Decatur Health System Inc

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 the review of proficiency testing (PT) records from American Proficiency Institute (API), the laboratory failed to successfully participate in PT for the analyte: unexpected antibody detection for two out of three consecutive proficiency testing events: 2020 Event 3 and 2021 Event 2 (refer to D2172). D2172 UNEXPECTED ANTIBODY DETECTION CFR(s): 493.861(e) Failure to achieve an overall testing event score of satisfactory for two consecutive 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 -- testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: A PT desk review and phone interview on 10/19/21 revealed the laboratory failed to successfully particiate in PT from API for unexpected antibody detection. Findings: 1. Review of the 2020 API 3rd Event revealed a score of 0% for unexpected antibody detection. 2. Review of the 2021 API 2nd Event revealed a score of 60% for unexpected antibody detection. 3. Phone interview 10/19/21 at 10:10 a.m. with the general supervisor confirmed, the laboratory failed to successfully particiate in PT from API for unexpected antibody detection. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) from the provider American Proficiency Institute (API) performed 2/22/19 to 9/22/21 and interview with General Supervisor #1 (GS#1) revealed that the laboratory director (LD) or designee failed to attest on 6 of 28 events that proficiency testing samples were handled in the same manner as patient samples. 1. Review of the attestation page for PT from API revealed the LD or designee signature was not present on: a. API 2020 Chemistry Core 3rd Event b. API 2020 Hematology/Coagulation 1st Event c. API 2020 Microbiology 3rd Event d. API 2020 Immunology/Immunohematology 2nd Event e. API 2020 Immunology /Immunohematology 3rd Event f. API 2020 Chemistry Miscellaneous 2nd Event 2. Interview with GS #1 on 9/22/21 at 12:30 p.m. confirmed, the LD or designee failed to attest on 6 of 28 events that proficiency testing samples were handled in the same manner as patient samples. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or 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 5 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's 2019, 2020, and 2021 to date of survey API PT documentation and interview with GS#1, the laboratory failed to verify the accuracy of hematology analytes that were assigned a ungraded proficiency testing score for one of seven events. Findings: 1. Review of the laboratory's 2019, 2020, and 2021 to date of survey API PT documentation for hematology analytes found the following ungraded results: 2020 Hematology/Coagulation 1st Event a. Blood Cell Identification samples ECI-01, 02, 03, 04 and 05 b. Fecal Leukocytes sample FW-01 2. Review of the laboratory's API PT Performance Review and

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 testing records the laboratory failed to successfully participate in proficiency testing from American Proficiency Institute for the analyte: alanine aminotransferase (ALT) for two out of three consecutive proficiency testing events: 2019 event 3 and 2020 event 2 (refer 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 for proficiency testing from the provider API for Chemistry, the regulated analyte ALT revealed the following performance scores for PT: 1. Third testing event 2019 revealed a score of 40% for ALT 2. Second testing event 2020 revealed a score of 60% for ALT. The laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive testing events for the analyte:ALT -- 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 review of the manufacturer's package insert instructions and interview with the General Supervisor #1 the laboratory failed to store quality control (QC) reagents under conditions consistent with the manufacturer's instructions. Findings include: 1. Review of the Bio-Rad Liquichek Immunoassay Plus Control package insert indicated that the storage temperature range was -20 degrees Centigrade to -70 degrees Centigrade. 2. Review of the freezer temperature logs revealed 2 occurrences in February 2019 in which the temperature did not met the manufacturer's storage range. On February 3, 2019 and Feb 21, 2019 the temperature of freezer was documented as -19 degrees Centigrade. 3. Interview with the General Supervisor #1 confirmed that the laboratory failed to follow manufacturer instructions for storing Bio-Rad Liquichek Immunoassay Plus Control on February 21, 2019 @ 1135 AM. 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 D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: A review of proficiency testing records from American Proficiency Institute (API) (a year consists of three testing events) and interview with laboratory Supervisor revealed the laboratory failed to verify the accuracy of analytes for which the proficiency testing program does not obtain the agreement required for scoring. Findings were as follows: a. Proficiency testing records form API for the third event of 2016, revealed that the proficiency testing program failed to obtain the agreement required for scoring the Free Thyroxin CHG--13 . : At the time of survey (04/03 /2018), there was no evidence of verification activities of accuracy by self grade (comparison to the published expected results) for any of these analytes available for review. An interview with the General Supervisor from the CMS form 209 on 04/03 /2018, at 10:20 hrs confirmed that no verification of accuracy. 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. 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 -- (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: A review of Temperature and humidity logs and interview with staff revealed the laboratory failed the humidity for the laboratory as the Tosoh AIA-360 Endocrinology analyzer requires. Findings were as follows: a. Based upon review of manufacture's operators guide the laboratory failed the humidity 40% to 80% . The laboratory failed to define the acceptable humidity range according to the manufacture's range, November 2017 through January 2018 b. At the time of the survey 04/03/2018 the laboratory failed to produce