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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: . A. Based on record review and interview with the Technical Supervisor, the laboratory failed to follow manufacturer's instructions for quality control performance for two (July 2022 to July 2024) of two years reviewed. Findings include: 1. A review of the laboratory's "Siemens Multistix" manufacturer's instructions revealed a section stating, "Test positive and negative controls with new lots, new shipments of reagents and when you open a new bottle of reagent strips. test reagents monthly that are stored for more than 30 days. Run QC tests to ensure reagent strips integrity; train new users; confirm test performance; and when patients' clinical conditions or symptoms do not match." 2. A review of the laboratory's quality control results for its Siemens Multistix testing revealed results of controls performed on 4/15/24 and no other results from July 2022 to July 2024. 3. A review of the laboratory's "Siemens Clinitek Microalbumin 2" manufacturer's instructions revealed a section titled "Quality Control" stating, "Test positive and negative quality controls with new lots, new shipments of reagents, and when you open a new bottle of reagent strips. Test reagents monthly that are stored for more than 30 days. Run QC tests to ensure reagent strips integrity; train new users; and when patients' clinical conditions or symptoms do not match." 4. A review of the quality control documentation revealed a lack of positive and negative controls performed for the Siemens Clinitek Microalbumin 2 from July 2022 to July 2024. 5. A review of the laboratory's "Afinion HbA1c" manufacturer's instructions revealed a section titled "Frequency of control testing" stating, "Controls should be analyzed: with each new shipment of Afinion HbA1c Test Kits, with each new lot of Afinion AbA1c Test kits, at least every 30 days, when training new Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- operators, and anytime an unexpected test result is obtained." 6. A review of the Afinion HbA1c quality control documentation revealed a lack of controls performed at least every 30 days from July 2022 and July 2024 and only performed controls on 5 /9/23, 7/28/23, and 4/15/24. 7. A review of the laboratory's "Coag-Sense Prothrombin Time PT/INR Monitoring System" manufacturer's instructions revealed a section titled "Quality Control" stating, "Each Test Strip kit is shipped with two Low Control Strips, two High Control Strips and Control Activation Solution. The plasma is generated from a pool of normal donors where the Vitamin K dependent proteins are removed and added back at different levels to represent the 'Low' and 'High' level ranges. Real plasma allows for a fully functional liquid control test of both the reagent's ability to generate a clot and the analyzer's ability to detect a clot. When done correctly, control testing confirms the performance of both the Meter and Test Strips and should be completed for each new lot of Test Strips, as soon as each lot is received, within the stated shelf life" 8. A review of the quality control documentation revealed a lack of control testing performed for the Coag-Sense Prothrombin Time test system from July 2022 to July 2024. 9. An interview on 7/10/24 at 11:41 am with the Technical Supervisor confirmed the laboratory failed to perform quality control testing for the CLIA-waived testing kits listed above. B. Based on record review and interview with the Technical Supervisor, the laboratory failed to follow manufacturer's instructions for reagent use for two (July 2022 to July 2024) of two years reviewed. Findings include: 1. The surveyor observed a paper reagent bottle holder with the Consult Diagnostics Strep A testing kit with two bottles that did not have matching lot numbers on 7/9/24 at 7:10 pm: a. Reagent 1 Lot number 0000709692 with the expiration date of 7/2/25. b. Reagent 2 Lot number 0000659515 with the expiration date of 3/31/25. 2. The surveyor observed a bag of six Consult Diagnostics Strep A testing kit bottles with two bottles of Reagent 1 and four bottles of Reagent 2 in the basket next to the paper reagent bottle holder with different lots. 3. A review of the laboratory's "Consult Diagnostics Strep A Test Dipstick Kit" manufacturer's instructions revealed a section stating, "Only use reagents provided in the kit." 4. An interview on 7/9/24 at 7:40 pm with the Technical Supervisor confirmed the laboratory had been mixing different lots of reagents against the manufacturer's instructions. C. Based on record review and interview with the Technical Supervisor, the laboratory failed to follow Accula SARS-CoV-2 Test Cassette manufacturer's instructions for use of testing kits beyond the expiration date for five (February 2024 to July 2024) of 5 months since the cassettes expired. Findings include: 1. The surveyor observed two boxes of Accula SARS-CoV-2 test cassettes with the expiration date of 2/15/2024 on 7/9/24 at 7:30 pm. 2. A review of the "Accula Test SARS-CoV-2" instructions for use revealed a section stating, "Do not use kit or reagents past the expiration date." 3. An interview on 7/9/24 at 7:30 pm with the Technical Supervisor confirmed the test cassettes had exceeded the expiration date. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such -- 2 of 11 -- timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: . Based on observation, record review and interviews, the laboratory failed to ensure contamination of its molecular testing area was minimized (refer to D3003) and failed to operate as a separate laboratory to comply with 493.43 (refer to D3009). D3003 FACILITIES CFR(s): 493.1101(a)(2) The laboratory must be constructed, arranged, and maintained to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. This STANDARD is not met as evidenced by: . Based on observation and interviews, the laboratory failed to ensure contamination of its molecular testing area was minimized for four (March 2024 to July 2024) of four months since the laboratory blocked the entryway into the general laboratory space. Findings include: 1. The surveyor observed the laboratory space on 7/9/24 at 6: 10 pm. The laboratory consisted of two connected spaces: one for hematology and chemistry testing and the other for molecular testing. Both had separate access points on each end, but a refrigerator was installed in front of the chemistry and hematology laboratory section's door. Staff working in that area or staff dropping off specimens are required to walk through the molecular testing area to get to the chemistry and hematology testing areas. Staff do not wear laboratory coats and the laboratory does not utilize dead air boxes or biosafety cabinets. 2. An interview on 7/10/24 at 9:41 am with Testing Personnel #2 revealed the refrigerator blocking access to the chemistry and hematology laboratories was installed in March 2024. 3. An interview on 7/10/24 at 12:13 pm with Testing Personnel #1 confirmed staff are frequently walking through the molecular laboratory area creating a risk for contamination. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on observation, record review, and interviews, the laboratory failed to operate as a separate laboratory to comply with 493.43 for one (5/28/24 to 6/28/24) of one month of laboratory operations at 911 East Nine Mile Road in Ferndale Michigan. Findings include: 1. The surveyor observed the laboratory testing area, instrumentation, reagents, control and calibration materials are shared with Laboratory B located at the same address on 7/9/24 at 6:10 pm. 2. A review of the laboratory's Form CMS-209 revealed the laboratory shared testing personnel with Laboratory B. 3. The surveyor requested the laboratory's policies and procedures, quality assessment program, proficiency testing, verification of accuracy, competency assessments, staff training, maintenance records, temperature monitoring, and control procedures that were separate and distinct from Laboratory B on 7/9/24 at 7:56 pm and the documentation was not available. 4. An interview on 7/9/24 at 10:00 pm with the -- 3 of 11 -- Laboratory Director, the owner of the medical practice, and the Technical Supervisor confirmed the laboratories were not separate and distinct. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: . Based on record review and interviews, the laboratory failed to ensure the optimum integrity of patient specimens for Complete Blood Count (CBC) testing (refer to D5203) and failed to follow its competency assessment policies (refer to D5209). D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Supervisor, the laboratory failed to ensure the optimum integrity of patient specimens for Complete Blood Count (CBC) testing for two (Patients #4 and #5) of six patient test records reviewed. Findings include: 1. A review of patient test records revealed the following patients with CBC testing performed more than 24 hours after collection: a. Patient #4 had their specimen collected on 5/15/24 at 8:41 am and testing reported on 5/16/23 at 2:47 pm. b. Patient #5 had their specimen collected on 5/29/24 at 8:28 am and testing reported on 5/31/24 at 9:56 am. 2. An interview on 7/10/24 at 2:58 pm with the Technical Supervisor confirmed the specimens had exceeded 24 hours from collection to test reporting. 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 record review and interview with the Technical Supervisor, the laboratory failed to follow its competency assessment policies for one (Testing Personnel #5) of one testing personnel hired since January 2024. Findings include: 1. A review of the laboratory's "Employee Evaluations" policy revealed a section stating, "All new lab -- 4 of 11 -- employees will have a competency evaluation after their initial training, at the 6 month interval, 12 months and every year thereafter. The Competency Evaluation form will be filled-out. The evaluations will include the Director, Technical Consultant and Testing Personnel." 2. A review of Testing Personnel #5's competency assessment documentation dated 4/12/24 revealed a lack of assessment for each area of testing performed: molecular testing, chemistry testing using the Abbott Architect, and hematology testing using the Sysmex analyzer. The documentation also did not include the Director and Technical Consultant. 3. An interview on 7/10/24 at 1:44 pm with the Technical Supervisor confirmed the laboratory had not assessed and documented competency for Testing Personnel #5 for each testing area for which testing is performed. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: . Based on observations, record review, and interviews, the laboratory failed to follow its specimen collection, labeling, acceptability, and rejection policies (refer to D5403 A), failed to establish specimen acceptability and rejection procedures for its Complete Blood Count (CBC) testing (refer to D5403 B), failed to ensure calibrators and blood specimen collection tubes had not exceeded expiration dates (refer to D5417) and failed to perform

Summary Statement of Deficiencies D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: . Based on observation and interviews, the laboratory failed to perform its open- system polymerase chain reaction (PCR) panel testing in a uni-directional workflow and have separate areas for specimen and reagent preparation for 17 (July 2022 to January 2024) of 17 months. Findings include: 1. The surveyor observed the PCR testing laboratory on 1/17/24 at 9:07 am and noticed mechanical pipettes had been in only one area of the laboratory and the biohazardous waste was housed in front of the area with the mechanical pipettes. 2. A verbal walkthrough of the laboratory's PCR panel testing process on 1/17/24 at 9:26 am Testing Personnel #1 revealed the laboratory prepares reagents in the same area specimens are prepared. The post- amplification PCR plates are discarded in the reagent preparation and specimen testing area. 3. An interview on 1/17/24 at 9:26 am with Technical Consultant #2 confirmed the laboratory had not used a uni-directional workflow and did not have separate areas for specimen and reagent preparation. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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. 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 -- This STANDARD is not met as evidenced by: . Based on observation and interview with the Technical Consultant, the laboratory failed to ensure stool specimen collection containers had not exceeded expiration dates for 5 of 5 stool collection containers observed. Findings include: 1. The surveyor observed five formaldehyde stool collection containers with the expiration date of "8/23" during a tour of the laboratory on 1/17/24 at 9:26 am. 2. An interview on 1/17/24 at 1:56 pm with the Technical Consultant confirmed the stool collection containers identified had exceeded the expiration date. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (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 record review and interview with Technical Consultant #2, the laboratory failed to verify manufacturer's reference intervals were appropriate for the laboratory's patient population for 7 (Apolipoprotein A1, Gamma-glutamyl transferase, Apolipoprotein B, Insulin, Transferrin, C-Reactive Protein, and Lipoprotein A) of 38 routine chemistry analytes on the laboratory's test menu. Findings include: 1. A review of the laboratory's verification of performance data for its routine chemistry analytes revealed the following lacked verification of reference interval appropriateness for its patient population for the following analytes: a. Apolipoprotein A1 b. Gamma-glutamyl transferase c. Apolipoprotein B d. Insulin e. Transferrin f. C- Reactive Protein g. Lipoprotein A 2. An interview on 1/17/24 at 10:50 am with Technical Consultant #2 confirmed the laboratory had not verified the manufacturer's reference intervals were appropriate for its patient population. -- 2 of 2 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL 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 record review and interviews, the laboratory failed to make policies and procedures for specimen collection, criteria for specimen acceptability and rejection for its laboratory-developed molecular Urinary Tract Infection (UTI) and Respiratory panels available to laboratory personnel for 1 (5/27/22 to 6/27/22) of 1 month since the procedures were established. Findings include: 1. A review of the laboratory's Allegation of Compliance submission on 6/13/22 revealed the laboratory established policies and procedures for specimen collection, criteria for specimen acceptability and rejection for its laboratory-developed molecular Urinary Tract Infection (UTI) and Respiratory panels effective 5/27/22. 2. A review of the laboratory's policies and procedures on 6/27/22 revealed a lack of policies and procedures for specimen collection, criteria for specimen acceptability and rejection for its laboratory- developed molecular Urinary Tract Infection (UTI) and Respiratory panels. 3. The surveyor requested the policies and procedures for specimen collection, criteria for specimen acceptability and rejection for its laboratory-developed molecular Urinary Tract Infection (UTI) and Respiratory panels on 6/27/22 at 10:17 am and were not made available. 4. An interview on 6/27/22 at 10:17 am with General Supervisor #2 indicated the procedures were kept in the bathroom. 5. A review of the laboratory's collection procedure in the bathroom on 6/27/22 titled "Instructions for Collecting a Clean Catch Urine Sample" revealed to be a urine self-collection policy for patients and not the policies and procedures the laboratory established for specimen collection, criteria for specimen acceptability and rejection for its laboratory-developed 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 -- molecular Urinary Tract Infection (UTI) and Respiratory panels on 5/27/22. 6. An interview on 6/27/22 at 10:37 am with General Supervisor #2 confirmed the policies and procedures established on 5/27/22 had not been available to laboratory personnel. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (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. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview with General Supervisor #2, the laboratory failed to establish the criteria for acceptability for controls used with the laboratory- developed molecular Urinary Tract Infection (UTI) and Respiratory panels (RPP Custom Control lot 3324868 and UTI Custom Control lot 3324869) for the current control materials in use. Findings include: 1. The surveyor received an email on 6/27 /22 from General Supervisor #2 noting the laboratory had resumed its laboratory- developed molecular UTI and Respiratory panels. 2. The surveyor observed the positive control material for the UTI and Respiratory panels, RPP Custom Control lot 3324868 and UTI Custom Control lot 3324869, on 6/27/22 at 10:00 am. 3. An interview on 6/27/22 at 10:00 am with General Supervisor #2 revealed the laboratory its positive control results acceptability range to have a Cycle Threshold (Ct) value between 9 and 30 and pass the internal control. 4. A review of the laboratory's "Molecular Quality Control Policy" on 6/27/22 revealed a section stating, "If the controls are within the manufacturers stated range, then the run can be accepted and patient results reported." 5. A review of the laboratory's "ThermoFisher Scientific Custom DNA Control" documentation revealed the controls were developed specifically for the laboratory's panels and the manufacturer did not establish ranges for control acceptability for the custom control lots RPP Custom Control lot 3324868 and UTI Custom Control lot 3324869. 6. A review of the laboratory's "EXT POS CONTROL 3 DAY VALIDATION" revealed documentation of three runs with the control materials and did not include statistical parameters or acceptability criteria established by the laboratory. 7. An interview on 6/27/22 at 10:04 am with General Supervisor #2 confirmed the control materials did not have manufacturer ranges for acceptability and the laboratory did not have a process for establishing criteria for acceptability of control materials used in its laboratory-developed molecular Urinary Tract Infection (UTI) and Respiratory panels. -- 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: . Based on record review and interview with Technical Consultant #2 (TC2), the laboratory failed to ensure all authorized fact sheets were included with test results for 1 (Accula SARS-CoV-2 Test) of 3 tests used to detect SARS-CoV-2 infections. Findings include: 1. A review of the laboratory's "Accula SARS-CoV-2 Test" Instructions For Use (IFU) revealed a section stating "Authorized laboratories using the Accula SARS-CoV-2 test must include with test result reports all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media." 2. An interview on 4 /28/22 at 2:40 pm with TC2 revealed the laboratory did not include with test results all authorized fact sheets for the Accula SARS-CoV-2 assay. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. 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 -- This CONDITION is not met as evidenced by: . Based on record review and interviews, the laboratory failed to meet applicable analytic system requirements and correct identified problems. Findings include: 1. The laboratory failed to establish policies and procedures for specimen collection, criteria for specimen acceptability and rejection for its laboratory-developed molecular Urinary Tract Infection (UTI) and Respiratory panels. Refer to D5403. 2. The laboratory failed to perform calibration verification at least every 6 months for Unsaturated Iron-Binding Capacity (UIBC) and Lactate Dehydrogenase (LDH) testing. Refer to D5439. 3. The laboratory failed to perform two control materials for each molecular amplification procedure for its molecular Urinary Tract Infection (UTI) and Respiratory panels. Refer to D5455. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: . Based on record review and a interview with office liaison (OL) and the Office Manager (OM) , the laboratory failed to enroll in a proficiency testing program for 10 (March to December) of 10 months of operation for the urinary tract infection (UTI) and the respiratory pathogens panel (RPP) polymerase chain reaction (PCR) testing in 2020. Findings include: 1. A record review revealed there was no documentation of proficiency testing for 10 (March to December) of 10 months of operation in 2020. 2. On 12/04/2020 when requested per email to OL and the OM, the OM responded via a phone call on 12/09/2020 at 12:27 PM. 3. A phone interview on 12/09/2020 at 12:27 PM the OM stated the PCR testing was not enrolled in a proficiency testing program at the present time. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) 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 -- Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: . Based on observation and interview with Testing Personnel #2 (TP2), the laboratory failed to label the reagents on the processing table used for the polymerase chain reaction (PCR) testing with the preparation dates when the reagents were put into use for 10 (March to December) of 10 months in use. Findings include: 1. An observation by the surveyor on 12/03/2020 at 9:09 AM during a tour of the PCR lab, the following reagents were noted to be in use with no open dates recorded on the bottles for the 10 (march to December) of 10 months in use. a. Invitrogen Ultra distilled water lot 2186750 b. Gibco pH 7.4 lot 2120787 c. Applied Biosystems MagMax Viral /Pathogens Wash Buffer lot 2004016 d. Applied Binding Solution lot 1910006 e. Applied Biosystems MagMax Proteinase K lot 2008036 f. Applied Biosystems MagMax Viral/Pathogen Elution lot 2003012 g. Applied Biosystems MVP II Binding Beads lot 00951034 h. Ethanol for Molecular Biology i. Applied Biosystems MagMax Viral/Pathogens Wash lot 2007087 2. An interview on 12/03/2020 at 9:09 AM with TP2 confirmed the open dates had not been recorded on the bottles or a log when put into use. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on observation and interview with Testing Personnel #2 (TP2), the laboratory failed to perform and document the function checks as required by the manufacturer for the ThermoScientific and Genex Beta pipettes for 10 (March to December) of 10 months of use. Findings include: 1. During a tour of the laboratory on 12/03/2020 at 9: 09 AM, the surveyor noticed a pipette stand with 5 ThermoScientific pipettes and 1 Genex Beta pipette. 2. A review of the "Standard Operating Procedure" manual revealed a lack of documentation for the pipette calibration from the manufacturer and a policy or procedure for the pipette calibrations. 3. On 12/03/2020 at 1:46 PM when queried, TP2 stated that the manufacturer package inserts were discarded when the pipettes were unpacked for use. 4. During the interview on 12/03/2020 at 1:46 PM, TP2 confirmed there was no documentation of pipette calibrations from the manufacturer or an outside source and no policy or procedure for pipette calibration and function checks. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant #2 (TC2), the laboratory failed to provide reference intervals on the complete blood cell count (CBC) test reports for 2 (#1 and #3) of 10 patient charts audited for 2 years. Findings include; 1. A record review for 2 (#1 and #3) of 10 patient charts audited revealed the test reports did not have a reference range listed on the final report in the electronic medical record (EMR) system for the following hematology parameters: a. red blood cell distribution width - SD b. mean platelet volume c. neutrophil % d. lymphocyte % e. mixed cell % f. eosinophil % g. basophil % 2. During an interview on 12/03/2020 at approximately 12:00 PM, TC2 confirmed the final CBC report in the EMR system did not contain all of the parameter reference ranges. -- 3 of 3 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to retain 1) the maintenance records for the chemistry Abbott Architect Plus ci 4100 analyzer for 12 (April 1, 2017 to March 6, 2018) of 18 months reviewed and 2) the daily hematology Sysmex XS-1000i analyzer background counts for 11 (September 2016 to July 2017) of 19 months reviewed in 2016, 2017, and 2018. Findings include: 1. On March 6, 2018 at 1:05 p.m. and 1:45 p.m., review of maintenance records revealed a lack of documentation for the chemistry analyzer and hematology analyzer as follows: a. chemistry Abbott Architect Plus ci 4100 - no monthly maintenance records for 12 of 18 months reviewed in 2016, 2017, and 2018 b. hematology Sysmex XS-1000i - no daily background counts for 11 of 19 months reviewed in 2016, 2017 and 2018 2. During the interview on March 6, at 1:05 and 1:45 p.m., technical consultant #2 as listed on the CMS-209 confirmed the records were not available on the day of the survey for the surveyor. 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: 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 record review and interview, the laboratory failed to verify the accuracy of testing for the endocrinology testing at least twice annually for two (2016 and 2017) of two years reviewed. Findings include: 1. On March 6, 2018 at 11:24 a.m., record review of the at least twice annual verification of accuracy for the endocrinology folate, ferritin, prostate-specific antigen (PSA) and the vitamin B12 testing revealed there was no documentation for: a. second verification in 2016 b. twice annual verification in 2017 2. During the interview on March 6, 2018 at 11:24 a.m., technical consultant #2 as listed on the CMS-209 confirmed the endocrinology testing was not verified for accuracy at least twice annually in 2016 and 2017. 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 record review and interview, the laboratory failed to perform and document the hematology Sysmex XS-1000i monthly maintenance for three (June and November 2017 and February 2018) of 18 months reviewed. Findings include: 1. On March 6, 2018 at 12:40 p.m., record review of the monthly "Maintenance Log Sysmex XS-1000i" log revealed there was no documentation to show the laboratory had performed the monthly maintenance for three of 18 months reviewed in 2016, 2017, and 2018. 2. During the interview on March 6, 2018 at 12:40 p.m., technical consultant #2 as listed on the CMS-209 confirmed the monthly maintenance tasks were not completed and documented as required for 2016, 2017, and 2018. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to perform and evaluate one (first calibration in 2017) of three Abbott Architect Plus ci 4100 chemistry analyzer calibration verifications at least once every six months as required. Findings include: 1. When requested on March 6, 2018 at 11:24 a.m., the technical consultant #2 as listed on the CMS-209 was not able to provide documentation showing the calibration verification was completed for one (first calibration in 2017) of three every six month calibrations in 2016 and 2017. 2. During the interview on March 6, 2018 at 11:24 a.m., the technical consultant confirmed the calibration verification was not completed at least every six months in 2017. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . Based on document review and interview, the laboratory failed to establish a system to ensure the Abbott Architect ci 4100 instrument chemistry tests values that were reported using calculations were accurately sent from point of entry to the final report for accuracy during the 18 (September to December 2016, 2017 and January to present date 2018) of 18 months of patient testing. Findings include: 1. On March 6, 2018 at 1:58 p.m., document review for the Abbott Architect Plus ci 4100 chemistry instrument identified five [estimated glomerular filtration rate (EGFR), urea nitrogen (BUN)/creatinine ratio, albumin/globulin (A/G) ratio, globulin, and the low density lipoprotein (LDL)] tests that require an instrument calculation. 2. On March 6, 2018 at 1:58 p.m. when queried, technical consultant #2 as listed on the CMS-209 was not able to provide the surveyor documentation that the calculations were checked for accuracy. 3. During the interview on March 6, 2018 at 1:58 p.m., technical consultant #2 confirmed the calculations were not checked for accuracy. -- 3 of 3 --