Konza Prairie Community Health Center,Inc

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 review of Jan 3, 2020 to March 10, 2020 patient test records and quality control (QC) records reveals that the laboratory failed to perform a positive and negative control material each day of patient testing on the Cephid for gonorrhea and Chlamydia for 31 out of 32 patients. Findings were as follows; a. A review of Cephid reports revealed the laboratory failed to perform QC testing on each day of use on the following dates: 01/22/2020, 01/23/2020, 01/24/2020, 01/27/2020, 01/28/2020, 01/29 /2020, 0130/2020, 02/05/2020, 02/07/2020, 02/13/2020, 02/14/2020, 02/18/2020, 02 /26/2020, 03/06/202. for 31/32 patients. b. Interview with the Technical Consultant#1 on March 10, 2020 @1230 PM confirmed that the laboratory failed to perform QC testing on each day of use and were performing QC monthly per manufacturer's instructions. No IQCP has been developed to enable the laboratory to reduce the frequency of QC. . 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 D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on lack of documents and interview at 09:00 hrs on 05/02/2018, the laboratory failed to have and follow policies and procedures to monitor, assess, and when indicated correct problems in: the establishment and following of written policies and procedures to assess proficiency testing .failures. Finding were as follows: a. Based upon a review of American Proficiency Institute (API) 2018 Microbiology 1 1st event C. Trichomatis specimen CGC-01 Unacceptable, N.gonnorrhoeae specimen CGC-01 Unacceptable. At the time of the survey the laboratory failed to produce documention of