clinical laboratory practice continued to move out of the physicians office and into the hospital laboratory.[30][31][32][33]

On December 5, 1967, the U.S. enacted Public Law 90-174, which included in Section 5 the "Clinical Laboratories Improvement Act of 1967." CLIA '67 set regulations on the licensing of clinical laboratories and the movement of samples in and out of them across state lines. Laboratories would be eligible for a full, partial, or exempt CLIA-67 license, depending on the laboratory's conducted tests.[34] However, CLIA '67 wasn't thorough, and only about 12,000 of nearly 200,000 U.S. laboratories were regulated. Physician office laboratories in particular were unaffected by the regulations.[35] Another attempt was made to place more clinical labs into the regulation net, with proposed but unsuccessful legislation in 1976 and 1977 that would have extended federal licensure to all hospital and independent laboratories. POLs again would have been exempted, requiring only participation in a federal proficiency testing program.[36]

The U.S. National Center for Health Statistics (NCHS) reported in its 1965 publication of Health Resources Statistics the following statistics for laboratories[37]:

  • In 1958, around 6,500 to 7,000 hospitals labs employed roughly 45,000 to 50,000 personnel.
  • In 1962, physician office laboratories employed roughly 25,000 to 30,000 personnel.[38]
  • In 1962, around 2,000 independent/commercial labs employed roughly 10,000 personnel.

The publication didn't mention the number of POLs in 1962. One could arguably assume hospital labs still outnumbered POLs that year. In the last year of its publication of Health Resources Statistics (1976–1977), the NCHS reported "[t]he largest number of clinical laboratories are in the offices of private physicians, and the next largest number are in hospitals,[39]" indicating a potential flip-flop in lab numbers over a period of nearly 15 years. The 1976–1977 report is also notable for its focus on the "independent clinical laboratory" (the commercial clinical laboratory) as defined by Medicare, indicating an increase from 2,355 such labs in 1967 to 3,024 on January 1976.[39]

1980 to present

Between 1983 and 1984 physician office testing increased by an estimated 11 percent, while the volume of physician-referred diagnostic tests to third-party labs declined 2 percent[40], likely buoyed by relatively inexpensive in-office laboratory equipment and more efficient drug monitoring capabilities.[41] The Deficit Reduction Act of 1984 further helped to increase the number of physician office laboratories by eliminating physicians' ability to mark up tests sent out to referral labs. Additional changes to Medicare reimbursement meant the laboratory that performed the tests got paid, while physicians were suddenly limited to a $3 payment per patient visit for collecting and distributing specimens. As physician laboratories were at that point still not regulated, physicians and equipment vendors alike saw an opportunity to expand physician office laboratory functions.[40] By the end of 1985, 10 percent of group practices with one to five physicians and 40 percent of those with six to 25 physicians were operating POLs.[42]

On January 1, 1987, the Health Care Financing Administration ruled physicians must accept assignment for performed in-office Medicare lab testing, significantly cutting physician revenues. This, combined with plans from third-party to reduce POL payments and increased pressure on Congress to regulate POLs like other clinical laboratories, led to suggestions of physicians banding together into limited partnerships to start their own reference labs.[42] That pressure on Congress led to the signing into effect of the Clinical Laboratory Improvement Amendments (CLIA) on October 31, 1988.[43] Regulations for implementing CLIA continued to be developed afterwards, with the Department of Health and Human Services considering thousands of comments to the proposed regulations. The final regulations were published February 28, 1992, set to be effective on September 1 of the same year. The new CLIA regulations put into place regulations concerning test complexity, certification, proficiency testing, patient test management, personnel requirements, quality assurance, and other processes in the clinical laboratory, including physician office laboratories.[44] Additional controls were placed on POLs that year by the Stark Amendment, which sought to prohibit physician referrals of designated health services for Medicare and Medicaid patients if the physician or an immediate family member had a financial relationship with that entity.[45]

By 1993, some physicians running POLs were already protesting CLIA, stating the legislation imposed too many rules, regulations, and fees on physicians who perform any kind of in-office testing.[46][47] A mix of public commentary and internal consideration caused the effective date of CLIA for labs to be extended on several occasions afterwards: on December 6, 1994 in the Federal Register (59 FR 62606), May 12, 1997 in the Federal Register (62 FR 25855), October 14, 1998 in the Federal Register (63 FR 55031), and December 29, 2000 in the Federal Register (65 FR 82941).[48]

"The extensions allowed previously unregulated laboratories time to understand and implement these requirements. The extensions also provided the Department of Health and Human Services (HHS) additional time to issue revised QC requirements, review board certification program requests for approval, and ensure that laboratory directors with a doctoral degree had sufficient time to successfully complete the requirements for board certification."[48]

By 2000, some physicians were still espousing the benefits of the POL despite the implementation of CLIA, stating that CLIA fees, proficiency testing fees, inspection fees, and staff time account for only roughly about three to four percent of overall lab costs.[49] However, a 2003 report from the College of American Pathologists found "a small, slow drop-off in the POL market as some laboratories close or move to waived testing.[50]"

In early 2011, researchers estimated the worldwide market for in vitro diagnostic company sales from over 100 companies to POLs was valued at around $2.3 billion U.S.[51]

In December 2013, the Centers for Medicare and Medicaid Services (CMS) reported nearly half of all CLIA-certified laboratories in the United States (120,399) were physician office laboratories.[52] However, as of December 2010 POLs only processed about eight percent of all clinical laboratory tests.[53]

Further reading


References

  1. ↑ "Chapter 16 - Laboratory Services" (PDF). Medicare Claims Processing Manual. Centers for Medicare and Medicaid Services. 20 June 2013. http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c16.pdf. Retrieved 3 April 2014. 
  2. ↑ 2.0 2.1 "Physician Office Laboratory Evaluation Program (POLEP)". Wadsworth Center New York State Department of Health. http://www.wadsworth.org/labcert/polep/. Retrieved 3 April 2014. 
  3. ↑ "Physician Office Laboratories or Clinics - Frequently Asked Questions about Clinical Laboratory Licensing and Registration" (PDF). California Department of Public Health. May 2008. http://www.cdph.ca.gov/programs/lfs/Documents/POL-FAQ.pdf. Retrieved 3 April 2014. 
  4. ↑ Trustees of the Vermont Asylum for the Insane (October 1837). First Annual Report of the Trustees of the Vermont Asylum for the Insane. E. P. Walton and Son. http://books.google.com/books?id=EWAxAQAAMAAJ&pg=PA261. Retrieved 14 April 2014. 
  5. ↑ Trustees of the Massachusetts General Hospital (1898). Eighty-Fourth Annual Report of the Trustees of the Massachusetts General Hospital. The Barta Press. http://books.google.com/books?id=dLk4AAAAYAAJ&pg=RA1-PA123. Retrieved 14 April 2014. 
  6. ↑ 6.0 6.1 Welch, William Henry (1920). "The Evolution of Modern Scientific Laboratories". Papers and Addresses by William Henry Welch. 3. The Johns Hopkins Press. pp. 200–211. http://books.google.com/books?id=utc0AQAAMAAJ&pg=200. Retrieved 14 April 2014. 
  7. ↑ 7.0 7.1 Simon, Charles E. (9 May 1896). "The Importance of Laboratory Methods in Diagnosis". Maryland Medical Journal 35 (4): 55–57. http://books.google.com/books?id=dooRAAAAYAAJ&pg=PA55. Retrieved 14 April 2014. 
  8. ↑ 8.0 8.1 Shoemaker, John V. (ed.) (November 1884). "Chemical Department at Jefferson Medical College". The Medical Bulletin: A Monthly Journal of Medicine and Surgery 6 (11): 277–278. http://books.google.com/books?id=DmQWAAAAYAAJ&pg=PA277. Retrieved 14 April 2014. 
  9. ↑ Wellcome, Henry S. (1911). "Chapter VI: The Advent of Scientific Urine Analysis". The Evolution of Urine Analysis: An Historical Sketch of the Clinical Examination of Urine. Burroughs Wellcome & Co.. http://catalog.hathitrust.org/Record/007935440. Retrieved 14 April 2014. 
  10. ↑ 10.0 10.1 Andrews, J. W. (1897). "Some of the Minor Ailments of the Stomach and Their Remedies". Northwestern Lancet 17: 291–294. http://books.google.com/books?id=ZhcTAAAAYAAJ&pg=PA291. Retrieved 14 April 2014. 
  11. ↑ Elliott, L. B. (March 1898). "Editorial". Journal of Applied Microscopy 1 (3): 57–58. http://books.google.com/books?id=bcjRAAAAMAAJ&pg=PA57. Retrieved 14 April 2014. 
  12. ↑ Koplik, Henry (1 August 1896). "The Rapid and Bacteriological and Clinical Diagnosis of Diphtheria". The New York Medical Journal 64: 147–151. http://books.google.com/books?id=M1s5AQAAMAAJ&pg=PA147. Retrieved 14 April 2014. 
  13. ↑ Bartley, Elias H. (1899). Manual of Clinical Chemistry. P. Blakiston's Son & Co. p. 53. http://books.google.com/books?id=FqPVAAAAMAAJ&pg=PA53. Retrieved 14 April 2014. 
  14. ↑ Harrower, Henry R. (July 1909). "The Physician's Office Laboratory". Practical Therapeutics 23 (1): 7–10. http://books.google.com/books?id=CxIxAQAAMAAJ&pg=PA7. Retrieved 14 April 2014. 
  15. ↑ Camac, C. N. B.; Cattell, Henry W. (ed.) (1901). "The Clinical Laboratory in Private Practice and in the Physician's Office". International Clinics: A Quarterly of Clinical Lectures. 3. J.B. Lippincott Company. pp. 289–299. http://www.forgottenbooks.org/readbook/International_Clinics_v3_1000133973#329. Retrieved 14 April 2014. 
  16. ↑ 16.0 16.1 16.2 American Medical Association (5 November 1921). "Clinical Laboratory Service for Physicians". Journal of the American Medical Association 77 (19): 1498–1499. http://books.google.com/books?id=dzMKAQAAMAAJ&pg=PA1498. Retrieved 5 April 2014.  Cite error: Invalid <ref> tag; name "TNHJan1921" defined multiple times with different content
  17. ↑ Saint Paul Medical Journal (March 1908). "What We Owe to the Manufacturing Pharmacist and the Commercial Scientific Laboratory". The Physician and Surgeon 30 (3): 130–131. http://books.google.com/books?id=E741AQAAMAAJ&pg=PA442. Retrieved 5 April 2014. 
  18. ↑ The American Society of X-Ray Technicians (September 1952). "Unknown". The X-Ray Technician / Radiologic Technology 24 (3): 251. http://books.google.com/books?id=pMwvAQAAMAAJ. Retrieved 5 April 2014. 
  19. ↑ New York Dept. of Health (1953). "Annual Report of the Dept. of Health of the City of New York". p. 72. http://books.google.com/books?id=-5E4AAAAIAAJ. Retrieved 5 April 2014. 
  20. ↑ "US Code of Federal Regulations, Title 20, Part 405, Subpart M, Sections 1301–1316". Office of the Federal Register. 1 January 1972. http://books.google.com/books?id=W-I5AAAAIAAJ&pg=PA533. Retrieved 14 April 2014. 
  21. ↑ Pettit, Roswell T. (September 1921). "The Diagnostic Hospital of a Small Community". The Modern Hospital 17 (3): 195–199. http://books.google.com/books?id=tcsyAQAAMAAJ&pg=PA196. Retrieved 5 April 2014. 
  22. ↑ Taylor, Holman (ed.) (October 1920). "Advertising Medical Laboratories (Encore)". Texas State Journal of Medicine 16 (6): 229–230. http://books.google.com/books?id=LbEDAAAAYAAJ&pg=PA229. Retrieved 5 April 2014. 
  23. ↑ Sondern, Frederic E. (ed.) (October 1921). "Commercial Laboratories". New York State Journal of Medicine 21 (10): 390. http://books.google.com/books?id=j7hYAAAAYAAJ&pg=PA390. Retrieved 5 April 2014. 
  24. ↑ 24.0 24.1 White, Courtland Y. (August 1922). "The Role of the Nonmedical Graduate in the Medical Laboratory". Kentucky Medical Journal 25 (11): 755–760. http://books.google.com/books?id=OTMTAAAAYAAJ&pg=PA755. Retrieved 5 April 2014. 
  25. ↑ Sundelof, E. M. (30 March 1922). "The Business Side of X-ray Diagnosis and Treatment". The Boston Medical and Surgical Journal 186 (13): 442–444. http://books.google.com/books?id=E741AQAAMAAJ&pg=PA442. Retrieved 5 April 2014. 
  26. ↑ Jones, Vernon R. (December 1922). "The County and Community Diagnostic Laboratory". Kentucky Medical Journal 20 (12): 836–841. http://books.google.com/books?id=WOcvAQAAMAAJ&pg=PA839. Retrieved 5 April 2014. 
  27. ↑ Sears, Victor H. (January 1921). "Need and Means of Educating Laboratory Assistants". The Journal of the National Dental Association 8 (1): 65–68. http://books.google.com/books?id=vcoyAQAAMAAJ&pg=PA68. Retrieved 5 April 2014. 
  28. ↑ National Academy of Sciences, National Research Council - Canada (1955). Scientific and Technical Societies of the United States and Canada. National Academies. pp. 100–101. http://books.google.com/books?id=3lIZAAAAYAAJ&pg=PA100. Retrieved 9 April 2014. 
  29. ↑ Kotlarz, V. R. (January–February 1998). "Tracing our roots: origins of clinical laboratory science". Clinical Laboratory Science 11 (1): 5–7. PMID 10177215. http://www.ncbi.nlm.nih.gov/pubmed/10177215. Retrieved 10 April 2014. 
  30. ↑ Haagensen, Cushman Davis; Lloyd, Wyndham Edward Buckley (1943). "Chapter 37: The Doctors' Dilemma". A Hundred Years of Medicine. Beard Books. pp. 375–412. ISBN 9781587980879. http://books.google.com/books?id=c_wze-n-y2oC&pg=PA375. Retrieved 9 April 2014. 
  31. ↑ Bernard, Claude (1957). "Part Two, Chapter X: The Physiologist's Laboratory and Various Methods Necessary to the Study of Experimental Medicine". An Introduction to the Study of Experimental Medicine. Courier Dover Publications. pp. 140–150. ISBN 9780486204000. http://books.google.com/books?id=MIx8D61JlboC&pg=PA140. Retrieved 9 April 2014. 
  32. ↑ Street, Charlotte (21 October 1957). "Should your child be a Medical Technologist?". LIFE 43 (17): 60–61. http://books.google.com/books?id=QFYEAAAAMBAJ&pg=PA60. Retrieved 9 April 2014. 
  33. ↑ Lavington, R. J. (23 January 1958). "A Guide to Careers: No. 61 - Medical laboratory technology". The New Scientist 3 (62): 37. http://books.google.com/books?id=AIAjKi5RaBQC&pg=PA37. Retrieved 9 April 2014. 
  34. ↑ "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. 
  35. ↑ Lieseke, Constance L.; Zeibig, Elizabeth A. (2012). Essentials Of Medical Laboratory Practice. F. A. Davis. p. 29. ISBN 9780803630352. http://books.google.com/books?id=IX_2AAAAQBAJ&pg=PA29. Retrieved 10 April 2014. 
  36. ↑ Peddecord, K. Michael; Hammond, Herbert C. (December 1990). "Clinical Laboratory Regulation under the Clinical Laboratory Improvement Amendments of 1988: Can It Be Done?" (PDF). Clinical Chemistry 36 (12): 2027–2035. PMID 2253342. http://www.clinchem.org/content/36/12/2027.full.pdf. Retrieved 10 April 2014. 
  37. ↑ National Center for Health Statistics (1965). Health Resources Statistics. U.S. Dept. of Health, Education, and Welfare; Public Health Service. p. 38. http://babel.hathitrust.org/cgi/pt?id=mdp.39015068164634;view=1up;seq=44. Retrieved 14 April 2014. 
  38. ↑ Chemical & Engineering News (15 July 1963). "The Chemist in the Clinical Lab". Chemical & Engineering News 41 (28): 102–118. doi:10.1021/cen-v041n028.p102. http://pubs.acs.org/doi/abs/10.1021/cen-v041n028.p102. 
  39. ↑ 39.0 39.1 National Center for Health Statistics (1976–77). Health Resources Statistics. U.S. Dept. of Health, Education, and Welfare; Public Health Service. p. 49; 359–361. http://babel.hathitrust.org/cgi/pt?id=mdp.39015068164634;view=1up;seq=44. Retrieved 14 April 2014. 
  40. ↑ 40.0 40.1 Gallivan, Mary (16 October 1985). "Physician offices invade clinical laboratory market". Hospitals 59 (20): 84, 89, 92–4. PMID 3899902. http://www.ncbi.nlm.nih.gov/pubmed/3899902. Retrieved 4 April 2014. 
  41. ↑ Cumins, L. (September 1984). "The In-Office Laboratory: Benefits for You and Your Patients". Computers in Healthcare 5 (9): 60–2. PMID 10267706. http://www.ncbi.nlm.nih.gov/pubmed/10267706. Retrieved 4 April 2014. 
  42. ↑ 42.0 42.1 Wilkinson, Richard (20 April 1987). "Are physician labs a competitive threat?". Hospitals 61 (8): 96, 98. PMID 3557409. http://www.ncbi.nlm.nih.gov/pubmed/3557409. Retrieved 4 April 2014. 
  43. ↑ "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. 
  44. ↑ "Regulations for Implementing the Clinical Laboratory Improvement Amendments of 1988: A Summary". Morbidity and Mortality Weekly Report 41 (RR-2): 1–17. 28 February 1992. PMID 1538689. http://www.cdc.gov/mmwr/preview/mmwrhtml/00016177.htm. Retrieved 24 March 2014. 
  45. ↑ Roberts, Rebecca; Valiant, Carrie (May–June 1992). "1992 brings significant regulation for physician office laboratories". Physician Executive 18 (3): 60. http://www.thefreelibrary.com/1992+brings+significant+regulation+for+physician+office+laboratories.-a012224764. Retrieved 4 April 2014. 
  46. ↑ Markle, George B. (8 March 1993). "Dear HCFA: don't handcuff us with these lab regs". Medical Economics 70 (5): 151. http://business.highbeam.com/62468/article-1G1-13564202/dear-hcfa-dont-handcuff-us-these-lab-regs. Retrieved 4 April 2014. 
  47. ↑ Carpi, John (15 July 1993). "AMA battle cry: get off our backs; in a broadside swipe at federal legislation, angry delegates reject CLIA, databank". Medical World News 34 (7): 28. http://trove.nla.gov.au/work/42776413?q=Off+our+backs&c=picture&versionId=55658033. Retrieved 4 April 2014. 
  48. ↑ 48.0 48.1 "Medicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications; Final Rule". Federal Register 68 (16): 3639–3714. 24 January 2003. PMID 12545998. http://www.gpo.gov/fdsys/pkg/FR-2003-01-24/html/03-1230.htm. Retrieved 24 March 2014. 
  49. ↑ Walpert, Bryan (February 2000). "How an office lab can help patients—and your income". ACP Internist. American College of Physicians. http://www.acpinternist.org/archives/2000/02/officelab.htm. Retrieved 4 April 2014. 
  50. ↑ Dolan, Thomas (June 2003). "What lies in wait for office labs?". CAP Today. College of American Pathologists. http://www.cap.org/apps/portlets/contentViewer/show.do?printFriendly=true&contentReference=cap_today%2Ffeature_stories%2Foffice_labs.html. Retrieved 14 April 2014. 
  51. ↑ "Healthcare Cost Worries Boost Physician Office Lab Market". Thomson Reuters. 10 February 2011. http://www.reuters.com/article/2011/02/10/idUS249575+10-Feb-2011+MW20110210. Retrieved 3 April 2014. 
  52. ↑ "Laboratories by Type of Facility" (PDF). Centers for Medicare and Medicaid Services. December 2013. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf. Retrieved 3 April 2014. 
  53. ↑ Carlson, Bruce (1 December 2010). "Physician Office Lab Diagnostic Market". GEN. Genetic Engineering & Biotechnology News. http://www.genengnews.com/gen-articles/physician-office-lab-diagnostic-market/3493/. Retrieved 3 April 2014. 
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