Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of the Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to follow its policies and procedures for assessing the competency of TP from 4/28/17 to the date of the survey. The finding include: 1. Twelve of twelve TP did not have a CA in 2018. 2. The TP #4 listed on CMS form 209 confirmed on 3/19/19 at 10:25 am that the laboratory did not follow its CA procedure. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), the lack of Quality Control Verification (QCV) records interview with the Testing Personnel (TP), the laboratory failed to established procedure for QCV for the Clinitek Advantus analyzer from 4/6 /17 to the date of survey . The TP #4 listed on CMS form 209 confirmed on 3/19/19 at 11:15 am that the laboratory did not have a QCV procedure. 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 -- D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation of the Quality Control (QC) material and interview with the Testing Personnel (TP), the laboratory failed to put open and new expiration dates on Urinalysis controls from 4/6/17 to the date of survey. The findings include. 1. The MPI for MAS UA Controls stated that QC material for Urinalisys expired 30 days after opening if stored at 2 to 8 degrees Celsius. 2. The TP was not aware that QC material expired 30 days after opening. 3. The TP #4 on CMS form 209 confirmed on 3/19/19 /19 at 10:30 am the laboratory failed to put new expiration dates on the control material. 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 surveyor review of the quality control records and interview with the testing personnel (TP), the laboratory failed to perform and document quality control for urinalysis performed on the Clinitek Advantus analyzer. from 1/30/19 to 2/7/19. the findings include: 1. The laboratory did not perform positive QC on 1/30/19, 1/31/19 and 2/1/19 - 2/7/19. 2. TP stated that "They ran out of positive controls for those dates" 3. The laboratory ran and reported 315 patients results. 4. The TP#4 listed on CMS form 209 confirmed on 3/14/19 at 1:15 pm tha the laboratory did not perform and document quality control on each day of testing. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on the lack of the Performance Specification (PS) records and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to ensure that all PS procedures were performed on the Clinitek Advantus analyzer were adequate from 2 /14/19 to the date of survey. The findings include: 1. Accuracy was not performed. 2. The TP #4 listed on the CMS form 209 confirmed on 3/19/19 at 11:15 am that PS records were not adequate. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Files (PF) and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to have appropriate education records for six out of twelve TP on file from 4/6/17 to the date of the survey. The finding includes: 1. This deficiency was cited on survey preformed on 4/6/17. 2.