ISO 15189:2007

1. Introduction to ISO 15189 ISO 15189:2007 Medical laboratories- Particular requirements for quality and competence 3/24/2010

2. Introduction: In the following slides ISO 15189:2007 standard is paraphrased and reworded for the training purpose. Refer to the standard to the actual text. This second edition cancels and replaces the first edition (ISO 15189:2003) in order to align it more closely with the second edition of ISO/IEC17025. 3/24/2010

3. ISO 15189…….the history <ul><li>Developed by TC 212- Clinical laboratory testing and in vitro diagnostic systems; </li></ul> ISO 15189:2003 (1st Edition) ISO 15189:2007 (2nd Edition) <ul><li>Written by medical laboratory professionals</li></ul>3/24/2010

4. ISO 15189……The history <ul><li>Requirements for quality and competence

5. It has its origins in two ISO Standards …ISO 9001 and ISO 17025</li></ul>3/24/2010

6. ISO 15189……The history Defining Quality as…… …… ‘The degree to which a set of inherent characteristics fulfills requirements’ Defining Competence as…. ……‘A demonstrated ability to apply knowledge and skills’ 3/24/2010

7. Accreditation: To become an accredited laboratory requirements for ISO 15189 must be implemented; Lab Management shall: <ul><li>Evaluate current QMS

8. Modify and update to meet standards

9. Document processes as a Quality Manual, procedures and work instructions.</li></ul>3/24/2010

10. Why standards? They’re important in international trade to eliminate barriers. They facilitate trade through enhanced product quality and reliability at reduced costs. To be recognized internationally. 3/24/2010

11. Why quality? To improve patient care. To be consistent & focus on process. To assure safety of clients & customers. For better customer satisfaction. For continuous improvement 3/24/2010

12. Benefits of ISO15189 More focus on patient safety & report test results Emphasizes on the total service of a medical laboratory (consultation, turn around time, cost etc.) Addresses ethics and information needs of the medical laboratory Be recognized as a competent laboratory worldwide. 3/24/2010

13. Quality System Essentials: <ul><li>Organization

14. Personnel

15. Equipment

16. Purchasing and Inventory

17. Process Control

18. Documents & Records</li></ul>3/24/2010

19. Quality System Essentials: <ul><li>Information Management

20. Investigation of non-conformities

21. Assessment

22. Process improvement

23. Service & satisfaction

24. Facilities and safety</li></ul>There are relationships between these QSE called “process map” ISO 15189 has 23 QSE 3/24/2010

25. process map: ORGANISATION & MANAGEMENT RESPONSIBILITY 4.1Organization and management responsibility 4.15 Management review 4.4 Service agreements QUALITY MANAGEMENT SYSTEM 4.2 Quality management system 4.3 Document control 4.13 Control of records Act Plan EVALUATION & CONTINUAL IMPROVEMENT 4.8 Resolution of Complaints 4.9 Identification and control of non conformities 4.10 Corrective action 4.11 Preventative action 4.12 Continual improvement 4.14 Evaluation and Internal audits 5.6 Ensuring the quality of results (in part) RESOURCE MANAGEMENT 5.1 Personnel 5.2 Accommodation and environmental conditions 5.3 Laboratory equipment, reagents and materials 5.9 Management of information systems 4.6 External supplies and services EXAMINATION PROCESSES Pre examination processes 4.5 Examination by referral laboratories 5.4 Pre examination processes Examination processes 5.5 Examination processes 5.6 Ensuring the quality of results (in part) Post examination processes 4.7 Advisory services 5.7 Post examination processes 5.8 Reporting results User Satisfaction or dissatisfaction User Requirements Check Do Report Request PROCESS INPUTS OUTPUTS 3/24/2010

26. Key Clauses in ISO 15189:2007 Organization & Management Quality Management System Resource Management Pre-examination procedures Examination Procedures Post-examination procedures Corrective & Preventive Action Continual Improvement 3/24/2010

27. Difference between ISO 15189 &9000: ISO 9001 certificate provides confidence about the laboratory’s quality management system. Therefore ISO 15189 is a measure of both technical competence and quality management and is the most appropriate process for laboratories use. 3/24/2010

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32. ISO 15189:2007- Requirements What does ISO 15189 require for quality & competency of medical laboratories? 3/24/2010

33. ISO 15189:2007- Requirements 3/24/2010

34. 4.1 Organization and Management The personnel responsible for patient care. medical lab or organization shall be legally identifiable. Medical lab services shall be designed to meet needs of patients and all clinical Responsibilities & authorities shall be defined. Lab management shall be responsible for the design, implementation, maintenance and improvement of the QMS. 3/24/2010

35. 4.1 Organization and Management Policies, processes, programmes, procedures and work instructions shall be documented and communicated to all relevant personnel. The QMS shall include, but not limited to, internal quality control and participation in interlaboratory comparisons such as external quality assessment schemes. 3/24/2010

36. 4.1 Organization and Management Quality policy shall be stated per Lab director and readily available to appropriate personnel. Quality policy shall be documented in a quality manual. Quality policy shall include: the scope of service of the lab, the objectives of the QMS. Lab’s commitment to good practice, the quality of its examinations, and compliance with the QMS. 3/24/2010

37. 4.2 Quality management system Quality manual shall describe the structure of the documentation used in the QMS. Roles & responsibilities of technical management & quality manager shall be defined in the manual. Lab management shall establish, implement and document a preventive maintenance and calibration programmes of instruments, reagents and analytical system. 3/24/2010

38. 4.3 Document control The lab shall define and maintain procedures to control all documents. The lab shall maintain their controlled document and shall define their retention period. All documents issued to lab personnel shall be reviewed and approved by authorized personnel prior to issue. 3/24/2010

39. 4.3 Document control Procedures shall be adopted to ensure that : Only current authorized versions of appropriate documents are available for active use. Obsolete documents are promptly removed from all points of use. Documents are periodically reviewed, revised when necessary, and approved by authorized personnel. 3/24/2010

40. 4.3 Document control Procedures are established to describe how changes to documents are to be made and controlled. All documents relevant to QMS shall be uniquely identified with title, current version number or revision number, authority for issue, etc… 3/24/2010

41. 4.4 Review of Contracts Procedures/policies shall be established for review of contracts. Records of reviews, including any significant changes and pertinent discussions, shall be maintained. 3/24/2010

42. 4.5Examinations by referral laboratories The lab shall have an effective procedure for selection and evaluation of referral laboratories. The lab shall maintain a register of all referral labs that it uses. The referring lab and not the referral lab shall be responsible for ensuring that examination results are provided to the requestor. 3/24/2010

43. 4.6External services and supplies The lab shall have a procedure for the selection and use of purchased consumable supplies and equipment that affect the quality of its services. There shall be criteria and procedures for inspection, acceptance/rejection and storage of consumable materials. 3/24/2010

44. 4.6 External services and supplies Purchased equipments and consumable supplies shall not be used until they have been verified as complying with requirements and pre-defined specifications. The lab shall evaluate suppliers and shall maintain records of these evaluations and list those approved. 3/24/2010

45. 4.7Advisory services Appropriate lab pro staff shall provide advices to the patient on choice of examinations and use of the services. There should be regular meetings of pro staff with the clinical staff regarding the use of lab services. 3/24/2010

46. 4.8 Resolution of complaints The lab shall have a procedure to deal with customer complaints and feedback. Records of complaints, root cause analysis, corrective actions and preventive actions shall be maintained. 3/24/2010

47. 4.9 Identification & control of nonconformities The lab shall have a policy or procedure to control any aspect of its examinations that does not conform with requirements. It shall ensure that: Personnel responsible for problem resolution are designated. Corrective action taken immediately. Examinations are halted and reports withheld. 3/24/2010

48. 4.10 Corrective action A procedure for corrective action shall explain how to find the true root cause of the non conformity, which will lead to preventive actions. Corrective action shall be appropriate to the magnitude of the problem and commensurate with possible risks. Lab management shall monitor corrective action and ensure that they have been effective. 3/24/2010

49. 4.11 Preventive action Action plans shall be developed to prevent occurrence of nonconformity. Preventive action shall be taken as an opportunity for improvement Preventive action is a pro-active process rather than a reaction to a nonconformity. 3/24/2010

50. 4.12 Continual improvement Lab management shall implement quality indicators for monitoring the lab’s contribution to patient care. All operational procedures shall be systematically reviewed by lab management to identify any potential sources of nonconformance or other opportunities for improvement. Action plans for improvement shall be developed, implemented and documented. 3/24/2010

51. 4.13 Quality & technical records The lab shall establish and implement policies and procedure for Identification, indexing, access, storage and overall control of quality records. Records shall be legible and stored such that they are retrievable. Records shall be stored in a suitable environment to prevent damage, loss or unauthorized access. 3/24/2010

52. 4.13 Quality & technical records The lab shall have a policy that defines the retention time for quality & technical records. Retention times vary with the type and nature of record. Records may include but not limited to: 3/24/2010

53. 4.14 Internal audits The lab shall have procedures and policies for internal audits schedule, frequency, methodology and required documentation. Internal audits of the QMS shall be conducted once every twelve month. Both managerial & technical system shall be subject for audit. 3/24/2010

54. 4.15 Management review <ul><li>Lab management shall review the lab QMS and all its medical services in support of patient care.

55. Results of the review shall be documented and shall result into action plans, objectives and goals.

56. Typical period for conducting is once every twelve month.</li></ul>3/24/2010

57. 4.15 Management review <ul><li>Management review agenda shall include but not limited to:

58. Follow-up of previous reviews

59. Status of corrective/preventive actions

60. The outcome of recent internal audits

61. Nonconformities

62. Evaluation of suppliers

63. Quality indicators

64. Customer complaints

65. Customer feedback</li></ul>3/24/2010

66. ISO 15189:2007- Requirements 3/24/2010

67. 5.1 Personnel <ul><li>Lab management shall have an organizational plan, personnel policies and job descriptions to define responsibility and authority of all personnel.

68. Lab management shall maintain records of relevant education, training and competency evaluation of all personnel.</li></ul>3/24/2010

69. 5.1 Personnel <ul><li>Responsibilities of the lab director or designees shall be relevant to the services offered by the laboratory.

70. Lab director or designees activities shall cover the following but not limited to:

71. Define, implement & monitor standards of performance & quality improvement.

72. Implement the QMS and monitor all work performed in the lab.

73. Provide educational programmes for the lab staff.

74. Ensure good staff morale</li></ul>3/24/2010

75. 5.1 Personnel <ul><li>Select & monitor all referral laboratories

76. Implement a safe laboratory environment for staff and patients.

77. Plan, set goals and allocate resources appropriate to the medical environment.

78. There shall be staff resources adequate to carry out operations in the lab and other functions of the QMS.

79. Lab management shall authorize personnel to perform particular tasks such as sampling, examination and operation of particular types of equipment.</li></ul>3/24/2010

80. 5.1 Personnel <ul><li>Policies shall be established which define who may use the computer system, who may access patient data and who is authorized to enter and change patient results, correct billing, or modify computer programms.

81. The competency of each person to perform tasks shall be assessed periodically. Retraining shall occur when necessary.

82. Confidentiality of info and data regarding patients shall be maintained by all personnel.</li></ul>3/24/2010

83. 5.2 Accommodation & environmental conditions <ul><li>The lab shall have an adequate space so that operations can be carried out without affecting the quality of work, safety personnel or patient care services.

84. Lab resources shall be maintained in a functional and reliable condition to support the lab activities.

85. The environment where the primary sample or examinations or both are collected shall be suitable and shall not invalidate test results.</li></ul>3/24/2010

86. 5.2 Accommodation & environmental conditions <ul><li>The lab should have procedures for checking that the environment (i,.e. energy sources, lighting, ventilation, water, etc…) does not adversely affect the performance of specimen collection and equipment.

87. The lab shall monitor, control and record environmental conditions. Attention should be paid to sterility, dust, humidity, electrical supply, temperature, etc… as appropriate to the technical activities concerned.</li></ul>3/24/2010

88. 5.2 Accommodation & environmental conditions <ul><li>Access to and use of areas affecting the quality of the examinations shall be controlled.

89. Communication systems within the lab shall be those appropriate to the size and complexity of the facility.

90. Relevant storage space and conditions shall be provided to ensure the continuing integrity of samples, slides, histology blocks, documents, files, manuals, reagents, records, results and supplies.</li></ul>3/24/2010

91. 5.3 Laboratory equipment <ul><li>The lab shall be furnished with all items of equipment required for the provision of services from specimen collection to report results.

92. Equipment shall comply with specifications relevant to the examinations concerned.

93. Equipment shall be capable to perform the testing as specified per the manufacturer’s catalogue.</li></ul>3/24/2010

94. 5.3 Laboratory equipment <ul><li>Laboratory management shall establish a program for regular maintenance of lab equipment.

95. Each item of equipment shall be uniquely labeled, marked or otherwise identified.

96. Records of healthcare equipments contributing to the performance of examinations shall be maintained and shall include:

97. Equipment name, serial number or other unique ID.

98. Current location

99. Manufacturer’s contact person or phone number.

100. Maintenance carried out and expected in the future

101. Qualifications and validation data.</li></ul>3/24/2010

102. 5.3 Laboratory equipment <ul><li>Equipment shall be maintained in a safe working condition and shall be operated by authorized personnel only.

103. Equipment which are defective, under repair, require calibration or out of service for a reason shall be clearly labeled and quarantined.

104. Equipments shall be safeguarded from adjustments or tampering that might invalidate test results.</li></ul>3/24/2010

105. 5.3 Laboratory equipment <ul><li>When computers or automated equipment are used for the collection, processing and reporting of examination data, the lab shall ensure that:

106. Computer software build into equipment is validated.

107. Procedures are established to protect the integrity of data.

108. Computer programmes are adequately protected to prevent access by unauthorized persons.</li></ul>3/24/2010

109. 5.4 Pre-examination procedures <ul><li>The request form should allow space for the inclusion of, but not limited to, the following:

110. Unique identification (name, sex, age, etc…) of the patient;

111. Name or ID of physician or authorized personnel requesting the examinations.

112. Type of primary sample and the anatomic site of origin, where appropriate.

113. Name of test requested.

114. Date and time of specimen collection

115. Date and time of receipt of samples by the laboratory.</li></ul>3/24/2010

116. 5.4 Pre-examination procedures <ul><li>Lab management shall have a documented instructions for primary sample collection. These instructions shall be contained in a primary sample collection manual and made available for assigned users.

117. The primary sample collection manual shall include the following:

118. A. Copies of or references:

119. Lists of available tests offered by the lab.

120. Consent forms, when applicable.

121. Instructions provided to patients before specimen collection.</li></ul>3/24/2010

122. <ul><li>B. Procedures for:

123. Instructions for the phlebotomist.

124. Identification of primary sample.

125. Description of containers and necessary additives for specimen collection.

126. C. Instructions for:

127. Completion of request form.

128. Type and amount of the primary sample to be collected.

129. Labeling of primary samples.

130. Safe disposal of materials used in the collection.

131. Special timing of collection.

132. D. Instructions for:

133. Storage of examined samples.

134. Time limits for requesting additional examinations.

135. Additional examinations.

136. Repeating of tests due to analytical failure or further examinations of same primary sample.</li></ul>3/24/2010

137. 5.4 Pre-examination procedures <ul><li>Primary samples shall be traceable, normally by request form, to an identified individual.

138. The lab shall monitor the transportation of samples to the lab so that they are transported</li></ul>a. Within a time frame appropriate to the nature of the requested examinations. b. Within a temperature interval specified in the primary sample collection manual. c. In a manner that ensures safety for the carrier, the public and the lab. 3/24/2010

139. 5.4 Pre-examination procedures Criteria shall be developed and documented for acceptance or rejection of primary samples. All primary samples received shall be recorded in an accession book, worksheet or computer system. The lab shall periodically review its sample volume requirements for phlebotomy to ensure sufficient volume is always taken. The lab shall have a documented procedures for the receipt, labeling, processing and reporting of those primary samples received by the lab. 3/24/2010

140. 5.5 Examination procedures The lab shall use examination procedures which meet the needs of the users of lab services and are appropriate for the examinations. The lab shall use only validated procedures for confirming that the examination procedures are suitable for the intended use. The lab shall record the results obtained and the procedure used for the validation. 3/24/2010

141. 5.5 Examination procedures <ul><li>All procedures shall be documented and available at the work station for relevant staff in. Documented procedures shall be available in a language commonly understood by the staff in the laboratory.

142. The procedure shall be based on the instructions for use (e.g. package insert) written by the manufacturer provided that they describe the procedure, as it is performed in the lab.</li></ul>3/24/2010

143. 5.5 Examination procedures <ul><li>Documentation should include, when applicable the following:

144. Purpose of the examination;

145. Principle of the procedure used for examinations;

146. Performance specifications (e.g. linearity, precision, accuracy, detection limit, measuring interval, trueness of measurement, etc…);

147. Primary sample system (e.g. serum, plasma, urine); </li></ul>3/24/2010

148. 5.5 Examination procedures <ul><li>Alert/critical values, where appropriate;

149. Type of container and additives;

150. Required equipment and reagents;

151. Laboratory interpretation;

152. Safety precautions;

153. Procedural steps;

154. Quality control procedures;

155. Principle of procedure for calculating results;

156. Potential sources of variability;

157. Calibration procedures (metrological traceability);</li></ul>3/24/2010

158. 5.5 Examination procedures <ul><li>Performance specifications for each procedure used in an examination shall relate to the intended use of that procedure.

159. The lab shall make its list of current examination procedures, including primary sample requirements, and relevant performance specifications and requirements, available to users of laboratory services.

160. Any planned changes to examination procedures which could influence test results or their interpretation, shall be explained to lab users prior to introduction.</li></ul>3/24/2010

161. 5.6 Assuring quality of examination procedures <ul><li>The lab shall design internal quality control system that verify the attainment of the intended quality of results. Special attention should be paid to the elimination of mistakes in the process of handling samples, requests, examinations, reports, etc.

162. The lab shall determine the uncertainty of results, where relevant and possible. Sources may be related to sampling, sample preparation, calibrators, equipment used, working environment condition of the sample, reference materials, and changes of operator.</li></ul>3/24/2010

163. 5.6 Assuring quality of examination procedures <ul><li>To provide confidence in the results the lab shall:

164. Participate in a suitable programme of inte-rlaboratory comparisons;

165. Use of suitable (certified) reference materials;

166. Examination or calibration by another procedure;

167. Ratio or reciprocity-type measurements;

168. Mutual consent standards or methods which are agreed upon by all.

169. The lab shall participate in inter-laboratory comparisons such as those organizes by external quality assessment schemes.. </li></ul>3/24/2010

170. 5.6 Assuring quality of examination procedures <ul><li>Lab management shall monitor outcome of EQA participation results and implement corrective actions as necessary.

171. Whenever a formal inter-laboratory comparison is not in place, the lab shall develop a mechanism (such as exchange samples with other labs) for determining the acceptability of procedures not otherwise evaluated. </li></ul>3/24/2010

172. 5.6 Assuring quality of examination procedures <ul><li>EAQ programmes should, as far as possible, provide clinically relevant challenges that mimic patient samples and have the effect of checking the entire examination process.

173. The lab shall document, record and, as appropriate, expeditiously act upon results from these comparisons. Problems or deficiencies identified shall be acted upon and records of actions retained. </li></ul>3/24/2010

174. 5.7 Post-examination procedures <ul><li>Authorized personnel shall systematically review the results of examinations, evaluate them in conformity with the clinical info for the patient and authorize the release of the results.

175. Storage of primary sample and other lab samples shall be in accordance with approved policy.

176. Disposal of samples (left over) shall be carried out in accordance with local regulations or recommendations for waste management and/or as per in house policy.</li></ul>3/24/2010

177. 5.8 Reporting of results <ul><li>Lab management shall be responsible for formatting reports. The format of the report and how to be communicated should be discussed with the users of lab services.

178. The lab and the requester both are responsible for ensuring report results are received by the appropriate individuals within an agreed-upon time interval.

179. Results shall be legible, without mistakes in transcription and reported to physicians or designated authorized personnel.</li></ul>3/24/2010

180. 5.8 Reporting of results <ul><li>The report shall include but not limited to:

181. Identification of the examination used;

182. Identification of the lab issuing the report;

183. Unique identification of the patient and destination of the report;

184. Name or other unique identifier and address of the requester;

185. Date & time of primary sample collection, and time of receipt by the lab;

186. Source & system (or primary sample type);

187. Biological reference intervals, where applicable;</li></ul>3/24/2010

188. 5.8 Reporting of results <ul><li>Date & time of release of report, if not on the report, shall be accessible;

189. Results reported in SI units or units traceable to SI units;

190. Interpretation of results, where appropriate;

191. Other comments (e.g. quality or adequacy of primary sample which may have compromised the result)

192. Identification of the person authorizing the release of the report;

193. Signature or authorization of the person releasing the report, where possible.</li></ul>3/24/2010

194. 5.8 Reporting of results <ul><li>The report shall indicate if the quality of the primary sample received was unsuitable for examination or could have compromised the result.

195. Copies or files of reported results shall be retained by the lab for prompt retrieval of info and retention time shall be consistent with the requirements regional, local or national.</li></ul>3/24/2010

196. 5.8 Reporting of results <ul><li>The lab shall have procedures for immediate notification of a physician when results fall in “alert” or “critical” intervals. Records of actions taken in response to panic values shall be maintained and shall include date, time, responsible lab staff member, person notified and examination results.

197. Turnaround times shall be established and agreed upon between lab management and requesters. There shall be a policy for notifying the requester when an examination is delayed. Turnaround times as well as feedback from clinicians in relation to it shall be monitored, recorded and reviewed by lab management.</li></ul>3/24/2010

198. 5.8 Reporting of results <ul><li>The lab shall have clearly documented procedures for the release of examinations results, including details of who may release results and to whom. The procedures shall also indicate guidelines for the release of results directly to patient.

199. The lab shall have written policies regarding the alteration of reports. When altered, the record must show the time, date and name of the person responsible for the change. Original entries shall remain legible when alterations are made.</li></ul>3/24/2010

200. References: ISO 15189:2007 Standards Contacts: Bilal Al-kadri Iso15189.consultant@gmail.com http://kw.linkedin.com/in/balkadri 3/24/2010