Laboratorio Clinico Pomales

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review off site survey was performed on September 12, 2024 to Laboratorio Clnico Pomales, 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 2024) and CASPER Report 0155D scores, it was determined that the laboratory obtained an unsuccessful participation in a Proficiency Testing Program for Hematocrit (HCT). Refer to D2130 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 (year 2024) and CASPER Report 0155D scores, it was determined that the laboratory obtained an unsuccessful participation in two consecutive testing events for the following routine Hematocrit (HCT) tests. The finding includes: 1. The Puerto Rico Proficiency Testing and CASPER Report 0155D scores, showed that the laboratory obtained following unsuccessful scores: Analyte: Hematocrit (HCT) a. First testing event for the year 2024 (20%) b. Second testing event for the 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 Puerto Rico Proficiency Testing scores (year 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 Hematocrit (HCT) 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 (year 2024) and CASPER Report 0155D scores, it was determined that the laboratory director did not ensure that the laboratory had a satisfactory participation for Hematocrit (HCT) tests during the first testing event of year 2024 and second testing event of year 2024. Refer to D2130 -- 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 review Proficiency Testing record (years 2020 to 2022), bacteriology patient's testing records, and laboratory supervisor interview, it was determined that the laboratory failed to enroll in an HHS approved Proficiency Testing Program for Bacteriology throat and ulcer cultures tests when it processed and reported sixteen out of sixteen patient's throat cultures and three out of three patient's ulcers cultures from January 17, 2020 to December 21, 2021. The findings include: 1. The Proficiency Testing records showed no results for Bacteriology throat and ulcer cultures tests since January 17, 2020. 2. On March 15, 2022 at 10:15 AM, the bacteriology patient's testing record showed that the laboratory performed the primary inoculation in patient's throat and ulcer cultures. The laboratory reported at 48 hours the no growth for the ulcer cultures, the normal flora for the throat culture and referred cultures plates to another laboratory for identification and susceptibility tests from January 17, 2020 to December 21, 2021. 3. The laboratory reported sixteen patient's throat cultures as Normal Throat Flora from January 17, 2020 to July 29 to 2021. 4. The laboratory reported three patient's ulcers cultures as No Growth After 48 HR Of Incubation from August 27, 2021 to December 21, 2021. 5. The supervisor confirmed on March 15, 2022 at 10:20 AM, that the laboratory performed the primary 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 -- inoculation for the patients throat and ulcer cultures, reported the no growth results for the ulcer culture, the normal flora results for the throat cultures and referred cultures plates to another laboratory for organisms identification and susceptibility tests since January 17, 2020. 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 General Immunology (Mycoplasma pneumoniae test) quality control records review(years 2020 to 2022) and interview with the laboratory supervisor, it was determined that the laboratory did not include each day of testing the external positive nor the negative control materials when 132 out of 132 patients specimens were tested and reported for of Mycoplasma pneumoniae patient testing from March 5, 2020 to March 14, 2022. The findings include: 1. The laboratory use the Immuno Card Mycoplasma Test Cassette method to perform the Mycoplasma pneumoniae qualitative tests since March 5, 2020. 2. On March 15, 2022 at 11:17 AM, review of Mycoplasma pneumoniae quality control record showed that the laboratory did not include each day of testing the external positive nor the negative control materials from March 5, 2020 to March 14, 2022. 3. The laboratory supervisor confirmed on March 15, 2022 at 11:20 AM, that the laboratory failed to include each day of testing the external negative and positive control material . He stated that the laboratory run the external control when it received a new reagent kit on 5/28/2020, 2/15/2021, 9/7 /2021 and 12/8/2021 and always verified the internal control. 4. The laboratory processed and reported 132 patient samples for Mycoplasma pneumoniae qualitative tests from March 5, 2020 to March 14, 2022. 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 Proficiency Testing record (years 2020 to 2022), bacteriology patient's testing records, General Immunology (Mycoplasma pneumoniae test) quality control records and laboratory supervisor interview, it was determined that the laboratory director failed to fulfill her responsibilities and duties to ensure compliance with the Proficiency Testing Program and the analytical system requirements. Refer to D 6088 (The laboratory director failed to ensure that the laboratory is enrolled in an HHS-approved proficiency testing program for for Bacteriology throat and ulcer cultures tests). Refer to D 6093 (The laboratory director failed to establish the quality control procedures for the Mycoplasma pneumoniae test). -- 2 of 3 -- D6088 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4) The laboratory director must ensure that the laboratory is enrolled in an HHS- approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on review Proficiency Testing record (years 2020 to 2022), bacteriology patient's testing records, and laboratory supervisor interview, it was determined that the laboratory director failed to ensure that the laboratory is enrolled in an HHS- approved proficiency testing program for for Bacteriology throat and ulcer cultures tests. Refer to D 2000 (The laboratory failed to enroll in an HHS approved Proficiency Testing Program for Bacteriology throat and ulcer cultures tests when it processed and reported sixteen out of sixteen patient's throat cultures and three out of three patient's ulcers cultures from January 17, 2020 to December 21, 2021). 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 test) quality control records review(years 2020 to 2022) and interview with the laboratory supervisor, it was determined that the laboratory director failed to establish the quality control procedures for the Mycoplasma pneumoniae test March 5, 2020 to March 14, 2022. Refer to D 5449 (The laboratory did not include every day of testing the positive and the negative control materials for Mycoplasma pneumoniae test). -- 3 of 3 --

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --