Laboratorio Clinico Country Club

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on ImmunoCard Mycoplasma pneumoniae manufacturer's instructions, Mycoplasma pneumoniae testing records, and laboratory director interview on October 11, 2023, at 12:20 PM; it was determined that the laboratory failed to follow manufacturer's instructions regarding to the established temperature range for Mycoplasma pneumoniae test. The findings include: 1. The manufacturer's instructions establish to perform the test procedures between 22 to 25C. 2. On October 11,2023 at 12:20PM, the Mycoplasma pneumoniae testing records showed that from January 9, 2023 to October 6, 2023, the laboratory processed and reported 57 out of 107 patient's specimens with a temperature range within 19 to 21C. 3. The laboratory director confirmed during interview on October 11,2023 at 12:37 PM, that the laboratory processed patient's samples outside the established temperature range. D6068 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425 The testing personnel are responsible for specimen processing, test performance, and for reporting test results. 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 -- This STANDARD is not met as evidenced by: Based on Mycoplasma pneumoniae manufacturer's instructions, Mycoplasma pneumoniae testing records and laboratory director interview on October 11,2023, at 1: 00 PM it was determined that the testing personnel did not follow the written instructions, when she processed 57 patient's specimens for Mycoplasma pneumoniae. Refer to D5413. -- 2 of 2 --

Summary Statement of Deficiencies D0000 T he laboratorio Clnico Country Club was found to be in substantial compliance with CLIA regulations (42 CFR Part 493, effective April 24, 2003). No deficiencies were cited as a result of an onsite survey performed on November 10, 2021. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on Covid-19 report records review and laboratory director interview on November 10, 2021 at 11:50 AM, it was determined that the laboratory failed to report the Covid- 19 results as required for five out of fourteen days reviewed from July 20, 2021 to October 27, 2021. The findings include: 1. The laboratory utilized the Health Department instruction to send the Covid-19 results to the Bioportal. 2. On November 10, 2021 at 11:50 AM, the Covid-19 rapid report records showed that the laboratory did not send the Covid-19 results in the required frequency (24 hrs) to the Bioportal in five out of fourteen days reviewed from July 20, 2021 to October 27, 2021.: Date Patients Date tested specimens reports tested sent 09/07/2021 1 09/09 /2021 09/21/2021 1 09/23/2021 09/25/2021 1 09/27/2021 10/26/2021 2 10/28/2021 10 /27/2021 1 not found 6. The laboratory director confirmed on November 10, 2021 at 11:50 AM, that the laboratory did not send those Covid-19 results in the required frequency (24 hrs) to the Bioportal. 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 D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on personnel file review and laboratory director interview on October 2, 2019 at 9:10 AM, it was determined that the laboratory director failed to follow the written procedures to monitor and ensure the annual competency evaluations of the technical supervisor. The findings include: 1. On October 2, 2019 at 9:10 AM, the personnel file showed that the laboratory director did not evaluate annually the competence of the technical supervisor since March 23, 2019. 2. The laboratory director confirmed on October 2, 2019 at 9:10 AM that she did not perform the annual competence of the technical supervisor since March 23, 2017. 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 --