Premier Plus Urgent Care

Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/05/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory manager at the conclusion of the survey. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to ensure proficiency testing attestation statements had been signed by the laboratory director for two of five events reviewed during 2021, 2022, and to date in 2023. Findings include: (1) A review of the third 2021; first, second, and third 2022; and first 2023 Hematology proficiency testing records identified the following for two of five events: (a) Nonchemistry Q1 2022 Event - The attestation statement had not been signed by the laboratory director; (b) Nonchemistry M1 2023 Event - The attestation statement had not been signed by the laboratory director. (2) The findings were reviewed with the laboratory manager who stated on 07/05/2023 at 11: 55 am, the attestation statements had not been signed by the laboratory director. 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 -- 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 a review of records, manufacturer's instructions, and interview with the laboratory manager, the laboratory failed to follow the manufacturer's instructions for implementing six of 15 new lot numbers of Hematology QC (quality control) materials during the review period of July 2022 through June 2023. Findings include: (1) On 07/05/2023 at 10:50 am, the laboratory manager stated the following: (a) The laboratory performed CBC (Complete Blood Count) testing using the Sysmex pocHi- 100i analyzer; (b) The laboratory used the manufacturer's stated ranges to evaluate QC results; (c) When new lot numbers of control materials were put into use the laboratory verified the stated value of the control materials by testing them twice a day for five days before putting into use. (2) A review of the manufacturer's instructions contained in the "Sysmex pocH-i Hematology Analyzer Implementation Manual" under section D titled, "New Lot of Quality Control Material" stated, "Upon receipt of a new lot of control material, it is recommended that controls of the new lot be run in parallel with the current lot for ten (10) replicates over multiple days"; (3) A review of the implementation records for new lots of QC materials from October 2022 through June 2023 identified the manufacturer's instructions had not been followed for six of 15 lots numbers as follows: (a) Low Abnormal Control lot #21940710, Normal Control lot #21940711, and High Abnormal Control lot # 21940712 - Put into use on 10/20/2022. Although the laboratory had tested each level of QC material for ten replicates, they were all tested on 10/19/2022 instead of multiple days; (b) Low Abnormal Control lot #23620710, Normal Control lot #23620711, and High Abnormal Control lot # 23620712 - Put into use on 01/14/2023. Although the laboratory had tested each level of QC material for ten replicates, they were all tested on 01/13/2023 instead of multiple days. (4) The records were reviewed with the laboratory manager who stated on 07/05/2023 at 12:50 pm, the laboratory had not followed the manufacturer's instructions for implementing new lot number of QC material as shown above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/13/19. The laboratory was found to be in compliance with standard-level deficiencies cited. The findings were reviewed with the clinic manager/testing person #1 at the conclusion of the survey. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on a review of records and interview with the clinic manager/testing person #1, the laboratory failed to test proficiency testing in the same manner as patient specimens. Findings include: (1) During the survey, the surveyor reviewed Hematology proficiency testing records for the third 2017, first 2018, second 2018, third 2018, and first 2019 events. The records indicated the laboratory had not tested proficiency testing samples in the same manner as patient specimens for 4 of 5 events as follows: (a) First 2018 Event - 5 of 5 specimens had been tested in duplicate: (i) Specimen 1 - Initially tested on 03/05/18 at 05:52 pm. The sample was retested on 03 /05/18 at 06:18 pm; (ii) Specimen 2 - Initially tested on 03/05/18 at 06:18 pm. The sample was retested on 03/05/18 at 06:21 pm; (iii) Specimen 3 - Initially tested on 03 /05/18 at 06:24 pm. The sample was retested on 03/05/18 at 06:26 pm; (iv) Specimen 4 - Initially tested on 03/05/18 at 06:45 pm. The sample was retested on 03/05/18 at 06:49 pm; (v) Specimen 5 - Initially tested on 03/05/18 at 06:58 pm. The sample was 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 -- retested on 03/05/18 at 07:01 pm. (b) Second 2018 Event - 3 of 5 specimens had been tested in duplicate: (i) Specimen 7 - Initially tested on 05/24/18 at 04:25 pm. The sample was retested on 05/24/18 at 04:26 pm; (ii) Specimen 8 - Initially tested on 05 /24/18 at 04:29 pm. The sample was retested on 05/24/18 at 04:32 pm; (iii) Specimen 10 - Initially tested on 05/24/18 at 04:37 pm. The sample was retested on 05/24/18 at 04:41 pm. (c) Third 2018 Event - 5 of 5 specimens had been tested in duplicate: (i) Specimen 11 - Initially tested on 10/23/18 at 12:06 pm. The sample was retested on 10 /23/18 at 12:10 pm; (ii) Specimen 12 - Initially tested on 10/23/18 at 12:13 pm. The sample was retested on 10/23/18 at 12:29 pm; (iii) Specimen 13 - Initially tested on 10 /23/18 at 12:39 pm. The sample was retested on 10/23/18 at 02:09 pm; (iv) Specimen 14 - Initially tested on 10/23/18 at 02:13 pm. The sample was retested on 10/23/18 at 02:16 pm; (v) Specimen 15 - Initially tested on 10/23/18 at 02:19 pm. The sample was retested on 10/23/18 at 02:23 pm. (d) First 2019 Event - 5 of 5 specimens had been tested in duplicate: (i) Specimen 1 - Initially tested on 02/13/19 at 04:24 pm. The sample was retested on 02/13/19 at 05:01 pm; (ii) Specimen 2 - Initially tested on 02 /13/19 at 05:08 pm. The sample was retested on 02/13/19 at 05:05 pm; (iii) Specimen 3 - Initially tested on 02/13/19 at 05:14 pm. The sample was retested on 02/13/19 at 05:16 pm; (iv) Specimen 4 - Initially tested on 02/13/19 at 05:19 pm. The sample was retested on 02/13/19 at 05:23 pm; (v) Specimen 5 - Initially tested on 02/13/19 at 05: 25 pm. The sample was retested on 02/13/19 at 05:29 pm. (2) The surveyor reviewed the records with the clinic manager/testing person #1 and asked if patient specimens were routinely tested in duplicate as the above proficiency specimens had been tested. The clinic manager/testing person #1 stated the following to the surveyor: (a) Patient specimens were routinely tested one time unless they met the criteria to repeat (i.e., critical values); (b) The results from the proficiency testing samples (above) did not meet the criteria to repeat, and therefore had not been tested using the laboratory's routine methods for patient testing. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the clinic manager/testing person #1, the laboratory failed to review and evaluate proficiency testing results. Findings include: (1) During the survey, the surveyor reviewed 2017, 2018, and 2019 Hematology proficiency testing records. The following failures were identified, for which