Tennessee Oncology Pllc

Summary Statement of Deficiencies D0000 Intakes: TN00062174 The laboratory was found to NOT be in compliance with the following 42 CFR PART 493, Requirements for Laboratories for the specialties /subspecialties for which it was surveyed: CFR 493.801 Condition: Enrollment and testing of samples CFR 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director Surveys were performed on the following laboratories: Laboratory A: Recertification Survey CLIA #44D1066106 Tennessee Oncology PLLC 250 25th Ave. N., STE 412 Nashville, TN 37203 Laboratory A does not perform testing for reticulocyte count. Testing performed: Complete Blood Count with automated White Blood Cell Differential (CBC w/Diff) Enrolled in Proficiency Testing (PT) with Medical Laboratory Evaluation (MLE) (Customer #014511) Laboratory B: Complaint & Recertification Survey 44D0882942 Tennessee Oncology PLLC 250 25th Ave. N. STE 100 Nashville, TN 37203 Testing performed: CBC w /Diff Reticulocyte Count (Retic) Protime (PT) Activated Partial Thromboplastin Time (PTT) Fibrinogen Fibrin Degradation Products (D-Dimer) General Chemistry Testing Enrolled in PT with Medical Laboratory Evaluation (MLE) (Customer #006664) Laboratory C: Complaint Survey 44D2120027 Tennessee Oncology PLLC 4488 Carothers Parkway, STE 310 Franklin, TN 37067 Laboratory C does not perform testing for PT, PTT, Fibrinogen and D-Dimer. Testing Performed: CBC w/Diff Chemistry Endocrinology Immunology Cytogenetics Enrolled in PT with the College of American Pathologists (CAP) (Customer #8095230-01) All three laboratories have the same technical consultant. Laboratory A and Laboratory B have the same laboratory director. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 observation of the laboratory, review of the laboratory's proficiency testing records and the Centers for Medicare & Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), patient test reports, interviews and review of email communications, the laboratory failed to ensure PT samples from other laboratories were not tested. The reticulocyte proficiency testing (PT) samples for Lab A were sent to Lab B to be performed for three of three PT events in 2022 - six of six retic samples (Refer to D2013 Citation number one) and the coagulation PT samples for Lab C were sent to Lab B to be performed for 2022 event two, 2022 event three, and 2023 event one--- seven samples per PT event for a total of twenty-one PT samples for coagulation testing (Refer to D2013 Citation number two). D2013 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(4) The laboratory must not send proficiency testing samples or portions of proficiency testing samples to another laboratory for any analysis for which it is certified to perform in its own laboratory. Any laboratory that CMS determines intentionally referred a proficiency testing sample to another laboratory for analysis may have its certification revoked for at least one year. If CMS determines that a proficiency testing sample was referred to another laboratory for analysis, but the requested testing was limited to reflex, distributive, or confirmatory testing that, if the sample were a patient specimen, would have been in full conformance with written, legally accurate and adequate standard operating procedures for the laboratory's testing of patient specimens, and if the proficiency testing referral is not a repeat proficiency testing referral, CMS will consider the referral to be improper and subject to alternative sanctions in accordance with 493.1804(c), but not intentional. Any laboratory that receives a proficiency testing sample from another laboratory for testing must notify CMS of the receipt of that sample regardless of whether the referral was made for reflex or confirmatory testing, or any other reason. This STANDARD is not met as evidenced by: Citation Number One: Reticulocyte Count Based on observation of the laboratory, review of the laboratory's proficiency testing (PT) records, the Centers for Medicare & Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), staff interviews, review of patient test reports, and review of email communications, laboratory B failed to ensure PT samples assigned under the PT enrollment for Lab A for reticulocyte count were not tested when the samples were sent to their lab for analysis for 2022 events one, two, and three for six of six reticulocyte PT samples. The findings include: 1. Observation of the laboratory on 04/19/23 at 8:50 am revealed the Sysmex XN 550 (serial #17517) in use for performing patient testing for CBC w/Diff and reticulocyte count. 2. Review of the laboratory's Hematology PT records and the Form CMS-209 revealed the following: Documentation provided during survey of this laboratory: The PT attestation statement for 2022 event one for Lab A was in the PT records for Lab B and signed by a testing person who worked in Lab B. The PT attestation statement for 2022 event three for Lab A was in the PT records for Lab B and signed by testing personnel that worked in Lab B. The date the -- 2 of 6 -- attestation statement was signed was 09/15/22. The MLE ID number for Lab A (014511) was recorded on the submission form. The instrument printouts for retic count for 2022 event three had the name, address, CLIA number and instrument serial number (17517) of Lab B. Documentation provided during survey of Lab A: 2022 Event A Retic The retic PT instrument printouts for 2022 event one, labeled RT-1 and RT-2, were dated 02/11/2022 and had the name, address, CLIA number and instrument serial number (17517) of the instrument located in Lab B. The attestation statement had an additional signature of a testing person who worked in Lab B. The results were submitted on 02/11/22. The event cutoff date was 02/25/22. The performance evaluation report for 2022 Event A included reporting for retics. 2022 Event B Retic The retic PT instrument printouts for 2022 event two, labeled RT3 and RT4, were dated 05/18/2022 and had the name, address, CLIA number and instrument serial number (17517)of the instrument located in Lab B. The attestation statement had an additional signature of a testing person who worked in Lab B. The results were submitted on 05/19/22. The event cutoff date was 06/03/22. The performance evaluation report for 2022 Event B included reporting for retics. 2022 Event C Retic The retic PT instrument printouts for 2022 event three, labeled RT5 and RT6, were dated 09/15/2022 and had the name, address,CLIA number and instrument serial number of the instrument located in Lab B. The attestation statement had an additional signature of a testing person who worked in Lab B. The results were submitted on 09 /15/22. The date of the testing personnel signature on the attestation statement was 09 /15/22. The event cutoff date was 09/30/22. The performance evaluation report for 2022 Event C included reporting for retics. PT samples tested on instrument serial #17517, located in Lab B were RT-1 and RT-2 for 2022 event one, RT-3 and RT-4 for 2022 event two and RT-5 and RT-6 for 2022 event three. 3. During an interview with the laboratory lead for Lab A on 04/10/23 at 12:30 pm the following was communicated: CBC instrument serial number 17517 (that performs retic) was moved to the downstairs lab (Lab B) that operates under the CLIA number 44D0882942 on 10 /28/21. When the 2022 PT samples for Lab A were delivered, the retic samples were taken to the downstairs lab (Lab B) to be performed since the upstairs lab (Lab A) did not have the capability to perform the retic counts. She stated that she had sent the updated PT change form to her supervisor, but for whatever reason it never got corrected with the PT program. A copy of the 2022 change form completed after the first event of 2022 was provided via subsequent email. 4. Review of patient test reports for testing performed after the move revealed the following: The last retic count performed for Lab A on instrument serial number 17517 was performed on 10 /28/21 (patient MRN 425311). The first retic count performed for Lab B was on instrument serial number 17517 performed on 10/29/21 (patient MRN 521528). 5. During a phone interview with the laboratory's PT provider (MLE) on 04/14/23 at 3: 20 pm, the customer service representative stated that the PT program did not have a record of any type of communication from Lab B for changes to their 2022 PT enrollment. 6. During an interview on 04/19/23 at 12:43 pm with the testing person who performed the PT testing for retic for 2022 events one and two, the testing person stated that the primary testing person in the Lab A brought the retic PT samples to the downstairs lab (Lab B) to be performed. He performed the testing, but did not enter on the PT provider website since he did not have the authorization for Lab A. 7. During a phone interview on 04/21/23 at 12:30 pm with the primary testing person in Lab A the following was communicated: The testing person was on leave during the transition period. When she came back on 01/27/22 the instrument that performs retic had been moved downstairs (Lab B). When the first PT event for 2022 came in the retic samples were included in the shipment. She stated she contacted the laboratory lead and was instructed to take them downstairs to Lab B to be performed. After the retic testing was complete she picked up the reports and entered them into the MLE data -- 3 of 6 -- submission for Lab A. PT samples for the upstairs lab (Lab A) kept coming for 2022 that included the retic samples. She was instructed to take the retic samples downstairs to Lab B and have the testing personnel in Lab B perform the testing. She then entered them on the MLE site under the PT enrollment for Lab A. 8. Review of email communication received on 04/21/2023 at 12:46 pm from the primary testing person in Lab A revealed communication on 02/09/22 at 1:16 pm for 2022 event one with instructions for taking the retic samples to Lab B to be performed. Additional email communication on 09/15/22 at 9:03 am revealed the retic for 2022 event three were also performed by Lab B. 9. During a phone interview on 04/21/23 at 3:08 pm with the testing person from Lab B who performed retic PT testing for 2022 event three, the following was communicated: The retic samples were brought to Lab B from the upstairs lab (Lab A) by the primary testing person. They were instructed to run the retic samples. The results were then put into the MLE website for evaluation by the primary testing person in Lab A. 10. Phone interview with the director of Lab C on 05 /10/23 at 2:45 pm confirmed the survey findings related to sharing of PT samples across sites. Citation number two: Coagulation Testing to include PT, PTT, Fibrinogen and D-Dimer Based on observation of the laboratory, review of the laboratory's proficiency testing (PT) records, the Centers for Medicare and Medicaid Casper Report 155 (CMS 155), document request, staff interviews, review of patient test reports, and review of email communications, laboratory B failed to ensure the PT samples assigned to Lab C for coagulation testing were not tested by Lab B for PT, PTT, Fibrinogen and D-Dimer for 2022 event two, 2022 event three, and 2023 event one. Each event included five samples for PT, PTT, and Fibrinogen and two samples for D-Dimer for a total of 21 PT samples in 2022 and 2023. The findings include: 1. Observation of the laboratory on 04/10/23 at 8:50 am revealed the ACLTOP 350 (serial #20072163) in use for performing patient testing for PT, PTT, Fibrinogen and D-Dimer. 2. Review of the laboratory's PT records revealed no proficiency testing records for the coagulation testing. 3. Review of the CMS 155 revealed no proficiency testing scores for the regulated coagulation analytes (PT, PTT and Fibrinogen). 4. A request was made to the technical consultant on 04/19/23 at approximately 10:30 am for the proficiency testing records for coagulation. She stated that the records were at their other lab in Franklin (Lab C) and she would have a courier bring them over. She further stated they were enrolled with CAP. 5. Review of the coagulation proficiency testing records provided during survey of this laboratory and additional documentation provided during the survey of Lab C revealed the following: Documentation provided during survey of this laboratory: 2022 Event B (CGL-B) The name and address of Lab C (Franklin) was on the CAP PT reports. The serial number on the instrument printouts was 20072163. The PT instrument printouts (dated 05/18 /22) were labeled as CG-DD3 and CG-DD4 for D-Dimer; CGL-6, CGL-7, CGL-8, CGL-9, CGL-10 for PT, PTT and Fibrinogen with "Tennessee Oncology Core Laboratory" on the printouts. The attestation statement was signed by a testing person who worked in Lab B and by the technical consultant for Lab A, Lab B, and Lab C. The event cutoff date was 05/31/22. 2022 Event C (CGL-C) The name and address of Lab C (Franklin) was on the CAP PT reports. The serial number on the instrument printouts was 20072163. The PT instrument printouts (dated 09/21/2022 for D-Dimer and 09/14/2022 for PT, PTT and Fibrinogen) were labeled as CG DD5 and CGDD6 for D-Dimer; CGL-11, CGL-12, CGL-13, CGL-14, CGL-15 for PT, PTT and Fibrinogen, with "Tennessee Oncology Core Laboratory" on the printouts. The results transaction history had the name of a testing person who did not work in this laboratory for the "approved" status dated 09/28/22. Attestation signed by testing person who worked at Lab B and by the technical consultant for Lab A, Lab B, and Lab C. The event cutoff date was 10/07/22. 2023 Event A (CGL-A) The name and address of Lab C (Franklin) was on the CAP PT reports. Documentation provided -- 4 of 6 -- during survey of Lab C: 2022 Event B (CGL-B) Attestation signed by testing person who worked at Lab B and by the technical consultant for Lab A, Lab B, and Lab C. The serial number on the instrument printouts was 20072163 (instrument observed in use on the date of the survey - 04/19/23). The PT instrument printouts (dated 05/18 /22) were labeled as CG-DD3 and CG-DD4 for D-Dimer; CGL-6, CGL-7, CGL-8, CGL-9, CGL-10 for PT, PTT and Fibrinogen with "Tennessee Oncology Core Laboratory" on the printouts. The event cut-off date was 05/31/22. 2022 Event C (CGL-C) Attestation signed by testing person who worked at Lab B and by the technical consultant for Lab A, Lab B, and Lab C. The serial number on the instrument printouts was 20072163 (instrument observed on the date of the survey - 04 /19/23). The PT instrument printouts (dated 09/21/2022 for D-Dimer and 09/14/2022 for PT, PTT and Fibrinogen) were labeled as CG DD5 and CGDD6 for D-Dimer; CGL-11, CGL-12, CGL-13, CGL-14, CGL-15 for PT, PTT and Fibrinogen, with "Tennessee Oncology Core Laboratory" on the printout. The transaction history report for 2022 event three indicated the upload approval to CAP was performed by a testing person who works in Lab C on 09/28/22. The event cut-off date was 10/07/22. 2023 Event A (CGL-A) Attestation signed by testing person who worked at Lab B and the technical consultant for Lab A, Lab B, and Lab C. The serial number on the instrument printouts was 20072163 (instrument observed on the date of the survey - 04 /19/23). The PT instrument printouts (dated 01/30/2023) were labeled as CG-DD1 and CG-DD2 for D-Dimer; CGL-01, CGL-02, CGL-03, CGL-04, CGL-05 for PT, PTT and Fibrinogen, with "Tennessee Oncology Core Laboratory" on the printout. The transaction history report for 2023 event one indicated the upload to CAP was performed by a testing person who works at Lab C on 02/07/23. The event cut-off date was 02/14/23. 6. Interview with the technical consultant on 04/19/23 at approximately 12:15 pm revealed the following: Lab C was enrolled in PT for coagulation testing. The ACLTOP 350 coagulation instrument was moved to Lab B "about a year ago." The proficiency testing samples for coagulation were sent by courier from Lab C to Lab B to be performed since that was where the instrument was located. She stated Lab C no longer performed PT, PTT, Fibrinogen and D-Dimer. She communicated that she did not understand that the CAP number was associated with a specific CLIA number. 7. Review of patient test records revealed the first patient testing for PT and PTT was performed on 10/18/21 in Lab B (patient MRN 421127). 8. Interview on 04/19/23 at 5 pm with the technical consultant and laboratory supervisor for Lab B confirmed that the coagulation PT samples for Lab C were received and tested in Lab B for 2022 events two and three, and 2023 event one. 9. Phone interview on 04/21/23 at 3:08 pm with the testing person who performed the coagulation PT for 2022 event two revealed the following: A courier brought the coagulation PT samples to them to be run since they had the instrument used for performing coagulation testing. The samples received were assigned to Lab C, but they were performed at Lab B. She further stated that she then entered the results on the CAP website. 10. Phone interview with the director of Lab C on 05/10/23 at 2:45 pm confirmed the survey findings related to sharing of PT samples across laboratory sites A, B, and C. 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. -- 5 of 6 -- This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing policy, the laboratory's proficiency testing records, and staff interviews, the laboratory director for Lab A failed to ensure the laboratory did not test PT samples from other laboratories. (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 review of the laboratory's proficiency testing policy, review of proficiency testing records and staff interviews, the laboratory director failed to ensure reticulocyte and coagulation PT samples were not tested when received from other laboratories in 2022 and 2023. The findings include: 1. Review of the laboratory's proficiency testing policy revealed the following statements: "Samples CANNOT be shared" 2. Review of proficiency testing records and staff interviews revealed following: The retic PT samples assigned to Lab A were sent to Lab B to be performed and then submitted under the PT enrollment for Lab A. (Refer to D2013 Citation One) The coagulation PT samples assigned to Lab C were sent to Lab B to be performed and then submitted under the PT enrollment for Lab C. (Refer to D2013 Citation Two) 3. Interview with the director of Lab C on 05/10/23 at 2:45 pm confirmed the survey findings. -- 6 of 6 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted with an onsite exit date of 04/19/23, but additional information was being gathered through 04/21/23. The facility was found NOT to be in compliance with the following 42 CFR Part 493, Requirements for Laboratories for the specialties/subspecialties for which it was surveyed: 493.801 Proficiency Testing 493.1215 Hematology 493.1403 Laboratory Director 493.1409 Technical Consultant 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 observation of the laboratory, review of patient test reports, staff interview, phone interview with the laboratory's proficiency testing provider, and email communications, the laboratory failed to enroll in proficiency testing for the regulated coagulation analytes for Prothrombin Time (PT), Activated Partial Thromboplastin Time (PTT) and Fibrinogen from the time the laboratory began patient testing on 10 /18/21 until the date of the survey on 04/19/23 with a total of 27,550 regulated coagulation tests reported. The findings include: 1. Observation of the laboratory on 04 /19/23 at 8:45 am revealed the Instrumentation Laboratories ACLTOP350 coagulation instrument on the counter in use for patient testing for regulated coagulation analytes (PT, PTT, and Fibrinogen). 2. Review of patient test reports revealed the first patient Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- for PT, PTT was reported on 10/18/21 (MRN 421127) and the first patient for fibrinogen was reported on 10/19/21 (MRN 331556). 3. In an interview with the technical consultant on the date of the survey (04/19/23) at 5 pm the technical consultant confirmed the laboratory had not been enrolled in proficiency testing for the regulated coagulation analytes in 2022 and 2023. 4. During a phone interview with the laboratory's proficiency testing provider (American Association of Bioanalysts Medical Laboratory Evaluation (AAB/MLE)) on 04/21/23 at 2:40 pm, the customer service representative stated there was no enrollment with AAB/MLE for coagulation modules. 5. An email received from the AAB/MLE proficiency testing program on 04 /21/23 at 3:29 pm with a copy of the order verification for the laboratory revealed no enrollment for coagulation testing for year 2023. 6. Email received from the technical consultant on 04/21/23 at 3:18 pm revealed the following patient test counts since testing began on 10/18/21. PT/INR 16005 PTT 9365 Fibrinogen 2180 D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of the laboratory procedure manual, manufacturer reagent package inserts, PT reagent lot history records, lack of documentation, patient test reports, staff interviews, email communications, and phone interviews, the laboratory failed to meet the condition of hematology. The laboratory failed to follow the policy for use of platelet poor plasma for frozen coagulation analytes (Refer to D5401), and failed to follow manufacturer instructions for establishing the Patient Normal Mean (used in the calculation of patient International Normalized Ratio(INR)) for new lots of Prothrombin Time (PT) reagent (Refer to D5411), resulting in IMMEDIATE JEOPARDY. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's personnel records, personnel policy, and staff interview, the laboratory personnel policy did not include assessing technical consultant (TC) competency, as required. The findings include: 1. Review of the laboratory personnel records revealed the following: Delegation of technical consultant duties by the lab director to one TC. There were no records for documentation of technical consultant competency by the director of the lab for 2021, 2022, and 2023. 2. Review of the laboratory personnel competency policy revealed no requirement for assessment of technical consultant competency. 3. Phone interview with the technical consultant on 04/25/23 at 2:20 pm confirmed the laboratory personnel competency policy did not include a requirement for technical consultant competency assessment performed by the lab director. -- 2 of 6 -- 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 observation of the laboratory, review of the laboratory procedure manual, review of patient test reports, phone interview with the laboratory lead, and email communication, the laboratory failed to ensure the frozen plasma used for performing patient coagulation testing was platelet poor as required by their own procedure since patient testing began on 10/18/21 with a total of approximately 204 patients performed since testing began. 1. Observation of the laboratory on 04/19/23 at 8:45 am revealed the Instrumentation Laboratories ACLTOP350 instrument in use for performing patient coagulation testing to include Prothrombin Time (PT) with INR calculation, Activated Partial Thromboplastin Time (PTT), Fibrinogen, and Fibrin Degradation Products (D-Dimer). Also observed was a centrifuge used for processing coagulation samples for testing (Beckman Coulter Allegra X30). 2. Review of the laboratory procedure manual revealed the following: "If testing is delayed by >24 hours centrifuge the sample and freeze platelet poor plasma at -20C." 3. Review of patient test reports revealed patient coagulation testing began on 10/18/21 (patient 421127). 4. During a phone interview with the laboratory lead on 04/21/23 at 11:40 am the following was discussed and confirmed: The laboratory receives frozen samples for coagulation testing if testing is delayed. A request was made for records of centrifuge validations for platelet poor plasma. The laboratory does not have a process in place to ensure the plasma is platelet poor. The centrifuge in use had not been validated to ensure platelet poor plasma is produced. The laboratory lead confirmed the laboratory failed to ensure the frozen plasma used for performing patient coagulation testing was platelet poor from the time testing began on 10/18/21 until the date of the survey on 04/19/23. 5. Email communication received from the technical consultant on 04/21/23 at 03:18 pm revealed an estimated total 204 patients tested from frozen plasma since testing began on 10/25/21. 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: Based on observation of the laboratory, review of manufacturer package insert, reagent lot history record, document request, patient test results, staff interview, email communication and phone interview with the technical consultant, the laboratory failed to perform Patient Normal Mean determination for two of two new lots of RecombiPlasTin 2G Prothrombin Time reagent before placing into use beginning 05 /02/22 until the date of the survey on 04/19/23 according to the manufacturer's requirements. The findings include: 1. Observation of the laboratory on 04/19/23 at 8: -- 3 of 6 -- 45 am revealed the Instrumentation Laboratories ACLTOP350 instrument in use for performing patient coagulation testing to include Prothrombin Time (PT) with INR calculation, Activated Partial Thromboplastin Time (PTT), Fibrinogen, and Fibrin Degradation Product (D-Dimer). The current lot of RecombiPlasTin 2G PT reagent observed in use was N0824895. 2. Review of the manufacturer package insert revealed the following statement: "Enter the ISI value from the insert and establish the Mean of the PT Normal Range with each new lot." 3. Review of the RecombiPlasTin 2G PT reagent lot history records revealed the following: Lot N1218411 activated /placed into use on 05/02/22 Lot N0824895 activated/placed into use on 11/29/22 4. Request made to the laboratory lead on 04/19/23 at 2:45 pm for the Patient Normal Mean study for lot N1218411 and lot N0824895 revealed no documentation was available. 5. Review of patient test results revealed patient number 479210 had PT /INRs reported on 11/7/22, 12/5/22, 12/19/22, 01/03/23, and 01/17/23 during the period when the lots were in use without a Patient Normal Mean determination study performed to use in the calculation of the INR. 6. Interview with the laboratory lead and the technical consultant on 04/19/23 at 5:00 pm confirmed the laboratory failed to establish the Patient Normal Mean for two new lot numbers of RecombiPlasTin 2G Prothrombin Time reagent beginning 05/02/22 until the date of the survey. 7. Email communication received on 04/20/23 at 6:33 am from the laboratory technical consultant revealed a total of 502 patient PT/INR results have been reported since 05 /02/22. 8. Phone interview with the technical consultant on 04/21/23 at 9:15 am confirmed the laboratory primarily performs the PT/INRs for monitoring of patient coumadin therapy. 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 observation of the laboratory, review of coagulation lot validation studies, and staff interviews, the laboratory director failed to ensure patient testing was performed in a manner to ensure accurate patient test results (Refer to D6007). D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) 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)(1) 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 observation of the laboratory, review of the laboratory procedure manual, manufacturer package inserts, patient test reports, phone interviews, and email -- 4 of 6 -- communications,the laboratory director failed to ensure the procedure for the use of platelet poor plasma was followed when frozen specimens were tested (Refer to D5401), and failed to ensure accurate analytic performance was maintained for the calculated INR used for monitoring patient coumadin therapy for two of two reagent lots from 05/02/22 until the date of the survey on 04/19/23 with a total of 502 patient PT/INR results reported since the new lots were started on 05/02/22. (Refer to D5411) D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of patient test records, technical consultant delegation of duties list, review of Casper report 0155D (Individual Laboratory Profile of proficiency testing scores) (CMS 155), the laboratory's proficiency testing records, and staff interview, the technical consultant failed to ensure enrollment and participation in proficiency testing for regulated analytes. (Refer to D6041) D6041 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(3) (b) The technical consultant is responsible for-- (b)(3) Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered; This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of patient test records, the list of duties delegated to the technical consultant by the lab director, the report CMS 155 and interview with the technical consultant, the technical consultant failed to ensure the laboratory was enrolled in proficiency testing for regulated analytes for coagulation and chemistry tests in 2021, 2022 and 2023. The findings include: 1. Observation of the laboratory on 04/19/23 at 8:45 am revealed instruments in use for patient testing for general chemistry, coagulation, and hematology. Testing performed included regulated analytes for all test systems. 2. Review of patient test records revealed the following: Chemistry testing began on 05/24/21 (patient MRN 520887) Coagulation testing began on 10/18/2021 (patient MRN 421127) 3. Review of the technical consultant delegation of duties list revealed the following as delegated by the laboratory director: "Enrollment of the laboratory in a CMS-approved proficiency testing (PT) program for the test performed." 4. Review of the CMS 155 revealed no proficiency testing scores for the regulated coagulation tests or the regulated chemistry tests. 5. Review of the laboratory's proficiency testing records revealed the following: No enrollment in proficiency testing for the regulated coagulation tests to include Prothrombin Time (PT), activated Partial Thromboplastin Time (PTT) and Fibrinogen in 2022 or 2023. No enrollment in proficiency testing for regulated chemistry analytes in 2021 or 2022 to include Glucose, Blood Urea Nitrogen, Sodium, Potassium, Chloride, Total Bilirubin, Aspartate Aminotransferase (AST/SGOT), Alanine Aminotransferase (ALT/SGPT), Total Protein, Calcium, Alkaline -- 5 of 6 -- Phosphatase, Albumin, Lactate Dehydrogenase (LDH), Magnesium, and Uric Acid. 6. Interview with the technical consultant on 04/19/23 at 5:00 pm confirmed the technical consultant failed to ensure the laboratory was enrolled in proficiency testing for regulated analytes for coagulation in 2022 and 2023 and for regulated chemistry analytes in 2021 and 2022. -- 6 of 6 --

Summary Statement of Deficiencies D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of the Medical Laboratory Evaluation (MLE) summary report for Hematocrit testing second event 2017 and interview with the Laboratory Supervisor revealed the laboratory failed to review and document remedial action for failed hematocrit analyte results second event 2017. Finding Include: 1. Review of the MLE summary report for Hematocrit testing second event 2017 revealed the laboartory failed to review and document remedial action for failed hematocrit analyte results second testing event 2017. 2. Interview with the Laboratory Supervisor on May 23,2018 at 13:25 pm confirmed the laboratory failed to review and document remedial action for failed hematocrit analyte results second testing event 2017. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. 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 lack of record review for comparison of test results using two of the same Complete Blood Count (CBC) analyzers and interview with the Laboratory Supervisor the laboratory failed to perform comparison of test results using two of the same CBC analyzers in 2016 and 2017. The Findings Include: 1. Lack of record review for comparison of test results using two of the same CBC analyzers the laboratory failed to perform comparison of test results for two of the same CBC analyzers in 2016 and 2017. 2. Interview with the Laboratory Supervisor on May 23, 2018 at 13:20 PM confirmed the laboratory failed to perform comparison of test results for two of the same CBC analyzers in 2016 and 2017. D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on review of validation records for Access-2 immunoassay analyzer and interview with the Technical Consultant failed to review and evaluate the verification data in July 2017. The Finding Include: 1. Review of the validation records for Access-2 immunoassay analyzer revealed the validation records were not reviewed for vitamin B-12, Vitamin-D and Folate analytes in July 2017 by the Technical Consultant. 2. Interview with the Laboratory Supervisor on May 23, 2018 at 1:15 pm confirmed the Technical Consultant failed to review the validation records for Vitamin B-12, Vitamim-D and Folate analytes in July 2017. -- 2 of 2 --