Laboratorio Clinico Freytes

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at Laboratorio Clinico Freytes on March 28, 2025. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The following standard level deficiencies were found during the recertification CLIA survey ending on March 28, 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 scores (year 2024), CASPER Report 0155D scores, proficiency laboratory records and interview with the laboratory director on March 28, 2025 at 9:20 AM, it was determined that the laboratory failed to take

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on facility records review and laboratory director interview on July 16, 2021 at 9:45 AM, it was determined that the laboratory failed to be in compliance with the Puerto Rico State laboratory requirements. The findings include: 1. The laboratory Biomedical Generator Number (BGN) was due since September 14, 2020. 2. The laboratory director confirmed on July 16, 2021 at 9:45 AM, that the BGN was due since September 14, 2020. D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) records (year 2020) and laboratory director interview on July 16, 2021 at 10:15 AM, it was determined that the laboratory failed to maintain the established Quality Assessment Program to monitor and evaluate the laboratory activities (pre-analytic, analytic and post-analytic systems) during the year 2020. The findings include: 1. The laboratory did not maintain the Quality Assessment documentation during the year 2020. 2. The laboratory director confirmed on on July 16, 2021 at 10:15 AM, that the laboratory did not have available the Quality Assessment documentation corresponding the year 2020. 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 -- 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 complete blood count (CBC) quality control records, manufacturer's instruction review and laboratory director interview on July 16, 2021 at 11:14 AM, it was determined that the laboratory failed to meet the analytic system requirements for Hematology specialty (CBC). Refer to D 5407 (The laboratory did not follow the manufacturer's instruction for quality control procedures when 140 out of 140 patients specimens were tested for CBC by the Act 5 system from February 8, 2021 to April 29, 2021. Refer to D 5417 (The laboratory used the CBC controls materials that have exceeded their expiration date from March 6, 2021 to March 8, 2021). D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on complete blood count (CBC) quality control records review and laboratory director interview on July 16, 2021 at 11:14 AM, it was determined that the laboratory failed to follow the manufacturer's instructionfor quality control procedures when 140 out of 140 patients specimens were tested for CBC by the Act 5 system from February 8, 2021 to April 29, 2021. The findings include: 1. The laboratory analyzed and reported CBC specimens by the Act 5 system and the manufacturer require three levels of control materials (low, normal and high). 2. On July 16, 2021 at 11:14 AM, the CBC quality control records showed that the laboratory did not include the three levels of CBC control materials the following days: Date level of control CBC patients not included specimens reported 02/08/2021 normal 14 02/16/2021 low 23 02 /22/2021 normal 23 03/01/2021 high 15 03/03/2021 normal 24 03/05/2021 normal 18 03/06/2021 normal 16 04/29/2021 normal nor 7 low 3. The laboratory director stated on July 16, 2021 at 11:14 AM, that the laboratory run every day of testing the three levels of control but the data of those days were lost in the system. 5. The laboratory tested and reported 140 out of 140 CBC patients specimens the following days: 02/08 /2021, 02/16/2021, 02/22/2021, 03/01/2021, 03/03/2021, 03/05/2021, 03/06/2021 and 04/29/2021. 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 -- 2 of 6 -- electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on lack of room temperature and room humidity records and laboratory director interview on July 16, 2021 at 12:00 PM , it was determined that the laboratory failed to monitor and document the room temperature and humidity of the laboratory since January 2020 to July 16, 2021. The findings include: 1. On July 16, 2021 at 12:00 PM, the laboratory did not monitor nor document the room temperature and humidity of the laboratory since January 2020. 2. The laboratory director confirmed on July 16, 2021 at 12:00 PM , that those records were not available. She stated that the days when the laboratory performed the RPR the room temperature and the room humidity was documented. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on complete blood count (CBC) quality control records review and laboratory director interview on July 16, 2021 at 11:14 AM, it was determined that the laboratory used the CBC controls materials that have exceeded their expiration date from March 6, 2021 to March 8, 2021. The findings include: 1. The laboratory analyzed and reported CBC specimens by the Act 5 system. 2. The laboratory used the following control materials in March 6, 2021 and in March 8, 2021: lots 360121, 370121 and 380121 with the exceeded their expiration of March 5, 2021. 3. The laboratory director confirmed on July 16, 2021 at 11:14 AM that the records showed that the laboratory used those CBC controls materials that have exceeded their expiration. 4. The laboratory processed and reported 16 CBC patients specimens on March 6, 2021 and 15 CBC patients on March 8, 2021. 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: Based on pregnancy test testing records review and interview with the laboratory director on July 16, 2021 at 11:40 AM, it was determined that the laboratory failed to include each day of testing a negative control material besides the positive control material when 38 out of 38 patients specimens were tested for qualitative hCG from January 15, 2021 to July 7, 2021. The findings include : 1. On July 16, 2021 at 11:40 AM, the pregnancy test testing records showed that the laboratory did not include each day of testing a negative control material besides the positive control material -- 3 of 6 -- when patients specimens were tested for qualitative hCG (Human Chrorionic Gonadotropin) tests from January 15, 2021 to July 7, 2021. 2. The laboratory director confirmed on July 16, 2021 at 11:40 AM, that the laboratory did not include the external negative control material when patients specimens were tested for qualitative hCG. 3. The laboratory tested and reported 38 out of 38 patients specimens for qualitative hCG from January 15, 2021 to July 7, 2021. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 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 lack of clinical consultant personnel file, lack of room temperature and room humidity record, review of facility records, CBC quality control records, manufacturer's instruction and laboratory director interview on July 16, 2021 at 12:00 PM, it was determined that the laboratory director failed to fulfill her responsibilities and duties to comply with the administration of the laboratory, laboratory analytic system and quality assessment requirements. Refer to D 6010 (The laboratory director failed to comply with the administration of the laboratory). Refer to D 6020 (The laboratory director failed to comply with the laboratory analytic system requirements). Refer to D 6021 (The laboratory director failed to comply with the Quality Assessment Program during the year 2020). D6010 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(2) 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)(2) Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed. This STANDARD is not met as evidenced by: Based on lack of clinical consultant personnel file, facility records review and laboratory director interview on July 16, 2021 at 9:45 AM, it was determined that the laboratory director failed to comply with the administration of the laboratory. Refer to D 3009 (The laboratory Biomedical Generator Number (BGN) was due since September 14, 2020). Refer to D 6056 (The laboratory director failed to have the Clinical Consultant position filled since 07/16/2019). 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 -- 4 of 6 -- 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 on lack of room temperature and room humidity records, review of pregnancy test testing records, complete blood count (CBC) quality control records, manufacturer's instruction and laboratory director interview on July 16, 2021 at 12:00 PM, it was determined that the laboratory director failed to comply with the laboratory analytic system requirements. Refer to D 5024 (The laboratory failed to meet the analytic system requirements for Hematology specialty). Refer to D 5413 (The laboratory failed to monitor and document the room temperature and humidity of the laboratory since January 2020 to July 16, 2021). Refer to D 5449 ( The laboratory failed to include each day of testing a negative control material besides the positive control material when 38 out of 38 patients specimens were tested for qualitative hCG from January 15, 2021 to July 7, 2021). 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 lack of Quality Assessment (QA) records (year 2020) and laboratory director interview on July 16, 2021 at 10:15 AM, it was determined that the laboratory director failed to comply with the Quality Assessment Program during the year 2020. Referred to D 3039 (The laboratory did not maintain the established Quality Assessment Program during the year 2020. D6056 CLINICAL CONSULTANT CFR(s): 493.1415 The laboratory must have a clinical consultant who meets the qualification requirements of 493.1417 of this part and provides clinical consultation in accordance with 493.1419 of this part. This CONDITION is not met as evidenced by: Based on lack of clinical consultant personnel file and laboratory director interview on July 16, 2021 at 9:45 A.M., it was determined that the laboratory director failed to have the Clinical Consultant position filled since 07/16/2019. Refer to D 6057 D6057 CLINICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1417 The clinical consultant must be qualified to consult with and render opinions to the laboratory's clients concerning the diagnosis, treatment and management of patient -- 5 of 6 -- care. The clinical consultant must-- (a) Be qualified as a laboratory director under 493. 1405(b)(1), (2), or (3)(i); or (b) Be a doctor of medicine, doctor of osteopathy or doctor of podiatric medicine and possess a license to practice medicine, osteopathy or podiatry in the State in which the laboratory is located. This STANDARD is not met as evidenced by: Based on lack of clinical consultant personnel file (credentials and competency records) and laboratory director interview on July 16, 2021 at 9:45 A.M, it was determined that the laboratory director failed to fill the Clinical Consultant position since 07/16/2019. The findings include: 1. The laboratory did not have the Clinical Consultant personnel file since 07/16/2019. 2. The laboratory director state on July 16, 2021 at 9:45 A.M, that the clinical consultant of the laboratory is the doctor of pediatric medicine that have an office near the laboratory but his personnel file was not available. -- 6 of 6 --

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 Puerto Rico Proficiency Testing Program (PRPTP) records review from February 2017 to February 2019 and laboratory general supervisor interview on May 9, 2019 at 9:22 AM, it was determined that the laboratory failed to enroll in an HHS approved Proficiency Testing Program for syphilis serology (Rapid Plasma Reagin - RPR) tests (Non-waived method) since January 3, 2018 to December 27, 2018. The findings include: 1. The laboratory processed and reported patients specimens for syphilis serology (RPR) tests by the Immuno RPR moderated method since January 3, 2018 to December 27, 2018. 2. The proficiency testing records showed that the laboratory failed to enrolled and participated in the proficiency testing samples for RPR tests since January 3, 2018 to December 27, 2018. 3. The laboratory general supervisor confirmed on May 9, 2019, that the laboratory not participated or enroll in HHS (Department of Health and Human Services) approved Proficiency Testing Program for RPR tests (Non Waived) from January 3, 2018 to December 27, 2019. 4. The laboratory processed and reported 1,016 out of 1,016 patients specimens for RPR tests by the Immuno RPR moderated method from January 3, 2018 to December 27, 2018. 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 -- 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 review from February 2018 to March 2019 and laboratory general supervisor interview on May 9, 2019 at 9:25 AM, it was determined that the laboratory failed to maintain the proficiency testing event records. The findings include: 1. Puerto Rico Proficiency Testing Program (PRPTP) records were reviewed from February 2018 to March 2019. 2. Review of proficiency testing records from February 2018 to December 2018, showed that the laboratory did not maintain the following proficiency testing event records: November 2018, December 2018 and February 2019. 3. The laboratory general supervisor confirmed on May 9, 2019, that the laboratory did not maintain these proficiency testing event records. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(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 Puerto Rico Proficiency Testing Program (PRPTP) records review and laboratory general supervisor interview on May 9, 2019 at 9:25 AM, it was determined that the laboratory failed to take and document