Lab Clinico Obymar

Summary Statement of Deficiencies D0000 A Proficiency Test (PT) Desk Review off site survey was performed on June 2, 2025 to Laboratorio Clinico Obymar, the laboratory was found out of compliance with the following conditions: 42 CFR 493.803 Proficiency Testing, Successful Participation 42 CFR 493.1403 Laboratory Director, Moderate Complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of proficiency testing records (years 2024-2025) and Casper Report 0155D scores, it was determined that the laboratory failed an unsuccessful participation in a Proficiency Testing Program for routine chemistry subspecialties. Refer to D2096. 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing records (years 2024-2025) and Casper Report 0155D scores, it was determined that the laboratory obtained an initial unsuccessful performance in two out of three consecutive testing events for the routine chemistry tests. The finding includes: 1. The Puerto Rico Proficiency Testing and Casper Report 0155D scores, showed that the laboratory obtained the following unsuccessful scores: Analyte: Sodium a. Second testing event year 2024 - 60% b. First testing event year 2025 - 60% 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 review of proficiency testing records (years 2024-2025) and Casper Report 0155D scores, it was determined that the laboratory director failed to ensure the laboratory's successful participation in a Proficiency Testing Program for routine chemistry tests. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of proficiency testing records (years 2024-2025) and Casper Report 0155D scores, it was determined that the laboratory director did not ensure that the laboratory has a satisfactory participation for routine chemistry test during the second testing event 2024 and first testing event 2025. Refer to D2096 -- 2 of 2 --

Summary Statement of Deficiencies D0000 An unannounced CLIA Recertification survey was conducted at the Laboratorio Clnico Obymar on February 5, 2025 by the Puerto Rico State Agency. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The following standard level deficiencies were found during the unannounced routine CLIA recertification survey on February 5, 2025. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (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 a review of syphilis serology quality control records, syphilis serology patient test worksheet (years 2023-2024), Aim Rapid Plasma Reagin (RPR) test manufacturer's instructions and laboratory director interview, on February 5, 2025, at 11:00 A.M., it was determined that the laboratory failed to follow the manufacturer's instructions regarding needle washing after each shift for the syphilis serology testing, when 218 out of 218 patient specimens were tested from January 3, 2024 to December 24, 2024. The findings include: 1. The laboratory uses the Aim RPR test to perform patient syphilis serology tests. Review of the Aim RPR manufacturer's instructions on February 5, 2025, at 11:00 A.M., established that the needle assembly must be thoroughly washed in distilled or deionized water and air dried after each shift. 2. On February 5, 2025, at 11:05 A.M., the syphilis serology quality control and patient test worksheet records were reviewed. The records showed that the laboratory did not perform nor document the needle wash as required by the manufacturer, when they processed and reported 218 out of 218 RPR patient specimens from January 3, 2024, to December 24, 2024. 3. The laboratory director confirmed during interview on 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 -- February 5, 2025, at 11:20 A.M., that the laboratory did not follow the manufacturer's instructions related to the needle wash. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and 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 syphilis serology quality control and patient test worksheet (RPR) record review and laboratory director interview on February 5, 2025, at 1:30 P.M., it was determined that the laboratory director failed to ensure that the laboratory general supervisor followed the manufacturer's instructions related to the needle wash after each shift. Refer to D6144. 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 syphilis serology quality control and patient test worksheet (RPR) record review and laboratory director interview on February 5, 2025, at 1:30 P.M., it was determined that the laboratory general supervisor did not assure that the testing personnel followed the manufacturer's instructions regarding needle washing after each shift for the syphilis serology testing. Refer to D5411. -- 2 of 2 --

Summary Statement of Deficiencies 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 syphilis serology quality control review ( year 2021-2022 ) , manufacturer's instructions and laboratory general supervisor interview on January 25, 2023 at 10:10 a.m., it was determined that the laboratory failed to follow the manufacturer's instruction when 31 out 31 patient specimen were tested for RPR (Rapid plasma reagin) by ASI syphilis/rpr method. The findings include: 1. The syphilis serology quality control records were reviewed since 1/2022. ( review on 1/25/23 at 10:10 a.m.) 2. On December 19, 2022 the syphilis serology records showed that the laboratory began to use a new method for RPR test ( ASI ) . 3. The manufacturer's instruction of the new method establishes that three levels of control material ( non reactive, minimal to moderate and reactive) must be included each day of testing. ( review on 1 /25/23 at 10:15 a.m.) 4. From 12/19/2022 to 1/25/2023, the syphilis serology quality control log showed that the laboratory included only two control material ( reactive and non reactive ) each day of testing. ( review on 1/25/23 at 10:18 a.m.) 5. The general supervisor confirmed on January 25, 2023 at 10:20 a.m., that the laboratory failed to follow the manufacturer's instruction when 31 out 31 patient specimens were tested for RPR by ASI syphilis/rpr method. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations 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 -- 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 General Immunology (Mycoplasma pneumoniae test) quality control records review (years 2022-2023) and laboratory general supervisor interview on January 25, 2023 at 9:26 a.m., it was determined that the laboratory did not include an external negative control material each day when 107 out 107 mycoplasma patient samples were reported and performed. The findings include: 1. The laboratory begin to test Mycoplasma pneumoniae test on October 2022. ( review on 1/25/23 at 9:27 a. m. ) 2. The quality control records were review since October 2022 to January 24, 2023. ( review on 1/25/23 at 9:30 a.m) 3. Review of Mycoplasma pneumoniae quality control record showed that the laboratory did not include an external negative control material each day of patient testing since October 2022. ( review on 1/25/23 at 9:30 a. m) 4. The laboratory general supervisor confirmed on January 25, 2023 at 9:40 a.m., that the laboratory failed to include a negative control material each day of testing when performed Mycoplasma pneumonia test. 5. The laboratory did not include a negative control material, when 107 out 107 patient specimen were processed and reported since October 2022. ( review on 1/25/23 at 9:35 a.m) 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 general immunology and syphilis serology control records review ( 2021- 2023 ) and laboratory general supervisor interview on January 25, 2023 at 11:00 a.m. it was determined that the laboratory director failed to comply with the analytic system requirements. Refer to D5405 - the laboratory failed to follow the manufacturer's instruction when 31 out 31 patient specimen were tested for RPR (Rapid plasma reagin) by ASI syphilis/rpr method. Refer to D5449 - the laboratory did not include an external negative control material each day when 107 out 107 mycoplasma patient samples were reported and performed. 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 general immunology and syphilis serology control records review ( 2021- 2023 ) and laboratory general supervisor interview on January 25, 2023 at 11:00 a.m. it was determined that the laboratory general supervisor failed to comply with the analytic system requirements. Refer to D5405 - the laboratory failed to follow the -- 2 of 3 -- manufacturer's instruction when 31 out 31 patient specimen were tested for RPR (Rapid plasma reagin) by ASI syphilis/rpr method. Refer to D5449 - the laboratory did not include an external negative control material each day when 107 out 107 mycoplasma patient samples were reported and performed. -- 3 of 3 --

Summary Statement of Deficiencies D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program records review ( 2019-2020 ) and laboratory general supervisor interview on April 16, 2021 at 9:00 A.M., it was determined that the laboratory failed to attain a satisfactory results in hematology event. The findings include: 1. P.R. Proficiency Testing Program records and results were reviewed from February 2019 to February 2021. 2. Review of Proficiency Testing records showed that the laboratory obtained unsatisfactory results of 36.1 % in the second hematology testing event performed in July 2020. 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 Bioportal records review ( December 2020 to February 2021 ) and laboratory general supervisor interview on April 16, 2021 at 10:30 AM, it was determined that the laboratory failed to report the SARS-CoV 2 tests results as required . The findings include: 1. The laboratory utilized the Health Department written instruction to reports the SARS-CoV 2 ( rapid test,total antibodies and Covid Antigen ) tests results by the Bioportal. 2. The test report records showed that from December 21, 2020 to January 26, 2021, the laboratory did not report the SARS-Co- 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 -- Antigen patients results in the required frequency (24 hrs) by the Bioportal. Patient date report : 12/21/20, 12/22/20, 12/28/20, 12/29/20, 12/30/20, 1/4/21, 1/5/21, 1/7,21, 1/8/21, 1/11/21, 1/12,21, 1/13/21, 1/14,21, 1/15/21, 1/18/21, 1/20/21, 1/23/21, 1/25 /21, 1/26/21. patient samples reported: 40 date reported : January 28, 2021 3. The test report records showed that from January 22,2021 to January 26, 2021, the laboratory did not report the SARS-Co-rapid tests patients results in the required frequency (24 hrs) by the Bioportal. Patient date report : 1/22/21, 1/23/21, 1/25/21. patient samples reported: 14 date reported : January 27, 2021 4. The test report records showed that from February 15, 2021 to February 18, 2021, the laboratory did not report the SARS- Co-rapid tests patients results in the required frequency (24 hrs) by the Bioportal. Patient date report : 2/15/2021, 2/16/2021, 2/17/2021, 2/18/2021. patient samples reported: 10 date reported : February 20, 2021 5. The laboratory general supervisor confirmed on April 16, 2021 at 10:30 AM, that those results of SARS-CoV 2 tests were not reported in 24 hrs. 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 document all control procedures performed. This STANDARD is not met as evidenced by: Based on endocrinology quality control records review ( 2020-2021) and laboratory general supervisor interview at 10:50 a.m. on April 16, 2021, it was determined that the laboratory did not evaluate a new lot of hCG- (human chorionic gonadotropin test ) for positive and negative reactivity prior to placed it in routine use. The findings include: a. The laboratory quality control records were review from 1/2020 to 4/2021. b. The laboratory received the following reagent kit and no evaluation of their reactivity was performed: Test Lot Expiration Date First day of use hCG 072343 9/30 /2021 7/3/2020 F910013 10/23/2021 11/3/2020 c. The laboratory processed and reported 36 hCG patient samples during those days. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Program testing records review ( 2019-2020 ) and laboratory general supervisor interview on April 16, 2021 at 9:15 A.M., it was determined that the laboratory director failed to ensure that proficiency testing samples were tested as required under Subpart H requirements. Refer to D2122. 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 endocrinology quality control records review (years 2019-2021) and laboratory general supervisor interview at 9:00 A.M on April 16, 2021, it was found that the laboratory director did not assure that quality control procedures related evaluation of new reagents lots were followed. The finding includes: 1. The laboratory did not evaluate the new hCG reagent . Refer to D5471. -- 3 of 3 --

Summary Statement of Deficiencies D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program records review ( 2019-2020 ) and laboratory general supervisor interview on April 16, 2021 at 9:00 A.M., it was determined that the laboratory failed to attain a satisfactory results in hematology event. The findings include: 1. P.R. Proficiency Testing Program records and results were reviewed from February 2019 to February 2021. 2. Review of Proficiency Testing records showed that the laboratory obtained unsatisfactory results of 36.1 % in the second hematology testing event performed in July 2020. 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 Bioportal records review ( December 2020 to February 2021 ) and laboratory general supervisor interview on April 16, 2021 at 10:30 AM, it was determined that the laboratory failed to report the SARS-CoV 2 tests results as required . The findings include: 1. The laboratory utilized the Health Department written instruction to reports the SARS-CoV 2 ( rapid test,total antibodies and Covid Antigen ) tests results by the Bioportal. 2. The test report records showed that from December 21, 2020 to January 26, 2021, the laboratory did not report the SARS-Co- 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 -- Antigen patients results in the required frequency (24 hrs) by the Bioportal. Patient date report : 12/21/20, 12/22/20, 12/28/20, 12/29/20, 12/30/20, 1/4/21, 1/5/21, 1/7,21, 1/8/21, 1/11/21, 1/12,21, 1/13/21, 1/14,21, 1/15/21, 1/18/21, 1/20/21, 1/23/21, 1/25 /21, 1/26/21. patient samples reported: 40 date reported : January 28, 2021 3. The test report records showed that from January 22,2021 to January 26, 2021, the laboratory did not report the SARS-Co-rapid tests patients results in the required frequency (24 hrs) by the Bioportal. Patient date report : 1/22/21, 1/23/21, 1/25/21. patient samples reported: 14 date reported : January 27, 2021 4. The test report records showed that from February 15, 2021 to February 18, 2021, the laboratory did not report the SARS- Co-rapid tests patients results in the required frequency (24 hrs) by the Bioportal. Patient date report : 2/15/2021, 2/16/2021, 2/17/2021, 2/18/2021. patient samples reported: 10 date reported : February 20, 2021 5. The laboratory general supervisor confirmed on April 16, 2021 at 10:30 AM, that those results of SARS-CoV 2 tests were not reported in 24 hrs. 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 document all control procedures performed. This STANDARD is not met as evidenced by: Based on endocrinology quality control records review ( 2020-2021) and laboratory general supervisor interview at 10:50 a.m. on April 16, 2021, it was determined that the laboratory did not evaluate a new lot of hCG- (human chorionic gonadotropin test ) for positive and negative reactivity prior to placed it in routine use. The findings include: a. The laboratory quality control records were review from 1/2020 to 4/2021. b. The laboratory received the following reagent kit and no evaluation of their reactivity was performed: Test Lot Expiration Date First day of use hCG 072343 9/30 /2021 7/3/2020 F910013 10/23/2021 11/3/2020 c. The laboratory processed and reported 36 hCG patient samples during those days. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Program testing records review ( 2019-2020 ) and laboratory general supervisor interview on April 16, 2021 at 9:15 A.M., it was determined that the laboratory director failed to ensure that proficiency testing samples were tested as required under Subpart H requirements. Refer to D2122. 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 endocrinology quality control records review (years 2019-2021) and laboratory general supervisor interview at 9:00 A.M on April 16, 2021, it was found that the laboratory director did not assure that quality control procedures related evaluation of new reagents lots were followed. The finding includes: 1. The laboratory did not evaluate the new hCG reagent . Refer to D5471. -- 3 of 3 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of Proficiency testing records, review of Puerto Rico Proficiency Testing records ( 2018) and laboratory supervisor interview on February 22, 2019 at 9: 40 A.M., it was determined that the laboratory failed to retain proficiency testing records for at least 2 years. The findings include: 1. Puerto Rico Proficiency Testing records were reviewed from February 2018 to December 2018. 2. The laboratory did not have available the proficiency testing records documentation from February 2017 to December 2017. 3. The laboratory general supervisor confirmed on February 22, 2019 at 9:45 A.M. , that the laboratory did not have available the Proficiency Testing records from February 2017 to December 2017. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on manufacturer's written instructions, hematology preventive maintenance records review ( 2017-2018) and laboratory general supervisor interview on February 22, 2019 at 10:15 A.M., it was determined that the laboratory failed to follow written instructions for the preventive maintenance of Cell Dyn 3600 systems. The findings include: 1. The laboratory uses since May 2018 the Cell Dyn 3600 system to perform 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 -- hematology tests. 2. The manufacturer's written instructions establishes that the laboratory must document and perform the daily, weekly preventive maintenance. 3. Review of preventive maintenance records since May 2018 , showed that the laboratory did not perform nor document the daily preventive maintenance (run auto- clean cycle, clean closed sample aspiration needle , clean closed sample tower) the weekly preventive maintenance ( clean sample loader and racks, check sample transfer pump tubing ) and the monthly preventive maintenance ( clean fan filter, run extended auto-clean and replace diluent/sheath filter). 4. The laboratory processed and reported 11,715 hematology patient samples on 2018. 5. The laboratory general supervisor confirmed on February 22, 2019 at 10:30 A.M. that the laboratory failed to follow written instructions for the preventive maintenance of Cell Dyn 3600 systems. 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. This STANDARD is not met as evidenced by: Based on review of general immunology quality control records and laboratory general supervisor interview on February 22, 2019 at 11:00 a.m. , it was determined that the laboratory failed to include a negative and positive control material when performed CRP (C-reactive protein) qualitative test. The findingS include : 1. The laboratory performed CRP ( C-reactive protein) by agglutination method ( Teco). 2. The general immunology quality control records were review from January 2017 to December 2018. 3. The records showed that the laboratory did not include a negative and positive control material the following days: January 22, 2018 - patient identification-101264 November 29, 2018 ( patient identification-1042871) 4. The laboratory general supervisor confirmed on February 22, 2019 at 11:00 A.M., that the laboratory failed include a negative and positive control material during those days. 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 hematology and general immunology quality control records ( 2017-2018) and interview with the laboratory general supervisor interview on February 22, 2019 at 11:30 A.M., it was determined that the laboratory director failed to ensure compliance with the requirements for analytic systems. The finding includes: 1. The laboratory failed to follow written instructions for the preventive maintenance of Cell Dyn 3600 systems. Refer to D5429. 2. The laboratory failed to include a negative and positive control material when performed CRP (C-reactive protein) qualitative test. Refer to D5449. -- 2 of 3 -- 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 review of hematology and general immunology quality control records ( 2017-2018) and interview with the laboratory general supervisor interview on February 22, 2019 at 11:30 A.M., it was determined that the laboratory general supervisor failed to ensure compliance with the requirements for analytic systems. The finding includes: 1. The laboratory failed to follow written instructions for the preventive maintenance of Cell Dyn 3600 systems. Refer to D5429. 2. The laboratory failed to include a negative and positive control material when performed CRP (C- reactive protein) qualitative test. Refer to D5449. -- 3 of 3 --