Frontier Medical Associates Of Paintsville

Summary Statement of Deficiencies D0000 A Recertification Survey was conducted on 07/11/2024. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. 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 review of the Form Centers for Medicare and Medicaid Services (CMS) - 116, the review of manufacturer's information addressing the laboratory's hematology quality control (QC) materials, document review, and confirmed in staff interview, the laboratory failed to monitor and document temperatures of the storage refrigerator each day of operation to ensure the quality control materials were maintained in accordance with manufacturer's specifications for 18 of 18 total months of temperature records reviewed (January 2023 through June 2024). Findings included: Review of the laboratory's Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (Form CMS - 116), signed and dated by the Laboratory Director (LD) on 07/10/2024, revealed the laboratory's normal days of operation were Monday through Saturday. Review of the manufacturer's information for the laboratory's hematology analyzer, revised in July 2013, revealed that after opening, control materials should be maintained at "2-8 [degrees] C [Celsius]" (35.6 degrees Fahrenheit (F) to 46.4 degrees F). Review of monthly refrigerator temperature logs for 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 refrigerator identified as "RH157" for the timeframe of 01/01/2023 through 06/30 /2024 revealed, "Take immediate action if temperature is too low (below 36 [degrees] F) or too high (above 46 [degrees] F)!" The logs also included instructions to, "Record the min/max [minimum/maximum] temperatures daily at the opening of the clinic of the previous 24 hours." The logs revealed multiple days of operation with no recorded temperatures for each month reviewed. During an interview on 07/11/2024 at 11:00 AM, the Clinic Manager (CM) confirmed the refrigerator identified as "RH157" was the refrigerator used for storing hematology quality control materials. The CM confirmed temperatures had not been monitored or recorded as required. -- 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 laboratory 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 proficiency testing desk review of the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER)-0155 and American Proficiency Institute (API) 2023 records (1st and 2nd events), the laboratory failed to successfully participate in a proficiency testing program approved by 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 Hematology for the cell identification or white blood cell differential (Cell ID or WBC Diff) analyte. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 and API records 2023 (1st and 2nd events), the laboratory failed to achieve satisfactory performance (80% or greater) for two (2) consecutive testing events in the specialty of Hematology for the cell identification or white blood cell differential (Cell ID or WBC Diff) analyte. 1.A review of the CASPER-0155 report revealed the following: Hematology 2023- 1st Event The Laboratory received an unsatisfactory score of 27% for the Cell ID or WBC Diff analyte. Hematology 2023- 2nd Event The Laboratory received an unsatisfactory score of 0% for the Cell ID or WBC Diff analyte. 2.A review of proficiency testing records from API 2023 confirmed the above findings. 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 Individual Laboratory Report and API 2023 records (1st and 2nd events), the laboratory director failed to provide overall management and direction of the laboratory services. (Refer to D6016) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on a proficiency testing desk review of the CASPER-0155 and API 2023 records (1st and 2nd events), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. (Refer to 2130) -- 3 of 3 --

Summary Statement of Deficiencies D0000 An initial certification survey was conducted on 10/20/2022, and the facility was found not to be in compliance with the laboratory requirements at 42 CFR, Part 493. 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 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)