William J Schulte, Md

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of Selective Strep Agar (SSA) media logs, the media Individualized Quality Control Plan (IQCP) and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 10:30 am on 2/11/2020, the laboratory failed to retain the SSA media quality control certificates for seven out of 11 lot numbers of SSA media used from June 2019 - February 2020. The findings include: 1. The laboratory's media IQCP states, "Quality control certificates from the manufacturer will be retained for each lot and shipment of exempt media." 2. At the time of the survey, the laboratory did not retain the SSA media quality control certificates for the following lot numbers of media: *123310, expiration date 07/31 /2019 *123976, expiration date 09/12/2019 *441219, expiration date 09/19/2019 *124402, expiration date 10/10/2019 *125244, expiration date 11/28/2019 *446500, expiration date 12/09/2019 *447700, expiration date 12/26/2019 D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: 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 -- Based on review of patient throat culture logs, Selective Strep Agar (SSA) media logs and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 11:00 am on 2/11/2020, the laboratory failed to ensure they did not use expired SSA media for two out of 14 patients who had throat cultures performed using lot number 441219 of SSA media. The findings include: 1. On 9/24 /2019, the laboratory performed throat cultures using lot number 441219 of SSA media on patient identifiers A & B. 2. SSA media lot number 441219 expired on 9/19 /2019. -- 2 of 2 --

Summary Statement of Deficiencies 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 quality control (QC) records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 10: 45 am on 03/20/2018, the laboratory failed to check each new lot number of Taxo A bacitracin disks for positive and negative reactivity for six out of nine lot numbers of disks received from 01/08/2016- 01/23/2018. The findings include: 1. The laboratory received the following lot numbers of Taxo A bacitracin disks from 01/08/2018 to 01 /23/2018: *5187786, expiration 01/31/2017; received 01/08/2016 *5275541, expiration 04/30/2017; received 03/11/2016 *6088601, expiration 09/30/2017; received 10/04/2016 *6157769, expiration 01/31/2018; received 11/29/2016 *6256782, expiration 03/31/2018; received 01/10/2017 *6292869, expiration 04/30 /2018; received 03/14/2017 *6307550, expiration 05/31/2018; received 06/23/2017 *7132999, expiration 11/30/2018; received 11/16/2017 *7142417, expiration 04/24 /2018; received 01/23/2018 2. Review of quality control records indicated that the laboratory did not perform QC on the following lot numbers: 6256782, 6292869, 6307550, 7132999, and 7142417. 3. At the time of the survey, personnel identifier # 2 confirmed that the laboratory did not have additional QC records. 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 --