Laboratorio Clinico Santa Olaya

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 (year 2023-2024), syphilis Rapid Plasma Reagin (RPR) written procedure, ASI RPR manufacturer's instructions review and laboratory director interview on April 3,2024 at 3:30 P.M., it was determined that the laboratory failed to ensure compliance with the analytic system requirements for syphilis serology tests. The finding includes: 1. The laboratory did not wash the dispensing needle after each day of use. (Refer to D5411) 2. The laboratory used an expired RPR antigen reagent. (Refer to D5417) D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on syphilis serology quality control, syphilis serology patient test worksheet records (years 2023-2024), ASI Rapid Plasma Reagin (RPR) manufacturer's instructions review and laboratory director interview, on April 3, 2024, at 12:40 P.M., 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 -- it was determined that the laboratory failed to follow the manufacturer's instructions regarding to the needle wash after each shift for the syphilis serology tests, when 205 out of 205 patient specimens were tested from January 4, 2023, to March 25, 2024. The findings include: 1. The laboratory uses the ASI RPR card test to perform patient syphilis serology tests. Review of the ASI RPR manufacturer's instructions on April 3 , 2024 at 12:40 P.M., established that the needle assembly must be thoroughly washed in distilled or deionized water and air dried after each shift. 2. On April 3, 2024, at 12: 45 P.M., the syphilis serology quality control and patient test worksheet records were reviewed. The records showed that the laboratory did not perform nor document the needle wash as required by the manufacturer, when they processed and reported 205 out of 205 RPR patient specimens from January 4, 2023, to March 25, 2024. 3. The laboratory director confirmed during interview on April 3,2024 at 12:50 P.M., that the laboratory did not follow the manufacturer's instructions related to the needle wash. 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 electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on Mycoplasma pneumoniae testing record review (years 2023-2024), ImmunoCard Mycoplasma manufacturer's instructions, ImmunoCard Mycoplasma written procedure review and laboratory director interview on April 3, 2024, at 12:00 P.M., it was determined that the laboratory failed to follow the manufacturer's instruction regarding to the established temperature range for Mycoplasma pneumoniae when 223 out of 223 patient's specimens were processed and reported for Mycoplasma pneumoniae from January 3, 2023, to March 26,2024. The findings include: 1. The laboratory uses the ImmunoCard Mycoplasma Test Kit to perform the Mycoplasma pneumoniae qualitative tests. (Reviewed on April 3,2024 at 12:00 P.M.) 2. On April 3,2024 at 12:02 P.M., the ImmunoCard Mycoplasma manufacturer's instructions and written procedure were reviewed. The manufacturer's instructions and the written procedure established to perform the Mycoplasma pneumoniae test procedures between 22C to 25 range temperature. 3. On April 3,2024 at 12:10 P.M., the Mycoplasma pneumoniae testing records review showing that the laboratory did not monitor nor document the room temperature when it processed and reported 223 out of 223 patient's specimens for Mycoplasma pneumoniae test from January 3,2023 to March 26,2024. 4. The laboratory director confirmed during interview on April 3,2024, at 12:27 P.M., that the laboratory did not monitor nor document the room temperature when it processed the patient's specimens for Mycoplasma pneumoniae test. 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 -- 2 of 4 -- deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: A. Based on direct observation in the phlebotomy area of the laboratory, chemistry patient census review (years 2023-2024), and interview with the general supervisor on April 3, 2024, at 8:45 A.M., it was determined that the laboratory used sample collection tubes with exceeded expiration dates. From December 1, 2023, to April 2, 2024, the laboratory collected, processed, and reported 1,411 out of 1,756 routine chemistry patient specimens with expired collection tubes. The findings include: 1. On April 3, 2024, at 8:45 A.M., the laboratory phlebotomy area was observed. The Improvacuter Gel & Clot Activator dark yellow top tubes, lot number A12012, with expiration date 2023-11 were found. The general supervisor established during interview that used the Improvacuter Gel & Clot Activator dark yellow for routine chemistry patient's specimens. 2 The chemistry patient census review on April 3, 2024, at 8:55A.M., showed that laboratory collected, processed, and reported 1,411 out of 1,756 patient's tests with sample collection tubes with exceeded expiration date from December 1,2023 to April 2,2024. 3.The general supervisor confirmed during interview, on April 3,2024, at 9:05 A.M., that the laboratory used sample collection tubes (Gel & Clot Activator for routine chemistry test sample) that exceeded their expiration date from December 1,2023 to April 2,2024. B. Based on direct observation of the hematology quality control material, Mindray hematology control inserts, hematology patient census review and laboratory director interview on April 3, 2024, at 11:15A.M., it was determined that the laboratory used the Complete Blood Count (CBC) controls materials with exceeded stability date. The laboratory processed and reported 51 out of 51 CBC patient's specimens from March 26,2024 to April 2,2024. The findings include: 1. The laboratory used the Mindray BC-5390 Auto Hematology Analyzer for patient's specimens. (Reviewed on April 3,2024 at 11: 15 A.M.) 2. On April 3,2024 at 11:25 A.M., the Mindray BC-5D Hematology control insert was revised. The insert stated that: "opened tubes/vials were stable for 14 days" since opened. 3. On April 3,2024 at 11:36 A.M., it was observed that the laboratory opened three hematology control material vials (Mindray BC-5D hematology control lot: BC-2403 BN, BC-2403 BH and BC-2403 BL) on March 11,2024. 4. The hematology patient census showed that the laboratory processed and reported 51 out of 51 CBC patient's specimens from March 26,2024 to April 2,2024, with exceeded stability date. (Reviewed on April 3,2024 at 11:40 A.M.) 5. On April 3,2024 at 11:45 A.M., the laboratory director confirmed during interview, that the laboratory used those controls material with exceeded stability date from March 26,2024 to April 2,2024. C. Based on syphilis serology quality control records (years 2023-2024), ASI Rapid Plasma Reagin (RPR) manufacturer's instructions review and laboratory director interview, on April 3, 2024, at 12:55 P.M., it was determined that the laboratory failed to follow the manufacturer's instructions for the syphilis serology tests, regarding antigen reagent, when 33 out of 33 RPR's patient specimens were tested between January 13, 2024, and April 2, 2024. The findings include: 1. The laboratory uses the ASI RPR Test Kit to perform patient syphilis serology tests. (Reviewed on April 3,2024 at 12:55 P.M.) 2. Review of the ASI RPR manufacturer's instructions on April 3 ,2024 at 1:100 P.M., establish that the carbon antigen may be stored for up to one month in the dropping bottle at 2C to 8C range temperature. 3. On April 3, 2024, at 1:15 P.M., the syphilis serology quality control records were reviewed and showed that the antigen lot number CA3E262, with expiration date in May 2025, was opened and dispensed in the dropping bottle on December 13, 2023. 4. The laboratory continue to use the antigen lot number CA3E262, after the new expiration date of January 12,2024. (Reviewed on April 3,2024 at 1:20 P.M.) 5. From -- 3 of 4 -- January 13, 2024, to April 2, 2024, the laboratory used an expired reagent to process and report 33 out of 33 RPR's patient specimens. (Reviewed on April 3,2024 at 1:27 P. M) 6. The laboratory director confirmed during the interview on April 3, 2024, at 1:39 p.m., that the laboratory continued to use the antigen lot #CA3E262 after the expiration date. 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 quality control records review, and laboratory director interview on April 3, 2024, at 3:15 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 D6093. D6093 LABORATORY DIRECTOR RESPONSIBILITIES 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 general immunology (Mycoplasma pneumoniae), syphilis serology (RPR), hematology quality control records review, and laboratory director interview on April 3, 2024, at 3:30 P.M., it was determined that the laboratory did not assure that the quality control procedures were followed for the mentioned analytes. Refer to: D5411, D5413 and D5417. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on quality control records review, and laboratory director interview on April 3,2024 at 3:45 P.M, it was determined that the general supervisor did not follow the manufacturer's instructions for general immunology (Mycoplasma pneumoniae), syphilis serology (RPR) and hematology control materials. Refer to D D5411, D5413 and D5417. . -- 4 of 4 --

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 (from January 1, 2019 to October 28, 2020) and laboratory director and general supervisor interview on October 28, 2020 at 9:45 AM, it was determined that the laboratory failed to be in compliance with the Puerto Rico State laboratory regulation. The findings include: 1. The laboratory Biomedical Generator Number (DBR OC-11-11-02-0288 RN 20) was due since July 17, 2020. 2. The laboratory director and general supervisor confirmed on October 28 2020, that the Biomedical Generator Number was due since July 17, 2020. 3. The state law establishes that the Biomedical Generator Number must be renew 60 days before the expired date. D6084 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions provide a safe environment in which employees are protected from physical, chemical, and biological hazards. This STANDARD is not met as evidenced by: Based on facility records review (from January 1, 2019 to October 28, 2020) and laboratory director and general supervisor interview at 9:45 AM on October 28, 2020, it was determined that the laboratory director failed to be in compliance with the 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 -- Puerto Rico State laboratory regulation. The finding includes: 1. The laboratory Biomedical Generator Number (DBR OC-11-11-02-0288 RN 20) was due since July 17, 2020. Refer to D3009. -- 2 of 2 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on Alere Afinion AS100 manufacturer's instructions, lack of preventive maintenance records and interview with the technical consultant on June 1, 2018 at 10: 00 AM, it was determined that the laboratory failed to follow manufacturer's instruction for preventive maintenance when 350 out of 350 patients specimens were tested and reported for glycohemoglobin by the Alere Afinion AS100 system from January 4, 2018 to June 1, 2018. The findings include: 1. The laboratory processed the glycohemoglobin tests by the Alere Afinion AS100 system. 2. The Alere Afinion AS100 manufacturer instructed the laboratory to perform every 30 days the cleaning of cartridge chamber. 3. The laboratory did not perform the cleaning of cartridge chamber of the Alere Afinion AS100 system from January 4, 2018 to June 1, 2018. 4. The technical consultant confirmed on June 1, 2018 at 10:00 AM, that the laboratory did not perform the cleaning of cartridge chamber of the Alere Afinion AS100 system from January 4, 2018 to June 1, 2018. 5. From January 4, 2018 to June 1, 2018, the laboratory tested and reported 350 out of 350 patients specimens for glycohemoglobin by the Alere Afinion AS100 system. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on HcG testing records (years 2016 to 2018) review and technical supervisor interview on June 1, 20168 at 11:00 AM, it was determined that the laboratory failed to meet the analytic requirement for Endocrinology (HcG qualitative tests). The finding includes: 1. The laboratory did not include each day of testing a negative and a positive control material when 7 out of 7 patients specimens were tested and reported for HcG qualitative test from June 15, 2017 to April, 20, 2018. Refer to D 5449. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (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 ECI system validation records (years 2016 to 2018) review and interview with the technical supervisor on June 1, 2018 at 10:15 AM, it was determined that the laboratory failed to perform to verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population when it validated the following tests: prostatic specific antigen (PSA), Vitamin D, thyroid stimulating hormone (TSH), thyroxin (T4), triodothyronine (T3) and free thyroxin (FT4) on May 31, 2016. The findings include: 1. The laboratory validated the following tests PSA, Vitamin D, TSH, T4, T3 and FT4 on May 31, 2016 by the ECI system. 2. On June 1, 2018 at 10:15 AM, the ECI system validation records showed that the that the laboratory did not verify that the manufacturer's reference intervals (normal values) of those new tests, are appropriate for the laboratory's patient population. 3. The technical supervisor confirmed on June 1, 2018 at 10:15 AM, that the laboratory did not verify that the manufacturer's reference intervals (normal values) of those tests, are appropriate for the laboratory's patient population. 4. From June 1, 2016 to June 1, 2018, the laboratory processed and reported by the ECI system the following patients specimens: Test Patients specimens a. PSA 590 b.TSH 2657 c. T4 676 d. T3 572 e. FT4 386 d. vitamin D 952 D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) 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 -- 2 of 5 -- 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 ECI system calibration verification records (years 2016 to 2018) review and interview with the technical consultant on June 1, 2018 at 10:45 AM, it was determined that the laboratory failed to perform at least once every 6 months the calibration verification of the vitamin D tests processed by the ECI system from June 1, 2016 to June 1, 2018. The findings include: 1. On June 1, 2018 at 10:45 AM, the ECI system calibration verification records showed that laboratory did not perform at least once every 6 months the calibration verification of the vitamin D tests ECI system from June 1, 2016 to June 1, 2018. The laboratory performed the calibration verification of the vitamin D tests on December 8, 2016, May 17, 2017 and January 23, 2018. 2. The technical supervisor confirmed on June 1, 2018 at 10:45 AM, that laboratory did not perform at least once every 6 months the calibration verification of the vitamin D tests by the ECI system. 3. The laboratory processed and reported 952 out of 952 patients specimens for vitamin D by the ECI system from June 1, 2016 to June 1, 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: Based on HcG testing records (years 2016 to 2018) review and technical supervisor interview on June 1, 20168 at 11:00 AM, , it was determined that the laboratory failed to include each day of testing a negative and a positive control material when 7 out of 7 patients specimens were tested and reported for HcG qualitative test from June 15, 2017 to April, 20, 2018. The findings include: 1. On June 1, 20168 at 11:00 AM, the HcG testing records showed that the laboratory did not include each day of testing a negative and a positive control material when 7 out of 7 patients specimens were tested and reported for HcG qualitative test from June 15, 2017 to April, 20, 2018: patients specimen # 75015 on June 15, 2017, patient specimen # 75231 on June 21, 2017, patient specimen # 28857 on February 6, 2018, patient specimen # 33357 on February 9, 2018, patient specimen # 52857 on February 20, 2018, patient specimen # 85657 on March 19, 2018 and patient specimen # 119657 on April 20, 2018. 2. The -- 3 of 5 -- technical supervisor confirmed on June 1, 20168 at 11:00 AM, that the HcG testing records did not include the documentatio of the quality control procedures those days. She also stated that the control procedures were performed but not recorded. 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 ECI system validation records (years 2016 to 2018), ECI system calibration verification records (years 2016 to 2018), HcG testing records (years 2016 to 2018) review and interview with the technical consultant on June 1, 2018 at 11:00 AM, it was determined that the laboratory director failed to fulfill her responsibilities and duties to ensure compliance with the laboratory analytical system for routine chemistry and endocrinology specialties. The finding includes: 1. The laboratory director did not comply with the laboratory analytical system for routine chemistry and endocrinology specialties. Refer to D 6020. 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 ECI system validation records (years 2016 to 2018), ECI system calibration verification records (years 2016 to 2018), HcG testing records (years 2016 to 2018) review and interview with the technical consultant on June 1, 2018 at 11:00 AM, it was determined that the laboratory director failed to comply with the analytic system requirement for routine chemistry and endocrinology specialties. The finding includes: 1. The laboratory director failed to ensure compliance with the analytic system requirement for routine chemistry and endocrinology specialties. Refer to D 5020 Refer to D 5421. Refer to D 5439. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; -- 4 of 5 -- This STANDARD is not met as evidenced by: Based on ECI system validation records (years 2016 to 2018), ECI system calibration verification records (years 2016 to 2018), HcG testing records (years 2016 to 2018) review and interview with the technical consultant on June 1, 2018 at 11:00 AM, it was determined that the technical consultant failed to comply with the analytic system requirement for routine chemistry and endocrinology specialties. Refer to D 5421. Refer to D 5439. Refer to D 5449. -- 5 of 5 --