Laboratorio Clinico Olympic Plaza

Summary Statement of Deficiencies D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(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-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on syphilis serology testing records(year 2023) review and laboratory director interview on January 3, 2024 at 10:27 AM, it was determined that the laboratory failed to include at least once a day, a negative control material and the control material with tittered reactivity when two (2) out of two (2) patients specimens were tested for syphilis serology by rapid plasma reagin (RPR) quantitative tests by ASI method from October 24, 2023 to December 4, 2023. The findings include: 1. The laboratory processed and reported the RPR quantitative tests by ASI method. 2. On January 3, 2024 at 10:19 AM, the syphilis serology testing records showed that the laboratory did not include at least once a day, the negative control material and the control material with tittered reactivity. 3. The laboratory director confirmed on January 3, 2024 at 10:27 AM, that the laboratory did not include the negative control material and the control material with tittered reactivity when it performed the quantitative RPR test. Two (2) out of two (2) patients specimens were tested for RPR quantitative tests by ASI method on the following days: October 24, 2023 and December 4, 2023. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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 -- 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 syphilis serology worksheet records review (year 2023), and interview with the laboratory director on January 3, 2024 at 11:10 AM, it was determined that the laboratory director did not ensure that quality control procedures for syphilis serology quantitative method being followed. Refer to D5451. -- 2 of 2 --

Summary Statement of Deficiencies D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(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-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on syphilis serology testing records(years 2020 and 2021) review and laboratory director interview on January 26, 2022 at 10:15 AM, it was determined that the laboratory failed to include at least once a day, a control material with tittered reactivity besides the non reactive control material when 20 out of 20 patients specimens were processed for syphilis serology quantitative tests by the rapid plasma reagin (RPR) method from January 25, 2021 to September 28, 2021. The findings include: 1. The laboratory processed and reported qualitative and quantitative syphilis serology test by the RPR method. 2. On January 26, 2022 at 10:15 AM, the syphilis serology testing records showed that the laboratory did not include at least once a day, the control material with tittered reactivity besides the non reactive control material when 20 out of 20 patients specimens were processed for syphilis serology quantitative test by the RPR method from January 25, 2021 to September 28, 2021. The laboratory include the following controls: non reactive, the weekly reactive and the reactive control 3. The laboratory director confirmed on January 26, 2022 at 10:15 AM, that the laboratory did not include each day of testing the control material with tittered reactivity when patients specimens were processed for syphilis serology quantitative test. She stated that the laboratory include the following controls without tittered: non reactive, the weekly reactive and the reactive. 4. 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 -- processed and reported 20 out of 20 patients specimens for syphilis serology quantitative tests the RPR method from January 25, 2021 to September 28, 2021. 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 syphilis serology testing records(years 2020 and 2021) review and laboratory director interview on January 26, 2022 at 10:15 AM, it was determined that the laboratory director failed to establish the quality control procedures for the syphilis serology quantitative tests by the RPR method. Refer to D 5451 ( The laboratory did not include each day of testing a control material with tittered reactivity besides the non reactive control material when 20 out of 20 patients specimens were processed for syphilis serology quantitative tests from January 25, 2021 to September 28, 2021). -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program (PRPTP) records (years 2018 and 2019) reviewed and interview with the laboratory director at 9:40 AM on January 23, 2020, it was determined that the laboratory failed to enroll in an HHS approved proficiency program for wight blood cell (WBC) 5 parameters differential from January 2018 to December 31, 2019. The laboratory processed and reported 8,046 out of 8,046 patient's specimens for WBC 5 parameters differential during this period of time. The findings include: 1. The laboratory processed and reported patient's specimens for WBC 5 parameters differential by the Sysmex 1000i system. 2. At 9:40 AM on January 23, 2020, the PRPTP records showed that the laboratory did not to enroll in an HHS approved proficiency program for WBC 5 parameters differential since January 2018. 3. The laboratory director confirmed on January 23, 2020 at 9:40 AM, that the laboratory was not enrolled in an HHS proficiency program for WBC 5 parameters differential since January 2018. 4. The laboratory processed and reported 8,046 out of 8,046 patient's specimens for WBC 5 parameters differential from January 2018 to December 31, 2019 by the Sysmex 1000i system. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, 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 Immuno Card Mycoplasma manufacturer's instructions, Mycoplasma IGM testing and quality control records (from July 1, 2019 to January 3, 2020) reviewed and interview with the laboratory director at 10:30 AM on January 23, 2020, it was determined that the laboratory failed to meet the requirements of the General Immunology (for qualitative Mycoplasma IgM tests). Refer to D 5405 ( The laboratory did not follow manufacturer's instruction for test procedure when 240 out of 240 patient's specimens were tested and reported for qualitative Mycoplasma IgM tests from July 1, 2019 to January 3, 2020 , by the Immuno Card Mycoplasma method). Refer to D5449 ( The laboratory director at 10:20 AM on January 23, 2020, it was determined that the laboratory failed to include each day of testing a negative and a positive control materials when 240 out of 240 patient's specimens were tested and reported for qualitative Mycoplasma IgM tests from July 1, 2019 to January 3, 2020 , by the Immuno Card Mycoplasma method). D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on Immuno Card Mycoplasma manufacturer's instructions, Mycoplasma IGM testing records (from July 1, 2019 to January 3, 2020) reviewed and interview with the laboratory director at 10:30 AM on January 23, 2020, it was determined that the laboratory failed to follow manufacturer's instruction for test procedure when 240 out of 240 patient's specimens were tested and reported for qualitative Mycoplasma IgM tests from July 1, 2019 to January 3, 2020 , by the Immuno Card Mycoplasma method. The findings include: 1. The Immuno Card Mycoplasma manufacturer instructed the laboratory to incubate at 22 to 25 C the Test Card during the test procedures. 2. At 10:30 AM on January 23, 2020, the Mycoplasma IGM quality testing records showed that the laboratory did not monitor nor recorded the room temperature when it processed the patient's specimens from July 1, 2019 to January 3, 2020. 3. The laboratory director confirmed at 10:30 AM on January 23, 2020, that the laboratory did not document the room temperature when it processed the patient's specimens for qualitative Mycoplasma IgM tests from July 1, 2019 to January 3, 2020 , by the Immuno Card Mycoplasma method. 4. The laboratory tested and reported 240 out of 240 patient's specimens for qualitative Mycoplasma IgM tests from July 1, 2019 to January 3, 2020 by the Immuno Card Mycoplasma method. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) -- 2 of 4 -- 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. This STANDARD is not met as evidenced by: Based on Mycoplasma IGM quality control records (from July 1, 2019 to January 3, 2020) reviewed and interview with the laboratory director at 10:20 AM on January 23, 2020, it was determined that the laboratory failed to include each day of testing a negative and a positive control materials when 240 out of 240 patient's specimens were tested and reported for qualitative Mycoplasma IgM tests from July 1, 2019 to January 3, 2020 , by the Immuno Card Mycoplasma method. The findings include : 1. At 10:20 AM on January 23, 2020, the Mycoplasma IGM quality control records showed that the laboratory did not include each day of testing the negative nor the positive control materials from July 1, 2019 to January 3, 2020. 2. The laboratory director confirmed at 10:20 AM on January 23, 2020, that the laboratory did not include the negative nor the positive control materials each day of qualitative Mycoplasma IgM 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 240 out of 240 patient's specimens for qualitative Mycoplasma IgM tests from July 1, 2019 to January 3, 2020 by the Immuno Card Mycoplasma method. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on PRPTP records (years 2018 and 2019), Immuno Card Mycoplasma manufacturer's instructions, Mycoplasma IGM testing and quality control records (from July 1, 2019 to January 3, 2020) reviewed and interview with the laboratory director at 10:30 AM on January 23, 2020, it was determined that the laboratory director failed to fulfill her responsibilities and duties to ensure compliance with the Proficiency Testing Program and with the analytic requirements of the General Immunology (for qualitative Mycoplasma IgM tests). Refer to D 6015. ( The laboratory director failed to ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the WBC 5 parameters differential from January 2018 to December 31, 2019). Refer to D 6020 (The laboratory director did not comply with the analytic requirements of the General Immunology (for qualitative Mycoplasma IgM tests). D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform -- 3 of 4 -- 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)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on PRPTP records (years 2018 and 2019) reviewed and interview with the laboratory director at 9:40 AM on January 23, 2020, it was determined that the laboratory director failed to ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the WBC 5 parameters differential from January 2018 to December 31, 2019. Refer to D 2000 ( The laboratory did not enroll in an approved proficiency program for wight blood cell (WBC) 5 parameters differential from January 2018 to December 31, 2019. The laboratory processed and reported 8,046 out of 8,046 patient's specimens for WBC 5 parameters differential during this period of time. 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 Immuno Card Mycoplasma manufacturer's instructions, Mycoplasma IGM testing and quality control records (from July 1, 2019 to January 3, 2020) reviewed and interview with the laboratory director at 10:30 AM on January 23, 2020, it was determined that the laboratory director failed to comply with the analytic requirements of the General Immunology (for qualitative Mycoplasma IgM tests). Refer to D 5014. -- 4 of 4 --