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 a record review and an interview with the technical consultant, the laboratory failed to have a policy or procedure to assess the competency of testing personal for tests performed on the Beckman-Coulter DxH 520 hematology analyzer and the position held by the technical consultant. The laboratory performed approximately 5,500 hematology tests annually. Findings include: 1. A review of the laboratory procedures revealed the laboratory failed to have a procedure or policy to assess all six procedures for the assessment of eight of eight testing personnel. 2. A review of the laboratory procedures revealed the laboratory failed to have a policy or procedure to assess the position of two of two technical consultant. 3. An interview on 12/06/2021, at 1:30 PM, with the technical consultant, confirmed the laboratory failed to have a policy or procedure to assess the competency for testing personnel and the technical consultant. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review, direct observation, and interview with testing personnel the laboratory failed to follow the manufacturer's instructions to monitor and document the humidity of the laboratory space which performed approximately 5,500 hematology tests on the Beckman-Coulter DxH analyzer. Findings include: 1. No criteria was established for the monitoring of room humidity. 2. No hygrometer was present in the laboratory during observation on 12/06/2021 at approximately 4:00 PM. 3. Beckman Coulter DxH instrument manual states "The instrument meets performance claims when operated at a maximum of 80% relative humidity". 4. In an interview on 12/06/2021 at approximately 3:00 PM, the testing personnel confirmed humidity was not monitored. 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 record review, direct observation, and interview with testing personnel, written expiration dates were not on three of three Beckman-Coulter quality control materials. The laboratory performs approximately 5,500 hematology test annually on the Beckman Coulter DxH instrument. Finding include: 1. The package insert for the Beckman Coulter DxH 500 Hematology Controls states that open tubes are stable for 14 days. 2. An observation on 12/06/2021, at 3:30 PM, revealed the expiration dates failed to be written on three of three controls. 3. In an interview on 12/06/2021 at approximately 3:30 PM, testing personnel confirmed that expiration dates are not written on the controls. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) 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 establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on record review and interview with testing personnel, the laboratory did not establish a maintenance protocol for the Beckman Coulter DxH instrument. The laboratory performs approximately 5,500 hematology tests annually. Findings include: 1. A record review of the laboratory procedures revealed the laboratory failed to -- 2 of 5 -- document and have a protocol for maintenance activities for the Beckman-Coulter DxH. 2. In an interview on 12/06/2021 at approximately 3:00 PM, the testing personnel confirmed there was not a maintenance protocol for the Beckman Coulter DxH instrument. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on record review, direct observation, and interview with laboratory staff, the laboratory director failed to provide management and direction to the laboratory by failure to ensure