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OLA Requirements 2008 - Important Changes

OLA Requirements 2008 - Important Changes. accreditation requirements. Ontario Laboratory Accreditation (OLA) Requirements are Subject to Biennial Review Version 1 (January 2002) Version 2 (May 2003) Version 3 (September 2005) Version 4 (December 2007) Version 4.1 (July 2008).

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OLA Requirements 2008 - Important Changes

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  1. OLA Requirements 2008 - Important Changes

  2. accreditation requirements Ontario Laboratory Accreditation (OLA) Requirements are Subject to Biennial Review • Version 1 (January 2002) • Version 2 (May 2003) • Version 3 (September 2005) • Version 4 (December 2007) • Version 4.1 (July 2008) July 2008

  3. accreditation requirements By the numbers… July 2008

  4. ontario laboratory accreditation Effective September 1, 2008 • Ontario licensed laboratories begin to receive reassessments • Optional Standards Council of Canada certificate available • Version 4.1 applies to any assessment • Assessments cover all of ISO 15189:2007 • 4-year certificates will be awarded • A 2-year upgradeable certificate may be issued July 2008

  5. sub version 4.1 release July 2008 Version 4.1 was released before version 4 was in use. Why? Changes in law (or other government directives) require immediate release of new requirements. July 2008

  6. recent changes in regulation Revised Regulation Laboratory and Specimen Collection Centre Licensing Act, Laboratories Regulation, O. Reg. 682 • Post-analytical requirement VIII.12.1 revised • Effective April 1/08 –report all positive findings that indicate the presumptive presence or presence of any reportable disease to the medical officer of health of the health unit in which the person who gives rise to the case resides July 2008

  7. recent changes in regulation Revised Legislation Ontario Health Protection and Promotion Act, 1990 • Revised Act – Health Protection and Promotion Act, R.S.O. 1990, Part VI.1, Section 77.8 • Post-analytical Process requirement VIII.2.10 guidance revised to allow the release of patient reports to the Chief Medical Officer of Health July 2008

  8. recent changes in regulation New Ontario Regulation Occupational Health and Safety Act, Needle Safety, O. Reg. 474/07 • Pre-analytical Process requirement V.A.10 reworded to allow for the use of safety engineered needles or needle-less systems. • Guidance revised to include effective dates of new regulation. July 2008

  9. requirements general housekeeping • Added “In Ontario” or “In Canada” where applicable • Requirements combined to reduce duplication • Bulleted points added for ease of reading • Guidance provided on the number or sample size assessors will look for • Discipline-specific guidance added and re-aligned July 2008

  10. changes to requirements I. Personnel Six good practice recommendations revised to requirements July 2008

  11. changes to requirements II. QMSSeven internal auditing good practice recommendations revised to requirements July 2008

  12. changes to requirements II. QMSFour management review good practice recommendations revised to requirements July 2008

  13. changes to requirements II. QMSTwo referral laboratory management good practice recommendations revised to requirements July 2008

  14. changes to requirements II. QMSFive new contract review requirements July 2008

  15. changes to requirements III. Physical FacilitiesThree good practice recommendations revised to requirements July 2008

  16. changes to requirements IV. Equipment, Reagents, SuppliesThree good practice recommendations revised to requirements July 2008

  17. changes to requirements V.Pre-analytical Process One requirement revised to reflect new legislation July 2008

  18. changes to requirements VI. Analytical ProcessesTwo good practice recommendations revised to requirements July 2008

  19. changes to requirements VII. Quality Assurance of Laboratory ExaminationsOne requirement revised July 2008

  20. changes to requirements VIII.Post analytical (Reporting)One good practice recommendation revised to requirement July 2008

  21. changes to requirements VIII.Post analytical (Reporting)One requirement’s guidance revised to reflect new legislation July 2008

  22. changes to requirements VIII.Post analytical (Reporting)One requirement revised to reflect new legislation July 2008

  23. changes to requirements IX. Laboratory Information System (LIS)Three good practice recommendations revised to requirements July 2008

  24. changes to requirements X. SafetyOne new requirement July 2008

  25. changes to requirements X. SafetyTwo good practice recommendations revised to requirements July 2008

  26. changes to requirements XI. Point-of-care Testing (POCT) Four good practice recommendations revised to requirements July 2008

  27. changes to guidance Changes to discipline-specific guidance… July 2008

  28. changes to guidance Changes to discipline-specific guidance… July 2008

  29. changes to references listing • Of particular note… • Added ISO 15189:2007(E) in its entirety • Deleted CAN/CSA 15189:2003 since it has been withdrawn • Added CAN/CSA Z-902 Blood and Blood Components July 2008

  30. changes to references listing • Housekeeping… • Increase user friendliness by providing spaces between • Improve consistency in style July 2008

  31. summary Starting September 1, 2008 • Ontario licensed laboratories begin to receive reassessments • 4-year certificates will be awarded • A 2-year upgradeable certificate may be issued July 2008

  32. summary Starting September 1, 2008 • Version 4.1 applies to any assessment occurring after August 2008 • Notifications began in May • Requirements cover all of ISO 15189:2007(E) July 2008

  33. summary Standards Council of Canada ISO 15189 accreditation certificate available to… • Laboratories who apply for OLA accreditation • Licensed Ontario medical laboratories undergoing reassessment * * Fees apply July 2008

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