Avera St Benedict Health Center

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 8/27/24. Avera St Benedict Health Center laboratory was found not in compliance with the following requirements: D5445. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform two levels of external controls each day of patient testing or establish an equivalent quality control (QC) method to verify the accuracy of one of one non-waived test (Profile-V Med Tox Scan Drugs of Abuse Test System) reviewed. Failure to run external QC could result in inaccurate reporting of patient results. Findings include: 1. Review on 8/27 /24 at 11:30 a.m. of the laboratory's August 2024 urine drug screen log sheet revealed: *Two external QC levels had been reported on 8/7/24, 8/14/24, and 8/21/24. All external QC had been within acceptable limits. *Two patient specimens had been reported on 8/1/24 (424258 and 415756). *One patient specimen had been reported on 8/6/24 (485391). *One patient specimen had been reported on 8/12/24 (619095). *Two patient specimens had been reported on 8/20/24 (803080 and 814821). *There was no documentation external QC had been processed on the days patient specimens had been processed. Review of the Profile-V Med Tox Scan Reader System Quick 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 -- Reference Instructions, last revised June 2021, revealed, "You should run external controls routinely or as needed for any of the following reasons: (1) to practice the test with a known control, (2) when you open a new lot of devices, (3) once a week, (4) if you suspect that the reader or test device is not working properly, (5) if you have had a repeated unexpected test result or (6) if you suspect that the test devices have been stored improperly." Review of the annual test volume form revealed the laboratory had reported approximately 45 urine drugs of abuse panels on patient specimens in 2023. Interview on 8/27/24 at 11:30 a.m. with lead technologist A revealed: *She confirmed the laboratory performed external QC on the urine drug screen kit on a weekly basis. *She confirmed the laboratory did not have an Individual Quality Control Plan (equivalent QA plan) that would have allowed the laboratory to perform external QC less frequently than each day of patient testing. *She stated that external QC had been run each day of testing originally. The laboratory's procedure stated external QC could be done daily or weekly. The laboratory had switched to running external QC weekly due to the increased number of patient tests. *She could not remember when the laboratory had switched from day of patient testing to processing external QC weekly. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 8/15/18. The Avera St Benedict Health Center laboratory was found not in compliance with the following requirements: D5471 and D5477. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the Individualized Quality Control Plan (IQCP) for streamlined quality control (QC) of commercial identification (ID) cards for the Vitek 2 and interview with the laboratory supervisor, the laboratory failed to check each lot number or shipment of five of five lot numbers reviewed of Vitek 2 gram positive and negative ID cards (lot # 241397440, 2410257403, 2410473203, 2420024123, and 2420535403) for their positive and negative reactivity prior to use for patient testing to ensure accurate identification of microorganisms. Findings include: 1. Review of the bacteriology QC records for three lot numbers of Vitek 2 gram negative ID cards (241397440, 2410267403 and 2410473203, tested 1/25/17, 9/13/17, and 6/18/18, respectively) revealed: *The cards did not have the positive reactivity checked in the L-pyrrolydonyl-arylamidase, L-arabitol, hydrogen sulfide production, glutamyl arylamidase pNA, beta-alanine arylamidase pNA, urease, D-Tagatose, 5-keto-D- gluconate, alpha-gluconidase, lysine decarboxylase, L-histidine assimilation, 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 -- coumarate, beta-glucoronidase, l-malate assimilation, ellman, and L-lactate assimilation biochemical wells. *The cards did not have the negative reactivity verified in the gamma-glutamyl-transferase biochemical well. *Gram negative ID card lot 2410473203 was currently in use for patient testing at the time of survey. 2. Review of the bacteriology QC records for two lot numbers of Vitek 2 gram positive ID cards (2420024123 and 242066503, tested 10/5/16 and 1/17/18, respectively) revealed: *The cards did not have the positive reactivity verified in the alpha- glucosidase, Ala-Phe-Pro arylamidase, cyclodextrin, L-aspartate arylamidase, leucine arylamidase, beta-glucaronidase, alanine arylamidase, D-sorbitol, and arginine dihydrolase 2 biochemical wells. *The cards did not have the negative reactivity verified in the arginine dihydrolase 1, beta-galactosidase, D-galactose, D-maltose, bacitracin resistance, novobiocin resistance, growth in 6.5% sodium chloride, D- mannitol, and D-trehalose biochemical wells. *Gram positive ID card lot 2420535403 was currently in use for patient testing. Review of the Vitek 2 ID IQCP policy, approved and signed by the laboratory director on 11/8/15, revealed the IQCP did not address the identity and number of QC organisms to be tested. Review of the annual testing volume survey form indicated 463 patient microorganism IDs had been performed on those lot numbers of cards in 2017. Interview on 8/15/18 at 10:10 a.m. with the laboratory supervisor revealed she thought the IQCP plan covered QC. She stated they were following Clinical Laboratory Standards Institute (CLSI) standards for streamlined QC. She was unaware that Clinical Laboratory Improvement Amendments of 1988 no longer accepted CLSI standards as of January 2015. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) record review, Individualized Quality Control Plan (IQCP) for commercially prepared Clinical Laboratory Standards Institute (CLSI)- Exempt Media policy, and interview with the laboratory supervisor, the laboratory failed to ensure QC had been performed on six of six different types of media (trypticase soy agar with 5% sheep blood agar, MacConkey II agar, chocolate agar, BacT/Alert SN blood culture bottles, BacT/Alert SA blood culture bottles, and BacT /Alert PF Plus blood culture bottles) for accurate and reliable performance prior to being used with patient culture specimens. Findings include: 1. Review of the Quality Control Log for Remel Media revealed no documentation of 27 lot numbers of the above identified media from 11/1/17 through 6/19/18 for the ability to support growth, the ability to select, or inhibit specific organisms, or produce a biochemical response as applicable for each type of media. The lot numbers reviewed were: *Tryticase soy agar with 5% sheep blood agar: 225334, 247681, 257728, 275159, 257864, 292395, 297390, 313825, 316520, 332624, and 352573. *MacConkey II agar: 229472, 245682, 275237, 251082, 293681, 322626, and 339263. *Chocolate agar: 225016, 294457, 265802, 295739, 323507, and 341166. *BacT/Alert SN blood culture bottle: 1050474. *BacT/Alert SA blood culture bottle: 1050578. *BacT/Alert PF Plus blood -- 2 of 3 -- culture bottle: 4050298. Review of the IQCP for Commercially Prepared CLSI- Exempt media policy, approved and signed by the laboratory director on 11/18/15 revealed: *An IQCP had been developed. *The quality control plan of the IQCP did not address the ability to support sterility, growth, select or inhibit specific organisms, or produce a biochemical response as applicable for each type of medal. Interview on 8 /15/18 at 10:10 a.m. with the laboratory supervisor revealed she thought their IQCP plan covered QC requirements. She stated they were following CLSI standards. She was unaware that Clinical Laboratory Improvement Amendments of 1988 no longer accepted CLSI standards as of January 2015. She was unaware that revision required documentation of physical characteristics of media, sterility, and ability to support growth of microorganisms upon receipt of a new lot number or shipment was required in-house on all media. -- 3 of 3 --