SKIM AKREDITASI MAKMAL MALAYSIA (SAMM) LABORATORY ACCREDITATION SCHEME OF MALAYSIA
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1 MOSTI SKIM AKREDITASI MAKMAL MALAYSIA (SAMM) LABORATORY ACCREDITATION SCHEME OF MALAYSIA STR SPECIFIC TECHNICAL REQUIREMENTS FOR ACCREDITATION OF ANATOMICAL PATHOLOGY (HISTOPATHOLOGY) LABORATORIES Issue 3, 5 January 2007 (Supplementary to MS ISO 15189) MS ISO JABATAN STANDARD MALAYSIA Department of Standards Malaysia
2 Contents Page 1 Introduction 1 2 Scope of accreditation 1 3 Terms and definitions 1 4 Personnel 2 5 Accommodation and environmental conditions 2 6 Laboratory equipment 3 7 Pre-examination procedures 4 8 Examination procedures 4 9 Assuring quality of examination procedures 5 10 Post-examination procedures 5 11 Reporting of results 6 Acknowledgements 7 Issue 3, 5 January 2007 i
3 SPECIFIC TECHNICAL REQUIREMENTS FOR ACCREDITATION OF ANATOMICAL PATHOLOGY 1 Introduction (a) This document describes the specific technical requirements to be complied by histopathology laboratories. (b) This document shall be read in conjunction with MS ISO Medical Laboratories - Particular Requirements for Quality and Competence and other specific criteria documents published by Department of Standards Malaysia (STANDARDS MALAYSIA). 2 Scope of accreditation The areas for which accreditation may be offered are listed below: 2.1 Diagnostic Histopathology 2.2 Intraoperative Frozen Sections 3 Terms and definition 3.1 Diagnostic histopathology - refers to examination of human tissue (macroscopic and microscopic) for the diagnosis and monitoring of disease. In relevant circumstances, this is supplemented by the use of special stains and/or other forms of examination, such as histochemical and immunohistochemical stains, electron microscopy and molecular techniques. 3.2 Intraoperative frozen sections - refers to the examination of human tissues removed during a surgical operation for the purpose of rapid diagnosis. This examination involves the production of smears from fresh tissues and/or histopathology sections from fresh frozen tissues as the initial step. This shall be followed by examination of routine paraffin sections made from the tissue, where relevant. Issue 3, 5 January 2007 Page 1 of 7
4 4 Personnel (clause 5.1 of MS ISO 15189) A histopathologist shall be a medical practitioner registered with the Malaysian Medical Council with a postgraduate qualification in pathology recognised by the Government of Malaysia and at least three years of training or working experience in histopathology whether as part of the pathology training programme or as a post-qualification experience. A medical laboratory technologist shall be a person with a Diploma in Medical Laboratory Technology or equivalent, and at least six months training in histopathology as part of the technology training programme or as post-qualification experience. A laboratory scientist shall be a person with a Bachelor of Biomedical Science Degree or equivalent, and at least six months training in histopathology as part of the training programme or as post-qualification experience. A technical assistant in histopathology shall be a person with appropriate practical experience and specific training to assist the medical laboratory technologist/laboratory scientist in the reception and registration of specimens, paraffin block microtomy, H&E staining, labeling and cross-checking of stained slides against the corresponding paraffin blocks. Only technical personnel with at least five years working experience in histopathology may be appointed as key technical personnel in the histopathology laboratory. 5 Accommodation and environmental conditions (clause 5.2 of MS ISO 15189) 5.1 Working environment There should be a separate room or dedicated area with adequate ventilation/fume extraction system for macroscopic examination and cutting (grossing) of fresh tissue as well as formalinfixed specimens Appropriate extraction systems shall be in place to minimise the level of noxious vapours Infectious material should be handled in a safety cabinet. Issue 3, 5 January 2007 Page 2 of 7
5 5.1.4 Examination of histopathology slides and dictation of reports shall be in an area free of distraction and noise that can affect the concentration of the personnel. 5.2 Storage There shall be adequately ventilated space for the storage of wet specimens The periods for retention of specimens shall comply with existing national guidelines Inflammable and dangerous substances shall be stored in a separate chemical store, and shall comply with relevant national regulations. 5.3 Disposal of chemicals and tissues Harmful chemicals such as formalin, xylene, diaminobenzidine and discarded tissues (including their effluents such as cysts and intestinal contents) shall be disposed in a manner so as not to contaminate or endanger the environment or the public. 6 Laboratory equipment (clause 5.3 of MS ISO 15189) 6.1 Grossing of specimens shall be performed under a fume hood. For extraction of formalin vapours, a down-draft system is preferable. 6.2 The fume hood shall have its airflow monitored regularly, its filters changed when saturated and the extract ducting checked for leakage according to manufacturer s specifications. 6.3 If a filter system is not used, the exhaust pipe of fume hoods shall be above the roof of the building where the laboratory is located. In the case where another building taller than the laboratory building is located in close vicinity to the laboratory, the exhaust pipe of fume hoods (if no filter system is used), shall be above the roof of that taller building. 6.4 Tissue processing fluids shall be changed regularly and records maintained. 6.5 The temperature of wax baths (e.g. in embedding centres and tissue processors) shall be checked before use and records maintained. Issue 3, 5 January 2007 Page 3 of 7
6 6.6 Flotation bath shall be cleaned before use. 6.7 Microtomes should have safety knife shields. 6.8 Staining solutions shall be changed regularly and records kept. Control slides may be used to determine this interval. 7 Pre-examination procedures (clause 5.4 of MS ISO 15189) 7.1 Clinical information shall include at least the provisional diagnosis of the requester. 7.2 All relevant further clinical information obtained for the case shall be recorded in the request form. If obtained verbally, the name of the person providing the information as well as the laboratory clinical personnel receiving the information shall be documented in the request form against the newly obtained information. 7.3 There shall be a system that allows retrieval of patients previous histopathological reports which are available in the laboratory. 7.4 The primary sample collection manual shall include in its instructions that all samples sent to the laboratory for examination in separate containers shall be itemised in the request form. The containers of such samples shall be similarly itemised and labeled with the patient s unique identification such that they can be cross-referenced to the patient and the anatomic site of origin of the sample. 7.5 Requests for intraoperative frozen section, electron microscopic examination and examinations by any special techniques shall be reviewed by the histopathologist. 8 Examination procedures (clause 5.5 of MS ISO 15189) 8.1 Sampling of the primary specimen shall be performed by a histopathologist or a medical practitioner under the direct supervision of a histopathologist. 8.2 The location from which each block is sampled from the primary sample shall be clearly documented in the final report. Issue 3, 5 January 2007 Page 4 of 7
7 8.3 Tapes or other media containing macroscopic description and findings shall be retained at least until the report has been finalised and the histopathologist has given approval for discard. 8.4 The authorised personnel responsible for each stage of the process from the receipt of the specimen till the production of the stained slide shall be identified. 8.5 Each slide shall be correctly labeled with unique identifiers which can be traced to the corresponding block. 8.6 Frozen sections cut by trainee technical personnel shall not be used for intraoperative frozen section service. 9 Assuring quality of examination procedures (clause 5.6 of MS ISO 15189) 9.1 Relevant controls shall be run with each batch of slides for special stains. 9.2 All special stain slides shall show on the slide label the date when the staining was performed. The control slide shall be traceable to the batch of staining. The control slides shall be retained with the slides whenever relevant. 9.3 The laboratory shall subscribe to at least one external quality assurance programme addressing all its diagnostic and technical activities. 9.4 The laboratory shall have an internal quality control system to ensure the quality of its routine Haematoxylin-Eosin (H+E) slides and special stain slides produced. 10 Post-examination procedures (clause 5.7 of MS ISO 15189) 10.1 The histopathologist shall be responsible for the content of the histopathology report and its release In exceptional circumstances the histopathologist may authorise another competent histopathologist to release his/her report on his/her behalf. This information shall be indicated Issue 3, 5 January 2007 Page 5 of 7
8 in the report. The laboratory shall have a clear procedure for such practices to safeguard the integrity of the report Infectious materials and surplus wet tissue no longer required after examination shall be disposed in a manner so as not to contaminate or endanger the environment or public, such as by burial or incineration. 11 Reporting of results (clause 5.8 of MS ISO 15189) 11.1 The histopathology report shall be issued to the medical practitioner who requested for the examination or a medical practitioner who is involved in the management of the patient The date and time of the verbal intraoperative frozen section report and the person notified shall be recorded. Issue 3, 5 January 2007 Page 6 of 7
9 Acknowledgements 1. Prof. Dr. Looi Lai Meng (Chairman) University of Malaya (UM) 2. Ms. Fariza Wan Abdullah (Secretary) Department of Standards Malaysia (STANDARDS MALAYSIA) 3. Prof. Dr. Cheah Phaik Leng University of Malaya (UM) 4. Prof. Dr. Nor Hayati Othman Science University of Malaysia (USM) 5. Assoc. Prof. Isa Mohamed Rose Hospital Universiti Kebangsaan Malaysia (HUKM) 6. Dr. Wahidah Abdullah Ministry of Health Malaysia (MOH) 7. Assoc. Prof. Dr. Nazarina Abdul Rahman University of Malaya (UM) 8. Mr. Hari Govindan Ministry of Health Malaysia (MOH) 9. Mr. Loh Kum Chee Pusat Perubatan Universiti Malaya (PPUM) 10. Ms. Rahimah Rahmat Hospital Universiti Kebangsaan Malaysia (HUKM) 11. Ms. Ng Pui Wan Department of Standards Malaysia (STANDARDS MALAYSIA) 12. Ms. Rohasmizah Ismail Department of Standards Malaysia (STANDARDS MALAYSIA) 13. Ms. Siti Norehan Ishak Department of Standards Malaysia (STANDARDS MALAYSIA) Issue 3, 5 January 2007 Page 7 of 7
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