Prime Care Medical Center, Pc

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing records and interview with the lead testing personnel, the laboratory failed to evaluate non-graded proficiency testing scores in 2018 and 2019. The findings include: 1) Review of the laboratory proficiency testing records for 2018 and 2019 revealed non-graded scores for the following: 2018 Chemistry-Miscellaneous-Event one, 25-OH (hydroxy) Vitamin D, sample number IAT-03 scored as "Not-Graded." 2019 Hematology/Coagulation Event one, Urine Sediment-sample number US-02-scored as "Not-Graded." There was no evaluation of the non-graded results to determine the laboratory's accuracy. 2) Interview with the lead testing personnel on July 15, 2019 at 4:30 pm confirmed the laboratory failed to evaluate the accuracy of non-graded proficiency testing scores in 2018 and 2019. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: The laboratory failed to follow procedure for complete blood count (CBC) quality control (QC) limits for the Sysmex XN 330 CBC instrument (Refer to D5401), failed to identify the testing personnel who performed QC for the Sysmex XN 330 CBC instrument (Refer to D5787), and failed to perform patient normal range study for the Sysmex XN 330 CBC instrument (Refer to D5421). D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual for the Sysmex XN 330 complete blood count (CBC) instrument, the manufacturer stated QC limits and the laboratory QC limits, patient number 18 test report, and interview with the lead testing personnel, the laboratory failed to follow the procedure for CBC QC limits for the Sysmex XN 330 CBC instrument in 2019. The findings include: 1) Review of the laboratory procedure manual for the Sysmex XN 330 revealed the laboratory uses manufacturer evidence based limits for quality control ranges. 2) Review of the stated manufacturer evidence based QC limits and the laboratory QC ranges for lot number 9158, level one (in use 6.24.19 to current date), revealed the evidence based limits were not correct as follows: White Blood Cell (WBC) - Correct limit = 9.6%, limit in use = 100%, resulting in a range of 0.0 to 4.66 th/uL for the WBC analyte. Red Blood Cell (RBC) - Correct limit = 5.1%, limit in use = 100%, resulting in a range of 0.0 to 4.58 mil/uL for the RBC analyte. Hematocrit (HCT) - Correct limit = 6.0%, limit in use = 100%, resulting in a range of 0.0 to 34.4 % for the HCT analyte. Hemoglobin (HGB) - Correct limit = 4.9%, limit in use = 100%, resulting in a range of 0.0 to 11.8 gm/dL for the HGB analyte. Platelet Count (PLT) - Correct limit = 30.5%, limit in use = 100%, resulting in a range of 0 to 114 th/uL for the PLT analyte. 3) Review of patient number 18 test report revealed patient testing for CBC on 07.15.2019. 4) Interview with the lead testing personnel on July 15, 2019 at 4:30 pm confirmed the laboratory failed to follow the procedure for use of correct manufacturer evidence based limits for CBC QC lot 9158, level one, in 2019 with patient testing performed. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. -- 2 of 6 -- This STANDARD is not met as evidenced by: Based on observation of the laboratory, patient number 17 test report, review of the validation studies for Syxmex XN 330 complete blood count instrument (CBC), and interview with the lead testing personnel, the laboratory failed to verify the patient normal range for the Sysmex XN 330 CBC instrument in 2019. The findings include: 1) Observation of the laboratory on July 15, 2019 at 8:10 am revealed the Sysmex XN 330 CBC instrument in use for patient testing. 2) Review of patient number 17 test report revealed patient testing performed on the Sysmex XN 330 CBC instrument beginning January 17, 2019. 3) Review of the validation studies performed for the Sysmex XN 330 revealed no study to verify the patient normal range. 4) Interview with the lead testing personnel on July 15, 2019 at 10:00 am confirmed the laboratory began using the Sysmex XN 330 CBC instrument on January 17, 2019 and did not verify the normal patient range. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of the quality control (QC) records for the Sysmex SN 330 complete blood count (CBC) instrument and interview with the lead testing personnel, there was no identification of the person performing the quality control for the Sysmex XN 330 CBC instrument in 2019. The findings include: 1) Review of the QC performed for the Sysmex XN 330 CBC instrument on January 17, 2019 and July 15, 2019 revealed no identification of the person who performed the quality control testing. 2) Interview with the lead testing personnel on July 15, 2019 at 4:30 pm confirmed the laboratory did not have a system in place to identify the person performing the QC for the Sysmex XN 330 CBC instrument in 2019. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: The technical consultant failed to review and approve validation studies for the Sysmex XN 330 complete blood count (CBC) instrument (Refer to D6040), failed to ensure testing personnel number four received training for performing moderately complex testing (Refer to D6045 citation number one), failed to ensure all testing personnel received training for the use of the Sysmex XN 330 CBC instrument (Refer to D6045 citation number two), failed to perform six month competency assessment for testing personnel number four (Refer to D6046), and failed to perform competency -- 3 of 6 -- assessment of testing personnel when the laboratory changed CBC instruments (Refer to D6055). D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the validation studies for the Sysmex XN 330 complete blood count (CBC) instrument, and interview with the lead testing personnel, the technical consultant failed to review and approve validation studies for the Sysmex XN 330 CBC instrument in 2019. 1) Observation of the laboratory on July 15, 2019 at 8:10 am revealed the Sysmex XN 330 instrument in use for patient testing for complete blood count. 2) Review of the validation studies for the Sysmex XN 330 revealed the technical consultant had not documented review of the studies for carryover, reportable range, accuracy, and precision. 3) Interview with the lead testing personnel on July 15, 2019 at 10:00 am confirmed the laboratory began using the Sysmex XN 330 CBC instrument on January 17, 2019 for patient testing. The validation studies for carryover, reportable range, accuracy and precision were not reviewed and approved for the Sysmex XN 330 CBC instrument by the technical consultant, prior to patient testing in 2019. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (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: Citation number one Based on review of testing personnel records and interview with the lead testing personnel, the technical consultant failed to ensure testing personnel number four received training for performing moderately complex testing prior to patient testing in 2018. The findings include: 1) Review of testing personnel records revealed a hire date of 10.1.2018 for testing personnel number four. There was no documentation of training for performing moderately complex testing. Testing personnel number four performs patient testing for the following moderately complex test systems: urine microscopy, wet prep, chemistry testing performed on the Beckman Coulter AU 480, chemistry and endocrinology performed on the Architect Access 1000i SR, and complete blood count (CBC) performed on the previous CBC instrument. 2) Interview with the lead testing personnel on July 15, 2019 at 10:30 am confirmed the technical consultant failed to ensure testing personnel number four received training for performing moderately complex testing in 2018 and is performing patient testing in all moderately complex areas. _______________________________________ Citation number two Based on observation of the laboratory, review of testing personnel records and instrument validation records, and interview with the lead testing personnel, the technical -- 4 of 6 -- consultant failed to ensure that testing personnel received training for the Sysmex XN 330 complete blood count (CBC) instrument in 2019. 1) Observation of the laboratory on July 15, 2019 at 8:15 am revealed the Sysmex XN 330 CBC instrument in use for patient testing. 2) Review of testing personnel records and validation records for the Sysmex XN 330 CBC instrument revealed no documented training for any of the four testing personnel performing patient testing on the Sysmex XN 330 CBC instrument (testing personnel numbers one, two, three, and four). 3) Interview with the lead testing personnel on July 15, 2019 at 10:00 am confirmed the technical consultant failed to ensure testing personnel received training for the use of the Sysmex XN 330 CBC instrument in 2019. The laboratory began using the Sysmex XN 330 CBC instrument on January 17, 2019 with no documented training of testing personnel. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of testing personnel number four six month competency assessment records and interview with the lead testing personnel, the technical consultant failed to evaluate the competency of testing personnel number four in 2019. 1) Review of the six month competency assessment for testing personnel number four dated 4.9.2019 revealed no signature of the technical consultant. 2) Interview with the lead testing personnel on July 15, 2019 at 10:30 am confirmed the technical consultant failed to perform the six month competency assessment for testing personnel number four in 2019. D6055 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing whenever test methodology or instrumentation changes. The individual's performance must be reevaluated to include the use of the new test methodology or instrumentation prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of instrument validation records and patient number 16 test report, personnel records, and interview with the lead testing personnel, the technical consultant failed to evaluate the competency of all testing personnel when the laboratory changed complete blood count (CBC) instruments in 2019. The findings include: 1) Observation of the laboratory on July 15, 2019 at 8:15 am revealed the Sysmex XN 330 CBC instrument in use for patient testing. 2) Review of validation records and patient test number 16 test report revealed validation studies for the Sysmex SN 330 were performed in December 2018 with patient testing beginning January 17, 2019. 3) Review of testing personnel records revealed no documented competency assessment for any testing personnel (testing personnel numbers one, two, three and four) for use of the newly implemented Sysmex XN 330 CBC instrument prior to patient testing. 3) Interview with the lead testing personnel -- 5 of 6 -- on July 15, 2019 at 10:00 am confirmed the technical consultant failed to ensure the competency of all testing personnel when the laboratory implemented the Sysmex XN 330 CBC instrument. Patient testing for the Sysmex XN 330 CBC instrument began on January 17, 2019. -- 6 of 6 --