Accreditation is a procedure by which an authoritative body gives formal recognition that an organization is competent to carry out specific tasks according to certain standards. Accreditation of pathology laboratories according to ISO 15189 is now becoming more and more a matter of course in continental Europe. This review describes some practical experience aspects with our own pathology laboratory accreditation according to ISO 15189, and outlines the advantages, addresses critical points, and discusses certain caveats of this process.

1.
The College Accreditation Steering Committee: Royal College of Pathologists' United Kingdom pilot study of laboratory accreditation. J Clin Pathol 1990;43:89-91.
2.
Anonymous: Pathology Department accreditation in the United Kingdom: a synopsis. Advisory Task Force on Standards to the Audit Steering Committee of the Royal College of Pathologists. J Clin Pathol 1991;44:798-802.
3.
Burnett D, Blair C, Haeney MR, et al: Clinical pathology accreditation: standards for the medical laboratory. J Clin Pathol 2002;55:729-733.
4.
Abu-Amero KK: Overview of the laboratory accreditation programme of the College of American Pathologists. East Mediterr Health J 2002;8:654-663.
5.
Allen TC: Quality: walk the walk. Arch Pathol Lab Med 2001;135:1384-1386.
6.
Gough LA, Reynolds TM: Is clinical pathology accreditation worth it? A survey of CPA-accredited laboratories. Clin Perform Qual Health Care 2000;8:195-201.
7.
Peter TF, Rotz PD, Blair DH, et al: Impact of laboratory accreditation on patient care and the health system. Am J Clin Pathol 2010;134:550-555.
8.
Schuerch C, Selna M, Jones J: Laboratory clinical effectiveness: pathologists improving clinical outcomes. Clin Lab Med 2008;28:223-244.
9.
Pennington GW: Accreditation of clinical pathology laboratories in the United Kingdom: the story so far. J Clin Pathol 1991;44:615.
11.
Washetine K, Long E, Hofman V, et al: The accreditation of a surgical pathology and somatic genetic laboratory (LPCE, CHU of Nice) according to the ISO 15189 norm: sharing of experience. Ann Pathol 2013;33:386-397.
12.
Röcken C, Manke H: Accreditation in pathology. Systematic presentation and documentation of activities in pathology. Pathologe 2010;31:268-278.
13.
Manke H, Röcken C: Accreditation in pathology. Pathologe 2008;29:388-398.
14.
Long-Mira E, Washetine K, Hofman P: Sense and nonsense in the process of accreditation of a pathology laboratory. Virchows Arch 2016;468:43-49.
15.
Epstein JI, Zelefsky MJ, Sjoberg DD, et al: A contemporary prostate cancer grading system: a validated alternative to the Gleason Score. Eur Urol 2016;69:428-435.
21.
Luna, LG: Manual of Histologic Staining Methods of the Armed Forces Institute of Pathology, ed 3. New York, Blakiston Division, McGraw-Hill, 1968.
22.
Menter T, Bachmann M, Tzankov A: A more accurate approach to amyloid detection and subtyping: combining in situ Congo red staining and immunohistochemistry. Pathobiology 2017;84:49-55.
23.
Hofman V, Ilie M, Gavric-Tanga V, et al: Role of the surgical pathology laboratory in the pre-analytical approach of molecular biology techniques. Ann Pathol 2010;30:85-93.
24.
Srinivasan M, Sedmak D, Jewell S: Effect of fixatives and tissue processing on the content and integrity of nucleic acids. Am J Pathol 2002;161:1961-1971.
25.
Wood WG: The preanalytical phase - can the requirements of the DIN-EN-ISO 15189 be met practically for all laboratories? A view of the ‘German situation'. Clin Lab 2005;51:665-671.
26.
Vacata V, Jahns-Streubel G, Baldus M, Wood WG: Practical solution for control of the pre-analytical phase in decentralized clinical laboratories for meeting the requirements of the medical laboratory accreditation standard DIN EN ISO 15189. Clin Lab 2007;53:211-215.
27.
Bogina G, Zamboni G, Sapino A, et al: Comparison of anti-estrogen receptor antibodies SP1, 6F11, and 1D5 in breast cancer: lower 1D5 sensitivity but questionable clinical implications. Am J Clin Pathol 2012;138:697-702.
28.
Zarbo RJ, Gephardt GN, Howanitz PJ: Intralaboratory timeliness of surgical pathology reports. Results of two College of American Pathologists Q-probes studies of biopsies and complex specimens. Arch Pathol Lab Med 1996;120:234-244.
29.
Landercasper J, Linebarger JH, Ellis RL, et al: A quality review of the timeliness of breast cancer diagnosis and treatment in an integrated breast center. J Am Coll Surg 2010;210:449-455.
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