Summary:
Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 9/24/19. The Milbank Area Hospital/Avera Health laboratory was found not in compliance with the following requirements: D5407, D5471, D5555, D5775, and D6120. 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 the review of laboratory procedure manuals and interview with the laboratory manager, the laboratory failed to ensure seven of ten procedure manuals were approved, signed, and dated by the new laboratory director prior to use. Findings include: 1. Observation on the morning of 9/24/19 revealed the following manuals had not been approved, signed, and dated by the new laboratory director before use: *Blood Bank Policies Manual (that manual contained numerous revised but unapproved policies). *Bio Merieux Vitek Compact 2 Manual. *Laboratory Policies Manual. *Laboratory Specimen Collection Manual. *Meditech C/S manual. *Laboratory Safety Manual. *Bacteriology Procedures Manual. An interview on 9/24 /19 at 3:40 p.m. with the laboratory manager revealed: *He confirmed the listed manuals and revised policies had not been approved, signed, and dated, to date. *He became laboratory director on 7/1/19. *He had made an initial visit to the laboratory on 9/9/19. *He had signed several manuals at that time. 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) 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 -- 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 observation of the potassium hydroxide (KOH) reagent, review of the annual test volume form, and interview with the laboratory manager and staff A, the laboratory failed to verify each lot number or shipment of the KOH reagent for its positive reactivity to ensure accurate results prior to testing patient specimens for twenty-one of twenty-one months (1/1/18 - 9/24/19). Findings include: 1. Observation on 9/24/19 at 12:50 p.m. revealed a bottle of KOH reagent (lot 4810K78, expiration date 9/21) was available for use on patient specimens. The bottle of KOH reagent was approximately three-quarters full. There was no documentation whether or not the missing reagent had been used on patient specimens or discarded. Review of available records revealed KOH quality control (QC) had not been documented in 2018 or to date in 2019 for any lot number or different shipments of the same lot number. Review of the annual testing volume survey form indicated twenty-seven KOH patient tests had been performed during 2018 without reagent QC to ensure accurate patient test results. Interview on 9/24/19 at the above time with the laboratory manager revealed he was unaware QC was required of a new lot number or shipment before use on patient samples. Interview with laboratory staff A on 9/24/19 at 3:45 p. m. revealed they had not done QC on the KOH reagent as long as she had worked there. She had worked there almost twenty years. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on observation, alarm check documentation review, quality assurance (QA) reports, blood bank refrigerator and freezer continuous temperature monitoring chart review, transfusion record review, policy and procedure reviews, and interview with the laboratory manager, the laboratory failed to: *Ensure the blood bank alarm system sounded at the appropriate temperature to ensure a prompt response when the internal blood storage refrigerator temperature was maintained within the correct range for six of seven quarterly alarm tests (4/22/18, 7/19/18, 10/18/18, 2/4/19, 5/16/19, and 8/25 /19). *Ensure the blood bank alarm sounded at the nurses station at the same time the alarm sounded in the laboratory. Findings include: 1. Observation on 9/24/19 at 1:00 p. m. of quarterly Blood Bank Thermometer - Alarm Check Report forms revealed: a. 4 /22/18: *Blood bank refrigerator low alarm activation temperature was -3.7 C. *Blood bank refrigerator high alarm activation temperature was 11.9 C. *Blood bank freezer high alarm activation temperature was -8.6 C. b. 7/9/18: *Blood bank refrigerator low -- 2 of 5 -- alarm activation temperature was -2.9 C. *Blood bank refrigerator high alarm activation temperature was 12.0 C. *Blood bank freezer high alarm activation temperature was -10.8 C. c. 10/18/18: *Blood bank refrigerator low alarm activation temperature was -2.1 C. *Blood bank freezer high alarm activation temperature was -16.1 C. d. 2/4/19: *Blood bank refrigerator low alarm activation temperature was -2.4 C. *Blood bank refrigerator high alarm activation temperature was 7.9 C. e. 5/16/19: *Blood bank refrigerator low alarm activation temperature was -2.9 C. *Blood bank freezer high alarm activation temperature was -13.9 C. f. 8/25/19 *Blood bank refrigerator low alarm activation temperature was-3.9 C. *Blood bank freezer high alarm activation temperature was -13.6 C. g. Laboratory staff B performed the above alarm activation check reports. *She had documented all the above blood bank activation alarm checks as acceptable. h. The laboratory manager signed the above alarm activation check reports. i. There was no documentation of