Sur -Med Medical Center, Corp

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at Sur -Med Medical Center on March 6, 2026. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The following standard level deficiencies were found during the recertification CLIA survey ending on March 6, 2026. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (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: Based on special chemistry instrument Access 2, maintenance quality control records review, manufacturer's instructions, and laboratory technical supervisor interview on March 6, 2026 at 1:55 PM, the laboratory failed to perform the following instrument weekly maintenance: clean instrument exterior, inspect liquid waste bottle, check waste filter bottle, inspect/clean primary probe, replace/clean aspirate probe, and run system check, when 13,227 patient specimens were processed and reported from January 8, 2025 to March 6, 2026 for special chemistry tests. The findings include: 1. The laboratory uses the Access 2 instrument to perform patient's special chemistry tests. 2. On March 6, 2026 at 1:50 PM, the Access 2 instrument manufacturer's instructions were reviewed, and showed that the instrument weekly maintenance includes the following: clean instrument exterior, inspect liquid waste bottle, check waste filter bottle, inspect/clean primary probe, replace/clean aspirate probe, and run system check. 3. On March 6, 2026 at 1:55 PM, the Access 2 instrument maintenance quality control records were reviewed, and showed that the laboratory failed to perform the instrument's weekly maintenance, when they processed and reported Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 13,227 patient specimens from January 8, 2025 to March 6, 2026 for special chemistry tests. 4. The laboratory technical supervisor confirmed on March 6, 2026 at 2:15 PM, that the laboratory did not perform the weekly maintenance of the special chemistry instrument from January 8, 2025 to March 6, 2026 when they processed and reported 13,227 patient specimens for special chemistry tests. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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 hematology calibration verification records, manufacturer's instructions, and laboratory technical supervisor interview on March 6, 2026 at 12:50 PM, the laboratory failed to perform the calibration verification procedures with at least the frequency recommended by the manufacturer's instructions (every six months) for the hematology tests performed by the XN-550 hematology system. The findings include: 1. The laboratory uses a XN-550 hematology system for CBC (Complete blood count) patient's tests. 2. Review of the manufacturer's instructions on March 6, 2026 at 12:45 PM showed that the laboratory must perform the calibration verification procedures every six months. 3. On March 6, 2026 at 12:50 PM, the calibration verification records of XN-550 hematology system showed that the laboratory did not perform at the scheduled calibration verification procedures for May 2025 and November 2025. 4. The laboratory processed and reported 24,951 CBC patient samples from November 23, 2024 to February 18, 2026. 5. The laboratory technical supervisor confirmed on March 6, 2026 at 12:55 PM, that the laboratory did not perform at least every 6 months the calibration verification procedures for the XN-550 hematology system. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value -- 2 of 4 -- is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. This STANDARD is not met as evidenced by: A. Based on chemistry quality control records review (years 2024 - 2026) and laboratory technical supervisor interview on March 6, 2026 at 1:32 PM, the laboratory failed to verify the stated value of the new lot of control materials, when the laboratory processed and reported the following tests: 4,419 Glycosylated hemoglobin (HbA1c), 3,291 Microalbumin, 686 Urine creatinine, and 1,443 Complete Metabolic Panel (CMP) patient samples from November 7, 2024 to March 6, 2026. The findings include: 1. The laboratory performs chemistry tests, which include HbA1c, Microalbumin, Urine creatinine, and CMP, with the Vitros 4600 analyzer. 2. On March 6, 2026 at 1:32 PM, the chemistry quality control records review (years 2024 - 2026), showed that there was no evaluation of the manufacturer's stated values for the following lot numbers: W2392 (HbA1c control level 1), X2393 (HbA1c control level 2), K2996 (Microalbumin control level 1), L2997 (Microalbumin control level 2), UC26081A (Urine creatinine control level 1), UC 26082A (Urine creatinine control level 2), E2828 (CMP control level 1), and P2830 (CMP control level 2), prior to placing them in routine. 3. The laboratory technical supervisor confirmed on March 6, 2026 at 1:38 PM, that no evaluations of the stated lots of control materials were performed prior to placing them in routine use. B. Based on special chemistry quality control records review (years 2024 - 2026) and laboratory technical supervisor interview on March 6, 2026 at 2:36 PM, the laboratory failed to verify the stated value of the new lot of control materials, when the laboratory processed and reported 2,572 Thyroid stimulating hormone (TSH), 489 Triiodothyronine uptake assay (T3U), 585 Thyroxine (T4), 804 Free thyroxine (FT4), 827 Carcinoembryonic Antigen (CEA), 793 Prostate specific antigen (PSA), 3,289 Vitamin D, 11 Creatinine Kinase- MB (CKMB), and 1,117 Troponin from September 30, 2024 to March 6, 2026. The findings include: 1. The laboratory performs special chemistry tests, which include TSH, T4, FT4, T3U, CEA, PSA, Vitamin D, CKMB, and Troponin, with the Access 2 analyzer. 2. On March 6, 2026 at 2:36 PM, the special chemistry quality control records review (years 2024 - 2026), showed that there was no evaluation of the manufacturer's stated values for the following lot numbers: 40461 (TSH, T4, FT4, T3U, CEA, PSA analytes control level 1), 40462 (TSH, T4, FT4, T3U, CEA, PSA analytes control level 2), 40463 (TSH, T4, FT4, T3U, CEA, PSA analytes control level 3), 1003711 (Vitamin D control level 1), 1003712 (Vitamin D control level 2), 27041 (CKMB control level 1), 27042 (CKMB control level 2), 27043 (CKMB control level 3), and 25041 (Troponin control level 1), 25042 (Troponin control level 2), and 25043 (Troponin control level 3), prior to placing them in routine. 3. The laboratory technical supervisor confirmed on March 6, 2026 at 2:45 PM, that no evaluations of the stated lots of control materials were performed prior to placing them in routine use. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on hematology manufacturer's instructions and calibration verification records, chemistry, and special chemistry quality control records review (years 2024 - 2026), and interview with the laboratory supervisor on March 6, 2026 at 2:45 PM, the laboratory director failed to fulfill her responsibilities and duties to ensure compliance with the manufacturer's instructions and laboratory quality control requirements. Refer to D5411, D5439, and D5469. D6117 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(4) (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on hematology manufacturer's instructions and calibration verification records, chemistry and special chemistry quality control records review (years 2024 - 2026), and interview with the laboratory technical supervisor on March 6, 2026, at 2:45 PM, the laboratory technical supervisor failed to fulfill her responsibilities to ensure compliance with the quality control requirements and manufacturer's instructions. Refer to D5411, D5439, D5469. D6177 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(3) (b)(3) Adhere to the laboratorys 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 hematology manufacturer's instructions and calibration verification records, chemistry and special chemistry quality control records review (years 2024 - 2026), and interview with the laboratory technical supervisor on March 6, 2026, at 2:45 PM, the laboratory testing personnel failed to perform and document all quality control activities to ensure compliance with the chemistry, special chemistry, and hematology quality control requirements and manufacturer's instructions. Refer to D5411, D5439, D5469. -- 4 of 4 --

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 --