Urgent Care Of Oconee - Watkinsville

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on April 17, 2024. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing D6000 - 42 CFR 493.1403 Condition: Moderate Complex 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 review of the Centers for Medicare and Medicaid (CMS) CASPER 155 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 -- report, the laboratory failed to successfully participate in proficiency testing (PT) for hematocrit (HCT) & Hemaglobin (HGB) resulting in the non-initial unsuccessful participation for HCT & HGB. Refer to D 2130 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 review of the CMS CASPER 155 report, the laboratory failed to demonstrate satisfactory performance in 3 out of 3 consecutive testing events for HGB & HCT, resulting in the non- initial unsuccessful participation for HGB & HCT. Findings: 1. A review of Casper Report 155 revealed the laboratory failed HGB on the following: 2022 Event 2 Score 0% 2022 Event 3 Score 0% 2023 Event 1 Score 0% 2. A review of Casper Report 155 revealed the laboratory failed HCT on the following: 2022 Event 2 Score 0% 2022 Event 3 Score 0% 2023 Event 1 Score 0% 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 review of the CMS CASPER 155 report, the laboratory director failed to provide overall management and direction for successful participation in PT. The laboratory director failed to ensure PT samples were tested as required. 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: Based on review of the CMS CASPER Report 155, the laboratory director failed to ensure successful PT participation in 3 out of 3 consecutive testing events. Refer to D 2130 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 26, 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: D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the general laboratory standard operating procedure manual (SOP) and staff interview, the laboratory failed to establish written instructions for sending specimens to an outside reference laboratory for testing The findings include: 1. The SOP did not include a written policy and procedure (to include collection, preservation, storage, transport, testing schedule times, or how to obtain additional assistance) for staff to follow when sending specimens to reference laboratory (Quest, and LabCorp). 2. During an interview on May 26, 2022 at: 11:45 AM with Testing Personnel #1(CMS 209), in an exam room in the back of the facility, confirmed that the laboratory did not have a written policy and procedure for staff to follow when sending specimens to reference laboratories. 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 D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on December 18, 2019. 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: 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: 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 Hematology calibrations document review and interviews with the Technical Consultant (TC), the laboratory failed to perform instrument calibrations every six months as required in 2018 and 2019 for the Cell dyn Emerald Hematology Analyzer. Findings include: 1. The Cell Dyn Emerald hematology analyzer calibrations document review revealed the laboratory performed instrument calibrations: 8/1/2017 to 4/2/2018 (8 months), 4/2/2018 to 8/6/2018 ( 4 months), 01/22 /2019 to 08/24/2019 (8 months). 2. An interview with the the (TC) on December 18, 2019 in the conference room at approximately 12:20 p.m. confirmed hematology analyzer calibrations were not performed during the aforementioned intervals in 2018 and 2019. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on July 23, 2018. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory 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 -- performance in two of three consecutive events (2nd event of 2017 and 1st event of 2018), resulting in the first unsuccessful occurrence for cell ID or WBC differential (DIFF) # 765 and white blood cell count (WBC) # 805. Findings include: Refer to D 2130 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three consecutive events (2nd event of 2017 and 1st event of 2018), resulting in the first unsuccessful occurrence for cell ID or WBC differential (DIFF) # 765 and white blood cell count (WBC) # 805. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #765 DIFF on event 2 of 2017 with a score of 40% and event 1 of 2018 with a score of 0% ( failure to participate) and failed WBC # 805 with a score of 60% on event 2 of 2017 and 0% (failure to participate) on event 1 of 2018. 2. Desk review of the laboratory's proficiency testing reports from American Association of Bioanalysts confirmed the laboratory failed DIFF and WBC on event 2 of 2017 and event 1 of 2018 resulting in the first unsuccessful performance. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 21, 2018. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. An immediate jeopardy situation was identified due to the laboratory's inability to demonstrate compliance in the speciality of Chemistry which resulted in Immediate Jeopardy. 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 proficiency test (PT) document review and a laboratory specialist consultant interview, the laboratory director (LD) failed to attest to the routine integration of the PT samples into the patient workload as required. Findings include: 1. American Association of Bioanalysts (AAB) PT document review revealed the LD failed to attest to the routine integration of the Hematology PT samples into the patient workload for the following PT events: 2017 Hematology Events 2 and 3 due to the inability to produce the documentation at the time of survey. 2. An interview with the laboratory specialist consultant on 5/21/18 in a conference room at approximately 4 p. m. confirmed there were no attestation statements for the aforementioned PT events at the time of survey. D3011 FACILITIES CFR(s): 493.1101(d) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation and staff interview, the laboratory did not ensure protection from physical and electrical hazards as required. Findings include: 1. Observation during the laboratory tour at approximately 5:00 p.m. on 5/21/18 revealed there was no fire extinguisher in the facility. 2. An interview with the technical consultant at the nurses station at approximately 6:15 p.m. on 5/21/18 confirmed there was not a fire extinguisher in the facility. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on document review, the laboratory failed to provide a laboratory director (LD) - approved policy and procedure manual (SOP), failed to perform quality control (QC) before evaluating chemistry patient samples, and failed to evaluate an unregulated chemistry analyte at least twice annually for accuracy and precision. This condition level contributed to the Immediate Jeopardy. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and a laboratory specialist consultant interview, the laboratory failed to twice annually verify the accuracy of any test it performs that is not included in subpart I for regulated analytes which contributed to the Immediate Jeopardy. Findings include: 1. PT document review revealed the laboratory failed to twice annually verify the unregulated analyte, troponin, for 2017 and 2018 thus far. 2. An interview with the laboratory specialist consultant on 5/21/18 in a conference room at approximately 4 p.m. confirmed the laboratory failed to twice annually verify the accuracy of the unregulated analyte, troponin, for 2017 and 2018 thus far. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the -- 2 of 7 -- overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on quality control (QC) document review and staff interview, the laboratory failed to monitor and evaluate the overall quality of the analytic systems and correct identified problems. This condition-level deficiency contributed to the Immediate Jeopardy. Refer to D5421, D5445 D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual (SOP) and a laboratory specialist consultant interview, the laboratory failed to follow written procedures for testing as specified in the SOP. Findings include: 1. SOP review revealed the laboratory failed to keep Emerald Cell-DYN Levy-Jennings charts for a minimum of two years as specified in the laboratory SOP. 2. An interview with the laboratory specialist consultant in a conference room on 5-21-18 at approximately 4: 00 p.m. confirmed the laboratory failed to keep the Emerald Cell-DYN Levy-Jennings charts for a minimum of two years. 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 review of analytical verification documents and a laboratory specialist consultant interview, the laboratory failed to demonstrate the accuracy, precision, and reportable range of each chemistry analyte before initiating patient testing which contributed to the Immediate Jeopardy. Findings include: 1. Chemistry verification document review revealed the laboratory failed to demonstrate the accuracy, precision, and reportable range for troponin before initiating patient testing in 2017. 2. An interview with a laboratory specialist consultant on 5/21/18 in a conference room at approximately 3:30 p.m. confirmed the accuracy, precision, and reportable range for troponin was not determined before initiating patient testing in 2017. D5437 CALIBRATION AND CALIBRATION VERIFICATION -- 3 of 7 -- CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on hematology calibration document review and a laboratory specialist consultant interview, the laboratory failed to perform calibrations with the frequency specified by the manufacturer. Findings include: 1. Cell-Dyn Emerald calibration document review revealed calibration was performed on the following dates: 9/22/16, 8/1/17, and 4/2/18. This calibration frequency was not consistent with manufacturer's specifications of every 6 months. 2. An interview with the laboratory specialist consultant on 5/21/18 at approximately 4:30 p.m. in a conference room confirmed the Cell-Dyn was not calibrated in 2017 and 2018 with the manufacturer's specified frequency. 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 quality control (QC) document review and a laboratory specialist consultant interview, the laboratory failed to monitor over time the accuracy and precision of test performance as required. Findings include: 1. Cell-Dyn Emerald QC document review revealed the laboratory failed to produce Levy-Jennings QC reports at the time of survey for January, 2017. 2. An interview with the laboratory specialist consultant on 5 /21/18 in a conference room at approximately 4 p.m. confirmed no Levy-Jennings QC reports were available at the time of survey. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations -- 4 of 7 -- 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: Based on review of quality control (QC) document review and a laboratory specialist consultant interview revealed the laboratory failed to perform and document control procedures as required which contributed to the Immediate Jeopardy. Findings include: 1. This STANDARD is not met as evidenced by a record review of i -STAT Chemistry QC reports revealed the laboratory failed to perform troponin QC on the i- STAT Chemistry Analyzer for the following dates that troponin patient samples were run: 8/21/17,4/7/18, and 5/3/18. 2. An interview with a laboratory specialist consultant on 5/21/18 in a conference room at approximately 3:30 p.m. confirmed troponin QC was not performed on the i-STAT for the aforementioned dates troponin patient test samples were performed. D5783