§ 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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 Centers for Medicare & Medicaid Services, HHS
Analyte or test
Iron, total ................................
Lactate dehydrogenase
(LDH).
LDH isoenzymes ...................
Magnesium ............................
Potassium ..............................
Sodium ...................................
Total Protein ..........................
Triglycerides ..........................
Urea nitrogen .........................
Uric acid .................................
(3) The criterion for acceptable per-
formance for qualitative routine chem-
istry tests is positive or negative.
(4) To determine the analyte testing
event score, the number of acceptable
analyte responses must be averaged
using the following formula:
Number of accept-
able responses for
the analyte
Total number of
challenges for the
analyte
(5) To determine the overall testing
event score, the number of correct re-
sponses for all analytes must be aver-
aged using the following formula:
Number of accept-
able responses for
all challenges
Total number of
all challenges
[57 FR 7151, Feb. 28, 1992, as amended at 68
FR 3702, Jan. 24, 2003]
§ 493.933 Endocrinology.
(a) Program content and frequency of
challenge. To be approved for pro-
ficiency testing for endocrinology, a
program must provide a minimum of
five samples per testing event. There
must be at least three testing events at
approximately equal intervals per year.
The annual program must provide sam-
ples that cover the clinically relevant
range of values that would be expected
in patient specimens. The samples may
be provided through mailed shipments
or, at HHS’ option, may be provided to
HHS or its designee for on-site testing.
(b) Challenges per testing event. The
minimum number of challenges per
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Criteria for acceptable per-
formance
Target value ±20%.
Target value ±20%.
LDH1/LDH2 (+ or ¥) or Tar-
get value ± 30%.
Target value ±25%.
Target value ±0.5 mmol/L.
Target value ±4 mmol/L.
Target value ±10%.
Target value ±25%.
Target value ±2 mg/dL or
±9% (greater).
Target value ±17%.
×100=Analyte score for
the testing event
×100=Testing event
score
1023
Frm 01023 Fmt 8010
§ 493.933
testing event a program must provide
for each analyte or test procedure is
five serum, plasma, blood, or urine
samples.
Analyte or Test
Cortisol
Free Thyroxine
Human Chorionic gonadotropin (excluding
urine pregnancy tests done by visual color
comparison categorized as waived tests)
T3 Uptake
Triiodothyronine
Thyroid-stimulating hormone
Thyroxine
(c) Evaluation of a laboratory’s analyte
or test performance. HHS approves only
those programs that assess the accu-
racy of a laboratory’s responses in ac-
cordance with paragraphs (c)(1)
through (5) of this section.
(1) To determine the accuracy of a
laboratory’s response for qualitative
and quantitative endocrinology tests
or analytes, a program must compare
the laboratory’s response for each
analyte with the response that reflects
agreement of either 80 percent of ten or
more referee laboratories or 80 percent
or more of all participating labora-
tories. The score for a sample in endo-
crinology is either the score deter-
mined under paragraph (c)(2) or (c)(3)
of this section.
(2) For quantitative endocrinology
tests or analytes, the program must de-
termine the correct response for each
analyte by the distance of the response
from the target value. After the target
value has been established for each re-
sponse, the appropriateness of the re-
sponse must be determined by using ei-
ther fixed criteria based on the per-
centage difference from the target
value or the number of standard devi-
ations (SDs) the response differs from
the target value.
Criteria for Acceptable Performance
The criteria for acceptable perform-
ance are—
Criteria for acceptable per-
Analyte or test formance
Cortisol ................................... Target value ±25%.
Free Thyroxine ...................... Target value ±3 SD.
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 § 493.937
Analyte or test
Human Chorionic
Gonadotropin (excluding
urine pregnancy tests done
by visual color comparison
categorized as waived
tests).
T3 Uptake ..............................
Triiodothyronine .....................
Thyroid-stimulating hormone
Thyroxine ...............................
(3) The criterion for acceptable per-
formance for qualitative endocrinology
tests is positive or negative.
(4) To determine the analyte testing
event score, the number of acceptable
analyte responses must be averaged
using the following formula:
Number of accept-
able responses for
the analyte
Total number of
challenges for the
analyte
(5) To determine the overall testing
event score, the number of correct re-
sponses for all analytes must be aver-
aged using the following formula:
Number of accept-
able responses for
all challenges
Total number of
all challenges
[57 FR 7151, Feb. 28, 1992, as amended at 58
FR 5229, Jan. 19, 1993; 68 FR 3702, Jan. 24,
2003]
§ 493.937 Toxicology.
(a) Program content and frequency of
challenge. To be approved for pro-
ficiency testing for toxicology, the an-
nual program must provide a minimum
of five samples per testing event. There
must be at least three testing events at
approximately equal intervals per year.
The annual program must provide sam-
ples that cover the clinically relevant
range of values that would be expected
in specimens of patients on drug ther-
apy and that cover the level of clinical
significance for the particular drug.
The samples may be provided through
mailed shipments or, at HHS’ option,
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Criteria for acceptable per-
formance
Target value ±3 SD positive
or negative.
Target value ±3 SD.
Target value ±3 SD.
Target value ±3 SD.
Target value ±20% or 1.0
mcg/dL (greater).
×100=Analyte score for
the testing event
×100=Testing event
score
1024
Frm 01024 Fmt 8010
42 CFR Ch. IV (10–1–03 Edition)
may be provided to HHS or its designee
for on-site testing.
(b) Challenges per testing event. The
minimum number of challenges per
testing event a program must provide
for each analyte or test procedure is
five serum, plasma, or blood samples.
Analyte or Test Procedure
Alcohol (blood) Phenytoin
Blood lead Primidone
Carbamazepine Procainamide
Digoxin (and metabolite)
Ethosuximide Quinidine
Gentamicin Theophylline
Lithium Tobramycin
Phenobarbital Valproic Acid
(c) Evaluation of a laboratory’s analyte
or test performance. HHS approves only
those programs that assess the accu-
racy of a laboratory’s responses in ac-
cordance with paragraphs (c)(1)
through (4) of this section.
(1) To determine the accuracy of a
laboratory’s responses for quantitative
toxicology tests or analytes, the pro-
gram must compare the laboratory’s
response for each analyte with the re-
sponse that reflects agreement of ei-
ther 80 percent of ten or more referee
laboratories or 80 percent or more of
all participating laboratories. The
score for a sample in toxicology is the
score determined under paragraph
(c)(2) of this section.
(2) For quantitative toxicology tests
or analytes, the program must deter-
mine the correct response for each
analyte by the distance of the response
from the target value. After the target
value has been established for each re-
sponse, the appropriateness of the re-
sponse must be determined by using
fixed criteria based on the percentage
difference from the target value
Criteria for Acceptable Performance
The criteria for acceptable perform-
ance are:
Analyte or test Criteria for acceptable per-
formance
Alcohol, blood ........................ Target Value ± 25%.
Blood lead .............................. Target Value ±10% or 4 mcg/
dL (greater).
Carbamazepine ..................... Target Value ± 25%.
Digoxin ................................... Target Value ± 20% or ± 0.2
ng/mL (greater).
Ethosuximide ......................... Target Value ± 20%.
Gentamicin ............................. Target Value ± 25%.
Lithium ................................... Target Value ± 0.3 mmol/L or
± 20% (greater).
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 Centers for Medicare & Medicaid Services, HHS
Criteria for acceptable per-
Analyte or test
Phenobarbital ......................... Target
Phenytoin ............................... Target
Primidone ............................... Target
Procainamide (and metabo- Target
lite).
Quinidine ................................ Target
Tobramycin ............................ Target
Theophylline .......................... Target
Valproic Acid .......................... Target
(3) To determine the analyte testing
event score, the number of acceptable
analyte responses must be averaged
using the following formula:
Number of accept-
able responses for
the analyte
×100=Analyte score for
the testing event
Total number of
challenges for the
analyte
(4) To determine the overall testing
event score, the number of correct re-
sponses for all analytes must be aver-
aged using the following formula:
Number of accept-
able responses for
all challenges ×100=Testing event
score
Total number of
all challenges
[57 FR 7151, Feb. 28, 1992, as amended at 58
FR 5229, Jan. 19, 1993; 68 FR 3702, Jan. 24,
2003]
§ 493.941 Hematology (including rou-
tine hematology and coagulation).
(a) Program content and frequency of
challenge. To be approved for pro-
ficiency testing for hematology, a pro-
gram must provide a minimum of five
samples per testing event. There must
be at least three testing events at ap-
proximately equal intervals per year.
The annual program must provide sam-
ples that cover the full range of values
that would be expected in patient
specimens. The samples may be pro-
vided through mailed shipments or, at
HHS’ option, may be provided to HHS
and or its designee for on-site testing.
(b) Challenges per testing event. The
minimum number of challenges per
testing event a program must provide
for each analyte or test procedure is
five.
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§ 493.941
Analyte or Test Procedure
formance
Cell identification or white blood cell dif-
Value ± 20% ferential
Value ± 25%. Erythrocyte count
Value ± 25%. Hematocrit (excluding spun microhemato-
Value ± 25%.
crit)
Value ± 25%. Hemoglobin
Value ± 25%. Leukocyte count
Value ± 25%. Platelet count
Value ± 25%. Fibrinogen
Partial thromboplastin time
Prothrombin time
(1) An approved program for cell
identification may vary over time. The
types of cells that might be included in
an approved program over time are—
Neutrophilic granulocytes
Eosinophilic granulocytes
Basophilic granulocytes
Lymphocytes
Monocytes
Major red and white blood cell abnormalities
Immature red and white blood cells
(2) White blood cell differentials
should be limited to the percentage
distribution of cellular elements listed
above.
(c) Evaluation of a laboratory’s analyte
or test performance. HHS approves only
those programs that assess the accu-
racy of a laboratory’s responses in ac-
cordance with paragraphs (c) (1)
through (5) of this section.
(1) To determine the accuracy of a
laboratory’s responses for qualitative
and quantitative hematology tests or
analytes, the program must compare
the laboratory’s response for each
analyte with the response that reflects
agreement of either 80 percent of ten or
more referee laboratories or 80 percent
or more of all participating labora-
tories. The score for a sample in hema-
tology is either the score determined
under paragraph (c) (2) or (3) of this
section.
(2) For quantitative hematology tests
or analytes, the program must deter-
mine the correct response for each
analyte by the distance of the response
from the target value. After the target
value has been established for each re-
sponse, the appropriateness of the re-
sponse is determined using either fixed
criteria based on the percentage dif-
ference from the target value or the
number of standard deviations (SDs)
the response differs from the target
value.
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