Regional Medical Associates Pa

Summary Statement of Deficiencies D0000 A Recertification Survey was conducted at approximately 8:30 am on September 23, 2022 at Regional Medical Associates. The laboratory was surveyed according to 42 CFR part 493 CLIA requirements. Specific deficiencies are as follows: D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: lack of documentation, and interview with the Laboratory Director (LD) and the Testing Personnel (TP). The laboratory failed to address any of the six elements of Competency Assessment(CA) of Testing Personnel. Additionally, there is no Standard Operating Procedure (SOP) addressing CA. Findings include: 1. At approximately 8: 30 am on September 23, 2022 during record review of CA, none was found for the the TP. 2. During the interview, the LD and TP stated that there was no CA for TP, and no SOP to specifically address the six minimal regulatory requirements for CA at all. 3. At the end of the interview at approximately 9:45 am, no documentation was provided that addressed Competency Assessment. 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 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 review of the Procedure Manual and interview with the General Supervisor it is determined that the Laboratory Director is not providing a Quality Assessment program to identify and communicate Quality Failures as they occur. Findings include: 1. In review of the Laboratory's Procedures no documents indicating a Quality Assessment Procedure or Program could be provided to the surveyor. 2. In interviewing the General Supervisor they confirmed that the Laboratory did not have a Quality Assessment or QulityAssurance program. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on review of procedure manual, personnel files and interview with the General Supervisor it was determined that the Laboratory Director failed to ensure 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 -- competency of personnel performing preanalytical, analytical, and post analytical phases of testing. Findings include: 1. Review of Procedures, Policies, and Personnel files failed to reveal documented evidence of evaluation and documentation of the competency of personnel for 2016, 2017, and 2018 to present. 2. Interview with the General Supervisor confirmed that competency had not been documented. The only documentation available was prior to 2016. -- 2 of 2 --