Deng Family Medicine & Careu

Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/12/2025 through 11/13/2025. The laboratory was found in compliance with standard-level deficiencies cited. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with testing person #1, the laboratory failed to ensure three of three bottle of Clia Waived MultiTox Urine quality controls were stored as required by the manufacturer. Findings include: (1) On 11/12 /2025 and 10:30 am, observation of the laboratory freezer and interview with testing person #1, identified the following: (a) Three bottles of Clia Waived MultiTox Urine QC, lot # CC02667, storage temperature of -10 to -20 degrees Celsius. (2) A review of records from August 2025, showed the temperature colder than negative 20 degrees Celsius for 18 of 20 days of testing. (3) Interview with testing person #1 on 11/12 /2025 at 10:30 am confirmed the bottles were being stored below the manufacturer's stated temperature requirements. D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that 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 testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of records and interview with testing person #1, the laboratory director failed to sign proficiency testing attestation statements for four of 15 events reviewed in 2024 and 2025. Findings include: (1) On 11/12/2025, a review of 2024 and 2025 chemistry and hematology proficiency testing events identified the following for four of 15 events: (a) First 2024 Chemistry Event - The attestation statement had not been signed by the laboratory director; (b) First 2024 Hematology Event - The attestation statement had not been signed by the laboratory director; (c) Third 2024 Hematology Event - The attestation statement had not been signed by the laboratory director; (d) First 2025 Chemistry Event - The attestation statement had not been signed by the laboratory director. (2) The findings were reviewed with testing person #1, who stated on 11/12/2025 at 10:00 am, the attestation statements had not been signed by the laboratory director. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with testing person #1, the laboratory failed to ensure expired supplies were not available for use. Findings include: (1) Observation of the laboratory on 11/12/2025 at 10:10 am, identified the following expired supplies were available for use: (a) Four Greiner PST Gel and Lithium Heparin tubes, Lot 456087P, Exp. 08/31/2025 (b) 17 BD Vacutainer SST tubes, Lot 4305369 Exp. 10/31 /2025 (c) Five UTM-RT Specimen collection swabs, Lot 220219, Exp. 04/19/2025 (d) One Gallon Citranox solution, Lot 015099590223571, Exp. 01/31/2025 (2) Interview with testing person #1 on 11/12/2025 at 10:30 am confirmed the expired supplies were available for use. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records and interview with testing person #1, the laboratory failed to utilize the demonstrated reportable ranges for five of five analytes reviewed for the Ortho Vitros XT 3400 test system. Findings include: (1) On 11/13/2024 at 10: -- 2 of 3 -- 00 am, testing person #1 stated the laboratory began using the Ortho Vitros XT 3400 analyzer to perform routine chemistry testing which included the analytes ALKP (Alkaline Phosphatase), GLU (Glucose), UREA (Urea Nitrogen), TRIG (Triglycerides), and TBIL (Total Bilirubin) in January 2024; (2) A review of the performance specifications records identified the laboratory had demonstrated the following reportable ranges for five of five analytes reviewed: (a) ALKP - 25-1372 (b) GLU - 34.6-598.8 (c) TBIL - 1.08-18.39 (d) TRIG - 28.3-454.3 (e) Urea - 3.2- 114.3 (3) Interview with testing person #1 on 11/13/2025 at 10:00 am confirmed the laboratory was using the following manufacturer's reportable ranges instead of the reportable ranges that had been demonstrated by the laboratory: (a) ALKP - 20-1500 (b) GLU - 20-625 (c) TBIL - 0.1-30 (d) TRIG - 10-525 (e) Urea - 2-120 D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) (a)(2) Function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturers established limits before patient testing is conducted. (b) Equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer. The laboratory must do the following: This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with testing person #1, the laboratory failed to ensure system checks were within the manufacturer's acceptable limits for 16 of 23 weeks reviewed. Findings include: (1) On 11/12/2025 at 12:50 pm, testting person #1 stated the laboratory performed Vitamin D, Thyroid Stimulating Hormone, Sex Hormone Binding Globulin, Testosterone, and Free T4 testing using the Beckman Access 2 test system: (2) A review of the Access 2 instructions for use stated, "Perform weekly system check, if results are not acceptable, Rerun, Troubleshoot System Check Results, or contact Technical Support"; (3) A review of the maintenance logs from June 2025 through November 2025 identified the following weekly system check failures: (a) 06/13/2025 to 09/26/2025 - the weekly system checks failed; (4) On 11/12/2025 at 12:50 pm, testing person #1 confirmed that the laboratory failed to ensure the weekly system checks were within manufacturer's acceptable limits. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/03/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director and the laboratory manager during an exit conference performed at the conclusion of the survey. 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 a review of records and interview with the laboratory manager, the laboratory failed to follow their policy to assess the competency of the technical consultant, based on the position responsibilities as listed in Subpart M, for one of three competencies performed during the review period of November 2021 through the current date. Findings include: (1) A review of records and interview with the laboratory manager on 01/03/2024 at 01:00 pm confirmed the laboratory director performed competencies for the technical consultant, based on job responsibilities, at least annually; (2) A review of the Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of November 2021 through the current date identified competencies, based on job responsibilities, had not been documented as performed after 11/22/2022 for one of one person listed as technical consultant on Form CMS-209; (3) The findings were reviewed the laboratory manager who stated on 01/03/2024 at 01:20 pm, the competency for the technical consultant had not been performed in 2023 as stated above. D5401 PROCEDURE MANUAL Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures, and interview with the laboratory manager, the laboratory failed to follow their written policy for verifying the stated values of control materials prior to implementation for 12 of 12 lot numbers used during the review period of 01/04/2023 through 10/06/2023. Findings include: (1) On 01/03/2024 at 12:30 pm, the laboratory manager stated the following: (a) The laboratory performed CBC (Complete Blood Count) testing using the Sysmex XP-300 hematology analyzer; (b) Three levels of EIGHTCHECK-3WP X-TRA QC (Quality Control) materials were tested each day of patient testing; (c) The manufacturer's provided ranges were used to determine acceptability of quality control results. (2) A review of the Laboratory Procedure Manual (book 1 of 2), policy No. 5.20, subject: Hematology Quality Control, section II. "Setting up New Lot Quality Control" stated the following: (a) "4. Run all 3 levels of QC twice a day for 5 days (total of 10 runs). a. Note: always run the current active QC after running the new QC. This must be done before patients are performed." (b) "5. After the 5 days, use the running means of the 10 runs as the new set mean for each level of QC. Check that these values of within the package insert range of mean." (c) "6. Once new mean is established. New QC is ready to use." (3) A review of records for 12 control lot numbers used from 01 /30/2023 through 10/06/2023 identified no documentation to prove the following lot numbers had been implemented per policy: (a) Lot #23620710, 23620711, and 23620712 used from 01/30/2023 through 03/31/2023; (b) Lot #30810710, 30810711, and 30810712 used from 04/03/2023 through 06/28/2023; (c) Lot #31650710, 31650711, and 31650712 used from 06/29/2023 through 09/20/2023; (d) Lot #32490710, 32490711, and 32490712 used from 09/21/2023 through 10/06/2023. (4) The findings were reviewed with the laboratory manager who stated 01/04/2024 at 1: 45 pm, the laboratory did not follow their written policy. 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 observation and interview with the laboratory manager, the laboratory failed to ensure five of five types of blood collection tubes were stored as required by the manufacturer, in a room denoted as the Dexa draw room. Findings include: (1) Observation of the draw room and interview with the laboratory manager on 01/03 /2024 at 10:25 am, identified the following: (a) 6 BD Vacutainer SST tubes, lot # -- 2 of 5 -- 3160661, storage temperature of 4-25 degrees (C) centigrade; (b) 3 BD Vacutainer SST tubes, lot # 3153061, storage temperature of 4-25 degrees C; (c) 3 BD Vacutainer K2EDTA 7.2mg, lot # 322731, storage temperature of 4-25 degrees C; (d) 2 BD Microtainer brand tubes, lot # 2301273, storage temperature of 4-25 degrees C; (e) 2 BD Microtainer brand tubes K2EDTA, lot # 2071821, storage temperature of 4-25 degrees C. (2) Interview with the laboratory and the laboratory manager on 01/03 /2024 at 10:30 am confirmed the laboratory was not monitoring the temperature of the draw room. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instruction manual, and interview with the laboratory manager, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures on the Sysmex XP-300 hematology analyzer during the review period of January 2023 through November 2023. Findings include: (1) On 01/03/2024 at 09:25 am, the laboratory manager stated CBC (Complete Blood Count) testing was performed using the Sysmex XP-300 hematology analyzer; (2) A review of the "Cleaning and Maintenance" on section 12 of the manufacturer's instructions manual required the following maintenance procedures: (a) Weekly "Clean SRV tray" (b) Monthly "Clean RBC and WBC Transducer; Clean Waste Chamber" (b) Every 3 months "Clean SRV" (3) A review of maintenance logs from January 2023 through November 2023 identified maintenance had not been documented as performed for the following: (a) Weekly: i. Between 06 /28/2023 and 07/14/2023 (b) Monthly: i. Between 06/08/2023 and 08/14/2023 (c) Every 3 months: i. Between 02/27/2023 and 07/14/2023 (4) The records were reviewed with the laboratory manager who stated on 01/03/2024 at 1:45 pm, maintenance procedures had not been documented as performed as stated above. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures, and interview with the laboratory manager, the laboratory failed to define a written function check protocol to ensure the urine centrifuge was functioning properly for two of two function checks performed from January 2022 through the current date. Findings include: (1) On 01/03 -- 3 of 5 -- /2024 at 10:00 am, the laboratory manager stated the following: (a) The laboratory performed urine microscopic testing; (b) The urine specimens were processed at a speed of 2000 rpm (revolutions per minute) for 5 minutes using the Select Medical Products PSS 602 centrifuge. (2) A review of the laboratory policy and procedure manual identified no evidence of a function check protocol that defined the frequency of the urine centrifuge speed and timer checks and the acceptable limits for the checks; (3) Interview with the laboratory manager on 01/03/2024 at 01:10 pm, confirmed the laboratory did not have a written function check protocol but the centrifuge speed was checked at least twice annually; (4) A review of records from January 2022 through the current date identified the following: (a) 06/30/2023 - Although the speed had been checked at 2107 rpm, there was no documentation the timer had been checked. In addition, there was no documentation if the result of the speed check was acceptable; (b) 12/18/2023 - Although the speed had been checked at 2072 rpm, there was no documentation the timer had been checked. In addition, there was no documentation if the result of the speed check was acceptable; (c) There was no documentation the centrifuge speed and timer had been checked prior to 06/30 /2023. (5) The findings were reviewed with the laboratory manager who stated on 01 /03/2024 at 01:15 pm, the laboratory did not have a written function check protocol for the urine centrifuge and did not ensure the urine centrifuge was functioning properly as shown above. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records, QC (quality control) package inserts, and interview with the laboratory manager, the laboratory failed to have control procedures that would detect immediate errors that would occur due to test system failure, adverse environmental conditions, and operator performance for TSH (Thyroid Stimulating Hormone) testing for three of three months reviewed from September through November 2023. Findings include: (1) On 01/03/2024 at 09:50 am, the laboratory manager stated the following: (a) The laboratory performed TSH testing using the Beckman Coulter Access 2 analyzer; (b) Two levels of Bio-Rad Liquichek Immunoassay Plus Control materials were performed each day of patient testing. (c) When new lot numbers of control materials were put into use, the laboratory established means and two SD (Standard Deviation) ranges for each analyte. (2) A review of the manufacturer's instruction (package insert) for the control materials stated, "The mean values and the corresponding +/-3SD ranges in the Assignment of Values Data Charts were derived from replicate analyses and are specific for this lot of product. Data from Unity Interlaboratory Program are included in the determination of some ranges. The tests listed were performed by the manufacturer and/or -- 4 of 5 -- independent laboratories using manufacturer supported reagents and a representative sampling of this lot of product. It is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides"; (3) A review of QC records for two lot numbers of control materials used during the review period of 09 /01/2023 through 11/30/2023 identified the following: (a) Level one lot #85331 and level three lot #85333 were in use - The laboratory was using ranges wider than the package insert guideline ranges as follows: (i) Level One - The package insert guideline range was 0.65-0.855 (aa) From 09/01/2023 through 09/30/2023, the laboratory was using a range of 0.48-0.96; (bb) From 10/01/2023 through 11/30/2023, the laboratory was using a range of 0.52-1.0. (ii) Level Three - The package insert guideline range was 26.1-36.9 (aa) From 09/01/2023 through 11/30/2023, the laboratory was using a range of 20.85-40.85. (4) The records were reviewed with the laboratory manager who stated on 01/03/2024 at 01:35 pm, the laboratory had used ranges wider than the package insert 3 SD (standard deviation) guideline ranges as shown above. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the technical consultant failed to ensure personnel performing moderate complexity testing had been evaluated at least annually for one of two persons. Findings include: (1) A review of personnel records for two persons performing moderate complexity testing from September 2022 through the current date identified the following: (a) Although an annual competency had been documented as completed on 06/02/2023, the competency form had not been signed and dated by the evaluator to definitively determine who performed the assessment. (2) The record was reviewed with the laboratory manager who stated on 01/03/2024 at 10:50 am, the competency assessment documentation had not been signed and dated by the evaluator. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database, the laboratory, and from the proficiency testing provider. The laboratory was found out of compliance with the following CLIA Conditions of Participation: 493.803; D2016: Successful Participation 493.1407; D6000: 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 a desk review of proficiency testing scores obtained from the Casper 0155D report and proficiency testing Comparative Evaluation obtained from American Proficiency Institute for the first and third 2022 events, the laboratory failed to 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 -- successfully participate in a proficiency testing program for the subspecialty of Routine Chemistry. Findings include: (1) The laboratory failed to achieve satisfactory performance for two of three consecutive testing events for the analyte ALT (Alanine Aminotransferase). 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 unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluation obtained from American Proficiency Institute, the the laboratory failed to achieve satisfactory performance for the analyte ALT (Alanine Aminotransferase) in two of three consecutive testing events. Findings include: (1) The laboratory received a score of 0% on the first 2022 event and a score of 0% on the third 2022 event. 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 a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for the analyte ALT (Alanine Aminotransferase) in two of three consecutive events. The laboratory failed to achieve a passing score of 80% for the first 2022 event and third 2022 event. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for the analyte ALT (Alanine Aminotransferase) in two of three consecutive events. The -- 2 of 3 -- laboratory failed to achieve a passing score of 80% for the first 2022 event and third 2022 event. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 03/23/2022. The findings were reviewed with the laboratory manager and laboratory director at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory director or designee failed to sign a proficiency testing attestation statement for one of 15 events. Findings include: (1) The surveyor reviewed 2020 and 2021 proficiency testing records and identified the following for one of five events: (a) Second 2021 Chemistry Miscellaneous Event - The attestation statement had not been signed by the laboratory director or designee and the testing person. (2) The surveyor reviewed the findings with the laboratory manager who stated on 03/23/2022 at 12:20 pm, the attestation statement had not been signed by the testing person and laboratory director or designee as shown above. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 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 -- 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 a review of records, manufacturer's storage instructions, and interview with the laboratory manager, the laboratory failed to ensure the hematology analyzer was being stored according to manufacturer's humidity requirements for three of four months; and failed to ensure collection devices were stored according to manufacturer's storage requirements for four of four months Findings include: HUMIDITY (1) On 03/23/2022 at 11:40 am, the laboratory manager stated the following to the surveyor: (a) CBC (Complete Blood Count) testing was performed using the Sysmex XP-300 analyzer; (2) On 03/23/2022, the surveyor reviewed the manufacturer's humidity requirements for the analyzer, which was 30% to 80%; (3) On 03/23/2022, the surveyor reviewed four months (November 2021 through February 2022) of laboratory humidity records and identified for three of four months the humidity readings were documented as less than 30% as follows: (a) December - 2 of 31 days (days 2,13); (b) January - 13 of 31 days (days 3,5,6,7,11,12,17,19,20,21,24,26,28) (b) February - 8 of 28 days (days 7,8,11,14,22,24,25,28). (4) The surveyor reviewed the records with the laboratory manager. The laboratory manager stated on 03/23/2022 at 03:55 pm the analyzer had been stored at a humidity below the manufacturer's requirement as indicated above. ROOM TEMPERATURE (1) On 03/23/2022 at 11:40 am, the laboratory manager stated the following to the surveyor: (a) CBC (Complete Blood Count) testing was performed using the Sysmex XP-300 analyzer; (b) Free T4 (Thyroxine), TSH (Thyroid Stimulating Hormone), SHBG (Sex Hormone Binding Globulin), Testosterone, and Vitamin D were performed on the Beckman Coulter Access 2 analyzer. (c) Blood collection tubes were stored in the laboratory draw room. (2) The surveyor reviewed the manufacturer's environmental requirements for the blood collection tubes, which required a room temperature 4-25 degrees C (Celsius). The following were examples of blood collection tubes stored in the rooms: (i) BD Vacutainer K2 EDTA (300 tubes of lot# 3919231); (ii) BD Vacutainer Tiger Top SST (300 tubes of lot# 1312504). (3) On 03/23/2022, the surveyor reviewed four months (November 2021 through February 2022) of draw room temperature records and identified for four of four months the temperature readings were documented as greater than 25 degrees C as follows: (a) November - 3 of 30 days (1,2,16) (b) December - 8 of 31 days (days 1,3,9,13,14,15,20,30); (b) January - 4 of 31 days (days 3,12,19,28) (b) February - 2 of 28 days (days 11,14). (4) The surveyor reviewed the records with the laboratory manager. The laboratory manager stated on 03/23/2022 at 04:10 pm the blood collection tubes had been stored at a temperature above the manufacturer's requirement as indicated above. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory -- 2 of 3 -- must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures for one of five quarterly maintenances; and failed to follow the weekly maintenance procedures for two of seven months. Findings include: SYSMEX XP-300 (1) On 03/23/2022 at 11:40 am, the laboratory manager stated the following to the surveyor: (a) CBC (Complete Blood Count) testing was performed using the Sysmex XP-300 analyzer. (2) The surveyor reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs. (a) Quarterly (i) Clean SRV (3) The surveyor reviewed maintenance records for 13 months (January 2021 through February 2022) and identified the following: (a) There was no evidence the quarterly maintenance had been performed (i) Between 07 /26/2021 and 02/08/2022 (missing the 4th quarter of 2021) (4) The surveyor reviewed the records with the laboratory manager. The laboratory manager stated on 03/23 /2022 at 01:34 pm, the maintenance had been performed but not documented. BECKMAN COULTER ACCESS 2 (1) On 03/23/2022 at 11:45 am, the laboratory manager stated the following to the surveyor: (a) Free T4 (Thyroxine), TSH (Thyroid Stimulating Hormone), SHBG (Sex Hormone Binding Globulin), Testosterone, and Vitamin D were performed on the Beckman Coulter Access 2 analyzer. (2) The surveyor reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs. (a) Weekly Maintenance (i) Clean Instrument Exterior (ii) Inspect Liquid Waste Bottle (iii) Check Waste Filter Bottle (iv) Inspect /Clean Aspirate Probes (v) Run System Check (3) The surveyor reviewed maintenance records for seven months (June 2021 through December 2021) and identified the following: (a) There was no evidence the weekly maintenance had been performed (i) Between 06/11/2021 and 06/23/2021 (ii) Between 08/27/2021 and 09/09 /2021 (4) The surveyor reviewed the records with the laboratory manager. The laboratory manager stated on 03/23/2022 at 01:58 pm, the maintenance had been performed but not documented. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of a patient report and interview with the laboratory manager, the laboratory failed to provide normal reference intervals for one of one urine sediment test report. Findings include: (1) On 03/23/2022 at 11:55 am, the laboratory manager stated the following to the surveyor: (a) The laboratory performed urine sediment testing. (2) The surveyor reviewed one test report for Patient #93840 tested on 03/18 /2022 at 09:57 am. The report did not include a normal reference range; (3) The report was reviewed with the laboratory manager, who stated on 03/23/2022 at 03:54 pm the patient report did not include a normal reference range. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/30/19. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director, testing person #1, and testing person #2 at the conclusion of the survey. 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 a review of records and interview with testing person #1, the laboratory failed to have a written technical consultant competency policy based on the job responsibilities as listed in Subpart M. Findings include: (1) During the survey, the surveyor reviewed personnel records for competency assessments performed during 2018 and to date in 2019. There was no evidence competencies had been performed for technical consultant #2 based on their job responsibilities; (2) The surveyor asked testing person #1 if a written policy to evaluate the technical consultant based on job responsibilities was available and if competencies had been performed during the review period. Testing person #1 stated a policy to evaluate the technical consultant based on job responsibilities had not been written; and competencies had not been performed. 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 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 -- 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 a review of records, manufacturer's instructions, and interview with testing person #1, the laboratory failed to follow the manufacturer's instructions for verifying flagged results. Findings include: (1) At the beginning of the survey, testing person #1 stated the following to the surveyor: (a) CBC (Complete Blood Count) testing was performed on the Sysmex XP-300 analyzer; (b) Manual differential testing was not performed in house. If a manual differential was required, the specimen would be sent to a reference laboratory. (2) Later during the survey, the surveyor reviewed the manufacturer's instructions for verifying flags obtained on the analyzer. For AG flags, the instructions stated, "Presence of nucleated red blood cells, effects of fragmented red blood cells, increase of large platelets, platelet aggregation or agglutination, precipitation of fibrin, etc". In addition, the instructions stated, "Check Smear. etc"; (3) The surveyor randomly reviewed 4 patient records which contained AG flags from CBC testing performed between April 2019 through the day of the survey. For 4 of 4 records, there was no evidence the laboratory followed the manufacturer's instructions for verifying the AG flags. The findings for the 4 records were: (a) Patient testing was performed on 04/15/19, with an AG flag obtained next to Platelet; (b) Patient testing was performed on 05/10/19, with an AG flag obtained next to Platelet; (c) Patient testing was performed on 07/30/19, with an AG flag obtained next to Platelet; (d) Patient testing was performed on 10/15/19, with an AG flag obtained next to Platelet. (4) The surveyor reviewed the records with testing person #1, who stated the flags obtained for the above 4 patients had not been verified as required by the manufacturer. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of patient test reports and interview with testing person #1, the laboratory failed to ensure patient test reports included either the patient's name and identification number, or a unique patient identifier and identification number. Findings include: (1) During the survey, the surveyor reviewed 3 patient reports from testing performed in the laboratory. The reports did not include a second unique identifier (only the patient's first and last name and date of birth were on the reports). The reports were: (a) #1 - KOH prep testing performed on 10/10/19 (b) #2 - Wet prep testing performed on 10/25/19 (c) #3 - CMP, Lipid Panel, Uric Acid, Urine Microscopic, CK (Creatine Kinase), TSH (Thyroid Stimulating Hormone), Free T4 (Thyroxine), Vitamin D, and CBC (Complete Blood Count) testing performed on 10 /25/19 (2) The surveyor reviewed the reports with testing person #1 who stated they -- 2 of 3 -- did not include a second unique identifier. CMP (Comprehensive Metabolic Panel) - BUN, Calcium, Creatinine, Glucose, Chloride, CO2, Potassium, Sodium, Albumin, ALT, AST, Alkaline Phosphatase, Total Bilirubin, and Total Protein Lipid Panel - Cholesterol, HDL Cholesterol, Triglyceride -- 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 --