Franklin County Medical Center

Summary Statement of Deficiencies D0000 During an offsite paper revisit the laboratory was found to be in compliance with CLIA regulations (42 CFR Part 493 effective April 24, 2003.), all previous deficiencies found were corrected. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of Vitros XT 3400 maintenance logs and an interview with the technical supervisor on 01/24/23, the laboratory failed to perform six (6) month maintenance as required by the manufacturer. The findings include: 1. A review of the Vitros XT 3400 monthly maintenance logs identified that the laboratory failed to perform the required six (6) month maintenance which includes performing correction factors and performing pad reflectance test in January 2022. 2. An interview with the technical supervisor on 01/24/23 at 11:37 am confirmed the above findings. 3. The laboratory reports performing 104,000 routine chemistry and endocrinology tests annually. 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. 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 review of pipette calibration reports, a direct observation, and an interview with the technical supervisor on 01/23/23, the laboratory failed to maintain calibrations on four (4) Vista Lab MLA pipettes. The findings include: 1. A review of the pipette calibration reports identified that the laboratory failed to have four (4) of four (4) pipettes calibrated. The pipettes were last calibrated on 06/25/21 with an expiration date of 06/25/22. 2. A direct observation of the four (4) Vista Lab MLA pipettes confirmed that the laboratory failed to have current calibration dates. Pipettes observed: 2 (two) 50/100/200 L adjustable volume pipettes, 1 (one) 50 L fixed pipette, and 1 (one) 250 L fixed pipette. 3. An interview with the technical supervisor on 01/23 /23 at 4:16 pm confirmed the above findings. 4. The laboratory reports performing 164,675 tests annually. -- 2 of 2 --

Summary Statement of Deficiencies 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 direct observation and an interview with the laboratory manger on 4/13 /2021, the laboratory failed to discontinue the use of expired specimen collection tubes. The findings include: 1. A direct observation of the phlebotomy draw trays on 4 /13/2021 identified that the laboratory failed to discontinue the use of seven (7) BD buffered sodium citrate 3.2%, 1.2 ml tubes, lot 0184335, expiration 1/31/2021 and sixteen (16) BD PST with polymer gel and lithium heparin tubes, lot 8249569, expiration 9/30/2019. 2. An interview with the laboratory manager on 4/13/2021 at 12: 00 pm confirmed the above finding. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a random review of maintenance logs and an interview with the laboratory manager on 4/12/2021, the laboratory failed to perform and document maintenance with the frequency defined by the manufacturer. The findings include: 1. A random review of laboratory maintenance logs from 2019, 2020 and 2021 identified 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 failed to perform and document maintenance as required by instrument manufacturers. No monthly maintenance was performed in January, February and March 2021 on the Tosoh AIA 900. The laboratory performed 348 tests on the Tosoh in January 2021, 298 tests in February 2021 and 382 tests in March 2021. No weekly maintenance was performed the third and fourth weeks in February 2021 on the Vitros 350. The laboratory performed testing on 151 patient samples the third week in February and 155 patient samples the fourth week in February on the Vitros 350. No daily maintenance was performed on the Horiba ABX Pentra, Tosoh AIA 900 and Vitros 350 on February 18, 2021. The laboratory performed tests on 47 patient samples on February 18, 2021. 2. An interview with the laboratory manager on 4/12 /2021 at 1:55 pm confirmed the above findings. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a random record review of Quality Control (QC) documentation and an interview with the laboratory manager on 4/12/2021 the laboratory failed to successfully perform two levels of QC daily for each quantitative procedure. The findings include: 1. A random record review of QC documents from the Vitros 350 for 2019, 2020 and 2021 identified that the laboratory failed to document QC results for all chemistry analytes on 9/8/2020. The laboratory performed chemistry tests on 60 patient samples on 9/8/2020. 2. A random record review of QC documents from the Sysmex CA-600 for 2019, 2020 and 2021 identified that the laboratory failed to document QC results for level 1 for D-dimer on 2/1/2021 and level 2 for D-dimer on 2 /15/2021. The laboratory performed one patient D-dimer test on each of the above days. 3. A random record review of QC documents from the Horiba ABX Pentra XL 80 for 2019, 2020 and 2021 identified that the laboratory failed to document QC results for level 1 and 2 for complete blood counts on 2/19/2021. The laboratory performed 25 compete blood counts on the Horiba ABX Pentra XL 80 on 2/19/2021. 4. An interview with the laboratory manager on 4/12/2021 at 3:55 confirmed the above findings. D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a random review of immunohematology quality control (QC) records and an -- 2 of 3 -- interview with testing personnel 2 (TP2) on 4/13/2021, the laboratory failed to document control material results with graded or titered reactivity and include negative control material. The findings include: 1. A random record review of immunohematology QC for 2019 and 2020 identified that the laboratory failed to document positive QC (1-4+) and negative QC on 1/8/2020, 2/22/2020 and 11/10 /2020 as required by regulation for blood and Rh type, antibody screen and crossmatch testing. 2. One prenatal screen and one blood and Rh type, antibody screen and crossmatch of two units were performed on 1/8/2020. One blood and Rh type, antibody screen and crossmatch of two units was performed on 2/22/2020. One blood and Rh type, antibody screen and crossmatch of two units was performed on 11/10 /2020. 3. An interview with TP2 on 4/13/2021 at 10:30 am confirmed the above findings. 4. The laboratory reports performing 300 immunohematology tests annually. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory testing personnel 1 (TP1) on 4/13/2021, the laboratory failed to check each lot of media for its ability to support growth and/or inhibit growth. The findings include: 1. A review of media quality control (QC) records that came with media received from Intermountain Laboratories identified that the laboratory failed to perform and document QC to show the ability of the media to support growth on MacConkey Agar lot number 21014081 (Becton Dickinson), Trypticase Soy Agar 5% Sheep Blood lot number 1007815 (Becton Dickinson), and Thioglycollate Liquid Medium (Becton Dickinson). 2. A review of patient test records and invoices from Hardy Diagnostics identified that the laboratory failed to perform and document QC to show the ability of the media to support growth in Strep B Carrot Broth and on GBS Detect Agar. 3. A review of media invoices Hardy Diagnostics and QC records that came with media received from Intermountain Laboratories identified that the laboratory failed to perform and document QC to show the ability of the media to inhibit growth on MacConkey Agar and in Strep B Carrot Broth. 4. An interview with TP1 on 4/13/2021 at 11:40 am confirmed that the laboratory failed to perform QC on media before it was used for patient testing. 5. The laboratory reports performing 830 bacterial cultures annually. -- 3 of 3 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a proficiency testing (PT) record review from the College of American Pathologists (CAP) and an interview with the laboratory manager, the laboratory failed to enroll in PT for the subspecialty of Parasitology since the last survey on July 27, 2017. Findings: 1. A CAP PT record review revealed the laboratory failed to enroll in PT for Giardia/ Cryptosporidium performed on the Cardinal Health combo kit since the last survey. 2. An interview on December 12, 2018 at 9:45 A.M., with the laboratory manager, confirmed the laboratory was not enrolled in a CMS-approved PT program since the last survey. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory manager, the laboratory failed to retain quality control results, calibration results, and patient test results printed from the Tosoh AIA immunoassay analyzer and the iStat analyzer since the last survey on July 27, 2017. Findings: 1. A review of calibration verification records revealed the laboratory failed to retain all the analyzer printouts for beta human chorionic gonadotropin, prostate-specific antigen, blood gases, and brain natriuretic peptide performed on the iStat and Tosoh. 2. An interview on December 12, 2018 at 11:45 A.M., with the laboratory manager, confirmed the laboratory failed to retain patient, quality control, and calibration verification data from the iStat and Tosoh. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) record review from the College of American Pathologists (CAP) and an interview with the laboratory manager, the laboratory failed to verify the accuracy of the chemistry analyte beta human chorionic gonadotropin (HCG) not scored for all three events in 2018. Findings: 1. A review of CAP PT documents revealed the laboratory failed to evaluate HCG test results not scored by CAP for all three events in 2018. 2. An interview on December 12, 2018 at 9:45 A.M., with the laboratory manager, confirmed HCG results that were not evaluated and scored by AAB and were not verified for accuracy for 2018. 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 proficiency a testing (PT) record review from the College of American Pathologists (CAP) and an interview with the laboratory manager, the laboratory failed to verify the accuracy of chemistry analytes scored an artificial 100% for all three events in 2018. This is a repeat deficiency from the previous survey performed on July 27, 2017. Findings: 1. A review of CAP PT documents revealed the laboratory failed to evaluate artificial 100% scores received from CAP for the analytes D-dimer, gamma-glutamyl transferase (GGT), free thyroxine (FT4), free triiodothyronine (FT3), myoglobulin, troponin, phosphorus-serum, and thyroid stimulating hormone (TSH) for all three events in 2018. 2. An interview on December 12, 2018 at 9:45 A. M., with the laboratory manager, confirmed artificial scores of 100% received from CAP for the chemistry analytes were not evaluated and verified for accuracy. -- 2 of 8 -- D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) record review from the College of American Pathologists (CAP) and an interview with the laboratory manager, the laboratory failed to verify the accuracy at least twice a year for chemistry, immunology, toxicology, hematology, and endocrinology analytes since the last survey on July 27, 2017. Findings: 1. A review of CAP PT documents revealed the laboratory failed to verify the accuracy at least twice a year for the following chemistry analytes performed on the Vitros 350: conjugated and unconjugated bilirubin and C-reactive protein; analytes performed on the Tosoh AIA: vitamin D, testosterone, and prostate- specific antigen; MedTox Profile V urine toxicology; iStat: Brain Natriuretic Peptide; Cardinal Health kit: Helicobacter pylori and Horiba Pentra: body fluid counts. 2. An interview on December 12, 2018 at 9:45 A.M., with the laboratory manager, confirmed the analytes were not verified for accuracy at least twice a year. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) record review from the College of American Pathologists (CAP) and an interview with the laboratory manager, the laboratory failed to establish and follow a written policy to monitor, correct, and document problems with proficiency testing since the last survey on July 27, 2017. Findings: 1. A review of proficiency testing (PT) records from the College of American Pathologists revealed the laboratory failed to review, evaluate, and document