Piedmont Physicians Urology Macon

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on July 21, 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 Diagnostics). 2. During an interview on July 21, 2022 at: 11:30 AM with the Office Manager, in an breakroom, 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. D5783

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on January 25, 2021. 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 153 and 155 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two out of three events (Events 1 & 2 of 2020), resulting in the first Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- unsuccessful occurrence for Routine Chemistry analyte #0245, Chloride (CL) analyte #0355, Creatine analyte #0405, Glucose (Non-Waived) analyte #0415, Potassium (K) analyte #0465, Sodium (NA) analyte #0475, BUN analyte #0505 the specialty of Routine Chemistry. The laboratory also failed to maintain satisfactory performance in two out of three events (Events 1 & 2 of 2020), resulting in the first unsuccessful occurrence for Hematology analyte #0760, Hematocrit (HCT) # 0785 and Hemoglobin (HGB) # 0795. Findings include: Refer to D2096 and D2130 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 153 and 155 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two out of three events (Events 1 & 2 of 2020), resulting in the first unsuccessful occurrence for Routine Chemistry analyte #0245, Chloride (CL) analyte #0355, Creatine analyte #0405, Glucose (Non-Waived) analyte #0415, Potassium (K) analyte #0465, Sodium (NA) analyte #0475, BUN analyte #0505 the specialty of Routine Chemistry. 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed Routine Chemistry analyte #0245, Chloride (CL) analyte #0355, Creatine analyte #0405, Glucose (Non-Waived) analyte #0415, Potassium (K) analyte #0465, Sodium (NA) analyte #0475, BUN analyte #0505, on Events 1 & 2 of 2020 with a score of 0% for all listed analytes for both events. 2. The criteria for acceptable performance for the specialty of Routine Chemistry is 80%. 3. Desk review of the laboratory's proficiency testing reports from the American Association of Bioanalysts (AAB) confirmed the laboratory failed Routine Chemistry analyte #0245, Chloride (CL) analyte #0355, Creatine analyte #0405, Glucose (Non-Waived) analyte #0415, Potassium (K) analyte #0465, Sodium (NA) analyte #0475, BUN analyte #0505 the specialty of Routine Chemistry for Events 1 and 2 of 2020 resulting in the first unsuccessful performance. 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 American Association of Bioanalysts (AAB) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two out of three events (Events 1 & 2 of 2020), resulting in the first unsuccessful occurrence for Hematology analyte #0760, Hematocrit (HCT) # 0785 and Hemoglobin (HGB) # 0795 the specialty of Hematology The findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed Hematology analyte #0760, Hematocrit (HCT) -- 2 of 4 -- # 0785 and Hemoglobin (HGB) # 0795, on Events 1 & 2 of 2020 with a score of 0% for both events. 2. The criteria for acceptable performance for the specialty of Hematology is a score of 80%. 3. Desk review of the laboratory's proficiency testing reports from American Association of Bioanalysts (AAB) confirmed the laboratory Hematology analyte #0760, Hematocrit (HCT) # 0785 and Hemoglobin (HGB) # 0795 on Events 1 & 2 of 2020 resulting in the first unsuccessful performance. 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two out of three consecutive events (Events 1 & 2 of 2020), resulting in the first unsuccessful occurrence for Routine Chemistry analyte #0245, Chloride (CL) analyte #0355, Creatine analyte #0405, Glucose (Non-Waived) analyte #0415, Potassium (K) analyte #0465, Sodium (NA) analyte #0475, BUN analyte #0505 the specialty of Routine Chemistry. The laboratory also failed to maintain satisfactory performance in two out of three events (Events 1 & 2 of 2020), resulting in the first unsuccessful occurrence for Hematology analyte #0760, Hematocrit (HCT) # 0785 and Hemoglobin (HGB) # 0795 the specialty of Hematology. The findings include: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two out of three consecutive events (Events 1 & 2 of 2020), resulting in the first unsuccessful occurrence for Routine Chemistry analyte #0245, Chloride (CL) analyte #0355, Creatine analyte #0405, Glucose (Non-Waived) analyte #0415, Potassium (K) analyte #0465, Sodium (NA) analyte #0475, BUN analyte #0505 in the specialty of Routine Chemistry. The laboratory also failed to maintain satisfactory performance in two out of three events (Events 1 & 2 of 2020), resulting in the first unsuccessful occurrence for Hematology analyte #0760, Hematocrit (HCT) # 0785 and -- 3 of 4 -- Hemoglobin (HGB) # 0795 in the specialty of Hematology. The findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed Routine Chemistry analyte #0245, Chloride (CL) analyte #0355, Creatine analyte #0405, Glucose (Non-Waived) analyte #0415, Potassium (K) analyte #0465, Sodium (NA) analyte #0475, BUN analyte #0505, on Events 1 & 2 of 2020 with a score of 0% for all listed analytes for both events. 2. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed Hematology analyte #0760, Hematocrit (HCT) # 0785 and Hemoglobin (HGB) # 0795, on Events 1 & 2 of 2020 with a score of 0% for both events. 3. The criteria for acceptable performance for the specialties of Routine Chemistry and Hematology is 80%. 4. Desk review of the laboratory's proficiency testing reports from the American Association of Bioanalysts (AAB) confirmed the laboratory failed Routine Chemistry analyte #0245, Chloride (CL) analyte #0355, Creatine analyte #0405, Glucose (Non-Waived) analyte #0415, Potassium (K) analyte #0465, Sodium (NA) analyte #0475, BUN analyte #0505for Events 1 and 2 of 2020 resulting in the first unsuccessful performance. The laboratory also failed Hematology analyte #0760, Hematocrit (HCT) # 0785 and Hemoglobin (HGB) # 0795, on Events 1 & 2 of 2020 resulting in the first unsuccessful performance. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on June 21, 2018. 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: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on Proficiency Testing (PT) documentation and staff interview, the laboratory was not rotating the performance between ALL testing personnel listed on the CMS 209 form. Findings: 1. Review of the PT documentation the laboratory was not rotating testing with all testing personnel: 2016 3rd event was performed by staff #2, #3, #7(CMS 209 form) 2017 1st event was performed by staff #2, #7 2017 2nd event was performed by staff #2, #3, #7 2017 3rd event was performed by staff #2, #7 2018 1st event was performed by staff, #2, #3, #7 Staff #4, #5, and #6, never performed PT samples. 2. Interview with the billing manager, and staff #3, and #7, (CMS form 209) on June 21, 208 at approximately 2:42 pm in the office manager's office, confirmed that PT testing was not being performed by all testing personnel listed on the CMS 209 form. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the Proficiency Testing (PT) Documentation, the laboratory failed to provide signed attestation documents stating that the PT samples were handled the same manner as patient samples for all testing events. Findings: 1. Review of the PT documents showed that the attestation statement was not signed both the testing personnel(TP) an the lab director (LD). 2016 3rd event, was signed by TP and LD 2017 1st event, was signed by TP only 2017 2nd event, was signed by TP only 2017 3rd event, was NOT signed 2018 1st event, was signed by TP only 2. Interview with the billing office manager, and staff #3, and #7, (CMS form 209) confirmed that the attestation statements were not being signed appropriate as indicated above. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the Proficiency Testing(PT) documents and staff interview, the laboratory failed to perform a self evaluation on the Prostate Specific Antigen testing that was not submitted for evaluation. Findings: 1 Review of the PT documents showed that the 2nd event for 2017 results were not graded due to not being submitted by the deadline. The results were not self evaluated. 2 Interview with the billing manager, and staff #3 and #4 (CMS 209 form) on June 21, 2018 at approximately 2: 35 pm in the office manager's office, confirmed that the unsubmitted results had not been self evaluated. 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 review of the proficiency testing(PT) documentation, and staff interview, the laboratory failed to verify the accuracy of the provider performed (PPM) urine microscopic procedure performed. Findings: 1. Review of the proficiency testing documentation the laboratory was not participating in a PT evaluation for the urine microscopic procedure. 2. Staff interview with the billing manager, and staff #3, and staff #7 (CMS form 209) on June 21, 2018 at approximately 2:48 pm in the office manager's office, confirmed the laboratory was not performing PT evaluation for the PPM urine microscopic procedure and was not performing peer review for the PPM urine microscopic procedure. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) -- 2 of 8 -- 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 procedure manuals and staff interview the laboratory failed to provide a written procedure for the definition of critical values for patient results. Findings: 1. Review of the procedure manuals revealed that there was not a procedure for listing the critical values for patient results and the procedure to follow when a critical value resulted and notifying the provider. 2. Staff interview with the billing manager, and staff #3, and #7 (CMS form 209) on June 21, 2018 at approximately 2: 42 pm, in the office manager's office confirmed that the laboratory did not have a procedure for the reporting of critical values for patient results. 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 Nano Entek Frend System (Frend System) specifications and staff interview, the laboratory failed to monitor the room temperature and the humidity in the laboratory area where the Frend system is located. Findings: 1. Review of the Frend System specifications revealed that the laboratory failed to follow manufacturer's recommendations for monitoring the optimal operating room temperature (15 to 30 degrees Celsius), and optimal operating humidity (10 % to 80%) for 2017 and 2018 up to the date of the survey. 2. An interview with the billing manager, and Testing Personnel (PT) #3 and #7, in the Office Manager's office, on June 21, 2018 at approximately 2:20 pm, confirmed that there were no laboratory room temperature records and no room humidity records in the testing area. Based on review of the maintenance logs and staff interview the laboratory failed to provide a log for the maintenance on the eyewash, the microscope, and the centrifuges. Findings: 1. Review of the maintenance logs revealed that the lab was not performing the daily or weekly maintenance on the eyewash station, also revealed the lab was not performing the maintenance on the microscope, or the centrifuges (the Lab Corp Horizon miniE was last calibrated 01/22/2008, and the Quest Vanguard V6500 was last calibrated on 04/24/1997). 2. Staff interview with the billing manager, and staff #3, and #7 (CMS form 209) on June 21, 2018 at approximately 2:42 pm, in the office manager's office confirmed that the laboratory was not performing maintenance on the eyewash, the microscope maintenance, or centrifuge maintenance. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) -- 3 of 8 -- 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: Based on observation and interview with testing personnel (TP), the lab failed to calibrate the LabCorp Horizon Mini E , Quest VanGuard V6500, or Stat Spin Express 2 centrifuges per the manufacturer. Findings include: 1. Observation during the lab tour revealed the LabCorp Horizon Mini E centrifuge was last calibrated on 1/22/18, Quest VanGuard V6500 was last calibrated on 4/24/97, StatSpin Express 2 was last calibrated in the factory - no calibration noted on the centrifuge. 2. Interviews with TP #--- (CMS 209 form) on 06/21/18 in the practice manager's office at approximately 230 PM, confirmed the centrifuges had not been calibrated as required. 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 the review of the Nano Entek Frend System (Frend System) specifications, and staff interview, the laboratory failed to perform Verification of Linearity and Precision as required in the Frend System Procedure. Findings: 1. Based on review of the Frend System Procedure, Verification of Linearity and Precision should be performed when a new analyzer is put into use and every 6 months thereafter, and documented on the Monthly Maintenance Log. There was no documentation that the Verification of Linearity and Precision was performed after January 2017 up until June 21, 2018, the date of the survey. 2. Interview with the billing manager, and Testing Personnel #3 and #7 (CMS form 209), in the Office Manager's office, on June 21, 2018 at approximately, 2:15 pm, confirmed that there was no documentation that the Verification of Linearity and Precision had been performed after January 2017 up until the date of the survey, June 21, 2018. -- 4 of 8 -- D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) 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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the Quality Control (QC) documents and staff interview, the laboratory failed to perform QC as required ,at least once a day patient specimens are assayed using two control materials of different concentrations, on the NanoEntek Frend System (Frend System). Findings: 1. Review of the QC documents for the Frend System, showed that two levels of liquid controls were not being performed once a day patient specimens were assayed. 2. Interview with the billing manager, and staff #3 and #7 (CMS form 209), at approximately 2:40 pm, on June 21, 2018, in the Office Manager's office, confirmed that two levels of liquid controls were not being performed once a day on days patients specimens were being assayed. D5789 TEST RECORDS CFR(s): 493.1283(b) Records of patient testing including, if applicable, instrument printouts, must be retained. This STANDARD is not met as evidenced by: Based on review of the proficiency testing (PT) documents and staff interview the laboratory failed to save the instrument printout from the the Prostate Specific Antigen (PSA) analyzer used for testing the PT samples. Findings: 1. Review of the PT documents for the 2016 - 3rd event , and 2017 - 1st, 2nd, and 3rd event, there were no instrument printouts for the analyte PSA attached to each event. 2. Interview with the billing manager, and staff #3, and #7, (CMS 209 form) on June 21, 2018 at approximately 2:33 pm, in the office manager's office, confirmed that there were no instrument printouts attached to the events listed above. 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