Bassan & Bloom Mds Pl

Summary Statement of Deficiencies D0000 A recertification survey conducted on 10/13/2022 found the BASAN & BLOOM MDS PL clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation and interview, the laboratory failed to store Eosin Y Stain Solution and Giemsa Stock Stain Solution according to the manufacturer's instructions. Findings include: During a tour of the laboratory on 10/13/2022 at 10:00 AM, the surveyor found three bottles of one liter each with Eosin Y Stain Solution and two of one liter each of Giemsa Stock Stain Solution stored in an open shelf under the Manual Stainer. Review of Mercedes Scientific safety date sheet for Eosin Y Stain Solution and Giemsa Stock Stain revealed that the storage condition was to "Store in an approved Flammable Liquids storage area". During an interview on 10/13/2022 at 11:30 AM, TP A confirmed that the laboratory failed to store the stains of reference outside of the flammable cabinet. 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 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 -- 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 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 record review and interview with testing personnel (TP), the laboratory failed to document the initial training and six months competency assessment on 1 out of 1 testing personnel for 2017 and 2018 period. Findings include: Review of employee documentation showed that the laboratory failed to have documentation of the initial training on testing person for the year 2017 and no six months competency assessment on 2018. During an interview on 10/30/2018 at 10:30 AM, with the TP, she confirmed that there was no initial and no six months competency assessment documented for the period of reference. 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 --