Anniston Family Practice

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of the 2018 - 2021 proficiency testing (PT) records, and an interview with the Technical Consultant, the surveyor determined the Laboratory Director failed to sign the attestation statements for three of eight surveys reviewed. The findings include: 1. A review of the 2018 - 2021 PT records revealed the Laboratory Director failed to sign the attestation statement for the following Hematology surveys: A) MLE (Medical Laboratory Evaluation) 2019-M2 B) API (American Proficiency Institute) 2020 Event #1 C) API 2020 Event #3 2. During a review of the PT records and an interview conducted on 4/28/2021 at 11:20 AM, the Technical Consultant confirmed the above noted findings. . D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those 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 3 -- failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of the proficiency testing (PT) records and an interview with the current Technical Consultant, the surveyor determined the laboratory failed to submit results for the API (American Proficiency Institute) 2020-Event 3 Hematology survey before the cutoff date. This was noted on one out of eight 2018-2021 PT survey events reviewed. The findings include: 1. A review of the Hematology instrument printouts for the API 2020-Event 3 survey revealed the PT specimens were run on 11/10/2020. A note dated 11/18/2020 from a previous testing personnel revealed, "Entered, need double check and submit", however the API 2020-Event 3 received a score of 0% due to failure to participate. API instructions specified the results should be submitted on- line on or before 11/24/2020. 2. During a review of the PT records and an interview conducted on 4/28/2021 at 11:20 AM, the current Technical Consultant confirmed the above noted findings. . D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on reviews of patient test reports and an interview with the Technical Consultant, the laboratory failed to ensure patient reports included all required parameters after the facility implemented a new EHR (Electronic Health Record) in January 2020. The findings include: 1. On 4/28/2021 at 2:45 PM, the surveyor reviewed the post-analytical process in the facility. Upon the surveyor's request, the Technical Consultant provided two final patient reports with CBC (Complete Blood Count) results from the Athena EHR. 2. A review of the EHR reports for two patients revealed the "Performing Lab" name and address were incorrect. The report also failed to include units of measurement for CBC parameters except WBC (White Blood Cells). 3. As the review continued, the Technical Consultant then provided the instrument printouts for the CBC's, and stated these were also used as patient reports. Upon review however, the surveyor noted the "Patient ID" (200891 and 200894) on the printouts did not match the patients' Medical Records Number (MRN) on the EHR reports. 4. In an interview on 4/28/2021 at 3:00 PM, the surveyor reviewed the reports with the Technical Consultant who confirmed the above noted findings, stating the "Patient ID" on the CBC printout was a sequential number automatically generated by -- 2 of 3 -- the Hematology instrument. The surveyor then asked when the facility implemented Athena as the new EHR; the Technical Consultant answered, "1/22/2020". SURVEYOR ID #32558 Licensure and Certification Surveyor -- 3 of 3 --

Summary Statement of Deficiencies 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 review of the Casper reports (#153/#155) and a review of the MLE (Medical Laboratory Evaluation) proficiency testing records, the surveyor determined the laboratory failed to successfully participate in proficiency testing for two consecutive testing events for WBC (White Blood Cell) Differential. This affected 2019 Events MLE M1 and MLE M2. The findings include: 1. A review of the Casper reports revealed the laboratory failed WBC Differential testing for two consecutive testing events in 2019, MLE M1 (73 %) and MLE M2 (66 %). 2. Review of the MLE proficiency testing records revealed the laboratory scored 73 % for the WBC Differential for Event 2019 MLE M1 and 66 % for 2019 MLE M2. 3. These two 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 -- consecutive failures resulted in the laboratory's initial unsuccessful proficiency testing participation. 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 review of the Casper reports (#153 and #155) and a review of the MLE (Medical Laboratory Evaluation) proficiency testing records, the surveyor determined the laboratory failed WBC (White Blood Cell) Differential testing for two consecutive testing events, 2019 MLE M1 and MLE M2. These failures resulted in unsuccessful performance in proficiency testing by the laboratory. The findings include: 1. A review of the Casper reports revealed the laboratory failed WBC Differential testing for two consecutive testing events in 2019, MLE M1 (73 %) and MLE M2 (66 %). 2. Review of the MLE proficiency testing records revealed the laboratory scored 73 % for the WBC Differential for Event 2019 MLE M1 and 66 % for 2019 MLE M2. 3. These two consecutive failures (unsatisfactory performance) resulted in the laboratory's initial unsuccessful proficiency testing participation. -- 2 of 2 --