Lab Clinico Caribe

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at LABORATORIO CLINICO CARIBE on July 17, 2024. 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 ending on July 17, 2024. 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: A. Based on endocrinology quality control records review ( years 2023-2024 ), patient's reports worksheets review (years 2023-2024) and laboratory general supervisor interview on July 17, 2024 at 10:45 AM, it was determined that the laboratory failed to include a negative and positive control material each day of testing when reported and performed hCG (Human chorionic gonadotropin) tests 4 out of 158 patient's samples in 3 out 73 of days (year 2023) and 15 out of 80 patient's samples in 6 out 45 of days (year 2024) by Aime One Step Method by Germaine. The findings include : 1. The laboratory performed hCG ( human chorionic gonadotropin) by Aim One Step method. Review on July 17, 2024 at 10:45 AM 2. The endocrinology quality control logs and patient's reports worksheets were reviewed from January 2, 2023 to July 16, 2024. Review on July 17, 2024 at 10:55 AM. 3. The endocrinology quality control logs and patient's reports worksheets records showed that the laboratory did not include a negative and positive control material each day of testing from January 2, 2023 to July 16, 2024, when peformed and reported 20 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 -- patient's samples in the following days: (reviewed on July 17, 2024 at 11:05 AM) Date hCG patient's samples 1/25/2023 2 3/20/2023 1 5/9/2023 1 1/24/2024 3 2/1/2024 2 2/6/2024 1 2/20/2024 5 2/23/2024 3 7/10/2024 1 4. The laboratory general supervisor confirmed on July 17, 2024 at 11:10 AM, that the laboratory failed to include a negative and positive control material each day of testing when performed hCG test. B. Based on general immunology quality control records review ( years 2023-2024 ), patient's reports worksheets review (years 2023-2024) and laboratory general supervisor interview on July 17, 2024 at 9:40 AM, it was determined that the laboratory failed to include a negative and positive control material each day of testing when reported and performed Mycoplasma Ig M tests 17 out of 406 patient's samples in 5 out 110 of days (year 2024) by Immunocard by Meridian. The findings include : 1. The laboratory performed Mycoplasma Ig M by Immunocard Meridian method. Review on July 17, 2024 at 9:40 AM 2. The general immunology quality control logs and patient's reports worksheets were reviewed from January 2, 2023 to July 16, 2024. Review on July 17, 2024 at 9:55 AM. 3. The general immunology quality control logs and patient's reports worksheets records showed that the laboratory did not include a negative and positive control material each day of testing from January 2, 2023 to July 16, 2024 when peformed and reported 17 patient's samples in the following days: (reviewed on July 17, 2024 at 10:05 AM) Date Mycoplasma IgM patient's samples 4/1/2024 4 4/2/2024 1 4/3/2024 7 4/22/2024 3 5/29 /2024 2 4. The laboratory general supervisor confirmed on July 17, 2024 at 10:10 AM, that the laboratory failed to include a negative and positive control material each day of testing when performed Mycoplasma Ig M patient's tests. 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 general immunology quality control (years 2023-2024) patient's reports worksheets review (years 2023-2024) and laboratory general supervisor interview on July 17, 2024 at 11:25 AM, it was determined that the director failed to ensure the compliance with the quality control program when reported and persormed hCG (Human chorionic gonadotropin) tests 4 out of 158 patient's samples in 3 out 73 of days (year 2023) and 15 out of 80 patient's samples in 6 out 45 of days (year 2024) by Aime One Step Method by Germaine and Mycoplasma Ig M tests 17 out of 406 patient's samples in 5 out 110 of days (year 2024) by Immunocard by Meridian. Refer to D5449. -- 2 of 2 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on Quality Assessment (QA) activities records review and laboratory director interview, it was determined that laboratory failed to evaluate and monitor the General Laboratory system requirements since January 2021. The findings include: a. On August 26, 2022 at 9:43 AM, the laboratory QA was requested. On August 26, 2022 at 11:19 AM the laboratory QA was requested again. No QA record was presented. b. Since January 2021 the laboratory did not evaluate practices related to: Patient confidentiality, specimen identification and integrity, compliant investigation, communications and personnel competency. c. The laboratory director confirmed on August 26, 2022 at 12:05 pm that the general laboratory QA evaluations were not available. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on Quality Assessment (QA) records and laboratory director interview, it was 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 -- determined that the laboratory failed to evaluate Quality Assessment Program and monitor the requirement for pre-analytic systems. The findings include: a. On August 26, 2022 at 9:43 AM, the laboratory QA record was requested. On August 26, 2022 at 11:19 AM was requested again. No QA records was presented. b. Since January 2021 the laboratory did not evaluate practices related to: test request, specimen submission and handling, specimen referral. c. The laboratory director confirmed on August 26, 2022 at 12:05 PM, that the pre-analytic system QA evaluations were not available. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 laboratory temperature records, manufacturer's instructions review and laboratory director interview it was determined that the laboratory did not monitor nor take any remedial actions when the temperature refrigerator charts showed were outside the manufacturer's inserts established ranges. The findings include: a. On August 26, 2022 at 11:00 AM, the laboratory refrigerator temperature records were review from January 7, 2021 to December 30, 2021. All documented temperature were within (9-10C) range. b. The manufacturer's inserts showed the following required storage temperature ranges: Chemistry (Vitros 250) reagents (2-8C); Rapid Plasma Reagin set (RPR) by Teco Diagnostics (2-8C); Mycoplasma IgM reagent Immunocard by Meridian (2-8C); Rheumatoid Factor a latex test (RA) by Teco Diagnostics (2-8C); C-Reactive Protein a latex test (CRP) by Teco Diagnostics (2- 8C). c. The laboratory refrigerator temperature from January 1, 2022 to August 25, 2022 was requested and was not presented. However no refrigerator temperature records were showed during the survey. d. The laboratory director confirmed on August 26, 2022 at 12:20 PM, that since January 7, 2021 to December 30, 2021 the temperature was documented out of range (9-10C). D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on Quality Assessment (QA) records and laboratory director interview, it was determined that the laboratory failed to evaluate Quality Assessment Program and monitor the requirement for analytic systems. The findings include: a. On August 26, 2022 at 9:43 AM, the laboratory QA record was requested. On August 26, 2022 at 11: 19 AM was requested again. No QA records was presented. b. Since January 2021 the laboratory did not evaluate practices related to: test procedures, accurate and reliable test system, equipment, instruments, reagents, materials, specimen and reagent storage conditions, system maintenance and function checks, verification of method -- 2 of 4 -- performance specifications, calibration, control procedures, comparison of test results, test records,

Summary Statement of Deficiencies D5012 SYPHILIS SEROLOGY CFR(s): 493.1207 If the laboratory provides services in the subspecialty of Syphilis serology, 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 syphilis serology quality control records review and laboratory director interview on August 16, 2018 at 10:43 AM, it was determined that the laboratory failed to included meet the requirements for syphilis serology by Rapid Plasma Reagin (RPR) quantitative tests. Refer to D5451. 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 urinalysis procedures manual, urinalysis quality control records review from January 7, 2018 to August 16, 2018 and laboratory director interview on August 16, 2018 at 10:55 AM, it was determined that the laboratory failed to follow manufacturer's instructions to perform the preventive maintenance of centrifuge and microscope. The findings include: 1. The laboratory did not perform the preventive maintenance of the centrifuge and microscope from January 7, 2018 to August 16, 2018. 2. The laboratory director confirmed on August 16, 2018, that those preventive maintenance did not perform from January 7, 2018 to August 16, 2018. 3. The 2017's 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 -- annual volume records showed that the laboratory processed 7,788 patients specimens. 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 quality control records review from January 7, 2017 to August 16, 2018 and laboratory director interview on August 16, 2018 at 10:42 AM, it was determined that the laboratory failed to include at least once a day, a negative control material and a control material with tittered reactivity when patients were tested for syphilis serology by Rapid Plasma Reagin (RPR) quantitative tests. The finding includes: 1. The laboratory performed Rapid Plasma Reagin (RPR) by TECO RPR Reagents set. 2. Review of syphilis serology quality control fro January 7, 2017 to August 16, 2018, showed that the laboratory did not include at least once a day, a negative control material and a control material with tittered reactivity when the following patient specimen was processed and report on May 12, 2017 (ID # 424829, R 1:8 dils.). 3. The laboratory director confirmed on August August 16, 2018, that the laboratory did not include at least once day, a control material and a control material with tittered reactivity when patients specimens were tested for serology quantitative this day. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on procedures manual, quality control records review from January 7, 2017 to August 16, 2018 and laboratory director interview on August 16, 2018, it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the following requirements for analytic systems: 1. failed to follow manufacturer's instructions to performed the preventive maintenance of centrifuge and microscope. Refer to D5429. 2. failed to follow the manufacturer's instructions when patient specimen were tested for quantitative RPR (Rapid Plasma Reagin) by TECO. Refer to D5451. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. -- 2 of 4 -- 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 procedures manual, quality control records review and laboratory director interview on August 16, 2018 at 11:58 AM, it was determined that the laboratory director failed to fulfill her responsibilities and duties to ensure compliance with the laboratory analytical system and quality assessment requirements. The finding includes: 1. The laboratory director did not comply with the requirements for analytical systems and quality assessment requirements. Refer to D6220 and D6221. 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 procedures manual, quality control records review and laboratory director interview on August 16, 2018 at 11;56 AM, it was determined that the laboratory director failed to ensure compliance with requirements for analytic systems. The finding includes: 1. The laboratory director did not assure that the laboratory: a. failed to perform the preventive maintenance of the centrifuges and microscope. Refer to D5429. b. failed to follow the manufacturer's instructions when patient specimen were tested for quantitative RPR (rapid Plasma Reagin) by TECO. Refer to D5451. D6021 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 quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on Quality Assessment (QA) records review and laboratory director interview on August 16, 2018 at 11:58 AM, it was determined that the laboratory director failed to ensure compliance with Quality Assessment (QA) requirements. The finding includes: 1. The laboratory director did not evaluate the established Quality Assessment Program to monitor and document the following requirement for analytic systems: a. failed to follow manufacturer's instructions to performed the preventive maintenance of centrifuge and microscope. Refer to D5429. b. failed to follow the manufacturer's instructions when patient specimen were tested for quantitative RPR (Rapid Plasma Reagin) by TECO. Refer to D5451. -- 3 of 4 -- D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate 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 procedures manual, quality control records review and laboratory director interview on August 16, 2018, it was determined that the testing personnel failed to follow the quality control requirements. The finding includes: 1. The laboratory testing personnel failed to following quality control procedures: a. failed to perform the preventive maintenance of the centrifuges and microscope. Refer to D5429. b. failed to follow the manufacturer's instructions when patient specimen were tested for quantitative RPR (rapid Plasma Reagin) by TECO. Refer to D5451. -- 4 of 4 --