Southwest Alabama Health Services

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on surveyor observation, review of the Piccolo Xpress Quick Reference Guide, and interviews with the Technical Consultant (TC), the Clinical Director (CD) and Testing Personnel 1 (TP1), the laboratory failed to follow the manufacturer's instructions to use Lithium Heparin for the Piccolo testing. The surveyor noted the Sodium Heparin tubes in the blood collection area which may have been used for the Piccolo patient testing. Findings Included: 1. During a tour of the facility on 01-20- 2026 at 11:27 AM, surveyor observation revealed Sodium Heparin tubes were available for use in the Piccolo testing. 2. Review of the Piccolo Xpress Quick Reference Guide on page 9 revealed manufacturer's requirement as follows, " ... Lithium heparin is the only anticoagulant recommended for use with the Piccolo Xpress." 3. Interviews with TC, CD and TP1 revealed the Sodium Heparin tubes may have been utilized for patient testing when the Piccolo testing went live. The CD stated that during the analyzer training in another location, the Piccolo trainer did not emphasize the necessity of using the Lithium Heparin for testing. 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 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 -- overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the reviews of the CLIA Standard Operating Manual, Policy and Procedure Manual, Personnel and Evaluation records, Proficicency Testing records, Piccolo Quick Reference Guide, the laboratory failed to monitor and assess the overall quality of its pre-analytical and analytical systems and be able to provide appropriate

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a tour of the Laboratory, a U.S. Food and Drug Administration (FDA) Recall Notice, and an interview with the Technical Consultant, the laboratory failed to enroll in an approved proficiency testing (PT) program for tests performed on the Abbott i-STAT Chemistry 8 (CHEM8) cartridge (this cartridge contains regulated moderate-complexity tests). This was noted from February 18, 2020 (FDA Class 2 Device Recall for i-STAT CHEM8) to the date of the current survey (November 2021). The findings include: 1. A tour of the Laboratory revealed the use of i-STAT CHEM8 cartridges. This cartridge includes the following analytes: a) Sodium b) Potassium c) Chloride d) Carbon dioxide e) Calcium f) Glucose g) Blood Urea Nitrogen h) Creatinine 2. A review of the FDA recall notice revealed the test was classified as waived until the date of the recall on February 18, 2020. After the recall, the FDA categorized CHEM8 tests as moderate complexity, and capillary whole blood was no longer an acceptable sample type. 2. During an interview on 11/04/2021 at 2:20 PM, the Technical Consultant (TC) confirmed the above findings. Also, the TC confirmed the laboratory continued to use the i-STAT CHEM8 for daily patient testing after the recall, and did enroll in an approved PT program. 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 -- 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 a tour of the Laboratory, a U.S. Food and Drug Administration (FDA) Recall Notice, a lack of verification of performance documents, and an interview with the Technical Consultant, the laboratory failed to demonstrate that it can obtain results comparable to specifications established by the manufacturer for accuracy, precision, reportable range, and reference intervals. This was noted from February 18, 2020 (FDA Class 2 Device Recall for i-STAT CHEM8) to the date of the current survey (November 2021). The findings include: 1. A tour of the Laboratory revealed the use of i-STAT CHEM8 cartridges. This cartridge includes the following analytes: a) Sodium b) Potassium c) Chloride d) Carbon dioxide e) Calcium f) Glucose g) Blood Urea Nitrogen h) Creatinine 2. A review of the FDA recall notice revealed the test was classified as waived until the date of the recall in February 18, 2020. After the recall, the FDA categorized CHEM8 tests as moderate complexity, and capillary whole blood was no longer an acceptable sample type. 3. The laboratory had no documentation of verification of performance. 4. During an interview on 11/04/2021 at 02:20 PM, the Technical Consultant confirmed the laboratory had not performed verification of performance since the FDA recall that changed the complexity from waived to moderate. 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. This STANDARD is not met as evidenced by: Based on reviews of the Quality Control (QC) records for the i-STAT, a U.S. Food and Drug Administration (FDA) Recall Notice, the Procedure Manual, and an interview with the Technical Consultant, the laboratory failed to run controls at least once each day patient testing was performed, or implement an Individualized Quality Control Plan (IQCP) for the i-STAT Chemistry 8 (CHEM8) cartridge. This was noted from February 18, 2020 (FDA Class 2 Device Recall for i-STAT CHEM8) to the date of the current survey (November 2021). The findings include: 1. A review of the Quality Control records for the i-STAT revealed after the FDA recall in February 2020, the laboratory continued to run QC as if the test was classified as waived. One Level (Level 1) was run monthly. Patient testing continued to be performed daily from February 2020 to November 2021 (day of survey). 2. A review of the FDA recall -- 2 of 3 -- notice revealed the test was classified as waived until the date of the recall on February 18, 2020. After the recall FDA categorized CHEM8 tests as moderate- complexity, and capillary whole blood was no longer an acceptable sample type. 3. A review of the procedure manual revealed, "i-STAT Meter Quality Control (Frequency) 1. One level of control will be tested upon receipt of cartridges and at least once a month for each additional month the lot number is in use...". 4. During an interview on 11/04/2021 at 12:30 PM, the Technical Consultant confirmed the laboratory performed the Level 1 control once a month for the i-STAT CHEM8, and patient testing was performed daily. -- 3 of 3 --

Summary Statement of Deficiencies D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) The laboratory director is responsible for the overall operation and administration of 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)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of the API (American Proficiency Institute) proficiency testing records, a review of the CMS CASPER Report 0096D (CLIA Application and Survey Summary), and an interview with the Technical Consultant, the surveyor determined the Laboratory Director failed to ensure testing personnel performed and submitted results for one of three 2017 Hematology surveys. The findings include: 1. A review of the CMS CASPER Report 0096D (CLIA Application and Survey Summary) revealed no results for the 2017 Event #3 Hematology survey. The report indicated CMS received no scores from the proficiency testing provider (API). 2. A review of the 2017 Event #3 API (American Proficiency Institute) proficiency testing records revealed the laboratory performed the surveys for Chemistry and waived testing, however there was no record of the Event #3 Hematology survey results. 3. During an interview on 8/29/2019 at 9:40 AM, the Technical Consultant explained he had noticed the survey was missing when he reviewed the records, and asked the Laboratory Supervisor (Testing Personnel #1 on Form CMS-209). The Technical Consultant stated they were unable to find any documentation the survey was performed, thus no results were submitted to API or CMS. SURVEYOR ID# 32558 Licensure and Certification Surveyor Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --