Lab Alejandrino, Inc, Corporation

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on Quality Assessment (QA) activities records review and laboratory general supervisor interview on February 9, 2023 at 10:10 AM, it was determined that laboratory failed to evaluate and monitor the specimen identification and integrity in the General Laboratory system from August 2022 to November 2022. The findings include: 1. On February 9, 2023 at 9:44 AM, the laboratory QA was requested. The QA showed that the laboratory has established in the sample identification and integrity that the verification were evaluated monthly. 2. On February 9, 2023 at 9:50 AM the QA showed that the laboratory failed to evaluate and monitor the sample identification and integrity requirements from August 2022 to November 2022. 3. The laboratory general supervisor confirmed on February 9, 2023 at 10:10 AM that the laboratory failed to evaluate and monitor the sample identification and integrity from August 2022 to November 2022. 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. 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 Immuno Card Mycoplasma pneumonia manufacturer ' s instructions, Mycoplasma testing records review and laboratory general supervisor interview on February 9, 2023 at 11:50AM , it was determined that the laboratory failed to follow the manufacturer ' s instructions when 6 out of 6 patient specimens were testes for Mycoplasma by Immuno Card Meridian method from November 18 , 20233 to January 4, 2023. The findings include: 1. On February 9, 2023 at 11:45 AM The manufacturer ' s instruction were reviewed and the manufacturer's establishes to perform the mycoplasma test procedures at room temperature from 22 to 25 C. 2. On February 9, 2023 at 11:48 AM the Mycoplasma testing records showed that the laboratory did not follow the manufacturer instruction when it processed patient results the following dates: November 18, 2022; December 7, 2022; December 8, 2022; December 13, 2022; December 14,2022; January 4, 2023. 3. The laboratory general supervisor confirmed on February 9, 2023 at 11:50 AM that the laboratory failed to follow the manufacturer ' s instructions when 6 out of 6 patient specimens were testes for Mycoplasma by Immuno Card Meridian method from November 18 , 20233 to January 4, 2023. 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 pneumonia rapid test manufacturer's instructions, mycoplasma test records and interview with the laboratory supervisor on February 9, 2023 at 11:50 AM, it was determined that the laboratory director fail to assure that the established quality control program for Mycoplasma pneumonia tests were followed. Refer to D5417. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment 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 Quality Assessment (QA) records reviewed and laboatory general supervisor interview on February 9, 2023 at 10:10 AM ; it was determined that the laboratory director failed to ensure compliance with QA requirements. Refer to D5291. -- 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 test report records review and laboratory director interview on May 10, 2021 at 8:57 AM, it was determined that the laboratory failed to report the Covid- 19 results as required for 11 out of 12 days reviewed from February 10, 2021 to February 24, 2021. The findings include: 1. The laboratory utilized the Health Department written instruction to reports the Covid-19 results to the Bioportal. 2. The laboratory processed the Covid-19 rapid test by Clarity Block method. 3. The tests report records showed that the laboratory did not report the Covid-19 results in the required frequency (24 hrs) to the Bioportal in 11 out of 12 days reviewed from February 10, 2021 to February 24, 2021: Date Patients Date sent to tested specimens Bioportal 02 /10/2021 2 02/17/2021 02/11/2021 4 02/17/2021 02/12/2021 2 02/17/2021 02/13/2021 6 01/17/2021 02/15/2021 1 02/17/2021 02/17/2021 3 02/26/2021 02/18/2021 2 02/26 /2021 02/19/2021 2 02/26/2021 02/22/2021 5 02/26/2021 02/23/2021 1 02/26/2021 02 /24/2021 1 02/26/2021 4. The laboratory director confirmed on on May 10, 2021 at 8: 57 AM, that those results of Covid-19 IgM and IgG 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-- At least once a day patient specimens are assayed or examined perform the following 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 -- 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 Mycoplasma IgM testing records (from November 05, 2020 to February 24, 2021), parallel check records review and interview with the laboratory director on May 10, 2021 at 8:57 AM, it was determined that the laboratory failed to include each day of testing a negative and a positives control materials when patients specimens were tested for qualitative Mycoplasma IgM test by the Immuno Card method. The findings include : 1. The parallel check records showed that the laboratory placed in routine use the reagent lot numbers 709030M112 of Mycoplasma IgM by the Immuno Card method on November 05, 2020. 2. The testing records showed that the laboratory did not include each day of testing a negative and a positive control materials when 5 out of 5 patients specimens were tested for qualitative Mycoplasma IgM by the Immuno Card Mycoplasma method from February 17, 2021 to February 24, 2021: Date processed specimen ID 02/17/2021 26810 02/19/2021 26860 02/22 /2021 26902 02/23/2021 26943 02/24/2021 26951 3. The laboratory director confirmed on May 10, 2021 at 8:57 AM, that the laboratory did not include each day of testing a negative and a positive control materials when patients serum specimens were tested for qualitative Mycoplasma IgM tests those days. She stated that the laboratory run a negative and a positive control materials when it places in routine use every new lot of the Immuno Card Mycoplasma reagents Kit. Also the laboratory director stated that the laboratory evaluated and documented the internal control and the room tmperature each day of testing of Mycoplasma IgM tests. 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 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 Mycoplasma IgM testing records, parallel check records review and interview with the laboratory director on May 10, 2021 at 8:57 AM, it was determined that the laboratory director failed to ensure compliance with the analytic system requirements for the qualitative Mycoplasma IgM test by the Immuno Card method from November 05, 2020 to February 24, 2021. Refer to D 5449 (The laboratory did not include each day of testing a negative and a positives control materials when patients specimens were tested for qualitative Mycoplasma IgM test by the Immuno Card 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 test report records review and laboratory director interview on May 10, 2021 at 8:57 AM, it was determined that the laboratory failed to report the Covid- 19 results as required for 11 out of 12 days reviewed from February 10, 2021 to February 24, 2021. The findings include: 1. The laboratory utilized the Health Department written instruction to reports the Covid-19 results to the Bioportal. 2. The laboratory processed the Covid-19 rapid test by Clarity Block method. 3. The tests report records showed that the laboratory did not report the Covid-19 results in the required frequency (24 hrs) to the Bioportal in 11 out of 12 days reviewed from February 10, 2021 to February 24, 2021: Date Patients Date sent to tested specimens Bioportal 02 /10/2021 2 02/17/2021 02/11/2021 4 02/17/2021 02/12/2021 2 02/17/2021 02/13/2021 6 01/17/2021 02/15/2021 1 02/17/2021 02/17/2021 3 02/26/2021 02/18/2021 2 02/26 /2021 02/19/2021 2 02/26/2021 02/22/2021 5 02/26/2021 02/23/2021 1 02/26/2021 02 /24/2021 1 02/26/2021 4. The laboratory director confirmed on on May 10, 2021 at 8: 57 AM, that those results of Covid-19 IgM and IgG 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-- At least once a day patient specimens are assayed or examined perform the following 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 -- 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 Mycoplasma IgM testing records (from November 05, 2020 to February 24, 2021), parallel check records review and interview with the laboratory director on May 10, 2021 at 8:57 AM, it was determined that the laboratory failed to include each day of testing a negative and a positives control materials when patients specimens were tested for qualitative Mycoplasma IgM test by the Immuno Card method. The findings include : 1. The parallel check records showed that the laboratory placed in routine use the reagent lot numbers 709030M112 of Mycoplasma IgM by the Immuno Card method on November 05, 2020. 2. The testing records showed that the laboratory did not include each day of testing a negative and a positive control materials when 5 out of 5 patients specimens were tested for qualitative Mycoplasma IgM by the Immuno Card Mycoplasma method from February 17, 2021 to February 24, 2021: Date processed specimen ID 02/17/2021 26810 02/19/2021 26860 02/22 /2021 26902 02/23/2021 26943 02/24/2021 26951 3. The laboratory director confirmed on May 10, 2021 at 8:57 AM, that the laboratory did not include each day of testing a negative and a positive control materials when patients serum specimens were tested for qualitative Mycoplasma IgM tests those days. She stated that the laboratory run a negative and a positive control materials when it places in routine use every new lot of the Immuno Card Mycoplasma reagents Kit. Also the laboratory director stated that the laboratory evaluated and documented the internal control and the room tmperature each day of testing of Mycoplasma IgM tests. 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 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 Mycoplasma IgM testing records, parallel check records review and interview with the laboratory director on May 10, 2021 at 8:57 AM, it was determined that the laboratory director failed to ensure compliance with the analytic system requirements for the qualitative Mycoplasma IgM test by the Immuno Card method from November 05, 2020 to February 24, 2021. Refer to D 5449 (The laboratory did not include each day of testing a negative and a positives control materials when patients specimens were tested for qualitative Mycoplasma IgM test by the Immuno Card method). -- 2 of 2 --