Quality in pathology and clinical medicine is the process of measuring efficiency at all levels of the laboratory test cycle, including pre-analytical, analytic, and post-analytical processes, to facilitate outstanding findings in medical treatment. Quality can develop productivity and production in the laboratory resulting in improved patient care and outcomes. This paper aimed to overview the standards of quality of histopathology laboratory and work facilities in developed countries. Quality evaluation, processing, and monitoring of establishment, procedures, and activities of histopathology laboratory are essential to function effectively and safely. Guaranteeing the safety of operational personnel as well as setting is also highly significant. Quality standards of histopathology laboratory and work facilities are a must and all the standards must be applied to function effectively. A Quality Committee should be established within each histopathology laboratory to ensure routine review of quality data and to initiate improvements where required.
1. Adyanthaya S, Jose M. Quality and safety aspects in histopathology laboratory. J Oral Maxillofac Pathol. 2013;17(3):402-7. doi:10.4103/0973-029X.125207.
2. Kohn LT, Corriga JM, Donaldson MS, editors. Washington (DC): National Academy Press; 1999. To Err is Human: Building a Safer Health System.
3. Iyengar JN. Quality control in the histopathology laboratory: an overview with stress on the need for a structured national external quality assessment scheme. Indian J Pathol Microbiol. 2009;52(1):1-5.
4. ISO 15189. Medical laboratories: particular requirements for quality and competence. Geneva: International Organization for Standardization; 2007.
5. Clinical and Laboratory Standards Institute. A quality management system model for health care: approved guideline, 2nd edition. HS1-A2. Wayne PA: NCCLS; 2004.
6. Laboratory quality management system: handbook. Geneva: World Health Organization; 2005.
7. Fleming KA, Naidoo M, Wilson M, Flanigan J, Horton S, Kuti M, et al. An essential pathology package for low-and middle-income countries. Am J Clin Pathol. 2017;147(1):15-32. doi:10.1093/ajcp/aqw143
8. National Pathology Quality Registry. American Society for Clinical Pathology. Available from: https://www.ascp.org/content/get-involved/institute-of-science-technology-policy/npqr, accessed 18 August 2019.
9. Adyanthaya S, Jose M. Quality and safety aspects in histopathology laboratory. J Oral Maxillofac Pathol. 2013;17(3):402-7. doi:10.4103/0973-029X.125207
10. World Health Organization. Medical equipment maintenance programme overview, 2011.
11. ASQ Statistics Division: Glossary and Tables for Statistical Quality Control, Fourth Edition (e-book) PDF, 200 pages, Published 2004, ISBN: 978-0-87389-631-3, Item Number: E1197
12. Mahrous MS. Agreement and disagreement on health care quality concepts among academic health professionals: the Saudi case. Am J Med Qual. 2014;29(3):247-55. doi:10.1177/1062860613493828
13. Al-Ahmadi H, Roland M. Quality of primary health care in Saudi Arabia: a comprehensive review. Int J Qual Health Care. 2005;17(4):331-46. doi:10.1093/intqhc/mzi046
14. Aljuaid M, Mannan F, Chaudhry Z, Rawaf S, Majeed A. Quality of care in university hospitals in Saudi Arabia: a systematic review. BMJ Open. 2016;6(2):e008988. doi:10.1136/bmjopen-2015-008988
15. Almutairi KM, Moussa M. Systematic review of quality of care in Saudi Arabia. A forecast of a high quality health care. Saudi Med J. 2014;35(8):802-9.
16. Algahtani FD. Healthy Lifestyle among Ha'il University Students, Saudi Arabia. Int J Pharm Res Allied Sci. 2020;9(1):160-7.
17. Hanawi SA, Saat NZ, Zulkafly M, Hazlenah H, Taibukahn NH, Yoganathan D, et al. Impact of a Healthy Lifestyle on the Psychological Well-being of University Students. Int J Pharm Res Allied Sci. 2020;9(2):1-7.
18. Sundus A, Ismail NE, Gnanasan S. Exploration of healthcare practitioner’s perception regarding pharmacist’s role in cancer palliative care, malaysia. Pharmacophores. 2018;9(4):1-7.
19. Shakeri H, Rahmanian V, Shakeri M, Mansoorian E. Study of anti-hbs antibody titer and associated factors among healthcare staff vaccinated against hepatitis B more than ten years in hospitals of Jahrom in 2016. Pharmacophore. 2018;9(1):156-61.
20. Mahrous MS. Key role players in health care quality: who are they and what do they think? An experience from Saudi Arabia. East Mediterr Health J. 2013;19(9):788-93.
21. Joe Mangino. Chapter 8: Quality Assurance and Quality Control. In: Simon Eggelston, Leandro Buendia, Kyoko Miwa, Todd Ngara, Kiyoto Tanabe., editors. IPCC Good Practice Guidance and Uncertainty Management in National Greenhouse Gas Inventories. 1st ed. Geneva (Switzerland): The Institute for Global Environmental Strategies (IGES) for the IPCC; 2006. [Last accessed on 2011 Jun 06]. Available from: http://www.ipcc-nggip.iges.or.jp/public/gp/english/8_QA-QC.pdf.
22. Sergi C, Mikuz G. External quality assurance as a revalidation method for pathologists in pediatric histopathology: Comparison of four international programs. BMC Clin Pathol. 2008;8(1):1-8.
23. Al-Ahmadi H, Roland M. Quality of primary health care in Saudi Arabia: a comprehensive review. Int J Q Health Care. 2005;17(4):331-46. doi:10.1093/intqhc/mzi046
24. Al-Qahtani MF, Al-Medaires MA, Al-Dohailan SK, Al-Sharani HT, Al-Dossary NM, Khuridah EN. Quality of care in accredited and nonaccredited hospitals: Perceptions of nurses in the Eastern Province, Saudi Arabia. J Egypt Public Health Assoc. 2012;87(3 and 4):39-44. doi:10.1097/01.EPX.0000417998.98106.9d
25. Alahmadi HA. Assessment of patient safety culture in Saudi Arabian hospitals. Qual Saf Health Care. 2010;19(5):e17.
26. Okuyama JH, Galvao TF, Silva MT. Healthcare professional’s perception of patient safety measured by the hospital survey on patient safety culture: a systematic review and meta-analysis. Sci World J. 2018;2018. doi:10.1155/2018/9156301
27. Wahabi HA, Alzeidan RA, Fayed AA, Esmaeil SA, Al Aseri ZA. Attitude and practice of the health care professionals towards the clinical practice guidelines in King Khalid University Hospital in Saudi Arabia. J Eval Clin Pract. 2011;17(4):763-7. doi:10.1111/j.1365-2753.2011.01694.x
28. Alshehry AS. Culture of quality in infection prevention of a hospital as perceived by health care workers. J Nurs Manag. 2019;27(6):1131-9. doi:10.1111/jonm.12783
29. Almoajel A. Quality of Palliative Care: Perspective of Healthcare Providers at a Tertiary Hospital in Riyadh, Saudi Arabia. J Relig Health. 2020;59(5):2442-57. doi:10.1007/s10943-020-00998-6
30. Khamis K, Njau B. Health care worker’s perception about the quality of health care at the outpatient department in Mwananyamala Hospital in Dar es Salaam, Tanzania. Tanzan J Health Res. 2016;18(1):122-7. doi:10.4314/thrb.v18i1
31. Krztoń-Królewiecka A, Oleszczyk M, Schäfer WL, Boerma WG, Windak A. Quality of primary health care in Poland from the perspective of the physicians providing it. BMC Fam Pract. 2016;17(1):151. doi:10.1186/s12875-016-0550-8
32. Wei H, Corbett RW, Rose MA, Wei TL. Parents' and healthcare professionals' perceptions of the quality of care: A PITSTOP model of caring. InNursing forum 2019 Oct (Vol. 54, No. 4, pp. 661-668). doi:10.1111/nuf.12391
33. Mohammedsaleh ZM. The role of technical quality control in histology laboratories. J Cytol Histol. 2014;5:264. doi:10.4172/2157-7099.1000264
34. McPherson RA, Pincus MR, eds. Henry's Clinical Diagnosis and Management by Laboratory Methods. 23rd ed. 2017, Philadelphia, PA: Elsevier Health Sciences.
35. Laboratory quality management system: handbook. Geneva: World Health Organization; 2005.
36. Iyengar JN. Quality control in the histopathology laboratory: an overview with stress on the need for a structured national external quality assessment scheme. Indian J Pathol Microbiol. 2009;52(1):1-5.
37. Rauch CA, Nichols JH. Laboratory accreditation and inspection. Clin Lab Med. 2007;27(4):845-58.
38. Gomez J, Frick R, Dietenberger J, Solak K. Systematic management of laboratory supplies. Med Lab Manag. 2013;2(4):2.
39. Jones RG, Johnson OA, Batstone G. Informatics and the clinical laboratory. Clin Biochem Rev. 2014;35(3):177-92.
40. List of priority medical devices for cancer management. Geneva: World Health Organization; 2017.
41. Iyengar JN. Quality control in the histopathology laboratory: an overview with stress on the need for a structured national external quality assessment scheme. Indian J Pathol Microbiol. 2009;52(1):1-5.
42. Wiwanitkit V. Types and frequency of preanalytical mistakes in the first Thai ISO 9002: 1994 certified clinical laboratory, a 6–month monitoring. BMC Clin Pathol. 2001;1(1):1-5.
43. Sharif MA, Mushtaq S, Mamoon N, Jamal S, Luqman M. Clinician's responsibility in pre-analytical quality assurance of histopathology. Pakistan J Med Sci. 2007;23(5):720-3.
44. Nakhleh RE. Lost, mislabeled, and unsuitable surgical pathology specimens. Pathol Case Rev. 2003;8(3):98-102.
45. Culling CF, Allison RT, Barr WT. 4th ed. London: Butterworth pub; 1985. Cellular Pathology Technique.
46. Nakhleh RE, Zarbo RJ. Surgical pathology specimen identification and accessioning: A College of American Pathologists Q-prodes study of 1 004 115 cases from 417 institutions. Arch Pathol Labo Med. 1996;120(3):227-33.
47. Bui MM, Smith P, Agresta SV, Cheong D, Letson GD. Practical issues of intraoperative frozen section diagnosis of bone and soft tissue lesions. Cancer Control. 2008;15(1):7-12.
48. Howanitz PJ, Hoffman GG, Zarbo RJ. The accuracy of frozen-section diagnoses in 34 hospitals. Arch Pathol Lab Med. 1990;114(4):355-9.
49. Nakhleh RE, Gephardt G, Zarbo RJ. Necessity of clinical information in surgical pathology: a College of American Pathologists Q-Probes study of 771 475 surgical pathology cases from 341 institutions. Arch Pathol Lab Med. 1999;123(7):615-9.
50. Rosai J, Ackerman S. Surgical pathology. Eigth edition, Mosby. 1996:1917-2020.
51. Bancroft JD, Cook HC. Edinburgh: Churchill Livingstone; 1994. Manual of Histological Techniques and their Diagnostic Application.
52. Owen DA, Tighe JR. Quality evaluation in histopathology. Br Med J. 1975;1(5950):149.
53. Zuk JA, Kenyon WE, Myskow MW. Audit in histopathology: description of an internal quality assessment scheme with analysis of preliminary results. J Clin Pathol. 1991;44(1):10-6.
54. Hocking GR, Niteckis VN, Cairns BJ, Hayman JA. Departmental audit in surgical anatomical pathology. Pathology. 1997;29(4):418-21.
55. Ramsay AD. Errors in histopathology reporting: detection and avoidance. Histopathology. 1999;34(6):481-90.
56. Berte LM. Laboratory quality management: a roadmap. Clin Lab Med. 2007;27(4):771-90.
57. Stricoff RS, Walters DB. Laboratory Health and safety handbook: A guide for the preparation of a chemical hygiene plan. New York: Wiley; 1990.
58. Ejilemele AA, Ojulu AC. Knowledge, attitude and practice of aspects of laboratory safety in Pathology Laboratories at the University of Port Harcourt Teaching Hospital, Nigeria. Niger J Clin Pract. 2005;8(2):102-6.
59. National Institute for Occupational Safety and Health. NIOSH pocket guide to chemical hazards. DHHS (NIOSH) Publication No. 2005-149; 2005. [Last accessed on 2011 Jul 01]. Available from: www.cdc.gov/niosh/docs/2005-149/pdfs/2005-149.pdf
60. Washington: National Academy Press; 1988. [Last accessed on 2011 Jul 01]. National Research Council. Prudent Practices for Handling Hazardous Chemicals in Laboratories; 233-5. Available from: library.med.utah.edu/WebPath/Histhtml/./Workchem.Pdf.
61. Miller BM. Washington: American Society for Microbiology; 1986. Laboratory Safety: Principles and Practices.Pike RM. Past and present hazards of working with infectious agents. Arch Pathol Lab Med. 1978;102:333-6.
62. Collins CH. London: Butterworths and Co. Ltd; 1983. Laboratory-Acquired Infections. UMHCC Policy 05-01-001.
63. The Environment of Care at UMHCC, Exhibit F, Equipment Management Plan. [Last accessed on 2011 Jul 02]. Available from: http://www.med.umich.edu/i/polices/umh/05-01-001f.html.
64. Ta L, Gosa L, Nathanson DA. Biosafety and Biohazards: Understanding Biosafety Levels and Meeting Safety Requirements of a Biobank. Methods Mol Biol. 2019;1897:213-25. doi:10.1007/978-1-4939-8935-5_19
65. Adyanthaya S, Jose M. Quality and safety aspects in histopathology laboratory. J Oral Maxillofac Pathol. 2013;17(3):402-7. doi:10.4103/0973-029X.125207
66. Steere NV. CRC handbook of laboratory safety. 2nd ed. Boca Raton: CRC Press Inc. 1971.