Buchanan County Health Center

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based upon review of personnel records and the Lab Quality Management Plan and confirmed by laboratory personnel identifiers #1 and #7 (refer to the Laboratory Personnel Form) at 8:31 am on 8/5/2024, the laboratory failed to follow written policies and procedures to document training, six month competencies, and annual competencies for nine out of 14 testing personnel. The findings include: 1. The Lab Quality Management Plan stated, "Upon hire, training in each area of the laboratory for the new employee will be provided using policy manuals, direct observation and training by competent staff. This training will be monitored and signed off utilizing the departmental orientation sheets and training documents relevant to the instrumentation." 2. Testing personnel identifier #2 did not have completed training documents. Several sections did not indicate training had occurred. 3. The Lab Quality Management Plan stated, "Staff will be assessed for competency initially, 6 months after the completion of training, and then annually thereafter." 4. Testing personnel identifiers #1 and #2 did not have six month competency documented. 5. Testing personnel identifiers #7 - #13 did not have 2022 annual competency documented. 6. Testing personnel identifiers #8 & #12 did not have 2023 annual competency documented. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by 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 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: A. Based on review of quality control records and the Stool Panel PCR procedure and confirmed by laboratory personnel #1 and #7 (refer to the Laboratory Personnel Report) at 12:15 pm on 8/5/2024, the laboratory failed to follow their quality control policy for one out of two lot number of stool panels performed on the Biofire analyzer from 2/19/2024 - 8/8/2024. The findings include: 1. The Stool Panel PCR procedure states, "External quality control testing is done with every new lot of Biofire Stool cartridge. 3 levels of control: Cary Blair Media green top empty (negative), Control L1 and Control L2." 2. On 2/19/2024 the laboratory only performed Control L1 and Control L2 for lot number 2ZL323 of stool cartridges. The laboratory did not perform the Cary Blair Media green top empty (negative) quality control. B. Based on lack of quality control (QC) records, review of the Gram Stain procedure and confirmed by laboratory personnel #1 and #7 (refer to the Laboratory Personnel Report) at 1:41 pm on 8/5/2024, the laboratory failed to follow their quality control policy for performing gram stain QC for one out of one day of patient testing in March 2024. The findings include: 1. The Gram Stain procedure states, "Each day a gram stain is performed quality control should be performed." 2. On 3/23/2024 Patient identifier A had a gram stain performed. 3. The laboratory did not document gram stain QC had been performed on this date. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the Blood Bank Maintenance procedure, blood bank system alarm check records, and confirmed by laboratory personnel identifier #1 and #7 (refer to the Laboratory Personnel Report) at 3:44 pm on 8/5/2024, the laboratory failed to perform quarterly alarm system checks for the blood bank refrigerator for three out of six quarters and the blood bank freezer for four out of six quarters from 01/01/2023- 8/5 /2024. The findings include: 1. The Blood Bank Maintenance Procedure stated that the alarms on the blood storage refrigerator and plasma freezer would be checked quarterly. 2. The laboratory performed blood bank refrigerator alarm checks on 10/23 /23, 2/9/2024, and 6/19/2024. 3. The laboratory performed plasma freezer alarm checks on 2/9/2024 and 7/11/2024. 4. At the time of the survey, the laboratory did not have additional blood bank refrigerator and freezer alarm system check records. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or -- 2 of 3 -- 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 upon review of the laboratory test list, observations made during the survey and confirmed by laboratory personnel #1 and #7 (refer to the Laboratory Personnel Report) at 1:24 pm on 8/5/2024 the laboratory failed to perform twice annual comparison testing for the analytes: influenza A, influenza B, respiratory syncytial virus (RSV), SARS-CoV-2, and Clostridioides difficile (C diff) toxin for one out of one time period from 2/1/2024 - 8/8/2024. The findings include: 1. In February 2024 the laboratory implemented new testing on the Biofire analyzer. The laboratory performed a respiratory panel on the Biofire which included influenza A, influenza B, RSV and SARS-CoV-2 testing. The laboratory also performed a stool panel which include C diff toxin testing. 2. The laboratory also performs influenza A, influenza B, RSV and SARS-CoV-2 testing using the Cepheid analyzer and C diff toxin testing using the Quick Check test kit. 3. At the time of the survey, the laboratory had not performed comparison testing between the Biofire and Cepheid for influenza A, influenza B, RSV and SARS-CoV-2 testing. In addition, the laboratory had not performed comparison testing between the Biofire and the Quick Check test kit for the C diff toxin. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was completed on May 2, 2024, the laboratory was found to be out of compliance with the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R 493.803 Condition: Successful Participation D6000 - 42 C.F.R 493.1043 Condition: Laboratory Director, moderate complexity 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 the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (API) and WSLH Proficiency Testing (WSLH), the laboratory failed to successfully 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 -- participate in three out of four consecutive testing events in the specialty of Hematology for the analyte, white blood cell differential (WBC DIFF). The laboratory had unsatisfactory scores for 2023 events 1 and 3 and 2024 event 1. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (API) and WSLH Proficiency Testing (WSLH), the laboratory failed to achieve satisfactory performance (80% or greater) for three out of four consecutive testing events in the specialty of Hematology for the analyte, WBC DIFF. The findings include: 1. For 2023 event 1, the laboratory received an unsatisfactory performance score of 40% for the analyte, white blood cell differential. 2. For 2023 event 3, the laboratory received an unsatisfactory performance score of 68% for the analyte, white blood cell differential. 3. For 2024 event 1, the laboratory received an unsatisfactory performance score of 64% for the analyte, white blood cell differential. 4. The CASPER 155 report and graded results from API and WSHL confirm the above findings. 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from API (2023 events 1 and 3) and WSLH (2024 event 1), the laboratory director failed to provide overall management and direction of the laboratory services. Refer to 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute -- 2 of 3 -- (API) and WSLH Proficiency Testing (WSLH), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130. -- 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: Based on review of proficiency records and reports, the laboratory failed to successfully participate in a proficiency testing program for the analyte, white blood cell differential, for two out of three consecutive testing events: 2023 events 1 and 3 (refer to D2130). D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in 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 -- 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 (PT) reports and records, the laboratory failed to achieve satisfactory performance for the analyte, white blood cell differential, for two out of three consecutive PT events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 40% for 2023 testing event 1 and 68% for 2023 testing event 3. -- 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 confirmed by laboratory personnel, the laboratory fails to successfully participate in a proficiency testing program for the analyte, compatibility testing, for three consecutive testing events: 2022 testing event 3, 2023 testing events 1 and 2 (refer to D2181). D2181 COMPATIBILITY TESTING CFR(s): 493.863(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: Based on review of proficiency testing reports and confirmed by laboratory personnel, the laboratory failed to achieve satisfactory performance for the analyte, compatibility testing, for three consecutive testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 60% for 2022 testing event 3 and 80% for 2023 testing events 1 and 2. -- 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 fails to successfully participate in a proficiency testing program for the analyte, compatibility testing, for two consecutive testing events: 2022 event 3 and 2023 event 1 (refer to D2181). D2181 COMPATIBILITY TESTING CFR(s): 493.863(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: Based on review of proficiency testing reports and records, the laboratory fails to achieve satisfactory performance for the analyte, compatibility testing, for two consecutive testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 60% for 2022 testing event 3 and 80% for 2023 testing event 1. -- 2 of 2 --

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: Based on review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 9: 40 am on 09/15/2022, the laboratory failed to perform a self evaluation when the laboratory received seven ungraded PT scores from three out of five PT testing events from 01/01/2021- 09/15/2022. The findings include: 1. For 2021 testing event 3, the laboratory received ungraded PT test scores for the following: *2021 Immunology /Immunohematology 3rd event: c-reactive protein (CRP) (specimen CRP-06) and direct antiglobulin test (DAT) (specimen DAT-06) 2. For 2022 testing event 1, the laboratory received ungraded PT test scores for the following: *2022 Microbiology 1st event: gram stain (specimen GS-05) *2022 Core Chemistry 1st event: total iron- binding capacity (TIBC) (specimens CH-02, CH-04, and CH-05) 3. For 2022 testing event 2, the laboratory received ungraded PT test scores for the following: *2022 Hematology/Coagulation 2nd event: vaginal wet prep (specimen VA-02) 4. At the time of the survey, the laboratory did not have additional documentation or

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 review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 10: 40 am on 10/23/2020, the laboratory director failed to attest to the routine integration of PT samples into the patient workload for three out of six proficiency testing events (2020 events 1, 2 and 3) from 1/1/2019 - 10/23/2020. The findings include: 1. For 2020 event 1, the laboratory director did not sign the core chemistry, hematology /coagulation, and immunology/immunohematology PT attestation statements. 2. For 2020 event 2, the laboratory director did not sign the core chemistry, hematology /coagulation, immunology/immunohematology and microbiology PT attestation statements. 3. For 2020 event 3, the laboratory director did not sign the core chemistry and microbiology attestation statements. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the media Individual Quality Control Plan (IQCP) and blood 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 -- culture quality control (QC) certificates and confirmed by laboratory personnel identifier #3 (refer to the Laboratory Personnel Report) at approximately 2:00 pm on 10/23/2020, the laboratory failed to retain the blood culture media QC certificates for three out of three lot numbers for blood culture media from October 2020. The findings include: 1. The IQCP plan indicated the laboratory would retain the manufacturer's QC certificates as documentation of blood culture media QC. 2. At the time of the survey, the laboratory did not retain the manufacturer's QC certificates for the following lot numbers of blood culture media: BD Bactec Plus Aerobic/F lot number 0093309, expiration date 1/31/2021; BD Bactec Lytic/10/Anaerobic/F lot number 0133703; expiration date 2/28/2021, and BD Bactec Peds Plus/F lot number 0133695, expiration date 2/28/2021. 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: Based on review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 10:40 am on 10/23/20, the laboratory failed to perform a self evaluation of ungraded PT scores for five out of five PT testing events (2019 events 1, 2, and 3 and 2020 events 1 and 2) from 1/1/2019 - 10/23/2020. The findings include: 1. For 2019 testing event 1, the laboratory received an ungraded PT score for urine drug screen specimen UDS-01. 2. For 2019 testing event 2, the laboratory received ungraded PT scores for urine sediment specimen US-02 and wet mount preparation specimen VKP-01. 3. For 2019 testing event 3, the laboratory received an ungraded PT score for molecular virology /respiratory panel specimen RSP-12. 4. For 2020 testing event 1, the laboratory received ungraded PT scores for molecular virology/respiratory panel specimen RSP- 03 and fecal leukocyte specimen FW-01. 5. For 2020 testing event 2, the laboratory received an ungraded PT score for molecular virology/respiratory panel specimen RSP-10. 4. At the time of the survey, the laboratory did not document a self evaluation for the ungraded PT scores. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: -- 2 of 5 -- Based on lack of centrifuge speed and timer check records, review of laboratory procedures and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 1:40 pm on 10/23/2020, the laboratory failed to document annual centrifuge function checks, including revolutions per minute (RPM) and timer checks for two out of two years from 1/1/2019 - 10/23/2020. The findings include: 1. Laboratory procedures indicated that centrifuge speed and timer checks will be performed annually. 2. The laboratory documented the centrifuge speed and timer checks from 2019 and 2020 had accidentally been discarded. 3. At the time of the survey, the laboratory did not have documentation of centrifuge speed and timer checks from 2019 and 2020. 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 calibration verification records and confirmed by laboratory personnel identifier #3 (refer to Laboratory Personnel Report) at approximately 1:50 pm on 10/23/2020, the laboratory failed to perform calibration verification procedures every six months for one out of four time periods for the analytes sodium, potassium, chloride and glycated hemoglobin from 1/1/2019 - 10/23/2020. The findings include: 1. The laboratory performed calibration verification procedures for the analytes sodium, potassium, chloride and glycated hemoglobin on 4/19/2019, 12/12/2019 and 10/23/2020. 2. At the time of the survey, the laboratory did not have calibration verification records for the time period between 12/12/2019 and 10/23/2020. *This is a repeat deficiency from the previous survey. 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 -- 3 of 5 -- 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 laboratory Individualized Quality Control Plans (IQCP) and i- STAT quality control (QC) records, and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 1:50 pm on 10/23/2020, the laboratory failed to perform two levels of QC each day of patient testing for the i- STAT test system (chem8+ and troponin cartridges) from 1/1/2019 - 10/23/2020. The findings include: 1. The laboratory followed manufacturer's instructions and performed QC with each new lot and/or shipment of chem8+ and troponin test cartridges. 2. At the time of the survey, the laboratory did not have an IQCP for the i- STAT test system allowing for less frequent QC. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of