Reproductive laboratory regulations, certifications and reporting systems

Reproductive Endocrinology and Infertility: Integrating Modern Clinical and Laboratory Practice

Volumn , Issue , 2010, Pages 55-70

  Keel, Brooks A ^a   Schalue, Tammie K ^b  

^a LOUISIANA STATE UNIVERSITY   (United States)

^b Birenbaum and Associates   (United States)

Author keywords

Andrology laboratory; Assisted Reproductive Technology Laboratory; Data registry systems; Embryology laboratory; Laboratory accreditation; Personnel certification

Indexed keywords

EID: 84862870821     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1007/978-1-4419-1436-1_5     Document Type: Chapter

References (89)

1. Keel B, Schalue T (2004) Accreditation of the ART laboratory: the North American perspective. In: Gardner D et al (eds) Textbook of assisted reproductive techniques. Laboratory and clinical perspectives. Martin Dunitz, Ltd, London, pp 41-50
2. Keel B, Schalue T (2001) Accreditation of the ART laboratory: the North American perspective. In: Gardner D et al (eds) Textbook of assisted reproductive techniques. Laboratory and clinical perspectives. Martin Dunitz, Ltd, London, pp 35-45
3. United States Food and Drug Administration. 2008 (cited 2008 March 19); Available from: http://www.fda.gov/
4. Code of Federal Register (1992) Clinical laboratory improvement amendments of 1988: final rule. Fed Regist 57:7002
5. Code of Federal Register (2003) Medicare, Medicaid, and CLIA programs; laboratory requirements relating to quality systems and certain personnel qualifications. Final rule. Fed Regist 68: 3639-3714
6. PL. 102-493 (1992) The fertility clinic success rate and certification act of 1992. 102nd Congress, Second Session
7. Food and Drug Administration. Human cells, tissues, and cellular and tissue-based products. 2008 (cited 2008 March 20); Available from: http://www.access.gpo.gov/nara/cfr/waisidx-07/21cfr1271-07.html
8. Keel B (1998) The assisted reproductive technology laboratories and regulatory agencies. In: May J (ed) Infertility and reproductive medicine clinics of North America. W.B. Saunders Co, Philadelphia, pp 311-330
9. Keel B (2000) Clinical laboratory improvement amendments of 1988 (CLIA'88): a review. In: Keel B, May J, DeJong C (eds) Handbook of the assisted reproduction laboratory. CRC Press, Boca Raton, FL, pp 327-357
10. Keel B (2000) The physician-laboratory relationship. In: Keel B, May J, DeJong C (eds) Handbook of the assisted reproduction laboratory. CRC Press, Boca Raton, FL, pp 359-366
11. Centers for Disease Control and Prevention. 2008 (cited 2008 March 19); Available from: http://www.cdc.gov/
12. Centers for Medicare and Medicaid Services. 2008 (cited 2008 March 19); Available from: http://www.cms.hhs.gov/
13. College of American Pathology (1992) CLIA'88 final rules: a summary of major provisions of the final rules implementing the clinical laboratory improvement amendments of 1998. The College of American Pathologists, Northfield, IL
14. Stull TM, Hearn TI, Hancock JS, Handsfield JH, Collins CL (1998) Variation in proficiency testing performance by testing site. JAMA 279:462-467
15. American Association of Bioanalysts. 2008 (cited 2008 March 19); Available from: http://www.aab.org/
16. College of American Pathologists. 2008 (cited 2008 March 19); Available from: http://www.cap.org/apps/cap.portal
17. Quinn P, Keel B, Serafy NTJ, Serafy NTS, Schmidt CF, Hortsman FC (1998) Results of the American Association of Bioanalysts (AAB) embryology proficiency testing (PT) program. Proceedings of the 55th Annual Meeting of the American Society for Reproductive Medicine, S100
18. Keel B, Quinn P, Schmidt CF, Serafy NTJ, Serafy NTS, Schalue T (2000) Results of the American association of bioanalysts national proficiency testing programme in andrology. Hum Reprod 15: 680-686
19. Keel B (2004) How reliable are results from the semen analysis? Fertil Steril 82:41-44
20. Keel B, Stembridge T, Pineda G, Serafy NTS (2002) Lack of standardization in performance of the semen analysis among laboratories in the United States. Fertil Steril 78:603-608
21. Tomlinson M, Barratt C (2000) Internal and external control in the andrology laboratory. In Keel B, DeJong C, May J (eds) Handbook of the assisted reproduction laboratory. CRC Press, Boca Raton, FL, p 269
22. Keel B (2002) Quality control, quality assurance, and proficiency testing in the andrology laboratory. Arch Androl 48:417-431
23. Johnson C, Kellum T, Boldt J et al (2000) Quality assurance in the embryology, andrology and endocrine laboratories. In Keel B, DeJong C, May J (eds) Handbook of the assisted reproduction laboratory. CRC Press, Boca Raton, FL, p 279
24. Go K (2000) Quality control: a framework for the ART laboratory. In: Keel B, DeJong C, May J (eds) Handbook of the assisted reproduction laboratory. CRC Press, Boca Raton, FL, pp 253-268
25. Centers for Medicare and Medicaid Services. Clinical Laboratory Improvement Amendments (CLIA) Laboratory Director Responsibilities. 2006 (cited 2008 March 20); Available from: http://www.cms.hhs.gov/CLIA/downloads/brochure7. pdf
26. United States Department of Health and Human Services. 2008 (cited 2008 March 19); Available from: http://www.hhs.gov/
27. Commission on Office Laboratory Accreditation. 2008 (cited 2008 March 19); Available from: http://www.cola.org/
28. The Joint Commission. 2008 (cited 2008 March 19); Available from: http://www.jointcommission.org/
29. Visscher R (1991) Partners in pursuit of excellence: development of an embryo laboratory accreditation program. Fertil Steril 56: 1201-1202
30. Lawrence L, Rosenwaks Z (1993) Implications of the fertility clinic success rate and certification act of 1992. Fertil Steril 59:288-290
31. Code of Federal Register (1999) Implementation of the fertility clinic success rate and certification Act of 1992 - A model program for certification of embryo laboratories. Fed Regist 64: 39374-39392
32. RESOLVE. 2008 (cited 2008 March 19); Available from: http:// www.resolve.org/site/PageServer?pagename=homepage
33. American Society for Reproductive Medicine. 2008 (cited 2008 March 19); Available from: http://www.asrm.org/
34. Society for Assisted Reproductive Technology. 2008 (cited 2008 March 19); Available from: http://www.sart.org/
35. American Society for Reproductive Medicine (2006) Revised guidelines for human embryology and andrology laboratories. Fertil Steril 86(Suppl.4):S57-S72
36. Food and Drug Administration. 21CFR1271: Human cells, tissues, and cellular and tissue-based products. 2007 (cited 2008 March 20); Available from: http://www.access.gpo.gov/nara/cfr/waisidx-07/21cfr1271-07.html
37. Food and Drug Administration (2001) Human cells, tissues, and cellular and tissue-based products; establishment registration and listing. Fed Regist 66:5447-5469
38. Food and Drug Administration (2004) Eligibility determination for donors of human cells, tissues, and cellular and tissue-based products. Fed Regist 69:29786-29834
39. Food and Drug Administration. Guidance for industry: eligibility determination for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). 2004 (cited 2008 March 20); Available from: http://www.fda.gov/cber/gdlns/tissdonor.pdf
40. Food and Drug Administration. Center for biologics evaluation and research. 2008 (cited 2008 March 20); Available from: http://www. fda.gov/cber/tiss.htm
41. Food and Drug Administration (2004) Current good tissue practice for human cell, tissue, and cellular and tissue-based product establishments; inspection and enforcement. Fed Regist 69: 68612-68688
42. The Joint Commission. Facts about Laboratory Accreditation. 2008 (cited February 22, 2008); Available from: http://www.jointcommission. org/AccreditationPrograms/LaboratoryServices/lab-facts.htm
43. American College of Microbiology. 2008 (cited 2008 March 19); Available from: http://www.microbiologycert.org/
44. American Board of Clinical Chemistry. 2008 (cited 2008 March 19); Available from: http://apps.aacc.org/abcc/
45. American Board of Bioanalysis. 2008 (cited February 20, 2008); Available from: http://www.aab.org/abb%20home%20page.htm
46. American Board of Medical Genetics. 2008 (cited 2008 March 19); Available from: http://www.abmg.org/
47. American Board of Histocompatibility and Immunogenetics. 2008 (cited 2008 March 19); Available from: http://www.ashi-hla.org/abhi/
48. American Board of Forensic Toxicology. 2008 (cited 2008 March 19); Available from: http://www.abft.org/
49. National Registry of Certified Chemists. 2008 (cited 2008 March 19); Available from: http://www.nrcc6.org/
50. Society for Assisted Reproductive Technology (1988) In vitro fertilization/ embryo transfer in the United States: 1985 and 1986 results from the National IVF/ET Registry. Fertil Steril 49:212-215
51. Society for Assisted Reproductive Technology (1996) Assisted reproductive technology in the United States and Canada: 1994 results generated from the American Fertility Society/Society for Assisted Reproductive Technology Registry. Fertil Steril 66:697-705
52. Society for Assisted Reproductive Technology (1995) Assisted reproductive technology in the United States and Canada: 1993 results generated from the American Fertility Society/Society for Assisted Reproductive Technology Registry. Fertil Steril 64:13-21
53. Society for Assisted Reproductive Technology (1993) Assisted reproductive technology in the United States and Canada: 1991 results from the Society for Assisted Reproductive Technology generated from the American Fertility Society Registry. Fertil Steril 59:956-962
54. Society for Assisted Reproductive Technology (1992) Assisted reproductive technology in the United States and Canada: 1992 results generated from the American Fertility Society/Society for Assisted Reproductive Technology generated Registry. Fertil Steril 62:1121-1128
55. Society for Assisted Reproductive Technology (1992) In vitro fertilization-embryo transfer (IVF-ET) in the United States: 1990 results from the IVF-ET registry. Fertil Steril 57:15-24
56. Society for Assisted Reproductive Technology (1991) In vitro fertilization-embryo transfer (IVF-ET) in the United States: 1989 results from the IVF-ET registry. Fertil Steril 55:14-22
57. Society for Assisted Reproductive Technology (1990) In vitro fertilization-embryo transfer in the United States: 1988 results from the National IVF-ET registry. Fertil Steril 53:13-20
58. Society for Assisted Reproductive Technology (1989) In vitro fertilization/embryo transfer in the United States: 1987 results from the National IVF-ET registry. Fertil Steril 51:13-19
59. Centers for Disease Control and Prevention (1997) 1995 assisted reproductive technology success rates. Centers for Disease Control and Prevention, Atlanta, GA
60. Society for Assisted Reproductive Technology (2007) Assisted reproductive technology in the United States: 2001 results generated from the American Fertility Society/Society for Assisted Reproductive Technology Registry. Fertil Steril 87:1253-1266
61. Society for Assisted Reproductive Technology (2004) Assisted reproductive technology in the United States: 2000 results generated from the American Fertility Society/Society for Assisted Reproductive Technology Registry. Fertil Steril 81:1207-1220
62. Society for Assisted Reproductive Technology (2002) Assisted reproductive technology in the United States: 1999 results generated from the American Fertility Society/Society for Assisted Reproductive Technology Registry. Fertil Steril 78:918-931
63. Society for Assisted Reproductive Technology (2002) Assisted reproductive technology in the United States: 1998 results generated from the American Fertility Society/Society for Assisted Reproductive Technology Registry. Fertil Steril 77:18-31
64. Society for Assisted Reproductive Technology (2000) Assisted reproductive technology in the United States: 1997 results generated from the American Fertility Society/Society for Assisted Reproductive Technology Registry. Fertil Steril 74:641-653
65. Society for Assisted Reproductive Technology (1999) Assisted reproductive technology in the United States: 1996 results generated from the American Fertility Society/Society for Assisted Reproductive Technology Registry. Fertil Steril 71:798-807
66. Society for Assisted Reproductive Technology (1998) Assisted reproductive technology in the United States and Canada: 1995 results generated from the American Fertility Society/Society for Assisted Reproductive Technology Registry. Fertil Steril 69: 389-398
67. Gunby J, Daya S (2005) Assisted reproductive technologies (ART) in Canada: 2001 results from the Canadian ART Register. Fertil Steril 84:590-599
68. Centers for Disease Control and Prevention (2004) Assisted reproductive technology surveillance - United States, 2001. MMWR 53
69. Gunby J, Daya S (2007) Assisted reproductive technologies (ART) in Canada: 2003 results from the Canadian ART Register. Fertil Steril 88:550-559
70. AIHW National Perinatal Statistics Unit. 2008 November 23, 2007 (cited 2008 March 19). Available from: http://www.npsu.unsw.edu. au/NPSUweb.nsf/page/ home
71. Waters A-M, Dean J, Sullivan E (2003) Assisted reproduction technology in Australia and New Zealand 2003. AIHW National Perinatal Statistics Unit, Sydney
72. Wang Y, Dean J, Sullivan E (2007) Assisted reproduction technology in Australia and New Zealand 2005. AIHW National Perinatal Statistics Unit, Sydney
73. Wang Y, Dean J, Grayson N, Sullivan E (2006) Assisted reproduction technology in Australia and New Zealand. AIHW National Perinatal Statistics Unit, Sydney
74. Lancaster P, Shafir E, Hurst T, Huang J (1997) Assisted conception Australia and New Zealand, 1994 and 1995. AIHW National Perinatal Statistics Unit, Sydney
75. Lancaster P, Shafir E, Huang J (1995) Assisted conception, Australia and New Zealand, 1992 and 1993. AIHW National Perinatal Statistics Unit, Sydney
76. Hurst T, Shafir E, Lancaster P (1999) Assisted conception Australia and New Zealand 1997. AIHW National Perinatal Statistics Unit, Sydney
77. Hurst T, Shafir E, Lancaster P (1997) Assisted conception, Australia and New Zealand 1996. AIHW National Perinatal Statistics Unit, Sydney
78. Hurst T, Lancaster P (2001) Assisted conception Australia and New Zealand 1999 and 2000. AIHW National Perinatal Statistics Unit, Sydney
79. Hurst T, Lancaster P (2001) Assisted conception Australia and New Zealand 1998 and 1999. AIHW National Perinatal Statistics Unit, Sydney
80. Dean J, Sullivan E (2003) Assisted conception Australia and New Zealand 2000 and 2001. AIHW National Perinatal Statistics Unit, Sydney
81. Bryant J, Sullivan E, Dean J (2002) Assisted reproduction technology in Australia and New Zealand. AIHW National Perinatal Statistics Unit, Sydney
82. Nygren K, Andersen AN (2001) Assisted reproductive technology in Europe, 1997. Results generated from European registers by ESHRE. Hum Reprod 16:384-391
83. Nygren K, Andersen AN (2002) Assisted reproductive technology in Europe, 1999. Results generated from European registers by ESHRE. Hum Reprod 17:3260-3274
84. Nygren K, Andersen AN (2001) Assisted reproductive technology in Europe, 1998. Results generated from European registers by ESHRE. Hum Reprod 16:2459-2471
85. Andersen AN, Goossens V, Gianaroli L, Felberbaum R, De Mouzon J, Nygren K (2007) Assisted reproductive technology in Europe, 2003. Results generated from European registers by ESHRE. Hum Reprod 22:1513-1525
86. Andersen AN, Gianaroli L, Nygren K (2004) Assisted reproductive technology in Europe, 2000. Results generated from European registers by ESHRE. Hum Reprod 19:490-503
87. Andersen AN, Gianaroli L, Felberbaum R, De Mouzon J (2006) Assisted reproductive technology in Europe, 2002. Results generated from European registers by ESHRE. Hum Reprod 21:1680-1697
88. Andersen AN, Felberbaum R, de Mouzon J, Nygren K (2005) Assisted reproductive technology in Europe, 2001. Results generated from European registers by ESHRE. Hum Reprod 20:1158-1176
89. Adamson G, de Mouzon J, Lancaster P, Nygren K, Sullivan E, Zegers-Hochschild F (2006) World collaborative report on in vitro fertilization, 2000. Fertil Steril 85:1586-1622