Laboratorio Neoclinico

Summary Statement of Deficiencies 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 review of Puerto Rico Proficiency Testing records ( 2023-2024) and laboratory testing personnel interview on September 6, 2024 at 9:30 A.M., it was determined that the laboratory failed to retain proficiency testing records for at least 2 years. The findings include: 1. Puerto Rico Proficiency Testing records were reviewed from February 2023 to August 2024. ( review on September 6, 2024 at 9:30 a.m.) 2. The laboratory did not have available documentation ( results print outs reported ) from the following testing events: second testing event 2023 and second testing event 2024 - special test performed by Access . third testing event 2023- hematology test ( complete blood cell ) 3. The laboratory testing personnel confirmed on september 6, 2024 at 9:45 A.M. , that the laboratory did not have available the Proficiency Testing print out results from those testing events perfomed in 2023 and 2024. 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 endocrinology quality control records review (2023-2024) and interview with the laboratory testing personnel on September 6, 2024 at 12:00 P.M., it was 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 -- determined that the laboratory failed to ensure compliance with the analytic system requirements for Endocrinology test. Refer D5405. 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: Based on manufacturer's instruction and endocrinology quality control records review year 2023-2024 and laboratory testing personnel interview on September 6, 2024 at 10:20 a.m., it was determined that the laboratory failed to follow manufacturer's instructions when patient specimens were tested for endocrinology chemistry tests by the Access 2 system. The findings include: 1. The laboratory uses Access 2 system to perform the following endocrinology patient tests: Thyroid stimulating hormone ( TSH ), T-uptake, free T4, free T3, Total T4, B12 vitamin, Follicule stimulating hormone (FSH), luteinizing hormone (LH), testosterone, prostate specific antigen ( PSA), carcinoembrionic antigen ( CEA), Vitamin D. 2. The manufacturer establishes that two levels of control material ( normal and high) must be included each day of testing. 3. Review of endocrinology quality control records from January 2023 to August 2024, showed that the laboratory did not include the two levels of controls since February 1, 2024 for the following tests: Thyroid stimulating hormone (TSH ), T-uptake, free T4, T4, B12 vitamin, Follicule stimulating hormone (FSH), luteinizing hormone (LH), testosterone, prostate specific antigen ( PSA),Vitamin D. 4. The laboratory processed and reported 2.970 endocrinology analytes during those days. 5. Review of endocrinology quality control records from January 2023 to August 2024, showed that the laboratory did not include the two levels of controls for the following test: carcinoembrionic antigen ( CEA) since June 2024 and free T4 since July 1, 2024. 6. The laboratory processed and reported 74 CEA samples test and 37 free T4 samples tests since June 2024 and July 1, 2024,, respectively. 7. The laboratory testing personnel confirmed on September 6, 2024 at 10:40 A.M.that the laboratory failed to follow manufacturer's instructions ( regarding testing of control materials ) when patient specimens were tested for endocrinology tests by the Access system. 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 endocrinology quality control records review ( year 2023-2024 ) and laboratory testing personnel interview on September 6, 2024 at 12:15 P.M., it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory quality control requirements. Refer to D 6093. D6093 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 4 -- CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control 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 endocrinology quality control records review (2023-2024), it was determined that the laboratory director did not ensure that quality control procedures related to endocrinology quality control procedures were performed as established by the manufacturer's instructions. Refer to D5405. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on personnel records review and testing personnel interview on September 6, 2024 at 9:15A.M., it was determined that the laboratory director failed to ensure that the new testing personnel, prior to testing patients' specimens have the appropriate training. The finding includes: 1. The laboratory hired a new testing personnel ( laboratory owner ) in January 2024. This testing personnel processed and reported patients specimens in the following areas: hematology, urinalysis, endocrinology, chemistry special tests, syphilis and general serology. However, the personnel records did not include the documented training. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of personnel records files and interview with the laboratory testing personnel on September 6, 2024 at 9:00 AM, it was determined that the laboratory director did not include the written duties of the laboratory director, technical supervisor, technical consultant and general supervisor. The finding includes: 1. The laboratory personnel files were reviewed on September 6, 2024 at 9:00 AM 2. During interview with the testing personnel stated that the personnel designated as technical supervisor, technical consultant and general supervisor was the laboratory director. 3. -- 3 of 4 -- Review of the laboratory director file record at 9:10 A.M., showed that no written duties were included. D6177 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(3) Each individual performing high complexity testing must adhere to the laboratory's 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 manufacturer's instructions and endocrinology quality control records review (years 2023-2024) and laboratory testing personnel interview on September 6, 2024 at 12:15 P.M., it was determined that the testing personnel failed to follow manufacturer's instructions when patient specimens were tested for endocrinology chemistry tests by the Access 2 system. Refer to D5405. -- 4 of 4 --

Summary Statement of Deficiencies D2072 SYPHILIS SEROLOGY CFR(s): 493.835(d) (1) For any unsatisfactory 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 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 2019 to December 2020 and laboratory general supervisor interview on February 19, 2021 at 9:35 AM, it was determined that the laboratory failed to take and document

Summary Statement of Deficiencies D5012 SYPHILIS SEROLOGY CFR(s): 493.1207 If the laboratory provides services in the subspecialty of Syphilis serology, 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 syphilis serology quality control records review and laboratory director and testing personnel interview on August 15, 2018 at 9:48 AM, it was determined that the laboratory failed to included meet the requirements for syphilis serology by Rapid Plasma Reagin (RPR) quantitative tests. Refer to D5451. D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, 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 general immunology quality control records review and laboratory director and testing personnel interview on August 15, 2018 at 10:12 AM, it was determined that the laboratory failed to included meet the requirements for general immunology by CRP (C-reactive protein) tests. Refer to D5449 (1). D5020 ENDOCRINOLOGY CFR(s): 493.1212 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 -- 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 endocrinology quality control records review and laboratory director and testing personnel interview on August 15, 2018 at 10:24 AM, it was determined that the laboratory failed to included meet the requirements for endocrinology by Alere hCG tests. Refer to D5449 (2). D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on observations, Urinalysis procedures manual review and laboratory director and testing personnel interview on August 15, 2018 at 12: 20 PM, it was determined that the laboratory failed to follow written policies for urinalysis specimen processing. The findings include: 1. The Urinalysis procedures manual establishes that the urinalysis samples must perform within 1 hour after the sample was taken. 2. On August 15, 2018 at 12:20 PM, the laboratory had over the counter the following urinalysis samples without processing: Sample Id sample hour taken 43026 9:15 AM 43035 9:59 AM 43042 10:17 AM 43048 10:29 AM 43054 10:39 AM 43062 10:58 AM 43070 11:09 AM 3. The laboratory director and testing personnel confirmed that the laboratory did not follow urinalysis specimen written procedures. 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 observations, urinalysis procedures manual, Quality Assessment (QA) records review, laboratory director and testing personnel interview on August 15, 2018 at 12:43 PM, it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the requirement for pre-analytic systems. The findings include: 1. The laboratory did not follow the written policies for urinalysis specimen processing, urinalysis samples must perform within 1 hour after the sample was taken, on August 15, 2018. Refer to D5311. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT -- 2 of 6 -- 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 electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on bacteriology quality control records review from January 2, 2018 to August 15, 2018, bacteriology procedures manual, laboratory director and testing personnel interview on August 15, 2018 at 9:23 AM, it was determined that the laboratory failed to monitor and document the bacteriology room temperature, relative humidity and incubator temperature. The finding includes: 1. The laboratory procedures manual establishes to monitor and document daily the bacteriology room temperature, relative humidity and incubator temperature. 2. Review of the bacteriology quality control, showed that the laboratory did not monitor and document the bacteriology room temperature, relative humidity and incubator temperature from January 2, 2018 to August 15, 2018. 3. The laboratory director and testing personnel confirmed on August 15, 2018, that the laboratory failed to monitor and document the bacteriology room temperature, relative humidity and incubator temperatures. 4. The laboratory performed 81 patients samples for urine cultures from January 2, 2018 to August 15, 2018. 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: 1. Based on general immunology quality control records review from January 10, 2017 to August 15, 2018, laboratory director and testing personnel interview on August 15, 2018 at 10:12 AM, it was determined that the laboratory failed to include a negative and positive control material when performed CRP (C-reactive protein) tests. The findings include: a. The laboratory performed CRP (C-reactive protein) tests by TECO. b. General immunology quality control records review from January 10, 2017 to August 15, 2018. c. Review of general immunology quality control records, showed that the laboratory did not include a negative and positive control material on January 17, 2018 (ID # 22300), February 1, 2018 (ID # 23651), February 8, 2018 (ID # 24836, # 24856, # 24926), February 14, 2018 (ID # 25734), February 15, 2018 (ID # 25802), February 26, 2018 (ID # 26861), February 28, 2018 (ID # 27002) and March 2, 2018 (ID # 27401). d. The testing personnel confirmed on August 15, 2018, that the laboratory did not include nor document control material during those days. 2. Based on endocrinology quality control records review from January 10, 2017 to August 15, 2018, laboratory director and testing personnel interview on August 15, 2018 at 10:24 -- 3 of 6 -- AM, it was determined that the laboratory failed to include a negative and positive control material when performed hCG (human Chorionic Gonadotropin) tests. The findings include: a. The laboratory performed hCG (human Chorionic Gonadotropin) tests by Alere hCG reagents. b. Endocrinology quality control records review from January 10, 2017 to August 15, 2018. c. Review of endocrinology quality control records, showed that the laboratory did not include a negative and positive control material on March 22 2017 (ID # 03058 and # 03061), December 9, 2017 (ID # 20214) and December 12, 2017 (ID # 20450). d. The testing personnel confirmed on August 15, 2018, that the laboratory include but not document control material during those days. D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(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-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on syphilis serology quality control records review from January 13, 2018 to August 15, 2018, laboratory director and testing personnel interview on August 15, 2018 at 9:48 AM, it was determined that the laboratory failed to include at least once a day, a negative control material and a control material with tittered reactivity when patients specimens were tested for syphilis serology by Rapid Plasma Reagin (RPR) quantitative tests. The finding includes: 1. The laboratory performed Rapid Plasma Reagin (RPR) by TECO RPR Reagents Set. 2. Review of syphilis serology quality control from January 13, 2018 to August 15, 2018, showed that the laboratory did not include at least once a day, a negative control material and a control material with tittered reactivity when the following patients specimen was processed and report: Identification number Date Results 25817 02/15/2018 R 1:4 dills. 28503 03/19/2018 R 1:8 dills. 28492 03/19/2018 R 1:8 dills. 35463 05/30/2018 R 1:4 dills. 38893 06/28 /2018 R 1:8 dills. 39202 07/05/2018 R 1:4 dills. 3. The testing personnel confirmed on August 15, 2018, that the laboratory did not include at least once day, a negative control material and a control material with tittered reactivity when patients specimens were tested for syphilis serology quantitative those days. 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 observations, procedures manual, quality control records review from January 2, 2017 to august 15, 2018, laboratory director and testing personnel interview on August 15, 2018 at 12:40 PM, it was determined that the laboratory -- 4 of 6 -- failed to follow the established Quality Assessment Program to monitor and evaluate the following requirements for analytic systems: 1. Failed to monitor and document the bacteriology room temperature, relative humidity and incubator temperature. Refer to D5413. 2. Failed to include a negative and positive control material when performed CRP (C-reactive protein) tests. Refer to D5449 (1). 3. Failed to include a negative and positive control material when performed hCG (human Chorionic Gonadotropin) tests. Refer to D5449 (2). 4. Failed to follow the manufacturer's instructions when patient specimen were tested for quantitative RPR (Rapid Plasma Reagin) by TECO. Refer to D5451. 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 observations, procedures manual , quality control records review and laboratory director and testing personnel interview on August 15, 2018 at 12:48 PM, it was determined that the laboratory director failed to fulfill her responsibilities and duties to ensure compliance with the laboratory analytical system and quality assessment requirements. The finding includes: 1. The laboratory director did not comply with the requirement for analytical systems and quality assessment requirements. Refer to D6020 and D6021. 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 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 observations, quality control records review and laboratory director and testing personnel interview on August 15, 2018 at 12:45 PM, it was determined that laboratory director failed to ensure compliance with the requirements for analytic systems. The finding includes: 1. The laboratory director did not assure that the laboratory: a. Failed to monitor and document the bacteriology room temperature, relative humidity and incubator temperature. Refer to D5413. b. Failed to include a negative and positive control material when performed CRP (C-reactive protein) tests. Refer to D5449 (1). c. Failed to include a negative and positive control material when performed hCG (human Chorionic Gonadotropin) tests. Refer to D5449 (2). d. Failed to follow the manufacturer's instructions when patient specimen were tested for quantitative RPR (Rapid Plasma Reagin) by TECO. Refer to D5451. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) -- 5 of 6 -- 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 Quality Assessment (QA) records review and laboratory director and testing personnel interview on August 15, 2018 at 12:48 PM, it was determined that laboratory failed to ensure compliance with quality assessment (QA) requirements. The finding includes: 1. The laboratory did not evaluate the established Quality Assessment Program to monitor and evaluate the following requirement for pre- analytic systems: a. failed to follow the written policies for urinalysis specimen processing, urinalysis samples must perform within 1 hour after the sample was taken, on August 15, 2018. Refer to D5311. 2. The laboratory did not evaluate the established Quality Assessment Program to monitor and evaluate the following requirement for analytic systems: a. failed to monitor and document the bacteriology room temperature, relative humidity and incubator temperature. Refer to D5413. b. failed to include a negative and positive control material when performed CRP (C- reactive protein) tests. Refer to D5449 (1). c. failed to include a negative and positive control material when performed hCG (human Chorionic Gonadotropin) tests. Refer to D5449 (2). d. failed to follow the manufacturer's instructions when patient specimen were tested for quantitative RPR (Rapid Plasma Reagin) by TECO. Refer to D5451. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's 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 observations, quality control records review and laboratory director and testing personnel interview on August 15, 2018 at 12:48 PM, it was determined that testing personnel failed to follow quality control procedures. The finding includes: 1. The laboratory testing personnel failed the following quality control procedures: a. to monitor and document the bacteriology room temperature, relative humidity and incubator temperature. Refer to D5413. b. to include a negative and positive control material when performed CRP (C-reactive protein) tests. Refer to D5449 (1). c. to include a negative and positive control material when performed hCG (human Chorionic Gonadotropin) tests. Refer to D5449 (2). d. to follow the manufacturer's instructions when patient specimen were tested for quantitative RPR (Rapid Plasma Reagin) by TECO. Refer to D5451. -- 6 of 6 --