Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency testing records review ( 2017-2018 ) and laboratory general supervisor interview on August 29, 2018 at 9:00 A.M., it was determined that the laboratory director and testing personnel failed to sign the attestation statements. The findings include: 1. Puerto Rico Proficiency testing records were review from February 2017 to July 2018. 2. The laboratory director and testing personnel did not sign the attestation statements of the Proficiency testing records since February 2017. 3. The laboratory general supervisor confirmed on August 29, 2018 at 9:00 A.M that the laboratory director and testing personnel failed to sign the attestation statements since 2017. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on Hematology quality control records reviewed ( 2017-2018 ) and laboratory general supervisor interview on August 29, 2018 at 11:40 A.M., it was determined Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- that the laboratory failed to retain the hematology quality control records. The findings include: 1. The laboratory performed hematology tests by the Cell Dyn 3200 system. 2. The laboratory did not have available the hematology quality control records from October 7, 2017 to November 26, 2017. 3. The laboratory processed and reported 270 CBC patient samples those days. 4. The laboratory general supervisor confirmed on August 29, 2017 at 11:40 A.M. , that the laboratory failed to retain the hematology quality control tests from October 7, 2017 to November 26, 2017. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) 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 routine chemistry calibration verification records review (2017-2018) and laboratory general supervisor interview on August 29, 2018 at 11:15 A. M., it was determined that the laboratory did not perform , at least every 6 months, the calibration verification procedures for the routine chemistry tests processed by the Chem Well -T system. The findings include: 1. The laboratory began to use the new routine chemistry system Chem Well-T on April 2017. The laboratory performed glucose and lipid panel by this system. 2. The laboratory did not perform the calibration verification procedures of the system since April 2017. 3. The laboratory performed and reported 20,365 routine chemistry patient samples (glucose, cholesterol, triglycerides and high density lipoprotein) since April 2017. 4. The laboratory general supervisor confirmed on August 29, 2018 at 11:15 A.M. that the laboratory failed to perform the calibration verification of the new system since April 2017. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following -- 2 of 5 -- for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on hematology quality control records review ( 2017-2018 ), manufacturer's instructions and laboratory general supervisor interview on August 29, 2018 at 11:40 A.M., it was determined that the laboratory failed to include three levels of control when complete blood count ( CBC) patient samples test were performed by the Cell Dyn 3200 system. The findings include: 1. The laboratory uses the Cell Dyn 3200 system to perform Complete blood count ( CBC) patient samples. 2. The manufacturer's establishes that three levels of control material ( low, normal and high) must be included each day of testing. 3. Hematology quality control records were reviewed from January 2017 to July 2018. 4. The laboratory processed hematology patient samples from October 7, 2017 to November 26, 2017 and did not have evidence that include the three levels of control. 5. The laboratory processed and reported 270 CBC patient samples those days. 6. The laboratory general supervisor confirmed on August 29, 2018 at 11:40 A.M. , that the laboratory did not have evidence that include the three levels of control those days. D5783