Solara Hospital Harlingen L P

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. . 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. This STANDARD is not met as evidenced by: Based on review of the laboratory's test menu, review of the laboratory's records, and staff interview, it was revealed the facility failed to have documentation of performing /evaluating verification studies for 1 of 1 new test cartridges on the iSTAT analyzer. The findings include: 1. A review of the laboratory's test menu revealed the laboratory starting using the iSTAT CG4+ cartridge in October 2021. 2. A review of the laboratory's verification records revealed the laboratory failed to have documentation of: a) evaluation of accuracy b) evaluation of precision c) performing reportable range analysis d) performing verification of patient normal ranges. 3. The laboratory was asked to provide documentation of the missing studies/evaluations. No documentation was provided. 4. An interview with the technical consultant on 11/30/2022 at 1122 hours in the laboratory - after his review of the records- confirmed the findings. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES 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 -- 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 the laboratory's submitted Form CMS 209, review of the laboratory's personnel records from 2022, and staff interview, it was revealed the laboratory failed to have documentation of the technical consultant performing competency assessments in 2022. The findings include: 1. A review of the laboratory's submitted Form CMS 209 revealed the laboratory identified 15 testing personnel. 2. A review of the laboratory's personnel records revealed 15 of 15 competency assessments performed on testing personnel were performed by someone other than the technical consultant. The person who performed the competency assessments was not qualified as a technical consultant. 3. The laboratory was asked to provide documentation of the technical consultant performing competency assessments in 2022. No documentation was provided. 4. An interview with the technical consultant on 11/30/2022 at 1055 hours in the laboratory confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the conditions of participation found in the CLIA regulations at 42 CFR 493 and recertification is recommended. 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 review of the laboratory's submitted Form CMS 209, review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, and confirmed in interview of facility personnel, the laboratory failed to test proficiency samples in the same manner as it tests patient specimens. The findings included: 1. This is a repeat deficiency from the survey conducted October 18, 2018. 2. Review of the laboratory's submitted Form CMS-209 approved by the laboratory director on July 1, 2021 revealed the laboratory identified fourteen testing personnel. 3. Review of proficiency testing events 2019 (events 1, 2, and 3), 2020 (events 1, 2, and 3), and 2021 (event 1) revealed that three out of fourteen testing persons participated in proficiency testing. a. By not involving all testing personnel who normally test patient specimens in the testing of proficiency testing samples, the facility failed to treat proficiency samples in the same manner as patient samples. 4. An interview of the Lead Respiratory Therapist on July 13, 2021 at 10:20 hours in the laboratory confirmed the findings. Key: CMS - Centers for Medicare and Medicaid Services D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Review of patient final reports and interview with facility personnel found the laboratory failed to ensure test requisitions included specimen collection time for three of six patient final patient reports reviewed. The findings included: 1. Review of six patient final reports found that the laboratory failed to document time of collection for three Arterial Blood Gas specimens. Last 4 digits of Patient Number: 8132 Date of Collection: 05-23-2021 Time Drawn: blank Last 4 digits of Patient Number: 8148 Date of Collection: 05-25-2021 Time Drawn: blank Last 4 digits of Patient Number: 8162 Date of Collection: 06-11-2021 Time Drawn: blank 2. Interview with the Lead Respiratory Therapist on July 13, 2021 at 10:45 hours confirmed the findings. He agreed the time of collection was missing on the reports. D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Review of patient final reports and interview with facility personnel found the laboratory failed to document specimen receive time for six of six patient final reports reviewed. The findings included: 1. Review of six of six patient final reports found that on Chemistry/Arterial Blood Gas Result Form there was not area to document specimen receive time. 2. Review of six of six patient final reports found the laboratory failed to document specimen receive times as follows: Last 4 digits of Patient Number: 8124 Date of Collection: 05-14-2021 No receive time Last 4 digits of Patient Number: 8130 Date of Collection: 05-15-2021 No receive time Last 4 digits of Patient Number: 8132 Date of Collection: 05-23-2021 No receive time Last 4 digits of Patient Number: 8148 Date of Collection: 05-25-2021 No receive time Last 4 digits of Patient Number: 8162 Date of Collection: 06-11-2021 No receive time Last 4 digits of Patient Number: 8207 Date of Collection: 06-30-2021 No receive time 3. An interview with the Lead Respiratory Therapist on July 13, 2021 at 11:15 hours in the laboratory confirmed the findings. 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: -- 2 of 5 -- Based on review of manufacturer's instructions, review of patient final reports, and confirmed in interview of facility personnel, the laboratory failed to follow the manufacturer's instructions to ensure specimens for Arterial Blood Gas (ABG) were tested within 10 minutes of collection. The findings included: 1. Review of the manufacturer's instructions for the Abbott i-STAT (Art. 714372-00P, Rev. 17-Apr- 2020) stated, "Time to Test: For the most accurate results, test samples immediately after drawing. Samples for lactate must be tested immediately. Samples for pH, PCO2, PO2, TCO2, and ionized calcium should be tested within 10 minutes ..." 2. Random review of patient final reports from May and June 2021 found the following six of six samples were tested and were not tested within 10 minutes or because time of collection was not documented it could not be determined is specimens were tested within 10 minutes of collection. Last 4 digits of Patient Number: 8124 Date of Collection: 05-14-2021 Time of Collection: 14:00 hours Analyzed Time: 14:41 hours (elapsed time past 10 minutes: 31 minutes) Last 4 digits of Patient Number: 8130 Date of Collection: 05-15-2021 Time of Collection: 02:15 hours Analyzed Time: 02:31 hours (elapsed time past 10 minutes: 6 minutes) Last 4 digits of Patient Number: 8132 Date of Collection: 05-23-2021 Time of Collection: blank Analyzed Time: 19:40 hours Note: Could not determine if specimen was tested within 10 minutes due to no time of collection Last 4 digits of Patient Number: 8148 Date of Collection: 05-25- 2021 Time of Collection: blank Analyzed Time: 12:56 hours Note: Could not determine if specimen was tested within 10 minutes due to no time of collection Last 4 digits of Patient Number: 8162 Date of Collection: 06-11-2021 Time of Collection: blank Analyzed Time: 01:58 hours Note: Could not determine if specimen was tested within 10 minutes due to no time of collection Last 4 digits of Patient Number: 8207 Date of Collection: 06-30-2021 Time of Collection: 09:00 Analyzed Time: 09:13 hours (elapsed time past 10 minutes: 1 minute) 3. The laboratory was asked to provide documentation of following the manufacturer's instructions to ensure specimens were tested within 10 minutes of collection. No documentation was provided. 4. An interview with the Lead Respiratory Therapist on July 13, 2021 at 10:45 hours confirmed the findings. He stated that some of the discrepancies were most likely due to wrong times being documented and agreed that if times were not written at all, the elapsed time could not be determined. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of