State Of Franklin Healthcare

Summary Statement of Deficiencies D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on a review of the laboratory's Centers for Medicare & Medicaid Services Laboratory Personnel Report (FORM CMS-209), personnel records, and staff interviews, the laboratory director failed to define the duties and responsibilities of one of two technical consultants (TC1). The findings include: 1. A review of the FORM CMS-209 revealed two technical consultants. 2. A review of the laboratory's personnel records revealed no job description or list of duties and responsibilities defined for one of two technical consultants (TC1). 3. An interview with both technical consultants on 07.14.2025 at 1:00 p.m. confirmed the survey 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 1 --

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 direct observation, review of the laboratory's procedures and environmental logs, and interview with the laboratory supervisor, determined the laboratory failed to ensure refrigerated storage fluctuations did not exceed approved temperature ranges for 146 of 177 days from 01.01.2023 through 08.31.2023. The findings include: 1. Observation of the laboratory at 09:25 am on 10.19.2023 revealed an Alinity refrigerated storage unit (S#221240021) in use for storing patient samples. 2. Review of the laboratory's "Temperature Ranges" procedure stated, "Acceptable ranges are established as follows: Refrigerator: 2-8C ....If any temperature is out of range, a supervisor should be notified immediately and action taken to remediate the problem. If the problem cannot be corrected reagents or patient samples should be moved to a safe storage area until the problem is resolved. Document all actions taken to correct the problem and monitor the temperature closely to assure the proper temperature is maintained." 3. Review of the laboratory's environmental records from 01.01.2023 through 08.31.2023 revealed temperatures below the accepted minimum temperature of 2C for the following dates: 2023-01-03, 2023-01-04, 2023-01-05, 2023-01-06, 2023-01-09, 2023-01-10, 2023-01-11, 2023-01-12, 2023-01-13, 2023-01-16, 2023-01- 17, 2023-01-18, 2023-01-19, 2023-01-20, 2023-01-23, 2023-01-24, 2023-01-25, 2023- 01-26, 2023-01-27, 2023-01-30, 2023-01-31, 2023-02-01, 2023-02-02, 2023-02-03, 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 -- 2023-02-06, 2023-02-07, 2023-02-08, 2023-02-09, 2023-02-10, 2023-02-13, 2023-02- 14, 2023-02-17, 2023-02-20, 2023-02-22, 2023-02-23, 2023-02-24, 2023-02-27, 2023- 02-28, 2023-03-01, 2023-03-02, 2023-03-06, 2023-03-07, 2023-03-08, 2023-03-09, 2023-03-10, 2023-03-13, 2023-03-14, 2023-03-15, 2023-03-16, 2023-03-21, 2023-03- 22, 2023-03-23, 2023-03-24, 2023-03-27, 2023-03-28, 2023-03-29, 2023-03-30, 2023- 04-03, 2023-04-04, 2023-04-05, 2023-04-06, 2023-04-07, 2023-04-10, 2023-04-11, 2023-04-12, 2023-04-13, 2023-04-17, 2023-04-18, 2023-04-19, 2023-04-20, 2023-04- 21, 2023-04-25, 2023-04-26, 2023-04-28, 2023-05-01, 2023-05-05, 2023-05-09, 2023- 05-10, 2023-05-11, 2023-05-15, 2023-05-16, 2023-05-17, 2023-05-18, 2023-05-22, 2023-05-23, 2023-05-24, 2023-05-25, 2023-05-30, 2023-05-31, 2023-06-05, 2023-06- 07, 2023-06-08, 2023-06-09, 2023-06-12, 2023-06-13, 2023-06-14, 2023-06-15, 2023- 06-16, 2023-06-19, 2023-06-20, 2023-06-21, 2023-06-22, 2023-06-23, 2023-06-26, 2023-06-28, 2023-06-29, 2023-06-30, 2023-07-03, 2023-07-04, 2023-07-05, 2023-07- 06, 2023-07-07, 2023-07-10, 2023-07-11, 2023-07-12, 2023-07-13, 2023-07-14, 2023- 07-17, 2023-07-18, 2023-07-19, 2023-07-20, 2023-07-21, 2023-07-24, 2023-07-25, 2023-07-26, 2023-07-27, 2023-07-28, 2023-07-31, 2023-08-01, 2023-08-02, 2023-08- 03, 2023-08-04, 2023-08-09, 2023-08-10, 2023-08-11, 2023-08-16, 2023-08-17, 2023- 08-18, 2023-08-21, 2023-08-22, 2023-08-23, 2023-08-24, 2023-08-28, 2023-08-29, 2023-08-30, 2023-08-31 4. Interview with the laboratory supervisor at 2:15 pm on 10.19.2023 confirmed the laboratory failed to ensure refrigerated storage fluctuations did not exceed approved temperature ranges for 146 of 177 days from 01.01.2023 through 08.31.2023. Word Key: C = degrees Celsius -- 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: =================================== Virology: The laboratory failed to maintain satisfactory participation in two out of three events for the Herpes Simplex Virus (HSV) analyte resulting in the initial unsuccessful proficiency testing (PT) occurrence for HSV. (Refer to D2064) =================================== D2064 VIROLOGY CFR(s): 493.831(e) 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 an overall testing event score of satisfactory performance for 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 desk review of the CMS CASPER Report 0155D and the laboratory's 2020/2021 Proficiency Testing (PT) performance summary records from the American Proficiency Institute(API) Proficiency Testing program, the laboratory failed to maintain satisfactory performance for the Herpes Simplex Virus (HSV) analyte in the 3rd event 2020 and 2nd event 2021, resulting in the initial unsuccessful PT occurrence. The findings include: 1. A review of the CMS 0155D report revealed unsatisfactory HSV analyte scores of 50% for the 3rd event of 2020 and 0% for the 2nd event of 2021. 2. A review of the laboratory's API Proficiency Testing records revealed the 2020 3rd event had unacceptable performance for HSV resulting in a 50% score. 3. A review of the laboratory's API Proficiency Testing records revealed the 2021 2nd event had unacceptable performance for HSV resulting in a 0% score, resulting in the initial unsuccessful PT occurrence. =================================== -- 2 of 2 --