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Definitions and Glossary of Terms

Accuracy

The degree of correctness of a number.  Testing an analyte of known concentration and recovering the correct or true value. 

Accreditation

Laboratories have a choice to subscribe to approval and at different levels of approval. Typically, those that subscribe go through a rigorous inspection process that is considered a high mark of quality. Standard guidelines are used to measure laboratory programs. Each accrediting agency has its own standards that must meet or exceed those recommended by the Clinical Laboratory Improvement Act of 1988 (CLIA '88.)  Examples of accrediting agencies include CAP, COLA, and JCAHO.

Analyte

The substance being identified and measured in an analysis.  For example, Glucose, Creatinine, cholesterol, potassium are all analytes that can be measured in blood samples.

Calibration

Calibration should not be confused with linearity or quality control. Calibration is a term that refers to the set up or internal workings of an instrument. The manufacturer typically performs it before being sent to a customer. Most accrediting and regulatory agencies want a verification of the calibration. This can be accomplished by testing at least three known samples (or what the manufacturer recommends) on the instrument. These samples should cover the range of reportable patient results. In most instances, calibration verification should be performed at least every six months.  Each accrediting agency lists its individual criteria for calibration verification.

CAP

 

College of American Pathologists.  The professional scientific organization that offers programs to a variety of laboratorians. One of these programs is the international laboratory accreditation program (CAP Inspection), which is designed to improve the quality of laboratory medicine. CAP inspections occur every two years and consist of a team of voluntary peer reviewers. CAP standards are often more stringent that the CLIA regulations. CAP has been given deemed status by HCFA and therefore, if an institution is accredited by CAP, an additional HCFA inspection or JCAHO inspection is unnecessary. CAP does not distinguish between waived, moderate, or high complexity testing. Everything is grouped as though it was a highly complex test and treated with stringent regulations. For more information, visit CAP's website at www.cap.org.

Certification

The act of being made proficient in a particular task by undergoing specialized instruction and practice.  Objectives and goals for this act must be well defined and accomplished upon the completion of the process.  Training in the use of a POC instrument and/or manual test enables a person to become certified in its use.

CIC

The Connectivity Industry Consortium (CIC) is a non-profit, organization comprised of device manufacturers, information system vendors and health care providers. The CICís objective is to enable a seamless information exchange between Point-of-Care (POC) devices, electronic medical records, and laboratory information systems. Their ultimate goal is to produce a standards-based connectivity solution that will be transferred to a chartered standards maintenance organization. For more information, visit the CICís website at www.poccic.org.

CLIA '88

 

 

Clinical Laboratory Improvement Amendments of 1988.  Was published in the Federal Register in February of 1992. This piece of federal legislation mandates that laboratory testing performed on human specimens be standardized. CLIA is the laboratory standards extension of the HCFA.  CLIA applies to physician offices, laboratories and other institutions that perform laboratory testing. Once a laboratory has been established, it must obtain the appropriate CLIA certificate, pay the appropriate fees, and comply with the governing regulations. CLIA certificates are divided into test complexity levels. A certificate can be waived, moderately complex (including Physician Performed Microscopy (PPM)), or highly complex. Most POCT is waived or moderately complex. The category of test complexity determines the rules an institution must follow in the areas of proficiency testing, quality control, quality assurance, types of testing personnel, and patient/test management.

Inspections of CLIA certified laboratories can be performed by the HCFA, the state authority, or an accrediting agency with deemed status (i.e. JCAHO, CAP or COLA.)  For more information, visit the HCFA website at www.hcfa.gov/medicaid/clia/cliahome.htm.

Much of CLIA'88 and its changes can be downloaded from the CDC website at www.phppo.cdc.gov/dls/clia/chronol.asp.

Comparison

An examination of two or more items to establish similarities and differences.  This is part of the process of validating a new method or correlating data from different instruments.

Competency

 

Competent personnel performing laboratory tests are qualified and knowledgeable to produce quality results on a particular analyte. A ďcompetencyĒ is the tool that measures the individualís competence or an individualís capability to perform up to defined expectations.  These expectations may include technical competence, which is detecting errors, following procedures, troubleshooting, and making no mistakes. Competence may also include fulfilling the responsibilities required of a health-care professional. There are many ways in which an institution implements competency programs. Regardless of what the institution has decided, it must have a policy, develop criteria for the performance standards, and keep up to date documentation.

Correlation

The process of assuring that two or more methods of testing the same analyte will produce the same data.  This is done in the laboratory by running 2 or more levels of a known standard of appropriate matrix material (i.e.: whole blood for bedside glucose) on all instruments that perform a particular test.       

CPT

Current Procedural Terminology. Five-digit numeric coding system for services and procedures. CPT's are submitted to the patient's insurance carrier for reimbursement. Most medical services and procedures have a corresponding CPT code. And for almost every CPT code there is a corresponding financial value.

The CPT book is updated annually and is owned and copyrighted by the American Medical Association (AMA). HCFA, which oversees the Medicare program, has a contract with the AMA to use CPT for claims processing and reimbursement of physician services. Most third-party carriers use it as well.  This service allows AMA members to have their CPT coding questions answered by phone or by written response. Information is also available on how non-members can receive CPT coding assistance. 

CV

 

 

Coefficient of Variation (CV).  This is a statistical term used to determine the precision of an instrument, reagent lot number, or any other statistical definable variable used on an instrument. The calculation is

%CV= (s/mean) x 100

Data is more precise when the CV is low. In most laboratory testing, the CV should be less than 5%. CVs are useful when comparing two separate sets of data to determine which one is more precise. For instance, when  comparing three different instruments to one reference method, the instrument with the lowest CV is favored.

When a new analyzer is considered for purchase, specimens would be run in parallel on the analyzer being considered and the analyzer that is currently being used in the facility (reference analyzer).  The results obtained from both would be reviewed and compared for accuracy.  The standard deviation and the coefficient variation (percent of the mean value) are two tolls used by laboratorians to compare precision of the two analyzers. 

Deemed Status

This is a rating that HCFA grants to organizations whose accrediting standards meet or exceed those set forth by CLIA. To date, the following organizations have been given deemed status:

  • American Association of Blood Bank (AABB)                                 

  • American Osteopathic Association (AOA)

  • American Society of Histocompatibility and Immunogenetics (ASHI)

  • College of American Pathologists (CAP)

  • Commission on Accreditation of Health Care Organizations (JCAHO)

  • Commission on Office Laboratory Accreditation (COLA)

EDI

Electronic Data Interface.  A pipeline of data from one computer system to another.  Often refers to an instrument interface, which carries results from the instrument to the LIS.

Firmware

The computer program contained permanently in a hardware device.  For  point of care testing purposes, the devices each manufacturer develops contain a certain amount of firmware which have features and functionality already pre-set within the instrument.  Upgrades to this firmware can only be performed by the device manufacturer.

HCFA    

(now CMS)

Health Care Financing Administration.  Regulates all laboratory testing performed on humans through CLIA.  HCFA duties include coordinating the certification process and collecting fees, approving proficiency testing programs, and accrediting programs.  For more information, visit the HCFA website at www.hcfa.gov.

HIS

Hospital Information System.  Mainframe or minicomputer system running the software, which serves the clinical needs of the hospital.   This system is usually interfaced to other "ancillary" systems that serve the specific needs of other departments within the hospital.  Examples of ancillary system units include, but are not limited to LIS, pharmacy, radiology, finance and billing.

ICD-9

 

 

This is a billing term used to classify a patientís disease state.  It means International Classification of Diseases, Ninth Revision as defined by the World Health Organization. These codes are used as the basis for determining the medical necessity of clinical laboratory tests.  Hence, when a physician orders a laboratory test, it is recommended that an ICD-9 code accompany this order for justification.  NCHS and HCFA are the U.S. governmental agencies responsible for overseeing all changes and modifications to the ICD-9-CM.

Interface

Interfacing is the transfer of data from one system to another.  In Point of Care, it is often implemented as an "Instrument Interface", which is the transfer of data from a laboratory instrument or data management system to an LIS.

JCAHO

 

 

Joint Commission on Accreditation of Healthcare Organizations.  JCAHO accredits many types and sizes of hospitals and healthcare organizations including healthcare networks, home healthcare organizations, nursing homes, and laboratories throughout the country. This stamp of approval means that the facility has met certain quality standards. When a JCAHO inspection is complete, it is made available to the public in the form of a percentage (the organizationís overall evaluation score) to inform the community of the organizationís performance.  For more information, visit the JCAHO website at www.jcaho.org.  Information regarding accreditation and the accreditation performance of an individual organization can be obtained through Quality Check under the JCAHO website.  

Laboratory Director

Individual qualified by virtue of documented training, expertise and experience in areas of analytic testing offered by the laboratory.  The director is responsible for the overall operation and administration of the laboratory to assure quality patient services.     

Levey-Jennings Chart

The Levey-Jennings Chart displays information about the quality control samples performed on laboratory analytes.  At a glance, one may see the control result on the Y-axis and the days of the month on the X axis (or any other increment of time). The mean value of the control result is shown with a solid line horizontally through the chart, with a range of acceptable values (typically two standard deviations) as horizontal lines above and below the mean. Any trending or shifting of the control results around the mean will be easily observed on this chart. If trending or shifting is present on the chart it must be investigated for any problems.

Linearity

Linearity describes the validity of the reportable range of the instrument. When testing the linearity of an instrument, one is checking for the relationship of at least three unknown concentration samples to three known concentration samples. Optimally, when charted, this relationship should form a straight line.

LIS

Laboratory Information System.  Mainframe or minicomputer system running software, which supports many of the computer needs for the laboratory.  LISís are often networked to the HIS via an interface (Orders interface, Results interface, ADT Interface) to enable the smooth flow of data back and forth to the laboratory.  Examples of LIS vendors include Sunquest, Cerner, SMS, Soft, Meditech, HBOC, VA Vista.

Medical Director

A physician (preferably a pathologist -CAP) or a doctoral scientist qualified by training, expertise, and experience in the areas of testing offered by the laboratory.  This individual is responsible for all patient laboratory testing results that are released from the institution or facility that has named him/her as the licensed medical director.  The CLIA certificate and other accrediting certificates contain this name for regulatory/responsibility purposes.

Medical Technologist

This is a type of laboratorian who performs patient testing on various types of instruments which he/she has been deemed competent to run.  A licensed medical technologist has obtained a specific number of clinical hours working within the hospital setting and has passed a standardized national test to enable him/her to practice the science of laboratory medicine in the healthcare field.  This person may possess a Bachelor of Science degree in clinical laboratory science or medical technology.

Methodology

Type of testing used by the instrument or test kit to obtain a result that can be qualitative or quantitative.  Every methodology should have its own range (normal, abnormal, critical, technical). Each methodology per analyte receives a different CPT code for billing purposes because each methodology requires a different amount of effort to discern a result.

Moderate Complexity

If a test gets a score of at least 12 or more from the 7 criteria against which CLIA analyses it, the test is considered to be moderately complex. When an institution has moderately complex tests, it must enroll in a proficiency-testing program. The institution must also have a defined quality control and quality assurance plan. The personnel who perform the testing must also meet the requirements under CLIA guidelines for moderately complex testing.

NCCLS

National Committee for Clinical Laboratory Standards.  Provides publications for healthcare professionals. These publications address issues such as quality control, testing procedures, and scientific evaluation protocols. A number of accrediting agencies use these standards as either references for their own standards or tolls to help them develop standards.  For more information, visit the NCCLS website at www.nccls.org.

Point-of-Care Testing (POCT)

 

 

 

"Diagnostic testing performed at or near the site of patient care"
- Kost, GJ.  Guidelines for point-of-care testing: improving patient outcomes. American Journal of Clinical Pathology 1995; 104 (Sup1):S111-S127.

A more restrictive definition as defined by CAP is "analytical patient testing activities provided within the institution, but performed outside the physical facilities of the clinical laboratories. It does not require permanent dedicated space, but instead includes kits and instruments, which are either hand carried or transported to the vicinity of the patient for immediate testing at that siteĒ. Point-of-Care testing, or POCT, has a number of names. Ancillary testing, bedside testing, alternate site testing and decentralized testing all mean POCT.

 

POC Coordinator (POCC)

 

 

A POCC is the individual who is responsible for implementing and coordinating all the laboratory tests performed on the patient care floors, of the healthcare facility. Their responsibilities include, but not be limited to:

  • Governing and administrating staff competencies.
  • Implementing a quality assessment programs which includes Quality Control (QC) and Proficiency Testing (PT).
  • Develop and distribute procedure manuals.
  • Coordinate test method selections.
  • Review patient and QC results for technical and clerical problems/errors.
  • Initiate and facilitate proposals for new POCT instruments.
  • Chair the POCT committee.
  • Ensure standardization in recording and reporting of results.

The POCC must also possess a working knowledge of standards and regulations of the various accrediting agencies. Many POC Coordinators are multi-faceted and must not only be the institutionís only POC Coordinator, but also work in various parts of the laboratory performing other duties or on the patient care floors.

Precision

The accuracy, exactness or refinement of a measurement.  When several measurements of the same substance duplicate or replicate one another, precision is determined.  The degree of closeness of these values determines the level of precision.

Procedure

 

Step by step process that explains exactly how to perform all testing.

Proficiency Testing

Under certain accrediting agency regulations, an institution performing patient testing must participate in this type of external unknown sample survey.  These samples with unknown values, are shipped to the institution at various times throughout the year. They are analyzed within a specified time by testing personnel who must treat them just like a patient sample. Once unknown samples have been tested and resulted, the values are sent to the external proficiency testing agency for evaluation. The evaluated results are then sent back to the institution in a report that compares the results obtained with the actual results and rates oneís institution to other institutions using the same methodology.  The successful completion of a proficiency survey is a benchmark for quality.

QA

 

Quality Assurance is a program that concentrates on producing quality laboratory tests. This program most always includes monitoring policies, procedures, and processes. It examines methodology/instrument selection as well a comprehensive competency program for all testing personnel. Sample collection, sample processing, and quality control are also part of the quality assurance program.

 

QC

Quality Control.  Process that checks an instrument or testing site to make sure it is reporting accurate results on patients. The reproducibility of a result from a testing site or instrument should fall within a certain range. Control solutions of known values are often times used for checking quality control. An institution may choose how often control solutions are run depending on the accrediting body and test complexity the analyte falls under. A program is not complete without the capacity to identify problems and correct them. Levy Jennings charts are often used identify problems with QC results.

Reagents

 

Substances that produce the reaction that results in an answer for any particular test. These substances can be in liquid form and are added to a strip or slide. They can also be impregnated on the strip or slide. Whatever the case, it is best to follow the manufacturers recommendations on storage and stability of reagents for optimal results.

Regulatory Agency

The most highly regarded and most important government regulatory body for clinical laboratories is CLIA. There are also state level regulations that must be just as strict as CLIA and meet the minimum requirements set forth by CLIA. Other agencies such as CAP and JCAHO are accrediting bodies which are voluntary and membership is not required of a laboratory which performs testing on human specimens. Do not confuse accrediting bodies with regulatory bodies or organizations.

Software

This is a type of computer program application. It is typically associated with hardware.  Software contains the look and feel of what is displayed on the computer screen.  It also contains the features and functionality of the program. 

Standard Deviation (SD)

A measure of variability representing an average distance of the data from the mean.  The greater the standard deviation, the greater the difference between the individual determinations and the less the precision of the method.  When the standard deviation of the number of determinations (20 or more) is calculated, approximately 68% of all values will fall within +-1 SD from the mean, approximately 95% within +- 2 SD and 99.7% within 3 +- 3SD.  Two to three standard deviations from the mean usually represents an acceptable range for control values.

Test

A significant chemical reaction that indicates the presence or composition of a substance under study.  For example the method by which glucose is identified and measured in a blood sample.      

Training

The act of being made proficient in a particular task by undergoing specialized instruction and practice.  Objectives and goals for this act must be well defined and accomplished upon the completion of the process.  Training in the use of a POC instrument and/or manual test enables a person to become certified in its use.

Waived Testing

 

Category of testing under CLIA including simple testing that competent staff members can perform. This category of tests has been approved by the FDA for home use, the methodologies are simple and accurate, and there is no risk of harm to the patient if performed incorrectly. Most POC testing is waived. Manufacturers work very hard to get their tests on the waived category list.

Validation

                      

The procedures involved in checking data for correctness, compliance with standards and conformance with the required specifications.  New methods of testing in a laboratory are validated by comparing results against the method currently in use and checking for accuracy and precision of the data.

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