Mcintosh Clinic Pc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on August 20, 2024. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on laboratory policy and procedure manual (SOP) review and staff interview, the laboratory failed to establish and follow a policy and procedure to assess (TP) competency as required. Findings include: 1. SOP review revealed there was no policy and procedure to assess (TP) competency available at the time of survey. 2. Lack of TP competency documents revealed there was no annual competencies performed for the following TP(CMS 209) TP #2 and #3. 3. An interview with TP #2 (CMS 209) on 08/20/24 at 3:20 PM in the laboratory confirmed the lack of a TP competency policy and procedure at the time of survey. During the same interview, TP #2 confirmed there were no competency documents available at the time of survey for the aforementioned staff . D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. 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 -- This STANDARD is not met as evidenced by: Based on American Proficiency Institute (API) proficiency testing (PT) document review and interviews with the lab director (LD) and testing personnel (TP) the laboratory failed to document

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on August 11, 2022. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) provider, and staff interview the laboratory failed to achieve satisfactory performance in the Specialty of Chemistry- Subspecialty Glycohemoglobin (A1C) , for 2/3 events in 2021. Findings: 1. Review of the API PT documents for 2021, for the Specialty Chemistry-subspecialty A1C, the laboratory received for the 1st event a score of 50%, event 2- score of 100% , event 3-a score of 0%. The laboratory did not submit specimen for event 3. 2. Interview with staff #2 (CMS 209 Personnel List) on August 11, 2022, at approximately 2:30pm in the upstairs office confirmed the aforementioned statements. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: 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 -- Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) provider, and staff interview the laboratory failed to document

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on November 18, 2020. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on the review of American Proficiency Institute (API) Proficiency Testing (PT) documents from the Third event, 2018 to the Third event, 2020, and staff interview the Laboratory Director(LD), failed to sign the Attestation Statement 19 out of 20 times. Findings: 1. Review of the APT PT documents, the Laboratory did sign the Attestation Statement for the following events.: 2020 - event 1, The LD did not sign the following Attestation Statements: Chemistry Misc. Chemistry Immunology Hematology/Coagulation 2020 - event 2, The LD did not sign the following Attestation Statements: Immunology Hematology/Coagulation 2019- event 1, The LD did not sign the following Attestation Statements Chemistry Misc Chemistry Immunology Hematology/Coagulation 2019 - event 2, The LD did not sign the following Attestation Statements Chemistry Misc. Chemistry Hematology /Coagulation 2019 - event 3, The LD did not sign the following Attestation Statements Chemistry Immunology Hematology/Coagulation 2018 - 3 event, The LD did not sigh the following Attestation Statements Chemistry Immunology Hematology /Coagulation 2. Interview with staff#2, (CMS 209 form), on 11/18/2020 at approximately 4:15 pm in the Radiology Department confirmed the above aforementioned information. 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 -- D2011 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(3) Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications pertaining to the results of proficiency testing sample (s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent. Laboratories with multiple testing sites or separate locations must not participate in any communications or discussions across sites/locations concerning proficiency testing sample results until after the date by which the laboratory must report proficiency testing results to the program. This STANDARD is not met as evidenced by: D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of the Beckman Coulter DxH600 Hematology Analyzer (DXH600) calibration reports, and staff interview, the laboratory failed to provide documentaion that the DXH600 was calibrated every 6 months. Findings: 1. Review of the calibration documents, the DXH600 was calibrated on 11-6-2018, and no other documented calibrations could be found. Review of the service request, did not indicate that any calibrations were performed due to service on the analyzer. 2. Interview with staff #2,(CMS 209 form), on 11/18/2020, at approximately 4 pm, in the X-ray department Bone Density room, confirmed that there was no documentation that the DXH600 had been calibrated since 11-6-2020. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on June 28, 2018. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of the Beckman Coulter LH500 hematology analyzer Quality Control(QC) print outs, and staff interview, the laboratory was not printing the monthly QC, including the Levey Jennings Charts, to monitor the accuracy and precision of the complete analytic process. Findings: 1. Review of the Beckman Coulter LH500 QC printouts showed that the laboratory was not printing the Monthly QC, which includes the Levey Jennings Charts to monitor the accuracy and precision of the complete analytic process. 2. Interview with staff #2 (CMS 209 form) on June 28, 2018 at approximately 2 pm, in the upstairs office, confirmed that the monthly QC reports, including the levey jennings charts were not being printed. 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 -- D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on review of the Testing Personnel (TP) training and competency documents and staff interviews, the Laboratory Director failed to meet the requlatory requirements for Competency Assessment of Testing Personnel. Findings: 1. Review of the TP competency assessment documents showed that the Yearly Employee Competency Testing consisted of a performing Proficiency Testing. The minimal six procedures for regulatory requirements for assessment of competency for all TP were not met. 2. Staff interview with the Laboratory Director, and Staff #2 (CMS form 209) on June 28, 2018 at approximately 1:50, in the upstairs office confirmed that the Competency assessment consited of the performance of Proficiency Testing. -- 2 of 2 --