Centro De Diagnostico Y Tratamiento De Anasco

Summary Statement of Deficiencies 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 2023) and laboratory director interview on September 4, 2024, at 11:00 A.M., it was determined that the laboratory failed to maintain the Quality Assessment Program documentation; used to monitor and evaluate the laboratory activities (general system, pre-analytic, analytic and post-analytic systems) for at least 2 years. The findings include: 1. On September 4, 2024, at 11:00 A.M., the QA program evaluation was requested. The QA Program evaluation was not available. The last documentation dated from December 2022. 2. The laboratory director confirmed on September 4, 2024, at 11:45 A.M., that the laboratory did not have available the Quality Assessment documentation in the laboratory. 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 the lack of Quality Assessment (QA) records (year 2023) and laboratory general supervisor interview on September 4, 2024, at 11:00 A.M., it was determined 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 laboratory failed to evaluate and monitor the requirements for General laboratory systems. The findings include: 1. On September 4, 2024, at 11:00 A.M. the laboratory general system QA year 2023 was requested. The laboratory General systems QA record of the year 2023 was not available for evaluation. 2. In the year 2023, the laboratory failed to evaluate and monitor the requirements of laboratory General systems: patient confidentiality, specimen identification and integrity, complaint investigation, communication and personnel competency. (Reviewed on September 4,2024, at 11:05 A.M.) 3. The laboratory director confirmed on September 4, 2024, at 11:45 A.M., that the laboratory QA General systems records were not evaluated and monitored during the year 2023. 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 the lack of the Quality Assessment (QA) records (year 2023) and laboratory general supervisor interview on September 4, 2024, at 11:10 A.M., it was determined that the laboratory failed to evaluate and monitor the requirement for Pre-Analytic systems. The findings include: 1. On September 4, 2024, at 11:10 A.M., the laboratory Pre-Analytic systems QA record was requested. The Pre-Analytic systems QA record of the year 2023 was not available for evaluation. 2. In the year 2023, the laboratory failed to evaluate and monitor the requirements of Pre-Analytic systems: test request, specimen submission and handling, specimen referral. (Reviewed on September 4,2024, at 11:15 A.M.) 3. The laboratory director confirmed on September 4, 2024, at 11:45 A.M., that the QA Pre-Analytic System records were not evaluated and monitored during the year 2023. 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 lack of the Quality Assessment (QA) records (year 2023) and laboratory general supervisor interview on September 4, 2024, at 11:20 A.M., it was determined that the laboratory failed to evaluate Quality Assessment Program and monitor the requirement for Analytic systems. The findings include: 1. On September 4, 2024, at 11:20 A.M., the laboratory analytic QA record was requested. The Analytic system QA record of the year 2023 was not available for evaluation. 2. In the year 2023, the laboratory failed to evaluate the requirements of Analytic systems: test procedures, accurate and reliable test system, equipment, instruments, reagents, materials, specimen and reagent storage conditions, system maintenance and function checks, verification of method performance specifications, calibration, control procedures, comparison of test results, test records,

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on Complete blood count ( CBC ) test reports (years 2022) review and laboratory testing personnel interview on October 20, 2022 at 10:15 a.m. , it was determined that the laboratory failed to indicate the laboratory facility address in the 100 per cent of the CBC test results reported by the laboratory information system. The findings include: 1. The laboratory facility physical address is Carr. 402, Km 1.8, Bo. Maras, Aasco,P.R. 00610. 2. On October 20, 2022 at 10:20 a.m. , the 100 per cent of the laboratory tests results (CBC ) reported by the laboratory did not include the location of the facility address in those results reports. (review from November 2021 to October 2022. 3. The laboratory testing personnel confirmed on October 20, 2022 at 10:25 a.m. , that the laboratory information system had not been updated yet and the hematology system ( Mindray ) report did not include the location of the facility address. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification 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 -- requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on personnel records review ( 2021 -2022 ) and laboratory director interview by phone call on October 20, 2022 at 9:30 a.m. , it was determined that the laboratory did not have a technical consultant that meets the qualifications requirements. Refer to D6034. D6034 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical consultation for each of the specialties and subspecialties of service in which the laboratory performs moderate complexity tests or procedures. The director of a laboratory performing moderate complexity testing may function as the technical consultant provided he or she meets the qualifications specified in this section. This STANDARD is not met as evidenced by: Based on personnel records review ( 2021 -2022 ) and laboratory director interview by phone call on October 20, 2022 at 9:30 a.m. , it was determined that the laboratory technical consultant position is not filled since September 29, 2022. The finding includes: 1. The laboratory director confirmed on October 20, 2022 at 9:30 a.m. by phone call , that the previous laboratory technical consultant resigned on September 29, 2022 and that the laboratory position was not filled. -- 2 of 2 --