Clara S P Chan Md Pc

Summary Statement of Deficiencies 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 review of instrument Quality Control (QC), Remedial Action Log and staff interview, the lab did not retain all quality control runs performed each day of patient testing. Findings include: 1. On 3/29/18; 6/18/18 and 7/31/18 lab quality control failed: on 7/31/18 instrument (Horiba MICROS 60) startup failed. 2. Review of the remedial action log on 3/29/18, the normal level QC was listed as out of range and repeated one time, however there was no evidence the lab saved the failed run. 3. Review of the remedial action log on 6/18/18, all three levels of QC were listed as out of range and repeated on 6/18 and 6/19, however there was no evidence the lab saved the failed run. 4. Review of the remedial action log on 7/31/18, all three levels of QC was listed as out of range and repeated, however there was no evidence the lab saved the failed run. 5.Review of the remedial action log on 7/31/18, the start-up was listed as failed, however there was no evidence the lab saved the failed run. 6. During interview with the testing individual at approximately 3:30pm, there was an admission that the QC and start-failures were trouble-shot and corrected, however the lab only kept records of the acceptable qc and did not maintain the unnaceptable qc and start- up records. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation and interview with laboratory (lab) staff, the lab did not have safety data sheets for cleaning supplies and reagents used for patient testing, to ensure that if there was a spill or an exposure, lab staff would have information concerning the chemical spilled to remediate. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of hematology records and staff interview, it was determined that the lab failed to monitor temperature records (see D5413); failed to ensure control materials meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results (see D5481); failed to follow