Lab Clinico Loiza Valley Inc

Summary Statement of Deficiencies D3009 Based on Covid-19 report and testing records review and laboratory director interview on August 23, 2021 at 10:52 AM, it was determined that the laboratory failed to report the Covid- 19 results as required for 7 out of 19 days reviewed from May 03, 2021 to May 27, 2021. The findings include: 1. The laboratory utilized the Health Department instruction to send the Covid-19 results to the Bioportal. 2. On August 23, 2021 at 10: 52 AM, the Covid-19 IgM and IgG qualitative tests report records showed that the laboratory did not send the Covid-19 results in the required frequency (24 hrs) to the Bioportal in 7 out of 19 days reviewed from May 03, 2021 to May 27, 2021: Date Patients Date tested specimens reports tested sent 05/03/2021 4 05/05/2021 05/06 /2021 1 05/10/2021 05/11/2021 1 05/13/2021 05/14/2021 2 05/17/2021 05/15/2021 9 05/17/2021 05/18/2021 4 05/21/2021 05/19/2021 1 05/21/2021 3. The laboratory director confirmed on August 23, 2021 at 10:52 AM, that the laboratory did not send the Covid-19 results in the required frequency (24 hrs) to the Bioportal. D5449 Based on Mycoplasma IGM testing records (from October 31, 2020 to April 14, 2021) review and interview with the laboratory director on August 23, 2021 at 10:46 AM, it was determined that the laboratory failed to include each day of testing a negative and a positive control materials when 11 out of 11 patients specimens were tested and reported for qualitative Mycoplasma IgM tests from November 4, 2020 to April 14, 2021 by the Immuno Card Mycoplasma method. The findings include : 1. On August 23, 2021 at 10:46 AM, the Mycoplasma IGM testing records showed that the laboratory did not include each day of testing the negative nor the positive control materials when the following patient's specimens were tested and reported from November 4, 2020 to April 14, 2021: Dated processed Patient's ID 11/04/2020 512707 11/06/2020 512883 11/09/2020 513088 11/10/2020 513129 11/13/2020 513357 11/14 /2020 513361 11/16/2020 513497 03/21/2021 521123 04/06/2021 521850 04/07/2021 521921 04/13/2021 522248 04/24/2021 522362 2. The laboratory includes the negative and the positive control materials when it placed in routine use the following lots numbers of the Immuno Card Mycoplasma reagents kit: lot 709030M112 in October 2020, lot 709030M113 and lot 709030M115 in March 2021. 3. The laboratory director confirmed on August 23, 2021 at 10:46 AM, that the laboratory 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 -- did not include the negative and the positive control materials each day of testing, instead the laboratory includes a negative and a positive control materials when it places in routine use every new lot or new shipping of the Immuno Card Mycoplasma reagents Kit. 4. The laboratory tested and reported 11 out of 11 patients specimens for qualitative Mycoplasma IgM tests from November 4, 2020 to April 14, 2021 by the Immuno Card Mycoplasma method. D6093 Based on Mycoplasma IGM testing records (from October 31, 2020 to April 14, 2021) review and interview with the laboratory director on August 23, 2021 at 10:46 AM, it was determined that the laboratory director failed to ensure compliance with the requirements for Mycoplasma IGM qualitative tests. Refer to D 5449 (The laboratory did not include each day of testing a negative and a positive control materials when 11 out of 11 patients specimens were tested and reported for qualitative Mycoplasma IgM tests from November 4, 2020 to April 14, 2021 by the Immuno Card Mycoplasma method. -- 2 of 2 --

Summary Statement of Deficiencies 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 and testing records review and laboratory director interview on August 23, 2021 at 10:52 AM, it was determined that the laboratory failed to report the Covid- 19 results as required for 7 out of 19 days reviewed from May 03, 2021 to May 27, 2021. The findings include: 1. The laboratory utilized the Health Department instruction to send the Covid-19 results to the Bioportal. 2. On August 23, 2021 at 10: 52 AM, the Covid-19 IgM and IgG qualitative tests report records showed that the laboratory did not send the Covid-19 results in the required frequency (24 hrs) to the Bioportal in 7 out of 19 days reviewed from May 03, 2021 to May 27, 2021: Date Patients Date tested specimens reports tested sent 05/03/2021 4 05/05/2021 05/06 /2021 1 05/10/2021 05/11/2021 1 05/13/2021 05/14/2021 2 05/17/2021 05/15/2021 9 05/17/2021 05/18/2021 4 05/21/2021 05/19/2021 1 05/21/2021 3. The laboratory director confirmed on August 23, 2021 at 10:52 AM, that the laboratory did not send the Covid-19 results in the required frequency (24 hrs) to the Bioportal. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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 for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. 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 IGM testing records (from October 31, 2020 to April 14, 2021) review and interview with the laboratory director on August 23, 2021 at 10:46 AM, it was determined that the laboratory failed to include each day of testing a negative and a positive control materials when 11 out of 11 patients specimens were tested and reported for qualitative Mycoplasma IgM tests from November 4, 2020 to April 14, 2021 by the Immuno Card Mycoplasma method. The findings include : 1. On August 23, 2021 at 10:46 AM, the Mycoplasma IGM testing records showed that the laboratory did not include each day of testing the negative nor the positive control materials when the following patient's specimens were tested and reported from November 4, 2020 to April 14, 2021: Dated processed Patient's ID 11/04/2020 512707 11/06/2020 512883 11/09/2020 513088 11/10/2020 513129 11/13/2020 513357 11/14 /2020 513361 11/16/2020 513497 03/21/2021 521123 04/06/2021 521850 04/07/2021 521921 04/13/2021 522248 04/24/2021 522362 2. The laboratory includes the negative and the positive control materials when it placed in routine use the following lots numbers of the Immuno Card Mycoplasma reagents kit: lot 709030M112 in October 2020, lot 709030M113 and lot 709030M115 in March 2021. 3. The laboratory director confirmed on August 23, 2021 at 10:46 AM, that the laboratory did not include the negative and the positive control materials each day of testing, instead the laboratory includes a negative and a positive control materials when it places in routine use every new lot or new shipping of the Immuno Card Mycoplasma reagents Kit. 4. The laboratory tested and reported 11 out of 11 patients specimens for qualitative Mycoplasma IgM tests from November 4, 2020 to April 14, 2021 by the Immuno Card Mycoplasma method. 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 Mycoplasma IGM testing records (from October 31, 2020 to April 14, 2021) review and interview with the laboratory director on August 23, 2021 at 10:46 AM, it was determined that the laboratory director failed to ensure compliance with the requirements for Mycoplasma IGM qualitative tests. Refer to D 5449 (The laboratory did not include each day of testing a negative and a positive control materials when 11 out of 11 patients specimens were tested and reported for qualitative Mycoplasma IgM tests from November 4, 2020 to April 14, 2021 by the Immuno Card Mycoplasma method. -- 2 of 2 --

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 review of validation records of the Architect i1000 system for free Thyroxin (T4 free), Vitamin D tests and testing personnel # 4 interview on June 6, 2019 at 10: 55 AM, it was determined that the laboratory failed to verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population before reporting 713 patients specimens for T4 free and 1,248 patient specimens for Vitamin D from July 1, 2018 to June 5, 2019. The findings include: 1. On June 6, 2019 at 10:55 AM, the Architect i1000 system validation records showed that the laboratory laboratory performed the validation procedures for T4 free and Vitamin D tests in June 2018 and it did not verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. 2. The testing personnel # 4 confirmed on June 6, 2019 at 10:55 AM, that the laboratory did not verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population before reporting T4 free and Vitamin D tests patient results. 3. The laboratory processed and reported 713 patients specimens for T4 free and 1,248 patient specimens for Vitamin D from July 1, 2018 to June 5, 2019. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) 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 -- (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on review of validation records of the Architect i1000 system for free Thyroxin (T4 free), Vitamin D tests and testing personnel # 4 interview on June 6, 2019 at 10: 55 AM, it was determined that technical consultant failed to ensure compliance with the requirements for analytic systems for T4 free and Vitamin D tests from July 1, 2018 to June 5, 2019. Refer to D 5421 ( (The laboratory did not complete the evaluation of the performance specifications of the new T 4 free and Vitamin D tests performed by the Architect i1000 system, before reporting 713 patients specimens for T4 free and 1,248 patient specimens for Vitamin D from July 1, 2018 to June 5, 2019) 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 review of validation records of the Architect i1000 system for free Thyroxin (T4 free), Vitamin D tests and testing personnel # 4 interview on June 6, 2019 at 10: 55 AM, it was determined that laboratory director failed to ensure compliance with the requirements for analytic systems for T4 free and Vitamin D tests from July 1, 2018 to June 5, 2019. Refer to D 5421 ( (The laboratory did not complete the evaluation of the performance specifications of the new T 4 free and Vitamin D tests performed by the Architect i1000 system, before reporting 713 patients specimens for T4 free and 1,248 patient specimens for Vitamin D from July 1, 2018 to June 5, 2019) -- 2 of 2 --