American National Standards Institute. Specifications and guidelines for quality systems for environmental data collection and environmental technology programs; ANSI/ASQC E-4. Milwaukee (WI): American Society for Quality; 2004. Google Scholar

ASTM D5172-91 (2015). Standard guide for documenting the standard operating procedures used for the analysis of water. West Conshohocken (PA): ASTM International; 2015. Google Scholar

ASTM D5847-02 (2020). Standard practice for writing quality control specifications for standard test methods for water analysis. West Conshohocken (PA): ASTM International; 2020. Google Scholar

ASTM D3856-11. Standard guide for management systems in laboratories engaged in analysis of water. West Conshohocken (PA): ASTM International; 2011. Google Scholar

Briggs R. Chapter 9: Analytical quality assurance. In: Bartram J, Ballance R, Eds., Water quality—A practical guide to the design and implementation of freshwater quality studies and monitoring programmes. Geneva (Switzerland): World Health Organization; 1996. Google Scholar

Garfield FM, Klestra E, Hirsch J. Quality assurance principles of analytical laboratories, 3rd Ed. Gaithersburg (MD): AOAC International; 2000. Google Scholar

ISO 9001:2008. Quality management systems—Requirements. Geneva (Switzerland): International Organization for Standardization; 2008. Google Scholar

ISO 14001:2005. Environmental management systems—Specification with guidance for use. Geneva (Switzerland): International Organization for Standardization; 2005. Google Scholar

ISO/IEC 17025. General requirements for the competence of testing and calibration laboratories. Geneva (Switzerland): International Organization for Standardization; 2005. Google Scholar

The NELAC Institute. 2022. [Accessed 2022 June]. http://www.nelac-institute.org/ Google Scholar

Ratliff TA Jr. The laboratory quality assurance system: A manual of quality procedures with related forms, 3rd Ed. Hoboken (NJ): Wiley; 2003. Google Scholar

R101—General requirements for accreditation of ISO/IEC 17025 laboratories. Frederick (MD): American Association for Laboratory Accreditation; 2011. Google Scholar

Root P, Hunt M, Kjeld K, Kundrat L. Microbiological water methods: QC measures for Federal Clean Water Act and Safe Drinking Water Act regulatory compliance. J AOAC Int. 2014;97(2):567–572. Google Scholar

Smith DL, Bolyard ML, Eller PM. Chapter C. Quality assurance. In: Schlecht PC, O’Conner PC, Eds. NIOSH manual of analytical methods, 4th Ed.; 1998. [accessed 2022 June]. http://www.cdc.gov/niosh/docs/2003-154/ Google Scholar

Storey A, Briggs R, Jones H, Russell R. Chapter 4: Quality assurance. In: Bartram J, Rees G, Eds., Monitoring bathing waters: A practical guide to the design and implementation of assessments and monitoring programmes, 3rd Ed. Geneva (Switzerland): World Health Organization; 2000. Google Scholar

Sutton S. Pharmaceutical quality control microbiology: A guidebook to the basics. River Grove (IL): Davis Healthcare International Publishing, LLC; 2007. Google Scholar

U.S. Environmental Protection Agency. Guidelines establishing test procedures for the analysis of pollutants under the Clean Water Act; analysis and sampling procedures. Final rule. 2012. Fed Reg. 77:29758. Google Scholar

U.S. Environmental Protection Agency. Guidance for preparing standard operating procedures (SOPs); QA/G-6. Washington (DC): U.S. Environmental Protection Agency; 2001. Google Scholar

1. Bordner RH, Winter JA, Scarpino PV, Eds. Microbiological methods for monitoring the environment, water and wastes; EPA-600/8-78-017. Cincinnati (OH): Environmental Monitoring and Support Laboratory, U.S. Environmental Protection Agency; 1978. Google Scholar

2. Miller JM. Quality control in microbiology. Atlanta (GA): Centers for Disease Control and Prevention, U.S. Department of Health and Human Services; 1987. Google Scholar

3. Hewitt W, Vincent S. Theory and application of microbiological assay. London (UK): Academic Press; 1989. Google Scholar

4. Parenteral Drug Association. Fundamentals of an environmental monitoring program; Technical Report No. 13 (Revised); 2014 [accessed 2021 May 28]. https://store.pda.org/TableOfContents/TR13_TOC.pdf Google Scholar

5. Lightfoot NF, Maier EA, Eds. Microbiological analysis of food and water: Guidelines for quality assurance. Amsterdam (Netherlands): Elsevier; 1998. Google Scholar

6. ASTM D3856. Standard guide for good laboratory practices in laboratories engaged in sampling and analysis of water. In: Annual book of ASTM standards, Vol. 11.01. West Conshohocken (PA): ASTM International; 2006. Google Scholar

7. U.S. Department of Defense. Consolidated quality systems manual (QSM) for environmental laboratories, Version 5.1. Department of Navy; 2017. Google Scholar

8. Federal Bureau of Investigation. Quality assurance guidelines for laboratories performing forensic analysis of chemical terrorism. Forensic Sci Commun. 2004;6(2);1–14. Google Scholar

9. U.S. Environmental Protection Agency. Quality assurance/quality control guidance for laboratories performing PCR analyses on environmental samples; EPA 815-B-04-001. Cincinnati (OH): U.S. Environmental Protection Agency; 2004. Google Scholar

10. Sutton S, Singer D. Microbiological best laboratory practices, USP <1117>: Value and recent changes to a guidance of quality laboratory practices. Amer Pharmaceutical Review. 2011;14(4):41–47. Google Scholar

11. Centers for Disease Control and Prevention. Biosafety in microbiological and biomedical laboratories (BMBL), 5th Ed. 2009 [accessed 2022 May]. http://www.cdc.gov/biosafety/publications/bmbl5/ Google Scholar

12. Reich RR, Miller MJ, Patterson H. Developing a viable environmental monitoring program for nonsterile pharmaceutical operations. Pharm Tech. 2003;27:92–100. Google Scholar

13. ASTM E2877-12(2019). Standard guide for digital contact thermometers. West Conshohocken (PA): ASTM International; 2019. Google Scholar

14. ASTM E319-85(2014). Standard practice for evaluation of single-pan mechanical balances. West Conshohocken (PA): ASTM International; 2014. Google Scholar

15. ASTM E898-88(2013). Standard methods of testing top-loading, direct-reading laboratory scales and balances. West Conshohocken (PA): ASTM International; 2013. Google Scholar

16. ASTM E617-18. Standard specifications for laboratory weights and precision mass standards. West Conshohocken (PA): ASTM International; 2018. Google Scholar

17. ASTM D1193-06(2018). Standard specification for reagent water. In: Annual book of ASTM standards, Vol. 11.01, West Conshohocken (PA): ASTM International; 2018. Google Scholar

18. U.S. Environmental Protection Agency. Manual for the certification of laboratories analyzing drinking water, 5th Ed.; EPA-815-R-05-004. Cincinnati (OH): U.S. Environmental Protection Agency; 2005. Google Scholar

19. International Organization for Standardization. Sterilization of health care products—Biological indicators part 3: Biological indicators for moist heat sterilization; ISO 11138-3:2006 (R) 2010. Geneva, Switzerland: International Organization for Standardization; 2010. Google Scholar

20. Schmitz S, Garbe C, Tebbe B, Orfanos C. Long-wave ultraviolet radiation (UVA) and skin cancer. Hautarzt. 1994;45(8):517–525. Google Scholar

21. Fleming DO, Hunt DH, Eds. Biological safety: Principles and practices, 4th ed. Washington (DC): ASM Press, American Society for Microbiology; 2006. Google Scholar

22. U.S. Environmental Protection Agency. Supplement 2 to the fifth edition of the manual for the certification of laboratories analyzing drinking water; EPA-815-F-12-006. Cincinnati (OH): U.S. Environmental Protection Agency; 2008. Google Scholar

23. ASTM E542-01(2021). Standard practice for calibration of laboratory volumetric apparatus. West Conshohocken (PA): ASTM International; 2021. Google Scholar

24. Geldreich EE, Clark HF. Distilled water suitability for microbiological applications. J Milk Food Technol. 1965;28:351–355. Google Scholar

25. American Chemical Society. Reagent chemicals, 10th Ed. New York (NY): Oxford University Press; 2005. Google Scholar

26. Brenner K, Rankin CC. New screening test to determine the acceptability of 0.45-micron membrane filters for analysis of water. Appl Environ Bacteriol. 1990;56(1):54–64. Google Scholar

27. International Organization for Standardization. Water quality, evaluation of membrane filters used for microbiological analyses; ISO 7704. Geneva (Switzerland): International Organization for Standardization; 1985. Google Scholar

28. ASTM D3863-87(2011). Standard test for retention characteristics of 0.4 to 0.45-µm membrane filters used in routine filtration procedures for the evaluation of microbiological water quality. West Conshohocken (PA): ASTM International; 2011. Google Scholar

29. Hanson CW, Martin WJ. Microwave oven for melting laboratory media. J Clin Microbiol. 1978;7(4):401–402. Google Scholar

30. U.S. Environmental Protection Agency. Guidance for preparing standard operating procedures (SOPs); QA/G-6. Washington DC: U.S. Environmental Protection Agency; 2001. Google Scholar

31. ASTM D5172-91(2015). Standard guide for documenting the standard operating procedures used for the analysis of water. West Conshohocken (PA): ASTM International; 2015. Google Scholar

32. ASTM D5847-02 (2020). Standard practice for writing quality control specifications for standard test methods for water analysis. West Conshohocken (PA): ASTM International; 2020. Google Scholar

33. U.S. Environmental Protection Agency. Validation of U.S. environmental protection agency environmental sampling techniques that support the detection and recovery of microorganisms; FEM Doc. No. 2012-11. Cincinnati (OH): U.S. Environmental Protection Agency; 2012. Google Scholar

34. U.S. Environmental Protection Agency. Supplement 1 to the fifth edition of the manual for the certification of laboratories analyzing drinking water; EPA-815-F-08-006. Cincinnati (OH): U.S. Environmental Protection Agency; 2008. Google Scholar

35. Committee on Indicators for Waterborne Pathogens, National Research Council. Chapter 5: New biological measurement opportunities. In: Indicators for waterborne pathogens. Washington (DC): National Academies Press; 2004. Google Scholar

36. Reichgott M. Reference strains: How many passages are too many? ATCC Connection. 2003;23:6–7. Google Scholar

37. EURACHEM/CITAC. Quantifying uncertainty in analytical measurement, 3rd ed. QUAM:2000.1, Guide CG 4, 2012; [accessed 2021 May 28]. http://eurachem.org/index.php/publications/guides/quam Google Scholar

38. Niemela SI. Uncertainty of quantitative determinations derived by cultivation of microorganisms; Pub. J4. Helsinki (Finland): Center for Metrology and Accreditation (MIKES); 2003. Google Scholar

39. Association of Official Analytical Chemists. AOAC International qualitative and quantitative microbiology guidelines for methods validation, microbiology guidelines. J AOAC Int. 1999;82(2):402–416. Google Scholar

40. ISO 13843:2017. Requirements for establishing performance characteristics of quantitative microbiological methods. Geneva (Switzerland): International Organization for Standardization; 2017. Google Scholar

41. ISO 17994:2014. Water quality—Requirements for the comparison of the relative recovery of microorganisms by two quantitative methods. Geneva (Switzerland): International Organization for Standardization; 2014. Google Scholar

42. Feldsine P, Abeyta C, Andrews WH. AOAC International methods committee guidelines for validation of qualitative and quantitative food microbiological official methods of analysis. J AOAC Int. 2002;85(5):1187–1200. Google Scholar

43. Sutton S. Validation of alternative microbiology methods for product testing: Quantitative and qualitative assays. Pharmaceut Technol. 2005;29:118–122. Google Scholar

44. U.S. Pharmacopeial Convention. 1223—Validation of alternative microbiological methods. U.S. Pharmacopeia 29 and National Formulary 24 Suppl. 1:3807; 2006. Google Scholar

45. European Pharmacopeia. 5.1.6 Alternative methods for control of microbial quality. Pharm Europa. 2009;5.5:4131. Google Scholar

46. U.S. Environmental Protection Agency. Method validation of U.S. Environmental Protection Agency microbiological methods of analysis; FEM Doc. No. 2009-1. Cincinnati (OH): U.S. Environmental Protection Agency; 2009. Google Scholar

47. U.S. Environmental Protection Agency. Good automated laboratory practices; EPA 2185. Research Triangle Park (NC): Office of Information Management; 1995. Google Scholar

48. Huber L. A primer—Good laboratory practice and current good manufacturing practice. Waldbronn (Germany): Agilent Technologies Deutschland GmbH; 2000. Google Scholar

49. Huber L. Validation of computerized analytical systems. Buffalo Grove (IL): Interpharm Press, Inc.; 1995. Google Scholar

50. Huber L. Validation and quantification in analytical laboratories, 2nd Ed. New York (NY): Informa Healthcare; 2007. Google Scholar

51. Haas CN. How to average microbial densities to characterize risk. Water Res. 1996;30(4):1036–1038. Google Scholar

52. Ilstrup DM. Statistical methods in microbiology. Clin Microbiol Rev. 1990;3(3):219–226. Google Scholar

53. Halvorson HD, Ziegler NR. Application of statistics to problems in bacteriology. J Bacteriol. 1933;25(2):101–121. Google Scholar

54. Gordon RD. Estimating bacterial populations by the dilution method. Biometrika. 1939;31:167–180. Google Scholar

55. Pearson ES. Note on the inverse and direct methods of estimation. Biometrika. 1939;311:87. Google Scholar

56. Fisher RA. On the mathematical foundations of theoretical statistics. Phil Trans Roy Soc. 1922;222:309–368. Google Scholar

57. Everitt BS. The cambridge dictionary of statistics. Cambridge (UK): Cambridge University Press; 1998, pp. 190. Google Scholar

58. Edwards AWF. Likelihood, 2nd ed. Baltimore (MD): John Hopkins University Press; 1992. Google Scholar

59. Weisstein EW. CRC concise encyclopedia of mathematics, 3rd ed. Boca Raton (FL): Chapman and Hall, CRC Press; 2013. Google Scholar

60. Helsel DR. Non detects and data analysis—Statistics for censored environmental data. Hoboken (NJ): John Wiley & Sons, Inc.; 2005. Google Scholar

61. ISO 5725-1:1994/Cor. 1: 2001. Accuracy of measurement methods and results package; Geneva (Switzerland): International Organization for Standardization; 2001. Google Scholar

1. Eleftheriadou M, Tsimillis KC, eds. Eurachem guide: Accreditation for microbiological laboratories, 2nd ed. [published 2013; accessed 2021 May 28]. https://www.eurachem.org/index.php/publications/guides/microbiol Google Scholar

2. U.S. Environmental Protection Agency. NELAC constitution, bylaws and standards; EPA/600/R-03/049. Washington (DC): U.S. Environmental Protection Agency; 2002. Google Scholar

3. Stein P. Why buy accredited? Qual Progress. 2004;7:94. Google Scholar

4. Manual for the certification of laboratories analyzing drinking water, 5th ed.; EPA-815-R-05-004. Cincinnati (OH): U.S. Environmental Protection Agency; 2005. Google Scholar

5. Supplement 1 to the fifth edition of the manual for the certification of laboratories analyzing drinking water; EPA-815-F-08-006. Cincinnati (OH): U.S. Environmental Protection Agency; 2008. Google Scholar

6. Supplement 2 to the fifth edition of the manual for the certification of laboratories analyzing drinking water; EPA-815-F-12-006. Cincinnati (OH): U.S. Environmental Protection Agency; 2008. Google Scholar