Summary:
Summary Statement of Deficiencies D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of patient test records, quality control records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 10:30 am on 07/24/2023, the laboratory failed to meet immunohematology requirements for ensuring the laboratory performed positive and negative quality controls each day of patient testing as specified in D5449. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual and confirmed by laboratory personnel identifer #1 (refer to the Laboratory Personnel Report) at approximately 11: 30 am on 7/24/2023, the laboratory director failed to approve, sign and date the laboratory procedure manual. The findings include: 1. The laboratory switched laboratory directors on 7/29/2022. 2. At the time of the survey, the new laboratory director had not approved, signed and dated the laboratory procedure manual. D5449 CONTROL PROCEDURES 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 -- 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 patient test records, quality control records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 10:30 am on 7/24/2023, the laboratory failed to perform and document positive and negative D (Rho) testing controls each day of patient testing for three out of four days from 6/1/2023 - 7/24/2023. The findings include: 1. Patient A had D (Rho) testing performed using lot number 22701, expiration date 4/2/2028 of Eldon cards on 6/20/2023. 2. Patient B had D (Rho) testing performed using lot number 22701, expiration date 4/2/2028 of Eldon cards on 7/3/2023. 3. Patient C had D (Rho) testing performed using lot number 22701, expiration date 4/2/2028 of Eldon cards on 7/18/2023. 4. On each of the above dates, the laboratory did not perform or document positive and negative quality controls. 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 review of patient test and quality control records, lack of quality assessment audit and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 10:30 am on 7/24/2023, the laboratory director failed to ensure the laboratory maintained a quality control program as specified in D6020 and failed to ensure the laboratory maintained a quality assessment program as specified in D6021. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of patient test records, quality control records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 10:30 am on 7/24/2023, the laboratory director failed to ensure the -- 2 of 3 -- laboratory performed positive and negative D (Rho) testing controls each day of patient testing for three out of four days from 6/1/2023 - 7/24/2023. Refer to D5449 for findings. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of patient test records, lack of quality assessment audits and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 11:30 am on 7/24/2023, the laboratory director failed to ensure the laboratory performed and documented quality assessment audits for 2022 and 2023. The findings include: 1. Laboratory personnel identifier #1 stated the laboratory performed regular audits for quality assessment. 2. At the time of the survey, laboratory personnel identifier #1 could not produce quality assessment audits for 2022 or 2023. -- 3 of 3 --