Minnesota Department Of Health

Summary Statement of Deficiencies D0000 A recertification survey was conducted from 12/03/2024 through 12/05/2024 and standard level deficiencies were cited. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of College of American Pathologists (CAP) proficiency testing (PT) records and in interview with general supervisor-7 (GS-7), the laboratory failed to ensure personnel signed attestation forms for 3 of 3 proficiency testing (PT) events (creatinine and specific gravity tests). Findings included: 1. Review of CAP PT documentation did not include the testing person and the laboratory director's (or designee) signatures on CM-B 2023 (specific gravity) and U-B 2024 (creatinine) attestation forms (signature required). For event CM-B 2024 (specific gravity), there was no testing person signature. 2. During an interview on 12/03/2024 at 2:05 pm, GS- 7 reviewed and confirmed CAP PT attestation forms had not been signed. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- Based on direct observation and media documents, the laboratory failed to retain American Type Culture Collection (ATCC) microorganism's manufacturer instructions to ensure instructions and expiration dates were followed for 9 of 9 microorganisms (random sampling). Findings included: 1. The laboratory was unable to provide ATCC microorganism's manufacturer instructions to ensure instructions and expiration dates were followed, the following was a sampling observed: a. During a tour of the mycology department on 12/05/2024 at 2:37 pm, the following expired quality control (QC) water stocks in glass vials with microorganisms and inoculated microorganism in media were observed stored in a cabinet (random sampling): T. mentagrophytes ATCC 9533, Lot 442-75-3, expiration date 06/2018 and the sterilized water it was in had a label with a made date of "Oct 06, 2016" and an expiration date of "April 06, 2017." (T. - Trichophyton) T. rubrum ATCC 28188, lot 444-86-4, expiration date 10/31/23 and the sterilized water it was in had a label with a made date of "Jan 24, 2022" and an expiration date of "July 24, 2022." T. interdigitale ATCC 9533 (no lot number or expiration date) in deionized water with a label that stated, made date of "3/11/24" and an expiration date of "9/11/24." T. tonsurans ATCC 28942 (no lot number), 10/31/23 (was not labeled with the meaning of this date) in deionized water with a label that stated, made date of "6/1/23" and an expiration date of "12/1/23." "Asp Glaucus 14/Aug/14" in distilled water with a label that stated, made date "July 23, 2014" and expiration date of "Jan 22, 2015." (Asp - aspergillus) Four slants that included inoculated microorganisms Trichophytum equinum ATCC 12545 on 11/1/24 (three slants) and T. interdigitale ATCC 9533 on 11/7/24 (one slant). b. During a tour of the mycology department on 12/05/2024 at 2:37 pm, yeast microorganisms were observed in a 30C (degrees Celsius) incubator: C. Albicans ATCC 60193 inoculated on Sabdex slant 12/2/24, C. Glabrata ATCC 66032 inoculated on Sabdex slant 12/2/24, and S. Aureus ATCC 25923 inoculated on a blood agar plate 12/2/24. (C. - Candida, S. - Staphylococcus) c. During a tour of the microbiology department on 12/05/2024 at 3:00 pm, the following microorganisms in vials with glycerol were observed stored in a -76C freezer (random sampling): "C. Albicans 90028 3-5-21" "S. Aureus 25923 2/3/23" "C. Glabrata ATCC 66032" The laboratory failed to ensure microorganisms were not used past the manufacturer's expiration date and water stock expiration dates (refer to D5417); and failed to ensure microorganisms stored in vials and inoculated in media were labeled with expiration dates to ensure they were used within those dates (refer to D5415). D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) 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: Based on direct observation and review of laboratory procedures, the laboratory failed to define temperature acceptable criteria for three of three syphilis test methods (random sampling of tests). Findings included: 1. During an observation of central accessioning on 12/05/2024 at 10:00 am, twelve red top Vacuette Serum Separator Tubes (SST) patient specimens for Rapid Plasmin Reagin (RPR) testing were observed in a rack on a counter. They were received at 9:17 am with the "condition" -- 2 of 11 -- as "refrigerated", and on the requisitions a temperature of 14.4C was documented. They were transported via courier from Ramsey County. A continued observation of central accessioning on 12/05/2024 at 10:35 am, five aliquoted serum specimens for RPR testing were observed being received and temperatures taken that included 13.3 C, 12.4C, 13.3C, 14.4C. The biohazard bag they were in had a "Refrigerated" label and were transported via courier from Alina Health. There was no documentation that defined an acceptable temperature range for RPR/syphilis testing specimens. 2. Review of "Specimen Receipt in the Infectious Disease Laboratory" standard operating procedure (SOP) 1002 on page 4 stated, "7.5 Perform specimen temperature readings" with step-by-step instructions of taking temperatures of specimens but no defined acceptability criteria or range of temperatures. 3. Review of the RPR procedure SOP 1001 stated, "7.3 Shipping, handling, and storage: 7.3.1 Specimens are usually transported at ambient temperatures. Specimens should not be exposed to extreme temperatures or long transport delays." Review of the syphilis antibody detection in cerebralspinal fluid (CSF) by venereal disease reserach laboratory (VDRL) SOP 1002 and syphilis antibody detection in serum by treponema pallidum particle agglutination (TPPA) SOP 1003 stated, "7.4 Specimens are usually transported at ambient temperatures. However, care must be taken to not expose them to extreme temperatures or long transport delays." Review of the laboratory's online instructions for submitting syphilis specimens stated, "Transport/Stability Store and ship at refrigeration temperature within 5 days of collection. Alternatively, ship frozen." The laboratory's SOPs of "transported at ambient temperatures" were not consistent with online instructions of "ship at refrigeration temperature." The laboratory did not define "ambient", "refrigeration", "extreme temperatures" and an acceptable temperature range when taking temperatures at receipt. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: A. Based on observation, review of the laboratory online test catalogue, review of laboratory policy, and interview with staff, the laboratory failed to define storage and transport temperature requirements for specimens. I. (a) The following samples were observed received from United Parcel Service (UPS) in the accessioning area, room 151, at approximately 10am on 12/05/2024 with a temperature recorded as 16.2C. 1. #240059677 - stool specimen in Cary Blair transport medium for Enteropathogenic E. coli (EPEC) testing, submission form marked "Refrigerated" by the laboratory. 2. #240059679 - stool specimen in Cary Blair transport medium for Salmonella species testing, submission form marked "Refrigerated" by the laboratory. 3. #240059681 - stool specimen in Cary Blair transport medium for Enteropathogenic E.coli (EPEC) testing, submission form marked "Refrigerated" by the laboratory. 4. #240059431 - isolate on blood agar slant for Streptococcus agalactiae testing, submission form marked "Ambient" by the laboratory. I. (b) The following sample was observed received from United Parcel Service (UPS) in the accessioning area, room 151, at approximately 10am on 12/05/2024 with a temperature recorded as 16.4C. 1. #240059743 - stool specimen (rectal swab) in Cary Blair transport medium for Shigatoxin producing gene testing, submission form marked "Ambient" by the laboratory. I. (c) The following isolates were observed in the TS Series "Whale -- 3 of 11 -- Shark" refrigerator in room 151 at approximately 10:30am on 12/05/2024. Laboratory receipt and accessioning date/time unknown. 1. #240059594 - isolate for CRPA Carbapenem-resistant Pseudomonas aeruginosa Project 2175 (CRPA). Recorded temperature "11.4" and submission form marked "Room Temp" by the laboratory. 2. #240059596 - isolate for Neisseria gonorrhoeae testing. Recorded temperature "11.3" and submission form marked "Room Temp" by the laboratory. 3. #240059640 - isolate for Carbapenem-resistant Acinetobacter (CRA) testing. Recorded temperature "15.4" and submission form marked "Room Temp" by the laboratory. 4. #240059602 - isolate for Methicillin-resistant Staphylococcus aureus (MRSA) testing. Recorded temperature "18.6" and submission form marked "Room Temp" by the laboratory. 5. #240059604 - isolate for Methicillin-resistant Staphylococcus aureus (MRSA) testing. Recorded temperature "18.3" and submission form marked "Room Temp" by the laboratory. II. (a) Review of the laboratory's online test catalogue (https://labinventory. web.health.state.mn.us/#/) found the following: 1. "Test Name ...EPEC (Enteropathogenic Escherichia coli) PCR Panel ...Transport/Stability Store at ambient temperature. Ship at ambient or refrigeration temperature." 2. "Test Name ... Salmonella Culture - Stool ... Transport/Stability Store at ambient temperature. Ship at ambient or refrigeration temperature." 3. "Test Name ...Streptococcus (Group B) Identification - Isolate ... Transport/Stability Store and ship at ambient temperature." II. (b) Review of the laboratory's online test catalogue (https://labinventory.web.health. state.mn.us/#/) found the following: 1. "Test Name Shiga toxin-producing E. coli (STEC) Culture - Stool ... Transport/Stability Store at ambient temperature. Ship at ambient or refrigeration temperature." II. (c) Review of the laboratory's online test catalogue (https://labinventory.web.health.state.mn.us/#/) found the following: 1. "Test Name Carbapenemase Detection in Pseudomonas - Isolate ... Transport/Stability Store and ship at ambient or refrigeration temperature." 2." Test Name Carbapenemase Detection in Acinetobacter - Isolate ... Transport/Stability Store and ship at ambient or refrigeration temperature." 3. "Test Name Neisseria gonorrhoeae - Isolate ... Transport/Stability Store and ship at ambient temperature." 4. "Test Name MRSA Isolate Submission ...Transport/Stability Store and ship at ambient temperature." III. Review of the laboratory policy titled "Specimen Receipt in the Infectious Disease Laboratory" index number "IDL OPS ACC SOP 1002" version 2 found the following: "7.5 Perform specimen temperature readings. 7.5.1 Open shipping packages one at a time. 7.5.2 Remove specimens from shipping cylinder /canisters ... 7.5.3.6 Record temperature reading from IR thermometer on submission form ... 7.5.5 Document intended shipping and IR thermometer temperatures on the upper right of the submission form or manifest. 7.5.6 Document intended shipping in the "Receipt Temp" column on the Specimen Receipt Time/Temperature Log. 7.5.6.1 Circle: AMB, REF, or FRZ." The laboratory policy did not define the temperature range for "AMB" (ambient)," REF" (refrigerated) or "FRZ" (frozen). IV. During interview on 12/04/2024 at 11am, the Quality Specialist of the Infectious Disease Laboratory confirmed the online test catalogue did not define specimen storage and transport temperatures. 43232 B. Based on review of laboratory's client services manual, laboratory's procedures, and direct observation, the laboratory failed to define storage and transport conditions temperature ranges in their instructions for submitters for three of three test methods (random sampling). Findings included: 1. Review of the laboratory's online instructions (client services manual) for submitting syphilis specimens stated, "Transport/Stability Store and ship at refrigeration temperature within 5 days of collection. Alternatively, ship frozen." "Refrigeration" and "frozen" was not defined. 2. Review of the RPR procedure SOP 1001 stated, "7.3 Shipping, handling, and storage: 7.3.1 Specimens are usually transported at ambient temperatures. Specimens should not be exposed to extreme temperatures or long transport delays." Review of the syphilis antibody detection in CSF by VDRL SOP -- 4 of 11 -- 1002 and syphilis antibody detection in serum by TPPA SOP 1003 stated, "7.4 Specimens are usually transported at ambient temperatures. However, care must be taken to not expose them to extreme temperatures or long transport delays." The laboratory's SOPs of "transported at ambient temperatures" was not consistent with online instructions of "ship at refrigeration temperature." 3. During an observation of central accessioning on 12/05/2024 at 10:35 am, the staff was observed taking and documenting temperatures of specimens for RPR testing but the laboratory had not defined acceptability criteria for temperatures. Refer to D5311. D5401 PROCEDURE MANUAL CFR(s): 493.1251(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 the laboratory's PT procedure, CAP PT records, and interview with GS-7, the laboratory failed to follow their own written procedure for reviewing and documenting their review of CAP PT within 30 days for 2 of 8 events (creatinine and specific gravity tests). Findings included: 1. Review of the laboratory's proficiency testing standard operating procedure (SOP 1001) stated, "6.4 Transcribing and Submitting (Testing personnel or unit supervisor) ...6.6.4 Submit results per the instructions pf the proficiency provider (fax, mail, or electronic reporting). 6.4.4.1 Compile the completed PT survey forms and all testing paperwork. Complete Section 1 of Proficiency Testing Summary Report as a coversheet and await receipt of the survey results from the provider. 6.4.4.2 Partially completed Proficiency Testing Summary Report and testing paperwork may be stored in an electronic or paper location of the unit's choice until the result summary is received and the packet is ready to be submitted for approvals through iPassport ....6.5 Reviewing Final Survey Results: ...NOTE: This review should be conducted within 30 days of receiving results. This is to ensure any failures are promptly investigated and appropriate follow- up resolution initiated." 2. Review of CAP PT documentation in iPassport for events U-B 2024 (results submitted 07/15/2024, creatinine) and CM-B 2024 (results submitted 09/10/2024, specific gravity) did not have documentation of their review within 30 days with a Proficiency Testing Summary Report. Both events included results recieved by the PT company. 3. During an interview on 12/03/2024 at 2:05 pm, GS-7 was asked for the timeline of Proficiency Testing Summary Reports, and she confirmed within 30 days. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) -- 5 of 11 -- The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of 2020 and 2021 personnel competency records and interview with the quality assurance officer (QA) #1, the laboratory failed to ensure 46 of 46 general supervisor (GS) and 13 of 13 technical supervisor (TS) competency assessments included specific position responsibilities listed in Subpart M. Findings include: 1. Review of competency records showed the laboratory failed to include documentation of evaluations of specific GS and TS responsibilities. 2. In an interview conducted on 09/13/2022 at approximately 2:30 P.M. QA #1 confirmed that competency assessments for GS and TS failed to include specific position responsibilities. D5401 PROCEDURE MANUAL CFR(s): 493.1251(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 a review of the mycology procedure manual, media agar log documentation, and interview with testing personnel (TP) #6, the laboratory failed to follow the procedure for failed media quality control (QC) for one of the five set-ups reviewed 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 -- for cornmeal agar. Findings include: 1. Review of document MDH Public Health Laboratory Division DOC -282 Revision 8, Quality Control of Media and Reagents section C 5 states "If media and reagents do not perform as expected when QC'd, troubleshooting should be employed and if media/reagents are unsatisfactory after assessment, they should not be put into use. The manufacturer or Media Services should be notified accordingly. Enter any failure in the

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) 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: Based on record review and interview, the laboratory failed to establish a specimen storage and transport procedure that followed the manufacturer's instructions for one of one SARS-CoV-2 serology tests reviewed. Findings: 1. Record review of the laboratory's procedure "SARS-CoV2 IgG detection in human sera by InBios SCoV-2 Detect ELISA" revealed in section "7.0 Specimen Requirements" under 7.5.1 to "Transport samples to MDH at refrigeration temperature (on ice packs, or at 2-8 C). If transport to MDH is delayed more than 7 days, specimens should be stored and shipped frozen." 2.. Review of the InBios SCoV-2 Detect (Trademark) IgG ELISA Instructions for Use (IFU) revealed under the section "Specimen Collection and Preparation" that "If assays are not completed within 8 hours, serum should be refrigerated at 2-8C. If assays are not completed within 48 hours, or the separated serum is to be stored beyond 48 hours, serum should be frozen at or below -20C." 3. In interview on February 4, 2021 at approximately 2:42 P.M., the laboratory's Quality Improvement Specialist and Clinical Quality Assurance Officer confirmed that specimens should be stored and transported according to the manufacturer's IFU. D5401 PROCEDURE MANUAL CFR(s): 493.1251(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 2 -- 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: A. Based on record review and interview, the laboratory failed to follow their procedure for viral cell culture selection for two of three specimens reviewed. Findings: 1. Record review of the"Viral Culture and Identification Worksheet" revealed two samples (147XX and 149XX) with the following cell lines inoculated: PRMK, MRC-5, and A549. 2. Review of procedure "Viral Specimen Preparation and Inoculation" revealed a section titled "11.2 Cell Culture Selection For Specimen Inoculation". The section included a chart listing the following headings: specimen type, request, RHMK, MRC-5, A549, HEP-2, Comments. The cell lines to inoculate for each specimen type and request was indicated. The chart did not indicate inoculation of PRMK, MRC-5, and A549 for any specimen type or request. 3. In interview on February 3, 2021 at approximately 12:00 P.M., GS#1 and the Quality Improvement Specialist confirmed the above findings. B. Based on record review and interview, the laboratory failed to follow their procedure for one of one specimens reviewed for PCR detection of Shiga-like Toxigenic Escherichia Coli (STEC). Findings: 1. Record review of specimen H20-XXXXX revealed that STEC Real-time Multiplex PCR was performed on July 13, 2020 and July 14, 2020. a. On July 13, 2020, the CT values were the following: stx1 = 34.05, eae = N/A, stx2 = 35.06, uidA = 20.18. b. On July 14, 2020, the CT values were the following: stx1= 35.25, eae - N /A, stx2 = 34.15, and uidA = 18.51. 2. Review of the final report for specimen H20- XXXXX for STEC PCR Panel - Culture Sweep revealed a result of "Shiga-like toxin present by PCR. Strongly Indicates presence of Shiga toxin-producing Escherichia coli." 3. Review of procedure "Real-time Multiplex PCR for Detection of Shiga-like Toxigenic Escherichia coli (STEC)" indicated in section "12.0 Interpretation" under "Table 5 STEC PCR assay results for specimen sample sweeps" that the Ct value for stx1 and stx2 should be less than or equal to 33. 4. During interview on February 4, 2021 at approximately 2:00 P.M., TS#1 confirmed the above findings. -- 2 of 2 --