Sherwood Urgent Care-Searcy,Ar

Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of the package insert for Triage D-Dimer Test patient D-Dimer test results in the laboratory log book, patient final test results from the medical records, lack of normal reference ranges, and interviews with the laboratory director, it was revealed the laboratory failed to make normal ranges for D-dimer available to the individuals responsible for using the test results. Survey findings include: A. The surveyor reviewed the package insert for Triage D-Dimer Test and determined the manufacturer's expected ranges stated, "The expected values from 208 apparently healthy individuals are less than 600 ng/ml. Each laboratory should establish a reference range that is representative of the patient population to be evaluated." B. In an interview, at 12:25 on 8/2/2023, the laboratory director (as listed on the form CMS- 209) stated that the laboratory did not establish a normal range for D-Dimer and further stated that she doesn't know how providers are made aware of abnormal D- Dimer results. C. The surveyor reviewed ten patient D-dimer results as documented in the laboratory records. Two of ten results reviewed were above the manufacturer's normal values listed in the package insert (600 ng/ml). On 6/13/2023 Patient #83019 had a D-Dimer result reported as 824 (documented in the column listed as "In Range"). On 7/21/2023 Patient #45280 had a D-Dimer result reported as 2380 (documented in the column listed as "In Range"). There was no documentation on either report (two of two) to indicate that the D-Dimer results were abnormal. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) 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 -- The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of the CMS-209 form dated 8/2/2023, a review of personnel records for eight of eight laboratory personnel, lack of documentation, and interviews with laboratory staff, the it was revealed the technical consultant failed to evaluate the performance of moderate complexity testing personnel at least annually. Survey findings include: A. The CMS-209 form dated 8/2/2023 included six testing personnel listed as #2, #3, #4, #5, #6, and #8 on the form. B. One of six testing personnel (#8) failed to have competency assessment documented in the last twelve months. A review of personnel records for #8, revealed the last documentation of competency assessment was dated 4/25/2022 (15 months prior to the survey date). C. In an interview, at 10:00 a.m. on 8/2/2023, the laboratory director stated that there were no other competency assessments available for review. -- 2 of 2 --

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: . Through a review of the 2020 Daily Maintenance Log for the Medonics M Series Hematology Analyzer, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to perform daily maintenance as specified by the manufacturer. As evidence by: A. A review of the Daily Maintenance Log for the Medonic M Series Hematology Analyzer revealed the following required daily maintenance: Check reagent levels, check printer paper, background count, clean probes with alcohol and perform quality controls. B. A review of the Medonic Hematology daily maintenance log revealed daily maintenance was not documented on three of thirty-one days in October 2020 (one of twelve months reviewed). C. A review of the Medonic Hematology daily maintenance log revealed daily maintenance was not documented on eleven of thirty-one days in November 2020 (two of twelve months reviewed). D. In an interview on 7/30/2021 at 10:30, the technical consultant confirmed the lack of documented daily maintenance for the Medonic M Series Hematology Analyzer. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

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: Through observations made during a tour of the laboratory, a review of the temperature log sheets for January through December 2018, and interviews with laboratory staff, it was determined the laboratory criteria for storage of Alere Triage Total 5 Controls was not consistent with manufacturer's instructions. Survey findings include: A. During a tour of the laboratory, at 12:25 on 1/23/2019, the surveyor observed 1 box of Alere Triage Total 5 Controls Level 1 (lot C3491A) and one box of Alere Triage Total 5 Controls Level 2 (lot C3456A) stored in the laboratory freezer. The manufacturer's storage requirements documented on the package states the acceptable storage temperature is less than or equal to -20 degrees Celsius. B. Review of the temperature log sheets for January through December 2018 showed the laboratory's acceptable storage requirement used for the freezer was less than or equal to -15 degrees Celsius instead of the manufacturer's required temperature as listed above. C. In an interview, at 12:25 on 1/23/2019, the laboratory director confirmed the acceptable temperature in use did not match the manufacturer's requirements. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) 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 -- 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 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: . Through a review of the Individualized Quality Control Plan (IQCP) for D-Dimer performed on the Alere Triage, quality control (QC) data, patient testing logs, lack of documentation, as well as interviews with staff, it was determined the laboratory failed to document QC when patients were tested. Survey findings include: A. The IQCP for D-Dimer performed on the Alere Triage states, "Triage Total 5 Control Levels 1 and 2 will be analyzed and within acceptable limits upon installation of each new cartridge lot and monthly prior to patient testing." B. A review of the D-Dimer QC data for 2018 revealed monthly quality control was documented on 8/14/2018 but was not documented in September 2018 (monthly qc not documented in 1 of 12 months). Quality control was not documented until 10/14/2018. C. A review of patient testing logs showed the following six patients (as listed on the Patient Identifier Worksheet) tested in September and October before the monthly external quality control was tested on 10/14/2019: Patient #1 had a D-Dimer performed on 9/16/2018, Patient #2 had a D-Dimer performed on 9/18/2018, Patient #3 had a D-Dimer performed on 9/20/2018, Patient #4 had a D-Dimer performed on 9/23/2018, Patient #5 had a D-Dimer performed on 10/11/2018, and Patient #6 had a D-Dimer performed on 10/11/2018. D. In an interview on 1/23/2019 at 10:40 a.m., the laboratory director (as listed on form CMS 209) confirmed patients were analyzed without performing monthly quality controls in between 8/14/2018 and 10/14/2018. D5785