Henry County Health Center Inc

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports and the Blood Culture procedure and interview by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at 2:22 pm on 06/11/2024, the laboratory failed to indicate the correct name and address of the testing facility for one out of 16 patient test reports reviewed from 1/1/2024 - 6/11 /2024. The findings include: 1. Patient identifier A had a blood culture and gram stain performed on 3/17/2024. 2. Laboratory personnel identifier #1 stated that when the laboratory received a positive blood culture, they would issue a preliminary positive blood culture result and then perform and report a gram stain on the specimen. The laboratory would then send the culture to a reference laboratory to perform the microbial identification and sensitivity testing. 3. The Blood Culture procedure confirmed this process. 4. The test report for patient identifier A indicated the reference laboratory reported the preliminary positive blood culture and gram stain results. 5. Laboratory personnel identifier #1 confirmed the test report did not have the correct facility name and address. 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 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. This STANDARD is not met as evidenced by: Based on review of the Laboratory Test List and Annual Volume form and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 10:05 am on 08/30/2022, the laboratory failed to perform comparison activities for serum human chorionic gonadotropin (HCG) testing performed by two methods twice annually for four out of four time periods from January 2020- December 2021. The findings include: 1. The Laboratory Test List and Annual Volume form listed serum HCG testing performed by both quantitative and qualitative methods. 2. At the time of the survey, personnel identifier #2 confirmed that the laboratory did not perform comparison activities for serum HCG testing performed by two methods twice annually from January 2020- December 2021. D5783

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 review of proficiency records and reports, the laboratory failed to successfully participate in a proficiency testing program for the analyte, lithium, for two consecutive testing events: 2021 events 2 and 3 (refer to D2118). D2118 TOXICOLOGY CFR(s): 493.845(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 proficiency testing (PT) reports and records, the laboratory fails to achieve satisfactory performance for the analyte, lithium, for two out of three consecutive PT events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 40% for 2021 testing event two and 20% for 2021 testing event three. -- 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 review of proficiency records and reports, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty, virology, for two out of three consecutive proficiency testing events: 2020 testing event 1 and 2020 testing event 3 (refer to D2064). D2064 VIROLOGY CFR(s): 493.831(e) Failure to achieve an overall testing event score of satisfactory performance for 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 review of proficiency testing reports and records, the laboratory failed to achieve an overall testing event score of satisfactory performance for two out of three consecutive testing events for the subspecialty, virology. The laboratory received unsatisfactory performance scores of zero for 2020 testing events 1 and 3 for the subspecialty, virology. -- 2 of 2 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the Individualized Quality Control Plans (IQCP) and quality control records for i-STAT analyzers, serial numbers (SN) 353208 and 393801, and confirmed by the laboratory personnel, identifier #2 (refer to the Laboratory Personnel Report) at approximately 12:40 pm on 10/28/2020; the laboratory failed to follow its IQCP for the frequency of external liquid quality control (QC) testing for the i-STAT analyzers for 3 out of 3 months (January-March 2020). The findings include: 1. The laboratory used the i-STAT analyzers to perform arterial and venous blood gas testing. 2. The laboratory's i-STAT IQCP required the laboratory to perform external control testing with each new shipment, monthly, new user and any suspect cartridge lot. 3. Records revealed that the laboratory performed monthly QC on only analyzer SN 353208 for January and February 2020 and only analyzer SN 393801 for March 2020. 4. During January and February 2020, the laboratory used analyzer SN 393801 to test 34 patient specimens and failed to perform external liquid QC testing. 5. During March 2020, the laboratory used analyzer SN 353208 to test one patient specimen and failed to perform external liquid QC testing. D5777 COMPARISON OF TEST RESULTS 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): 493.1281(b)(c) (b) The laboratory must have a system to identify and assess patient test results that appear inconsistent with the following relevant criteria, when available: (b)(1) Patient age. (b)(2) Sex. (b)(3) Diagnosis or pertinent clinical data. (b)(4) Distribution of patient test results. (b)(5) Relationship with other test parameters. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of immunohematology testing records (ABO, Rh, antibody screen and compatibility testing) for February 2020 and interview with the laboratory personnel identifier #2 (Refer to the CMS-209 form, Laboratory Personnel Report) at 10:40 am on 10/28/2020, the laboratory failed to document the patient history check for 12 out of 12 patients who had testing performed for transfusion purposes. The findings include: 1. According to the laboratory personnel identifier #2, the testing personnel who performs the tests is to check the patient history in the laboratory information system and document the check. 2. Review of patient test records from February 2020 revealed that the laboratory failed to document the patient history check. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the histopathology patient test records and reports and confirmed by laboratory personnel identifier #2 (refer to Laboratory Personnel Report, Form CMS-209) at approximately 2:50 pm on 10/28/2020; the laboratory failed to indicate on the test report the name and address of the laboratory performing frozen section testing for 7 out of 7 patients from January-October 2020. The findings include: 1. Records reveal that frozen sections were performed and read at the laboratory on the following patients and dates: patient identifier #1 01/20/2020; patient identifier #2 01 /30/2020; patient identifier #3 03/26/2020; patient identifier #4 05/28/2020; patient identifier #5 06/26/2020; patient identifier #6 09/03/2020 and patient identifier #7 10 /01/2020. 2. Review of the test reports for the patient identifiers #1-#7 revealed that the reports did not indicate the name and address of the laboratory location where the frozen sections testing was performed. -- 2 of 2 --

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of the calibration verification records and confirmed by laboratory personnel identifier #2 (refer to Laboratory Personnel Report) at approximately 12:30 pm on 06/19/2018, the laboratory failed to perform calibration verification every six months for two out of three time periods for the analytes: sodium, potassium, and chloride and three out of three time periods for the anlayte, hemoglobin A1C from 1/1 /2017 - 6/19/2018. The findings include: 1. The laboratory performed calibration 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 -- verification for the analytes: sodium, potassium, and chloride on 6/20/2017. 2. At the time of the survey, the laboratory did not have additional calibration verification records for the analytes: sodium, potassium, and chloride from 1/1/2017 - 6/19/2018. The laboratory did not have any calibration verification records for the analyte, hemoglobin A1C. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual and confirmed by laboratory personnel, identifier #2, (refer to the Laboratory Personnel Report) on 6/19/2018 at approximately 3:30 pm, the laboratory director failed to ensure that the laboratory established and maintained a quality assessment program that included the four quality systems: general laboratory, pre analytical, analytical, and post analytical. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of personnel records and confirmed by laboratory personnel identifier #2 (refer to Laboratory Personnel Report) at approximately 10:00 am on 06 /19/2018, the technical supervisor failed to assess the competency of individuals performing high complexity testing at least semiannually during the first year the individual tests patient specimens for one out of eight testing personnel (laboratory personnel identifier #8). The findings include: 1. The laboratory completed training records for testing personnel, identifier #8 in March 2017. 2. At the time of survey, the laboratory did not have records documenting the semiannual training for testing personnel, identifier #8. -- 2 of 2 --