Laboratorio Clinico Almirante Norte Corp Ii

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at Laboratorio Clinico Central de Levittown IV on August 6, 2026. 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 August 6, 2026. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 daily maintenance, temperatures, voltage and relative humidity records review ( 2025-2026) on August 6, 2026 at 10:22 A.M. and general supervisor interview , the laboratory failed to maintain accurate and timely documentation of the required environmental monitoring,equipment temperature monitoring and equipment maintenance activities. The findings include: 1. During the survey conducted on August 6, 2026 at 10:22 A.M. , it was observed that records of the following required monitoring and maintenance activities were documented until August 8, 2026, two days after the survey date: room temperature, voltage, relative humidity, bleeding area temperature, refrigerator temperature, freezer temperature, centrifuge maintenance and microscope maintenance. 2. The general supervisor confirmed on August 6, 2026 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 -- at 11:00 A.M. that the laboratory maintenance records contain documentation dated August 8, 2026 which was two days in advance of the survey date. (August 6, 2026 ) D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of hematology performance specifications records ( 2026) and laboratory general supervisor ( testing personnel ) interview on August 6, 2026 at 10: 10 A.M., the laboratory failed to complete the evaluation of the performance specifications of the new hematology system. The findings include: 1. The laboratory acquired on May 2026 a new system to perform hematology tests ( Cell Dyn Ruby ). 2. The performance specifications records showed that the laboratory did not verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. 3. The laboratory general supervisor ( testing personnel) confirmed on August 6, 2026 at 10:10 A.M., that the laboratory did not verify if the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population prior to begin to test patient's samples. 4. The laboratory processed and reported approximately 648 hematology tests performed by Cell Dyn Ruby system since May 2026. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 review of the Urinalysis ( Mission U500 ) , hematology ( Cell Dyn Ruby ) daily maintenance records( 2025-2026) and the manufacturer's instructions, the laboratory failed to perform and accurately document the daily maintenance as required by the manufacturer. Review of the maintenance records on August 6, 2026 at 10:12 A.M., showed that daily maintenance entries for future dates had already been completed, dated, and signed before the required maintenance activities could have been performed. The findings include: 1. The laboratory used the Mission U 500 system to perform urinalysis sample. a. The urinalysis system ( Mission U 500 ) maintenance log showed that the urinalysis system required daily maintenance. b. Review of the daily maintenance records on August 6, 2026 at 10:12 A.M., showed that maintenance entries for August 7, 2026, through August 8, 2026 had already been completed, dated, and signed. c.The laboratory failed to accurately document the daily maintenance activities as they were performed. d. The laboratory general supervisor confirmed on August 6, 2026 at 10:12 A.M., that the testing personnel failed to accurately document the daily maintenance activities as they were performed. 2. The -- 2 of 3 -- laboratory used the Cell Dyn Ruby system to perform hematology sample. a. The hematology system maintenance log showed that the system required daily , weekly and monthly maintenance. b. Review of the maintenance records on August 6, 2026 at 10:10 A.M, showed that maintenance entries for August 7, 2026, through August 8, 2026 had already been completed and dated. c.The laboratory failed to accurately document the daily, weekly and monthly maintenance activities as they were performed. d. The laboratory general supervisor confirmed on August 6, 2026 at 10: 10 A.M., that the testing personnel failed to accurately document the daily, weekly and monthly maintenance activities as they were performed. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and 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: 1. Based on daily maintenance, temperatures, voltage and relative humidity records review , Urinalysis ( Mission U500 ) , hematology ( Cell Dyn Ruby ) daily maintenance records ( 2025-2026), the laboratory director failed to ensure that the testing personnel maintain accurate and timely documentation of the required environmental monitoring,equipment temperature monitoring and equipment maintenance activities. Refer to D5413, D5429. 2. Based on hematology performance specifications records review ( 2026) and interview with the laboratory supervisor on August 6, 2026 at 11:00 A.M, the laboratory director failed to ensure that the evaluation of the performance specifications of the new hematology system begin to use on May 2026 was completed. Refer to D5421. D6177 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(3) (b)(3) Adhere to the laboratorys quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed; This STANDARD is not met as evidenced by: Based on daily maintenance, temperatures, voltage and relative humidity records review , Urinalysis ( Mission U500 ) , hematology ( Cell Dyn Ruby ) daily maintenance records ( 2025-2026), the laboratory testing personnel failed to ensure that the testing personnel maintain accurate and timely documentation of the required environmental monitoring,equipment temperature monitoring and equipment maintenance activities. Refer to D5413, D5429. -- 3 of 3 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency testing records review ( 2021-2022 ) and laboratory general supervisor interview on August 10,2022 at 10:00 A.M., it was determined that the laboratory director and testing personnel failed to sign the attestation statements. The findings include: 1. Puerto Rico Proficiency testing records were review from February 2021 to July 2022. ( ( review at 10:00 A.M. ) 2. The laboratory director and testing personnel did not sign the attestation statements of the Proficiency testing records since February 2021. ( review at 10:05 A.M.) 3. The laboratory general supervisor confirmed on August 10,2022 at 10:10 A.M that the laboratory director and testing personnel failed to sign the attestation statements since 2021. ( review at 10:15 A.M.) D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). 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 -- This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program ( PRPTP ) records review ( 2021- 2022) and laboratory general supervisor interview on August 10, 2022 at 9:30 A.M., it was determined that the laboratory failed to verify the accuracy of the hematology specialty when the PRPTP did not have hematology samples in the second testing event performed in June 2021. The findings include: 1. Proficiency testing records were reviewed from February 2021 to July 2022. ( review at 9:30a.m. ) 2. In the Hematology second testing event performed in June 2021 , the Puerto Rico Proficiency Testing office sent to the laboratory a letter that oriented them that in absence of an event the regulation establishes that the laboratory must be verify the accuracy of the tests ( platelet, white blood cells, red blood cells, hemoglobin, hematocrit ) . 3. The proficiency testing records showed that the laboratory did not verify the accuracy of the hematology specialty tets in June 2021. review at 9:35 a.m. ) 4. The general supervisor stated on August 10, 2022 at 9:40 A.M. that the laboratory did not have a mechanism to verify the accuracy of the hematology tests. 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