A reference laboratory can be defined in many different ways; however, there are two broad senses to the term:
- a laboratory that performs reference or calibration measurement procedures or assigns reference values to test objects, later potentially providing those associated reference values for references or sources of traceability of test results; alternate names include: reference measurement, reference testing, and calibration laboratory
- a laboratory — typically privately-owned — that performs quality and cost-effective high-volume and esoteric testing of biological samples for physicians, hospitals, and other laboratories; alternate names include: referral, diagnostic, or commercial testing laboratory
Reference measurement and calibration
The idea of a laboratory dedicated to performing reference measurements for the benefit of the general public apparently had been conceived and implemented in Germany before the beginning of the twentieth century; however, as of 1902, few if any of this laboratory type existed in the United States and other parts of the world. Researcher Richard L. Humphrey, writing on cement testing in municipal laboratories in 1902, stated:
At the present time only a few of the better equipped municipal laboratories compile and publish in a systematic manner the results of their tests. These tests serve as a guide to aid the engineer, the architect, or the builder (who possess no facilities for making tests of this character), in selecting the best and most suitable material for their work. As these results are obtained under different conditions they are not related and there seems to be no basis for a comparison. Without a knowledge of the methods in vogue and the personal equation of the engineer in charge, it is impossible to form any idea of the relative quality of two cements, where one is tested in one laboratory and the other in another. There is therefore a most urgent need for a central or reference laboratory, conducted under impartial conditions, at the service of the general public, where fixed standards can be maintained and to which all materials of construction can be referred in case of dispute between the producer and consumer or for purposes of general information as to its properties.
Several foreign laboratories, notably that at Charlottenburg, Germany, are conducted on these lines under government direction and are of immeasurable value. There is no government laboratory of this character in this country at the present time, Most manufacturers and many engineers will no doubt agree that there is a growing need for the same. Such a laboratory could establish standards of excellence and could conduct its tests in such a manner that the published results would be related and be of general use.
Today numerous laboratories offer the reference measurement services requested by Humphrey and more, including:
- creation of reference materials for instrument calibration.
- aid with measurement or metrological traceability, the "property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty."
- creation and/or promotion of measurement standards.
- assistance with other labs' quality control.
An example of a reference lab as quality control: a reference measurement laboratory could provide reference samples "with a known but undisclosed value" to a recipient lab, which would then test those samples and give the results to the reference measurement lab, which would compare the recipient lab's results with the reference lab's original undisclosed value. Alternatively, the reference measurement lab could collect multiple samples from a participating lab, test those samples, and then compare the results with those from the participating lab. Either way, if the results don't match within a certain agreed percentage, further action can be taken to trace the cause of the differentiation.
Accreditation of these reference measurement and calibration labs is largely governed by the ISO 15195 and ISO 17025 standards.
Referral and diagnostic
The idea of a reference laboratory as an independent referral or diagnostic facility that handles many samples and a wide variety of tests is likely a more recent phenomena. Hospitals and physicians will often turn to an external reference or diagnostic laboratory to handle complex or rarely-utilized tests, as these types of labs have intentionally invested in the machinery and personnel to conduct them. These facilities often produce a more cost-effective and time-efficient accessioning process as opposed to doing it in-house. Additionally, some perfectly functional labs that already perform tests for a hospital or physician may be confronted with an ordered test which the laboratory is not suited to handle. This may then result in contracting a secondary reference lab to perform the test, though such activity may result in the problematic situation of dealing with who's responsible for the billing of the test and reporting of the results.
In most cases, specimens are shipped via courier to the reference or diagnostic laboratory for processing, though in rare cases patients may be directed to go to the lab themselves for sample collection and/or drop-off. The specimens are then accessioned and processed, and the results of the tested specimen(s) are processed and reported via an electronic transfer back to the ordering entity.
- Czichos, Horst ; Saito, Tetsuya; Smith, Leslie R., ed. (2006). "2. Measurement Strategy and Quality". Springer Handbook of Materials Measurement Methods. Springer. p. 17–92. ISBN 3540303006. http://books.google.com/books?id=8lANaR-Pqi4C&pg=PA17.
- Siekmann, Lothar (November 2007). "Requirements for Reference (Calibration) Laboratories in Laboratory Medicine" (PDF). The Clinical Biochemist Reviews 28 (4): 149–154. PMC PMC2282407. http://www.ifcc.org/media/147899/LS%20Clin%20Biochem%20Rev%202007_28_149-154.pdf.
- Esteridge, Barbara H.; Reynolds, Anna P.; Walters, Norma J. (2000). "1-1 The Medical Laboratory". Basic Medical Laboratory Techniques (4th, revised ed.). Cengage Learning. p. 3–11. ISBN 0766812065. http://books.google.com/books?id=qMgAbOHSlsMC&pg=PA3.
- ↑ 1.0 1.1 Czichos, Horst ; Saito, Tetsuya; Smith, Leslie R., ed. (2006). Springer Handbook of Materials Measurement Methods. Springer. p. 83–84. ISBN 3540303006. http://books.google.com/books?id=8lANaR-Pqi4C&pg=PA83. Retrieved 02 May 2013.
- ↑ 2.0 2.1 2.2 Siekmann, Lothar (November 2007). "Requirements for Reference (Calibration) Laboratories in Laboratory Medicine" (PDF). The Clinical Biochemist Reviews 28 (4): 149–154. PMC PMC2282407. http://www.ifcc.org/media/147899/LS%20Clin%20Biochem%20Rev%202007_28_149-154.pdf. Retrieved 02 May 2013.
- ↑ 3.0 3.1 "ISO 15195:2003 - Laboratory medicine -- Requirements for reference measurement laboratories". International Organization for Standardization. 2003. http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=38363. Retrieved 02 May 2013.
- ↑ 4.0 4.1 Proceedings of the Fifth Annual Meeting, Volume II. American Society for Testing Materials. 1902. p. 158–159. http://books.google.com/books?id=9J-2AAAAIAAJ&pg=PA159. Retrieved 02 May 2013.
- ↑ 5.0 5.1 Barnes, Jeff; O'Hanlon, Barbara; Feeley III, Frank; McKeon, Kimberly; Gitonga, Nelson; Decker, Caytie (2010). Private Health Sector Assessment in Kenya. The World Bank. p. 97. ISBN 0821383639. http://books.google.com/books?id=Xd3rQeEGytIC&pg=PA97. Retrieved 02 May 2013.
- ↑ 6.0 6.1 6.2 Raghu, B. (2003). Practical Biochemistry for Medical Students. Jaypee Brothers Publishers. p. 23. ISBN 818061106X. http://books.google.com/books?id=-bdRvKaEIFYC&pg=PA23. Retrieved 02 May 2013.
- ↑ 7.0 7.1 7.2 Jones, Steven L., ed. (2001). Clinical Laboratory Pearls. Lippincott Williams & Wilkins. p. 569. ISBN 0781725798. http://books.google.com/books?id=3L3Az0yIPF0C&pg=PA569. Retrieved 02 May 2013.
- ↑ 8.0 8.1 Esteridge, Barbara H.; Reynolds, Anna P.; Walters, Norma J. (2000). Basic Medical Laboratory Techniques (4th, revised ed.). Cengage Learning. p. 4. ISBN 0766812065. http://books.google.com/books?id=qMgAbOHSlsMC&pg=PA4. Retrieved 02 May 2013.
- ↑ 9.0 9.1 Vaden, Shelly L.; Knoll, Joyce S.; Smith, Jr., Francis W. K.; Tilley, Larry P., ed. (2011). Blackwell's Five-Minute Veterinary Consult: Laboratory Tests and Diagnostic Procedures - Canine and Feline (5th ed.). John Wiley & Sons. p. XXVII–XXXI. ISBN 0470961031. http://books.google.com/books?id=htie9uqN19wC&pg=PR28. Retrieved 02 May 2013.
- ↑ Wolman, Dianne Miller; Kalfoglou, Andrea L.; LeRoy, Lauren (2000). Medicare Laboratory Payment Policy: Now and in the Future. National Academies Press. p. 171. ISBN 0309183618. http://books.google.com/books?id=Wib8r9PuEx4C&pg=PA171. Retrieved 02 May 2013.
- ↑ 11.0 11.1 Runge, Dawn; Smith, Michele A. (2005). Lab Billing And Coding: Effective Strategies for Compliance. HC Pro, Inc. p. 160–162. ISBN 157839676X. http://books.google.com/books?id=ET9rAt5By3MC&pg=PA160. Retrieved 02 May 2013.
- ↑ 12.0 12.1 Doolin, Peter J. (2007). Medical Assisting Made Incredibly Easy: Lab Competencies. Lippincott Williams & Wilkins. p. 3. ISBN 0781763479. http://books.google.com/books?id=ryfLQUvF_iQC&pg=PT16. Retrieved 02 May 2013.
- ↑ "International vocabulary of metrology – Basic and general concepts and associated terms (VIM), 3rd Edition". Joint Committee for Guides in Metrology. 2012. p. 29. http://www.bipm.org/en/publications/guides/vim.html. Retrieved 02 May 2013.