First Choice Immediate Care Mcreary

Summary Statement of Deficiencies D0000 A Recertification Survey was initiated on 05/26/2023 and concluded on 05/26/2023. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on observation, document review, and interview, the laboratory failed to perform and verify accuracy, precision, and reportable range of 1 of 1 test instruments. Findings included: During the laboratory tour on 05/26/2023 at 10:05 AM, an Abbott I-Stat was observed. Testing Personnel-1 (TP-1) stated the facility acquired the instrument "a few months ago." Per TP-1, staff used the Abbott I-Stat to perform the troponin, creatine kinase-myocardial band (CK-MB), basic metabolic panel (BMP), and B-type natriuretic peptide (BNP) tests. Review of the testing procedure for the "I-Stat" showed prior to patient testing, staff performed QC and calibrations on 03/30/2023. Further review revealed it was signed and approved by the Laboratory Director (LD) on 04/03/2023. During an interview on 05/26/2023 at 11:55 AM, TP-1 stated the I-Stat instrument was previously used at another clinic and then moved to its present location. On 05/26/2023 at 12:23 PM, TP-1 presented the Surveyor with the installation and performance specification records from the installation of the instrument at the prior location, dated 08/28/2019. TP #1 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 -- acknowledged there was no performance specification verification to include accuracy, precision, and reportable range for the instrument at the current laboratory. (Review of the "I-Stat" testing showed the laboratory performed 18 tests with the I- Stat from 04/13/2023 through 05/26/2023.) -- 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 record review and staff interview on 10/13/2020, the laboratory failed to monitor and document room temperature and humidity to ensure manufacturer's temperature requirements were met for the operation of the Beckman Coulter AcT Diff hematology instrument from 08/08/2019 through 10/12/2020. Findings include: Review of the manufacturer's operations manual under 4.1 Instrument Specifications stated Temperature, Ambient Operating range of 16 degrees Centigrade to 35 degrees Centigrade (61 degrees Fahrenheit to 95 degrees Fahrenheit) and Humidity range of 20 percent to 85 percent without condensation. Review of temperature logs failed to reveal recordings of room temperature and humidity from the date of installation of the hematology instrument on 08/08/2019 through 10/12/2020. Testing personnel acknowledged in an interview at 11:00 AM on 10/13/2020, the laboratory failed to follow the manufacturer's requirements for monitoring room temperature and humidity for the operation of the Beckman Coulter AcT Diff hematology instrument. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of 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 laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on record review and staff interview on 10/13/2020, the laboratory director failed to review and evaluate the verification procedures used to determine the precision, accuracy, reportable ranges, and reference (normal) ranges for the Complete Blood Count (CBC) analytes reported on the Beckman Coulter AcT Diff Hematology analyzer prior to reporting patient results. Findings include: Record review revealed the AcT Diff hematology instrument was installed 08/08/2019. Record review revealed patient samples were tested and results reported 08/09/2019. Record review failed to reveal documentation of evaluation and approval of the verification procedures prior to patient testing. An interview with Testing Personnel at 11:00 AM on 10/13/2020, revealed the Laboratory Director failed to review, evaluate, and approve the verification procedures on the AcT Diff Hematology instrument prior to reporting CBC analyte results -- 2 of 2 --