Summary:
Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 a review of the IL GEM 3500 blood gas analyzer operator manual, and interview with the laboratory lead testing personnel, the laboratory failed to maintain and store the IL GEM analyzer and cartridges per the manufacturers instructions. Findings include: 1. According to the manufacturers operation manual, the IL GEM 3500 is to be maintained at a humidity level between 15 to 85% and the IL GEM cartridges must be stored at 15 to 25 degrees centigrade. 2. There were no humidity and temperature records from January 1, 2022, to March 31, 2023. 3. The GEM cartridges are stored at the lead testing personnel office, the laboratory failed to have documentation of humidity and temperature records. 4. Interview with the lead testing personnel on 07/12//2023, at 4:00 PM, confirmed these findings. 5. The laboratory performed 871 arterial blood gas tests in 2022, and 217 arterial blood gas tests in 2023. D5807 TEST REPORT CFR(s): 493.1291(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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of the IL GEM 3500 procedure manual, patient results in the laboratory information system (LIS), and interview with the lead testing personnel, the laboratory failed to provide the reference ranges or normal values for the arterial blood gas analytes PO2 and PCO2 to the authorized persons responsible for the test results. Findings include: 1. Review of the laboratory's IL GEM 3500 blood gas analyzer procedure manual, the reference ranges for PO2 were 75 to 100 mmHg and PCO2 was 35 to 45 mmHg. 2. The reference ranges were missing in the LIS and the patient report on one of one patient test report was reviewed. 3. The laboratory provided no other sources for the test requester to access the normal reference ranges, other than the patient test report. 4. Interview with the lead testing personnel on July 12, 2023, at 4:00 PM, confirmed these findings. 5. The laboratory performed 871 arterial blood gas tests in 2022 and 217 arterial blood-gas tests in 2023. D5813 TEST REPORT CFR(s): 493.1291(g) The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values. This STANDARD is not met as evidenced by: Based on a review of patient test results and an interview with the lead testing personnel, the laboratory failed to document the date, time, test results, and the person to whom the critical test results were reported. Findings include: 1. Review of a patient's electronic medical record with a critical pH of 7.26, revealed there was a lack of documentation for the date, time, test results, and the name of the person to whom the results were given. 2. Interview with the lead testing personnel on July 12, 2023, at 4:00 PM, confirmed these findings. 3. The laboratory performed 871 arterial blood gas in 2022 and 217 arterial blood gas in 2023 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 a review of personnel records, training, competency records, proficiency testing (PT) records, and Quality Assurance (QA) records, the laboratory director (LD) failed to provide overall management and direction of the laboratory. Refer to D6019, D6021, D6029 and D6032. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of -- 2 of 4 -- 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)(4)(iv) Ensure that an approved