Pathology Services Accreditation (General) Regulations 2001

i Pathology Services Accreditation (General) Regulations 2001 S.R. No. 11/2001 TABLE OF PROVISIONS Regulation Page 1. Objectives 1 2. Authorising provisions 2 3. Definitions 2 4. Acceptable quality control programs 2 5. Minimum standards and requirements 3 6. Prescribed science 3 7. Minimum qualifications for persons in charge 3 8. Minimum qualifications for persons conducting tests 4 9. Register 5 10. Accreditation fees 5 11. Application and renewal form 5 12. Prohibited advertising 5 13. Transitional 6 14. Expiry 6 __________________ SCHEDULES 7 SCHEDULE 1—Minimum standards and requirements 7 SCHEDULE 2—Prescribed sciences 12 SCHEDULE 3—Application form 13 ═══════════════ ENDNOTES 18 -- 1 of 20 -- 1 STATUTORY RULES 2001 S.R. No. 11/2001 Pathology Services Accreditation Act 1984 Pathology Services Accreditation (General) Regulations 2001 The Governor in Council makes the following Regulations: Dated: 27 February 2001 Responsible Minister: JOHN THWAITES Minister for Health HELEN DOYE Clerk of the Executive Council 1. Objectives The objectives of these Regulations are to— (a) prescribe minimum standards and other requirements for accredited pathology services; (b) prescribe minimum qualifications for persons in charge of accredited pathology services and persons conducting pathology tests; (c) prohibit certain advertising practices; (d) prescribe various fees, forms and other matters authorised or required to be prescribed by the Pathology Services Accreditation Act 1984. -- 2 of 20 -- S.R. No. 11/2001 Pathology Services Accreditation (General) Regulations 2001 2 2. Authorising provisions These Regulations are made under section 40 of the Pathology Services Accreditation Act 1984. 3. Definitions In these Regulations— "Criteria for Assessment of External Quality Assurance Programs" means the document of the same name produced by NPAAC in the following volumes— (a) Volume 1, Clinical Biochemistry, Haematology, Microbiology, AGPS, Canberra, 1995; (b) Volume 2, Anatomical Pathology, Cytology, Transfusion Serology, AGPS, Canberra 1996; "NPAAC" means the National Pathology Accreditation Advisory Council; "Retention of Laboratory Records and Diagnostic Material" means the document of the same name produced by NPAAC, AGPS, Canberra, 1998; "the Act" means the Pathology Services Accreditation Act 1984. 4. Acceptable quality control programs An external quality assurance program is an acceptable quality control program if it complies with the requirements of the NPAAC document "Criteria for Assessment of External Quality Assurance Programs". r. 2 -- 3 of 20 -- S.R. No. 11/2001 Pathology Services Accreditation (General) Regulations 2001 3 5. Minimum standards and requirements The minimum standards and requirements to apply to accredited pathology services generally are specified in Schedule 1. 6. Prescribed science For the purpose of the definition of "scientist" in section 3(1) of the Act, a prescribed science is a science specified in Schedule 2. 7. Minimum qualifications for persons in charge The prescribed minimum qualifications required for the person in charge of each category of accredited pathology service are specified in Table 7. TABLE 7 — Minimum qualifications for persons in charge Category Minimum qualifications G, B M, S, U A pathologist1. A scientist2 who has a postgraduate qualification in a prescribed science3 and 5 years experience working in a pathology service since obtaining the postgraduate qualification. A scientist who has at least 10 years experience working in a pathology service since obtaining the qualification referred to in paragraph (a), (b) or (c) of the definition of "scientist" in section 3(1) of the Act. A medical practitioner. A medical practitioner, pathologist or scientist. r. 5 -- 4 of 20 -- S.R. No. 11/2001 Pathology Services Accreditation (General) Regulations 2001 4 8. Minimum qualifications for persons conducting tests (1) The prescribed minimum qualifications required for a person conducting tests in each category of accredited pathology service are as follows— (a) a medical practitioner; (b) a pathologist; (c) a scientist. (2) There are no prescribed minimum qualifications required for a person conducting tests in a category M accredited pathology service, if the person is performing the test under the direct supervision of a medical practitioner. (3) There are no prescribed minimum qualifications required for a person conducting tests in a category U accredited pathology service, if the person is performing the test under the supervision of a medical practitioner, a pathologist or a scientist. (4) There are no prescribed minimum qualifications required for a person conducting tests in a category G, B or S accredited pathology service if the test is performed under the direct supervision of a medical practitioner, a pathologist or a scientist who— (a) is qualified in the relevant division of pathology; or (b) has conducted tests of that kind for an aggregate period of at least one year during the 5 years before commencement of the supervision. r. 8 -- 5 of 20 -- S.R. No. 11/2001 Pathology Services Accreditation (General) Regulations 2001 5 9. Register The following particulars are prescribed for the purposes of section 11(1)(e) of the Act— (a) the date of initial accreditation of each pathology service accredited under section 13(8)(a) of the Act; (b) the date of initial deemed accreditation of each pathology service deemed to be accredited under section 18A of the Act; (c) an accreditation number for each accredited pathology service. 10. Accreditation fees The prescribed fees for accreditation or for renewal of accreditation of a pathology service are— (a) for a category G or B pathology service, $410; (b) for a category M, S or U pathology service, $176. 11. Application and renewal form The form of an application for accreditation or for renewal of accreditation of a pathology service is the form set out in Schedule 3. 12. Prohibited advertising The proprietor or person in charge of a pathology service must not make any written or oral statement or place an advertisement or cause or permit any other person to make any written or oral statement or place an advertisement which— (a) is false, misleading or deceptive; or (b) is designed to mislead or deceive; or r. 9 -- 6 of 20 -- S.R. No. 11/2001 Pathology Services Accreditation (General) Regulations 2001 6 (c) deprecates any other pathology service; or (d) compares pathology services; or (e) offers any reward or inducement, including any reward or inducement calculated to attract referral of patients by the person receiving the reward or inducement. Penalty: 5 penalty units. 13. Transitional A person who has conducted tests in a category of pathology service for an aggregate period of at least 5 years in the 10 years before 2 March 1990 is to be treated as having the prescribed minimum qualifications to conduct tests in that category of pathology service. 14. Expiry These Regulations cease to have force and effect on 30 June 2003. __________________ r. 13 -- 7 of 20 -- S.R. No. 11/2001 Pathology Services Accreditation (General) Regulations 2001 7 SCHEDULES Regulation 5 SCHEDULE 1 MINIMUM STANDARDS AND REQUIREMENTS 1. Staff Sufficient professional and support staff with adequate training, experience and qualifications must be provided at all times to supervise and conduct the work of the pathology service. 2. Space Sufficient effective space and facilities must be provided for the satisfactory performance of the pathology service. 3. Storage facilities Sufficient safe and secure storage facilities must be provided for the satisfactory performance of the pathology service. 4. Bench space 4.1. Sufficient conveniently located bench space must be provided for the efficient handling of specimens, performance of tests, and housing of equipment and reagents. 4.2. Bench surfaces must be of a material and quality so as to allow easy cleaning, disinfecting and decontamination. 5. Emergency power Emergency power must be provided for essential functions in case of power failure except for a category M or U pathology service. 6. Water supply Adequate water supply must be provided for the satisfactory performance of the pathology service. Sch. 1 -- 8 of 20 -- S.R. No. 11/2001 Pathology Services Accreditation (General) Regulations 2001 8 7. Staff amenities Separate staff amenities areas must be located convenient to and distinct from the work areas of the pathology service. 8. Equipment 8.1. Equipment provided in the pathology service must be appropriate to the tests performed at the service. 8.2. Equipment must be in good working order. 8.3. Operating manuals for all equipment must be readily available and staff handling the equipment must be able to check the critical operating characteristics and must do so at intervals appropriate to the equipment and workload. 8.4. Equipment must be properly serviced and maintained. 8.5. Records of calibration, repairs and maintenance of each item of equipment must be kept and retained in compliance with the NPAAC document "Retention of Laboratory Records and Diagnostic Material". 8.6. Cleaning and decontamination of instruments and equipment must be performed on a regular basis. 8.7. Voltage stabilisers must be fitted if electrical power fluctuations are liable to occur which would adversely affect laboratory instruments. 9. Blood bank refrigeration equipment Blood bank refrigeration equipment must have a continuous temperature monitor and must be fitted with appropriate alarm systems that indicate a temperature deviation or equipment failure. 10. Methods manual 10.1. A methods manual listing all methods and procedures authorised for use in the pathology service must be available in the work areas of the pathology service. 10.2. The methods manual must be reviewed at least annually and reauthorised by the person in charge of the pathology service after each review. 10.3. The methods manual must include the following information— (a) the source for or reference for a procedure; (b) the date the test was last reviewed; Sch. 1 -- 9 of 20 -- S.R. No. 11/2001 Pathology Services Accreditation (General) Regulations 2001 9 (c) the calibration standards and controls required; (d) the step-by-step outline of the test method; (e) the instructions for handling specimens and reporting results including appropriate reference ranges; (f) identification of the person authorising the method or procedure. 11. Quality management system An efficient quality management system appropriate to the size, complexity and testing of the pathology service must be implemented by the service in accordance with Australian Standard for General Requirements for the Competence of Testing and Calibration Laboratories AS ISO/IEC 17025 published by Standards Australia on 21 December 1999. 12. Quality management manual A quality management manual must be available at the pathology service detailing the policies and operational procedures of the service including the procedures for the following matters— (a) monitoring the validity of test results; (b) corrective action to be taken after detection of testing failures and departures from documented procedures; (c) auditing the pathology service; (d) reviewing the quality system; (e) dealing with complaints. 13. Quality control Efficient internal quality control must be undertaken, as well as an acceptable external quality assurance program, if available, that will ensure that the results of the pathology service meet adequate performance standards. 14. Minimum delay for reporting A report of the results of tests must be furnished to the person requesting the tests in a timely manner commensurate with good patient care. 15. Written reports Sch. 1 -- 10 of 20 -- S.R. No. 11/2001 Pathology Services Accreditation (General) Regulations 2001 10 Reports must be in a written form either in a hard copy or electronic version and must include the following information— (a) the name of the pathology service; (b) the address of the pathology service; (c) the name of the patient or some other means of identifying the patient; (d) the date of collection of the specimen; (e) the type of specimen; (f) the date of the report; (g) the qualitative or quantitative results of the tests; (h) if appropriate, the units of concentration or activity and reference intervals; (i) the name of the person who assumes responsibility for the report. 16. Urgent reports 16.1. Urgent reports of test findings may be communicated by telephone, facsimile or other electronic transmission or by other appropriate means to responsible medical or other authorised staff. 16.2. An urgent communication which is not in written form in either a hard copy or electronic version or which does not include all the information listed in clause 15 must be followed by a full written report. 17. Confidentiality of reports A person by virtue of his or her office or employment in a pathology service must not disclose information about patients or the results of investigations except in the performance of his or her duties. 18. Records Records of results relating to patient specimens and quality control material must be kept in accordance with the NPAAC document "Retention of Laboratory Records and Diagnostic Materials". 19. Identification Sch. 1 -- 11 of 20 -- S.R. No. 11/2001 Pathology Services Accreditation (General) Regulations 2001 11 19.1. Each specimen must be fully and uniquely identified and labelled unless the specimen is totally consumed in a test performed immediately after it is taken. 19.2. Adequate techniques must be used for the correct identification and matching of specimens and results. 20. Retention of specimens Specimens must be retained by the pathology service for the period of time as specified in the NPAAC document "Retention of Laboratory Records and Diagnostic Materials". 21. Collection manual 21.1. A collection manual must be kept available for the information and use of staff at each collection centre operated by a pathology service. 21.2. The collection manual must include the following information— (a) instructions for taking specimens; (b) details of specimen identification procedures; (c) instructions on the recording of a patient's history in brief (if necessary); (d) listing of required patient details, including fasting or non-fasting, drug dosage and other appropriate information; (e) details of container storage and transport requirements; (f) arrangements for emergency collections. ————————— Sch. 1 -- 12 of 20 -- S.R. No. 11/2001 Pathology Services Accreditation (General) Regulations 2001 12 SCHEDULE 2 Regulation 6 PRESCRIBED SCIENCES Biochemistry Chemistry Cytogenetics Cytology Genetics Haematology Histopathology Immunohaematology Immunology Microbiology Molecular biology Mycology Parasitology Pathology Pharmacology Toxicology Virology ————————— Sch. 2 -- 13 of 20 -- S.R. No. 11/2001 Pathology Services Accreditation (General) Regulations 2001 13 SCHEDULE 3 Regulation 11 APPLICATION FORM Pathology Services Accreditation Act 1984 Pathology Services Accreditation (General) Regulations 2001 APPLICATION FOR ACCREDITATION OR FOR RENEWAL OF ACCREDITATION OF A PATHOLOGY SERVICE IN VICTORIA To: THE REGISTRAR, PATHOLOGY SERVICES ACCREDITATION BOARD. I/We apply for accreditation/renewal of accreditation of a pathology service and supply the following information in support of the application: NAME OF PATHOLOGY SERVICE Address of Pathology Service (to appear on register) Postcode Telephone number of Pathology Service Facsimile number of Pathology Service (where applicable) Address for communication during application (if same as above write 'AS ABOVE') Postcode Telephone number for communication during application (if same as above write 'AS ABOVE') CATEGORY FOR WHICH ACCREDITATION IS SOUGHT Sch. 3 -- 14 of 20 -- S.R. No. 11/2001 Pathology Services Accreditation (General) Regulations 2001 14 List the addresses of all Collection Centres operated by the Pathology Service NAME(S) OF PROPRIETOR(S) Address of proprietor(s) Is the proprietor an incorporated body? YES/NO (if yes, State the Name) List names and addresses* of all other pathology services conducted from separate premises owned by the proprietor(s) PERSON IN CHARGE OF PATHOLOGY SERVICE (Full Name) Address Postcode Telephone number(s) Professional details of person in charge Relevant Qualifications Institution Date Completed ___________________________________________________ Does the person in charge supervise other pathology services? YES/NO If YES, please list SUPERVISION Sch. 3 -- 15 of 20 -- S.R. No. 11/2001 Pathology Services Accreditation (General) Regulations 2001 15 How many hours per week does the person in charge supervise the pathology service? What are the normal working hours of the pathology service? What are the arrangements for supervision of the pathology service outside normal working hours? What are the arrangements for supervision of the pathology service when the person in charge is absent for short periods (e.g. a morning) and for long periods (e.g. a month or so)? STAFF Staff Numbers (effective full-time) Pathologists Other Medical Practitioners Scientists Trainee Scientists Qualified Technicians Trainee Technicians Nurses (only those involved in pathology testing) Laboratory Assistants Other (exclusive of domestic and clerical staff) Please specify. Total SUB-SPECIALTIES Please indicate the average number of specimens tested per month in each sub-specialty. Where no tests are performed in a sub-specialty write N/A for not applicable. List the external quality assurance programs in which the Sch. 3 -- 16 of 20 -- S.R. No. 11/2001 Pathology Services Accreditation (General) Regulations 2001 16 pathology service is enrolled. Please attach copies of certificates of enrolment for each of the programs listed. Sub-specialty Specimen Numbers External Quality Assurance Program Haematology Blood banking/grouping/cross- matching Clinical biochemistry Microbiology Immunology Anatomical pathology Cytology Cytogenetics Infertility/pregnancy tests APPROVAL OF TESTS For Categories M, S and U pathology services please attach a list of the tests for which Accreditation/Renewal of Accreditation is sought. INSPECTION ARRANGEMENTS Has your pathology service been inspected by an agency approved by the Board to carry out inspections? YES/NO If YES and the inspection report is available please attach a copy to this application. Sch. 3 -- 17 of 20 -- S.R. No. 11/2001 Pathology Services Accreditation (General) Regulations 2001 17 If NO or the inspection report is not yet available please attach evidence that arrangements have been made with an approved agency to perform an inspection. CERTIFICATION I/We certify that the statements made in this application and attached documents are to the best of my/our knowledge and belief true. Enclosed is the prescribed fee of $ ________________________________________________________ Signature(s) of Applicant(s) Printed Name(s) Dated / / 20 ═══════════════ Sch. 3 -- 18 of 20 -- S.R. No. 11/2001 Pathology Services Accreditation (General) Regulations 2001 18 ENDNOTES 1 Regulation 7: "Pathologist" is defined in the Act. 2 Regulation 7: "Scientist" is defined in the Act. 3 Regulation 7: See Schedule 2 for the list of prescribed sciences. Table of Applied, Adopted or Incorporated Matter Required by the Subordinate Legislation Regulations 1994 Note that the following table of applied, adopted or incorporated matter is included in accordance with the requirements of regulation 6 of the Subordinate Legislation Regulations 1994. Statutory Rule Provision Title of applied, adopted or incorporated document Matter in applied, adopted or incorporated document Regulation 4 Criteria for Assessment of External Quality Assurance Programs produced by NPAAC in the following volumes— (a) Volume 1, Clinical Bio- chemistry, Haematology, Microbiology, AGPS, Canberra, 1995; (b) Volume 2, Anatomical Pathology, Cytology, Transfusion Serology, AGPS, Canberra 1996; The whole Schedule 1 Items 8.5, 18 and 20 Retention of Laboratory Records and Diagnostic Material produced by NPAAC, AGPS, Canberra, 1998; The whole Endnotes -- 19 of 20 -- S.R. No. 11/2001 Pathology Services Accreditation (General) Regulations 2001 19 NOTES—continued Statutory Rule Provision Title of applied, adopted or incorporated document Matter in applied, adopted or incorporated document Schedule 1 Item 11 AS ISO/IEC 17025 Australian Standard for General Requirements for the Competence of Testing and Calibration Laboratories published by Standards Australia, 21 December 1999; The whole -- 20 of 20 --