Laboratorio Clinico Miraflores

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review off site survey was performed on August 8, 2024 to Laboratorio Clnico Miraflores, the laboratory was found out of compliance with the following conditions: 42 CFR 493.803 Proficiency Testing, Successful Participation 42 CFR 493.1441 Laboratory Director, high complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing scores (year 2023-2024) and CASPER Report 0155D scores, it was determined that the laboratory obtained a unsuccessful participation in a Proficiency Testing Program for Uric Acid tests. Refer to D2096. 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing scores (years 2023-2024) and CASPER Report 0155D scores, it was determined that the laboratory a unsuccessful performance in two out three consecutive testing events for Uric Acid tests. The finding includes: 1. The Puerto Rico Proficiency and CASPER Report 0155D scores, showed that the laboratory obtained following unsuccessful scores: Analyte: Uric Acid a. Third testing event year 2023 -60% b. Second testing event year 2024 -60% 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 review of Puerto Rico proficiency testing scores (years 2023-2024) and CASPER Report 0155D scores, it was determined that the laboratory director failed to ensure the laboratory's successful participation in a Proficiency Testing Program for Uric Acid tests. Refer to D6079. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on Puerto Rico proficiency testing scores (years 2023-2024) and CASPER Report 0155D scores, it was determined that the laboratory director did not ensure that the laboratory had a satisfactory participation for Uric Acid tests during the third testiing event of year 2023 and first testing event of year 2024. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an announced CLIA recertification survey at Laboratorio Clnico Miraflores on August 16,2024. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The following standard level deficiencies were found during the announced routine CLIA recertification survey ending on August 16, 2024. 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 (PRPT) scores review ( year 2023-2024 ) and laboratory general supervisor interview on August 16, 2024 at 9:40 A.M., it was determined that the laboratory failed to take and document

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the Urinalysis microscopic quality control review it was determined that the laboratory did not include the negative microscopic control material when 4,300 patient were processed and reported from January 4, 2021 to December 30, 2021. The findings include: 1. The Urinalysis microscopic quality control was review on September 15, 2022 at 11:13 am. No negative quality control material was documented. 2. The laboratory director confirmed on September 15, 2022 at 11:20 am that no microcopy negative control was included from January 2022 to May 2022 whn 1,267 patient were processed and reported under the microcope. 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. 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 Urinalysis microscopic quality control records review from January 4, 2021 to Decmber 30, 2021 and laboratory director interview, it was determined that the laboratory director failed to comply with the analytic system requirements. Refer 5445. -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on calibration verification records (years 2017 and 2018) review for the routine chemistry tests, laboratory work load record (years 2017 and 2018) review and interview with the laboratory director on September 21, 2018 at 9:40 AM, it was determined that the laboratory failed to retain the instrument (Daytona system) printouts for the calibration verification procedures performed from August 2017 to August 2018. Also the laboratory did not retained the insert of the calibrator materials used in the calibration verification procedures from August 2017 to August 2018. The findings include: 1. On September 21, 2018 at 9:40 AM, the calibration verification records showed that the laboratory processed the calibration verification for the routine chemistry tests in August 2017, February 2018 and August 2018. 2. The laboratory did not retain the Daytona system printouts for those calibration verification procedures performed from August 2017 to August 2018. Also the laboratory did not retained the insert of the calibrator materials used in the calibration verification procedures from August 2017 to August 2018. The records were documented with the calibrator lot number, not include the expiration date, the name of the calibrator nor calibrator manufacture name. 3. The laboratory director confirmed on September 21, 2018 at 9:40 AM, that the calibration verification records did not include the required information. 4. The laboratory work load record showed that the laboratory processed and reported 2,023 out of 2,023 CMP patients specimens from August 2017 to August 2018. D5012 SYPHILIS SEROLOGY 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 -- 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 ASI manufacturer's instruction for rapid plasma reagin (RPR) qualitative test, RPR testing records (years 2017, 2018) review and laboratory director interview on September 21, 2018 at 11:30 AM, it was determined that the laboratory failed to meet the requirements for the subspecialty of Syphilis serology. Refer to D 5405 (The laboratory failed to follow manufacturer's instructions when 21 out of 21 patients specimens for RPR qualitative tests were processed and reported from March 29, 2017 to August 30, 2018). 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 ASI manufacturer's instruction for rapid plasma reagin (RPR) qualitative test, RPR testing records (years 2017, 2018) review and laboratory director interview on September 21, 2018 at 11:30 AM, it was determined that the laboratory failed to follow manufacturer's instructions when 21 out of 21 patients specimens for RPR qualitative tests were processed and reported from March 29, 2017 to August 30, 2018. The findings include: 1. The ASI manufacturer instructed the laboratory to include each day of testing the three levels of control materials (nonreactive, weakly reactive and reactive), to monitor the room temperature, to verify the needle calibration and the velocity of the rotator. 2. On September 21, 2018 at 11:30 AM, the RPR testing records showed that the laboratory did not include the three levels of control materials, did not monitor the room temperature, did not verify the needle calibration nor the velocity of the rotator when 21 out of 21 patients specimens for RPR qualitative tests were processed and reported from March 29, 2017 to August 30, 2018: Date processed number of patients and reported specimens tested March 27, 2017 7 specimens March 13, 2018 2 specimens May 17, 2018 3 specimens June 1, 2018 2 specimens June 21, 2018 3 specimens August 30, 2018 4 specimens 3. The laboratory director confirmed on September 21, 2018 at 11:40 AM, that the RPR testing records did not include the requirements information. She stated that the testing personnel performed the test as the manufacture requires but not recorded the information those days. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. -- 2 of 5 -- This STANDARD is not met as evidenced by: 1. Based on Daytona system manufacturer's instruction, Daytona system preventive maintenance records (years 2016, 2017 and 2018), laboratory work load records (year 2018) review and interview with the laboratory director on September 21, 2018 at 10: 00 AM, it was determined that the laboratory failed to follow manufacturer instructions for the preventive maintenance of the Daytona system when 455 out of 455 patients comprehensive metabolic panel (CMP) specimens were processed and reported from March 1, 2018 to July 31, 2018. The findings include: a. The laboratory processed and reported the CMP patients specimens by the Daytona system. b. The Daytona manufacturer requires a monthly preventive maintenance for this system. c. On September 21, 2018 at 10:00 AM, the Daytona system preventive maintenance records showed that the laboratory did not perform the monthly preventive maintenance in the following moths: March 2018, May 2018, June 2018 and July 2018. d. The laboratory director confirmed on September 21, 2018 at 10:10 AM, that the preventive maintenance record did not include the preventive maintenance those months. e. The laboratory work load records showed that it processed and reported 455 out of 455 CMP patients specimens from March 1, 2018 to July 31, 2018. 2. Based on Cell Dyn 1700 system Manufacturer's instructions, Cell Dyn 1700 system preventive maintenance records (Years 2016, 2017, 2018) review, laboratory work load records (year 2018) review and interview with the laboratory director on September 21, 2018 at 10:40 AM it was determined that the laboratory failed to follow manufacturer instructions for the preventive maintenance of the Cell Dyn 1700 system when 401 out of 401 patients complete blood count (CBC) specimens were processed and reported from March 1, 2018 to June 30, 2018. The findings include: a. The laboratory processed and reported the CBC patients specimens by the Cell Dyn 1700 system. b. The Cell Dyn 1700 manufacturer requires a monthly preventive maintenance for this system. c. On September 21, 2018 at 10:40 AM, the Cell Dyn 1700 system system preventive maintenance records showed that the laboratory did not perform the monthly preventive maintenance in the following moths: March 2018, May 2018 and June 2018. d. The laboratory director confirmed on September 21, 2018 at 10:50 AM, that the preventive maintenance record did not include the preventive maintenance those months. e. The laboratory work load records showed that it processed and reported 401 out of 401 CBC patients specimens from March 1, 2018 to June 30, 2018. 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 ASI manufacturer's instruction for rapid plasma reagin (RPR) qualitative test, RPR testing records (years 2017, 2018), Daytona system manufacturer's instruction, Cell Dyn 1700 system Manufacturer's instructions, Daytona system preventive maintenance records (years 2016, 2017 and 2018), Cell Dyn 1700 system preventive maintenance records (Years 2016, 2017, 2018) review and interview with the laboratory director on September 21, 2018 at 11:30 AM, it was determined that the laboratory director failed to fulfill her responsibilities and duties to comply with the -- 3 of 5 -- analytic system and records retention. Refer to D 6079 (The laboratory director failed to ensure that the laboratory retain for at least 2 years calibration verification records). Refer to D 6093 (The laboratory director failed to comply with the analytic system). D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on calibration verification records (years 2017 and 2018) review for the routine chemistry tests, laboratory work load record (years 2017 and 2018) review and interview with the laboratory director on September 21, 2018 at 9:40 AM, it was determined that the laboratory director failed to ensure that the laboratory retain for at least 2 years calibration verification records. Refer to D 3031. 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 ASI manufacturer's instruction for rapid plasma reagin (RPR) qualitative test, RPR testing records (years 2017, 2018), Daytona system manufacturer's instruction, Cell Dyn 1700 system Manufacturer's instructions, Daytona system preventive maintenance records (years 2016, 2017 and 2018), Cell Dyn 1700 system preventive maintenance records (Years 2016, 2017, 2018) review and interview with the laboratory director on September 21, 2018 at 11:30 AM, it was determined that the laboratory director failed to comply with the analytic system. Refer to D 5012 (The laboratory failed to meet the requirements for the subspecialty of Syphilis serology). Refer to D 5429 (1) (2) ( The laboratory failed to follow manufacturer's instructions for preventive maintenance). 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. -- 4 of 5 -- This STANDARD is not met as evidenced by: Based on ASI manufacturer's instruction for rapid plasma reagin (RPR) qualitative test, RPR testing records (years 2017, 2018), Daytona system manufacturer's instruction, Cell Dyn 1700 system Manufacturer's instructions, Daytona system preventive maintenance records (years 2016, 2017 and 2018), Cell Dyn 1700 system preventive maintenance records (Years 2016, 2017, 2018) review and interview with the laboratory director on September 21, 2018 at 11:30 AM, it was determined that the general supervisor failed to comply with the analytic system. Refer to D 5405 (The laboratory failed to follow manufacturer's instructions when 21 out of 21 patients specimens for RPR qualitative tests were processed and reported from March 29, 2017 to August 30, 2018. meet the requirements for the subspecialty of Syphilis serology). Refer to D 5429 (1) (2) ( The laboratory failed to follow manufacturer's instructions for preventive maintenance). -- 5 of 5 --