Laboratorio Clinico Mayaguez

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at Laboratorio Clinico Mayaguez on March 27, 2025. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The following standard level deficiencies were found during the recertification CLIA survey ending on March 27, 2025. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) (a )Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (a)(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (a)(2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (a)(2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (a) (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (a)(3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on hematology calibration records, manufacturer's instructions reviewed and laboratory supervisor interview on March 27, 2025 at 12:17 PM, it was determined that the laboratory failed to perform the calibration procedures with at least the frequency recommended by the manufacturer's instructions (annually) for the hematology tests performed by the Sysmex XN-1000 hematology system. The laboratory process and report 1,488 out of 1,488 from January 2024 to December 2024. The findings include: 1. The laboratory uses a Sysmex XN-1000 hematology 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 -- system for CBC (Complete blood count) patient's tests. 2. The manufacturer's instructions establishes that the laboratory must perform the calibration procedures annually. 3. On March 27, 2025 at 12:07 PM, the calibration records of XN-1000 hematology system showed that the laboratory did not perform at least annually the calibration procedures that was included in the annually preventive maintenance. The last calibration procedures were done on July 2023. 4. The laboratory supervisor confirmed on March 27, 2025 at 12:17 PM, that the laboratory did not perform at least annually the calibration procedures for the XN-1000 hematology system. The laboratory processed and reported 1,488 CBC patient samples from from January 2024 to December 2024. D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) (b)(2) Verification of the test procedures performed and establishment of the laboratorys test performance characteristics, including the precision and accuracy of each test and test system; This STANDARD is not met as evidenced by: Based on Hematology quality control records review and interview with the laboratory supervisor on March 27, 2025 at 12:25 PM, it was determined that the laboratory supervisor failed to ensure that the quality control of hematology specialty were follow. Refer to D 5437. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A complaint survey at Laboratorio Clinico Mayaguez was completed on November 13, 2024 by Puerto Rico state agency. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. Specific standard level deficiencies cited are as follows : D5311, D5317, D5801, D6093 and D6144. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on temperature checks records (year 2024), written protocol titled "Protocol for specimen arriving from outside the laboratory" and interview with the laboratory general supervisor on November 13, 2024, at 2:40 PM; it was determined that the laboratory did not follow the established procedure for specimen arrival. The findings include: 1. The laboratory general supervisor stated on November 13, 2024, at 2:40 PM, that Laboratorio Clinico Mayaguez acts as a reference laboratory for Doctor's Clinical Laboratory at: 1010 10ST Estate Thomas, St Thomas, VI 00802. 2. .Review of the "Protocol for specimen arriving from outside the laboratory" on November 13, 2024, at 2:40 PM, showed that after the opening of the samples package the laboratory must check for temperature adequacy according to sample requirements. 3. On November 13, 2024, at 2:42 PM, the temperature check records for specimens 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 -- received from Doctor's Clinical Laboratory were requested. The laboratory general supervisor stated at 3:00 PM, there were no temperature records from samples received from Doctor's Clinical Laboratory. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on review of written procedures for sample collection and interview with the laboratory general supervisor on November 13, 2024, at 1:30 PM, it was determined that the laboratory did not provide to the referral laboratory written instructions for specimens handling. The findings include: 1. The laboratory acts as a reference laboratory for Doctor's Clinical Laboratory at: 1010 10ST Estate Thomas, St Thomas, VI 00802. 2. The laboratory general supervisor stated on November 13,2024 at 1:30 PM, that the referred samples could be tested at Laboratorio Clinico Mayaguez / doing business as (dba) Specialty Laboratories of Puerto Rico or another external reference laboratory contracted by Laboratorio Clinico Mayaguez. 3. During interview on November 13,2024 at 1:45 PM, laboratory general supervisor stated that those samples processed at Laboratorio Clinico Mayaguez /dba Specialty Laboratories of Puerto Rico, no specimen collection guide was available. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of patient specimens list referred by Doctor's Clinical Laboratory to Laboratorio Clinico Mayaguez and interview with the laboratory general supervisor on November 7, 2024, at 9:40 AM, it was found that Laboratorio Clinico Mayaguez did not process not reported 29 out of 29 patient's sample referred between October 7, 2024 and October 10,2024. The findings include: 1. The list of patient samples referred by Doctor's Clinical Laboratory was reviewed: a. The patient samples on October 7, 2024, were received at the Laboratorio Clinico Mayaguez on October 9, 2024. (Reviewed on November 7,2024 at 9:40 AM) b. The patient samples on October 10, 2024, were received at the Laboratorio Clinico Mayaguez on October 14, 2024. (Reviewed on November 7,2024 at 9:40 AM) 2. The laboratory general supervisor stated on November 7,2024 at 9:45 AM, that the samples were received in -- 2 of 3 -- the laboratory, however, were not processed not reported, due nonpayment issues. 3. The general supervisor of the laboratory confirmed on November 7,2024 at 9:50 AM, that the samples were returned to Doctor's Clinical Laboratory on October 21, 2024. 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 temperature check records (year 2024) and laboratory general supervisor interview on November 13, 2024, at 5:45 P.M., it was determined that the laboratory director failed to assure that the receiving temperature of samples received at that laboratory, and the provide sample collection guide. Refer to: D5311 and D5317. 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 temperature check records (year 2024) and laboratory general supervisor interview on November 13, 2024, at 5:45 P.M, it was determined that the general supervisor did not assure that the personnel in charge of sample receiving monitor and documented the samples arriving temperature. Refer to: D5311 and D5317. -- 3 of 3 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on observation, quality control records review (years 2019-2020) and laboratory general supervisor interview on March 5, 2020 at 11:45 AM, it was determined that the laboratory used the Wright stain reagent kit with exceeded expiration date. The findings include: 1. The laboratory uses Wright's One Step Stain for hematology manual differential count. 2. The records showed that the laboratory used the following Wright's One Step Stain reagent Lot # 4857-00, expiration date: August 2010 with exceeded expiration date from September 2019 to March 4, 2020. 3. The laboratory processed and reported twenty one (21) CBC manual differential count patient's samples 20 days during those days. 4. The laboratory supervisor confirmed that the laboratory used this Wright's One Step Stain reagent with exceeded expiration for the 100 % of manual differential count patient's samples stained for Wright's One Step Stain September 2019 to March 4, 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 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 -- 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 (years 2019-2020) and laboratory general supervisor interview at 11:00 AM on March 5, 2020, it was determined that the laboratory did not evaluate the new lots of hCG (human chorionic gonadotropin) test for positive and negative reactivity prior to placed it in routine use. The findings include: 1. The laboratory quality control records were review from August 12, 2019 to March 3, 2020. 2. The laboratory received the following reagent kit and no evaluation of their reactivity was performed Lot. # Expiration Date #Tests 069943 6/30/2020 14 072242 7/31/2021 6 3. The laboratory processed and reported twenty (20) hCG (human chorionic gonadotropin patient's samples since August 12, 2019 to March 3, 2020. (August 12, 2019-January 28, 2020 = 14 hCG patient's sample tests and February 5, 2020 to March 2, 2020 = 6 hCG patient's sample tests) 4. The laboratory general supervisor confirmed that the laboratory did not evaluate the new lots of hCG (human chorionic gonadotropin) test for positive and negative reactivity prior to placed it in routine use. 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 hematology and endocrinology quality control records review (years 2019- 2020) and laboratory general supervisor interview at 11:30 AM on March 5, 2020, it was found that the laboratory director did not assure that quality control procedures related to used the Wright stain reagent kit with exceeded expiration date and evaluation of new reagents lots were followed. The findings include: 1. The laboratory used the Wright stain reagent kit with exceeded expiration date. Refer to D5417. 2. The laboratory did not evaluate the new lots of hCG (human chorionic gonadotropin) test 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 hematology and endocrinology quality control records review (years 2019- 2020) and laboratory general supervisor interview at 11:30 AM on March 5, 2020, it was determined that the general supervisor did not assure that quality control procedures were followed by the testing personnel. The findings include: 1. The laboratory used the Wright stain reagent kit with exceeded expiration date. Refer to D5417. 2. The laboratory did not evaluate the new lots of hCG (human chorionic -- 2 of 3 -- gonadotropin) test for positive and negative reactivity prior to placed it in routine use. Refer to D5471. -- 3 of 3 --