Laboratorio Clinico Melania

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at LABORATORIO CLINICO MELANIA on July 17, 2024. 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 July 17, 2024. 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: A. Based on manufacturer's instructions, syphilis serology quality control records review ( year 2023-2024) and laboratory general supervisor interview at 11:39 A.M. on July 17, 2024, it was determined that the laboratory failed to perform syphilis serology test as required by manufacturer's instructions by ASI RPR (Rapid plasma reagin) method, when 71 out of 82 patient's specimens were processed and reported for RPR (Rapid plasma reagin) test from January 5, 2024, to July 15,2024. The findings include: 1. The laboratory uses the ASI RPR to perform the RPR syphilis qualitative tests. (Reviewed on April 24,2024 at 11:39 A.M.) 2. On July 17 ,2024 at 11:45 A.M., the ASI RPR manufacturer's instructions were reviewed. The manufacturers establishes that the RPR test must be performed at room temperature between 20 C to 30 C. 3. On July 17,2024 at 11:50 A.M., the syphilis serology quality control records review showed that the laboratory processed and reported 71 out of 82 patient's specimens for RPR test from January 5,2024 to July 15,2024, with a temperature range within 19.1C to 19.9C 4. The laboratory general supervisor 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 -- confirmed during interview on July 19,2024, at 12:00 P.M., that the laboratory processed patient's samples outside the established temperature range by manufacturer. B. Based on ImmunoCard Mycoplasma manufacturer's instructions, Mycoplasma pneumoniae testing record review (years 2023-2024), and laboratory general supervisor interview on July 17, 2024, at 12:30 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 93 out of 93 patient's specimens were processed and reported for Mycoplasma pneumoniae from November 28, 2023, to July 15,2024. The findings include: 1. The laboratory uses the ImmunoCard Mycoplasma Test Kit to perform the Mycoplasma pneumoniae qualitative tests. (Reviewed on July 17,2024 at 12:30 P.M.) 2. On July 17,2024 at 12: 35 P.M., the ImmunoCard Mycoplasma manufacturer's instructions were reviewed. The manufacturer's instructions established to perform the Mycoplasma pneumoniae test procedures between 22C to 25 range temperature. 3. On July 17,2024 at 12:45 P. M., the Mycoplasma pneumoniae testing records review showed that the laboratory processed and reported 93 out of 93 patient's specimens for Mycoplasma pneumoniae test from November 28, 2023, to July 15,2024, with a temperature range within 19.1C to 21.3C 4. The laboratory general supervisor confirmed during interview on July 17,2024, at 1:00 P.M., that the laboratory processed patient's samples outside the established temperature range by manufacturer. 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 RPR and Mycoplasma pneumoniae manufacturer's instructions, syphilis serology and Mycoplasma pneumoniae testing records and laboratory general supervisor interview on July 14,2024, at 1:45 P.M .,it was determined that the laboratory director failed to ensure compliance with the requirement for analytic systems. Refer to D5411. 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 RPR and Mycoplasma pneumoniae manufacturer's instructions, syphilis serology and Mycoplasma pneumoniae testing records and laboratory general supervisor interview on July 14,2024, at 1:45 P.M .,it was determined that the general supervisor (testing personnel) not assure that the manufacturer's instructions regarding to the established temperature range for RPR and Mycoplasma pneumoniae test's, when the laboratory processed and reported 77 out of 90 patient's for RPR test and 93 out of 93 patient's specimens for Mycoplasma pneumoniae. Refer to D5411. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on proficiency testing records review in year 2018 and laboratory general supervisor interview at 11:30 AM on July 12, 2018, it was determined that the laboratory failed to lended 5 of 5 proficiency testing samples for first testing event of proficiency testing (April 2018) for general immunology and syphilis serology samples from Puerto Rico Proficiency Testing Program to Laboratorio Clnico Bristol Angeli (40D0658091) The findings include: 1. The Laboratorio Clnico Melania general supervisor stated during interview on July 12, 2018 at 11:30 AM that personnel from Laboratorio Clnico Bristol Angel requested the loan of the general immunology first testing event (year 2018) proficiency samples. 2. The Laboratorio Clnico Melania general supervisor stated that she lended the following proficiency samples to Laboratorio Clnico Bristol Angeli on May 22, 2018. a. Syphillis serology PT samples: 2018-321, 2018-322, 2018-323, 2018-324 and 2018-325. b. Rheumatoid Arthritis (RA latex), C reactive protein (CRP) and Mononucleosis (Mono) proficiency samples; 2018-351, 2018-352, 2018-353, 2018-354 and 2018-355. 3. Review of the proficiency samples intermediate work showed that the proficiency samples were processed at the Laboratorio Clnico Melania on May 8, 2018. 4. Review of 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 3 -- proficiency records attestation statement showed that Laboratorio Clnico Melania reported the samples results to the PTNET on May 25, 2018. Refer to D2011 and D2013. D2011 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(3) Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications pertaining to the results of proficiency testing sample (s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent. Laboratories with multiple testing sites or separate locations must not participate in any communications or discussions across sites/locations concerning proficiency testing sample results until after the date by which the laboratory must report proficiency testing results to the program. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing records review in year 2018 and laboratory general supervisor interview at 11:30 AM on July 12, 2018, it was determined that the laboratory failed to lend to another laboratory. The findings include: 1.The laboratory was enrolled in the Puerto Rico Proficiency Testing Program for general immunology and syphilis serology proficiency samples. 2.The Laboratorio Clnico Melania general supervisor stated that she lended the proficiency testing samples from April 2018 (First Testing Event - syphilis serology and general immunology RPR (2018-321 to 2018-325), RA (2018-351 to 2018-355), CRP (2018-351 to 2018-355) and Monotest (2018-351 to 2018-355) to Laboratorio Clnico Bristol Angeli on May 22, 2018. 3.The laboratory general supervisor stated on July 12, 2018, that the Laboratorio Clnico Bristol Angeli returned the proficiency samples from April 2018 (First Testing Event - syphilis serology and general immunology) to Laboratorio Clnico Melania on May 28, 2018. D2013 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(4) The laboratory must not send proficiency testing samples or portions of proficiency testing samples to another laboratory for any analysis for which it is certified to perform in its own laboratory. Any laboratory that CMS determines intentionally referred a proficiency testing sample to another laboratory for analysis may have its certification revoked for at least one year. If CMS determines that a proficiency testing sample was referred to another laboratory for analysis, but the requested testing was limited to reflex, distributive, or confirmatory testing that, if the sample were a patient specimen, would have been in full conformance with written, legally accurate and adequate standard operating procedures for the laboratory's testing of patient specimens, and if the proficiency testing referral is not a repeat proficiency testing referral, CMS will consider the referral to be improper and subject to alternative sanctions in accordance with 493.1804(c), but not intentional. Any laboratory that receives a proficiency testing sample from another laboratory for testing must notify CMS of the receipt of that sample regardless of whether the referral was made for reflex or confirmatory testing, or any other reason. This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on review of the Puerto Rico Proficiency Testing intermediate work records review in year 2018 and laboratory general supervisor interview at 11:30 AM on July 12, 2018, it was determined that the laboratory lended tje general immunology first testing event of year 2018 to Laboratorio Clnico Bristol Angeli. The findings include: 1. The laboratory general supervisor stated that the PT samples were requested by Laboratorio Clnico Bristol Angeli on May 22, 2018. 2. The laboratory general supervisor stated on July 12, 2018, that the PT samples were returned to the laboratory on May 28, 2018. 3. The PT samples intermediate work showed that the laboratory processed their PT samples on May 8, 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 proficiency testing records review (year 2018) and laboratory general supervisor interview at 11:30 AM on July 12, 2018, it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory proficiency testing samples requirements. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on proficiency testing records review (year 2018) and laboratory general supervisor interview at 11:30 AM on July 12, 2018, it was determined that the laboratory failed to prevent that proficiency testing samples were lended to another laboratory. The finding includes: 1.The laboratory general supervisor stated on July 12, 2018 at 11:30 AM, that she lended on the general immunology first testing event (year 2018) proficiency samples to Laboratorio Clnico Bristol Angeli. -- 3 of 3 --