Sanford Sheldon Medical Center

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of gram stain quality control (QC) records, patient test reports and the Gram Stain Procedure - Sheldon and confirmed by interview with technical supervisor (TS) #1 at 12:06 pm 2/20/2025, the laboratory failed to follow the gram stain procedure and perform QC with each patient for one of one patient reviewed on 12/4/2024. The findings include: 1. The Gram Stain Procedure - Sheldon sates, "A premade QC slide containing gram positive and gram negative organisms will be stained daily with each patient sample or with each new lot change." 2. Patient identifier A had a gram stain performed on 12/4/2024. 3. The laboratory did not have documentation of gram stain QC being performed on 12/4/2024. 4. TS #1 confirmed the laboratory did not follow their procedure for performing gram stain QC. 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 --

Summary Statement of Deficiencies 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 review of Stago coagulation test system records and confirmed by laboratory personnel identifiers #2 and #3 (refer to the Laboratory Personnel Report) at approximately 12:45 pm on 02/07/2023, the laboratory failed to verify the manual calculation of the international normalized ratio (INR) for one out of one lot number of prothrombin time reagent (259495, expiration 06/30/2023). The findings include: 1. At the time of the survey, the laboratory had in use prothrombin time reagent lot number 259495 (expiration 06/30/2023). 2. The coagulation reagent verification records for prothrombin time reagent lot number 259495 did not include verification of the accuracy of the INR calculation from the instrument. 3. Personnel identifiers #2 and #3 confirmed that the laboratory did not verify the accuracy of the INR calculation from the instrument. 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 --

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 review of proficiency testing (PT) records, the Laboratory Test List & Annual Volume form, and confirmed by laboratory personnel identifier #3 (refer to the Laboratory Personnel Report) at approximately 12:30 pm on 02/06/2019, the laboratory failed to enroll in an approved proficiency testing program for the subspecialty of bacteriology for three out of three years from 2017-2019. The findings include: 1. The Laboratory Test List & Annual volume form indicated that the laboratory performed limited bacteriology testing, including throat cultures. 2. At the time of the survey, personnel identifier #3 confirmed that the laboratory did not enroll in an approved proficiency testing program for the subspecialty of bacteriology (throat cultures) from 2017-2019. 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 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 -- 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 review of the laboratory's Individualized Quality Control Plan (IQCP), quality control (QC) logs, and confirmed by laboratory personnel identifier #3 (refer to the Laboratory Personnel Report) at approximately 3:45 pm on 02/06/2019, the laboratory failed to perform two levels of urine drug screen QC weekly for 22 out of 27 weeks from 04/01- 09/30/2018. The findings include: 1. The laboratory implemented and began using the Medtox urine drug screen test system in August 2017. 2. The laboratory's IQCP stated that QC would be performed with each new lot of tests and weekly. 3. The laboratory received five new lots of tests from 04/11- 09/06 /2018: *Lot TD067M19, expiration 12/31/19 (Received 04/11/2018) *Lot TD080C20, expiration 03/31/20 (No receipt date recorded) *Lot TD081C20, expiration 03/31/20 (Received 05/25/2018) *Lot TD091D20, expiration 04/30/20 (Received 07/09/2018) *Lot 604022, expiration 06/30/20 (Received 09/06/2018) 4. The laboratory performed QC on the following dates: *04/11/2018 (Lot TD067M19) *05/21/2018 (Lot TD080C20) *06/30/2018 (Lot TD081C20) *08/12/2018 (Lot TD091D20) *09/16 /2018 (Lot 604022) 5. At the time of the survey, personnel identifier #3 confirmed that the laboratory only performed QC with each new lot of tests and not weekly. -- 2 of 2 --