493.931—Routine chemistry.

(a) Program content and frequency of challenge. To be approved for proficiency testing for routine chemistry, 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 samples that cover the clinically relevant range of values that would be expected in patient specimens. The specimens 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 testing event a program must provide for each analyte or test procedure listed below is five serum, plasma or blood samples.

Analyte or Test Procedure

Alanine aminotransferase (ALT/SGPT)

Albumin

Alkaline phosphatase

Amylase

Aspartate aminotransferase (AST/SGOT)

Bilirubin, total

Blood gas (pH, pO2, and pCO2)

Calcium, total

Chloride

Cholesterol, total

Cholesterol, high density lipoprotein

Creatine kinase

Creatine kinase, isoenzymes

Creatinine

Glucose (Excluding measurements on devices cleared by FDA for home use)

Iron, total

Lactate dehydrogenase (LDH)

LDH isoenzymes

Magnesium

Potassium

Sodium

Total Protein

Triglycerides

Urea Nitrogen

Uric Acid

(c) Evaluation of a laboratory's analyte or test performance. HHS approves only those programs that assess the accuracy of a laboratory's responses in accordance with paragraphs (c)(1) through (5) of this section.

(1) To determine the accuracy of a laboratory's response for qualitative and quantitative chemistry 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 laboratories. The score for a sample in routine chemistry is either the score determined under paragraph (c)(2) or (3) of this section.

(2) For quantitative chemistry tests or analytes, the program must determine 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 response, the appropriateness of the response must be determined by using either fixed criteria based on the percentage difference from the target value or the number of standard deviations (SDs) the response differs from the target value.

The criteria for acceptable performance are—

Analyte or test	Criteria for acceptable performance
Alanine aminotransferase (ALT/SGPT)	Target value ±20%.
Albumin	Target value ±10%.
Alkaline phosphatase	Target value ±30%.
Amylase	Target value ±30%.
Aspartate aminotransferase (AST/SGOT)	Target value ±20%.
Bilirubin, total	Target value ±0.4 mg/dL or ±20% (greater).
Blood gas pO2	Target value ±3 SD.
pCO2	Target value ±5 mm Hg or ±8% (greater).
pH	Target value ±0.04.
Calcium, total	Target value ±1.0 mg/dL.
Chloride	Target value ±5%.
Cholesterol, total	Target value ±10%.
Cholesterol, high density lipoprotein	Target value ±30%.
Creatine kinase	Target value ±30%.
Creatine kinase isoenzymes	MB elevated (presence or absence) or Target value ±3SD.
Creatinine	Target value ±0.3 mg/dL or ±15% (greater).
Glucose (excluding glucose performed on monitoring devices cleared by FDA for home use	Target value ±6 mg/dl or ±10% (greater).
Iron, total	Target value ±20%.
Lactate dehydrogenase (LDH)	Target value ±20%.
LDH isoenzymes	LDH1/LDH2 ( or −) or Target value ±30%.
Magnesium	Target value ±25%.
Potassium	Target value ±0.5 mmol/L.
Sodium	Target value ±4 mmol/L.
Total Protein	Target value ±10%.
Triglycerides	Target value ±25%.
Urea nitrogen	Target value ±2 mg/dL or ±9% (greater).
Uric acid	Target value ±17%.

(3) The criterion for acceptable performance for qualitative routine chemistry 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:

(5) To determine the overall testing event score, the number of correct responses for all analytes must be averaged using the following formula:

[57 FR 7151, Feb. 28, 1992, as amended at 68 FR 3702, Jan. 24, 2003]

CFR

493.931—Routine chemistry.