Cdt-Cmt Group, Corp

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA Recertification survey at the CDT-CMT Group, Corp. on March 26, 2025. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. During a recertification survey on March 26, 2025, the laboratory was found out of compliance with the following conditions: 42 CFR 493.801 Enrollment and testing of samples 42 CFR 493.1441 Laboratory director; high complexity testing D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing (PRPT) scores (years 2023 - 2025), CASPER Report 0155D scores, toxicology patient's testing record and laboratory director interview on March 26, 2025 at 9:30 AM, it was determined that the laboratory failed to enroll in a HHS approved Proficiency Testing Program for valproic acid test, when processed and reported 480 to 523 valproic acid patient's test from January 1, 2023 to March 25, 2025. The findings include: 1. On March 26, 2025, at 9:30 AM, review the PRPT and CASPER Report 0155D scores, showed no results for valproic acid test from January 1, 2023, to December 31, 2024. 2. On March 26, 2025, at 10:00 AM, the toxicology patient's testing records showed that the laboratory 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 -- processed and reported 480 to 523 valproic acid patients tests from January 1, 2023 to March 25, 2025. 3. The laboratory director confirmed on March 26, 2025, at 10:15 AM that the laboratory failed to enroll in a HHS approved Proficiency Testing Program for valproic acid test. 4. This deficiency was cited on February 7, 2023. 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 PRPT, CASPER Report 0155D scores, toxicology patients testing record and laboratory director interview on March 26, 2025, at 10:15 AM, it was determined that the laboratory director failed to fulfill her responsibilities and duties to ensure compliance with the laboratory Proficiency Testing Program. Refer to D6088. The findings include: 1. This deficiency was cited on February 7, 2023. D6088 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4) (e)(4) Ensure that the laboratory is enrolled in an HHS-approved proficiency testing program for the testing performed and that-- This STANDARD is not met as evidenced by: Based on review PRPT, CASPER Report 0155D scores, toxicology patients testing record and laboratory director interview on March 26, 2025, at 10:15 AM, it was determined that the laboratory director failed to ensure the laboratory enrollment in an HHS approved Proficiency Testing Program for valproic acid test. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review off site survey was performed on August 8, 2024 to Laboratorio Clnico CDT CMT Group, Corp. , 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 (years 2023-2024) 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 -- CASPER Report 0155D scores, it was determined that the laboratory obtained a unsuccessful participation in a Proficiency Testing Program for Anti-HBs tests. Refer to D2085. D2085 GENERAL IMMUNOLOGY CFR(s): 493.837(g) Failure to achieve an overall testing event score of satisfactory performance for 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 two consecutive testing events for Anti-Hbs tests. The findings include: 1. The Puerto Rico Proficiency and CASPER Report 0155D scores, showed that the laboratory obtained following unsuccessful scores: Analyte: Anti-Hbs a. Third testng event year 2023 -40%. b. First testing event year 2024 -20%. 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 Anti-HBs 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 scores (years 2023-2024) and CASPER Report -- 2 of 3 -- 0155D scores, it was determined that the laboratory director did not ensure that the laboratory had a satisfactory participation in the Anti-HBs tests during the third testiing event of year 2023 and first testing event of year 2024. Refer to D2028. -- 3 of 3 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing (PRPT) records (years 2021 to 2022), bacteriology patient's testing records and laboratory director interview on February 7, 2023 at 12:02 PM, it was determined that the laboratory failed to enroll in a HHS approved Proficiency Testing Program for bacteriology throat, stool, rectal and urine cultures tests when it processed and reported 796 out of 796 patients cultures specimens from July 1, 2021 to February 5, 2023. The findings include: 1. On February 7, 2023 at 12:02 PM, review the PRPT records showed no results for bacteriology throat, stool, rectal and urine cultures tests from January 2021 to December 2022. 2. On February 7, 2023 at 12:05 PM, the bacteriology patient's testing records showed that the laboratory performed the primary inoculation in the following patients cultures from July 1, 2021 to February 5, 2023: throat, stool, rectal and urine. 3. On February 7, 2023 at 12:05 PM, the bacteriology patient's testing records showed that the laboratory laboratory reported at 48 hours the following results: a. 142 out of 142 patient's throat cultures as - Abundant growth of normal throat flora. No further ID. b. 27 out of 27 patient's stool cultures as - Abundant growth of normal stool flora. No Shigella or Salmonella isolated. c. 374 out of 374 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- patient's rectal cultures as - Abundant growth of normal rectal flora. No Shigella or Salmonella isolated, d. 133 out of 133 patient's urine cultures as - Less than 10,000 col /ml of organism isolated. No further ID. The laboratory referred the patient's cultures plates that have abnormal results for identification and susceptibility tests. 4. The laboratory director confirmed on February 7, 2023 at 12:10 PM, that the laboratory performed the primary inoculation in the following patients cultures from July 1, 2021 to February 5, 2023: throat, stool, rectal and urine and reported the colony count of the urine cultures and the normal flora for the throat, stool and rectal cultures. 5. The laboratory processed and reported 796 out of 796 patients cultures specimens from July 1, 2021 to February 5, 2023. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program (PRPTP) records (years 2021 and 2022) review and laboratory director interview on February 7, 2023 at 1:30 PM, it was determined that the laboratory failed to maintain the attestation statements provided by the PT program, signed by the analyst and the laboratory director from February 2021 to December 2022. The findings include: 1. The PRPTP were reviewed from February 2021 to February 2022. 2. On February 7, 2023 at 1:30 PM, the PRPTP records showed that the attestation statements were not signed by the analyst nor by the laboratory from February 2021 to February 2022. 3. On February 7, 2023 at 2:19 PM, the laboratory director confirmed that the attestation statements were not signed from February 2021 to December 2022. D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of bacteriology procedures manual, bacteriology patient's testing records(years 2021 to 2022), lack of incubator temperature chart and laboratory director interview on February 7, 2023 at 12:02 PM, it was determined that the laboratory failed to failed to ensure compliance with the analytic system requirements of bacteriology. Refer to D 5413 (The laboratory failed to follow written procedures to monitor and document daily the temperature of the bacteriology incubator when it -- 2 of 6 -- processed and reported 796 out of 796 patients cultures specimens from July 1, 2021 to February 5, 2023). D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of bacteriology procedures manual, bacteriology patient's testing records(years 2021 to 2022), lack of incubator temperature chart and laboratory director interview on February 7, 2023 at 12:02 PM, it was determined that the laboratory failed to follow written procedures to monitor and document daily the temperature of the bacteriology incubator when it processed and reported 796 out of 796 patients cultures specimens from July 1, 2021 to February 5, 2023. The findings include: 1. On February 7, 2023 at 12:02 PM, review of the bacteriology procedures manual showed that an incubation temperature of 35 to 37 C was required for primary inoculation procedures. 2. On February 7, 2023 at 12:04 PM, the incubator temperature chart was request to the laboratory director. The laboratory director stated that she did not have the temperature records available from July 1, 2021 to February 5, 2023. 3. On February 7, 2023 at 12:05 PM, the bacteriology patient's testing records showed that the laboratory performed the primary inoculation in the following patients cultures from July 1, 2021 to February 5, 2023: throat, stool, rectal and urine. 4. On February 7, 2023 at 12:05 PM, the bacteriology patient's testing records showed that the laboratory laboratory reported at 48 hours the following results: a. 142 out of 142 patient's throat cultures as - Abundant growth of normal throat flora. No further ID. b. 27 out of 27 patient's stool cultures as - Abundant growth of normal stool flora. No Shigella or Salmonella isolated. c. 374 out of 374 patient's rectal cultures as - Abundant growth of normal rectal flora. No Shigella or Salmonella isolated, d. 133 out of 133 patient's urine cultures as - Less than 10,000 col/ml of organism isolated. No further ID. 5. The laboratory processed and reported 796 out of 796 patients cultures specimens from July 1, 2021 to February 5, 2023. 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 instructions, Easy Lyte system preventive maintenance records (years 2022 to 2023) review and interview with the laboratory general supervisor on February 7, 2023 at 11:40 AM, it was determined that the laboratory failed to follow written instructions for the preventive maintenance of the the Easy -- 3 of 6 -- Lyte system when 57 out of 57 patients specimens where processed and reported for lithium ( Li ) test from January 2, 2022 to February 5, 2023. The findings include: 1. On February 7, 2023 at 11:40 AM, review of the manufacturer instructions showed, that the laboratory must perform the following preventive maintenance for the Easy Lyte system: a. To replace the Li electrode every six months. b. To replace the sample probe every 12 months. 2. On February 7, 2023 at 11:44 AM, Easy Lyte system preventive maintenance records showed that the laboratory did not replace the Li electrode nor replace the Easy Lyte system sample probe from January 2, 2022 to February 5, 2023. 3. On February 7, 2023 at 11:45 AM, the general supervisor confirmed that the laboratory did not perform those preventive maintenance from January 2, 2022 to February 5, 2023. 4. The laboratory processed and reported 57 out of 57 patients specimens Li test from January 2, 2022 to February 5, 2023. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on routine chemistry quality control records review (years 2022 to 2023) and general supervisor interview on February 7, 2023 at 11:18 AM, it was determined that the laboratory failed to perform, at least every 6 months, the calibration verification procedures for the lithium (Li) test when 57 out of 57 patients specimens where processed and reported for Li by the Easy Lyte system from January 2, 2022 to February 5, 2023. The findings include: 1. On February 7, 2023 at 11:18 AM, the routine chemistry quality control records showed that the laboratory did not perform any calibration verification procedures for Li tests by the Easy Lyte system since January 2, 2022. 2. On February 7, 2023 at 11:30 AM, the laboratory general supervisor confirmed that the laboratory did not perform the calibration verification procedures for the Li tests from January 2, 2022 to February 5, 2023. 3. The laboratory processed and reported 57 out of 57 patients Li tests by the Easy Lyte system from January 2, 2022 to February 5, 2023. D6076 LABORATORY DIRECTOR -- 4 of 6 -- 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 PRPT, bacteriology testing records, bacteriology and routine chemistry quality control records, laboratory director and general supervisor interview on February 7, 2023 at 12:02 PM, it was determined that the laboratory director failed to fulfill her responsibilities and duties to ensure compliance with the laboratory Proficiency Testing and quality control requirements. Refer to D 6088 Based on review of Puerto Rico Proficiency Testing (PRPT) records (years 2021 to 2022), bacteriology patient's testing records and laboratory director interview on February 7, 2023 at 12:02 PM, it was determined that the laboratory director failed to ensure that the is enrolled in a HHS approved Proficiency Testing Program for bacteriology throat, stool, rectal and urine cultures tests. Refer to D 6089 Based on Puerto Rico Proficiency Testing Program (PRPTP) records (years 2021 and 2022) review and laboratory director interview on February 7, 2023 at 1:30 PM, it was determined that the laboratory director failed to maintain the attestation statements provided by the PT program, signed by the analyst and by her from February 2021 to December 2022. Refer to D 2016. Refer to D 6093 Based on review of bacteriology procedures manual, bacteriology patient's testing records, lack of incubator temperature charts, manufacturer's instructions and Easy Lyte system preventive maintenance records and interview with the laboratory director, general supervisor and testing personnel on February 7, 2023 at 12:02 PM, it was determined that the laboratory director failed to ensure compliance with the analytic system requirements for the Bacteriology and Routine Chemistry specialties. D6088 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4) The laboratory director must ensure that the laboratory is enrolled in an HHS- approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing (PRPT) records (years 2021 to 2022), bacteriology patient's testing records and laboratory director interview on February 7, 2023 at 12:02 PM, it was determined that the laboratory director failed to ensure that the is enrolled in a HHS approved Proficiency Testing Program for bacteriology throat, stool, rectal and urine cultures tests from July 1, 2021 to February 5, 2023. The findings include: 1. The laboratory was not enroll in a PT Program for Bacteriology subspecialty. Refer to D 2000. 2. During the interview on February 7, 2023 at 12:05 PM, the laboratory director stated that she was in charge of the laboratory proficiency enrollment procedure. 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. -- 5 of 6 -- This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program (PRPTP) records (years 2021 and 2022) review and laboratory director interview on February 7, 2023 at 1:30 PM, it was determined that the laboratory director failed to maintain the attestation statements provided by the PT program, signed by the analyst and by her from February 2021 to December 2022. Refer to D 2015. 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 bacteriology procedures manual, bacteriology patient's testing records, lack of incubator temperature charts, manufacturer's instructions, Easy Lyte system preventive maintenance records and interview with the laboratory director, general supervisor and testing personnel on February 7, 2023 at 12:02 PM, it was determined that the laboratory director failed to ensure compliance with the analytic system requirements for the Bacteriology, Hematology and Routine Chemistry specialties. Refer to D 5002 (The laboratory failed to failed to ensure compliance with the analytic system requirements of bacteriology). Refer to D 5429 (The laboratory failed to follow written instructions for the preventive maintenance of the the Easy Lyte system from January 2, 2022 to February 5, 2023). Refer to D 5439 (The laboratory failed to perform at least every 6 months the calibration verification procedures for the Li tests by the Easy Lyte system from January 2, 2022 to February 5, 2023). 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 quality control records and interview with the laboratory personnel on February 7, 2023 at 12:02 PM, it was determined that the general supervisor did not assure that the testing personnel followed the established quality control procedures for Li tests and the Easy Lyte preventive maintenance. The findings includes: 1. No calibration verification procedure for Li test were performed during year 2022 ( Refer to D 5439). 2. No preventive maintenance instructions were followed for the Easy Lyte instrument since January 2, 2022 (Refer to D 5429). -- 6 of 6 --