Especificaciones de calidad legislativas utilizadas en EUU. CLIA.

1. § 493.929 42 CFR Ch. IV (10–1–03 Edition)
§ 493.929 Chemistry. those programs that assess the accu-
The subspecialties under the spe- racy of a laboratory’s responses in ac-
cialty of chemistry for which a pro- cordance with paragraphs (c)(1)
ficiency testing program may offer pro- through (5) of this section.
(1) To determine the accuracy of a
ficiency testing are routine chemistry,
laboratory’s response for qualitative
endocrinology, and toxicology. Specific
and quantitative chemistry tests or
criteria for these subspecialties are
analytes, the program must compare
listed in §§ 493.931 through 493.939.
the laboratory’s response for each
§ 493.931 Routine chemistry. analyte with the response that reflects
agreement of either 80 percent of ten or
(a) Program content and frequency of
more referee laboratories or 80 percent
challenge. To be approved for pro-
or more of all participating labora-
ficiency testing for routine chemistry,
tories. The score for a sample in rou-
a program must provide a minimum of
tine chemistry is either the score de-
five samples per testing event. There
termined under paragraph (c)(2) or (3)
must be at least three testing events at
of this section.
approximately equal intervals per year.
(2) For quantitative chemistry tests
The annual program must provide sam-
or analytes, the program must deter-
ples that cover the clinically relevant
mine the correct response for each
range of values that would be expected
analyte by the distance of the response
in patient specimens. The specimens
from the target value. After the target
may be provided through mailed ship-
value has been established for each re-
ments or, at HHS’ option, may be pro-
sponse, the appropriateness of the re-
vided to HHS or its designee for on-site
sponse must be determined by using ei-
testing.
ther fixed criteria based on the per-
(b) Challenges per testing event. The
centage difference from the target
minimum number of challenges per
value or the number of standard devi-
testing event a program must provide
ations (SDs) the response differs from
for each analyte or test procedure list-
the target value.
ed below is five serum, plasma or blood
samples. Criteria for Acceptable Performance
Analyte or Test Procedure The criteria for acceptable perform-
Alanine aminotransferase (ALT/SGPT) ance are—
Albumin Criteria for acceptable per-
Alkaline phosphatase Analyte or test formance
Amylase
Aspartate aminotransferase (AST/SGOT) Alanine aminotransferase Target value ±20%.
Bilirubin, total (ALT/SGPT).
Albumin .................................. Target value ±10%.
Blood gas (pH, pO2, and pCO2)
Alkaline phosphatase ............ Target value ±30%.
Calcium, total Amylase ................................. Target value ±30%.
Chloride Aspartate aminotransferase Target value ±20%.
Cholesterol, total (AST/SGOT).
Cholesterol, high density lipoprotein Bilirubin, total ......................... Target value ±0.4 mg/dL or
Creatine kinase ±20% (greater).
Creatine kinase, isoenzymes Blood gas pO2 ....................... Target value ±3 SD.
Creatinine pCO2 ..................................... Target value ±5 mm Hg or
±8% (greater).
Glucose (Excluding measurements on devices
pH .......................................... Target value ±0.04.
cleared by FDA for home use) Calcium, total ......................... Target value ±1.0 mg/dL.
Iron, total Chloride ................................. Target value ±5%.
Lactate dehydrogenase (LDH) Cholesterol, total .................... Target value ±10%.
LDH isoenzymes Cholesterol, high density Target value ±30%.
Magnesium lipoprotein.
Potassium Creatine kinase ...................... Target value ±30%.
Sodium Creatine kinase isoenzymes MB elevated (presence or ab-
sence) or Target value
Total Protein ±3SD.
Triglycerides Creatinine .............................. Target value ±0.3 mg/dL or
Urea Nitrogen ±15% (greater).
Uric Acid Glucose (excluding glucose Target value ±6 mg/dl or
performed on monitoring ±10% (greater).
(c) Evaluation of a laboratory’s analyte devices cleared by FDA for
or test performance. HHS approves only home use.
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2. Centers for Medicare & Medicaid Services, HHS § 493.933
Analyte or test Criteria for acceptable per- testing event a program must provide
formance
for each analyte or test procedure is
Iron, total ................................ Target value ±20%. five serum, plasma, blood, or urine
Lactate dehydrogenase Target value ±20%. samples.
(LDH).
LDH isoenzymes ................... LDH1/LDH2 (+ or ¥) or Tar- Analyte or Test
get value ± 30%.
Magnesium ............................ Target value ±25%.
Potassium .............................. Target value ±0.5 mmol/L. Cortisol
Sodium ................................... Target value ±4 mmol/L. Free Thyroxine
Total Protein .......................... Target value ±10%. Human Chorionic gonadotropin (excluding
Triglycerides .......................... Target value ±25%. urine pregnancy tests done by visual color
Urea nitrogen ......................... Target value ±2 mg/dL or
±9% (greater). comparison categorized as waived tests)
Uric acid ................................. Target value ±17%. T3 Uptake
Triiodothyronine
(3) The criterion for acceptable per- Thyroid-stimulating hormone
formance for qualitative routine chem- Thyroxine
istry tests is positive or negative.
(c) Evaluation of a laboratory’s analyte
(4) To determine the analyte testing
event score, the number of acceptable or test performance. HHS approves only
analyte responses must be averaged those programs that assess the accu-
using the following formula: racy of a laboratory’s responses in ac-
cordance with paragraphs (c)(1)
Number of accept- through (5) of this section.
able responses for (1) To determine the accuracy of a
the analyte ×100=Analyte score for laboratory’s response for qualitative
the testing event
Total number of and quantitative endocrinology tests
challenges for the or analytes, a program must compare
analyte
the laboratory’s response for each
analyte with the response that reflects
(5) To determine the overall testing agreement of either 80 percent of ten or
event score, the number of correct re-
more referee laboratories or 80 percent
sponses for all analytes must be aver-
aged using the following formula: or more of all participating labora-
tories. The score for a sample in endo-
Number of accept- crinology is either the score deter-
able responses for mined under paragraph (c)(2) or (c)(3)
all challenges ×100=Testing event
score of this section.
Total number of (2) For quantitative endocrinology
all challenges tests or analytes, the program must de-
termine the correct response for each
[57 FR 7151, Feb. 28, 1992, as amended at 68 analyte by the distance of the response
FR 3702, Jan. 24, 2003] from the target value. After the target
value has been established for each re-
§ 493.933 Endocrinology. sponse, the appropriateness of the re-
(a) Program content and frequency of sponse must be determined by using ei-
challenge. To be approved for pro- ther fixed criteria based on the per-
ficiency testing for endocrinology, a centage difference from the target
program must provide a minimum of value or the number of standard devi-
five samples per testing event. There ations (SDs) the response differs from
must be at least three testing events at the target value.
approximately equal intervals per year.
The annual program must provide sam- Criteria for Acceptable Performance
ples that cover the clinically relevant
range of values that would be expected The criteria for acceptable perform-
in patient specimens. The samples may ance are—
be provided through mailed shipments Criteria for acceptable per-
or, at HHS’ option, may be provided to Analyte or test formance
HHS or its designee for on-site testing.
Cortisol ................................... Target value ±25%.
(b) Challenges per testing event. The
Free Thyroxine ...................... Target value ±3 SD.
minimum number of challenges per
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3. § 493.937 42 CFR Ch. IV (10–1–03 Edition)
Analyte or test Criteria for acceptable per- may be provided to HHS or its designee
formance for on-site testing.
Human Chorionic Target value ±3 SD positive (b) Challenges per testing event. The
Gonadotropin (excluding or negative. minimum number of challenges per
urine pregnancy tests done testing event a program must provide
by visual color comparison
categorized as waived
for each analyte or test procedure is
tests). five serum, plasma, or blood samples.
T3 Uptake .............................. Target value ±3 SD.
Triiodothyronine ..................... Target value ±3 SD. Analyte or Test Procedure
Thyroid-stimulating hormone Target value ±3 SD.
Thyroxine ............................... Target value ±20% or 1.0 Alcohol (blood) Phenytoin
mcg/dL (greater). Blood lead Primidone
Carbamazepine Procainamide
(3) The criterion for acceptable per- Digoxin (and metabolite)
Ethosuximide Quinidine
formance for qualitative endocrinology
Gentamicin Theophylline
tests is positive or negative. Lithium Tobramycin
(4) To determine the analyte testing Phenobarbital Valproic Acid
event score, the number of acceptable
analyte responses must be averaged (c) Evaluation of a laboratory’s analyte
using the following formula: or test performance. HHS approves only
those programs that assess the accu-
Number of accept- racy of a laboratory’s responses in ac-
able responses for cordance with paragraphs (c)(1)
the analyte ×100=Analyte score for through (4) of this section.
the testing event (1) To determine the accuracy of a
Total number of
challenges for the laboratory’s responses for quantitative
analyte toxicology tests or analytes, the pro-
gram must compare the laboratory’s
response for each analyte with the re-
(5) To determine the overall testing sponse that reflects agreement of ei-
event score, the number of correct re- ther 80 percent of ten or more referee
sponses for all analytes must be aver- laboratories or 80 percent or more of
aged using the following formula: all participating laboratories. The
score for a sample in toxicology is the
Number of accept- score determined under paragraph
able responses for
all challenges ×100=Testing event (c)(2) of this section.
score (2) For quantitative toxicology tests
Total number of or analytes, the program must deter-
all challenges mine the correct response for each
analyte by the distance of the response
from the target value. After the target
[57 FR 7151, Feb. 28, 1992, as amended at 58 value has been established for each re-
FR 5229, Jan. 19, 1993; 68 FR 3702, Jan. 24, sponse, the appropriateness of the re-
2003] sponse must be determined by using
fixed criteria based on the percentage
§ 493.937 Toxicology.
difference from the target value
(a) Program content and frequency of
challenge. To be approved for pro- Criteria for Acceptable Performance
ficiency testing for toxicology, the an-
The criteria for acceptable perform-
nual program must provide a minimum
ance are:
of five samples per testing event. There
must be at least three testing events at Analyte or test Criteria for acceptable per-
approximately equal intervals per year. formance
The annual program must provide sam- Alcohol, blood ........................ Target Value ± 25%.
ples that cover the clinically relevant Blood lead .............................. Target Value ±10% or 4 mcg/
range of values that would be expected dL (greater).
Carbamazepine ..................... Target Value ± 25%.
in specimens of patients on drug ther- Digoxin ................................... Target Value ± 20% or ± 0.2
apy and that cover the level of clinical ng/mL (greater).
significance for the particular drug. Ethosuximide ......................... Target Value ± 20%.
Gentamicin ............................. Target Value ± 25%.
The samples may be provided through Lithium ................................... Target Value ± 0.3 mmol/L or
mailed shipments or, at HHS’ option, ± 20% (greater).
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4. Centers for Medicare & Medicaid Services, HHS § 493.941
Criteria for acceptable per- Analyte or Test Procedure
Analyte or test formance
Cell identification or white blood cell dif-
Phenobarbital ......................... Target Value ± 20% ferential
Phenytoin ............................... Target Value ± 25%. Erythrocyte count
Primidone ............................... Target Value ± 25%. Hematocrit (excluding spun microhemato-
Procainamide (and metabo- Target Value ± 25%.
crit)
lite).
Quinidine ................................ Target Value ± 25%. Hemoglobin
Tobramycin ............................ Target Value ± 25%. Leukocyte count
Theophylline .......................... Target Value ± 25%. Platelet count
Valproic Acid .......................... Target Value ± 25%. Fibrinogen
Partial thromboplastin time
(3) To determine the analyte testing Prothrombin time
event score, the number of acceptable (1) An approved program for cell
analyte responses must be averaged identification may vary over time. The
using the following formula: types of cells that might be included in
an approved program over time are—
Number of accept-
able responses for Neutrophilic granulocytes
the analyte Eosinophilic granulocytes
×100=Analyte score for
the testing event Basophilic granulocytes
Total number of Lymphocytes
challenges for the
analyte Monocytes
Major red and white blood cell abnormalities
Immature red and white blood cells
(4) To determine the overall testing (2) White blood cell differentials
event score, the number of correct re- should be limited to the percentage
sponses for all analytes must be aver- distribution of cellular elements listed
aged using the following formula: above.
Number of accept-
(c) Evaluation of a laboratory’s analyte
able responses for or test performance. HHS approves only
all challenges ×100=Testing event those programs that assess the accu-
score racy of a laboratory’s responses in ac-
Total number of
all challenges cordance with paragraphs (c) (1)
through (5) of this section.
(1) To determine the accuracy of a
[57 FR 7151, Feb. 28, 1992, as amended at 58 laboratory’s responses for qualitative
FR 5229, Jan. 19, 1993; 68 FR 3702, Jan. 24, and quantitative hematology tests or
2003] analytes, the program must compare
the laboratory’s response for each
§ 493.941 Hematology (including rou- analyte with the response that reflects
tine hematology and coagulation).
agreement of either 80 percent of ten or
(a) Program content and frequency of more referee laboratories or 80 percent
challenge. To be approved for pro- or more of all participating labora-
ficiency testing for hematology, a pro- tories. The score for a sample in hema-
gram must provide a minimum of five tology is either the score determined
samples per testing event. There must under paragraph (c) (2) or (3) of this
be at least three testing events at ap- section.
proximately equal intervals per year. (2) For quantitative hematology tests
The annual program must provide sam- or analytes, the program must deter-
ples that cover the full range of values mine the correct response for each
that would be expected in patient analyte by the distance of the response
specimens. The samples may be pro- from the target value. After the target
vided through mailed shipments or, at value has been established for each re-
HHS’ option, may be provided to HHS sponse, the appropriateness of the re-
and or its designee for on-site testing. sponse is determined using either fixed
(b) Challenges per testing event. The criteria based on the percentage dif-
minimum number of challenges per ference from the target value or the
testing event a program must provide number of standard deviations (SDs)
for each analyte or test procedure is the response differs from the target
five. value.
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