Laboratorio Clinico Quimed

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review off site survey was performed on August 18, 2025 to Laboratorio Clinico Quimed, 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 Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (year 2025) and CASPER Report 0155D scores, it was determined that the laboratory obtained a unsuccessful participation in a Proficiency Testing Program for Sodium tests. Refer 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 Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (year 2025) and CASPER Report 0155D scores, it was determined that the laboratory obtained an initial unsuccessful performance in two out of two consecutive testing events for Sodium tests. The finding includes: 1. The Puerto Rico Proficiency and Casper Report 0155D scores, showed that the laboratory obtained the following unsuccessful scores: Analyte: Sodium a. First testing event year 2025 - 60% b. Second 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 Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (year 2025) and CASPER Report 0155D scores, its was determined that the laboratory director failed to ensure the laboratory's successful participation in a Proficiency Testing Program for Sodium 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 Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2025) and CASPER Report 0155D scores, it was determined that the laboratory director did not ensure that the laboratory had a satisfactory participation for Sodium tests during the first testing event of the year 2025 and second testing event of the year 2025. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of chemistry quality control records review and interview with the laboratory director on October 4, 2024; it was determined that the laboratory failed to meet requirements for analytic systems. Refer to D 5445 and D6093. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Routine Chemistry quality control records, patient's record and interview 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 -- with the laboratory director on October 4, 2024 at 12:04 PM; it was determined that the laboratory failed to include two levels of control material each day that processed patient's sample for potassium test by the Vitros 250 instrument. The laboratory processed 189 out of 338 potassium test without a control material from January to May 2024. The findings include: 1. The laboratory used the Vitros 250 by Orthodiagnostics to performed the chemistry test. 2. On October 4, 2024 at 10:17 AM, the monthly Levey Jennings graphs were reviewed and showed that the laboratory only run 2 levels of controls material for the potassium analyte, once or twice a month. The laboratory processed the 2 levels of controls on the following dates: January 9, 2024; January 26, 2024; February 2, 2024; February 22, 2024; March 15, 2024; April 19, 2024, and May 17 2024. 3. On October 4, 2024 at 11:10 AM; the patient record of chemistry was reviewed from January 2024 to May 2024, and showed that the laboratory processed the Comprehensive Metabolic Panel (CMP), that include the potassium analyte, on the following dates: January 9, 2024; January 19, 2024; January 26, 2024; February 2, 2024; February 9, 2024; February 22, 2024; March 1, 2024; March 8, 2024; March 15, 2024; March 27, 2024; April 8, 2024; April 19, 2024; April 26, 2024; May 3 2024; May 10, 2024; May 17, 2024; May 24, 2024; May 31, 2024. 4. On October 4, 2024 at 12:04 PM the laboratory director confirmed that the laboratory failed to include the two level of control material each day of patient testing for the potassium analyte. Also confirmed, that the laboratory processed and reported 189 out of 338 without the 2 level of control metrial of potassium analyte. 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 chemistry records review (year 2024), patients record review and interview with the laboratory director (sole practitioner) on October 4, 2024 at 12:04 PM; it was determined that the laboratory director failed to ensure that the two levels of control material for potassium were included each day of patient testing. Refer to D5445. -- 2 of 2 --

Summary Statement of Deficiencies D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on Immunohematology procedures manual, quality control records, and interview with the laboratory director, it was determined that the laboratory failed to meet the quality control requirements for the subspecialty of Immunohematology. Refer to D5551. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the Urinalysis quality control review and interview with the laboratory director; it was determined that the laboratory documented the microscopic quality control result from November 1, 2022 to November 30, 2022 even though the survey 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 -- date was on November 18, 2022. The findings include: 1. The Urinalysis quality control was reviewed on November 18, 2022 at 11:55 am. 2. The laboratory documented the urinalysis microscopic control result from November 1, 2022 to November 30, 2022. The survey date was on November 18, 2022. 3. The laboratory director confirmed on November18, 2022 at 11:58am that she documented the microscopic control of the whole month. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of routine chemistry quality control Levey-Jennings charts and laboratory director interview; it was determined that the laboratory did not evaluate, document or take remedial actions when the quality control results showed deviations (outliers, shift or trends). The findings include: a. The laboratory use a Vitros 250 by Ortho Clinical Diagnostics for routine chemistry test. The menu included Basic metabolic panel Comprehensive metabolic panel, Renal Panel, Lipid Panel. b. On November 18, 2022 at 9:30 am the quality control Levey-Jennings charts were reviewed. From October 18, 2022 to October 19, 2022 the Total bilirubin, Chlorine and sodium Levey-Jennings quality control chart showed both control levels (Verifier I and Verifier II) materials showed over three (3) deviation (3SD) and no remedial action were documented. b. The laboratory processed and reported two (2) patient's sample for comprehensive metabolic panel. f. On November 21, 2022 at 9:52 am the laboratory director confirmed that no remedial action were documented when the Levey-Jennings quality control chart showed both control levels (Verifier I and Verifier II) materials showed over three (3) deviation (3SD). D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, -- 2 of 3 -- as specified in this section. This STANDARD is not met as evidenced by: Based on immunohematology quality control records review and laboratory director interview, it was determined that the laboratory failed to perform quality control procedures for ABO and Rh group. The findings include: 1. On November 18, 2022 at 11:00 am the laboratory immunohematology quality control records showed, that the laboratory did not include any control material, when ABO and Rh group was performed from January 18, 2022 to October 3, 2022. 2. The laboratory processed and reported 12 patients for ABO & Rh group from January 18, 2022 to October 3, 2022. Thw forward and reverse result compare. 4. On November 18, 2022 the laboratory director confirmed that no quality control procedure was performed. 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 control records and and laboratory director interview on November 18, 2022, at 12:00 pm, it was determined that the laboratory director failed to fulfill his responsabilities and duties to ensure compliance with the laboratory quality control requirements. Refer to D5026 and D6093 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 routine chemistry quality control records, Urinalysis microscopic control and Immunohematology reviewed since January 2022 and laboratory director interview, it was determined that laboratory director failed to ensure compliance with the requirements for analytic systems. Refer to D5445, D5469 and D5551. -- 3 of 3 --