Spring: Lab Regulations

legislatures pass statutes that create ___

law, act, code

rules or reqs typically written by a gov agency to enforce a law

regulation

certification, typically by a professional org, that designated stds have been met

accreditation

allows entity to operate or engage in a business practice or occupation

license

What federal agencies are under the Dept of Health & Human Services (HHS)?

• Center for Medicare & Medicaid (MediCal) Services (CMS)

• FDA

What federal agencies are under the Center for Medicare & Medicaid Services (CMS) ?

• CLIA

• Office of the Inspector General (OIG)

HHS

Department of Health & Human Services

CMS

Center for Medicare & Medicaid Services

OIG

Office of the Inspector General

What are the federal agencies that impact labs?

HHS & OSHA

CLIA

Clinical Laboratory Improvement Amendments

Which org involved lab licensing and interstate transport of samples?

CLIA ‘67

Which org:

• response to concerns about unregulated labs, physician office labs, pap smear ‘mills’

• set min standards under which labs would operate

CLIA ‘88

facility for examination of materials derived from the human body for the purpose of providing info for the diagnosis, prevention, or Tx of any disease of impairment of, or the assessment of the health of, human beings

CLIA ‘88 lab definition

What are CLIA exempt labs?

• labs operated by federal & state agencies

• SAMHSA drug testing labs

• labs only doing forensic testing

• research labs if the results are not released for use in Pt care decisions

• Labs in CLIA exempt states

What are labs operated by federal & state agencies?

• Veterans Administration

• Military

• Public Health labs

SAMHSA

substance abuse and mental health services administration

PPM

provider performed microscopy

non-waived tests

• moderate complexity (i.e. PPM)

• high complexity

Who determines the test complexity level for all approved tests?

FDA

What type of tests are always considered high complexity?

• in-house developed tests

• any deviation from manufacturer instructions

What type of tests:

• employ methodologies that are so simple & accurate as to render the likelihood of erroneous results by the user negligible

• pose no unreasonable risk of harm to the patient if performed incorrectly

waived tests

original waived test analytes

• urine dipstick

• fecal occult blood

• ovulation test (LH)

• urine pregnancy

• ESR

• Hgb

• blood glucose

• spun Hct

moderately complex tests

• provider performed microscopy

• automated hematology

• automated chemistry

• automated UA

provider performed microscopy tests

• KOH

• wet mount

• urine sediment

• qualitative semen

• ferning

• post-coital exams

• pinworm

• nasal leukocytes

• fecal leukocytes

criteria for test complexity

• knowledge

• training

• reagent & material prep

• chars of operational steps

• calibration, QC, & PT

• troubleshooting & maintenance

• interpretation & judgment

What score designates a moderately complex test?

≤12

What score designates a highly complex test?

>12

PT

proficiency testing

proficiency testing reqs for regulated analytes

lab must enroll in PT for each regulated analyte w/ 3 challenges/yr and 5 samples/challenge

proficiency testing reqs for non-regulated analytes

lab must test accuracy of the test at least 2x/yr

How is proficiency testing done for non-regulated analytes?

• proficiency testing program vendor

• trade samples w/ another lab that performs the test

• retest blinded samples

What is the PT min success rate for immunohematology?

100%

What is the PT min success rate for cervical cytology?

90%

What is the PT min success rate for most tests?

80%

What PT result = jeopardy

2 successive or 2/3 failures

What PT results causes a lab to stop a test?

3 failures

What do you do for PT if you have 2 of the same machine?

test only the primary machine and match the 2nd machine to the primary

What are the reqs if different methods or instruments are used to measure a specific analyte (incl 2 of the same instrument)?

document comparability of results 2x/yr

systems to detect unusual test results

• normal range

• critical values

• technical limits

test validation reqs on FDA approved tests

• accuracy

• precision

• reportable range

• verify manufacturer’s normal range or establish your lab’s normal range

test validation reqs on modified FDA or “home brew” tests in addition to the reqs for FDA approved tests

• analytic sensitivity

• analytic specificity

• specimen stability

• interferences

• est that mod has not changes test chars or performance

What type of data is used to compare QC results over time for shifts & trends?

Levy-Jennings plots

How many levels are req for QC of quantitative tests?

2-3

How do you establish control ranges?

• use manufacturer mean & SD values

• calculate mean & SD based on repeat testing of ‘new’ control material

• moving averages

What is moving averages for establishing control ranges?

uses real time avg of Pt data to detect systematic errors

How many repeats should be done to calculate mean & SD for ‘new’ control material?

10-20

Westgard 1-2s rule

one value out of mean by 2 SDs

Westgard 1-3s rule

one value out of mean by 3 SDs

Westgard 2-2s rule

two values out of mean by 2 SDs on same side

Westgard 4-1s rule

four samples on one side of the mean, out of mean by 1 SD

Westgard 10x rule

10 samples all on one side of mean

maintenance & fxn checks for unmodified, FDA approved tests

follow manufacturer’s instructions

maintenance & fxn checks for modified FDA or non-FDA approved tests

est maintenance & fxn checks that ensure test quality

mean of normal pop testing ±2 SD (central 95% of values)

normal range

range of results achievable w/o sample dilution or concentration

analytic measurement range

AMR

analytic measurement range

NR

normal range

What is the analytic measurement range bound by?

• limit of detection (low end)

• limit of linearity (high end)

range of reportable values w/ sample dilution or concentration

clinically reportable range

CRR

clinically reportable range

values prod from repeated measurements of diluent alone (noise)

limit of blank

LOB

limit of blank

lowest amt of analyte the assay can reliably detect

limit of detection

LOD

limit of detection

lowest amt of analyte the assay can reliably quantitate

limit of quantitation

LOQ

limit of quantitation

highest assay signal where the relationship between concentration and signal is constant

limit of linearity

LOL

limit of linearity

adjusting a test system or instrument to est a correlation between test output and analyte conc

calibration

What is used for test calibration?

• set of 3-5 calibrators w/ known values that span the analytical measurement range

• limit of detection

• limit of linearity

What may be used to establish linearity, accuracy & precision?

calibration

measuring samples w/ known conc to confirm calibration

calibration verification

When is calibration verification performed?

• at least every 6 months

• after a complete reagent change

• after maintenance

• if control results show shift or trend

values that are outside the normal range to a degree that may constitute an immediate health risk to the Pt or req immediate action from the ordering physician

critical value

results that may not req immediate provider notification but would be detrimental to the Pt if not addressed

sub-critical results

testing records reqs

• Pt identification

• accession #

• date & time of collection

• criteria for rejection (if sample rejected)

• date, time & place testing was performed

• name of individual who performed testing

personnel reqs for labs performing highly complex tests

• director

• technical consultant

• clinical consultant

• general supervisor

• testing personnel

How often are lab inspections req?

every 2 yrs

What are the accrediting orgs?

• College of American Pathologists

• The Joint Commission

• Commission on Lab Accreditation

• American Association of Blood Banks

• American Association of Lab Accreditation

• American Society for Histocompatibility and Immunogenetics

• American Osteopathic Association

CAP

College of American Pathologists

TJC

The Joint Commission

COLA

Commission on Lab Accreditation

AABB

American Association of Blood Banks

A2LA

American Association of Lab Accreditation

ASHI

American Society for Histocompatibility and Immunogenetics

AOA

American Osteopathic Association

Which inspection:

• based on general & section specific checklists

  • phase 1 & phase 2 deficiencies

  • inspector recommendations

• performed by staff from another inspected lab

  • each lab must field an inspection team

• inspections are unannounced

CAP inspection

Which inspection:

• based on standards

  • open to interpretation by inspector

• performed by staff inspectors

  • typically laboratorians

  • tracer methodology

• inspections are unannounced

TJC inspection

inspector follows a sample from point it comes out of Pt to point result is transmitted and sample stored

tracer methodology

OSHA 4-step process

• ID that a hazard poses significant risk

• demonstrate that the standard would significantly diminish or eliminate the risk

• select best protective exposure limit that is economically possible

• seek cost-effective ways for employers to meet exposure limit

OSHA engineering practices

• self-sheathing needles

• sharps containers

• red biowaste bags

Which org:

• oversight of instruments or test kits that are marketed to labs for testing

  • pre-market approval process

• incomplete assays

  • bulk reagents

  • analyte specific reagents

• determine CLIA test complexities

FDA

ASR

analyte specific reagents

What are the CA regulations?

• business & professions code

• health & safety code

• personnel standards (CLS, MLT)

• non-licensed personnel

• autoverification

• lab license reqs

special CA regulations

• licensure for out of state labs

• inspections by Laboratory Field Services

• phlebotomy certification

• HIV & infectious disease reporting reqs

• consent for HIV testing

• who may order tests

• release of test results

LFS

Laboratory Field Services