Leveraging ISO s Quality Management System to Achieve 24/7 Inspection Readiness. Randy Querry Accreditation Manager Clinical

Transcription

1 Leveraging ISO s Quality Management System to Achieve 24/7 Inspection Readiness Randy Querry Accreditation Manager Clinical

2 Goals Provide brief background on A2LA Differentiate between CLIA and ISO ISO Implementation Ideas Identify ISO Elements that support inspection readiness 24/7 Results

3 About A2LA Non-profit, non-governmental, publicservice organization Providing accreditation to laboratories since 1978 Largest multi-disciplined Accreditation Organization in the U.S., third worldwide

4 A2LA Today Over 2,935 organizations currently accredited Approximately 200 technical assessors Government, R&D, internal quality control and commercial testing and calibration laboratories

5 About A2LA Multiple domestic and international recognitions A2LA is the only accreditation body in the world holding CMS deemed status and International Laboratory Accreditation Cooperation (ILAC) recognition Internationally renowned for participation in the ISO and ILAC arenas

6 Clinical Program Options CLIA ISO Platinum Choice (CLIA + ISO 15189) AABB/A2LA Accreditation Program

7 CLIA 88 Regulatory standard created to correct specific conditions Very strong on focused areas:!!!! Personnel requirements QC requirements Proficiency Testing requirements Enforcement requirements

8 CLIA 88 CLIA includes pieces of management system requirements!!!!!!! Confidentiality Specimen collection Complaint investigation Communication breakdown Lab personnel competency assessments Corrective action and monitoring Procedure manual for pre-examination, examination and post examination

9 ISO standard approach Empowers laboratory personnel Improves lab productivity and efficiency Reduces need for constant technical oversight Creates synergy between laboratory management and technical staff Provides credibility to outside parties, and international recognition if accredited

10 ISO Standards Management system elements Encompasses all levels of staff Reaches to departments of the business outside of the laboratory Emphasizes Continuous Improvement Applies tools and processes to stay current with changes

11 ISO Management System Requirements Technical Requirements Sets broad standards for best practices Addresses pre-analytical, analytical and post analytical Requires policies and procedures

12 ISO Documents Terms Document / Procedure / Plan Instructions / Manual / Criteria Arrangements / Agreements Programs / System Define / Describe Quality Objectives / Quality Indicators

13 ISO Record Terms Record Register List Monitor In writing Evaluate Feedback Check Validate Document Identify Verify Examine

14 CMS Top 10 Deficiencies in the Nation January The laboratory must have a director who meets the qualification requirements of and provides overall management and direction in accordance with

15 ISO Organization and management responsibility and 5.1 Personnel

16 CMS Top 10 Deficiencies 9 Reagents, solutions, culture media must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality.

17 ISO Reagents and consumables requires procedure for reception, storage acceptance testing and inventory management and records.

18 CMS Top 10 Deficiencies 8 Lab must perform and document calibration verification procedures following the manufacturer s calibration verification instructions using the criteria verified by the lab at least once every 6 months.

19 ISO Equipment requires procedures for equipment acceptance testing, instructions for use, equipment calibration and traceability, program for preventive maintenance, adverse incident reporting and detailed records.

20 CMS Top 10 Deficiencies 7 Test systems must be selected by the lab. The testing must be performed following the manufacturer s instructions and in a manner that provides test results within the lab s stated performance specifications for each test system as determined under

21 ISO Selection, verification and validation of examination procedures! The lab shall select procedures that have been validated! Exam procedures used without modification shall be independently verified to see that it meets manufacturer s performance characterizations

22 CMS Top 10 Deficiencies 6 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency.

23 ISO Competence assessment requires that the laboratory establish criteria to assess the competency of each person to perform assigned tasks the laboratory shall have a procedure for selecting and evaluating referral laboratories and consultants

24 CMS Top 10 Deficiencies 5 The test report must indicate the following: for positive patient identification, either the patient s name and identification number, or a unique patient identifier and identification number, the name and address of the lab location where the test was performed, and other requirements specified in (c).

25 ISO Reporting of results includes requirements for a defined format and medium of the report, and the manner in which it is communicated from the laboratory. The report shall include attributes and report content.

26 CMS Top 10 Deficiencies 4 The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in analytic systems specified in through

27 ISO Identification and control of nonconformities requires the laboratory to have a procedure to identify and manage nonconformities

28 CMS Top 10 Deficiencies 3 The procedure manual must include the requirements for specimen acceptability, microscopic examination, step by step performance of the procedure, preparation of materials for testing, etc.

29 ISO Document control requires that the laboratory control internal documents and documents from external sources. Documents are to be periodically reviewed and updated so to ensure fit for purpose.

30 CMS Top 10 Deficiencies 2 At least twice annually the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I or this part.

31 ISO Ensuring the quality of examination results specifically alternative approaches when PT is not available including use of CRMs, samples previously examined, materials from tissue or cell repositories, exchange of samples with other labs and control materials that are test daily in interlab comparison programs.

32 CMS Top 10 Deficiencies Number 1! The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation and these conditions must be monitored and documented

33 ISO Accommodation and environmental conditions requires that the laboratory monitor, control and record environmental conditions in the laboratory facilities and a documented procedure specific to reagent and consumable storage to manufacturer s specification.

34 Implementing ISO is: Saying what you do Doing what you say And Proving it

35 Schultz s famed security blanket

36 Bill Watterson s

37 Internal audits ISO Internal audits require! Trained and qualified auditor! Independent of area being audited! Audit program ISO Labs quality manual and procedures Pre-analytical, analytical and post analytical! Report findings and non-conformities! Corrective action and monitoring

38 Corrective Actions are used to address: Complaints Non-conforming work Internal audits External inspections / assessments Proficiency testing outliers

39 Management Review Conducted by Top Management Takes into account:! Suitability of procedures! Assessment of user feedback! Staff suggestions! Internal audits

40 Management Review Takes into account:! Risk management! Use of quality indicators! Reviews by external organizations! Results of participation in PT

41 Management Review Takes into account:! Monitoring and resolution of complaints! Performance of suppliers! Identification and control of nonconformities! Results of continual improvement CAR/PAR

42 Management Review Takes into account:! Follow up action from previous management reviews! Changes in volume and type of work, personnel, and premises that could impact quality! Recommendations for improvements

43 Management Review Analyze the inputs for causes of nonconformities, trends and patterns that indicate process problems The review shall include assessing these opportunities for improvement and the need for changes The quality and appropriateness of the lab s contribution to patient care shall to the extent possible be evaluated

44 Management Review Review output! This shall be a record that documents decisions made and actions taken Improvement of effectiveness of the QMS Improvement of service to customers Resource needs! Findings and actions shall be recorded and reported to staff and actions completed within a defined timeframe.

45 Preparing Obtain the ISO Become familiar with Accreditation Body (AB) website, requirements, policies and website tools Obtain relevant assessor checklists Identify the person in charge of the management system (usually the quality manager) Create and implement quality manual, policies and procedures

46 Preparing Conduct internal audits to determine gaps or weaknesses Initiate corrective action Perform a management review

47 ISO standard approach Empowers laboratory personnel Improves lab productivity and efficiency Reduces need for constant technical oversight Creates synergy between laboratory management and technical staff Provides credibility to outside parties, and international recognition if accredited

48 Rewards of an implemented management system include: " Results in a consistent, efficient process / work flow " Provides accountability and system checks " Serves as a training aid " ISO standards are being recognized as the bench mark in court cases, marketing, government specifications, regulations " Finds your problems before your customer does.

49 Trends we ve witnessed Study included:! Clinical laboratories! Minimum 3 assessments

50 ISO demonstrated continuous improvement 24 on-site assessments 166 deficiencies 8 total deficiency average

51 ISO demonstrated continuous improvement Average 15 deficiencies initial assessments Average 5 deficiencies renewal assessments

52 Feedback Received Since achieving ISO Accreditation labs say they have been better prepared for CLIA inspections

53 Feedback Received Since receiving ISO Accreditation CLIA inspection findings have decreased

54 Feedback received Since receiving ISO Accreditation the occurrence of internal non-conforming work has decreased

55 Greatest benefits of ISO Accreditation More efficient operations Improved quality

56 Questions?

57 Contact Info Randall Querry A2LA 5202 Presidents Court, Suite 220 Frederick, MD Direct line: Fax: