Phlebotomy Chapter 2

• Quality assurance (QA)


  Continuous self-evaluation and process monitoring to improve performance and guarantee quality patient care
• Continuous quality improvement (CQI) program


  Protocols developed for all processes used and the personnel involved, formally adopted by the institution
• Measurement of performance and quality improvement projects are now part of the accreditation requirements for all types of healthcare facilities and are found in every aspect of health care, including phlebotomy
• The Joint Commission (TJC)


  Independent, not-for-profit organization that establishes standards for the operation of hospitals and other health-related facilities and services
• TJC


  • Accredits and certifies more than 20,000 healthcare organizations (HCOs) and programs in the United States
  • To receive and maintain TJC's Gold Seal of Approval, an organization must undergo and pass an on-site evaluation by a survey team at least every 3 years (every 2 years for laboratories)
• TJC's revised model for the clinical laboratory

  • Incorporates activities intended to reduce total analytical error by improving the pre- and postanalytical processes and more oversight of point-of-care testing
• Direct Impact Standards Requirements

  Critical care process-related requirements that if not met may pose an immediate risk to patient safety
• Indirect Impact Standards Requirements

  Planning and evaluation requirements that are less of an immediate threat to patient safety and quality care but, over time, may put patients at risk
• Situational Decision Rules


  Failure to meet these rules, such as finding unlicensed personnel working in the facility, will result in Preliminary Denial of Accreditation (PDA)
• Immediate Threat to Health and Safety

  Noncompliance in this category, such as a blood bank refrigerator temperature out of range or serious problems with specimen labeling or patient identification, will result in Preliminary Denial of Accreditation (PDA)
• TJC's Office of Quality Monitoring was created to evaluate and track complaints related to HCOs' quality of care
• Sentinel event (SE)


  Any unfavorable event that is unexpected and results in death or serious physical or psychological injury, signaling the need for immediate investigation and response
• Communication is listed as the leading factor in the root causes of SEs reported to TJC for the years 1995 through 2005
• National Patient Safety Goals (NPSGs)

  Part of the overall CQI requirements for accreditation, addressing critical areas of safety concerns and describing expert-based solutions
• Examples of areas addressed by NPSGs

  • Patient identification
  • Communication
  • Healthcare-associated infections
  • Medication safety
  • Patient involvement
• College of American Pathologists (CAP)


  National organization that offers proficiency testing and a continuous form of laboratory inspection by a team made up of pathologists and laboratory managers
• Clinical Laboratory Improvement Amendments of 1988 (CLIA '88)

  Federal regulations that establish quality standards for all facilities, including clinics and physicians' office laboratories, that test human specimens
• Clinical Laboratory Improvement Advisory Committee (CLIAC)

  Provides technical and scientific advice and guidance to the Centers for Medicare and Medicaid Services (CMS) on the need for revisions to the CLIA '88 standards and the impact the proposed revisions will have on laboratory practice
• All laboratory facilities subject to CLIA '88 regulations are required to obtain a certificate from the CMS
• Laboratories


  Test human specimens for the purpose of providing information used to diagnose, prevent, or treat disease and assess health status
• Standards


  • Address QA, quality control (QC), proficiency testing, laboratory records, and personnel qualifications
• Aim of the standards

  To ensure the accuracy, consistency, and reliability of patient test results regardless of the location, type, or size of the laboratory
• Clinical Laboratory Improvement Advisory Committee (CLIAC)

  Provides technical and scientific advice and guidance to the appropriate people in CMS who are administering the regulations
• CLIAC's purpose


  To advise on the need for revisions to the standards under which clinical laboratories are regulated and the impact the proposed revisions will have on laboratory practice
• CLIA '88 regulations


  All laboratory facilities subject to these regulations are required to obtain a certificate from the CMS according to the complexity of testing performed there
• Categories of testing


  • Waived (simple, with a low risk of error)
  • Moderate (including provider-performed microscopy)
  • High complexity
• Complexity of testing


  Based on the difficulty involved in performing the test and the degree of risk of harm to a patient if the test is performed incorrectly
• CLIA requirements are more stringent for laboratories that perform moderate- and high-complexity testing than waived testing, and their facilities are subject to routine inspections
• Specimen collection is an important part of CLIA inspections, and laboratories that are of moderate- or high-complexity testing are required to have written protocols for patient preparation, specimen collection, labeling, preservation, and transportation
• CMS began on-site visits to approximately 2% of Certificate of Waiver (CoW) laboratories across the country to address significant gaps in the quality of waived testing practices
• The on-site visits were known in advance and were intended for education and the gathering of information
• CMS has now conducted visits in all 50 states and will continue to visit 2% of the CoW laboratories throughout the United States each year
• The CLIAC, in cooperation with CDC, FDA, accrediting agencies and manufacturers, is committed to ensuring that the waived laboratories receive the education needed to produce accurate and reliable test results
• Good Laboratory Practices (GLPs)

  Ten QA recommendations for CoW laboratories developed by CLIAC to emphasize QA in collecting and performing blood work using waived testing kits
• The GLPs are intended to inform, but are not mandatory
• Clinical and Laboratory Standards Institute (CLSI)


  A global, nonprofit, standards-developing organization with representatives from the profession, industry, and government, whose mission is to develop clinical and laboratory practices and promote their use worldwide
• National Accrediting Agency for Clinical Laboratory Sciences (NAACLS)


  Recognized by the U.S. Department of Education as an authority on quality clinical laboratory education, with a mission to be the premier international agency for accreditation and approval of educational programs in the clinical laboratory sciences and related health professions
• The NAACLS accreditation process involves an external peer review of the program, including an on-site evaluation, to determine whether the program meets certain established educational standards
• The NAACLS approval process for phlebotomy programs requires that the program meet educational standards called "competencies" designed to improve student outcomes and maintain quality education
• Quality Assurance (QA)


  A program or process that is designed to prevent problems in the future by evaluating present and past performance, striving to guarantee quality service through scheduled reviews