Cookeville Medical Center, Pllc

Summary Statement of Deficiencies D0000 Based on desk review of 2025 proficiency testing (PT) scores, the laboratory failed to meet the following conditions, resulting in an initial unsuccessful PT participation: D2016 - 42 C.F.R. 493.803 Condition: Successful participation 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 desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and American Proficiency Institute (API) proficiency testing records, the laboratory failed to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 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 perticipate in the Free Thyroxine (FREE TY) analyte. Refer to D2107. . D2107 ENDOCRINOLOGY CFR(s): 493.843(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and the API 2025 PT records (Events 1 and 2), the laboratory failed to achieve satisfactory performance (80% or better) for the same analyte in two consecutive testing events in the specialty of Endocrinology for the Free Thyroxine (FREE TY) analyte. The findings include: 1. A review of the CASPER 0155 report revealed the following results: 2025 Event One: The laboratory received a 60% score for Free Thyroxine. 2025 Event Two: The laboratory received a 20% score for Free Thyroxine. 2. A review of the API 2025 PT records (2025 Chemistry - Core - 1st and 2nd Events) confirmed that 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 CASPER 0155 report and American Proficiency Institute 2025 records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure the overall quality of the laboratory services provided. 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 CASPER 0155 report and American Proficiency Institute 2025 records, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2107. -- 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: Based on an off-site desk review of the laboratory's Centers for Medicare and Medicaid Services Casper Report 155 (CMS 155) and the laboratory's American Proficiency Institute (API) Proficiency Testing (PT) evaluation reports, the laboratory failed to maintain satisfactory performance for two consecutive PT events for the Creatinine analyte, resulting in the first unsuccessful PT occurrence for the Creatinine analyte. (Refer to D2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on an off-site desk review of the laboratory's Centers for Medicare and Medicaid Services Casper Report 155 (CMS 155) and the laboratory's American Proficiency Institute (API) Proficiency Testing (PT) evaluation reports, thelaboratory failed to maintain satisfactory performance for two consecutive PT events for the Creatinine analyte, resulting in the first unsuccessful PT occurrence for the Creatinine analyte. The findings include: 1. Review of the report CMS 155 revealed the following scores for the Creatinine analyte: 2024 Event one = 20% 2024 Event two = 40% 2. Review of the laboratory's API PT evaluation reports revealed the following: Creatinine scored as 20% for 2024 event one and 40% 2024 event two, resulting in the first unsuccessful PT occurrence for the Creatinine analyte. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of manufacturers' operator's manuals, lack of records, and staff interview, the laboratory failed to monitor humidity in the area where the Medonic M Series Complete Blood Count (CBC) and Horiba ABX Pentra 400 chemistry instruments were in use for patient testing in 2021, 2022, and 2023. The findings include: 1. Observation of the laboratory on 08/21/23 at 8:30 am revealed the following: - The Medonic M Series (SN: 46110) analyzer in use for performing patient CBC testing. - The Horiba ABX Pentra 400 (SN: 212P4-3201) analyzer in use for performing routine chemistry patient testing. - No device for monitoring of humidity was present in the testing area. 2. Review of the manufacturers' operator's manuals revealed the following humidity requirements: - Medonic M Series = Less than 85% relative humidity - Horiba ABX Pentra 400 = 20 - 85% relative humidity, without condensation 3. There were no records for humidity monitoring available for surveyor review. 4. Interview with laboratory manager on 08 /21/23 at 2:00 pm confirmed the laboratory did not monitor the humidity in the area where the Medonic M Series CBC instrument and the Horiba ABX Pentra 400 chemistry instrument were in use for patient testing in 2021, 2022, and 2023. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 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, review of the manufacturer control package inserts, and staff interview, the laboratory failed to label control vials used for performing quality control (QC) on the Medonic M Series and Horiba ABX Pentra 400 analyzers with corrected expiration date. The findings include: 1. Observation of the laboratory on 8/21/23 at 8:30 am revealed the following: - Medonic M Series complete blood count (CBC) instrument (SN: 46110) and Horiba ABX Pentra 400 (SN: 212P4-3201) chemistry instrument in use for patient testing. - Three levels of opened Boule Con-Diff controls (Lot: 22306) in use for CBC QC and were not labeled with an open date or corrected expiration date. - Reconstituted ABX Pentra N MultiControl (Lot: 21053) and ABX Pentra P MultiControl (Lot: 21052) in use for chemistry QC and were not labeled with an open date or corrected expiration date. 2. Review of the manufacturer control package inserts revealed the following: - Opened vials of Boule Con-Diff Controls are stable for 14 days stored at 2 - 10 degrees Celsius (C). - ABX Pentra MultiControl stability after reconstitution is 12 hours at 15- 25 degrees C, 5 days at 2-8 degrees C, and 28 days at -15 to -25 degrees C. 3. Interview with the laboratory manager on 8/21/23 at 2:00 pm confirmed the laboratory failed to label controls used to monitor CBC and Chemistry patient testing with corrected expiration date for five of five control vials observed on the date of the survey (8/21/23). -- 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: Based on an off-site desk review of the laboratory's Centers for Medicare and Medicaid Services Casper Report 155 (CMS 155) and the laboratory's American Proficiency Institute (API) Proficiency Testing (PT) evaluation reports, the laboratory failed to maintain satisfactory performance for two consecutive PT events for the Total Bilirubin analyte, resulting in the first unsuccessful PT occurrence for the Total Bilirubin analyte. (Refer to D2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on an off-site desk review of the laboratory's Centers for Medicare and Medicaid Services Casper Report 155 (CMS 155) and the laboratory's American Proficiency Institute (API) Proficiency Testing (PT) evaluation reports, the laboratory failed to maintain satisfactory performance for two consecutive PT events for the Total Bilirubin analyte, resulting in the first unsuccessful PT occurrence for the Total Bilirubin analyte. The findings include: 1. Review of the report CMS 155 revealed the following scores for the Total Bilirubin analyte: 2022 event three = 40% 2023 event one = 60% 2. Review of the laboratory's API PT evaluation reports revealed the following: Total Bilirubin scored as 40% for 2022 event three and 60% for 2023 event one, resulting in the first unsuccessful PT occurrence for the Total Bilirubin 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 in three out of four events for Chloride (CL), resulting in the SECOND Unsuccessful Proficiency Testing (PT) occurrence. (Refer to D2096) =================================== D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: =================================== Based on a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid Services CASPER report 155 (CMS 0155D) and American Proficiency Institute (API) Testing performance summary, the laboratory failed to maintain satisfactory performance in three out of four events for the Chloride (CL) analyte, 3rd event 2020, 1st and 3rd events 2021, resulting in the SECOND unsuccessful PT performance occurrence. The findings include: 1. A review of the CMS 0155D report for 2020 revealed the CL score for event three = 40%. 2. A review of the CMS 0155D report for 2021 revealed the CL scores for event one = 60% and event three = 20%. 3. A review of the 2020 API PT Performance Summary for event three revealed CL was graded as unsatisfactory with a score of 40%. 4. A review of the 2021 API PT Performance Summary for event one revealed the CL was graded as unsatisfactory with a score of 60%, and event three was graded as unsatisfactory with a score of 20% resulting in the SECOND Unsuccessful PT occurrence. =================================== 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: =================================== The Laboratory Director failed to provide direction for successful Proficiency Testing (PT) Participation in Three of Four Events for Chemistry in 2020 and 2021 resulting in the SECOND Unsuccessful PT occurrence (Reference 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 desk review of the Centers for Medicare and Medicaid Services Casper report 155 (CMS 155) and the laboratory's 2020 and 2021 American Proficiency Institute (API) Testing proficiency testing (PT) evaluation reports, the laboratory director failed to ensure the laboratory performed proficiency testing in such a manner as to achieve and maintain satisfactory performance, resulting in unsatisfactory performance for three out of four consecutive perficiency testing events for the Chloride analyte and the second unsuccessful PT -- 2 of 3 -- occurrence. The findings include: 1. A review of the CMS 0155D evaluation reports revealed the following unsatisfactory Chloride scores: 2020 event three = 40% 2021 event one = 60% 2021 event three = 20% 2. A review of the laboratory's API PT evaluation reports revealed the following unsatisfactory Chloride scores: 2020 event three = 40% 2021 event one = 60% 2021 event three = 20% =================================== -- 3 of 3 --

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: ==================================== Chemistry: The laboratory failed to maintain satisfactory participation in two out of three events for the Sodium (NA) analyte resulting in the initial unsuccessful proficiency testing (PT) occurrence for NA. (Refer to D2096) ==================================== D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: ===================================== Based on a desk review of the CMS CASPER Report 0155D and the Laboratory's 2021 Proficiency Testing (PT) Program Performance Summary, determined the Laboratory failed to maintain satisfactory performance in two out of three events for the Sodium (NA) analyte, events one and three of 2021, resulting in the initial unsuccessful PT occurrence. The findings include: 1. A review of the CMS CASPER Report 0155D for Proficiency Testing revealed the NA score as 40% for events one and three of 2021. 2. A review of the 2021 PT Program Performance Summary for NA revealed an unsatisfactory score of 40% for events one and three of 2021, resulting in the initial unsuccessful PT occurrence for the NA 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 sucessfully participate in two out three proficiency testing (PT) events for the analyte Chloride (CL) resulting in the first unsucessful PT occurence. (refer to D 2096) 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 review of the Centers for Medicare and Medicaid Services Casper report 155 (CMS 155) and American Proficiency Institute (API) performance summary report, the laboratory failed to achieve satisfactory performance in the 3rd event 2020 and 1st event 2021 for the anaylte Chloride (CL). Findings include: 1. Review of the CMS 155 revealed a score of 40% for 3rd event 2020 and a score of 60% for 1st event 2021 for Analyte Chloride. 2. Review of the API performance summary revealed a score of 40% for 3rd event 2020 and a score of 60% for 1st event 2021 for Analyte Chloride. -- 2 of 2 --