(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)AlbuminAlkaline phosphataseAmylaseAspartate aminotransferase (AST/SGOT)Bilirubin, totalBlood gas (pH, pO2, and pCO2)Calcium, totalChlorideCholesterol, totalCholesterol, high density lipoproteinCreatine kinaseCreatine kinase, isoenzymesCreatinineGlucose (Excluding measurements on devices cleared by FDA for home use)Iron, totalLactate dehydrogenase (LDH)LDH isoenzymesMagnesiumPotassiumSodiumTotal ProteinTriglyceridesUrea NitrogenUric 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.
Criteria for Acceptable Performance
The criteria for acceptable performance are-- ------------------------------------------------------------------------
Criteria for acceptable
Analyte or test 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%.Billirubin, 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 Target value 1B6 mg/dl or
monitoring devices cleared by FDA for 10% (greater).
home use.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:[GRAPHIC] [TIFF OMITTED] TR25SE06.023
(5) To determine the overall testing event score, the number of correct responses for all analytes must be averaged using the following formula:[GRAPHIC] [TIFF OMITTED] TR25SE06.022 [57 FR 7151, Feb. 28, 1992, as amended at 68 FR 3702, Jan. 24, 2003]