HOKLAS SC-24 - Innovation and Technology …

HOKLAS SC-24 - Innovation and Technology … HOKLAS SC-24 Issue No. 5 Issue Date : 24 June 2015 Implementation Date: 24 June 2015 Page 1 of 17 HOKLAS Supplementary Criteria No. 24 ‘Medical Testing’ Test Category - Cytopathology 1 Introduction 1.1 This supplementary criteria is an amplification and interpretation of the requirements of HKAS 002 and HOKLAS 015 for the accreditation of examinations in cytopathology within the Medical Testing test category. This document sets out only those specific requirements that require further elaboration but does not include all the accreditation requirements. Therefore, this Supplementary Criteria needs to be read in conjunction with HKAS 002, HOKLAS 015 and HOKLAS SC-33. 1.2 The checklist given in the Annex serves as guidance for laboratories to self-assess their management system and operation procedures against the requirements given in HOKLAS 015 and this document. 2 Scope of accreditation HKAS provides accreditation under HOKLAS for the following areas: 2.1 Fine needle aspiration (FNA) cytology 2.2 Gynaecological cytology (GYN cytology) General Screening 2.3 Non-gynaecological cytology (excluding FNA) Note: For molecular testing in cytopathology, please refer to HOKLAS Supplementary Criteria No. 30 „Medical Testing? - Molecular Genetics. HOKLAS SC-24 Issue No. 5 Issue Date : 24 June 2015 Implementation Date: 24 June 2015 Page 2 of 17 3 Personnel 3.1 Medical personnel 3.1.1 A qualified anatomical pathologist shall be a pathologist who has obtained postgraduate qualification in anatomical pathology (including cytology), such as the Fellowship of the Hong Kong College of Pathologists, or equivalent as advised by the College. 3.1.2 Medically qualified specialists in disciplines other than anatomical pathology shall have adequate cytology training equivalent to the level as advised by the Hong Kong College of Pathologists and similar to that of a fellow under the specialty of anatomical pathology. 3.1.3 A non-trainee medically qualified individual shall be a person medically trained but not registered with the Hong Kong College of Pathologists as specialists, who have adequate cytology training and experience and working under supervision of a qualified pathologist. 3.1.4 Additional certification in cytology is desirable for all medical personnel. 3.1.5 All medical personnel shall have continuous working experience after completion of training. Proof of proficiency is required if there is a break of service for more than 2 years. Evidence of participation in continuous cytology education is expected. 3.2 Technical personnel (referred to as “cytotechnologist”): 3.2.1 A qualified cytotechnologist shall have registration with the Hong Kong Medical Laboratory Technologists (MLT) Board, certification by passing CT (International Academy of Cytology) examination or equivalent, and continuation of work in cytology after certification. Proof of proficiency is required if there is a break of service for more than 2 years. Evidence of participation in continuous cytology education is expected. 3.2.2 A supervisory-level cytotechnologist shall be a qualified cytotechnologist with at least 5-year continuous working experience in cytology and Part I registration with the MLT Board. 3.3 Workload 3.3.1 There shall be a written workload policy with evidence of documentation. HOKLAS SC-24 Issue No. 5 Issue Date : 24 June 2015 Implementation Date: 24 June 2015 Page 3 of 17 There shall be sufficient qualified personnel available to handle the volume and variety of cytology cases submitted to the laboratory. 3.3.2 Screening workload limits for GYN cytology: 3.3.2.1 A cytotechnologist performing either primary screening or re-screening manually without other duties shall screen no more than 100 slides per 24 hours (in no less than an 8-hour working period) or average 12.5 slides per hour. A part-time cytotechnologist shall observe the same workload limits. 3.3.2.2 An anatomical pathologist should aim to report a minimum of 20 abnormal cases per month in order to maintain diagnostic acumen. 3.3.2.3 If there is no screener in the laboratory and the anatomical pathologist performs primary screening as well as reporting, he or she shall be bound by the same workload limits as for cytotechnologist screeners. 3.3.3 An anatomical pathologist should aim at reporting no less than 750 cytology (GYN and non-GYN together) cases per year in order to maintain diagnostic acumen. 3.3.4 A cytotechnologist should aim at examining no less than 3000 (GYN and non-GYN together) cases per year in order to maintain screening skill. 3.3.5 If the minimum number respectively stated in clause 3.3.3 and 3.3.4 is not met, the laboratory should design other systems that verify the attainment of screening skill of the cytotechnologist(s) and/or the maintenance of diagnostic acumen of the anatomical pathologist(s). 3.3.6 To ensure adequate exposure to a wide variety of cases, the laboratory should handle a minimum of around 500 abnormal smears per year. If this number is not met due to the setting of the laboratory, the laboratory should design other systems to maintain the screening skills and diagnostic acumen. The recommended standards as stated above in clause 3.3.2 to 3.3.4 should be followed. 4 Accommodation and environmental conditions 4.1 For laboratories running an FNA clinic, there shall be an area for patients to rest HOKLAS SC-24 Issue No. 5 Issue Date : 24 June 2015 Implementation Date: 24 June 2015 Page 4 of 17 after undergoing the procedure. Simple resuscitation equipment shall be available at that area. 4.2 The screening area shall be well-lit and suitable for work requiring a high degree of concentration. The workstation design shall satisfy ergonomic principles. 4.3 All fresh non-GYN specimens and FNA materials shall be handled in a biosafety cabinet. 4.4 When the laboratory is responsible for operating a fine needle aspiration clinic, appropriate safety instructions shall be provided to the sample collectors and operators to handle all aspirates for smear preparation in a biosafety cabinet when available. Where the aspirate has been collected at sites where a biosafety cabinet is not installed, the laboratory shall provide appropriate safety instructions to the collectors and operators to ensure that appropriate personal protective equipment shall be worn during operation and precautionary measures are also taken to protect other personnel in the surrounding area. 5 Laboratory equipment, reagents and consumables 5.1 Manual staining system shall be available as back up if auto-stainer and auto-coverslipper are used. 5.2 If the laboratory uses high throughput automated specimen processing machines, suitable back up system or arrangement capable of handling similar workload should be in place. 5.3 There shall be adequate facilities that permit simultaneous viewing of microscopic slides by at least two persons. 5.4 Performance of all equipment, reagents and consumable that would affect the quality of examination results (e.g. autostainers and stains), shall be validated or verified before putting into service. 6 Pre-examination processes 6.1 A manual for the operation of FNA clinics shall be available. The manual should cover the nature of the procedure, instructions to the patient, the role of assisting technician, the need for female chaperon and consent form, etc. HOKLAS SC-24 Issue No. 5 Issue Date : 24 June 2015 Implementation Date: 24 June 2015 Page 5 of 17 6.2 Upon receipt of every glass slide, it shall be properly and adequately identified by marking the patient?s name and another identifier on it. The identifiers shall be identical to those on the request form. 7 Examination processes 7.1 There shall be a hierarchical system for cytology screening (sequential review of the same case, when indicated, by individuals with increasing levels of experience/responsibility). 7.2 Peer review on difficult cases before reporting should be encouraged and facilitated. 7.3 In cases of apparent discrepancy in diagnosis between the current sample and previous samples from the patient, previous cytologic and histologic results shall be retrieved and reviewed. 8 Ensuring quality of examination results 8.1 General 8.1.1 There should be a feedback mechanism to inform the cytotechnologist when the final diagnosis in the report is different from the cytotechnologist?s interpretation. 8.2 Non-gynecological cytology cases 8.2.1 The immediate preceding negative examination results from the same site or organ should be reviewed when significant abnormalities are identified in the current sample. 8.2.2 An effort shall be made to obtain cytology/histology correlation in cases with positive cytologic findings. The definition of significant discrepancy used by the laboratory shall be defined and documented. The performance of the laboratory shall be monitored according to its defined percentage of acceptable performance. The Laboratory should make reasonable efforts at obtaining correlation of all positive non-gynaecological cases, with record of actions taken if not achieved. 8.2.3 If significant disparities exist between the histologic and cytologic diagnoses that may affect current patient management, these shall be HOKLAS SC-24 Issue No. 5 Issue Date : 24 June 2015 Implementation Date: 24 June 2015 Page 6 of 17 reconciled in the report with appropriate recommendations. 8.3 Gynecologic cervical cytology cases 8.3.1 The method for assessing specimen adequacy shall be standardized and consistently applied. The current version of the Bethesda system is recommended. 8.3.2 All disparities found between the histologic and cytologic diagnoses that may have impact on current patient management shall be reconciled in the report with appropriate recommendations or actions. 8.3.3 Statistical records to be maintained shall include proportion of unsatisfactory specimen, proportion of negative, atypical cellular changes, low grade and high-grade lesions. 8.3.4 An effort shall be made to obtain cytology/histology correlation in cases with HSIL or above. The laboratory shall define its target percentage of correlation (<= 1 tier difference) for cases with a definite cytological diagnosis of HSIL to be confirmed on cervical histology within 6 month?s time. The laboratory should aim to obtain 100% correlation of all gynecologic cervical cytology cases with HSIL or above, with record of actions taken if not achieved. 8.3.5 There shall be a re-screening of 10% randomly selected negative cases prior to reporting or rapid re-screening of all negative cases prior to reporting. For automated screening or re-screening, appropriate evidence-based protocol should apply. 8.3.6 There shall be a policy for re-screening of negative smears or slides in high risk cases by a supervisory level cytotechnologist or a qualified anatomical pathologist as defined in clause 3.1.1 or a pathology trainee under supervision by a qualified anatomical pathologist. 8.3.7 The number of cases with significant discrepancy in diagnoses found on re-screening of cytology slides or histology-cytology correlation shall be recorded. 8.4 A laboratory may enroll in External Quality Assessment Schemes (EQAS) as a single entity. The return of EQAS results shall be in accordance with routine procedures for reporting patient samples. HOKLAS SC-24 Issue No. 5 Issue Date : 24 June 2015 Implementation Date: 24 June 2015 Page 7 of 17 8.5 All individuals involved in reporting examination results shall examine relevant EQAS slides independently and record his/her own results. A record of individual performance in examining these EQAS slides should be available to the Laboratory Director and be available for examination by the assessment team. 8.6 Laboratories should take part in EQAS that cover the accredited examinations. f EQAS is not available, interlaboratory comparisons should be arranged. I Failing both, the laboratory should record the effort they have made in sourcing appropriate EQAS and their attempt to arrange interlaboratory comparisons. 9 Post-examination processes 9.1 The minimum retention periods for the following records and specimens shall be: Materials Minimum Retention period Request forms 3 years Copies of cytology reports 20 years Cytology slides for GYN screening 6 years Cytology slides (all others) 10 years Residual cytology material 7 days after reporting 10 Reporting of results 10.1 Report sign-out policy: 10.1.1 Non-GYN exfoliative cytology 10.1.1.1 All non-GYN exfoliative cytology with the exception of “saliva only” sputum shall be re-screened and signed out by a qualified anatomical pathologist (or qualified pathologist as advised by the HKCPath) or a pathology trainee under supervision by a qualified anatomical pathologist. HOKLAS SC-24 Issue No. 5 Issue Date : 24 June 2015 Implementation Date: 24 June 2015 Page 8 of 17 10.1.1.2 Non-GYN exfoliative cytology negative reports can also be signed out by non-trainee medically qualified individuals as defined in clause 3.1.3 with appropriate experience and under supervision of a qualified anatomical pathologist. 10.1.2 GYN cervical cytology 10.1.2.1 Negative cases can be delegated to a qualified cytotechnologist or non-trainee medically qualified individuals under supervision and with appropriate experience for signing reports. All other cases shall be reported by a qualified anatomical pathologist (or qualified pathologist as advised by the HKCPath) or a pathology trainee under supervision by a qualified anatomical pathologist. 10.1.2.2 Negative smears or slides with previous high risk history shall be eported by a supervisory level cytotechnologist, or a qualified r anatomical pathologist (or qualified pathologist as advised by the HKCPath) or a pathology trainee under supervision by a qualified anatomical pathologist. 10.2 A descriptive diagnosis shall be used for cytology reporting. The current version of Bethesda system should preferably be used for gynecologic cytology reporting. 10.3 There shall be provision for comments and recommendations as required by a qualified anatomical pathologist in the reports. 10.4 The laboratory shall use a consistent diagnostic coding system for reporting. - End - HOKLAS SC-24 Annex: Checklist on compliance with HOKLAS requirements – Cytopathology Page 9 of 17 Issue No. 5 Clause Clause Lab’s (HOKLAS (HOKLAS Assessment Team’s remarks / Document thth1 015, 5 * Y N NA HOKLAS Requirement 015, 4questions to be asked at the Reference or edition and edition and laboratory 2Remarks relevant SC) relevant SC) Please ensure that the General Checklist (HOKLAS 021) is also completed for each discipline. Discipline0B Specific Technical Requirements Personnel1B 5.1 5.1 Medical Personnel2B ? Have the laboratory?s medical personnel had continuous working experience SC-24 3.1.5 SC-24 3.1.5 after completion of training and is there proof of proficiency if there is a break of service for more than 2 years? Technical Personnel3B ? Have the laboratory?s cytotechnologists obtained registration with the Hong SC-24 3.2.1 SC-24 3.2.1 Kong MLT Board, certification by passing CT (International Academy of Cytology) examination or equivalent, and continued to work in cytology after certification? ?Is there any proof of proficiency when a cytotechnologist has a break of service SC-24 3.2.1 SC-24 3.2.1 for more than 2 years? ? Has the laboratory?s supervisory-level cytotechnologist obtained Part SC-24 3.2.2 SC-24 3.2.2 I-registration with the Hong Kong MLT Board, certification by passing CT (International Academy of Cytology) examination or equivalent, and had continuous working experience in cytology for at least 5 years? Workload ? Is there a written workload policy with evidence of documentation to SC-24 3.3.1 SC-24 3.3.1 demonstrate that there are sufficient qualified personnel available to handle the volume and variety of cytology cases submitted to the laboratory? Note: 1. The assessor should concentrate on items marked with a ?; other items will be checked by the team leader. 2. Please put down the laboratory?s document reference(s) where there are descriptions or procedures related to the requirement. HOKLAS SC-24 Annex: Checklist on compliance with HOKLAS requirements – Cytopathology Page 10 of 17 Issue No. 5 Clause Clause Lab’s (HOKLAS (HOKLAS Assessment Team’s remarks / Document thth1 015, 5 * Y N NA HOKLAS Requirement 015, 4questions to be asked at the Reference or edition and edition and laboratory 2Remarks relevant SC) relevant SC) ? Does a cytotechnologist performing either primary screening or re-screening SC-24 SC-24 manually without other duties screen no more than 100 slides per 24 hours (in no 3.3.2.1 3.3.2.1 less than an 8-hour working period) or average 12.5 slides per hour? Does a part-time cytotechnologist observe the same workload limits? ? If there is no screener in the laboratory and the pathologist performs primary SC-24 SC-24 screening as well as reporting, is he or she bound by the same workload limits as 3.3.2.3 3.3.2.3 for cytotechnologist screeners? ? Does each pathologist report a minimum of 750 cytology (GYN and non-GYN SC-24 3.3.3 SC-24 3.3.3 together) cases per year in order to maintain diagnostic acumen? ?Does each cytotechnologist screen a minimum of 3000 (GYN and non-GYN SC-24 3.3.4 SC-24 3.3.4 together) cases per year in order to maintain screening skill? ? If this minimum no. of cases per year is not met, is there any other system SC-24 3.3.5 SC-24 3.3.5 established to verify the attainment of screening skill of the cytotechnologist? ? Does the laboratory handle a minimum of around 500 abnormal smears per year? SC-24 3.3.6 SC-24 3.3.6 If this minimum number is not met, is there any other system established to SC-24 3.3.6 SC-24 3.3.6 ? maintain the screening skills and diagnostic acumen? 4BAccommodation and environmental conditions 5.2 5.2 ?Is the screening area of the laboratory well-lit and conducive to concentrated 5.2.2 5.2.5 work with ergonomic workstation? ? Are non-GYN specimens and FNA materials handled in a biosafety cabinet? SC-24 4.3 SC-24 4.3 Note: 1. The assessor should concentrate on items marked with a ?; other items will be checked by the team leader. 2. Please put down the laboratory?s document reference(s) where there are descriptions or procedures related to the requirement. HOKLAS SC-24 Annex: Checklist on compliance with HOKLAS requirements – Cytopathology Page 11 of 17 Issue No. 5 Clause Clause Lab’s (HOKLAS (HOKLAS Assessment Team’s remarks / Document thth1 015, 5 * Y N NA HOKLAS Requirement 015, 4questions to be asked at the Reference or edition and edition and laboratory 2Remarks relevant SC) relevant SC) ? Are appropriate safety instructions provided to sample collectors and operators to N/A SC-24 4.4 handle all aspirates for smear preparation in a biosafety cabinet? ? Where the aspirates are collected at sites where a biosafety cabinet is not N/A SC-24 4.4 installed, does the laboratory provide appropriate safety instructions to the collectors and operators to ensure that appropriate personal protective equipment are worn during operation and precautionary measures are also taken to protect other personnel in the surrounding area? Laboratory 7Bequipment, reagents and consumables 5.3 5.3 Automated Machines and Systems ? If computer-assisted automatic screening and re-location machines for cervical 5.3.11 5.3.13 cytology operated both for primary screening or quality assurance purpose, is the quality control in the laboratory maintained in accordance to the manufacturer?s manual and in strict compliance with prevailing standards established by professional bodies and evidence based studies? Reagents ? Are all working solutions of cytology stains properly labelled and dated? 5.3.4 5.3.2.7 ? Are all cytology stains and reagents stored as recommended by the manufacturer 5.3.4 5.3.2.7 and used within their indicated expiration date? ? Are Papanicolaou staining solutions, alcohol and xylene filtered or replaced 5.3.4 5.3.2.7 regularly? Note: 1. The assessor should concentrate on items marked with a ?; other items will be checked by the team leader. 2. Please put down the laboratory?s document reference(s) where there are descriptions or procedures related to the requirement. HOKLAS SC-24 Annex: Checklist on compliance with HOKLAS requirements – Cytopathology Page 12 of 17 Issue No. 5 Clause Clause Lab’s (HOKLAS (HOKLAS Assessment Team’s remarks / Document thth1 015, 5 * Y N NA HOKLAS Requirement 015, 4questions to be asked at the Reference or edition and edition and laboratory 2Remarks relevant SC) relevant SC) 5.4 5.4 Pre-examination processes ?Is there a manual for the operation of the FNA Clinic, including the nature of the SC-24 6.1 SC-24 6.1 procedure, instructions to the patient, the role of assisting technician, the need for female chaperon and consent form, etc.? ?In the primary sample collection manual, do the instructions include the preferred 5.4.3 5.4.2 (d) method for smear preparation and proper fixation of slides (FNA and GYN specimens)? ?Do the instructions include the method of collection and proper fixation of all 5.4.3 5.4.2 (d) non-gynecological specimens (sputum, urine, gastric washings, body fluids, bronchial aspirations, fine needle aspirations, etc.)? 5.5 Examination processes Preparation of diagnostic smears/slides8B ? Are all stains checked for predicted staining characteristics each day of use? 5.5.2 5.5.1.2 / 5.3.2.3 ? Is there a written policy ensuring that non-gynecologic specimens with a high 5.5.3 5.5.3 (l) potential for cross-contamination are processed and stained separately from other specimens? ? Are the cellular and nuclear details of sufficient quality for diagnosis? 5.5.3 5.6.2.2 ? Is there a documented evidence of daily review of the technical quality of cytologic 5.5.3 5.6.2.2 preparations by the supervisory cytotechnologist or pathologist and that the problems identified are documented and investigated? Note: 1. The assessor should concentrate on items marked with a ?; other items will be checked by the team leader. 2. Please put down the laboratory?s document reference(s) where there are descriptions or procedures related to the requirement. HOKLAS SC-24 Annex: Checklist on compliance with HOKLAS requirements – Cytopathology Page 13 of 17 Issue No. 5 Clause Clause Lab’s (HOKLAS (HOKLAS Assessment Team’s remarks / Document thth1 015, 5 * Y N NA HOKLAS Requirement 015, 4questions to be asked at the Reference or edition and edition and laboratory 2Remarks relevant SC) relevant SC) Screening ? Are there adequate and up-to-date references in cytopathology? 5.5.4 5.5.1.1 ?Is there a hierarchical method of cytology screening (sequential review of same SC-24 7.1 SC-24 7.1 specimen, when indicated, by individuals with increasing levels of experience/responsibility)? ? Is there a written criteria for referral of specimens to a supervisory level 5.5.3 4.5.1 cytotechnologist and pathologist? ?In case of apparent discrepancy in diagnosis with prior samples received from the SC-24 7.3 SC-24 7.3 patient, are the previous cytologic and histologic results searched for and reviewed? Ensuring quality of examination results 5.6 ? Is there a system in place to evaluate and document the ongoing performance of 5.6.1 5.6.2.3 individuals who do cytology screening against the overall annual statistics for the laboratory as a whole? ?Is there a documentation of each individual?s diagnostic discrepancies and 5.6.1 5.6.2.3 corrective action taken? For non-gynecological cytology cases ? Is there any feedback mechanism in place when the final diagnosis in the report is SC-24 8.1.1 SC-24 8.1.1 different from the cytotechnologist?s interpretation? Note: 1. The assessor should concentrate on items marked with a ?; other items will be checked by the team leader. 2. Please put down the laboratory?s document reference(s) where there are descriptions or procedures related to the requirement. HOKLAS SC-24 Annex: Checklist on compliance with HOKLAS requirements – Cytopathology Page 14 of 17 Issue No. 5 Clause Clause Lab’s (HOKLAS (HOKLAS Assessment Team’s remarks / Document thth1 015, 5 * Y N NA HOKLAS Requirement 015, 4questions to be asked at the Reference or edition and edition and laboratory 2Remarks relevant SC) relevant SC) ?Has the laboratory reviewed the immediate preceding negative examination results SC-24 8.2.1 SC-24 8.2.1 from the same site or organ when significant abnormalities are identified in the current sample? ?Has the laboratory made an effort to obtain cytology/histology correlation in SC-24 8.2.2 SC-24 8.2.2 cases with positive cytologic findings? ? Has the laboratory defined “significant discrepancy”? SC-24 8.2.2 SC-24 8.2.2 ? Does the laboratory monitor its own performance in accordance to the defined SC-24 8.2.2 SC-24 8.2.2 percentage of acceptable performance with respect to cytology/histology correlation? ?If disparities are found between the histologic and cytologic diagnoses that may SC-24 8.2.3 SC-24 8.2.3 have an impact on current patient management, are they reconciled in the report with appropriate recommendations or actions? For gynecologic cervical cytology cases ? Is there any feedback mechanism in place when the final diagnosis in the report is SC-24 8.1.1 SC-24 8.1.1 different from the cytotechnologist?s interpretation? ? Is the method for assessing specimen adequacy standardized and consistently SC-24 8.3.1 SC-24 8.3.1 applied? ? Are there guidelines for comments and follow-up recommendations and are these 5.6.1 5.6.2.1 consistently applied? ? If disparities are found that may have impact on current patient management, are SC-24 8.3.2 SC-24 8.3.2 they reconciled in the report with appropriate recommendations or actions? Note: 1. The assessor should concentrate on items marked with a ?; other items will be checked by the team leader. 2. Please put down the laboratory?s document reference(s) where there are descriptions or procedures related to the requirement. HOKLAS SC-24 Annex: Checklist on compliance with HOKLAS requirements – Cytopathology Page 15 of 17 Issue No. 5 Clause Clause Lab’s (HOKLAS (HOKLAS Assessment Team’s remarks / Document thth1 015, 5 * Y N NA HOKLAS Requirement 015, 4questions to be asked at the Reference or edition and edition and laboratory 2Remarks relevant SC) relevant SC) ?Are statistical records maintained which include proportion of unsatisfactory SC-24 8.3.3 SC-24 8.3.3 specimen, proportion of negative, atypical cellular changes, low grade and high-grade lesions? ? Has the laboratory made an effort to obtain cytology/histology correlation in SC-24 8.3.4 SC-24 8.3.4 cases with HSIL or above? ? Has the laboratory defined its target percentage of correlation? SC-24 8.3.4 SC-24 8.3.4 ? For quality control of cervical cytology, does the laboratory has a system of SC-24 8.3.5 SC-24 8.3.5 re-screening of 10% randomly selected negative cases prior to reporting or rapid re-screening of all negative cases prior to reporting? ? If automated screening or re-screening is carried out, does it apply an SC-24 8.3.5 SC-24 8.3.5 evidence-based protocol? ?Is there a policy for re-screening of current negative smears or slides in high-risk SC-24 8.3.6 SC-24 8.3.6 cases by a supervisory level cytotechnologist or a qualified anatomical pathologist (or qualified pathologist as advised by the HKCPath) or a pathology trainee under supervision? ?Is the number of cases with significant discrepancy found on re-screening of SC-24 8.3.7 SC-24 8.3.7 cytology slides or histology – cytology correlation recorded? ?Are the available negative smears and histologic material for the prior 3 years 5.6.1 5.6.2.3 reviewed whenever significant atypia (HSIL or above, AG-US favor neoplastic or above, etc.) is identified? Note: 1. The assessor should concentrate on items marked with a ?; other items will be checked by the team leader. 2. Please put down the laboratory?s document reference(s) where there are descriptions or procedures related to the requirement. HOKLAS SC-24 Annex: Checklist on compliance with HOKLAS requirements – Cytopathology Page 16 of 17 Issue No. 5 Clause Clause Lab’s (HOKLAS (HOKLAS Assessment Team’s remarks / Document thth1 015, 5 * Y N NA HOKLAS Requirement 015, 4questions to be asked at the Reference or edition and edition and laboratory 2Remarks relevant SC) relevant SC) Post examination processes 5.7 Are minimum retention periods for the following met:5B SC-24 9.1 SC-24 9.1 ? Cytology report copies – 20 years? ? Cytology slides for GYN screening – 6 years? ? Cytology slides (all others) – 10 years? ? Residual cytology material – 7 days after reporting? N.B. Other records are required by HKAS to be retained for at least three years. Reporting of results6B 5.8 ? Are all non-GYN exfoliative cytology with the exception of “saliva only” sputum SC-24 SC-24 re-screened and signed out by a qualified anatomical pathologist (or qualified 10.1.1.1 10.1.1.1 pathologist as advised by the HKCPath) or pathology trainee under supervision? ? Do non-trainee medically qualified individuals who sign out non-GYN SC-24 SC-24 exfoliative cytology negative reports have appropriate experience and are they 10.1.1.2 10.1.1.2 under supervision of a qualified pathologist? Note: 1. The assessor should concentrate on items marked with a ?; other items will be checked by the team leader. 2. Please put down the laboratory?s document reference(s) where there are descriptions or procedures related to the requirement. HOKLAS SC-24 Annex: Checklist on compliance with HOKLAS requirements – Cytopathology Page 17 of 17 Issue No. 5 Clause Clause Lab’s (HOKLAS (HOKLAS Assessment Team’s remarks / Document thth1 015, 5 * Y N NA HOKLAS Requirement 015, 4questions to be asked at the Reference or edition and edition and laboratory 2Remarks relevant SC) relevant SC) ? Are all GYN cervical cytology except negative cases without previous high9B-risk SC-24 SC-24 history reported by a qualified anatomical pathologist (or qualified pathologist as 10.1.2.1 10.1.2.1 advised by the HKCPath) or pathology trainee under supervision? ? Are current negative cases with previous high-risk history reported by a SC-24 SC-24 supervisory level cytotechnologist, or a qualified anatomical pathologist (or 10.1.2.2 10.1.2.2 qualified pathologist as advised by the HKCPath) or pathology trainee under supervision? ? Is specimen adequacy for diagnostic purposes indicated in the report? 5.8.3 (k) 5.8.3 (l) ? Is a descriptive diagnosis used for cytology reporting? SC-24 10.2 SC-24 10.2 ?Is there any provision for comments and recommendations as required? SC-24 10.3 SC-24 10.3 ? Is there a consistent system for diagnostic coding? SC-24 10.4 SC-24 10.4 Note: 1. The assessor should concentrate on items marked with a ?; other items will be checked by the team leader. 2. Please put down the laboratory?s document reference(s) where there are descriptions or procedures related to the requirement.