Lifemed Alaska Llc

Summary Statement of Deficiencies D5781

Summary Statement of Deficiencies 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 a review of refrigerator temperature logs and an interview with the laboratory director, the laboratory failed to regularly perform and document alarm checks verifying an audible alarm was activated at the appropriate temperature(s) in refrigerators where blood products are stored. Findings include: 1. A request was made to review documentation of alarm checks when the refrigerator temperature falls outside the acceptable range, and documentation could not be provided. 2. An interview conducted on May 31, 2023 at approximately 3:00 PM, the laboratory director confirmed the laboratory did not have written documentation or evidence of alarm checks. 3. The laboratory reports storing packed red blood cells in refrigerators at the Anchorage, Fairbanks, Palmer, Soldotna, Dutch Harbor and Juneau bases. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. 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 -- This STANDARD is not met as evidenced by: Based on a review of the Individualized Quality Control Plan (IQCP), quality assessment records, and interview with the laboratory director, the laboratory failed to establish and follow a quality assessment plan for the ongoing monitoring of the effectiveness of the IQCP for the Abbott i-STAT CG8+ cartridges. Findings include: 1. A request was made to review the IQCP for the Abbott i-STAT CG8+ cartridges and the quality assessment part of the plan could not be provided. 2. An interview conducted on May 31, 2023 at approximately 3:00 PM, the laboratory director confirmed the laboratory did not have written documentation or evidence of the quality assessment plan as part of the IQCP. 3. The laboratory reports performing approximately 5,100 i-STAT tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of American Proficiency Institute (API) proficiency testing (PT) records for 2018-2019, the laboratory unsuccessfully participated in PT for the Routine Chemistry analyte p02. See D2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of American Proficiency Institute (API) proficiency testing (PT) records for 2018-2019, the laboratory failed to achieve satisfactory analyte performance for p02 for two consecutive testing events. Findings: 1. API Chemistry Core result evaluations for 2018-3 and 2019-1 were reviewed. 2. The laboratory received the following scores for p02: a. 2018 third testing event: 60% b. 2019 first testing event: 60% -- 2 of 2 --

Summary Statement of Deficiencies D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of testing personnel records and technical consultant interview, the laboratory did not have copies of diplomas, transcripts or primary source verification (PSV) for the testing personnel. Findings: 1. There were 39 new testing persons hired since the last survey in 2016. 35 of them did not have copies of their diploma, transcript, or primary source verification. 2. The laboratory performs approximately 1300 tests annually. 3. The technical consultant and laboratory director confirmed these findings on 12/3/18 at 12:00 pm. 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 --