Lab Clin Asociacion Maestros De Pr

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review off site survey was performed on July 7, 2025 to Laboratorio Clinico Asociacin de Maestros, 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 2024-2025) and CASPER Report 0155D scores, it was determined that the laboratory obtained a unsuccessful participation in a Proficiency Testing Program for Hemoglobiin (HGB) tests. Refer D2130. 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 scores (years 2024-2025) and CASPER Report 0155D scores, it was determined that the laboratory obtained an initial unsuccessful performance in two consecutive testing events for Hemoglobin (HGB) tests. The finding includes: 1. The Puerto Rico Proficiency and Casper Report 0155D scores, showed that the laboratory obtained the following unsuccessful scores: Analyte: Hemoglobin (HGB) a. Third testing event year 2024 - 0% b. First testing event year 2025 - 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 2024-2025) 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 hamatology tests. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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 scores (years 2024-2025) and CASPER Report 0155D scores, it was determined that the laboratory director did not ensure that the laboratory had a satisfactory participation for Hemoglobin (HGB) tests during the third testing event of the year 2024 and first testing event of the year 2025. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Laboratorio Clnico Asociacion de Maestros on December 10, 2024 by the Puerto Rico State Agency. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D5291 General Laboratory Systems Quality Assessment CFR(s): 493.1239 (a) D5391 PreAnalytic Systems Quality Assessment CFR(s): 493.1249 (a) D5791 Analytic Systems Quality Assessment CFR(s): 493.1289 (a)(c) D5891 Postanalytic Systems Quality Assessment CFR(s): 493.1299 (a) 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) program review (years 2023-2024) and laboratory general supervisor interview on December 10, 2024, at 11:00 A.M., it was determined that the laboratory failed to follow the established QA program to monitor and evaluate the following requirements for General laboratory systems: patient confidentiality, specimen identification and integrity, complaint investigations and communications. The findings include: 1. On December 10, 2024, 2024, at 10:00 A. M., review of the laboratory QA program showed that: a. Patient confidentiality must be evaluated annually; the record showed that the last evaluation was performed in January 2023. b. Specimen identification and integrity must be evaluated with each event that occurs, and annually; the record showed that the last evaluation was performed on June 15, 2023. c. Complaint investigations, must be evaluated monthly; the record showed that the last evaluation was performed in December 2023. d. Communications must be evaluated with each event that occurs; the record showed 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 -- that the last evaluation was performed in January 2023. 2. The laboratory general supervisor confirmed during interview on December 10, 2024, at 11:30 A.M., that the general systems QA evaluations were not performed during year 2024. 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) program review (years 2023-2024) and interview with the laboratory general supervisor interview on December 10, 2024, at 11:07 A. M., it was determined that the laboratory failed to follow the established QA Program to monitor and evaluate the following requirements for preanalytic systems: patient test requests and specimen submission, handling and referral. The findings include: 1. On December 10, 2024, 2024, at 11:07 A.M., review of the laboratory QA program showed that: a. Patient test requests must be evaluated every six months; the record showed that the last evaluation was performed on December 28, 2023. b. Specimen submission, handling and referral must be evaluated annually; the record showed that the last evaluation was performed on October 25, 2023. 2. The laboratory general supervisor confirmed during interview on December 10, 2024, at 11:30 A.M., that the preanalytic systems QA evaluations were not performed during year 2024. 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) program review (years 2023-2024) and interview with the laboratory general supervisor interview on December 10, 2024, at 11:12 A. M., it was determined that the laboratory failed to follow the established QA Program to monitor and evaluate the following requirements for analytic systems: comparison of test results and test records. The findings include: 1. On December 10, 2024, 2024, at 11:12 A.M., review of the laboratory QA program showed that: a. Comparison of test results must be evaluated every six months; the record showed that the last evaluation was performed on December 9, 2023. b. Specimen submission, handling and referral must be evaluated annually; the record showed that the last evaluation was performed on June 22, 2023. 2. The laboratory general supervisor confirmed during interview on December 10, 2024, at 11:30 A.M., that the analytic systems QA evaluations were not performed during year 2024. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an -- 2 of 3 -- ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on quality assessment (QA) program review (years 2023-2024) and interview with the laboratory general supervisor interview on December 10, 2024, at 11:17 A. M., it was determined that the laboratory failed to follow the established QA Program to monitor and evaluate the following requirements for postanalytical systems: patient test reports and turn around time (TAT). The findings include: 1. On December 10, 2024, 2024, at 11:17 A.M., review of the laboratory QA program showed that: a. Patient test reports must be evaluated annually; the record showed that the last evaluation was performed in December 2023. b. TAT must be evaluated annually; the record showed that the last evaluation was performed in December 2023. 2. The laboratory general supervisor confirmed during interview on December 10, 2024, at 11:30 A.M.,that the postanalytic systems QA evaluations were not performed during year 2024. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment 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 QA program review and interview with the laboratory general supervisor on December 10, 2024, at 11:30 A.M., it was determined that the laboratory director failed to ensure that the technical supervisor evaluated, as required, the QA activities. Refer to D6117. D6117 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(4) The technical supervisor is responsible for establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results. This STANDARD is not met as evidenced by: Based on QA program review and interview with the laboratory general supervisor on December 10, 2024 at 11:30A.M., it was determined that the laboratory technical supervisor failed to fulfill her responsibility to ensure that the QA activities was evaluated, as required, in the year 2024. Refer to D5291, D5391, D5791 and D5891. -- 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 lack of Puerto Rico Proficiency testing records review ( 2017) and interview with the laboratory general supervisor on August 8, 2018 at 11:00 A.M., it was determined that the laboratory failed to enroll in an approved proficiency program for cell identification, sed rate, hCG, urinalysis, urine sediment and syphilis serology in year 2017. The findings includes: 1. The proficiency testing records ( 2017 ) showed that the laboratory failed to enroll and participate in proficiency testing samples for cell identification, sed rate, hCG, urinalysis, urine sediment and syphilis serology in year 2017 ( June, July , August and December ). 2. The laboratory general supervisor confirmed on August 8, 2018, that the laboratory failed to enroll and participate in proficiency testing samples for cell identification, sed rate, hCG, urinalysis, urine sediment and syphilis serology in year 2017 ( June, July , August and December ). 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 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 -- 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 ( 2017-2018) and laboratory general supervisor interview on August 8, 2018 at 11:00 A.M., it was determined that the laboratory failed to participate in the syphilis serology second and third testing event performed in August and December 2017. The findings include: 1. Proficiency testing records were reviewed from February 2017 to July 2018. 2. The laboratory did not participate in the second and third testing event of syphilis serology performed in August and December 2017. 3. The laboratory general supervisor confirmed on August 8, 2018 at 11: 00 A.M., that the laboratory failed to participate in the second and third testing event of syphilis serology performed in August and December 2017. 4. This deficiency was cited on the last survey performed on June 1, 2016. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(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 ( 2017-2018) and laboratory general supervisor interview on August 8, 2018 at 11:00 A.M., it was determined that the laboratory failed to participate in the routine chemistry second testing event performed in June 2017. The findings include: 1. Proficiency testing records were reviewed from February 2017 to July 2018. 2. The laboratory did not participate in the second testing event of routine chemistry ( urinalysis and urine sediment) performed in June 2017. 3. The laboratory general supervisor confirmed on August 8, 2018 at 11: 00 A.M., that the laboratory failed to participate in the second testing event of routine chemistry ( urinalysis and urine sediment) performed in June 2017. 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 -- 2 of 4 -- 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 ( 2017-2018) and laboratory general supervisor interview on August 8, 2018 at 11:00 A.M., it was determined that the laboratory failed to participate in the endocrinology ( human chorionic hormone) second testing event performed in June 2017. The findings include: 1. Proficiency testing records were reviewed from February 2017 to July 2018. 2. The laboratory did not participate in the second testing event of endocrinology ( human chorionic hormone) performed in June 2017. 3. The laboratory general supervisor confirmed on August 8, 2018 at 11: 00 A.M., that the laboratory failed to participate in the second testing event of endocrinology sub- specialty in June 2017. 4. This deficiency was cited on the last survey performed on June 1, 2016. D2123 HEMATOLOGY CFR(s): 493.851(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: 1. Based on Puerto Rico Proficiency Testing Program records reviewed ( 2017-2018) and laboratory general supervisor interview on August 8, 2018 at 11:00 A.M., it was determined that the laboratory failed to participate in the hematology second testing event performed in July 2017. The findings include: a. Proficiency testing records were reviewed from February 2017 to July 2018. b. The laboratory did not participate in the second testing event of hematology ( cell identification and sed rate) performed in July 2017. c. The laboratory general supervisor confirmed on August 8, 2018 at 11: 00 A.M., that the laboratory failed to participate in the second testing event of hematology in July 2017. 2. Based on Medical Laboratory Evaluation ( MLE) Proficiency Testing Program records reviewed ( 2017-2018) and laboratory general supervisor interview on August 8, 2018 at 11:00 A.M., it was determined that the laboratory failed to participate in the hematology first testing event performed in March 2017. The findings include: a. Proficiency testing records were reviewed from February 2017 to July 2018. b. The laboratory did not participate in the second testing event of hematology (complete blood count) performed in March 2017. c. The laboratory general supervisor confirmed on August 8, 2018 at 11: 00 A.M., that the -- 3 of 4 -- laboratory failed to participate in the second testing event of hematology in March 2017. 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 Puerto Rico Proficiency testing records review ( 2017-2018 ) and laboratory general supervisor interview on August 8, 2017 at 11:00 AM. , it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the proficiency testing requirements. Refer to D 6089. 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. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency testing records review ( 2017-2018 ) and laboratory general supervisor interview on August 8, 2018 at 11:00 A.M., it was determined that the laboratory director failed to ensure that proficiency testing samples were tested as required under Subpart H requirements. Refer to D2067, D2089, D2100 and D2123. 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 Puerto Rico proficiency testing records review ( 2017-2018 ) and laboratory general supervisor interview on August 8, 2018 at 11:00 A.M., it was determined that the general supervisor failed to ensure that the proficiency testing were tested as required under Subpart H requirements. Refer to D2067, D2089, D2100 and D2123. -- 4 of 4 --