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Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. Standard level deficiencies were cited. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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: I. Based on review of manufacturer's instructions, temperature charts, patient testing logs, interview, and pre-survey paperwork, the laboratory failed to monitor the temperature for the Sysmex XP-300 Hematology analyzer for performing CBC (Complete Blood Count) testing for two out of 13 days of patient testing reviewed. Findings follow. A. Review of the Sysmex XP-300 Instructions for Use, AU553517 October 2012, at 14. Technical Information, 14.1 Specifications, stated, "Operating Environment... Ambient temperature: 15 to 30 degrees Celsius". B. Review of the laboratory's Room Temperature/Humidity Log from 03/01/2025 - 05/31/2025 showed no temperatures recorded for 1. 03/10/2025 2. 04/14/2025. C. Review of the Daily Testing Log showed the CBCs tested: Date Account # 1. 03/10/2025 8X800695309 2. 04/14/2025 8X702981216 D. Interview with the Technical Consultant on August 26, 2025 at 1120 hours in the office confirmed the findings. E. Review of the CMS-Form 116 showed an annual test volume of 408. II. Based on review of manufacturer's 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 -- instructions, humidity charts, patient testing logs, interview, and pre-survey paperwork the laboratory failed to monitor the humidity for the Sysmex XP-300 Hematology analyzer for performing CBC (Complete Blood Count) testing for two out of 13 days of patient testing reviewed. Findings follow. A. Review of the Sysmex XP-300 Instructions for Use, AU553517 October 2012, at 14. Technical Information, 14.1 Specifications, stated, "Operating Environment... Relative humidity: 30% to 85%". B. Review of the laboratory's Room Temperature/Humidity Log from 03/01 /2025 - 05/31/2025 showed no humidity recorded for 1. 03/10/2025 2. 04/14/2025. C. Review of the Daily Testing Log showed the CBCs tested: Date Account # 1. 03/10 /2025 8X800695309 2. 04/14/2025 8X702981216 D. Interview with the Technical Consultant on August 26, 2025 at 1120 hours in the office confirmed the findings. E. Review of the CMS-Form 116 showed an annual test volume of 408. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: Based on review of QC (quality control) records, patient testing records, interview, and pre-survey paperwork, the laboratory failed to run controls every day of patient testing for the Complete Blood Count (CBC) tested using the Sysmex XP-300 Hematology analyzer for one out of 13 days of patient testing reviewed. Findings follow. A. Review of monthly QC printouts from 03/01/2025 - 05/31/2025 showed there was no QC run on 03/18/2025. B. Review of the Sysmex XP-300 data log from 03/01/2025 - 05/31/2025 showed 13 days of patient testing with 1 patient, 8X701637913, reported on 03/18/2025 for the CBC. C. Interview with the Technical Consultant on August 26, 2025 at 1105 hours in the office confirmed the findings. D. Review of the CMS-Form 116 showed an annual test volume of 408. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of quality control (QC) records, patient testing records, and interview, the laboratory failed to ensure 2 levels of QC were within range for the Red Blood Cell (RBC), Hemoglobin (HGB), and Hematocrit (HCT) before performing and reporting patient test results using the Sysmex XP-300 Hematology analyzer for one out of 13 days of patient testing reviewed. Findings follow. A. Review of the monthly QC printouts from 03/01/2025 - 05/31/2025 showed the Normal and High levels of QC were out of range on 04/14/2025 for RBC, HGB, and HCT. Controls were not repeated. B. Review of the Sysmex XP-300 data log showed 13 days of patient testing with 1 patient, 8X702981216, reported on 04/14/2025 for RBC, HGB, and HCT. C. Interview with the Technical Consultant on August 26, 2025 at 1115 hours in the office confirmed the findings. -- 2 of 3 -- D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the laboratory test reports, interview, and pre-survey paperwork, the laboratory failed to include the patient's name and identification number for one out of eight Complete Blood Count (CBC) test reports reviewed. Findings follow. A. Review of eight random patients' CBC test reports showed one without a name and complete identification number, 8X8005945, tested on 11/16/2024. B. Interview with the Practice Manager on August 26, 2025 at 1215 hours in the office confirmed the findings. C. Review of the CMS-Form 116 showed an annual test volume of 408. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. 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 observation, review of manufacturer's instructions, interview, and pre- survey paperwork, the laboratory failed to ensure expired K2 EDTA (dipotassium ethylenediaminetetraacetic acid) tubes were not used for CBC (Complete Blood Count) patient testing. Findings follow. During a tour of the laboratory on December 6, 2023 at 1045 hours, the surveyor observed the only available 4 mL purple top (K2 EDTA) tubes were expired. There were 6 tubes on the phlebotomy tray, and 10 tubes on the manufacturer's tray. The tubes showed an expiration date of 8/31/2023 (elapsed time 98 days). Interview with the Triage Nurse and former Supervisor on December 6, 2023 at 1045 hours confirmed the findings. Review of the CMS form 116 showed the estimated annual test volume of the CBC was 126. 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 D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Review of manufacturer's instructions, patient final reports and interview of facility personnel found the laboratory failed to follow the manufacturer's instructions when using the Abbott ID NOW Covid-19 test kits for testing 5543 patients tested between December 1, 2020 and December 13, 2021. The findings included: 1. Review of the manufacturer's instructions found on page 21 under the heading CONDITIONS OF AUTHORIZATION FOR LABORATORY " Authorized laboratories using your product must include with the test result reports, all authorized Fact Sheets." 2. Review of patient results found no fact sheets included with the final report for three of three patient reports reviewed. 3. Interview of the Technical Consultant conducted December 14, 2021, 2021 at 09:41 AM confirmed that the authorized Fact Sheets were not included with the patient test results for Covid -19 testing using the Abbott ID NOW test kits. 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 D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Review of package inserts, policy and procedures, observations, quality control records and interview of facility personnel found that the laboratory failed to follow the manufacturer's instructions when using the Siemens 10 SG Urinalysis Reagent strips. The laboratory failed to test external quality control materials as defined by the manufacturer when using the Siemens 10 SG Urinalysis Reagent strips lot 002064 expiration 2021-08-31. Findings included: 1. Review of the package insert for the Siemens 10 SG urinalysis reagent strips found under the heading QUALITY CONTROL - "Test known negative and positive specimens or controls whenever a new bottle is first opened." 2. Observations made during the tour the laboratory found that the laboratory was currently using Siemens 10 SG Urinalysis Reagent Strips lot 002064 expiration 2021-08-31. The bottle had approximately 20 dipsticks remaining and there was no documentation of the date opened on the bottle. 3. Review of Quality control records for urinalysis testing using the Siemens 10 SG urinalysis reagent strips found no documentation of external quality control materials tested with Lot 002064. 4. Interview of testing person one conducted on September 17, 2020 at 10:13 AM found that external quality control materials were not tested when each new bottle of urinalysis reagent strips is first opened. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations 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 -- 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: Review of Hematology quality control records, maintenance logs, patient test records and interview of facility personnel found that the laboratory failed to test at least two levels of quality control materials on 2 of 92 days between March 1, 2019 and May 31, 2019 when using the Sysmex XP-300 hematology analyzer for Complete Blood Counts (CBC). The findings included: 1. Review of quality control summary logs found no documentation of quality control materials tested on Thursday, March 21, 2019 and Friday, May 24, 2019. 2. Review of maintenance logs found testing person 13 documented performance of quality control for Thursday, March 21, 2019 and Friday, May 24, 2019. Review of patient test records found 10 patient specimens were tested without quality control materials being tested as follows: March 21, 2019 -eight patient specimens were tested patient 882074 patient 1313098 patient 1355878 patient 1272648 patient 1247212 patient 1263218 patient 1169601 patient 802256 May 24, 2019-two patient specimens were tested patient 1278664 patient 1060584 3. Interview of the Technical Consultant conducted on September 17, 2020 at 11:37 AM confirmed the above findings. D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. This STANDARD is not met as evidenced by: Based on review of competency assessments and interview, the technical consultant failed to include direct observation of routine test performance for the Complete Blood Count (CBC) for 7 of 11 personnel with semi-annual and annual competency assessments. Findings follow. 1. Review of the Personnel Assessment forms documenting competency assessments for testing personnel (TP) listed on the CMS form 209 found the technical consultant failed to document the use of direct observation in the following competency assessments: TP 1 was lacking the direct observation from the first semi-annual competency assessment for 2-8/2020 TP 7 was lacking direct observation from the second initial competency assessment for 2-8 /2018 and the 2019 competency assessment TP 8 was lacking direct observation from the second initial competency assessment from 1-7/2018 TP 9 was lacking direct observation from the 2018 competency assessment TP 11 was lacking direct observation from the second initial competency assessment for 11/2018-6/2019. TP 12 was lacking direct observation from the 2019 competency assessment, and TP with the pintails JG not on the CMS209, was lacking the direct observation from 2018. 2. Interview with the technical consultant at 0940 in the office/laboratory acknowledged it was difficult to see a direct observation during the time she is on-site and does request TP to notify her when they have a specimen so that she can observe them testing. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES -- 2 of 3 -- CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Review of the quality control records, maintenance records, patient test records and interview of facility personnel found that the Technical Consultant failed to ensure that testing personnel performed quality control procedures as documented on the quality control worksheets for each day of patient testing when using the Sysmex XP 300 hematology analyzer. -- 3 of 3 --