Richard E Neils Md

Summary Statement of Deficiencies D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: Based on surveyor review of records and interview with the office manager, the laboratory did not retain the gross examination test reports from the reference laboratory when the director performed the microscopic diagnostic interpretation for three of three random samples reviewed. Findings include: 1. Review of reports and records of three patient results with microscopic diagnostic interpretations performed by the laboratory director showed no evidence of the report from the reference laboratory that performed the gross examination of the tissue. 2. Interview with the office manager on June 2, 2022, at 9:25 AM confirmed the laboratory did not retain the reference laboratory's gross examination test reports received with the slides for microscopic diagnostic interpretation by the laboratory director. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on surveyor review of quality assurance and prior survey records and interview 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 -- with the office manager, the laboratory director did not maintain the quality assessment program to assure the quality of services and identify failures in quality as they occurred for three of three quality evaluations from the second half of 2021 and the two evaluations in 2022. Findings include: 1. Review of the '

Summary Statement of Deficiencies D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with office manager, staff A, the laboratory director did not maintain the quality assessment program to ensure the quality of laboratory services were assessed to identify failures in quality that require

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 surveyor review of accuracy evaluation records and interview with the office manager, the laboratory did not verify the accuracy of the dermatopathology slide interpretations performed in 2018. Findings include: 1. Review of accuracy evaluation records showed no evidence of evaluation in 2018 for dermatopathology slide interpretations. 2. Interview with the office manager, staff A, on May 31, 2019 at 9:30 AM confirmed the laboratory did not perform the twice-annual accuracy evaluation of dermatopathology slide interpretations in 2018. 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 --