Laboratorio Clinico Canovanas

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA Recertification survey at the Laboratorio Clnico Canovanas on November 13, 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 November 13, 2025. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (e)(1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing Service Program (PRPTSP) (year 2024 and 2025), Certification and Survey Provider Enhanced Report (CASPER) Report 0155D scores, proficiency laboratory records and interview with the laboratory director on November 13, 2025 at 9:50 AM, it was determined that the laboratory failed to take

Summary Statement of Deficiencies 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) testing records review from February 2020 to September 2021 and laboratory director interview on October 15, 2021 at 9:28 AM, it was determined that the laboratory failed to maintain a copy of the proficiency testing event records. The findings include: 1. The PRPTP records were reviewed from February 2020 to September 2021. 2. On October 15, 2021, the PRPTP records showed that the laboratory did not have the following proficiency testing records for November 2020 and December 2020 testing events. 3. The laboratory director confirmed on October 15, 2021 at 9:28 AM, that those proficiency testing event records were not available in the laboratory. 4. This deficiency was cited on May 29, 2019. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program (PRPTP) records review from February 2020 to September 2021 and laboratory director interview on October 15, 2021 at 9:35 AM, it was determined that the laboratory failed to take and document

Summary Statement of Deficiencies 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) testing records review ( years 2017, 2018 and 2019) and laboratory directro interview on May 29, 2019 at 9:35 AM, it was determined that the laboratory failed to maintain a copy of all proficiency testing records during the year 2018. The findings include: 1. The PRPTP records were review from February 2017 to April 2019. 2. On May 29, 2019, the PRPTP records showed that the laboratory did not have the following proficiency testing records for the year 2018: a. Proficiency testing processing records: February 2018 and March 2018 events. b. PRPTP score results reports: February 2018, March 2018 and October 2018 events. c. Copy attestation statement: February 2018, March 2018 and April 2018. 3. The laboratory director confirmed on May 29, 2019 at 9:35 AM, that those proficiency testing records were not available in the laboratory. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of endocrinology, special chemistry and routine chemistry quality control records(year 2018) ) and laboratory director interview on May 29, 2019 at 11: 30 AM, it was determined that the laboratory failed to retain the quality control records of the year 2018 for the endocrinology, special chemistry and routine chemistry tests. The findings include: 1. The laboratory did not have available the endocrinology and special chemistry quality control records from January 1, 2018 to May 29, 2018, Refer to D 5405 (1). 2. The laboratory did not not have available the Levy-Jennings records of the routine chemistry test from January 1, 2018 to December 31, 2018. Refer to D 5481. 3. The laboratory director confirmed on May 29, 2019 at 11:30 AM, that those quality control records were not available. This deficiency was cited on May 23, 2017. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program (PRPTP) testing records review ( years 2017, 2018 and 2019) and laboratory director interview on May 29, 2019 at 9:35 AM, it was determined that the laboratory failed to retain all proficiency testing records for at least 2 years. The findings include: 1. The PRPTP records were review from February 2017 to April 2019. 2. The laboratory did not maintain all the proficiency testing records for the year 2018. Refer to D 2015. 3. The laboratory director confirmed on May 29, 2019 at 9:35 AM, that those proficiency testing records were not available in the laboratory. This deficiency was cited on May 23, 2017 D5020 ENDOCRINOLOGY CFR(s): 493.1212 If the laboratory provides services in the subspecialty of Endocrinology, 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 lack of preventive maintenance records for the Access 2 system, lack of Access 2 system endocrinology and special chemistry quality control records (January 1, 2018 to May 29, 2018), Access 2 manufacturer's instructions, patients reports records review and laboratory director interview on May 29, 2019 at 11:30 AM, it was determined that the laboratory failed to meet the analytic system requirements for the following tests: T 3 uptake (T 3), Thyroxine (T4), Thyroid stimulating hormone (TSH) and Prostatic specific antigen (PSA) from January 1, 2018 to May 29, 2019. Refer to D 5405(1) (The laboratory failed to follow written instructions for quality -- 2 of 10 -- control procedures of the Access 2 system). . Refer to D 5429 (The laboratory failed to follow written instructions for the preventive maintenance of the Access 2 system). This deficiency was cited on May 23, 2017. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on manufacturer's instructions, hematology quality control records (years 2018 and 2019) review and interview with the laboratory director on May 29, 2019 at 1:00 PM, it was determined that the laboratory failed to meet the analytic system requirements for Hematology specialty (CBC) tests from February 15, 2019 to December 26, 2018. Refer to D 5405 (2) (The laboratory failed to follow quality control procedures when 150 out of 150 patients specimens were processed and reported for complete cell count (CBC) from February 15, 2019 to December 26, 2018 by the Coulter Act 5 diff system). This deficiency was cited on 05/23/2017. D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: 1. Based on lack of endocrinology and special chemistry quality control records (January 1, 2018 to May 29, 2018), manufacturer's instructions, patients reports records review and laboratory director interview on May 29, 2019 at 11:30 AM, it was determined that the laboratory failed to follow manufacturer instructions when the laboratory processed and reported the following patients specimens by the Access 2 system from January 1, 2018 to May 29, 2018: 793 patients specimens for T 3 uptake (T 3), 785 patients specimens for Thyroxine (T4), 2714 patients specimens for Thyroid stimulating hormone (TSH) and 470 patients specimens for Prostatic specific antigen (PSA) by the Access 2 system. The findings include: a. The laboratory processed and reported patients specimens for T 3, T4, TSH and PSA by the Access 2 system. b. The manufacturer instructed the laboratory to run two levels of control each day of testing. c. On May 29, 2019 at 11:30 AM, the laboratory did not have available the quality control records for the T 3, T4, TSH and PSA tests from January 1, 2018 to May 29, 2018. d. The laboratory director confirmed on May 29, 2019 at 11:30 AM, that the quality control procedures for this period were not available. He stated that the laboratory performed the quality control procedures but the record were not available. e. The laboratory processed and reported the following patients specimens by the Access 2 system from January 1, 2018 to May 29, 2018: 793 patients specimens for T3 , 785 patients specimens for T4, 2714 patients specimens for TSH and 470 patients specimens for PSA. This deficiency was cited on 05/23/2017. 2. Based on manufacturer's instructions, hematology quality control records (years 2018 -- 3 of 10 -- and 2019) review and interview with the laboratory director on May 29, 2019 at 1:00 PM, it was determined that the laboratory failed to follow quality control procedures when 150 out of 150 patients specimens were processed and reported for complete cell count (CBC) from February 15, 2019 to December 26, 2018 by the Coulter Act 5 diff system. The findings includes: a. The laboratory processed and reported the CBC patients specimens by the Coulter Act 5 diff system. b. The manufacturer instructed the laboratory to include the three levels of CBC control material each day of testing . c. The hematology quality control records showed that the laboratory did not include the three levels of CBC control material when the following 150 patients specimens were processed and reported for CBC: from February 15, 2018 to February 26, 2019 the laboratory reported 119 patients specimens for CBC and no records of three levels of control material were available for those dates; on April 7, 2019 the laboratory reported 15 patients specimens for CBC and no records of three levels of control material were available for this date; on April 10, 2019 the laboratory reported 1 patient specimen for CBC and no records of three levels of control material were available for this date; on June 21, 2018 the laboratory reported 2 patients specimens for CBC and no records of the high nor the normal level of control materials were available for this date and on December 26, 2018 13 patients specimens were reported and no records for the low level control material was available for this date. d. The laboratory director stated on May 29, 2019 at 11:30 AM, that the laboratory performed the quality control procedures but the quality control records for those dates were not available. This deficiency was cited on 05/23/2017. 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, lack of preventive maintenance records for the Access 2 system and interview with the laboratory director on May 29, 2019 at 12:10 PM, it was determined that the laboratory failed to follow written instructions for the preventive maintenance of the Access 2 system when it processed and reported the following patients specimens from January 1, 2018 to May 29, 2019: 2,518 patients specimens for T 3, 2,432 patients specimens for T4, 18,612 patients specimens for TSH and 1,371 patients specimens for PSA. The findings include: 1. The Access manufacturer instructed the laboratory to perform the daily and weekly preventive maintenance procedures. 2. On May 29, 2019 at 12:10 PM, the laboratory did not have available the daily and weekly preventive maintenance log of the Access 2 system from January 1, 2018 to May 29, 2019. 3. The laboratory director confirmed on May 29, 2019 at 12:10 PM, that the laboratory did not document the preventive maintenance log of the Access 2 system from January 1, 2018 to May 29, 2019. He stated, that the laboratory only maintained in record the print out of the Access temperatures verification. 4. The laboratory processed and reported the following patients specimens from January 1, 2018 to May 29, 2019: 2,518 patients specimens for T 3, 2,432 patients specimens for T4, 18,612 patients specimens for TSH and 1,371 patients specimens for PSA. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) -- 4 of 10 -- 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 calibration verification records reviewed and laboratory director interview on May 29, 2019 at 10:50 AM, it was determined that the laboratory failed to perform at least every 6 months the calibration verification procedures for glucose and lipid panel tests when it processed and reported 96 patients specimens for glucose tests and 1,788 patients specimens for lipid panel tests by the Hitachi 914 system from February 2, 2019 to May 29, 2019. The findings include: 1. The laboratory processed and reported the glucose and the lipids panel tests by the Hitachi 914 system. 2. On May 29, 2019 at 10:50 AM, the calibration verification records of the Hitachi 914 system showed that the laboratory did not perform at least every 6 months the calibration verification of the glucose and the lipids panel tests. The laboratory performed the calibration verification of those tests on August 1, 2018 and not performed the calibration verification procedures as scheduled in February 2019. 3. The laboratory director confirmed on May 29, 2019 at 10:50 AM, that the laboratory did not perform at least every 6 months the calibration verification for the glucose and the lipids panel tests. He stated that the laboratory performed the calibration verification procedures for those tests on August 1, 2018. 4. The laboratory processed and reported 96 patients specimens for glucose tests and 1,788 patients specimens for lipids panel tests from February 2, 2019 to May 29, 2019. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of routine chemistry quality control Levy-Jennings records (year 2018) and laboratory director interview on May 29, 2019 at 10:45 AM, it was determined -- 5 of 10 -- that the laboratory failed to run and evaluated the two levels of control materials when 4397 patients specimens for lipid panel were processed and reported from February 2018 to October 2018 by the Hitachi 914 system. The findings include: 1. The laboratory processed the lipid panel by the Hitachi 914 system. 2. On May 29, 2019 at 10:45 AM, the laboratory did not have available the routine chemistry quality control Levy-Jennings records for the year 2018. 3. The laboratory director confirmed on May 29, 2019 at 10:45 AM, that the laboratory the laboratory processed and reported 4397 patients specimens for lipid panel , but the routine chemistry quality control Levy- Jennings records were not available. 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 lack of endocrinology, special chemistry and routine chemistry quality control records(year 2018), lack of all the proficiency testing records for the year 2018, lack of preventive maintenance records for the Access 2 system, lack of Access 2 system endocrinology and special chemistry quality control records (January 1, 2018 to May 29, 2018), Access 2 manufacturer's instructions, Coulter Act 5 diff system manufacturer's instructions, hematology quality control records (years 2018 and 2019), lack of routine chemistry quality control Levy-Jennings records (year 2018), calibration verification records of routine chemistry tests, patients reports records, personnel file review and laboratory director interview on May 29, 2019 at 1: 40 PM, it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory records retention, proficiency testing records, analytical system requirements, clinical consultant qualification requirement and testing personnel training. The findings include: 1. Refer to D 6079 (The laboratory director did not comply with the laboratory's records retention requirements). 2. Refer to D 6091 (The laboratory director did not comply with the proficiency testing records). 3. Refer to D 6093 (The laboratory director did not comply with the analytical systems requirements). 4. Refer to D 6101 (The laboratory director did not comply with the Clinical Consultant requirements for his qualification). 5. Refer to D 6102 (The laboratory director did not comply with testing personnel training). This deficiency was cited on May 23, 2017. 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. -- 6 of 10 -- This STANDARD is not met as evidenced by: Based on lack of endocrinology, special chemistry and routine chemistry quality control records(year 2018), lack of all the proficiency testing records for the year 2018 and laboratory director interview on May 29, 2019 at 11:30 AM, it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory's records retention requirements. Refer to D 3031 (Proficiency Testing Program records retention). Refer to D 3037 (Quality Control records retention). D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require