Sur -Med Medical Center, Corp

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review off site survey was performed on August 18, 2025 to Laboratorio Clinico Sur Med Medical Center, Corp., 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: Based on review of Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (year 2025) and CASPER Report 0155D scores, it was determined that the laboratory obtained a unsuccessful participation in a Proficiency Testing Program for Amylase tests. Refer 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) (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 Service Program (PRPTSP) scores (year 2025) and CASPER Report 0155D scores, it was determined that the laboratory obtained an initial unsuccessful performance in two out of two consecutive testing events for Amylase tests. The finding includes: 1. The Puerto Rico Proficiency and Casper Report 0155D scores, showed that the laboratory obtained the following unsuccessful scores: Analyte: Amylase a. First testing event year 2025 - 20% b. Second testing event year 2025 - 60% 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 Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (year 2025) and CASPER Report 0155D scores, its was determined that the laboratory director failed to ensure the laboratory's successful participation in a Proficiency Testing Program for Amylase 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: Based on Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (year 2025) and CASPER Report 0155D scores, it was determined that the laboratory director did not ensure that the laboratory had a satisfactory participation for Amylase tests during the first testing event of the year 2025 and second testing event of the year 2025. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies 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 proficiency testing records (years 2023-2024), it was determined that the laboratory failed to attain successful participation in a Proficiency Testing Program for routine chemistry subspecialty. Refer to D2096. 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 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: A. Based on review of proficiency testing records (years 2023-2024), it was determined that the laboratory failed to achieve satisfactory performance in two out consecutive testing events for Amylase. The finding includes: 1.The laboratory obtained unsatisfactory results for Amylase in third testing event for year 2023 (40%) and first testing event of year 2024 (60%). B. Based on review of proficiency testing records (years 2023-2024), it was determined that the laboratory failed to achieve satisfactory performance in two out consecutive testing events for AST (Aspartate Aminotransferase). The finding includes: 1.The laboratory obtained unsatisfactory results for AST (Aspartate Aminotransferase) in third testing event for year 2023 (20%) and first testing event of year 2024 (40%). 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 proficiency testing records (years 2023-2024), it was determined that the laboratory director failed to ensure the laboratory's successful participation in a Proficiency Testing Program for routine chemistry tests. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies 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 ImmunoCard Mycoplasma pneumoniae (Meridian) manufacturer's instructions, Mycoplasma pneumoniae testing records review (years 2023-2024) and laboratory general supervisor interview on January 23, 2024 at 10:45 AM, it was determined that the laboratory failed to follow the manufacturer's instruction regarding to the established temperature range 365 out of 365 days when patient's specimens were tested and reported for Mycoplasma pneumoniae of year 2023. The findings include: 1. The laboratory uses ImmunoCard Mycoplasma (Meridian) to perform Mycoplasma patient's samples tests. (Reviewed on January 23, 2024 at 10:00 AM) 2. The ImmunoCard Mycoplasma (Meridian) manufacturer's instructions establish that the Mycoplasma test must be performed at room temperature between 22 C to 25 C. (Reviewed on January 23, 2024 at 10:10 AM) 3. On January 23, 2024 at 10:35 AM, the records of the Mycoplasma pneumoniae testing showed that the laboratory did not monitor nor document the room temperature when patient's specimens were tested for Mycoplasma by Immuno Card Meridian method from from January 1, 2023 to December 31, 2023. 4.The laboratory general supervisor confirmed during an interview, on January 23,2024 at 10:45 AM, that the laboratory did not monitor nor document the room temperature when it processed the patient's specimens for Mycoplasma pneumoniae test. 5. The laboratory processed and reported 4978 out 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 -- of 4978 patient's samples for Mycoplasma pneumoniae test from January 1, 2023 to December 31, 2023. 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 Mycoplasma pneumoniae manufacturer's instructions, Mycoplasma pneumoniae testing records (years 2023-2024) and laboratory general supervisor interview on January 23, 2024 at 10:45 AM, it was determined that the laboratory director did not assure that the manufacturer's instructions regarding to the established temperature range for Mycoplasma pneumoniae test, when the laboratory processed and reported 4,978 out of 4,978 patient's specimens for Mycoplasma pneumoniae of year 2023. Refer to D5413. 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 Mycoplasma pneumoniae manufacturer's instructions, Mycoplasma pneumoniae testing records and general supervisor interview on January 23, 2024 at 10:45 AM, it was determined that the general supervisor did not assure that the manufacturer's instructions were followed by the testing personnel regarding to temperature range for Mycoplasma pneumoniae test. Refer to D5413. D6177 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(3) Each individual performing high complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on Mycoplasma pneumoniae manufacturer's instructions, Mycoplasma pneumoniae testing records and general supervisor interview on January 26, 2024 at 11:30 AM, it was determined that the testiing personnel failed to follow the manufacturer's instructions regarding to the established temperature range for Mycoplasma pneumoniae test, when the laboratory processed and reported 4,978 out of 4,978 patient's specimens for Mycoplasma pneumoniae. Refer to D5413. . -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the general supervisor, the clinical consultant, the testing personnel records (years 2018-2019) and laboratory general supervisor interview on January 22, 2019 at 1:00 PM, it was determined that the laboratory failed to follow written policies to assess the clinical consultant, general supervisor competency and testing personnel. (MT#5985, MT#6785, Mt#5931 and MT#5857) (MD #6620). The findings include: 1. The general supervisor, clinical consultant and testing personnel records were reviewed on January 22, 2019 at 10:30 AM. 2. The laboratory schedule for testing personnel competence evaluation showed that it must be performed every year. 3. Review of the general supervisor, the clinical consultant and the testing personnel records, showed that the laboratory technical supervisor did not evaluate the personnel competence during year 2019. 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: 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 -- Based on manufacturer's instructions, syphillis serology quality control records review (years 2018-2019) and laboratory general supervisor interview at 10:30 AM on January 22, 2020, it was determined that the laboratory failed to perform syphillys serology test as required by manufacturer's instructions by ASI RPR method. The findings include: 1. The manufacturer's establishes that the RPR (Rapid plasma reagin) test must be performed at room temperature between 20 C to 30 C . 2. Review of syphillis serology quality control records from January 2019 to January 21, 2020, the records showed that the laboratory processed and reported one thousand twenty two (1,222) RPR (Rapid plasma reagin) patient's tests in 2019 that was performed at temperatures below the range in 112 of 211 days. (19 C). 3. The laboratory proccessed and reported one thousand twenty two (1,222) RPR (Rapid plasma reagin) patient's samples those days. 4. The laboratory general supervisor confirmed that the laboratory performed RPR (Rapid plasma reagin) tests below the range established by the manufacturer's those days. (19C) 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 syphillis serology quality control records review (years 2018-2019) and laboratory general supervisor interview at 10:30 AM on January 22, 2020, it was found that the laboratory director did not assure that quality control procedures related to perform syphillys serology test as required by manufacturer's instructions by ASI RPR method. The findings include: 1. The laboratory failed to perform syphillys serology test as required by manufacturer's instructions by ASI RPR method. The manufacturer's establishes that the RPR (Rapid plasma reagin) test must be performed at room temperature between 20 C to 30 C . 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 syphillis serology quality control records review (years 2018-2019) and laboratory general supervisor interview at 10:30 AM on January 22, 2020, it was determined that the general supervisor did not assure that quality control procedures were followed by the testing personnel. Refer to D6177. D6177 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(3) Each individual performing high complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on syphillis serology quality control records review (years 2018-2019) and laboratory general supervisor interview at 10:30 AM on January 22, 2020, it was determined that testing personnel failed to follow quality control procedures related to manufacturer's instructions.. The finding includes: 1. The laboratory failed to perform syphillys serology test as required by manufacturer's instructions by ASI RPR method. The manufacturer's establishes that the RPR (Rapid plasma reagin) test must be performed at room temperature between 20 C to 30 C . Refer to D5411. -- 3 of 3 --

Summary Statement of Deficiencies 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 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 review of calibration, calibration verification records and interview with the laboratory supervisor , it was determined that the laboratory did not perform calibration verification procedures for albumin or cholesterol each six months, from April 2017 to January 2018. The findings include: a. The laboratory performed comprehensive metabolic panel (CMP) by the Fusion 5.1 instrument. b. Review of the calibration records for years 2016 to 2018 on February 22, 2018 at 10:00 AM, showed 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 -- the following: i. cholesterol test: last two calibration done on May 16, 2017 and January 14, 2018. ii. albumin test: the last two calibrations done on April 19, 2017 and January 12, 2018. c. The laboratory did not perform calibration verification procedures for albumin or cholesterol. d. The laboratory reported 122,100 (CMP) patient's tests from April 2017 to January 2018.. e. The laboratory supervisor stated that the she was not aware of the situation. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of Quality Assessment (QA)manual , Q.A, records and interview with the laboratory supervisor, it was determined that the laboratory did not follow the established Quality Assessment Program to monitor and evaluate the following requirements for analytic systems: control procedures. The findings include: a. Review of the QA procedure manual on February 22, 2018 at 1:15 PM, showed that a calibration procedures must be monitored each year. A page was provided for documentation. b. Review of the QA procedures for years 2016 to 2018 showed that the laboratory did not document, in the provided page, the monitoring of the calibration verification procedures since year 2018 c. The laboratory supervisor stated that they omitted to review the QA procedure. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on quality assessment (QA) procedures manual, quality assessment records review (2014-2016) and laboratory supervisor interview on February 22, 2018 at 1:15 PM, it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the following post-analytic systems requirement: Test report. The findings include: a. Review of the quality assessment program showed that evaluations to patient's final test reports must be evaluated every year and the evaluation must include twenty patient reports. b. Review of the quality assessment records showed that the laboratory did not evaluate the patient report during year 2016 or 2017. c. The laboratory supervisor stated that the laboratory did not perform evaluations to patient's final test reports during years 2016 and 2017. 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 -- 2 of 3 -- identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on Quality Assessment (QA) records review and laboratory supervisor interview on February 22, 2018 at 1:15 PM, it was determined that laboratory director did not ensure compliance with quality assessment (QA) requirements. The findings include: a. Quality Assessment records showed that the laboratory did not monitor the calibration verification assessment not the test report either. Refer to D5791 and D5891. D6177 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(3) Each individual performing high complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on review of calibration and verification records, it was found that the testing personnel did not perform calibration verification procedures for cholesterol or albumin each six months since year 2017. The findings include: a. The calibration records showed that for cholesterol the testing personnel performed calibration on May 16, 2017 and February 14, 2018. b. The calibration records showed that for albumin the testing personnel performed calibration on April 19, 2017 and February 14, 2018. c. Review of the calibration verification records on February 22, 2018 at 10: 00 AM did not included calibration verification procedures for cholesterol or albumin. Refer to D5439. -- 3 of 3 --