Cardiovascular Clinic Of West Tn Pc

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: 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: Based on a proficiency testing desk review from the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER) 0155 report and the laboratory's American Proficiency Institute (API) 2025 Proficiency Testing (PT) records, the laboratory failed to successfully participate 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 failed to successfully participate in PT for the analyte Erythrocyte count (Red Blood Cell) (RBC). Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a PT desk review of the CASPER 0155 report and the laboratory's 2025 API PT records, the laboratory failed to achieve satisfactory performance (80% or better) for the same analyte for two consecutive testing events in the subspecialty of Hematology for the analyte RBC. The findings include: 1. A review of the CASPER 0155 report revealed the following results: An unsatisfactory score of 0% for the RBC analyte for 2025 Event Two. An unsatisfactory score of 60% for the RBC analyte for 2025 Event Three. 2. A review of the laboratory's 2025 API PT records confirmed the laboratory received the above results. 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 proficiency testing desk review of the CASPER 0155 report and the laboratory's 2025 API PT records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure proficiency testing samples were tested as required. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and the laboratory's 2025 API PT records, the laboratory director failed to ensure proficiency testing samples were tested as required. The laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D0000 During a recertification survey conducted on 01/16/2025, the laboratory was found out of compliance with 493.1210 Condition: Routine Chemistry. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on laboratory observation, a review of the laboratory's Individualized Quality Control Plan for the Abaxis Piccolo Express chemistry instrument, quality control records, patient test records, and staff interview, the laboratory failed to follow the Quality Control procedure for the Abaxis Piccolo Express instrument (Refer to D5401) and failed to verify the control ranges used for evaluating quality control data for the Abaxis Piccolo Express instrument (Refer to D5469). D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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's Individualized Quality Control Plan (IQCP) for the Abaxis Piccolo Express, a review of 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 3 -- laboratory's quality control (QC) records, patient test results and staff interview, the laboratory failed to follow the QC plan for the Abaxis Piccolo Express chemistry instrument in 2024 when the system was not re-validated during gaps in QC performance, the laboratory failed to perform two levels of QC on 01/24/2024, and QC for the Lactic Dehydrogenase (LDH) analyte was not repeated when level two QC was unacceptable on 06/17/2024, with four patients reported after the unacceptable QC run and the next acceptable QC run. Approximately 35 patient chemistry panels were reported during the 2024 calendar year when the QC Plan for the Abaxis Piccolo Express was not followed. 1. Observation of the laboratory on 01/16/2025 at 8:15 a.m. revealed the Abaxis Piccolo Express instrument used for patient testing for Sodium (Na+), Potassium (K+), Chloride (Cl-), Total Carbon Dioxide (CO2), Glucose (Glu), Blood Urea Nitrogen (BUN), Creatinine (Crea), Calcium (Ca+), Lactate Dehydrogenase (LDH), and Magnesium (Mg) analytes using the Basic Metabolic Plus test disc. 2. A review of the laboratory's IQCP for the Abaxis Piccolo revealed the following statements under the section titled "Liquid QC": "2 levels of QC must be performed, with every new lot #, new shipment or every 30 days. Document the assay ranges and ensure all QC was in acceptable ranges. If a level should fail it must be repeated and in acceptable range before patient testing is performed. If over 30 days pass before QC is run, a validation must be performed. Validation is performed by running 2 levels of QC, 3 times each and all in acceptable ranges. This validation must be completed before patient testing may be done." 3. A review of the laboratory's QC records for the Abaxis Piccolo revealed the following: Level one QC was performed on 01/24/2024. QC was not performed again until 03/26/2024. There was no documentation that the re-validation was performed when there was a gap in QC performance. Level two QC was not performed on 01/24/2024. QC was performed on 04/25/2024. QC was not performed again until 06/17/2024. There was no documentation that the re-validation was performed when there was a gap in QC performance. QC was performed on 06/17/2024. QC was not performed again until 07 /22/2024. There was no documentation that the re-validation was performed when there was a gap in QC performance. QC was performed on 08/29/2024. QC was not performed again until 12/02/2024. There was no documentation that the re-validation was performed when there was a gap in QC performance. The level two quality control for LDH performed on 06/17/2024 was outside the acceptable QC range compared to the QC package insert. The range in the QC package insert was 395 - 569 U/L. The QC value for the level two control was 358 U/L. The level two QC was not repeated. 4. A review of patient reports revealed that the LDH analyte was reported on 06/26/2024 for patient number 25739, on 07/01/2024 for patient number 26760, on 07 /10/2024 for patient number 28700, and on 07/15/2024 for patient 13589, after the level two QC was unacceptable on 06/17/2024, and before acceptable QC was obtained on 07/22/2024. 6. The laboratory liaison confirmed the survey findings during a phone interview on 01/24/2025 at 4:35 p.m. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control -- 2 of 3 -- materials having previously determined statistical parameters. This STANDARD is not met as evidenced by: Based on laboratory observation, a review of the laboratory's quality control (QC) records, a review of patient test results, and staff interview, the laboratory failed to ensure the QC ranges used were verified for eight of eight QC lots used from 01/04 /2024 to 01/07/2025 for the tests performed on the Abaxis Piccolo Express instrument, with 38 patients reported during the period when the incorrect QC ranges were used. 1. Observation of the laboratory on 01/16/2025 at 8:15 a.m. revealed the Abaxis Piccolo Express instrument used for patient testing for Na+, K+, CL-, CO2, Glu, BUN, Crea, Ca+, LDH, and Mg analytes using the Basic Metabolic Plus test disc. 2. A review of the laboratory's QC records (package inserts and QC printouts) for the Abaxis Piccolo Express chemistry tests revealed incorrect quality control ranges used for the evaluation of quality control results as follows: QC lot number 2307009 (level one and level two): The QC ranges programmed into the instrument for QC lot number 2307009, level one, were incorrect for the Na+, K+, Cl-, CO2, Glu, BUN, Ca+, LDH, and Mg analytes (nine of ten analytes). The level one QC lot was used for performing QC on 01/04/2024 and 01/24/2024. The QC ranges programmed into the instrument for QC lot number 2307009, level two, were incorrect for the Na+, K+, Cl-, CO2, Crea, BUN, Glucose, and LDH analytes (eight of ten analytes). The level two QC lot was used for performing QC on 01/24/2024. QC lot number 2309018 (level one and level two): The QC ranges programmed into the instrument for QC lot number 2309018, level one, were incorrect for the Na+, Cl-, CO2, Crea, Glu, BUN, Ca+, and LDH analytes (eight of ten analytes). The level one QC lot was used for performing QC on 03/25/2024 and 04/25/2024. The QC ranges programmed into the instrument for QC lot number 2309018, level two, were incorrect for the Na+, K+, Cl- , Crea, BUN, Glucose, Mg, and LDH analytes (eight of ten analytes). The level two QC lot was used for performing QC on 03/25/2024 and 04/25/2024. QC lot number 2402008 (level one and level two): The QC ranges programmed into the instrument for QC lot number 2402008, level one, were incorrect for the Na+, K+, Cl-, CO2, Crea, BUN, Glucose, Ca+, Mg, and LDH analytes (ten of ten analytes). The level one QC lot programmed with the incorrect QC ranges was used for performing QC on 06 /17/2024. The QC ranges programmed into the instrument for QC lot number 2402008, level two, were incorrect for the Na+, K+, Cl-, CO2, Crea, BUN, Glucose, Ca+, Mg, and LDH analytes (ten of ten analytes). The level two QC lot programmed with the incorrect QC ranges was used for performing QC on 06/17/2024. The QC range programmed into the instrument for QC lot number 2402008, level one, was incorrect for the Glucose analyte when QC was performed on 07/22/2024, 08/08 /2024, and 08/29/2024 (one of ten analytes). QC lot number 2404034 (level one and level two): The QC ranges programmed into the instrument for QC lot number 2404034, level one, were incorrect for the Na+, K+, Cl-, CO2, Crea, Glu, BUN, Ca+, and LDH analytes (nine of ten analytes). The level one QC lot was used for performing QC on 12/02/2024 and on 01/07/2025. The QC ranges programmed into the instrument for QC lot number 2404034, level two, were incorrect for the Na+, K+, Cl-, CO2, Crea, BUN, Glucose, Ca+, Mg, and LDH analytes (ten of ten analytes). The level two QC lot was used for performing QC on 12/02/2024 and on 01/07/2025. 3. A review of patient results revealed that 38 patients were reported from 01/04/2024 to 01 /16/2025 (survey date) during the period when the incorrect QC ranges were used. Analytes reported included the Na+, K+, CL-, CO2, Glu, BUN, Crea, Ca+, LDH, and Mg analytes. 4. The laboratory liaison confirmed the survey findings during a phone interview on 01/24/2025 at 04:35 p.m. -- 3 of 3 --

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the manufacturer operator's manual, review of laboratory calibration records, and staff interview, the laboratory failed to follow manufacturer requirements for calibration of the Cell-Dyn Emerald complete blood count (CBC) instrument at least every six months in 2023. The findings include: 1. Observation of the laboratory on 11/29/2023 at 9:10 am revealed the Cell-Dyn Emerald (Serial #8328) hematology instrument in use for patient testing for CBC. 2. Review of the Cell-Dyn Emerald Operator's Manual section six titled "When to Calibrate" revealed the Cell-Dyn Emerald was to be calibrated "At least every six months". 2. Review of the calibration records for the Cell-Dyn Emerald revealed the Cell-Dyn Emerald instrument was calibrated on 08/04/2022 and 08/03/2023. The calibration that was due on 02/04/2023 was not performed resulting in a 12 month period between calibrations. 4. Interview on 11/29/2023 at 11:25 am with the laboratory liaison confirmed the laboratory failed to follow the manufacturer's requirements for calibration of the Cell-Dyn Emerald CBC instrument in 2023. 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 -- 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: Citation I. Based on observation of the laboratory, review of the laboratory's individualized quality control (QC) plan (IQCP) for the Piccolo Xpress chemistry instrument, QC records, lack of records, random patient final test report review, and staff interview, the laboratory failed to follow the IQCP for the external QC frequency and documentation of electronic QC in 2022 and 2023. The findings include: 1. Observation of the laboratory on 11/26/2023 at 9:10 am revealed a Piccolo Xpress (Serial #P08693) instrument in use for performing patient testing for chemistry analytes to include glucose, urea nitrogen, sodium, potassium, chloride, carbon dioxide, magnesium, calcium, creatinine, and lactate dehydrogenase. 2. Review of the laboratory's IQCP for the Piccolo Xpress revealed the following: Two levels of external QC to be performed with each new lot, new shipment of same lot, or every seven days. Electronic Quality Control must be documented as acceptable prior to patient testing. 3. Review of the QC records for the Piccolo Xpress revealed external quality control was not performed every seven days as required by the IQCP for 19 of 19 months reviewed (04/2022, 06/2022, 10/2022, 11/2022, 01/2023-11/2023) for 2022 and 2023. 4. Electronic QC was not documented from 08/2022 through the date of the survey (11/29/2023). 5. Random review of final patient test reports revealed the following patients that were performed on the Piccolo Xpress chemistry instrument: 07 /14/2022 Patient #18289 06/15/2023 Patient #17383 08/31/2023 Patient # 18733 09/07 /2023 Patient #24697 09/13/2023 Patient #29166 11/08/2023 Patient #29244 6. Interview on 11/29/2023 at 11:15 am with the laboratory liaison confirmed the laboratory failed to follow it's own IQCP for the Piccolo Xpress used for patient chemistry testing when the external QC was not performed every seven days and electronic QC was not documented in 2022 and 2023. Citation II. Based on observation of the laboratory, review of the laboratory's IQCP for the VerifyNow AccuMetrics hematology instrument, QC record review, random patient final test report review, and staff interview, the laboratory failed to follow the IQCP for the external QC frequency in 2022 and 2023. The findings include: 1. Observation of the laboratory on 11/26/2023 at 9:10 am revealed a VerifyNow AccuMetrics (Serial #3153) hematology instrument in use for performing patient testing for Platelet glycoprotein IIB/IIIA receptor blockade. 2. Review of the laboratory's IQCP for the VerifyNow instrument revealed two levels of external QC to be performed with each new lot, new shipment of the same lot, or every seven days. 3. Review of the QC records for the VerifyNow revealed external QC was not performed every seven days as required by the IQCP for 16 of 16 months reviewed (02/2022 through 04/2022, 08 /2022, 11/2022, 01/2023, 02/2023, 04/2023, 06/2023 through 11/2023) for 2022 and 2023. 4. Random review of final patient test reports revealed the following patients -- 2 of 4 -- that were preformed on the VerifyNow hematology instrument: 07/13/2022 Patient #20767 07/14/2022 Patient #18289 09/13/2023 Patient #29166 5. Interview on 11/29 /2023 at 11:15 am with the laboratory liaison confirmed the laboratory failed to follow it's own IQCP for the VerifyNow used for patient hematology testing when the external QC was not performed every seven days in 2022 and 2023. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies 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: Based on review of the laboratory's proficiency testing (PT) records and interview with the laboratory liaison, the laboratory failed to verify the accuracy of the activated clotting time (ACT) twice a year in 2021. The findings include: 1. Review of the laboratory's PT performance summary records revealed the following: a. 2021 second event score: 50%. b. 2021 third event score: 0%. 2. Interview on February 1, 2022 at approximately 5:00 pm with the laboratory liaison confirmed the laboratory failed to verify the accuracy of ACT twice a year when it failed two PT events in 2021. The laboratory liaison further confirmed no additional studies had been done after the two failed PT events to verify accuracy. 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) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with the laboratory liaison, the laboratory failed to label controls with open and close dates in 2022. The findings 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 -- include: 1. Observation of the laboratory on February 1, 2022 at approximately 8:30 am revealed quality control (QC) material for the Cell-DYN Emerald complete blood count (CBC) analyzer that were in use. They were not labeled with open date or corrected expiration date. 2. Interview with the laboratory liaison on February 1, 2022 at approximately 5:00 pm confirmed the laboratory failed to label controls with open date and corrected expiration date in 2022. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of the laboratory's individualized quality control plan (IQCP) for fibrin degradation product (D-Dimer), the laboratory's quality control (QC) logs, patient test records, and interview with the laboratory liaison, the laboratory failed to follow the quality assessment section of the IQCP for D-Dimer in 2021. The findings include: 1. Review of the laboratory's IQCP for D-Dimer revealed the following: External quality control would be performed with each new lot, new shipment or every 30 days. The quality assessment section of the IQCP stated that monthly review of the QC records would occur to determine if QC is acceptable and correction action performed if unacceptable. If an interruption of the QC frequency occurs, the electronic QC followed by two levels of wet QC must be run before any patients are performed. 2. Review of the laboratory's QC log sheet revealed the D-Dimer QC due on May 1, 2021 was not performed. The 30 day requirement for external QC was not met. The error was noted on the quality control log, however, there were no documents showing

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: The laboratory failed to maintain satisfactory participation for two out of three proficiency testing events for creatinine resulting in the first unsuccessful proficiency testing (PT) occurrence for the creatinine analyte. (Refer to D2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2020 and 2021 proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory performance for two out of three proficiency testing events for the creatinine analyte. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory creatinine scores: 2020 event three 0%, 2021 event two 60%. 2. Review of the 2020 PT event three evaluation report revealed a score of 0% for "Failure to Participate" for the creatinine analyte. 3. Review of the 2021 PT event two evaluation report revealed unacceptable scores for creatinine for sample numbers CH-06 and CH-08, resulting in an overall score of 60%, and the first unsuccessful PT performance for the creatinine analyte. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: The laboratory failed to maintain satisfactory participation for two consecutive proficiency testing (PT) events for the Lactic Dehydrogenase (LDH) analyte, resulting in the first unsuccessful PT occurrence for the LDH analyte. (Refer to D2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2019 proficiency testing (PT) records, the laboratory failed to maintain satisfactory performance for the Lactic Dehydrogenase (LDH) analyte for two consecutive events, resulting in the first unsuccessful occurrence. The findings include: 1) Review of the CMS 155 report revealed the following unsatisfactory scores for the LDH analyte: 2019 event two: 60%; 2019 event three: 0%. 2) Review of the 2019 event two PT summary report revealed the following for the LDH analyte: Sample numbers CH-6N and CH-8N scored as "Fail" resulting in an overall score of 60%. 3) Review of the 2019 event three PT summary report revealed the following for the LDH analyte: Sample numbers CH-11N, CH-12N, CH-13N, CH- 14N and CH-15N were scored as "Fail-No Results Received", resulting in a score of 0%, and the first unsuccessful PT occurrence. -- 2 of 2 --

Summary Statement of Deficiencies 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: Based on review of the 2018 proficiency testing (PT) records, patient number one final report and interview with the technical consultant, the laboratory failed to participate in the 2018 proficiency testing events two and three for the lactate dehydrogenase (LDH). The findings include: 1) Review of the 2018 PT records revealed no participation for the LDH in events two and three. The 2018 event one documented