Lab Diaz Garcia

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review off site survey was performed on August 8, 2024 to Laboratorio Clnico Daz Garca, the laboratory was found out of compliance with the following conditions: 42 CFR 493.803 Proficiency Testing, Successful Participation 42 CFR 493.1441 Laboratory Director, high 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 Puerto Rico Proficiency Testing scores (year 2023-2024) and CASPER Report 0155D scores, it was determined that the laboratory obtained a unsuccessful participation in a Proficiency Testing Program for Chloride tests. 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) 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 scores (years 2023-2024) and CASPER Report 0155D scores, it was determined that the laboratory obtained a unsuccessful performance in two out three consecutive testing events for Chloride tests. The finding includes: 1. The Puerto Rico Proficiency and CASPER Report 0155D scores, showed that the laboratory obtained following unsuccessful scores: Analyte: Chloride a. Third testing event for year 2023 -60%. b. Second testing event for year 2024 -0% 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 review of Puerto Rico proficiency testing scores (years 2023-2024) 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 Chloride tests. Refer to D6079. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on Puerto Rico proficiency testing scores (years 2023-2024) and CASPER Report 0155D scores, it was determined that the laboratory director did not ensure that the laboratory had a satisfactory participation for Chloride tests during the third testing event of year 2023 and second testing event of year 2024. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D5020 ENDOCRINOLOGY CFR(s): 493.1212 If the laboratory provides services in the subspecialty of Endocrinology, 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 serum Human Chrorionic Gonadotropin (hCG) test quality control records (years 2019 to 2020) and interview with the laboratory laboratory general supervisor on September 17, 2020 at 11:10 AM, it was determined that the laboratory failed to ensure compliance with the analytic system requirements for serum hCG qualitative tests. The finding includes: 1. The human chorionic gonadotropin (hCG) test quality control records (years 2019-2020) showed that the laboratory did not include each day of testing a negative and a positive control material when patients specimens were processed and reported for serum hCG qualitative test. Refer to D 5449. 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 endocrinology quality control records review ( year 2019-2020 ) and interview with the laboratory general supervisor on September 17, 2020 at 11:10 AM , 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 -- it was determined that the laboratory failed to include a negative and positive control material each day of testing when performed hCG test. The findings include : 1. The laboratory performed hCG ( human chorionic gonadotropin) by one step method. 2. Endocrinology quality control logs were reviewed from January 2019 to September 17, 2020. 3. The records showed that the laboratory did not include a negative and a positive control material when performed hCG test from January 2020 to September 2020. 4. The laboratory performed and reported sixty one ( 61 ) patient samples in 2020. 5. The laboratory laboratory general supervisor confirmed on September 17, 2020 at 11:15 A.M., that the laboratory did not include a negative and a positive control material each day of testing when performed hCG test since January 2020. 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: 1. Based on syphilis serology quality control records review ( year 2019-2020 ) and laboratory general supervisor interview on September 17, 2020 at 10:30 a.m., it was determined that the laboratory did not evaluate the new lots of Rapid plasma reagin ( RPR) tests for positive and negative reactivity prior to placed it in routine use. The findings include: a. The laboratory quality control records were review since January 2019. b. The laboratory received the following reagent kits and no evaluation of their reactivity was performed: Test Lot Exp. Date First day of use RPR 81440 1/31/2020 7 /12/2019 85142 4/17/2020 4/17/2020 2. Based on endocrinology quality control records review ( year 2019-2020 ) and laboratory general supervisor interview on September 17, 2020 at 10:30 a.m. , it was determined that the laboratory did not evaluate a new lot of hCG- Human Chrorionic 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 January 2019 to September 2020. b. The laboratory received the following reagent kit and no evaluation of their reactivity was performed: Test Lot Exp.Date First day of use hCG F812010 12/17 /2020 07/2019 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 quality control records review ( year 2019-2020 ) and laboratory general -- 2 of 3 -- supervisor interview on September 17, 2020 at 11:30 A.M.. , 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 endocrinology and syphilis serology quality control records review (from January 1, 2019 to September 2020) and laboratory director and testing personnel interview on September 17, 2020 at 11:30 A.M., it was determined that the laboratory director failed to follow quality control procedures for hCG test. The finding includes: 1. The laboratory did not include each day of testing a positive and negative control materials for hCG tests. Refer to D 5449. 2. The laboratory did not evaluate the new lots of Rapid plasma reagin ( RPR) and hCG tests for positive and negative reactivity prior to placed it in routine use. 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 endocrinology quality control records review (years 2019-2020) and laboratory general supervisor interview at 11:30 AM on September 17, 2020, it was determined that the general supervisor did not assure that quality control procedures were followed by the testing personnel. Refer to D6177. D6177 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(3) Each individual performing high complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on quality control records review (years 2019-2020) and laboratory general supervisor interview at 11:30 AM on September 17, 2020, it was determined that testing personnel failed to follow quality control procedures. The findings include: 1. The testing personnel failed to include a negative and positive control material each day of testing when performed hCG test. Refer to D5449. 2. The testing personnel did not evaluate new RPR and hCG reagent lots for positive and negative reactivity prior to placed it in routine use. Refer to D5471. -- 3 of 3 --