Clay County Hospital Laboratory

Summary Statement of Deficiencies D0000 D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] 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: D2016 Based on a review of the PT evaluation reports from the API (American Proficiency Institute) and an interview with the Laboratory Manager, the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing for Mono and PMN (polymorphonuclear neutrophils) CSF (cerebrospinal 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 -- fluid), non-regulated analytes in the specialty of Hematology. The laboratory failed two consecutive PT events, Event #1 in 2025 and Event #3 in 2025, resulting in initial unsuccessful proficiency testing performance. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (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 a review of the Proficiency Testing (PT) evaluation reports from API (American Proficiency Institute) and an interview with the Laboratory Manager, the laboratory failed to successfully participate (achieve scores of 80% or greater) in PT for Mono and PMN (polymorphonuclear neutrophils) CSF (cerebrospinal fluid), non- regulated analytes in the specialty of Hematology. The laboratory failed two consecutive PT events, Event #1 in 2025 and Event #3 in 2025, resulting in initial unsuccessful proficiency testing performance. The findings included: 1. Based on review of the PT evaluation reports, the laboratory received the following failing scores, resulting in unsatisfactory performances for two consecutive events, as follows: A. 2025-Event #1: Mono CSF: 50%; PMN CSF: 50% B. 2025-Event #3: Mono CSF: 50%; PMN CSF: 50% 2. During the exit interview on 6/10/26 at 12:30 pm, the Lab Manager confirmed 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 a review of the PT (Proficiency Testing) evaluation reports from the API (American Proficiency Institute) the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. 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 review of the Proficiency Testing (PT) evaluation reports from the API (American Proficiency Institute) the laboratory director failed to ensure the laboratory had successful participation in an HHS approved PT program for Mono and PMN (polymorphonuclear neutrophils) CSF (cerebrospinal fluid), for two consecutive API PT events, resulting in initial unsuccessful participation for the analyte. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies 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 a review of the Respiratory records, and an interview with TP (Testing Personnel) #8, the laboratory failed to retain documentation of daily Respiratory quality control (QC) performed on the Roche Cobas b 221 Respiratory analyzer from the date of the previous survey (7/13/2022) to the current survey (5/8/2024) . The findings include: 1. A review of the Roche Cobas b 221 QC records revealed the laboratory retained the Roche Diagnostics Quality Assurance Reports (peer group evaluations) for each Respiratory QC lot number from August 2022 through to the current 2024 report. There was no evidence of daily Respiratory QC data retained after July 2022. 2. During an interview on 5/8/2024 at 11:27 AM, TP #8 explained they moved into the Respiratory Manager role shortly after the last inspection in 2022. They were not aware they needed to print daily QC. TP #8 confirmed patients are not able to be performed until all three levels of QC are acceptable. D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B 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 -- grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (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 a review of the Blood Bank QC (Quality Control) records, a review of the policy and procedure manual, and an interview with the Technical Consultant, the laboratory failed to document Blood Bank QC per the laboratory requirements. This was noted for 1 of 30 days reviewed in October 2022. The findings include: 1. A review of the Blood Bank QC revealed no evidence of ABO and Rh interpretation documentation for 10/22/2022. 2. A further review of the policy and procedure under "Quality Control Testing- Reagents, Equipment" revealed, "...Quality control reactions.... must be documented in the Blood Bank Log." 3. During an interview on 5 /7/2024 at 1:53 PM, The Technical Consultant confirmed the above findings. -- 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 a review of the Cobas b221 analyzer records (used for performing Arterial Blood Gases [ABGs] in the Respiratory Therapy Department and an interview with Testing Personnel #10 (the Respiratory Therapy Supervisor), the laboratory failed to ensure the kit for the June 2021 calibration verification was utilized before expiration. This affected one of four ABG calibration verifications performed in 2021-2022. The findings include: 1. A review of the Cobas b221 ABG analyzer records revealed the June 2021 calibration verification was performed on July 31, 2021. The laboratory utilized Lot # 21491930 with an expiration date of June 2021. 2. During an interview on July 13, 2022, at 12:59 PM, testing personnel #10 confirmed the above noted findings. SURVEYOR ID# 32558 Licensure and Certification Surveyor 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 D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) proficiency testing records for 2018 - 2020, and an interview with the Laboratory Manager, the surveyor determined the laboratory failed to satisfactorily perform the crossmatch testing for Immunohematology, Event #1, 2020. The laboratory scored eighty percent (80 %), a failing score. This affected one of eight Immunohematology events reviewed by the surveyor. The findings include: 1. A review of the API proficiency testing records for 2020 revealed the laboratory scored 80 % for the crossmatch for Event #1. For Immunohematology, this is considered a failing score. 2. In an interview on 10/08 /2020 at 2:55 PM - 3:25 PM, the laboratory manager confirmed the score and acknowledged understanding of the failure. 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. 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 -- This STANDARD is not met as evidenced by: Based on a review of the 2018 - 2020 temperature and humidity logs for the Respiratory Unit (Arterial Blood Gas testing) and an interview with the laboratory manager, the surveyor determined the laboratory failed to document room temperature and humidity for several days in July and August of 2020. This affected two months in 2020, from January to October 8, 2020 (exit day of the survey). The findings include: 1. A review of the temperature and humidity logs revealed the following missing documentation: a) The laboratory did not document the room temperature (established 15 - 31 degrees Celsius) on August 3, 4 and 6; and July 23, 25 and 26, 2020. b) The laboratory did not document the humidity (established 15 - 20 percent) on August 4 and 5; and July 23, 25 and 26 of 2020. 2. In an interview on 10/06/2020 at 3:46 PM, the laboratory manager of the Respiratory Unit stated he was out from July 31 to August 13, 2020; however the other employees should have monitored and documented the temperatures and humidity. In the exit interview on 10/08/2020 at 2: 55 PM - 3:25 PM, the laboratory manager confirmed the above noted findings. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a review of the 2019 - 2020 monthly quality control records (Roche Diagnostics Quality Assurance Reports) for the Arterial Blood Gases (ABGs), a review of the manufacturer's package inserts for the quality control, and an interview with the laboratory manager of the Respiratory Unit, the surveyor determined the laboratory staff failed to ensure quality control material was not used beyond the expiration dates. In March of 2019, the laboratory analyzed patient samples with three levels of controls; however two levels (Level 1 and 2) had exceeded their expiration dates. This affected one month in 2019 of twenty four months reviewed by the surveyor. The findings include: 1. A review of the Roche Diagnostics Quality Assurance Reports for 2019 revealed only Auto-Trol Level 3 quality control was uploaded to the monitoring system for March. 2. Further review of the Roche Diagnostics Quality Assurance Reports revealed in March of 2019, the three levels of quality control in use were as follows: 21480959 Level 3; 21460854 Level 2 expired 12/2018; and 21470758 Level 1 expired 02/2019. 3. An attached

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --