James R Bollinger Md Lab

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 lack of documentation and interview with the Laboratory Director (LD) , the laboratory failed to verify twice annually the accuracy of Post Vasectomy examinations performed from 03/30/2021 through the date of the survey. Findings include: 1. On the day of survey, 04/11/2023 at 10:00 am, the laboratory could not provide documentation of verification of accuracy for Post Vasectomy examinations (semen analysis for presence or absence) performed from 03/30/2021 through the date of the survey. 2. The LD reported a total of 108 semen analysis examinations were performed annually (CMS116). 3. The LD confirmed the findings above on 04/11 /2023 at 10:00 a.m. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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 qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Laboratory record review and interview with the Laboratory Director (LD), the laboratory failed to document a positive and negative control each day patient 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 -- specimens were examined for post vasectomy semen check from 03/30/2021 to 04/11 /2023. Findings include: 1. Laboratory records reviewed at the time of survey on 04/11 /2023 at 09:50 am, revealed the laboratory did not include a negative and positive control, at least once each day patient testing was performed (semen analysis for presence or absence). 2. The LD reported a total volume of 108 tests were performed annually (CMS116). 3. The LD confirmed the above findings on 04/11/2023 at 9: 50AM. -- 2 of 2 --

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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 qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control record review and interview with the Laboratory Director on (03/30/2021), the laboratory failed to document all Quality Control procedures performed for sperm morphology examination. Findings include: 1.Quality Control documentation was not found for 66 sperm morphology examination tests preformed from 08/30/2018 through the date of survey. 2. During the survey, the Laboratory Director, confirmed that Quality Control was not documented each day of patient testing for sperm morphology examination. D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) The laboratory director must ensure an approved

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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 qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Laboratory Quality Control record review and interview with the Office Manager and Laboratory Director, on the date of the survey (08/30/2018), the laboratory failed to document Quality Control each day patients specimens were examined for sperm morphology, from 03/29/2017 through 08/30/2018. Findings include: 1. Laboratory Quality Control records reviewed at the time of survey (10:30 08/30/2018), revealed the Laboratory did not include sperm morphology controls, at least once each day patients specimens were examined for sperm morphology. 2. 37 sperm morphology tests were preformed from 03/29/2017 through 08/30/2018. 3. During the survey, the Office Manager, confirmed that sperm morphology controls are not documented. D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) The laboratory director must ensure an approved