Laboratory Accreditation Program Quality Management: Lab Director s Role R. Bruce Williams, MD, FCAP Chair, Commission on Laboratory Accreditation May 16, 2007 Copyright 2007 (CAP). All rights are reserved. Participants are permitted to duplicate the materials for educational use only within their own institution. These materials may not be used for commercial purposes or altered in any way. 1 Learning Objectives After participating in today s session, you will be able to: Define key elements of a documented quality management program (QMP) Describe the role of the laboratory director in developing, implementing and overseeing the program Identify criteria that evaluate your own QMP for effectiveness 2 Why have a QM Program? Maximizes operational efficiency, effectiveness and adaptability Enhances patient care Promotes quality and patient safety through risk reduction and continuous improvement 3 1
Tools used in Developing a QM Program Identify current and future: Organizational vision/mission Organizational values Customers/needs Organization s SWOT Risks/control actions 4 Key Elements of a Quality Management Program 5 Key Elements of a QM Program Written QM plan Implementation Data collection Analyze and evaluate data Implement corrective actions Evaluate Improvements Communicate results Documentation 6 2
Key Elements of a QM Program Purpose Ensure/improve quality of patient care Structure systematic and objective Universal application of the plan - inclusivity Monitor and evaluate activities Resolve problems and improve patient care Scope of the plan includes All laboratory activities All patients All phases of testing 7 Key Elements of the Program Risk assessment Key focus areas & Key focus indicators - consider aspects unique to facility Benchmarks sources referenced Encourage better than benchmark attitude through continuous improvement Evaluation/revisions Annual process 8 Laboratory Director s Role and Responsibilities in the Quality Management Program 9 3
Laboratory Director s Responsibilities (CLIA) The laboratory director is responsible for the overall operation and administration of the laboratory and for assuring compliance with the applicable regulations (CLIA 88). 14 items: Attachment A 10 CAP-Team Leader Checklist TLC.10900 Is the laboratory director actively involved in the Design Implementation Oversight of the quality management system? 11 Lab Director s Role in the QMP Development Encourage benchmarking Require benchmarks where possible Established multi-institutional data Ensuring implementation Assessment and reassessment of activities Monitoring improvements Communication Ensuring integration with institution s program Strategic and proactive guidance 12 4
Assessment of the Quality Management Program 13 Evaluating a (Your) QM Program 1. Is the QM plan comprehensive? 2. Is the plan implemented as written? 3. Is data analyzed? 4. Are corrective actions implemented? 5. How are improvements evaluated? 6. How and to whom are results communicated? 14 1. Is the QM Plan Comprehensive? Written plan Contain key elements Scope of the plan includes All laboratory activities All patients All phases of testing 15 5
Key Elements and Issues Specific to the Laboratory can Arise from Many Sources Hospital staff/nursing Lab personnel Pathologists Medical staff Patients Physician offices 16 Facility Specific Issues 1. Affects large number of patients 2. Affects few patients but high risk 3. Affects customer satisfaction 17 Examples of Areas of Study Turn-around times Satisfaction with services Specimen labeling Specimen rejection Critical value notification Issues identified in case review/root cause analyses Telephone service Patient identification armbands Issues identified by failure mode/effect analyses {FMEA} 18 6
Quality Control Daily quality control is an integral part of the QMP Have you reviewed the QC acceptability criteria recently? Do you agree with them? Are rules being applied properly, consistently and acted upon when needed? Be involved in ensuring quality in the laboratory and not simply delegating responsibility 19 Proficiency Testing Objective and structured review Review PT failures and implement corrective action Do you rely on vendor defined criteria for acceptability or do you have tighter criteria and act before a trend becomes significant? If not graded, what assessment do you perform? 20 Examples: CP Specific Anticoagulant monitoring Blood product wastage T&S completion prior to initiation of surgical procedure Glycohemoglobin monitoring Compliance with new method implementation protocol Single blood cultures QC control rules QC SD experience vs. defined limit set by medical director Interaction of test system with collection device Effectiveness of new employee orientation and training Stool microbiology Blood culture contamination 21 7
Examples: AP Specific History/tissue diagnosis correlation Cytopathology indicators Quality of specimens Inter/intra departmental consultations Clinical/autopsy findings correlation Frozen section/final diagnosis correlation Case review/root cause analysis 22 AP Items to include in the QMP Completeness of requisition forms Condition of specimen at time of receipt Specimens submitted for special testing are handled in the correct manner IHC monitoring Fixative Antibody evaluation and validation Validation of new reagent lot Quality control Assess inter-observer variability How many data pairs analyzed? 23 Written QM Plan Describes lab s approach to managing quality and patient safety Provides reasonable assurance that lab Complies with laws and regulations Meets defined standards of laboratory practice Engages in quality improvement activities The plan is NOT the entire QM program 24 8
2. Is the Plan Implemented as Written? Is data collection performed in a timely fashion? Are the correct people collecting the data? Is the whole lab involved? In this process, are new problems identified? 25 3. Is Data Collected/Analyzed? Ensure data is collected and available in an organized fashion One approach use a dashboard to quickly identify compliance with targets Attachment B 26 Analyzing Problems Risk to patient if not addressed? Number of patients involved? Problem prone area? Is the service or process new to the operation? Is patient satisfaction affected? Is it important? Urgent? Can it wait? How hard is it to achieve? What resources will it require? What happens if we don t do it? Is it vital to meeting goals: Organization s mission, vision, and strategic initiatives 27 9
Evaluating Quality Monitors Is the monitor objective? Is it measurable? Is it linked to patient outcome or customer need? Is it precisely and consistently defined? Is the monitor simple? Is it phrased in a manner readily understood by all who will be assessing its utility? Is it reproducible? Is it valid? Are appropriate data mining resources available? Are the benchmarks current, objective and have they been validated? 28 4. Are Corrective Actions Implemented? If data collection reveals benchmarks are not being met Are problems investigated? Are appropriate individuals included in problem-solving? Are potential solutions discussed/evaluated? Are changes instituted? Are changes evaluated for effectiveness? 29 Implementing Changes Who should be involved? When do you stop monitoring? High risk, high volume, problem prone, and/or high cost Periodic reassessment to ensure improvement is maintained Who needs to know? Communicate inside and outside the lab Ensure the lab QMP is integrated with the facility QMP 30 10
5. Evaluating Improvements? Beware of unintended consequences Implementing new activated clotting time instrument with significantly different target value without adequate physician notification Implementing high sensitivity CRP without adequate education Implementing new aptt reagent without addressing heparin sensitivity, nomogram design, and physician notification Implementing new tumor marker reagent without addressing clinical need for correlative date (e.g., PSA performed q 12 months) 31 6. Communicating Results? Is there a formal reporting structure? Who needs to know? Who gets to know? Is there a facility-wide committee? Who serves on the committee? How are report results received/valued? 32 QM Suggestions for the Laboratory Director Communicate importance of the QM Program Lead by Example Lead the monthly QM meeting Communicate with staff regarding changes Use in-services as a QM resource Encourage discussion of problems Discuss unusual cases, aberrant results, etc. Cover all shifts Make rounds on evening and night shifts Assess strengths/weaknesses of staff on shifts with which you do not routinely interact 33 11
Suggestions for Laboratory Directors Be available Have your name, telephone number, and e-mail address print on each lab report Provide resources Develop a laboratory website and post helpful information 34 Key Points for the Laboratory Director Focus on those items that are Meaningful Patient centered Problematic Risk reducing Director driven Reflective of a culture of quality Be visible Be involved Communicate 35 Summary The quality management plan is a living document and requires ongoing review and improvement Active involvement of the laboratory director is key to providing quality patient care and ensuring patient safety Developing and following a strategic plan focused on quality and service helps ensure the improvement of patient care and should be a key component of the QM Program 36 12
Resources Quality Management in Anatomic Pathology (2005) Quality Management in Clinical Laboratories (2005) Clinical and Laboratory Standards Institute HS1-A2 A Quality Management System Model for Health Care (2004) GP26-A3 Application of a Quality System Model for Laboratory Services (2004) GP22-A2 Continuous Quality Improvement (2004) 37 Thank You Questions and Answers 38 13
Attachment A Exhibit 6. Responsibilities of the Laboratory Director Under CLIA 1 The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. The laboratory director must (1) Ensure that testing systems developed and used for each of the test performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; (2) Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical, and biological hazards; (3) Ensure that: (i) The test methodologies selected have the capability of providing the quality of results required for patient care; (ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and (iii) Laboratory personnel are performing the test methods as required for accurate and reliable results; (4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed and that: (i) The proficiency testing samples are tested as required under subpart H of this part; (ii) The results are returned within the timeframes established by the proficiency testing program; (iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory s performance and to identify any problems that require corrective action; and (iv) An approved corrective action plan is followed when any proficiency testing results are found to be unacceptable or unsatisfactory; (5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; (6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; (7) Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory s established performance specifications are identified, and that patient test results are reported only when the system is functioning properly; (8) Ensure that reports of test results include pertinent information required for interpretation; (9) Ensure that consultation is available to the laboratory s clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions; (10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart; (11) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; (12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; (13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; and (14) Specify, in writing, the responsibilities and duties of each consultant and each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. 1 This excerpt taken from Quality Management in Clinical Laboratories: Promoting Patient Safety Through Risk Reduction and Continuous Improvement (Northfield:, 2005): 53. 2007. All rights reserved. LAP Audioconference: Quality Management: Lab Director s Role, May 16, 2007 Page 1 of 1
CBC by 0700 for ICUs Attachment B Continuous Improvement Indicator Review North Texas Institute of Pathology Indicator Description: JCAHO Function HEMATOLOGY 0700 SCA TAT - Hematology test Check all that apply: results released by 0700 for SCA tests ordered for AM cart run Check all that apply: Ethics, Rights and Responsibilities Medical Staff _x_ Provision of Care _x_ Department Process: _x_ Medication Management JCAHO Function Team Outcome: x Improving Organizational Performance CI Team Leadership _x_ KFA/KPI (Specify type below) Management of the Environment of Care _x_ Satisfaction Management of Human Resources _x_ Quality High Risk Management of Information Financial Performance High Volume Surveillance, Prevention, Infection Operational Performance High Cost Community Health x Problem Prone _x_ Other - Outcomes FY 2004 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Annual N 338 354 363 366 389 335 336 352 363 358 355 367 4276 n 4 3 4 3 4 4 7 6 10 7 7 6 65 (N-n)/Nx10 98.8 99.2 98.9 99.2 99.0 98.8 97.9 98.3 97.2 98.0 98.0 98.4 98.5 Target 93 93 93 93 93 93 93 93 93 93 93 93 Definitions N = Total SCA Hematology tests (CBC/H&H) received in early AM for Target: 93% Target Source: Lab History 6 random days per month n = Total SCA Hematology tests not released into LIS by 0700 Sample review of 6 random days per month Data Source: Daily computer TAT reports 100 98 96 94 92 90 88 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec (N-n)/Nx100 Target 2007. All rights reserved. LAP Audioconference: Quality Management: Lab Director s Role, May 16, 2007 Page 1 of 1