Laboratorio Clinico D Maes

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA Recertification survey at the Laboratorio Clnico D'MAES Clinical Lab on April 10, 2025. 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 April 10, 2025. D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) (d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing scores (year 2024) and CASPER Report 0155D scores, it was determined that the laboratory failed to participate in the routine chemistry third testing event performed on October 2024. The findings include: 1. The proficiency testing records were reviewed from January 2023 to December 2024. Reviewed on April 10, 2025 at 10:30 AM. 2. The laboratory did not participate in the third testing event for routine chemistry (routine chemistry, urinalysis, urine sediment) performed in October 2024, a testing score of 0 % as obtained. Review on April 10, 2025 at 11:00 AM. 3. The deadlineof the third testing event report of routine chemistry was October 24, 2024. 4 The laboratory director confirmed on April 10, 2025 at 11:10 AM, that the laboratory failed to participate in the third testing event of routine chemistry specialty in October 2024. D2104 ENDOCRINOLOGY CFR(s): 493.843(d) (d) Failure to return proficiency testing results to the proficiency testing program 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 -- within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing scores (year 2024) and CASPER Report 0155D scores, it was determined that the laboratory failed to participate in the endocrinology second testing event performed on October 2024. The findings include: 1. The proficiency testing records were reviewed from January 2023 to December 2024. Reviewed on April 10, 2025 at 10:30 AM. 2. The laboratory did not participate in the third testing event for endocrinology (human chorionic gonadrotopin (hCG)) performed in October 2024, a testing score of 0 % as obtained. Review on April 10, 2025 at 11:00 AM. 3. The deadlineof the third testing event report of endocrinology was October 24, 2024. 4 The laboratory director confirmed on April 10, 2025 at 11:10 AM, that the laboratory failed to participate in the third testing event of endocrinology subspecialty in October 2024. D6041 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(3) (b)(3) Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered; This STANDARD is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing scores (year 2024) and CASPER Report 0155D scores, it was determined that the laboratory director failed to ensure that the technical consultant would participate during the third testing event of year 2024 of proficiency testing sample. Refer to D2093 and D2104. -- 2 of 2 --

Summary Statement of Deficiencies D2067 SYPHILIS SEROLOGY CFR(s): 493.835(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program records reviewed (years 2017- 2019) and laboratory director interview on April 2, 2019 at 10: 00 A.M., it was determined that the laboratory failed to participate in the syphilis serology second testing event performed in August 2018. The findings include: 1. Proficiency testing records were reviewed from March 2017 to March 2019. 2. The laboratory did not participate in the second testing event of syphilis serology performed in August 2018. 3. The laboratory director confirmed on April 2, 2019 at 10:00 A.M., that the laboratory failed to participate in the second testing event of syphilis serology specialty in August 2018. D2077 GENERAL IMMUNOLOGY CFR(s): 493.837(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended 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 -- during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program records reviewed (years 2017- 2019) and laboratory director interview on April 2, 2019 at 10: 00 A.M., it was determined that the laboratory failed to participate in the general immunology (Rheumatoid Artritis and Monotest) second testing event performed in August 2018. The findings include: 1. Proficiency testing records were reviewed from March 2017 to March 2019. 2. The laboratory did not participate in the second testing event of general immunology (RA and Monotest) performed in August 2018. 3. The laboratory director confirmed on April 2, 2019 at 10:00 A.M., that the laboratory failed to participate in the second testing event of general immunology specialty in August 2018. D2100 ENDOCRINOLOGY CFR(s): 493.843(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program records reviewed (years 2017- 2019) and laboratory director interview on April 2, 2019 at 10: 00 A.M., it was determined that the laboratory failed to participate in the endocrinology (Human Chorionic gonadotropin qualitative) third testing event performed in October 2018. The findings include: 1. Proficiency testing records were reviewed from March 2017 to March 2019. 2. The laboratory did not participate in the third testing event of endocrinology (hCG qualitative) performed in October 2018. 3. The laboratory director confirmed on April 2, 2019 at 10:00 A.M., that the laboratory failed to participate in the third testing event of endrocrinology specialty in October 2018. D6116 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(3) The technical supervisor is responsible for enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered. This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on Puerto Rico Proficiency Testing Program records reviewed (years 2017- 2019) and laboratory director interview on April 2, 2019 at 10: 00 A.M., it was determined that the technical supervisor did not make sure to participate in all proficiency program testing events of year 2018. The finding includes: 1. The laboratory processed and reported patients specimens for syphillis serology (Rapid plasma reagin), general immunology (RA and Monotest) and endocrinology (hCG qualitative) during year 2018. 2. Review of proficiency testing results showed that the laboratory did not participated in the second testing event of year 2018 for syphillis serology, Monotest and Rheumatoid factor, not third testing event for serum qualitative hCG tests. 3. The laboratory director stated on April 2, 2019 at 10:00 AM that although the laboratory performed patients samples testing, they did not participate in the second proficiency testing event and third proficiency testing event of year 2018. -- 3 of 3 --