Q Med Laboratory Llc

Summary Statement of Deficiencies 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: I. Based upon observations, review of policies and procedures, manufacturer's instructions, quality control records, patient test records and interview of facility personnel, the laboratory failed to follow the manufacturer's instructions when performing 197 Rapid Plasma Reagin (RPR) tests between July 1, 2025 and August 31, 2025. The findings included: 1. Observations made during the demonstration of the procedure on September 17, 2025 at 9:35 AM found testing person 3 dispensed one drop of the non- reactive and reactive control material or serum specimen into each circle needed for testing. He then dispensed one free falling drop of the carbon antigen (using the dropper bottle) into the circles that contained controls or serum specimens. He then placed the test card onto the rotator and started the timer for the 8 minute rotation. Upon completion of testing, he placed the cap on the dropper bottle and and placed it in the refrigerator until needed. Testing person 3 was then asked to read the procedure and repeat the testing. Testing person 3 removed a plastic coated card from the drawer and labeled each of the circles for each of the controls and patient specimens to be tested. He then used the control bottles to dispense the non- reactive, weakly reactive and reactive controls into the appropriate circles and used the dispensters to dispense the patient specimens into each of the circles. He removed the cap from the antigen bottle and was about to dispense a drop of RPR antigen (using the dropper bottle) into each of the circles for testing. He was stopped and asked to reread the procedure before continuing. He applied the needle to the dropper bottle and dispensed the antigen into each circle. He took the card to the rotator and 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 -- set the timer for 8 minutes. 2. Review of the laboratory's own written policy (approved 02/15/2024) found on page 2 under the heading Rapid Plasma Reagin (RPR): Bring reagents and samples to room temperature. Place 0.05 mL of patient serum onto the designated circles of the RPR card. Add one drop of Germaine RPR antigen reagent. Gently rotate card for 8 minutes at 100 rpm. Read results macroscopically under a strong light." 3. Review of the Aim RPR Test manufacturer's instructions found under the heading PRECAUTIONS: "5. The needle assembly must be thoroughly washed in distilled or deionized water and air dried after each use. Place the needle back into the plastic sleeve. Do not remove the dropper bottle tip when washing the needle assembly. Let the assembly air dry. Before the next use, make sure that no large water droplets remain in the dropping bottle and needle by shaking and squeezing the bottle assembly." Continued review found under the heading Materials required but not provided: Mechanical Rotator adjustable to 100 rpm + 5 rpm, circumscribing 3/4 inch diameter w/ humidity cover." under the heading Qualitative test Procedure: "Place the Test Card on the rotator and cover to maintain humidity. Rotate at 100 rpm (+ 5 rpm) for eight (8) minutes." 4. Review of patient test records found the laboratory tested 196 patient specimens for RPR between July 1, 2025 and August 31, 2025 6. During interview of testing person 3 conducted September 17, 2025 at 9:35 AM, he confirmed he did not follow the manufacturer's instructions for adding carbon antigen to each of the test circles when testing specimens for RPR. He went on to confirm that he did not use the dispensing needle to dispense the carbon antigen, and he did not always test all 3 controls with each run. He went on to confirmed that the laboratory did not have a humidity cover for the mechanical rotator to maintain humidity during the rotation of RPR testing. 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 upon review of the manufacturer's instructions, the open stability chart, observations, patient test records and interview of facility personnel the laboratory failed to ensure BioRad Specialty Immunoassay Controls were not used beyond their opened stability to assess the quality of Parathyroid Hormone (PTH) results. 26 patient specimens were tested for PTH using the expired control material between September 15, 2025 and September 17, 2025. The findings included: 1. Review of the BIO RAD Lyphochek Specialty Immunoassay Control instructions for use found under the heading STORAGE AND STABILITY: " Reconstituted and refrigerated: After reconstituting and storing tightly capped at 2-8 C, the product will be stable as follows: All Analytes 30 days Except: PTH (Intact): 4 days Continued review found under the heading LIMITATIONS: "The product should not be used past the expiration." 2. The opened stability chart located on the wall defined an open stability date of 4 days for PTH. 3. Observations made on September 17, 2025 at 12:08 PM found the laboratory had documented 09/11/20225 as the date of opening on the BioRad Specialty Immunoassay Controls level 1 and 3 controls (lot 88760 expiration 2027-04-30) located in the refrigerator in the tray of quality control materials currently in use. The laboratory did not document a new expiration date for the controls. 4. Review of patient test records found the laboratory tested patient specimens using the quality control materials that exceeded the manufacturer's open -- 2 of 4 -- stability date: a. 09/15/2025 - 5 patients tested for PTH as follows: Specimen 250915023 Specimen 250915028 Specimen 250915016 Specimen 250915048 Specimen 250915029 b. 09/16/2025 - 20 patient specimens were tested for PTH follows: Specimen 250915065 Specimen 250915083 Specimen 250915062 Specimen 250915066 Specimen 250915158 Specimen 250915180 Specimen 250915176 Specimen 250915063 Specimen 250915063 Specimen 250915169 Specimen 250915030 Specimen 250915080 Specimen 250915107 Specimen 250915087 Specimen 250916033 Specimen 250916062 Specimen 250916061 Specimen 250916080 Specimen 250916075 Specimen 250916055 Specimen 250916074 c. 09/17 /2025 - Specimen 250916159 was tested for PTH. 5. During interview of testing person 5 conducted September 17, 2025 at 12:08 PM, he confirmed that the laboratory used the Specialty Immunoassay Controls levels 1 and 3 for 3 days days after reconstitution and did not document a new expiration date when the bottles had been opened. 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 upon review of Creatine Kinase (CK) verification studies, manufacturer's instructions for use, patient reports and interview of facility personnel, the laboratory failed to verify the manufacturer's reference range used for CK were appropriate for their patient population. The reference range defined for CK on 5 of 5 patient reports tested between May, 2025 and September 2025 was not the same as the manufacturer's The findings included: 1. Review of the verification study for CK (added March 2025) found no evaluation of reference ranges to ensure the manufacturer's ranges were appropriate for the laboratory's patient population. 2. Review of the Beckman Coulter CK Instructions for use found on page 6 under the heading EXPECTED RESULTS: "Adults 30-223 U/L. Expected values may vary with age, sex, diet and geographical location. Each laboratory should determine its own expected values as dictated by good laboratory practice." 3. Review of 5 final patient reports found the laboratory had defined a reference interval for CK as 30-170 U/L. 4. During interview of testing person 5 conducted September 17,2025 at 11:02 AM, he confirmed the laboratory did not verify the manufacturer's reference range was acceptable for their patient population. He went on to say the reference range defined on the final report was the same as used for a reference laboratory. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and -- 3 of 4 -- This STANDARD is not met as evidenced by: Based upon review of Creatine Kinase (CK) verification studies, manufacturer's instructions for use, patient reports and interview of facility personnel, the laboratory failed to verify the manufacturer's reference range used for CK were appropriate for their patient population. (See D5421) D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results; This STANDARD is not met as evidenced by: Based upon observations, review of policies and procedures, manufacturer's instructions, quality control records, patient test records and interview of facility personnel, the laboratory failed to follow the manufacturer's instructions when performing 197 Rapid Plasma Reagin (RPR) tests between July 1, 2025 and August 31, 2025. (See D5411) -- 4 of 4 --

Summary Statement of Deficiencies 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 upon review of quality control records and interview of facility personnel, the laboratory failed to establish and maintain the quality control program for eight of eight Chemistry procedures tested using the UniCel DxI 600 ( Serial number 902285) and 26 of 26 analytes tested on the DxC 700. The findings included: 1. Review of Quality control records for the Immunoassay control levels 1 and 3 (lot 3530821) for March 2023 found the laboratory had different acceptable values defined in the UniCel Dxi 600 ( Serial number 902285) and the Schuylab laboratory information system for Vitamin D. a. UniCel DxI acceptable values were defined as follows: Lot 35308211 - Mean value of 19.3 ng/mL with an acceptable range of 15.44 to 23.16 Lot 35308213 - Mean value of 60.3 ng/mL with an acceptable range of 47.70 to 72.90 b. Schuylab acceptable values were defined as follows: Lot 35308211 - Mean value of 21.3 ng/mL with an acceptable range of 16.44 to 26.16 Lot 35308213 - Mean value of 56.8 ng/mL with an acceptable range of 45.24 to 68.36 2. Review of quality control records for the Techpath level 1 and 3 controls (lot 1150621) for March 2023 found the laboratory had different acceptable values defined in the DxC 700 and the 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 -- Schuylab laboratory information system for Sodium. a. DxC700 acceptable values were defined as follows: Level 1 lot 11506211 - Mean value of 119.8 mEq/L with an acceptable range of 97.6 to 146.4. Level 3 lot 11506213 - Mean value of 169.4 mEq/L with an acceptable range of 136.8 to 205.2. 3. During interview of testing person four on the CMS Report 209 Laboratory Personnel report conducted September 6, 2023 at 1:22 PM, he confirmed that he did not maintain the quality control values in the UniCel DxI and the DxC 700 to detect immediate error. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (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: Review of the laboratory's own IQCP's, quality control records, patient test records, and interview of facility personnel found that the laboratory director failed to ensure that the quality control program had been established and maintained. (see D 5445) D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based upon review of policies and procedures, personnel records and interview of facility personnel, the technical consultant failed to perform semi-annual competency assessments for one of five testing personnel performing Hematology and Chemistry testing in the first year of employment. The findings included: 1. Review of policies and procedures found on page 1 of the policy titled LABORATORY PERSONNEL COMPETENCY: " All Clinical Laboratory Technologists in Q Med are to be tested every 6 months and annually for competency in all areas of laboratory." 2. Review of personnel files found no semi-annual competency assessments for testing person two ( hire date 02/22/2022). One annual competency assessment was performed 05/15 /2023. 3. During interview of testing person four on the CMS Report 209 Laboratory Personnel Report conducted 09/05/2023 at 11:54 AM, he confirmed there were no semi-annual competency assessments for testing person two available for review. -- 2 of 2 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 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: Review of manufacturer's instructions and interview of facility personnel found the laboratory failed to follow the manufacturer's instructions when using the CareStart COVID-19 Antigen Test. The findings included: 1. Review of the manufacturer's instructions found under the heading CONDITIONS OF AUTHORIZATION FOR LABORATORY " Authorized laboratories using your product must include with the test result reports, all authorized Fact Sheets." 2. Interview of testing person 4 on the CMS report 209 Laboratory Personnel Report conducted on August 11, 2021 at 11:03 AM confirmed that the laboratory did not include the Fact Sheets with the patient test results for COVID-19 Antigen testing. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Review of the CMS 209 Laboratory Personnel Report, proficiency testing records and interview of facility personnel found that the laboratory failed to ensure that all testing personnel performing moderately complex testing participated in proficiency testing 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 -- for Chemistry and Hematology testing events in 2020 (three events each year). The findings included: 1. Review of the CMS Report 209 Laboratory Personnel Report provided during the survey found the laboratory listed four testing personnel performing moderate complexity testing. 2. Review of the American Proficiency Institute (API) Chemistry and Non-Chemistry attestations for 2020 found testing person 4 performed three of three events for both Chemistry and Non-Chemistry with testing person 1 performing Hemoglobin A1C and Human Chorionic Gonadotropin (HCG) testing in the 1st, 2nd and 3rd testing events for Chemistry. Testing persons 2 and 3 (both hired in 2019) did not participate in proficiency testing events. 3. Interview of testing person 4 conducted on August 11, 2021 at 10:14 AM confirmed that he had done most of the proficiency testing events. He went on to say that he was "going to let them do one". D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Review of proficiency testing records, patient test records and interview of the facility personnel found the laboratory failed to verify the accuracy of results for SARS/Covid testing at least twice each year in 2020 and 2021. The findings included: 1. Review of the American Proficiency Institute (API) proficiency testing records for 2020 and 2021 ( three events each year) found that the laboratory had no proficiency records for SARS/Covid testing using the Healgen COVID-19 IgG/IgM Rapid test cassette. 2. Documentation of verification of accuracy of results for SARS/Covid testing using the Healgen COVID-19 IgG/IgM Rapid test cassette was requested but not provided. 3. Review of patient test records found 6320 patients tested using the Healgen COVID- 19 IgG/IgM Rapid test cassette between April 28, 2020 and august 11, 2021. $. Interview of testing person 4 on the CMS report 209 Laboratory Personnel Report conducted August 11, 2021 at 11:08 AM confirmed that the laboratory did not enroll in a proficiency testing program or have another means to verify the accuracy of results obtained using the Healgen COVID-19 IgG/IgM Rapid test cassette. 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: Review of manufacturer's instructions, patient test records and interview of facility personnel found the laboratory failed to follow the manufacturer's instructions when using the Healgen COVID-19 IgG/IgM Rapid Test Cassette in 2020 and 2021. The findings included: 1. Review of the manufacturer's instructions found under the heading CONDITIONS OF AUTHORIZATION FOR LABORATORY " Authorized laboratories using the Healgen COVID-19 IgG/IgM Rapid Test Cassette must include with result reports, all authorized Fact Sheets." 2. Review of patient test records found -- 2 of 3 -- the laboratory tested 6320 patient specimens using the Healgen COVID-19 IgG/IgM Rapid Test Cassette between April 28, 2020 and August 11, 2021. 3. Interview of testing person 4 on the CMS report 209 Laboratory Personnel Report conducted on August 11, 2021 at 11:03 AM confirmed that the laboratory did not include the Fact Sheets with the patient test results for COVID-19 IgG/IgM. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Survey conducted October 28, 2019 through October 31, 2019, and exit conference held on October 31, 2019. On February 14, 2020, additional information was submitted to complete the survey. The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780: 493.1240 Condition: Preanalytic systems 493. 1441 Condition: Laboratories performing high complexity testing; laboratory director. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of manufacturer's instructions for use, laboratory policies and procedures, verification studies, patient test records and interview with facility personnel, the laboratory failed to meet the requirements for pre analytic systems when testing patient blood specimens using the Diatron Abacus 5 hematology analyzer. The laboratory failed to follow the manufacturer's instructions for testing blood specimens for Complete Blood Count (CBC) within 7 hours of collection using the Diatron Abacus 5 hematology analyzer. (see D5311) D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of 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 -- the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions for use, laboratory policies and procedures, patient test records and interview with facility personnel, the laboratory failed to follow the manufacturer's instructions for testing blood specimens for CBC using the Diatron Abacus 5 hematology analyzer. The findings included: 1. Review of the Abacus 5 Analyzer Operator's Manual (v2.0) found on page 53 under the heading Sample Collection and Handling:"Analyze blood samples within 7 hours of collection." 2. Review of the laboratory's written policy titled Criteria for Rejection of Hematology Specimens (dated 04/22/2019) found it was the policy of the laboratory to reject Blood Specimens "older than 24 hours" for Blood Counts. 3. Review of patient test records found the laboratory had tested approximately 11,756 patient specimens for CBC between March 15, 2019 and October 25, 2019. A random sampling of 25 patient reports from June 2019 and October 2019 found the laboratory tested 14 of 25 patient specimens that were greater than 7 hours old. a. Accession 190626012 - collected 06/25/2019 at 1:50 PM and tested 24 hours and 43 minutes later on 06/26/2019 at 2:33 PM. b. Accession 190626013- collected 06/25/2019 at 4: 40 PM and tested 21 hours and 52 minutes later on 06/26/2019 at 2:32 PM c. Accession 190627002 - collected 06/26/2019 at 09:00 AM and tested 27 hours and 31 minutes later on 06/27/2019 at 12:31 PM. d. Accession 190627003 - collected 06/26 /2019 at 09:05 AM and tested 27 hours and 24 minutes later on 06/27/2019 at 12:27 PM e. Accession 190628102 - collected 06/28/2019 at 08:30 AM and tested 7 hours and 53 minutes later on 06/28/2019 at 4:23 PM. f. Accession 191025046 - collected 10 /25/2019 at 09:00 AM and tested 7 hours and 39 minutes later on 10/25/2019 at 5:39 PM. g. Accession 191025095 - collected 10/25/2019 at 09:25 AM and tested 8 hours and 42 minutes later on 10/25/2019 at 6:07 PM h. Accession 191025089 - collected 10 /24/2019 at 5:10 PM and tested 25 hours and 1 minute later on 10/25/2019 at 6:11 PM. i. Accession 191025088 - collected 10/25/2019 at 09:30 AM and tested 8 hours and 8 minutes later on 10/25/2019 at 5:38 PM j. Accession 191025001 - collected 10 /24/2019 at 09:00 AM and tested 27 hours and 11 minutes later on 10/25/2019 at 12: 11 PM k. Accession 191025008 - collected 10/24/2019 at 08:00 AM and tested 28 hours and 10 minutes later on 10/25/2019 at 12:10 PM l. Accession 191025010 - collected 10/24/2019 at 11:07 AM and tested 23 hours and 45 minutes later on 10/25 /2019 at 12:08 PM. m. Accession 191025013 - collected 10/24/2019 at 12:20 PM and tested 23 hours and 45 minutes later on 10/25/2019 at 12:25 PM n. Accession 191025017 - collected 10/24/2019 at 09:15 AM and tested 26 hours and 56 minutes later on 10/25/2019 at 12:01 PM 5. Interview of the Technical Consultant on the CMS report 209 Laboratory Personnel Report confirmed that the laboratory would pick up specimens using their own courier services around 3:00 PM each day and bring them back to the laboratory for testing. Analytes included in the CBC : White Blood Cell (WBC) Red Blood Cell (RBC) Hemoglobin (Hgb) Hematocrit (Hct) Mean Corpuscular Volume (MCV) Mean Corpuscular Hemoglobin (MCH) Mean Corpuscular Hemoglobin Concentration (MCHC) D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) -- 2 of 5 -- Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions for use, laboratory policies and procedures, establishment studies, patient test records and interview with facility personnel, the laboratory failed to ensure establishment studies for Analytical sensitivity, Analytical specificity to include interfering substances, and any other performance characteristics required for test performance were completed prior to testing patient specimens when using the Diatron Abacus 5 hematology analyzer to test specimens for Complete Blood Counts (CBC) , using specimens greater than seven hours old. The findings included: 1. Review of the Abacus 5 Analyzer Operator's Manual (v2.0) found on page 53 under the heading Sample Collection and Handling:"Analyze blood samples within 7 hours of collection." 2. Review of the laboratory's written policy titled Criteria for Rejection of Hematology Specimens (dated 04/22/2019) found it was the policy of the laboratory to reject Blood Specimens "older than 24 hours" for Blood Counts. 3. Review of the laboratory's establishment studies (signed by the Laboratory Director dated 03/15/2019) found: a. The laboratory failed to include verification studies including accuracy, precision and reportable range for the analyte Hemoglobin. b. The laboratory failed to establish the analytic sensitivity of each of the analytes included in the CBC When specimens were tested beyond the manufacturer's specifications of 7 hours. c. the laboratory performed an analytic specificity study but failed to include the assessment of potential interfering substances for each of the analytes included in the CBC when testing specimens older than 7 hours. d. The laboratory failed to establish other performance characteristics including specimen stability over time including variations in temperature and age of specimens. FDA approved tests that have been modified are considered high-complexity and the establishment of accuracy, precision, analytic sensitivity, analytic specificity including interfering substances, reportable range, reference intervals, and any other performance characteristic required for test performance are to be established by the laboratory as a laboratory developed test method. e. The laboratory failed to establish its own reference range for analytes included in the CBC using specimens that were greater than 30 minutes or less than seven hours. f. The laboratory failed to evaluate the establishment studies against the manufacturer's claims for acceptability of performance for analytes included in the CBC. 4. Review of patient test records found the laboratory had tested approximately 11,756 patient specimens for CBC between March 15, 2019 and October 25, 2019. 5. Interview of the Technical Consultant on the CMS report 209 Laboratory Personnel Report confirmed that the laboratory evaluated the establishment studies based upon the "pass or fail arguments" previously defined in the EP Evaluator formulas for accuracy, precision and reportable ranges. He went on to say the comparison studies were performed with the reference laboratory but he did not know the methodology used. Analytes included in the CBC : White Blood Cell (WBC) Red Blood Cell (RBC) Hemoglobin (Hgb) Hematocrit (Hct) Mean Corpuscular Volume (MCV) Mean -- 3 of 5 -- Corpuscular Hemoglobin (MCH) Mean Corpuscular Hemoglobin Concentration (MCHC) Red Cell Distribution Width (RDW) Platelet (PLT) Mean Platelet Volume (MPV) 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 a review of laboratory policies and procedures, Diatron Abacus 5 establishment studies, patient test records, and interview of facility personnel, the laboratory director failed to provide overall management and direction of the laboratory services. (see D6082 and D6086) D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, manufacturer's instructions,verification records, and instructions to clients for the collection, storage and handling of specimens, the laboratory director failed to ensure the quality of services for preanalytical systems. The laboratory failed to have documentation of studies to support the stability of patient specimens tested for CBC more than seven hours after collection when using the modified FDA-approved Diatron Abacus hematology analyzer . (see D5311 and D5423) D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, manufacturer's instructions for use, establishment studies, patient test records and interview with facility personnel, the laboratory director failed to ensure establishment studies for Analytical sensitivity, Analytical specificity to include interfering substances, and any other performance characteristics required for test performance were completed when using the Diatron Abacus 5 hematology analyzer to test specimens for Complete Blood Counts (CBC) , using specimens greater than seven hours old. Analytes included in the CBC: White Blood Cell (WBC) Red Blood Cell (RBC) Hemoglobin (Hgb) Hematocrit (Hct) Mean -- 4 of 5 -- Corpuscular Volume (MCV) Mean Corpuscular Hemoglobin (MCH) Mean Corpuscular Hemoglobin Concentration (MCHC) Red Cell Distribution Width (RDW) Platelet (PLT) Mean Platelet Volume (MPV) (see D5423) -- 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 CMS (Center for Medicare Services) national database and verified with the proficiency testing company,American Association of Bioanalysts (AAB). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 successful participation in a proficiency testing program 493.1403 laboratories performing moderate complexity testing; laboratory director 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: 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 -- Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Association of Bioanalysts (AAB), it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of chemistry for the analyte Blood Urea Nitrogen (BUN). Refer to D2096. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS form 155 and AAB records found the laboratory failed to attain a score of at least 80% of acceptable responses for each analyte in the subspecialty of chemistry for the analyte blood urea nitrogen (BUN). Findings: 1. AAB 2018 - 2nd event the laboratory received an unsatisfactory score of 40% for BUN. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Review of the CMS report 155 and AAB proficiency testing records found that the laboratory failed to participate in the 2016-2nd Testing Event resulting in a score of 0% for the all analytes in the speciality of Chemistry, constituting unsatisfactory performance. Findings: 1. AAB 2018 - 3rd event reported No Data Received resulting in the following unsatisfactory scores: Routine Chemistry event 0% Alanine aminotransferase ALT 0% Albumin 0% Alkaline Phosphatase 0% Aspartate aminotransferase AST 0% Bilirubin Total 0% Calcium 0% Total Cholesterol 0% Cholesterol HDL 0% Creatinine 0% Glucose 0% Potassium 0% Sodium 0% Total Protein 0% Triglycerides 0% Blood Urea Nitrogen BUN 0% D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on a review of proficiency testing records it was revealed that the laboratory failed to return all proficiency testing results to the proficiency testing program within the time frame specified by the program. for the speciality of chemistry. Findings were: 1. AAB - 3rd event. the laboratory received an unsatisfactory result of 0% for the chemistry testing event.. 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 desk review of proficiency testing records, it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of Chemistry for the analyte blood urea nitrogen (BUN). Two out of three unsatisfactory scores results in unsuccessful PT performance. Findings: 1. AAB 2018 - 2nd event the laboratory received an unacceptable score of 40% for BUN. 2. AAB 2018 - 3rd event the laboratory received an unacceptable score of 0% for BUN. D2098 ENDOCRINOLOGY CFR(s): 493.843(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's AAB endocrinology proficiency testing (PT) results it was revealed that the laboratory failed to attain a satisfactory score (80% or greater) for the analyte of human chronic gonadatropin (HCG) the first testing event of 2015. Findings: 1. AAB 2015 - 1st event the laboratory received an unsatisfactory score of 0 % for HCG. D2099 ENDOCRINOLOGY CFR(s): 493.843(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on the review the CMS 155 report and AAB proficiency testing records found the laboratory failed to attain a satisfactory score of at least 80% for the overall event in the speciality of Endocrinology. Findings: 1. AAB 2015 - 1st event the laboratory received an event score of 66 % for Endocrinology. -- 3 of 5 -- D2100 ENDOCRINOLOGY CFR(s): 493.843(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Review of the CMS report 155 and proficiency testing records found that the laboratory failed to participate in the 2018 3rd Testing Event for Endocrinology, resulting in a score of 0% for all regulated analytes for the speciality of Endocrinology, constituting unsatisfactory performance. Findings: 1. Laboratory received the following unsatisfactory scores from AAB 2018 - 3rd event: Thyroid Stimulating Hormone TSH - 0% D2104 ENDOCRINOLOGY CFR(s): 493.843(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based upon a review of AAB proficiency records it was found the lab failed to return a proficiency testing event on time resulting unsatisfactory performance and a zero score. Findings: 1. AAB 2018 - 3rd event the laboratory received an unsatisfactory score of 0% for endocrinology 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 laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. 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 -- 4 of 5 -- 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 results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2096 -- 5 of 5 --

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 --