Summary:
Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to demonstrate that it can obtain precision performance specifications comparable to those established by the manufacturer for 29 of 29 chemistry analytes tested on the Roche Hitachi Cobas 6000/c501 (Cobas) analyzer prior to reporting patient test results. Findings include: 1. Review on 3/7/12 of the precision studies for alanine aminotransferase, albumin, alkaline phophatase, amylase, aspartate aminotransferase, direct bilirubin, total bilirubin, blood urea nitrogen, calcium, carbon dioxide, chloride, high-density liproprotein cholesterol, total cholesterol, creatinine, glucose, magnesium, phosphorus, total protein, sodium, triglycerides, uric acid, carbamazepine, digoxine, lithium, phenobarbital, phenytoin theophylline and valproic acid analytes revealed testing was performed in May 2017 but the results were not reviewed and approved by the laboratory director until 6/21/17. 2. Interview on 3/7/18 at 11:25 a.m. with the technical supervisor confirmed the above finding and revealed that the laboratory began testing and reporting patient test results for all 29 analytes using the Cobas analyzer on 6/8/17. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to verify calibration spanning the full reportable ranges every six months for 22 of 22 routine chemistry analytes performed on the Roche Hitachi Cobas 6000/c501 (Cobas) chemistry analyzer. Findings include: 1. Review on 3/7/18 of verification of performance specifications for alanine aminotransferase (ALT), albumin, alkaline phophatase, amylase, aspartate aminotransferase (AST), direct bilirubin, total bilirubin, blood urea nitrogen (BUN), calcium, carbon dioxide, chloride, high-density liproprotein (HDL) cholesterol, total cholesterol, creatinine, glucose, magnesium, phosphorus, total protein, sodium, triglycerides, and uric acid analytes revealed the reportable ranges had been verified in May 2017 and approved by the laboratory director on 6/7/2017. Albumin's upper limit for reportable range was 5.85 g/dL. 2. Review on 3/7/18 of calibration verification for ALT, albumin, alkaline phophatase, amylase, aspartate aminotransferase AST, direct bilirubin, total bilirubin, BUN, calcium, carbon dioxide, chloride, HDL cholesterol, total cholesterol, creatinine, glucose, magnesium, phosphorus, total protein, sodium, triglycerides, and uric acid analytes revealed it was performed on 11/13/17 but the data from this testing was not reviewed and approved by the laboratory director until 1/31/18. Albumin failed to pass calibration verification spanning the full reportable range; the highest value verified was 4.783 g/dL. The laboratory performed additional calibration verification testing on 2/14/18, this data was not reviewed and approved by the laboratory director until 3/2/18. 3. Interview on 3/7/18 at 11:15 a.m. with the technical supervisor confirmed the above findings and revealed that the laboratory continued to test for albumin between 1/31/18 and 3/2/18 using the upper limit of the reportable range that had not been verified (5.85 g/dL). D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory (lab) failed to provide the approved reference intervals for hemoglobin (Hgb) on test reports from January 2018 to March 2018 for male patients over the age of 18 years. Findings include: 1) Review on 3/7/18 of a complete blood count (CBC) test report for a 95 year old male reported on 3/7/18 revealed a reference range for Hgb was 13.0 - 17.7 g/dL. 2) Review on 3/7 /18 of the lab's approved procedure "Hematology Reference Intervals" effective 8/28 /17 revealed the Hgb reference range for males over the age of 18 years was 12.6 - 17.7 g/dL. 3) Interview on 3/7/18 at 10:00 a.m. with the technical supervisor (TS) confirmed the above findings. The TS revealed the reference intervals included on all CBC test reports had been changed in January 2018 by the lab's corporate office prior to obtaining the laboratory director's signed approval of the new procedure. -- 3 of 3 --