Leveraging ISO 15189’s Quality Management System to ...Leveraging ISO 15189’s Quality Management System to Achieve 24/7 Inspection Readiness Randy Querry Accreditation Manager

Leveraging ISO 15189’s Quality Management System to Achieve 24/7 Inspection

Readiness

Randy Querry Accreditation Manager Clinical

Goals

•  Provide brief background on A2LA •  Differentiate between CLIA and ISO

15189 •  ISO Implementation Ideas •  Identify ISO 15189 Elements that

support inspection readiness 24/7 •  Results

About A2LA

•  Non-profit, non-governmental, public-service organization

•  Providing accreditation to laboratories since 1978

•  Largest multi-disciplined Accreditation Organization in the U.S., third worldwide

A2LA Today

•  Over 2,935 organizations currently accredited

•  Approximately 200 technical assessors

•  Government, R&D, internal quality control and commercial testing and calibration laboratories

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

Clinical Program Options

•  CLIA •  ISO 15189 •  Platinum Choice (CLIA + ISO 15189) •  AABB/A2LA Accreditation Program

CLIA 88

•  Regulatory standard created to correct specific conditions

•  Very strong on focused areas: !  Personnel requirements ! QC requirements !  Proficiency Testing requirements !  Enforcement requirements

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

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

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

ISO 15189

•  Management System Requirements •  Technical Requirements •  Sets broad standards for best practices •  Addresses pre-analytical, analytical

and post analytical •  Requires policies and procedures

ISO 15189 Documents Terms

•  Document / Procedure / Plan •  Instructions / Manual / Criteria •  Arrangements / Agreements •  Programs / System •  Define / Describe •  Quality Objectives / Quality Indicators

ISO 15189 Record Terms

•  Record •  Register •  List •  Monitor •  In writing •  Evaluate

•  Feedback •  Check •  Validate •  Document •  Identify •  Verify •  Examine

CMS Top 10 Deficiencies in the Nation – January 2016

•  10 The laboratory must have a director who meets the qualification requirements of 493.1405 and provides overall management and direction in accordance with 493.1407

ISO 15189

•  4.1 Organization and management responsibility and 5.1 Personnel

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.

ISO 15189

•  5.3.2 Reagents and consumables requires procedure for reception, storage acceptance testing and inventory management and records.


•  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.

ISO 15189

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


•  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 493.1253

ISO 15189

•  5.5.1 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


•  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.

ISO 15189

•  5.1.6 Competence assessment requires that the laboratory establish criteria to assess the competency of each person to perform assigned tasks

•  4.5.1 the laboratory shall have a procedure for selecting and evaluating referral laboratories and consultants


•  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 493.1291(c).

ISO 15189

•  5.8 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.


•  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 493.1251 through 493.1283.

ISO 15189

•  4.9 Identification and control of non-conformities requires the laboratory to have a procedure to identify and manage nonconformities


•  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.

ISO 15189

•  4.3 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.


•  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.

ISO 15189

•  5.6 Ensuring the quality of examination results specifically 5.6.3.2 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.


• 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…

ISO 15189

•  5.2 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.

Implementing ISO 15189 is:

Saying what you do

Doing what you say

And Proving it

Schultz’s famed security blanket

Bill Watterson’s

Internal audits ISO 15189 4.14

•  Internal audits require !  Trained and qualified auditor !  Independent of area being audited ! Audit program

•  ISO 15189 •  Labs quality manual and procedures •  Pre-analytical, analytical and post analytical

!  Report findings and non-conformities ! Corrective action and monitoring

Corrective Actions are used to address:

•  Complaints •  Non-conforming work •  Internal audits •  External inspections / assessments •  Proficiency testing outliers

Management Review

•  Conducted by Top Management •  Takes into account:

!  Suitability of procedures ! Assessment of user feedback !  Staff suggestions !  Internal audits

Management Review

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

Management Review

•  Takes into account: ! Monitoring and resolution of

complaints ! Performance of suppliers !  Identification and control of non-

conformities ! Results of continual improvement

CAR/PAR

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

Management Review

•  Analyze the inputs for causes of non-conformities, 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

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.

Preparing •  Obtain the ISO 15189 •  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

Preparing •  Conduct internal audits to determine gaps

or weaknesses •  Initiate corrective action •  Perform a management review

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

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.

Trends we’ve witnessed

•  Study included: ! Clinical laboratories ! Minimum 3 assessments

ISO demonstrated continuous improvement

•  24 on-site assessments •  166 deficiencies •  8 total deficiency average

ISO 15189 demonstrated continuous improvement

•  Average 15 deficiencies initial assessments

•  Average 5 deficiencies renewal assessments

Feedback Received

•  Since achieving ISO 15189 Accreditation labs say they have been better prepared for CLIA inspections

Feedback Received

•  Since receiving ISO 15189 Accreditation CLIA inspection findings have decreased

Feedback received

•  Since receiving ISO 15189 Accreditation the occurrence of internal non-conforming work has decreased

Greatest benefits of ISO 15189 Accreditation

•  More efficient operations •  Improved quality

Questions?

Contact Info

Randall Querry A2LA

5202 Presidents Court, Suite 220

Frederick, MD 21703 Direct line: 301 644 3221

Fax: 301 662 2974 [email protected]

www.A2LA.org