Valley Physician Services, Pc

Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on surveyor review of the Accession Log (AL), Work Records (WR) and interview with the General Supervisor (GS) the laboratory failed to maintain accurate information for Hematology testing from 4/1/20 through 5/19/20. The findings include: 1. Review of the AL and revealed: a. The front of the AL recorded that hematology testing was performed from 4/1/20 through 5/19/20. b. The back of the AL recorded "No Pt testing" through the above mentioned dates. 2. The GS confirmed at 11:00 am on 5/11/21 the laboratory did not main an accurate information system. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the General Supervisor (GS), the laboratory failed to establish a procedure for verifying 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 -- manually entered results from 8/21/18 to the date of survey. The GS confirmed on 5/11 /21 at 10:30 am that the laboratory did not have the procedure mentioned above. -- 2 of 2 --

Summary Statement of Deficiencies 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: Based on surveyor review of the Procedure Manual, Competency Assessment (CA) records and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to establish a Competency Assessment (CA) procedure with the required elements from 6/7/16 to the date of the survey. The TP confirmed on 8/21/18 at 1:20 pm that a CA procedure was not established accurately. 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 --