Jerry M Cunningham Md

Summary Statement of Deficiencies 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 laboratory records since the last survey on 2/18/20 and interview with testing personnel (TP) #1 on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory failed to have a system for verifying the accuracy of urine colony count performed on the Bacticult Aidian Uricult test system at least twice annually in 2020. Findings Include: 1. Review of laboratory records for 2020 and 2021 revealed the laboratory used a proficiency testing module to verify accuracy of the urine colony count, performed on the Bacticult Aidian Uricult test system, twice annually. 2. Review of proficiency testing records for 2020 revealed the laboratory had unacceptable scores for the 1st and 3rd events of 2020. There was no other verification for accuracy of the colony counts performed in 2020. 3. An interview with TP #1 on 6/21/2022 at 12:00 p.m. confirmed the laboratory had not verified accuracy twice a year for urine colony count in 2020. 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: Based on review of proficiency records (PT) for 2020, 2021, 2022 and confirmation with testing personnel (TP) #1, there was no documentation of

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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 3/17/20, the laboratory has not successfully participated in proficiency testing for CHLORIDE. Findings include: Our records indicate the following proficiency testing scores for your laboratory for CHLORIDE: PROFICIENCY TESTING PROVIDER: American Proficiency Institute CHLORIDE: Year 2019 3rd Event 20% Year 2020 1st Event 60% Scores less than 80% for this 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 -- analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. 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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 3/17/20, the laboratory has not successfully participated in proficiency testing for CHLORIDE. Findings include: Our records indicate the following proficiency testing scores for your laboratory for CHLORIDE: PROFICIENCY TESTING PROVIDER: American Proficiency Institute CHLORIDE: Year 2019 3rd Event 20% Year 2020 1st Event 60% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 2 of 2 --

Summary Statement of Deficiencies D0000 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 proficiency testing (PT) records since the last survey on 3-19-18, and interview with testing personnel #1 listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory failed to have a system for verifying the accuracy of the testing for Prostate Specific Antigen (PSA) performed on the Beckman Coulter Access 2 analyzer, at least twice a year. Findings include: 1. The proficiency testing records for 2018 and 2019 reveal the laboratory did not verify accuracy for PSA by successful participation in proficiency testing for 2018 and 2019. 2. The laboratory's PSA proficiency testing

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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 4/2/2018, the laboratory had not successfully participated in proficiency testing for SODIUM. Findings include: Our records indicate the following proficiency testing scores for your laboratory for SODIUM: PROFICIENCY TESTING PROVIDER: American Proficiency Institute SODIUM: Initial Unsuccessful Performance: Year 2016 1st Event 20% Year 2016 2nd Event 40% Non-Initial Unsuccessful Performance: Year 2017 2nd Event 60% Year 2018 1st Event 60% Scores less than 80% for this analyte or parameter indicate failure for 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 -- unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. Repeat failures are scored as non-initial unsuccessful performance. 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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 4/2/2018, the laboratory had not successfully participated in proficiency testing for SODIUM. Findings include: Our records indicate the following proficiency testing scores for your laboratory for SODIUM: PROFICIENCY TESTING PROVIDER: American Proficiency Institute SODIUM: Initial Unsuccessful Performance: Year 2016 1st Event 20% Year 2016 2nd Event 40% Non-Initial Unsuccessful Performance: Year 2017 2nd Event 60% Year 2018 1st Event 60% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. Repeat failures are scored as non-initial 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system on 4/2/2018, the laboratory director has not provided overall management and direction in accordance with 493.1407 of this subpart. 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 surveyor desk review of the laboratory proficiency testing (PT) records -- 2 of 3 -- graded copies from the proficiency testing provider and the Center for Medicare and Medicaid Services data system on 4/2/2018, the laboratory director has failed to ensure the proficiency testing samples were tested as required under subpart H of this part. -- 3 of 3 --