Metro Pavia Clinic Bella Vista

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation, quality control records review and testing personnel interview on July 21, 2021 at 12:55 PM, it was determined that the laboratory used the Wright stain reagent with exceeded expiration date when 10 out of 10 patients smears were stained and examined from July 1, 2021 to July 19,2021. The findings include: 1. On July 21, 2021 at 12:55 PM, the Wright stain reagent was observed at the hematology area (lot 9780-00 Exp. 06/30/2021). 2. The quality control records showed that the laboratory used the Wright stain reagent with exceeded expiration date from July 1, 2021 to July 19,2021. 3. The testing personnel confirmed on July 21, 2021 at 12:55 PM, that the laboratory used the Wright stain reagent with exceeded expiration date from July 1, 2021 to July 19,2021. 4. The laboratory stained and examined 10 out of 10 patients smears with the Wright stain reagent (lot 9780-00 Exp. 06/30/2021) from July 1, 2021 to July 19,2021. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: 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 -- Based on written procedures, preventive maintenance records (years 2020 and 2021) review and interview with the laboratory director on July 21, 2021 at 12:20 PM, it was determined that the laboratory failed to follow written instructions for the preventive maintenance of cobas c 311 analyzer when 1,716 out of 1,716 patient's specimens for comprehensive metabolic panel (CMP) tests were processed from 12/01/2020 to 07/20 /2021. The findings include: 1. On July 21, 2021 at 12:20 PM, the cobas c 311 analyzer preventive maintenance records showed that the laboratory did not perform in the manufacturer's required frequency the every 2 months nor the quarterly preventive maintenance of the cobas c 311 analyzer from 12/01/2020 to 07/20/2021. 2. The laboratory director confirmed on July 21, 2021 at 12:20 PM, that the preventive maintenance records showed that the laboratory did not follow the manufacturer instruction for the every 2 months and the quarterly preventive maintenance procedures for the cobas c 311 analyzer. 3. The laboratory processed 1,716 out of 1,716 patient's specimens for CMP tests from 12/01/2020 to 07/20/2021. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on observation, quality control records, preventive maintenance records (years 2020 and 2021) review, testing personnel and laboratory director interview on July 21, 2021 at 12:55 PM, it was determined that the laboratory director failed to comply with the requirements for hematology and routine chemistry tests. Refer to D 5417 (The laboratory used the Wright stain reagent with exceeded expiration date when 10 out of 10 patients smears were stained and examined from July 1, 2021 to July 19,2021). Refer to D 5429 (The laboratory failed to follow written instructions for the preventive maintenance of cobas c 311 analyzer when 1,716 out of 1,716 patient's specimens for comprehensive metabolic panel (CMP) tests were processed from 12/01 /2020 to 07/20/2021). D6177 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(3) Each individual performing high complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on observation, quality control records, preventive maintenance records (years 2020 and 2021) review, testing personnel and laboratory director interview on July 21, 2021 at 12:55 PM, it was determined that the testing personnel failed to follow quality control procedures for hematology and routine chemistry tests. Refer to D 5417 (The laboratory used the Wright stain reagent with exceeded expiration date when 10 out of 10 patients smears were stained and examined from July 1, 2021 to July 19,2021). Refer to D 5429 (The laboratory failed to follow written instructions for the -- 2 of 3 -- preventive maintenance of cobas c 311 analyzer when 1,716 out of 1,716 patient's specimens for comprehensive metabolic panel (CMP) tests were processed from 12/01 /2020 to 07/20 -- 3 of 3 --

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 lack of validation records for the urine microscopic examination, urine microscopic examination reports records reviewed and interview with the technical supervisor at 11:22 AM on December 20, 2019, it was determined that the laboratory failed to perform the validation for the urine microscopic examination procedure before reporting 783 out of 783 patient's urine microscopic examination results from June 19, 2019 to December 19, 2019. The findings include: 1. The laboratory did not perform the validation of the urine microscopic examination procedure. 2. On December 20, 2019 at 11:22 AM , the urine microscopic examination reports showed that the laboratory reported 783 out of 783 patient's urine microscopic examination results from June 19, 2019 to December 19, 2019. 3. The technical supervisor confirmed at 11:22 AM on December 20, 2019, that the laboratory did not validated the urine microscopic examination procedure. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on lack of validation records for the urine microscopic examination, urine microscopic examination reports records reviewed and interview with the technical supervisor at 11:22 AM on December 20, 2019, it was determined that the laboratory director failed to ensure compliance with the analytic system requirements for the urine microscopic examination procedure. Refer to D 5421. -- 2 of 2 --