Ph Enterprises Inc Dba Mag-Lab

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on an absence of thermometer function check protocols, function check records or current certificates of accuracy and interview, the laboratory failed to define and perform a function check protocol for the thermometers. Findings: 1. No documentation of a function check protocol for the thermometers was available at the time of survey. 1. No documentation was available for performance of function checks on 7 of 7 thermometers for a 2 year period. 2. No documentation was available for current certification of accuracy on 7 of 7 thermometers for a 2 year period. 2. Interview with Technical Consultant #1 on 3/31/2021 at 10 a.m. confirmed, the laboratory failed to define and perform a function check protocol for the thermometers. 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 D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of microbiology MacConkey and Blood agar and interview with technical supervisor #1 the laboratory failed to check new lot numbers and shipments of MacConkey and Blood agar for positive and negative reactivity from January 2016 to present day. Findings. 1. Review of MacConkey and Blood agar showed no documentation for positive and negative reactivity with new shipments and lot numbers. 2. Interview with the technical supervisor #1 on July 20, 2018 at 11:00 am confirmed the laboratory failed to check new lot numbers and shipments of MacConkey and Blood agar for positive and negative reactivity. 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 --