Hospital Menonita Ponce

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review off site survey was performed on August 18, 2025 to Laboratorio Clinico Hospital Menonita de Ponce, the laboratory was found out of compliance with the following conditions: 42 CFR 493.803 Proficiency Testing, Successful Participation 42 CFR 493.1403 Laboratory Director, Moderate 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: A. Based on review of the Certification And Survey Provider Enhanced Reports (CASPER) 0155D and Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (year 2025), it was determined that the laboratory obtained a unsuccessful participation in a Proficiency Testing Program for pO2 (arterial blood gases) tests. 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 -- Refer D2096. B. Based on review of the Certification And Survey Provider Enhanced Reports (CASPER) 0155D and Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2024-2025), it was determined that the laboratory obtained a unsuccessful participation in a Proficiency Testing Program for T3 Uptake tests. Refer D2107. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 the Certification And Survey Provider Enhanced Reports (CASPER) 0155D and Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (year 2025), it was determined that the laboratory obtained an initial unsuccessful performance in two out of two consecutive testing events for pO2 (arterial blood gases) tests. The finding includes: 1. The Casper Report 0155D and PRPTSP scores, showed that the laboratory obtained the following unsuccessful scores: Analyte: pO2 a. First Testing event year 2025 - 60% b. Second testing event year 2025 - 40% D2107 ENDOCRINOLOGY CFR(s): 493.843(f) (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 the Certification And Survey Provider Enhanced Reports (CASPER) 0155D and Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2024-2025), it was determined that the laboratory obtained an initial unsuccessful performance in two out of three consecutive testing events for Triiodothyronine (T3) Uptake tests. The finding includes: 1. The Casper Report 0155D and PRPTSP scores, showed that the laboratory obtained the following unsuccessful scores: Analyte: T3 Uptake a. Third testing event year 2024 - 0% b. Second testing event year 2025 - 0% 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 review of the Certification And Survey Provider Enhanced Reports (CASPER) 0155D and Puerto Rico Proficiency Testing Service Program (PRPTSP) -- 2 of 3 -- scores (year 2025), its was determined that the laboratory director failed to ensure the laboratory's successful participation in a Proficiency Testing Program for Sodium tests and pO2 (arterial blood gases) tests.. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: A. Based on review of the Certification And Survey Provider Enhanced Reports (CASPER) 0155D and Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (year 2025), it was determined that the laboratory director did not ensure that the laboratory had a satisfactory participation for pO2 (areterial blood gases) tests during the first testing event of the year 2025 and second testing event of the year 2025. Refer to D2096. B. Based on review of the Certification And Survey Provider Enhanced Reports (CASPER) 0155D and Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2024-2025), it was determined that the laboratory director did not ensure that the laboratory had a satisfactory participation for T3 Uptake tests during the third testing event of the year 2024 and second testing event of the year 2025. Refer to D2107. -- 3 of 3 --

Summary Statement of Deficiencies 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 direct observation , hematology and routine chemistry procedures manuals review and hematology and routine chemistry areas supervisors interview on July 17, 2019 at 11:45 AM, it was determined that the laboratory failed to follow written policies for patient's specimen labeling. The findings include: 1. The hematology and routine chemistry procedures manuals establishes that all patient's specimen must be labeling with the date and time of sample collection and the signature or initials of the personnel who performed the sample collection. 2. On July 17, 2019 at 843 AM, it is observed that ten patients specimens were received and processed in the laboratory for complete blood cell (CBC) tests. Six out of ten patient's specimens labels did not include the time of sample collection nor the signature or initials of the personnel who collected the sample. 3. On July 17, 2019 at 11:45 AM, it is observed that fifteen patients specimens were received and processed in the laboratory for routine chemistry tests. Ten out of fifteen patient's specimens labels did not include the time of sample collection nor the signature or initials of the personnel who collected the sample. 4. The supervisors of the hematology and routine chemistry areas confirmed on July 17, 2019 at 11:45 AM, that those label of patients specimens did not include the require information. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT 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 -- 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 Quality Assessment Program (QAP) records review (years 2018 and 2019) and laboratory general supervisor interview on July 17, 2019 at 2:00 PM, it was determined that the laboratory failed to establish and follow written policies to monitor and assess the preanalytic systems requirements since January 2018 ( Patient's specimen labeling). The findings include: 1. On July 17, 2019 at 2:00 PM, the QAP records showed that the laboratory did not establish nor follow written policies to monitor and assess the patient's specimen labeling since January 2018. 2. The laboratory failed to follow written policies for patient's specimen labeling. Refer to D 5411. 3. The general supervisor confirmed on July 17, 2019 at 2:00 PM, that the laboratory did not assess the patient's specimen labeling in the QAP since January 2018. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment 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 Quality Assessment (QA) records review (years 2018 and 2019) and and laboratory general supervisor interview on July 17, 2019 at 2:00 PM, it was determined that laboratory director failed to ensure compliance with the QA requirements (pre-analytic systems) since January 2018. Refer to D 5391. -- 2 of 2 --