Laboratorio Clinico Villa Ana

Summary Statement of Deficiencies D5012 SYPHILIS SEROLOGY CFR(s): 493.1207 If the laboratory provides services in the subspecialty of Syphilis serology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on manufacturer instructions, syphilis serology quality control records, patient's reports worksheets review (years 2022-2023) and laboratory general supervisor interview on February 8, 2023 at 11:00 AM, it was determined that the laboratory failed to ensure compliance with the analytic system requirements for syphillis serology tests. Refer to D5411 (the laboratory failed to perform syphilis serology test as required by the manufacturer's instruction when reported and performed 128 out of 128 syphilis serology patient's samples by Aim Rapid plasma reagin (RPR) method in 37 out of 37 days.) Refer to D5471 (the laboratory did not evaluate the new lot of Rapid Plasma Reagin (RPR) test by Aim RPR Method for reactive and non-reactive prior to placed it in routine use when reported and performed 122 out of 122 syphilis serology patient's samples). D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. 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 5 -- A. Based on manufacturer's instructions, syphilis serology quality control records, patient's reports worksheets review (years 2022-2023) and laboratory general supervisor interview on February 8, 2023 at 10:35AM, it was determined that the laboratory failed to perform syphilis serology test as required by the manufacturer's instruction when reported and performed 128 out of 128 syphilis serology patient's samples by Aim Rapid plasma reagin (RPR) method in 37 out of 37 days. The findings include: 1. The laboratory uses Aim Rapid plasma reagin (RPR) method to perform RPR (rapid plasma reagin) syphilis serology patient's samples tests. Reviewed on February 8, 2023 at 10:35 AM. 2. The manufacturer requires that the laboratory must perform the needle calibration and rinsed with distilled water each day of testing and allowed to air dry. In addition, the laboratory should be adjusted and verify the mechanical rotator at 100 5 rpm for eight (8) minutes and monitor the room temperature (20 to 30 C) in the laboratory. Reviewed on February 8, 2023 at 10:40 AM. 3. From October 5, 2022 to February 6, 2023 (37 days out of 37 days), the syphilis serology quality control records showed that the laboratory did not document nor verify the needle calibration, needle clean, rotator rpm and did not monitor the room temperature in the RPR (Rapid plasma reagin) testing area the following days: ( Reviewed on February 8, 2023 at 10:45 AM.) Date #samples 10/5/22 2 10/12/22 1 10 /17/22 3 10/19/22 1 10/22/22 2 10/28/22 1 11/3/22 1 11/12/22 1 11/14/22 2 11/15/22 39 11/16/22 2 11/17/22 1 11/18/22 2 11/19/22 1 11/22/22 3 11/28/22 1 11/29/22 8 11 /30/22 2 12/1/22 2 12/5/22 1 12/6/22 1 12/14/22 1 12/15/22 1 1/4/23 1 1/9/23 1 1/11 /23 1 1/12/23 4 1/13/23 3 1/16/23 1 1/17/23 1 1/18/23 16 1/19/23 4 1/20/23 2 1/23/23 3 2/2/23 10 2/4/23 1 2/6/23 1 4. The laboratory processed and reported one hundred twenty-eight (128) RPR (Rapid plasma reagin) patient's samples tests those days. Reviewed on February 8, 2023 at 10:45 AM. 5. The laboratory general supervisor stated on February 8, 2023 at 10:55 AM, that the laboratory did not document nor verify the needle calibration, clean needle, rotator rpm nor the room temperature monitoring in the RPR (Rapid plasma reagin) testing area those days. B. Based on manufacturer's instructions, syphilis serology quality control records, patient's reports worksheets review (years 2022-2023) and laboratory general supervisor interview on February 8, 2023 at 10:35AM, it was determined that the laboratory failed to follow the manufacturer's instruction when reported and performed 128 out of 128 syphilis serology patient's samples by Aim Rapid plasma reagin (RPR) method in 37 out of 37 days. The findings include: 1. The laboratory uses Aim Rapid plasma reagin (RPR) method when patient specimen were tested for syphilis serology since January 2021. Reviewed on February 8, 2023 at 10:35 AM. 2. The manufacturer's instruction establishes that three levels of control material (non-reactive, minimal to moderate and reactive) must be included each day of testing. Reviewed on February 8, 2023 at 10:40 AM. 3. From October 5, 2022 to February 6, 2023 (37 days - thirty seven days), the syphilis serology quality control records showed that the laboratory did not include the three levels of control material when it processed and reported 128 out of 128 patients specimens for syphilis serology by Aim RPR method. Reviewed on February 8, 2023 at 10:45 AM. 4. The laboratory general supervisor stated on February 8, 2023 at 10:55 AM that the laboratory did not include the three levels of control material when it processed and reported patients specimens for syphilis serology by Aim RPR method those days. 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 -- 2 of 5 -- 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 (Meridian) manufacturer's instructions, general immunology quality control records review (years 2022-2023) and laboratory general supervisor review on February 8, 2023 at 9:50 AM, it was determined that the laboratory failed to follow the manufacturer's instruction when patient' s were tested for Mycoplasma by ImmunoCard Meridian in 58 out of 152 days. The laboratory performed Mycoplasma tests outside the established temperature range and did not monitor the temperature range. The findings include: 1. The laboratory uses ImmunoCard Mycoplasma (Meridian) to perform Mycoplasma patient's samples tests. Reviewed on on February 8, 2023 at 9:50 AM. 2. The ImmunoCard Mycoplasma (Meridian) manufacturer's instructions establishes that the Mycoplasma test must be performed at room temperature between 22 C to 25 C. Reviewed on on February 8, 2023 at 9:55 AM. 3. Review of general immunology records from January 2022 to February 8, 2023, showed that the laboratory processed and reported one hundred twenty three (123) Mycoplasma patient's samples tests when the temperature range was outside the established temperature range ( 22C - 25 C ) in the following days. ( Reviewed on on February 8, 2023 at 10:05 AM.) Date Temp # Mycoplasma samples 1 /7/2022 21C 2 1/14/2022 21C 1 1/17/2022 21C 1 1/20/2022 21C 2 2/10/2022 21C 1 4 /26/2022 21C 2 5/2/2022 21C 10 5/3/2022 20C 2 5/4/2022 21C 3 5/13/2022 20C 3 5 /31/2022 27C 1 6/3/2022 28C 3 6/8/2022 20C 1 6/21/2022 20C 3 6/22/2022 21C 1 6 /23/2022 21C 1 8/2/2022 26C 1 8//8/2022 21C 1 8/18/2022 21C 2 9/13/2022 20C 3 10 /4/2022 21C 1 10/6/2022 20C 3 10/11/2022 21C 1 10/13/2022 21C 1 11/1/2022 21C 3 11/2/2022 21C 5 11/3/2022 20C 3 12/6/2022 21C 2 12/9/2022 21C 1 12/12/2022 20C 4 12/13/2022 21C 3 12/14/2022 21C 5 12/15/2022 21C 4 12/16/2022 21C 3 12/19 /2022 21C 1 12/21/2022 21C 3 4. Review of general immunology records from January 2022 to February 8, 2023, showed that the laboratory did not monitor nor document the room temperature when processed and reported 37 out of 37 Mycoplasma patient's samples tests the following days. ( Reviewed on on February 8, 2023 at 10:05 AM.) Date Temp # Mycoplasma samples 4/4/2022 ND 3 4/7/2022 ND 1 4/8/2022 ND 1 5/14/2022 ND 2 6/11/2022 ND 1 8/6/2022 ND 1 9/17/2022 ND 1 9 /30/2022 ND 1 11/23/2022 ND 3 1/9/2023 ND 2 1/10/2023 ND 3 1/11/2023 ND 1 1 /12/2023 ND 3 1/13/2023 ND 1 1/16/2023 ND 1 1/17/2023 ND 3 1/18/2023 ND 1 1 /24/2023 ND 4 1/25/2023 ND 1 1/26/2023 ND 1 1/30/2023 ND 1 2/6/2023 ND 1 ND = Not documented 4. The laboratory general supervisor confirmed on February 8, 2023 at 10:30 AM that the laboratory performed Mycoplasma patient's samples tests at temperature outside the established range and did not monitor the room temperature. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must -- 3 of 5 -- document all control procedures performed. This STANDARD is not met as evidenced by: Based on syphilis serology quality control records, patient's reports worksheets review (years 2022-2023) and laboratory general supervisor interview on February 8, 2023 at 10:35AM, it was determined that the laboratory did not evaluate the new lot of Rapid Plasma Reagin (RPR) test by Aim RPR Method for reactive and non-reactive prior to placed it in routine use when reported and performed 122 out of 122 syphilis serology patient's samples. The findings include: 1.The laboratory syphilis serology quality control records were review from January 2022 to February 7, 2023. Reviewed on February 8, 2023 at 10:35AM. 2. The patient's reports worksheets (years 2022-2023) showed on February 8, 2023 at 10:45AM, that the laboratory received the following reagent kit for RPR Method and no evaluation of their reactivity was performed: Test New Lot RPR 20554 Exp. 9/30/2023 3. The laboratory had in use the lot 20554 exp. 9 /30/2023 from July 1, 2022 to present and processed and reported one hundred twenty two (122) syphilis patient's samples (RPR). ( Reviewed on February 8, 2023 at 10:55 AM.) 4. The laboratory general supervisor confirmed on February 8, 2023 at 10: 55AM that the laboratory did not evaluate the new lot of Rapid plasma reagin (RPR) test for reactive and non-reactive prior to placed it in routine use. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on manufacturer's instructions, general immunology and syphilis serology quality control records, patient's reports worksheets review (years 2022-2023) and laboratory general supervisor interview on February 8, 2023 at 11:00 AM, it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory quality control requirements. Refer to D 6093 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 manufacturer instructions, general immunology and syphilis serology quality control records, patient's reports worksheets review (years 2022-2023) and laboratory general supervisor interview on February 8, 2023 at 11:00 AM, it was found that the laboratory director did not assure that quality control procedures related to follow manufacturer instructions and evaluation of new reagents lots were followed. The findings include: 1. The laboratory failed to perform syphilis serology test as required by the manufacturer's instruction when reported and performed 128 out of 128 syphilis serology patient's samples by Aim Rapid plasma reagin (RPR) -- 4 of 5 -- method in 37 out of 37 days. Refer to D5411. 2. The laboratory failed to follow the manufacturer's instruction when patient' s were tested for Mycoplasma by ImmunoCard Meridian in 58 out of 152 days. Refer to D5413. 3. The laboratory did not evaluate the new lot of Rapid Plasma Reagin (RPR) test by Aim RPR Method for reactive and non-reactive prior to placed it in routine use when reported and performed 122 out of 122 syphilis serology patient's samples. Refer to D5471. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on manufacturer instructions, general immunology and syphilis serology quality control records, patient's reports worksheets review (years 2022-2023) and laboratory general supervisor interview on February 8, 2023 at 11:00 AM, it was determined that the general supervisor did not assure that quality control procedures were followed by the testing personnel. Refer to D5411, D5413 and D5471. -- 5 of 5 --

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 test report records review and general supervisor interview on May 7 2021 at 1:40 PM, it was determined that the laboratory failed to report the Covid-19 IgG /IgM rapid tests results as required for 18 out of 22 days reviewed from March 1, 2021 to March 30, 2021. The findings include: 1. The laboratory utilized the Health Department written instruction to reports the Covid-19 IgG/IgM rapid tests results to the Bioportal. 2. The laboratory processed the Covid-19 IgG/IgM rapid tests by Healgen method. 3. The test report records showed that 18 out of 22 days from March 1, 2021 to March 30, 2021, the laboratory did not report the Covid-19 IgI/IgM patients results in the required frequency (24 hrs) to the Bioportal: Date Patients Date tested specimens reported 03/01/2021 8 03/04/2021 03/02/2021 5 03/04/2021 03/04 /2021 5 03/09/2021 03/05/2021 6 03/09/2021 03/06/2021 5 03/09/2021 03/09/2021 1 03/15/2021 03/10/2021 7 03/15/2021 03/11/2021 5 03/15/2021 03/12/2021 7 03/15 /2021 03/13/2021 3 03/15/2021 03/15/2021 5 03/18/2021 03/16/2021 6 03/18/2021 03 /18/2021 6 03/24/2021 03/19/2021 3 03/24/2021 03/22/2021 2 03/24/2021 03/24/2021 4 04/12/2021 03/25/2021 5 04/12/2021 03/30/2021 3 04/12/2021 4. The laboratory general supervisor confirmed on May 7 2021 at 1:40 PM, that those results of Covid- 19 IgG/IgM rapid tests were not reported in 24 hrs. 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-- 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 -- 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. This STANDARD is not met as evidenced by: Based on Covid-19 IgG/IgM test quality control records review and interview with the laboratory supervisor on May 7, 2021 at 1:40 PM, it was determined that the laboratory failed to include each day of testing a negative and a positive control materials when 71 out of 71 patients specimens were tested and reported for qualitative Covid-19 IgG/IgM tests from March 2, 2021 to March 30, 2021 by the Healgen method. The findings include : 1. On May 7, 2021 at 1:40 PM, the Covid-19 IgG/IgM test quality control records showed that the laboratory did not include each day of testing the negative nor the positive control materials from March 2, 2021 to March 30, 2021. 2. The laboratory includes the negative and the positive control materials when it placed in routine use a new box of reagents kit: on 03/02/2021, 03/08 /2021, 03/12/2021, 03/18/2021 and 03/30/2021. 3. The laboratory did not include the negative nor the positive control materials when 71 out of 71 patients specimens were processed the following days from March 2, 2021 to March 30, 2021: Day tested patients specimens 03/03/2021 6 03/04/2021 6 03/05/2021 5 03/06/2021 4 03/07/2021 1 03/10/2021 7 03/11/2021 4 03/15/2021 6 03/16/2021 6 03/17/2021 9 03/19/2021 3 03/20/2021 1 03/22/2021 1 03/23/2021 2 03/24/2021 4 03/25/2021 5 03/29/2021 1 4. The general supervisor confirmed on May 7, 2021 at 1:40 PM, that the laboratory did not include each day of testing the negative nor the positive control materials when patients specimens were tested for the Covid-19 IgG/IgM test. She stated that the laboratory includes the negative and the positive control materials when it placed in routine use a new box of reagents kit 5. The laboratory tested and reported 71 out of 71 patients specimens for qualitative Covid-19 IgG/IgM test from March 2, 2021 to March 30, 2021 by the Healgen method. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (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 Covid-19 IgG/IgM test quality control records review and interview with the laboratory supervisor on May 7, 2021 at 1:40 PM, it was determined that the technical consultant failed to ensure compliance with the requirements of the analytic systems for the Covid-19 IgG/IgM tests from March 2, 2021 to March 30, 2021. Refer to D 5449 (The laboratory did not include each day of testing a negative and a positive control materials when 71 out of 71 patients specimens were tested and reported for qualitative Covid-19 IgG/IgM tests from March 2, 2021 to March 30, 2021 by the Healgen method. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) -- 2 of 3 -- 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 Covid-19 IgG/IgM test quality control records review and interview with the laboratory supervisor on May 7, 2021 at 1:40 PM, it was determined that the laboratory director failed to ensure compliance with the requirements for the Covid-19 IgG/IgM tests from March 2, 2021 to March 30, 2021. Refer to D 5449 (The laboratory did not include each day of testing a negative and a positive control materials when 71 out of 71 patients specimens were tested and reported for qualitative Covid-19 IgG/IgM tests from March 2, 2021 to March 30, 2021 by the Healgen method. -- 3 of 3 --

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 test report records review and general supervisor interview on May 7 2021 at 1:40 PM, it was determined that the laboratory failed to report the Covid-19 IgG /IgM rapid tests results as required for 18 out of 22 days reviewed from March 1, 2021 to March 30, 2021. The findings include: 1. The laboratory utilized the Health Department written instruction to reports the Covid-19 IgG/IgM rapid tests results to the Bioportal. 2. The laboratory processed the Covid-19 IgG/IgM rapid tests by Healgen method. 3. The test report records showed that 18 out of 22 days from March 1, 2021 to March 30, 2021, the laboratory did not report the Covid-19 IgI/IgM patients results in the required frequency (24 hrs) to the Bioportal: Date Patients Date tested specimens reported 03/01/2021 8 03/04/2021 03/02/2021 5 03/04/2021 03/04 /2021 5 03/09/2021 03/05/2021 6 03/09/2021 03/06/2021 5 03/09/2021 03/09/2021 1 03/15/2021 03/10/2021 7 03/15/2021 03/11/2021 5 03/15/2021 03/12/2021 7 03/15 /2021 03/13/2021 3 03/15/2021 03/15/2021 5 03/18/2021 03/16/2021 6 03/18/2021 03 /18/2021 6 03/24/2021 03/19/2021 3 03/24/2021 03/22/2021 2 03/24/2021 03/24/2021 4 04/12/2021 03/25/2021 5 04/12/2021 03/30/2021 3 04/12/2021 4. The laboratory general supervisor confirmed on May 7 2021 at 1:40 PM, that those results of Covid- 19 IgG/IgM rapid tests were not reported in 24 hrs. 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-- 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 -- 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. This STANDARD is not met as evidenced by: Based on Covid-19 IgG/IgM test quality control records review and interview with the laboratory supervisor on May 7, 2021 at 1:40 PM, it was determined that the laboratory failed to include each day of testing a negative and a positive control materials when 71 out of 71 patients specimens were tested and reported for qualitative Covid-19 IgG/IgM tests from March 2, 2021 to March 30, 2021 by the Healgen method. The findings include : 1. On May 7, 2021 at 1:40 PM, the Covid-19 IgG/IgM test quality control records showed that the laboratory did not include each day of testing the negative nor the positive control materials from March 2, 2021 to March 30, 2021. 2. The laboratory includes the negative and the positive control materials when it placed in routine use a new box of reagents kit: on 03/02/2021, 03/08 /2021, 03/12/2021, 03/18/2021 and 03/30/2021. 3. The laboratory did not include the negative nor the positive control materials when 71 out of 71 patients specimens were processed the following days from March 2, 2021 to March 30, 2021: Day tested patients specimens 03/03/2021 6 03/04/2021 6 03/05/2021 5 03/06/2021 4 03/07/2021 1 03/10/2021 7 03/11/2021 4 03/15/2021 6 03/16/2021 6 03/17/2021 9 03/19/2021 3 03/20/2021 1 03/22/2021 1 03/23/2021 2 03/24/2021 4 03/25/2021 5 03/29/2021 1 4. The general supervisor confirmed on May 7, 2021 at 1:40 PM, that the laboratory did not include each day of testing the negative nor the positive control materials when patients specimens were tested for the Covid-19 IgG/IgM test. She stated that the laboratory includes the negative and the positive control materials when it placed in routine use a new box of reagents kit 5. The laboratory tested and reported 71 out of 71 patients specimens for qualitative Covid-19 IgG/IgM test from March 2, 2021 to March 30, 2021 by the Healgen method. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (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 Covid-19 IgG/IgM test quality control records review and interview with the laboratory supervisor on May 7, 2021 at 1:40 PM, it was determined that the technical consultant failed to ensure compliance with the requirements of the analytic systems for the Covid-19 IgG/IgM tests from March 2, 2021 to March 30, 2021. Refer to D 5449 (The laboratory did not include each day of testing a negative and a positive control materials when 71 out of 71 patients specimens were tested and reported for qualitative Covid-19 IgG/IgM tests from March 2, 2021 to March 30, 2021 by the Healgen method. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) -- 2 of 3 -- 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 Covid-19 IgG/IgM test quality control records review and interview with the laboratory supervisor on May 7, 2021 at 1:40 PM, it was determined that the laboratory director failed to ensure compliance with the requirements for the Covid-19 IgG/IgM tests from March 2, 2021 to March 30, 2021. Refer to D 5449 (The laboratory did not include each day of testing a negative and a positive control materials when 71 out of 71 patients specimens were tested and reported for qualitative Covid-19 IgG/IgM tests from March 2, 2021 to March 30, 2021 by the Healgen method. -- 3 of 3 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on manufacturer's instructions, syphillis serology quality control records review (years 2017-2019) and laboratory director interview at 10:30 AM on February 26, 2019, it was determined that the laboratory failed to perform syphillys serology test as required by manufacturer's instructions by Detector RPR method. The findings include: 1. The manufacturer's establishes that the RPR (Rapid Plasma Reagin) test must be performed at room temperature between 23 C to 29 C . 2. From February 2018 to February 25, 2019, showed that the laboratory performed RPR (Rapid Plasma Reagin) patient's samples test during seventeen (17) days. 3. The records showed that a total of eighty six samples patient's were processed and reported with temperatures outside the acceptable range:: Date temp.C # samples 2/10/18 22.0 1 4/7/18 22.0 14 5 /16/18 22.0 2 6/25/18 22.0 2 7/20/18 22.0 3 8/8/18 22.0 27 8/14/18 22.0 2 9/6/18 22.0 13 9/18/18 22.0 6 10/9/18 22.0 1 10/13/18 22.0 2 10/23/18 22.0 5 11/26/18 22.0 1 12/8 /18 22.0 1 1/14/19 22.0 3 1/26/19 22.0 1 2/8/19 22.0 2 4. The laboratory director confirmed that the laboratory performed RPR (Rapid plasma reagin) tests below the range established by the manufacturer's those days. 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 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 -- 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 manufacturer's instructions, hematology quality control records review (years 2017-2019) and laboratory director interview on February 26, 2019 at 10:00 AM, it was determined that the laboratory failed to perform the calibration verification procedures with at least the frequency recommended by the manufacturer (each six months) for the hematology tests performed by the ABX Pentra 60 C+ system. The findings include: 1. The laboratory uses a ABX Pentra 60 C+ hematology system for CBC (Complete blood count) patient's tests. 2. The manufacturer's instructions showed that for the ABX Pentra 60 C+ system establish that the laboratory must perform the calibration verification procedures each six months. 3. Review hematology records from March 2017 to February 2019, showed that the laboratory did not perform at least every 6 months the calibration verification procedures for the ABX Pentra 60 C+ hematology system. The laboratoy performed the calibration verification for ABX Pentra 60 C+ system on March 2017 and September 2018, once a year. 4. The laboratory director stated on February 26, 2019, that the laboratory did not perform at least 6 months the calibration verification procedures for ABX Pentra 60 C+ system. 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 manufacturer's instructions, syphillis serology quality control records review (years 2017-2019) and laboratory director interview at 11:00 AM on February 26, 2019, it was determined that laboratory director failed to ensure compliance with the requirements for analytic systems. The findings include: 1. The laboratory failed to perform syphillys serology test as required manufacturer's instructions by Detector RPR method. Refer to D5411. 2. The laboratory failed to perform the calibration verification procedures with at least the frequency recommended by the manufacturer -- 2 of 3 -- (each six months) for the hematology tests performed by the ABX Pentra 60 C+ system. Refer to D5439. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on syphillis serology quality control records review in 2017-2019 and laboratory director interview at 11:00 AM on February 26, 2019, it was determined that the general supervisor failed to follow quality control procedures. The findings include: 1. The laboratory supervisor failed to perform syphillys serology test as required by manufacturer's instructions by Detector RPR method. Refer to D5411. 2. The laboratory supervisor failed to perform the calibration verification procedures with at least the frequency recommended by the manufacturer (each six months) for the hematology tests performed by the ABX Pentra 60 C+ system. Refer to D5439. -- 3 of 3 --