Medical Network Of Alaska

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based a review of temperature/humidity records, manufacturer instructions, and an interview with the Technical Consultant (TC), the laboratory failed to define criteria for room temperature and humidity consistent with the manufacturer's operating instructions for the Sysmex pocH-100i from January 2024 through July 2025. The findings include: 1. A review of temperature/humidity logs for May, June, and October 2024 and July 2025 showed the acceptable room temperature range for Sysmex pocH-1001 operation of 31-95 F, and the remaining months revealed an acceptable range of 61-95 F, misssing were logs for November, December 2024 and January and February 2025. 2. Review of temperature/humidity logs listed the acceptable humidity range as 20-80%, missing were logs for November, December 2024 and January and February 2025. 3. A review of the Sysmex pocH-100i manufacturer operating instructions showed that acceptable temperature range is 59- 86 F and humidity range is 30-85%. 4. An on-site interview with the TC 8/28/25 at 12: 00 PM confirmed that ranges on the temperature log were inconsistent and did not match the manufacturer operating ranges. 5. The laboratory reports performing 1100 Complete Blood Counts (CBCs) on the Sysmex pocH-100i annually. 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 -- D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on surveyor observation, record review, and interview with the Technical Consultant (TC), the laboratory failed to perform and document function checks to ensure three (3) of three (3) thermometers (refrigerator, freezer, and room temperature) where reagents and patient specimens are stored for the Complete Blood Count (CBC) on the Sysmex pocH-100i. Findings include: 1. Observation on 8/28/25 at 11:00 AM showed the refrigerator and freezer thermometers had a sticker that says 'QC passed 06' but no date of certification, in-use date, or expiration date. 2. Observation on 8/28/25 at 11:00 AM showed the room temperature thermometer had no date of certification, in-use date, or expiration date. 3. A request was made to review the documentation for verification of temperature checks or the process in place to verify the accuracy of thermometer readings, and none could be provided. 4. An on-site interview with TC 8/28/25 at 12:00 PM confirmed thermometer function checks were not documented. 5. The laboratory reports performing 1100 Complete Blood Counts (CBCs) on the Sysmex pocH-100i annually. D5785

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 an off-site desk review of the laboratory's 2020 and 2021 American Academy of Family Physicians (AAFP) proficiency testing (PT) records and telephone interview with the technical consultant on May 6, 2021, it was determined that the laboratory failed to successfully participate in PT. See D-tag 2130, unsatisfactory performance for the same analyte in two out of three consecutive hematology PT events. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of 2020 and 2021 hematology proficiency test (PT) performance reported to the CLIA database by the PT provider and phone interview with the technical consultant, the laboratory failed to achieve satisfactory performance for the hemoglobin and hematocrit analytes in two of three testing events. Findings: 1. The laboratory obtained an unsatisfactory score of 60% for hemoglobin and hematocrit analytes in the second testing event of 2020. 2. The laboratory obtained an unsatisfactory score of 60% for hemoglobin and hematocrit analytes in the first testing event of 2021. 3. Phone interview with the technical consultant on May 6, 2021 at 15: 30 confirmed the laboratory failed to achieve satisfactory performance for hemoglobin and hematocrit analytes in the second testing event of 2020 and the first testing event of 2021. -- 2 of 2 --