150 clause 44 Evaluation of Audits Page Sof 49 tie sez ‘endment No60 IssueDate:e7e22es2 Amendment Date: medall {QUALITY SYSTEM MANUAL MMPLIQSM6 > The results of evaluation and improvement activites are included in the input tothe management review. 4142 Periodic review of requests, and sultablity of procedures and sample requirements: Lab Director! QM and authorized personnel at MHPL periodically review tre ‘examinations provided by the laboratory to ensure that they are cinicly appropriate forthe requests receive. MHPL periodically review its sample volume, collection device and Dreservative requirements for blood, urine, other body fluids, tissue and other sample types, 35 applicable, to ensure that neither insufficient nor excessive amounts of sample are collected and the sample is propetly «collected to preserve the measurand. 4443 Assessment of user feedback: MHPL seeks information relating to user perception as to whether the service has met the needs and requirements of users. The methods for ‘obtaining and using this information include cooperation with uses or thee representatives in monitoring the laboratory's performance, provided that ‘the laboratory ensures confidentiality to other users: Records are Kept of Information collected and actions taken. 4.444 Staff suggestior MHPL encourages staff to make suggestions for the improvement of ary aspect of the laboratory service, Suggestions are evaluated, implemented as appropriate and feedback provided to the staff. Records of suggestions and _action taken by the management are maintained, 4145 Internal audit: [MPL conducts Internal audits by QM to comply with requirement of ISO ‘163207 at planned intervals (once In a year) to determine whether ab "MHPLHOSUR DESIGNATION “SIGNATURE PREPARED & ISSUED BY ‘QUALITY MANAGER REVIEWED & APPROVED BY LAB DIRECTOR.(QUALITY SYSTEM MANUAL MHPLQsI6 150 Clause 4.4 ~ Evaluation of Audits Page 96 of 149 ‘we Nos 02 “Amendment No: 00 | tmebaucerenaour | amentnante medall | ‘actvites in the quality management system, technical sytem including pre- ‘examination, examination, and post examination 8) conform to the requirements of ISO 15189:2012 Stancard, NABL 12 — speci criteria for medical laboratories and to requirements established by the laboratory, and ) are implemented, effective, and maintained. ‘Audits are formerly planned organized and carried out by QM and trained Internal auditors of the laboratory to assess the performance of managerial, and technical processes of the qualty management system. The aut Programme takes into account the status and importance of the processes ‘and technical and management areas to be auited, as wellas the results of previous audits. The audit criteria, scope, frequency and methods are defined and documented. Selection of auditors and conduct of audits ensures objectivity and Impartiality ofthe aut proces. Auditors are independent ofthe activity to be audited + QW ensures that personnel at MHPL will not aut thelr own activites / department a the time of Internal Quality Aut, ‘+ Method of Auditing ~ Inspection, Observation, Enquiry, Analytical Procedure Horizontal aul. MPL has a documented procedure to define the responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (MHPLILABIQSP/«2 ~ Evaluation and Audits). 1. Determine whether documented procedures and instructions meet the requirements of the Standard 2. erty whether procedures and instructions are being implemented. ‘MHP HOSUR ‘DESIGNATION ‘SGNATURE PREPARED atssueDeY | Quaumvmanacer | PCy] [REVIEWED & APPROVED BY LAB DIRECTOR pe150 Clause 4.4 Evaluation of Audits Page 97 of 149 (QUALITY SYSTEM MANUAL, MHPLIQSM oO mon Ferment 00 ImveDnteerenasma | amendment Deter medall 3. amine thd andquty record nue for cmplance wh specified procedure. 44 _Asceranto ensure the ate; understanding of procedures, instrictons andfolowp. 5 Observe the tasking cred out to se whether these conform to ‘pected norms and procedures. Personne responsible fr the area being ated ensure that appropriate action is promptly undertaken when nonconfomites are iene. Corrective actions are taken without undue delay to eliminate the aus of the detected nonconfrmities. The results of interna aus ae submited tolaboratry management during management review 44986 Rls Management: MPL trough the quality manager evaluates the impact of work processes ard potenti aires on examination resus asthe affect patient safety, and modity processes to reduce or eliminate the identied sks. The decisions and action taken re documented. 4947 Quay Indicators: IW has xtabohed quai ndotors (deine im NABL 13) to montr and evaluate performance troughout cal aspects of preexaminatin, ‘amination and post-examinaton processes HMHPL curently monitors the following Quality Indators for contin Improvement as ndatedin 412 + TumAroundTine +Customer Feedackincidng suggestion and comple + Sample Rejection + eqas + Money evs " MHPUHOSUR ~~. ~—~—~S*C«éCESIGNATION PREPAREDAISSUED AY | QUAL MANAGER wy eveweDaarproweoey | aapnecron | pe 1[QUALITY SYSTEM MANUAL MHPLIQsM 150 Clause 4.14 ~Evaluation of Audits Page 98 of 149 Issue No: 02 ‘Amendment No: 00 tsveDateoz0na0r2 __AmendmentDste medall Equipment downtime + Sample collection and identification. ‘+ Transportation and processing of samples + Analysis and reporting ‘The process of monitoring quality Indicators are planned, which includes «establishing the objectives, methodology, interpretation, limits, action plan and duration of measurement. ‘The indicators are periodically reviewed, to ensure cheir continued appropriateness "MEPL, In consultation with the users, has established tumaround times for {2th of its examinations that reflect clinical needs. MPL. periodically {evaluate whether or not itis meeting the established turnaround times. 4.148 Reviews by external organizations: When reviews by extemal organizations (Ike NABL and cther inspection bodies) indicate the laboratory has nonconformities or potential onconformities, MHPL takes appropriate immediate ations and, 35, appropriate, corrective action or preventive action to ensure continuing compliance will the 1SO 15189:20!2 standard and NABL requirements. Records are kept ofthe reviews and of the corrective actionsand preventive actions taken and also presented in_management review, [ MHPLIWOSUR | -——DEsicnaTioN PREPARED & ISSUED BY ‘QUALITY MANAGER REVIEWED & APPROVED BY LAB DIRECTOR.QUALITY SYSTEM MANUAL (MHPLIQSM)s7 oO ISO Clause 4.15-Manogement Review Page 99 of 147 Issue Nos 02 “Amendment Nos 00 medall Issue Date: 07.02.2022 Amendment Date: — Purpose This section explains the conduct of Management Review Meeting (MRM). 8. Scope: Management Review covers all the elements and methodology for tracking the ‘tfectiveness ofthe system, customer complaints and achievements in respect of Qualty Policy and Objectives. . Responsibility: Lab Director & Quality Manager Clause & Interface: louse: 1+ Cause No 415 of 50 518932012 + Clause 4.5 of NABL 12 “pectic Criteria for Accreditation of Medical Laboratories. Interface: ‘+ MIHPLQSPjo8- Ensuring Quality of Examination Results 1+ MHPLUQSPt External Services and Supplies ‘+ MHPL/QSP/n2~ Evaluation and Audits ‘+ MHPLIQSE/3 Management Review + MHPLIQSP/4 ~ Corrective action + MHPLIQSPII5~ Preventive Action 4+ MHPLQSP/6 Resolution of Complains *+ MHPLUQSP/7 ~Control of Non Conformities TPL HOSUR DESIGNATION SIGNATURE PREPARED & ISSUED BY ‘QUALITY MANAGER a [REVIEWED & APPROVED BY LAB DIRECTOR Bee| quaurysrsrem manual | mnrugsi So dause maine medall Issue No. 02 Issue Date: 07.02.2022 - 4485, Management Review: 4854 Genera [MHP reviews the quality management system at planned intervals (Once n a Year) to ensure its continuing suitably, adequacy and effectiveness and support ‘of patent care, Management review Is done ance In year. Lab Director! QM «constitute the authorized for to conduct the management review 4952 Review Input: ‘The input to management review includes information from the resus of ‘evaluations of atleast but not ited to: 2) the periodic review of requests, and suitability of procedures and sample requirements ) assessment of use feedback; ©) staff suggestions; 46) internal audits; ©) rskmanagement; 1) use of qualtyindcators; 8) reviewsby extemal organizations; 1) results of participation in interlaboratory comparison programmes (PTIEQA, |) monitoring and resolution of complaints; 1) performance o suppliers ) identification and control of noncanformiies; |) results of continual Improvement including current status of corrective actions and preventive actions; 'm) follow-up actions from previous management reviews; MHPLHOSUR DESIGNATION SIGNATURE maeraneoassucoey | qunurvnawacen | PVC —y] reveweoaarmoveoey | iavonécton | pe=—1QUALITY SYSTEM MANUAL MHPLIQSM7 Soamaes9-homgenetiny mgr CD Issue No 02 ‘Amendment No. 00 medall IssueDate: 07022022 Amendment Date: 1") changes nthe volume and scope of wor, personnel and premises that could affect the qulty management stem; ©) Recommendations forimprovernentncudng techical requirements 44953 Revlew Activites: ‘The review analyses the input information for causes of nonconformiies, trends and pattems that indicate process problems. Tis review indudes assessing opportunites for improvement and the need for changes tothe quality management system, inddng the quality policy and quality objectives. ‘The qualty and approprateness of the laboratory's contribution to patient care shallto the extent posible alo be objectively evaluated. 4354 Review Output The output fom the management reviews are incorporated into a record that documents any decisions made and actions taken during management review relatedto: 2) Improvement of the effectiveness ofthe qualty management system and is processes, 1) improvement of sence to users ©) Resource needs. Findings and actions arsng from management reviews ae recorded and reported to laboratory staf, MPL ensures that actions arn from management review are completed within a defined timeframe. [__MRPUmosuR” | pestewaTion | ——~stewatne PREPARED & ISSUED BY (QUALITY MANAGER [REVIEWED & APPROVED BY LAB DIRECTOR.‘QUALITY SYSTEM MANUAL MMPLIQSMs oO 150 Clause 51~ Personnel Page 102 of 149 tse No 02 “Amendment No 00 | medall Issue Date: 07022022 Amendment Date: ‘A. Purpose: The purpose of this section is to ensure that the personnel performing specific operations related to testing are competent enough to carry ou the operations. 8. Scope: Requirement, Training and performance evaluation of staff tall evels. . Responsibitity: HRO and Lab Director D. Clause & Interface: louse: 1 Clause 5 of 80 s5189:2012 + Clause 5.1 of NABL 12 “Spectc Criteria for Accreditation of Medical Laboratories”. Interface: ‘+ MHPL/QsPIo4 ~ Personne! 1 MHPLIQSPIN Safety + MHPLIQSPI31~ Staff traning ‘+ MHPLIQSPi4g Procedure for personnel polices ‘+ MHPLIQSMIN Roles and Responsibly + Departmental Manual + Lab Safety Manual 5.4. Personnel: 5.11 General MHPL has documented procedure for personnel management and maintin records for all personnel to indicate compliance with requirements (MHPLILABIQSPI0g ~ Personnel) Records are maintained with HA department 5.4.2. Personnel qulifiations: MHPL has documented personnel qualifications for each postion. The ‘ualfications reflect the appropriate education, training, experience and ‘demonstrated skis needed, and are appropriate ta the tasks periormed. ‘+ MIL ensures that the authorize signatories have the necessary qualification in the concerned specialty as per the requirements of Clause 5.1.1 & 5.1 Table 2 [ MAPyHOSUR DESIGNATION ‘SIGNATURE PREPARED & ISSUED BY quauirymanacer | 2X yy = REVIEWED aw APPROVED BY | LAB DIRECTOR Ge[QUALITY SYSTEM MANUAL MHPLigsms oO 1S0 clase 5.1 ~ Personnel Page 13 of 149 issue Nos02 “Amendment No 00 | medall Ise Date:o7022022 Amendment Dates | of NABL 12 “Specific Criteria for Accreditation of Medical Laboratories” ‘demonstrate knowledge and competence inthe concemed specialty. + Technical staffs of MHPL have the necessary qualifitions as per the requirements of Clause 5.1.4 of NABL 112 “Specific Criteria for Accreditation of Medical Laboratories” ‘The personnel making judgments with reference to examinations has the applicable theoretical and practical background and experience + IF MHPL elects to provide professional judgemerts tke opinions, interpretations, predictions and value, itis given by the Lab-Ditector or authorised designee who has the applicable theoretical and practical background. 54.3. Job descriptions: MHPL has defined job descriptions that describe responsibilites, authorities and tasks forall personnel. ‘5.14 Personnel introduction tothe organizational environment: MHPL has programme (Induction training) to introduce new staff to the ‘organization, the department or area in which the person will work the terms and conditions of employment, staff facts, health and saety requirements (including fire and emergency), and occupational health services, 54.5 Training: [NPL provides traning forall personnel which includes but not limited to the following areas: a) the quality management system 1) assigned work pracesses and procedures; the applicable laboratory Information system (LIS) 4) health and safety, including the prevention or containmen: ofthe effects of adverse incidents; ©) ethics ‘mvipuwiosun” | ~~ ESIGNATION siquaruRe PREPARED & ISSUED BY quaurymanacer — | 2X] REVIEWED & APPROVED BY | _LABDIREcTOR eh(QUALITY SYSTEM MANUAL (MHPLIQSMNS Oo 150 clause 51 — Personnel Page 1040f 49 | TesueWoz2 medall tue Date 0722022 4) Confidentiatty of patient information, Personnel that are undergoing training are supervise at all times ‘The effectiveness of the traning programme Is periodically reviewed by Lab Director HRIQMiT™, 54.8 Competence assessment: 8) MIHPL assesses the competence ofeach person to perform assigned managerial ‘or technical tasks according to estabished criteria following raining. ') Al the employees are assessed in ther core working areas as well asin other ‘elated areas to ensure that they are continually sutatle and competent enough to their work requirements, 9 ‘+ Employee Performance Apprasal for managerial, technical and key support Personnel involved in testing are done as per Government Plc. *+ Assessment of all employees Is done ance in a year by Lab Director/Qualty ‘Manager andi based on their knowledge; past performance, sls, present ob respensibilties and requirements and the detals are entered in the Employee Performance Appraisal Form Employee Competency Evaluation Form. Ressresements given at regula tev und when necessary Reviews of staff performance: Im adetion to the assessment of technical competence, MHPL of HRJLab Director ensues that reviews of staff performance consider the needs of the laboratory and ofthe individual in order to maintain or improve the qualty of sevice given to the users and encourage productive working relationships. 54.8 Continuing education and professional development: ‘A continuing education programme is available to personnel who participate in ‘managerial and technical processes. Personnel at MHPL, take pat in continuing education. The effectiveness ofthe continuing education programme is periodically reewed. Tan HOSUR DeSGRATION STORE | preraneoassueoey | Qunurvnaacer | BVO ReVEWED APPROVED BY | _LABomecTon | Gpe——L{QUALITY SYSTEM MANUAL MMPLIQsms oO 150 Clause 5: Personnel Page 105 of 149, Tee Noc02 “Amendment Ho 00 | medall Issue Date: 07-02-2022 Amendment Date: ‘+ MHPL has formulated the plan with respect to the continuing education for the laboratory personnel to meet the requirements of the laboratory and the regular educational presentations; > case presentations; > review of Qualty Assurance Programme educational material and > Review of interesting or abnormal blood fis, cultures, sides ete Components of extemal continuing education may include: > regular educational presentations; > membership of relevant professional societies; and > Attendance at meetings, conferences and workshops with evidence maintained. Personnel at MHPL, take part in regular professional development or other professional isizon activites, 5.9 Personnel records: [MHPL maintains records ofthe relevant educational and professional qualifeations, ‘raining and experience, and assessments of competence ofall personnel. ‘These records are really avaiable withthe HRYLab Director andinclude but not be limited tothe followings 2) educational and professional qualifications; b) copy of certification or license, when applicable; ©) previous work experience; 8) job descriptions; ©)_ Introduction of new staf tothe laboratory environment; ‘MPL HOSUR DESIGNATION SIGNATURE PREPARED & ISSUED BY (QUALITY MANAGER REVIEWED & APPROVED BY LAB DIRECTOR.QUALITY SYSTEM MANUAL 150 clause 5: ~ Personnel Issue Date: 0702-2022 ‘Amendment No: 00 ‘Amendment Date: 1) traningin current job tasks; 8) competency assessments; MHPLIQSMs oO Page 106 of 149 medall 1) records of continuing education and achievements; 1) reviews of staff performance; |) reports of accidents and exposure to occupational hazards; )_ immunization status, when relevant to assigned duties 1) OfferLeter "MPL HOSUR DESIGNATION SIGNATURE ‘PREPARED & ISSUED BY QUALITY MANAGER a REVIEWED & APPROVED BY LAB DIRECTOR Spe‘QUALITY SYSTEM MANUAL 150 Clause 5.2 ~ Accommodation and Environmental Conditions Issue Nos 02 ‘Amendment No: 00 Issue Date: 07.02:2022 | Amendment Date: MHPLIQSm9 Page 107 of 147 ¢ ) medall ‘A. Purpose: This section details the infrastructure and suitable accommodation and environmental conditions required for testing. B. Scope: Work envionment ofthe laboratory. Responsibility: Lab Director & Quality Manager . Clause terface: Clause: + Clause 5.2 of 5015189: 2012 ‘+ Cause 5.2 of NABL 12 “Specific Criteria for Accreditation of Medical -aboratories" Interface ‘+ MHPLQSPJo2 — Accommodation & Environmental condition ‘+ Departmental Manual 52 Accommodation & Environmental Condition: 5.24 General [MHPL has space allocated adequately forthe performance ofits work that is designe to ensure the qualty, safety and efficacy ofthe service provided tothe users and the health and safety of laboratory personnel, patients and vistors [MHPL nas evaluated and determined the sufficiency and adequacy of the space allocated forthe performance of the work, ‘+ For effective operation, MHPL-Department of Laboratory Medicine and its aavmmoveoey | rsowecron | pe=—1_(QUALITY SYSTEM MANUAL MHPLIQsM/as Soduse5s-ReporigatRenits —ragewrotuy — CD sue Noon “Amendment N00 IssueDate:e7.022022 Amendment Date: medall 582 583 authorised signatories ensure the correctness of transriptien of results before releasing the reports Report attributes: MHPL ensures that the following report attributes effectively communicate laboratory results and meet the users needs: 8) comments on sample qualty tht might compromise examination results; ) comments regarding sample sultabilty with respect to acceptanceeejection criteria; ©) atc results, where applicable; 4) MHPL does not havea system for automated selection and reporting of results Hence tis sections not applicable, Report content The report includes, but not be limited to, the following 12) clear, unambiguous identification of the examination including, where appropriate, the examination procedure; 'b) the identiiation ofthe laboratory that issued the report; ©) identification of all examinations that have been performed by a referral laboratory ) patient identification and patient location on each page; «@) name or other unique kdentifer of the requester and the requester’ contact details 4) date of primary sample colection (and time, when avalatle and relevant to patient care 8) typeof primary sample; fh) measurement procedure, where appropriate; ') examination results reported in SI units, units traceable to SI units, oF other applicable units; ‘MHPLHOSUR DESIGNATION SIGNATURE PREPARED & ISSUED BY (QUALITY MANAGER a enewaoanereoveoey | usorecro | Gpe=—E.Issue No.2 ‘Amendment No: 00 Issue Dat (QUALITY SYSTEM MANUAL 150 Clause 5.8 Reporting of Results 37022022, Amendment Date: 1) biological reference intervals, clinical decision values, oF dlagramsinomograms supporting clinical decision values, where applicable; 1) Interpretation of results, where appropriate; 1) other comments such as cautionary or explanatory notes (eg. qualty or adequacy of the primary sample which may have compromised the result, resultslinterpretations from referral laboratories, use of developmental procedure} 'm) identification of examinations undertaken as pat of a research or development programme and fr which no specific claims on measurement performance are -avalable; 1) Identitcation ofthe person(s) reviewing the results and authorizing the ease ‘ofthe report (f not containedin the report, realy avalable when needed; ©) ate ofthe report, and time of release (not contained in the report, readily _avalable when needed) ) page number to total numberof pages (eg. “Page tof 5", “Page 2 of, etc). ‘MPLHOSUR ~~ DESIGNATION SIGNATURE PrepaneDaissueDey | quaurywanncen | 2 —y] ‘eweweoaarmnoweoey | tasomecron | ge(QUALITY SYSTEM MANUAL MnPLiQsMi26 oO ISO CLAUSES.9-RELEASEOF RESULTS Page 44 of 4g ‘ issue Nozo2 “Amendment No: 00 medall [Issue Date: 07022022 Amendment Date: — ‘A. Purpose: This section explain the activity relating to report geneatior and issue of test reports. B. Scope: Applcabe to al test given in the scope of testing, 6. Responsibty: Authorised Signatories as per NABL. 11 & Lab Director, Cuslty Manager D. Interface: clause: + Cause 5.9 of 80 15:89:2072 Interface: ‘+ MHPL{QSP/43 Release of results + MHPLIQSM/K~ Master List of Forms and Records ‘+ Departmental Manual 59 Release of Results: 594 Genera [MHPL has established documented procedures fr the release of exami results Including etal of who may release results and to whom (MHPLIQSPH8 ion Reporting of resus). The procedures ensure that the fellowig conditions are met: ®) When the quality of the primary sample received is unsuitable for ‘amination, or could have compromised the result his isindcated in the report. *+ MHPL considers lipaemic, aemolysed and clotted sampes as unsuitable {or testing and are labeled appropriately. A specific column has been THPLHOSUR ‘DESIGNATION ‘SIGNATURE ; PREPARED aissueDey | quaumvanacen | DVO y}——— [REVIEWED & APPROVED BY {AB DIRECTOR |{QUALITY SYSTEM MANUAL MHPLIQSM26 oO ISO CLAUSES.9—RELEASE OF RESULTS Page 45 of 49 Issue No o2 ‘Amendment No. 00 medall LIssue Date:07022022 Amendment Date:— ‘created in the LIS before the end of the report to comment on the specimen quality. ) When examination results fall within established “alert” or “rica” intents — a physcon (or other authorized health professonal) i notified Immediately [ths indudes results received on samples sent to referral laboratories for examination); — records are maintained of actions taken that document date, time, Fesponsible laboratory staff member, person notified and examination results conveyed, and any diffcutes encountered in notikations. 2) Resuits are legible, without mistakes in transcription, and reported ¢o persons authorized to receive and use the information. 9) When results are transmitted a an interim report, the final reports ahways forwarded tothe requester. 592 Automated zlection and reporting of results: [MHPL. does not has a system for automated selection and reporting of results Hence this clause isnot applicable, 593. Revisedreports: [MHL has documented written Instructions for revision (MHPLIQSPIS ~ Reporting of results) when an orginal reports revised so that: 8) the revised report is clearly Identified as 3 revision and inces reference to the date and patient's identy in the original report ) theuseris made aware af the revision; "MHPLHOSUR DESIGNATION SIGNATURE preraneoaissuepsy | qualivnanacen | 2X yf — [REVIEWED & APPROVED BY_ LAB DIRECTOR ‘dpe—A{QUALITY SYSTEM MANUAL MHPLIQSMY26 oO ISO CLAUSE5.9-RELEASE OFRESULTS Page 6 of 49 | esuenoso2 “Amendment No. 00 medal “Issue Date:07.022022 Amendment Date:— | ©) the revised record shows the time and date ofthe change and the name of the person responsible for the change; ) the origina report entries remain inthe record when revisions are made. Results that have been made availabe fr clinical decision making and revised ‘re retained in subsequent cumulative reports and cleary identified as having been revised. ‘+ MHPL retains copies or files of reported results fr a minimum period of + {year as per the requirement of clause 4.13 of NABL 12 “Speci Criteria for ‘Accreditation of Medical Laboratories", such that promp retrieval of the Information is posible. The length of time that reported data are retained ‘may vary; however, the reported results are retrievable for as long as ‘medially relevant or as required by national, regional or loa requirement. MHL maintains a record when the reporting. system cannot capture amendments, changes or alterations. ‘mPLHOSUR DESIGNATION ‘SIGNATURE ~ preranco a ssuebey | quainvmanacer | Ly} revewevaarenoveoy | tavonecron | pe——4{QUALITY SYSTEM MANUAL, MHPLIQSsM/27 oO 150 Clause5.10~Lab Information System Page 147 of 199 “Tesue No 02 “Amendment No: 00 medall [Issue Date: 07022022 Amendment Date: ‘A. Purpose: The purpose of this procedure is to explain the laboratory Information ‘management. B. Scope: This procedure covers all the activities at MHPL protecting the laboratory information management systems, . Responsibility: Lab Director®Qualty Manager D. Interfacer clause: + use 510 of 501518932082 Interface: ‘+ MHPLIQSP| 23 — Data Storage and Security + MHPLIQSP/ 24 ~ Guidelines for User Responsibity + MHPLIQSP/25 ~System Maintenance ‘+ MHPLIQSP/26 Patient Confdentaity ‘+ MHPL{QSPI37 Information Management System + Departmental Manual {510 Laboratory information management: 5401 General IMHPL has access to the data and Information needed to provide a serie ‘hich meets the needs and requirements of the user (MHPLIQSP] 23 ~ Dasa Storage and Security) [MHPL has a documented procedure to ensure that the confidentiality of Patient information is maintained at all times (MHPLIQSPI26 — Patient onfdentiaity). 510.2 Authorities and responsibilities: "MHPLWOSUR (DESIGNATION ‘SIGNATURE erancoassusoey | quaimvmanacer | LVC—y| reveweDaarmoveoy | iasoimecron | pe(QUALITY SYSTEM MANUAL MHPLIQsM27 oO 150 Cause 5.10-Lab information System Page 48 of 49 |TssueNoz02 “Amendment NO. 00 medall Issue Date:o7022022 Amendment Date:—- [MPL ensures thatthe authorities and responsibilities forthe management Of the Information system are defined, including the maintenance and "modification to the information systems) that may affect patient care. IMHPL has defined the authortes and responsibilities ofl personnel who se the system, in particular those who: 18) access patient data and information; b) enter patient data and examination results; (change patient data or examination resus; <) authorize the release of examination cesuits and reports, $5103 Information system management ‘The system(s) used for the collection, processing, recording, reporting, storage or retrieval of examination data and information are 8) validated by the supplier and verifed for functioning by the laboratory before introduction, with any changes to the sysiem authorized, ‘documented and verified before Implementation; ) documented, and the Jotamentation, Incuaing that for day to day functioning ofthe system, readily avalable to authorzedusers; ©) protected from unauthorized access 4) safeguarded against tampering o loss; ©) operated inan environment that complies with supplier specifications or, in the case of non-computerized systems, provides conditions which safeguard the accuracy of manual recording and transcription; 4) maintained in a manner that ensures the integity of the data and Information and includes the recording of system failures and the _ appropriate immediate and corrective action "MHPLIHOSUR DESIGNATION ‘SENATURE PREPARED awsueDey | quaimvuanaces | PV —y [REVIEWED & APPROVED BY LAB DIRECTOR |QUALITY SYSTEM MANUAL, MHPLIQsM37 150 Cause 510-Lab Information Sytem Page 4g of 9 [ue Nas oz “Amendment NO. 00 medall Ise Onter07.022012 _ Rmendiment Date-- {8 in compliance with national or international requirements regarding date protection [MHPL vertes thatthe results of examinations, associated information and ‘comments are accurately reproduced and in hard copy where relevant, by ‘the Information systems external to the laboratory intended to dlrecly receive the information (eg. computer systems, fax machine, e-mail). When ‘3 new examination or automated comments are implemented, MPL verifies that the changes are accurately reproduced by the information systems extemal tothe laboratory intended to directly receive information from the laboratory. [MPL has documented contingency plans to maintin services inthe event of faure or downtime in information systems that affects MHPL's ality :o provide sence. ‘When the information system(s) are managed and maintained offsite or subcontracted to an alternative provider, MMPL i responsible for ensuring ‘at che provider oF operator of the system complies with all applicable ‘equicements of 50 15189 2012 and NABL 2 "MHPLHOSUR DestenaTION SIGNATURE PaepaneDaissueDey | quauivmanacer | DX —y] [REVIEWED & APPROVED BY_ LABDIRECTOR Bp CONTROLLED copy,