Urology Centers Of Alabama, Pc

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (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 a review of Policies and Procedures, a review of BioRad CFX96 Quality Control (QC) records, and an interview with the General Supervisor, the laboratory failed to perform Quality Control each day of patient testing or follow an approved Individual Quality Control Plan (IQCP). This was noted for three out of three months reviewed in 2023. The findings include: 1. A review of Policies and Procedures revealed the following under "Quality Control of RT-PCR Molecular Testing Reagents": "...The above controls are performed on any new lots prior to use for any clinical specimens, and on a weekly basis thereafter...". There was no evidence of an implemented IQCP 2. A review of QC records for the BioRad CFX96 revealed controls were run weekly, not daily prior to patient testing, for Urinary Tract Infection (UTI) Panels in March 2023, June 2023, and September 2023. 3. During an interview on 4/25/2024 at 11:54 AM, the General Supervisor confirmed no IQCP was in place for UTI Panels run on the BioRad CFX96 at the time of survey. 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 D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that 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 a review of the validation records for two Thermocyclers for PCR (Polymerase Chain Reaction) molecular testing for wound/urinary tract and respiratory infections, and an interview with the Laboratory Manager (also the General Supervisor), the surveyor determined the Laboratory Director (LD) failed to ensure the acceptability of the study, prior to patient testing. The LD further failed to ensure the validation procedure of the newly installed Ace Alera, Chemistry analyzer, was reviewed and approved for use in the laboratory. This affected two of five newly installed instruments/methodologies, implemented in the laboratory, since the previous survey on 2/21/2018. The findings include: 1. A review of validation records (no date) for two Thermocyclers for PCR molecular testing revealed the LD had not signed, indicating review and approval of the equipment for use in the laboratory. 2. During an interview on 10/21/2020 at 10:51 AM, the surveyor inquired about the installation of the equipment and the date of validation. The Laboratory Manager (LM) stated the documents were sent to her electronically by technical personnel, listed on the CMS form #209 (she identified as a technical supervisor, not employed by the laboratory). The LM confirmed the documents did not have the LD's signature, nor the signature of a qualified Technical Supervisor, and had not been reviewed by the LD. The documents, sent electronically, failed to include a date for the validation study, however the LM stated the validation study was performed on July 6, 2020. The LM further stated patient testing on the equipment began August 18, 2020. 3. In an interview at 4:10 PM on 10/21/2020, the LD confirmed she had not reviewed and signed the validation of the PCR testing. 4. A review of the validation records for 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 2 -- Ace Alera, Chemistry analyzer, revealed the validation procedures (accuracy, reportable range study, precision and method correlations) were done on May 27, 2020. The LM signed the validation studies, however the LD had not reviewed and approved the validation, which may have been indicated by her signature and effective date. Laboratory staff were currently testing patient specimens on the analyzer, which had not been approved for use by the LD. 5. In an interview on 10/21 /2020 at 4:46 PM, the LD reviewed the validation of the Ace Alera and stated she could not see on the documents anywhere she had signed. 6. On 10/21/2020 at 4:46 PM, the surveyor discussed with the LD director the responsibility for ensuring validations were acceptable, prior to use in the laboratory; the importance of her signature and the effective dates for validations and policies/procedures; and letters of delegation. -- 2 of 2 --

Summary Statement of Deficiencies D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on a review of Medical Laboratory Evaluation (MLE) proficiency testing records and an interview with Testing Personnel # 1, the surveyor determined the Laboratory failed to ensure Hematology results for one of three 2016 surveys was submitted within the timeframes specified by the proficiency testing program. This affected one of six proficiency testing surveys reviewed. The findings include: 1. A review of the results from the 2016-Event #2 Hematology survey revealed a score of 0 % (percent) due to failure to participate. 2. In an interview conducted on 2/21/2018 at 3:30 PM, Testing Personnel #1 stated the laboratory performed the proficiency testing, but failed to submit the results within the time frame specified by the proficiency testing provider. TP #1 also stated the Microbiology Instrument was out of service and the laboratory did not want to submit a portion of the testing to the proficiency testing provider. D5437 CALIBRATION AND CALIBRATION VERIFICATION 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, 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 -- 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 a review of the Cell Dyn Emerald Hematology calibration records and an interview with Testing Personnel #1 (TP #1), the laboratory failed to perform a calibration at least every six months as required by the laboratory's policy. This affected one of three calibrations performed. The findings include: 1. A review of the Cell Dyn Emerald calibration records revealed a calibration was performed on 2/17/16 and 4/27/16. The next calibration was not performed until 9/18/2017, greater than a year after the previous calibration date. 2. In an interview conducted on 2/21/2018 at 3: 30 PM, TP # 1 reviewed the calibration records with the surveyor and confirmed the laboratory had no other calibration records for 2017. D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) 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)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of Medical Laboratory Evaluation (MLE) proficiency testing records and an interview with Testing Personnel # 1, the surveyor determined the Laboratory Director failed to ensure Hematology results for one of three 2016 surveys were submitted within the timeframes specified by the proficiency testing program. The findings include: 1. Refer to D2127. Jeremy Westry, BS, MT (ASCP) Licensure and Certification Surveyor -- 2 of 2 --