Scott County Community Hospital, Inc

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 the laboratory's proficiency testing (PT) records and staff interviews, the laboratory director/designee failed to sign eight of twelve PT attestation statements reviewed from 2025. The findings include: 1. A review of the laboratory's American Proficiency Institute (API) PT records revealed that the laboratory director/designee did not sign the attestation statements for the following events: -2025 2nd and 3rd events for Hematology/Coagulation -2025 2nd and 3rd events for Immunology/Immunohematology -2025 2nd and 3rd events for Chemistry Core -2025 2nd and 3rd events for Microbiology 2. An interview with the Laboratory Manager on 01.06.2026 at 11:00 a.m.confirmed the above survey findings. 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 on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (Form CMS-209), laboratory policy, personnel records, and staff interviews, the laboratory failed to follow its policy for annual competency 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 -- assessment for three of eleven testing personnel who performed high-complexity patient testing in 2024. The findings include: 1. A review of Form CMS-209 provided by the laboratory on 01.06.2026 revealed eleven testing personnel (TP) who perform high complexity patient testing. 2. A review of the laboratory policy titled "Medical Laboratory Supervisor Responsibilities" revealed that "Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. Evaluations must be performed at least annually unless test methodology or instrumentation changes." 3. A review of the laboratory's personnel records revealed no documentation of annual competency assessment for TP2, TP3, and TP9 in 2024. 4. An interview with the Laboratory Manager and interim Chief Executive Officer on 01.06.2026 at 12:50 p.m. confirmed the above survey findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 . The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 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: . Based on a desk review of proficiency testing (PT) records from the Certification 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 -- and Survey Provider Enhanced Reporting (CASPER) 0155 report and American Proficiency Institute (API) 2025 records, the laboratory failed to successfully participate in a proficiency testing program approved by Health and Human Services (HHS), for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Chemistry for the Phenobarbital analyte. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 unsuccessful performance. This STANDARD is not met as evidenced by: . Based on a proficiency testing desk review of the CASPER 0155 report and the American Proficiency Institute (API) 2025 records, the laboratory failed to achieve satisfactory performance (80% or better) for the same analyte in two out of three consecutive testing events in the specialty of Chemistry for the Phenobarbital analyte. Findings included: 1. Review of the CASPER 0155 report revealed the following results: *Chemistry 2025-1st Event: The laboratory received an unsatisfactory score of 60% for the Phenobarbital analyte. *Chemistry 2025-3rd Event: The laboratory received an unsatisfactory score of 60% for the Phenobarbital analyte. 2. A review of the API proficiency testing records confirmed the laboratory received the above results. 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 proficiency testing desk review of the CASPER 0155 report and American Proficiency Institute (API) 2025 records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure the overall quality of the laboratory services provided. 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 proficiency testing desk review of the CASPER 0155 report and American Proficiency Institute (API) proficiency 2025 records, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory -- 2 of 3 -- director failed to ensure successful participation in an HHS-approved proficiency testing program. Refer to D2096 -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 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: Based on a desk review of proficiency testing (PT) records from the Certification and 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 -- Survey Provider Enhanced Reporting (CASPER) 0155 report and American Proficiency Institute (API) 2025 records, the laboratory failed to successfully participate in a proficiency testing program approved by Health and Human Services (HHS), for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Routine Chemistry for the Creatine Kinase Total (CK Total), and Glycohemoglobin (HgbA1c) analytes. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and the American Proficiency Institute (API) 2025 records, the laboratory failed to achieve satisfactory performance (80% or better) for the same analyte in two consecutive testing events in the specialty of Routine Chemistry for the CK Total and HgbA1c analytes. Findings included: 1. Review of the CASPER 0155 report revealed the following results: *Chemistry 2025-1st Event: The laboratory received an unsatisfactory score of 40% for the CK Total analyte and 60% for the HgbA1c analyte. *Chemistry 2025-2nd Event: The laboratory received an unsatisfactory score of 60% for the CK Total analyte and 40% for the HgbA1c analyte. 2. A review of the API proficiency testing records confirmed the laboratory received the above results. 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 proficiency testing desk review of the CASPER 0155 report and American Proficiency Institute (API) 2025 records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure the overall quality of the laboratory services provided. 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 proficiency testing desk review of the CASPER 0155 report and American Proficiency Institute (API) proficiency 2025 records, the laboratory director failed to -- 2 of 3 -- ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program. Refer to D2096 -- 3 of 3 --

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the manufacturer control package insert, and interview with the laboratory supervisor, the laboratory failed to label three of three control vials used for performing quality control on the Complete Blood Count (CBC) hematology analyzer with an open date and a revised expiration date on the date of the survey (07.22.2024). The findings include: 1. Observation of the laboratory on 07.22.2024, at 9:00 a.m., revealed the Sysmex XN-550 (serial number 27402) used for patient testing. Also observed were three levels of Sysmex XN-L check controls (L1: lot 41801401, L2: lot 41801402, and L3: lot 41801403) not labeled with an open date and revised expiration date. 2. A review of the manufacturer's control package insert revealed that the controls remained stable for 15 days after opening. 3. An interview with the laboratory supervisor on 07.22.2024 at 9: 00 a.m. confirmed the above survey findings. 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. 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 -- This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare & Medicaid Services Laboratory Personnel Report (CLIA) (FORM CMS-209), testing personnel (TP) records, laboratory policy review, and staff interview, the technical supervisor failed to evaluate the semiannual competency for two of two (TP5 and TP6) new testing personnel who began patient testing in 2023. The findings include: 1. A review of the FORM CMS-209 revealed seven personnel (TP1 through TP7) who performed high- complexity patient testing. TP5 and TP6 were new testing personnel listed since the last laboratory survey. 2. A review of the laboratory's testing personnel records revealed no documentation of semiannual competency for TP5 and TP6 during the first year of testing in 2023. 3. A review of the section titled "Procedure" in the laboratory's New Laboratory Employee Orientation policy revealed the following statement: -"Competency assessment will be completed at 6 months and 1 year of employees hire date." 4. An interview with the laboratory supervisor on 07.22.2024 at 11:20 a.m. confirmed the above survey findings. -- 2 of 2 --

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Intakes: TN00070425 Based on observation of the laboratory area and staff interview, the facility failed to ensure the safety and protection of laboratory reagents and personnel from potential exposure to biohazardous waste material that leaked into the laboratory walk-in refrigerator on July 15, 2024. The findings include: 1. Observation of the laboratory area on 07.22.2024 at 9:28 a.m. revealed a wood-lined walk-in refrigerator for storing the laboratory's reagents. Also observed were noticeable stains and evidence of residue in the middle of the refrigerator located on the ceiling and the floor directly below the stains on the ceiling. 2. During an interview on 07.22.2024 at 9:30 a.m., the Laboratory Supervisor stated, "The facility had more plumbing issues, and the waste leaked into the walk-in refrigerator on July 15th." She also confirmed that the stains and remaining residue on the ceiling and floor of the walk-in refrigerator were evidence of biohazardous wastewater from a busted sewer pipe that leaked into the refrigerator on 07.15.2024. 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 D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the 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: Based on request of the Laboratory's Calibration records for the Hematology analyzer, review of the Laboratory's calibration procedure and upon interview with the Laboratory Manager, determined the laboratory failed to follow the laboratory's policy to ensure that calibration was performed at six month intervals for 2021 and 2022. The findings include: 1. A request of Calibration records for the hematology analyzer (Advia 2120) revealed one calibration performed on 10.3.2022. No other calibration documented for 2021 and 2022, thus not being performed at 6 months intervals. 2. Laboratory's Hematology analyzer, Advia 2120 Calibration procedure states, "Technologist/technicians will follow the procedures below in accordance with regulatory requirements. Calibrate on an as needed basis and in each of the following cases: o at installation o when there is a significant shift in control values after replacing a critical hydraulic or optical component o when installing reagents with a different lot number o any time commercial control products and/or moving averages are out of range and you have verified that the out-of-control condition is not instrument related o every 6 months 3. An interview with the Laboratory Manager at approximately 2:00 p.m. on February 15, 2023 confirmed the laboratory failed to follow the laboratory's policy to ensure that calibration was performed at six month intervals for 2021 and 2022. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 4 -- 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: Citation #1 1. Based on observation of the laboratory thermometers, review of the laboratory's Thermometer Calibrations policy and upon interview with the Laboratory Manager, it was determined the laboratory failed to ensure accuracy of thermometers from January 26, 2023 through February 15, 2023. The findings include: 1. Observation at approximately 9:15 a.m. on February 15, 2023, of laboratory thermometers, revealed expired accuracy verification for the following 5 thermometers: a. Refrigerator #1 (VSR37644702), freezer thermometer (210062574)- expiration date of 1/26/23 b. Refrigerator #4 (115430201140416), freezer thermometer (210062582) -expiration date of 1/26/23 c. Refrigerator #4 (115430201140416), refrigerator thermometer (210062510)-expiration date of 1/26 /23 d. Refrigerator #5 (2539639013), freezer thermometer (210062590) -expiration date of 1/26/23 e. Refrigerator #5 (2539639013), refrigerator thermometer (210062572) -expiration date of 1/26/23 2. Review of the laboratory's Thermometer Calibrations policy states, "Thermometers will be replaced upon expiration. If not replaced, then they will be calibrated annually or if there is any reason to suspect changed or damage." 3. An interview at approximately 2:00 p.m. on February 15, 2023 with the Laboratory Manager confirmed that thermometer accuracy verifications for 5 thermometers had not been performed from January 26, 2023 through February 15, 2023. Citation #2 2. Based on observation of the laboratory's hallway storage room, request of the laboratory's environmental logs, review of manufacturer's storage requirements listed on the Siemens Advia 2120i reagent bottles, and interview with the laboratory manager, determined the laboratory failed to document environmental conditions and ensure proper storage of Siemens Advia 2120i reagents for February 15, 2022 through February 15, 2023. The findings include: 1. Observation of the laboratory's hallway storage room revealed Siemens Advia 2120i Perox 1,2, & 3 reagents on shelves and no device for temperature monitoring. 2. Request for laboratory's hallway storage room environmental logs revealed none were present. 3. Review of the manufacturer's storage requirements listed on the Siemens Advia 2120i reagent bottles states, "store at 15-30 degrees Celsius." 4. An interview at approximately 2:00 p.m. on February 15, 2023 with the Laboratory Manager confirmed that the laboratory failed to ensure proper storage of Siemens Advia 2120i reagents for February 15, 2022 through February 15, 2023. 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 -- 2 of 4 -- 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 laboratory's Individualized Quality Control Plan (IQCP) for iSTAT CG4+ systems in the Respiratory Therapy department, lack of external monthly quality control (QC) documentation and interview via email with the Respiratory Therapy Laboratory Manager, determined the laboratory failed to follow their IQCP for performing monthly external QC for the iSTAT CG4+ for July 10, 2022 to August 13, 2022 for 26 patients tested. The findings include: 1. Review of IQCP for iSTAT CG4+ systems in the Respiratory Therapy department states, "External quality control=Assay normal and abnormal quality control every 30 days, upon opening a new lot #, and new shipment." 2. Lack of external monthly QC documentation for the iSTAT CG4+ systems in the Respiratory Therapy department from July 10, 2022 to August 13,2022 for 26 patients tested. 3. Interview via email on February 16, 2023 with the Respiratory Therapy Laboratory Manager confirmed the laboratory failed to follow their IQCP for performing monthly external QC for the iSTAT CG4+ for July 10, 2022 to August 13, 2022 for 26 patients tested. 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 observation of the Laboratory's two Triage Meters in use for performing Brain Natriuretic Peptide (BNPs), lack of documentation of twice a year comparison evaluation for 2022 and upon interview with the Laboratory Manager, it was determined the laboratory failed to perform and document twice a year evaluation between the two Triage Meters for performance of BNPs in 2022. The findings include: 1. Observation of the Laboratory's Alere Triage Meter (S#00079631) and Biosite Triage Meter (S#00055727) in use for performing Brain Natriuretic Peptide (BNPs) in the laboratory for patient testing. 2. Lack of documentation for twice a year comparison evaluations between the two instruments for 2022. 3. An interview at approximately 2:00 p.m. February 15, 2023 with the Laboratory Manager confirmed the laboratory failed to perform and document twice a year evaluation between the two Triage Meters for performance of BNPs in 2022. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on Testing Personnel (TP) listed on the Center for Medicare and Medicaid (CMS) Form 209, competency documentation and interview with the Laboratory Manager, determined the Supervisor failed to document training and competencies for 2022. The findings include: 1. One of six Testing Personnel (TP#3) listed on the CMS Form 209, lacked annual competency documentation for 2022. 2. Two of six Testing Personnel (TP#1 & TP#4) listed on the CMS Form 209, hired 6.27.2022 (TP#1) and hired 11.15.2022 (TP#4), lacked training and competency documentation upon hire. 3. An interview at approximately 2:00 p.m. on February 15, 2023 with the Laboratory Manager confirmed that 1 of 6 TP lacked annual competency documentation for 2022, 2 of 6 TP lacked training and competency upon hire dates of 6.27.2022 and 11.15.2022. -- 4 of 4 --

Summary Statement of Deficiencies D3007 FACILITIES CFR(s): 493.1101(b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs. This STANDARD is not met as evidenced by: =================================== Based on the Laboratory's test menu on 11/15/19 and upon review of reagents for Magnesium, Digoxin, Phenobarbitol, Vancomycin and BNP (Brain Natriuretic Peptide) analytes and upon interview with the Medical Laboratory Technician (MLT) and the Laboratory Supervisor, it was determined the laboratory failed to have sufficient reagents to perform these tests that are within the laboratory's stated test performance menu. The findings include: 1. Based on the Laboratory's test menu as stated on 11/15/19 and review of reagents for Magnesium, Digoxin, Phenobarbitol, Vancomycin and BNP, the laboratory failed to have sufficient reagents to perform these tests that are within the laboratory's stated test performance menu. 2. An interview at approximately 4:00 p.m. on November 15, 2019 with the MLT and Laboratory Supervisor confirmed the laboratory was unable to perform tests Magnesium, Digoxin, Phenobarbitol, Vancomycin and BNP due to lack of sufficient reagents. ==================================== D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- This STANDARD is not met as evidenced by: =================================== Based on a review of the send out log for 15 Complete Blood Count (CBC) reports for 10/15/19 and 10/16/19, lack of original reports from the testing laboratory, lack of testing laboratory's name, address and correct normal ranges on final report (which was manually entered into primary laboratory's computer system) and upon interview with the Medical Laboratory Technician (MLT), it was determined the CBC final reports did not contain the testing laboratory's name, address, correct normal ranges and the original reports had not been saved. The findings include: 1. A review of the send out log revealed 15 CBC's for 10/15/19 and 10/16/19 had been sent out for testing. 2. The laboratory failed to save the original CBC reports from the testing laboratory. 3. The laboratory failed to include the name and address of testing laboratory on final patient reports upon manual entry into laboratory/hospital computer system. 4. The laboratory failed to include the correct normal ranges from the testing laboratory upon manual entry into the laboratory/hospital computer system. 5. An interview at approximately 4:00 p.m. on November 14, 2019 with the MLT confirmed the 15 CBC final reports reviewed were sent to another laboratory for testing on 10/15/19 and 10/16/19 and did not contain testing laboratory's name and address, correct normal ranges from testing laboratory and that original report from testing laboratory had not been saved. =================================== D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: ==================================== Based on lack of Laboratory Director review of the Proficiency Testing (PT) records for 2018 and 2019 and interview with the Laboratory Supervisor, determined the Laboratory Director failed to ensure that PT evaluations and verification activities were reviewed and evaluated consistently for the two year period. The findings include: 1. There was no documentation of Laboratory Director review for Proficiency Testing evaluations for 2nd Event Chemistry in 2018 and 1st Event Chemistry in 2019. 2. There was no documentation of Laboratory Director review of Proficiency Testing attestation pages for 1st Event Chemistry and 3rd Event Blood Bank in 2018 and 1st and 2nd Event Chemistry, 1st Event Miscellaneous Chemistry, and 2nd Event Microbiology in 2019. 3. An interview with the Laboratory Supervisor at approximately 4:00 p.m. November 15, 2019 confirmed there was not consistent documentation of Laboratory Director review of PT evaluations and verification activities for 2018 and 2019. ===================================== D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other -- 2 of 14 -- materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)