Summary:
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 on review of the Abbott iSTAT operator's guide, the laboratory temperature logs, patient results and interview with the technical consultant (TC) #1, the laboratory failed to ensure the room temperature and humidity was maintained (monitored and documented) as required by the manufacturer in 2024, 2025 and to date March 23, 2026. Findings: 1. Review of the Abbott iSTAT operator's guide states "operating temperature 16-30 degrees Celsius and operating environment relative humidity 10-90%." 2. Review of the laboratory temperature logs showed no documentation of room temperature and humidity in 2024, 2025 and to date March 23, 2026. 3. Review of patients results showed the laboratory performs approximately 9500 patient tests per year. 4. Interview with the technical consultant (TC) #1 on March 23, 2026, at 2:00 PM confirmed the laboratory failed to ensure the room temperature and humidity was maintained as required by the manufacturer. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) 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 -- (d) 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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493. 1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on review of the laboratory's individualized quality control plan (IQCP) for the i-STAT chem 8+ and the high sensitivity troponin-I testing, i-STAT chem 8+ and high sensitivity troponin-I quality control (QC) records, patient results and interview with the technical consultant (TC) #1, the laboratory failed to ensure that the IQCP for the i-STAT chem 8+ and high sensitivity troponin-I testing was followed for two of fourteen months in 2025 and 2026. Findings: 1. Review of the laboratory's IQCP for the i-STAT chem 8+ and high sensitivity troponin-I states, "Two levels of liquid quality control (LQC) are performed with each new shipment of cartridges and at least monthly thereafter." 2. Review of the i-STAT chem 8+ quality control (QC) records from January 2025 to February 2026 showed QC was not performed for the i-STAT chem 8+ in February 2026. 3. Review of the i-STAT high sensitivity troponin-I quality control (QC) records from January 2025 to February 2026 showed QC was not performed for the i-STAT high sensitivity troponin-I in March 2025. 4. Review of patient test results showed the laboratory performed 73 chem 8+ patient tests in February 2026 and 11 high sensitivity troponin-I patient tests in March 2025 when QC was not performed. 5. Interview with the TC #1 on March 23, 2026, at 2:00 PM confirmed the laboratory failed to ensure the i-STAT chem 8+ and high sensitivity troponin-I IQCP was followed. D5807 TEST REPORT CFR(s): 493.1291(d) (d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of laboratory procedures , review of 1 of 1 patient reports in the laboratory's LIS system, patient results and interview with the technical consultant (TC) #1, the laboratory failed to ensure the reference intervals or normal values on the patient report in the laboratory's LIS system matched the approved laboratory procedure. Findings: 1. Review of the approved laboratory procedure "Laboratory- CRMC - POCT iSTAT Procedure" showed the following normal ranges: Glucose 70 - 139 mg/dL BUN 8 - 23 mg/dL Creatinine 0.7 - 1.2 mg/dL Hematocrit 38 - 50 % 2. Review of the patient report in the laboratory's LIS system showed the following normal ranges: Glucose 74 - 106 mg/dL BUN 9 - 23 mg/dL Creatinine 0.7 - 1.3 mg /dL Hematocrit 40 - 54 % 3. Review of patients results showed the laboratory performs approximately 9500 patient tests per year 4. Interview with the TC #1 on March 23, 2026 at 2:00 PM confirmed the normal values on the patient report in the laboratory's LIS system did not match the laboratory procedure. -- 2 of 3 -- D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on review of laboratory training documentation, patient results and interview with the technical consultant (TC) # 1 , the technical consultants failed to identify training needs for five of sixteen testing personnel (TP). Findings: 1. Review of laboratory training documentation showed no documentation of initial training for TP # 1, TP #5, TP #6, TP #13, and TP #14. 2. Review of patients results showed the laboratory performs approximately 9500 patient tests per year. 3. Interview with technical consultant #1 on March 23, 2026 at 2:00 PM confirmed the technical consultants failed to identify initial training needs for five testing personnel. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records, patient results and interview with the technical consultant (TC) #1, the technical consultants (TC) failed to evaluate and document the performance of one of sixteen testing personnel (TP) at least semiannually during the first year the individual tests patient specimens in 2025. Findings: 1. Review of laboratory personnel records showed the TC failed to perform the semiannual competency evaluation for TP #1. 2. Review of patients results showed the laboratory performs approximately 9500 patient tests per year. 2. Interview with the technical consultant (TC) #1 on March 23, 2026 at 2:00 PM, confirmed the TC failed to evaluate and document the performance of TP #1 semiannually during the first year the individual tests patient specimens. -- 3 of 3 --