Atlantic Ambulance Corporation

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on surveyor review of the Biannual Assessment (BA) records and interview with the General Supervisor (GS), the laboratory failed to ensure that all Testing Personnel (TP) who performed Lactate tests participated in the BA from 3/20/18 to the date of survey. The finding includes: 1. A review of all BA events revealed that only one out of one hundred fifty TP performed BA from 3/20/18 to the date of survey. 2. The GS confirmed on 10/13/21 at 2:00 pm that BA events were not rotated between TP. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on surveyor review of the Biannual Assessment (BA) records and interview with the General Supervisor (GS) the Laboratory Director (LD) failed to ensure that the laboratory participated in an accurate split sample assessment for Lactate tests. The findings include: 1. A review of the BA records revealed that the BA was not completed by blind testing of materials with known values. 2. TP performing BA 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 -- knew the concentration values of BA material before performing and documenting BA. 3. The GS confirmed on 10/13/21 at 2:20 am that the LD did not ensure the laboratory participated in an accurate split sample assessment for Lactate tests. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor observation of the Statstrip Lactate Meter Quality Control Log Sheets (SLMQCLS), Manufacturers Package Insert (MPI) interview with the General Supervisor (GS), the laboratory failed to follow MPI for control values from 5/1/21 to 5/31/21. The findings include: 1) SLMQCLS had the Low Range Quality Control (LRQC) documented as 5.4-7.4 mmol/L the MPI had the LRQC as .3-.09 mmol/L. 2) SLMQCLS had the High Range Quality Control (HRQC) documented as .3-.09 mmol /L, the MPI had HRQC as 5.4-7.4 mmol/L 3) The GS confirmed on 10/13/21 at 1:30 pm the MPI was not followed. -- 2 of 2 --

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 surveyor review of Temperature Records (TR) and interview with the Quality Manager (QM) the laboratory failed to monitor and record the Temperature (T) and Humidity (H) where Nova Stat Strip Lactate Meters were stored in each unit in January (Jan) and February (Feb) 2018. The findings include: 1. T and H were not monitored or out of range as follows: a. Unit 7 - 16 out of 31 days in Jan and 4 out of 28 days in Feb. T was out of range 4 out of 15 days in Jan. b. Unit M8 - 3 out of 31 days and T was out of range 5 out of 28 days in Jan. c. Unit 11 - 9 days out of 31 in Jan and 9 out of 28 days in Feb. d. Unit 902 - 14 days out of 28 in Feb. 2. The QM confirmed on 3/20/18 at 1:45 pm that T and H were not monitored and recorded. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) 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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: Based on survey review of Quality Control (QC) records and interview with the Quality Manager (QM), the laboratory failed to perform and document controls each day of patient testing for Lactate Tests performed on the Nova Stat Strip analyzer in January (Jan) and February (Feb) 2018. The findings include: 1. A review of the QC record revealed controls were not run as follows: a. Unit 7 - Jan 5 and 8. b. Unit M8 - Jan 11. c. Unit 11 - Jan 1, 5, 7 and Feb 26. 2. Approximately 1 to 2 patients were run per unit each day control was not run. 3. The QM confirmed on 3/20/18 at 1:25 pm that QC was not done on each day of patient testing. D5783