Platte Health Center Avera

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 12/4/24. Platte Health Center Avera laboratory was found not in compliance with the following requirements: D5209 and D6125 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 record review and interview the laboratory failed to establish written policies and procedures to assess the competency of laboratory personnel to perform preanalytical, analytical and post-analytical tasks in 2023 and 2024 through the date of the survey on 12/4/24. Findings Include: 1. Review of the laboratory records revealed competency assessments had been performed for testing personnel in 2023 and 2024. A copy of the laboratory's competency assessment policy was requested on 12/4/24 at 10:40 a.m. The laboratory staff was unable to provide a copy of the policy. Interview on 12/4/24 at 10:45 a.m. with technical supervisor A revealed: *She did not think the laboratory had a written policy for competency assessment. *She was not aware a written competency assessment policy was required, since they performed competencies for testing personnel on a yearly basis. D6125 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview, the technical supervisors failed to assess competency through the testing of blind samples or external proficiency samples on all testing platforms for three of five laboratory personnel (C, D, E) in 2023 and 2024. Assessment of blind testing and/or external proficiency testing (PT) helps ensure competency of staff reporting patient test results. Findings include: Review on 12/4/24 at 9:30 a.m. of the laboratory staff's annual competency assessment records revealed: *Technical supervisor C had: - Annual competency evaluations on 12/27/23 and 12/2 /24. -Not completed blind sample testing or PT samples for the departments of hematology and coagulation in 2023 and microbiology in 2024. -Performed patient testing in the departments of hematology, coagulation and microbiology during 2023 and 2024. *Testing personnel D had: -Annual competency evaluations on 12/18/23 and 12/2/24. -Not completed blind sample testing or PT samples for the department of immunohematology in 2023. -Performed patient testing in the department of immunohematology in 2023. *Technical supervisor E had: -Annual competency evaluations on 11/27/23 and 11/8/24. -Not completed blind sample testing or PT samples for the departments of immunohematology in 2023 and hematology and coagulation in 2024. -Performed patient testing in the departments of immunohematology, hematology and coagulation during 2023 and 2024. A copy of the laboratory's competency assessment policy was requested on 12/4/24 at 10:40 a.m. The laboratory staff was unable to provide a copy of this policy. Interview on 12/4/24 at 10:45 a.m. with Technical Supervisor A revealed: *She confirmed that technical supervisors B, C, E and herself had been involved with the competency assessment process. *She confirmed that laboratory staff C, D, and E had processed patient specimens in all testing departments within the laboratory. *PT events were rotated between staff, but there were only two to three PT events per year. *She had not been aware that blind testing or external proficiency testing was required for competency assessment in all departments within the laboratory annually. *The laboratory did not have a policy for performing competency assessments. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 9/13/18. The Platte Health Center Avera laboratory was found not in compliance with the following requirements: D2015, D5471, and D6091. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) events, quality assurance (QA) activities, and interview with laboratory manager, the laboratory failed to ensure the laboratory director signed the attestation statements for nine of sixteen PT events (Immunology /Immunohematology 2017 3rd, 2018 1st and 2nd events, Hematology/Coagulation 2017 3rd, and 2018 1st events, Chemistry Miscellaneous 2018 1st event, Microbiology 2018 1st and 2nd events, and 2018 CG-S4-A) submitted for grading to American Proficiency Institute and College of American Pathologists. Findings include: 1. Review of the records for the PT events identified above revealed the attestation statements had not been signed by the laboratory director attesting the PT specimens had been tested in the same manner as patient specimens. Review of QA 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 -- activities for 2017 and to date in 2018 revealed review of the attestation forms had not been included in PT testing review. Interview on 9/13/18 at 9:10 a.m. with the laboratory manager revealed the laboratory director comes on a quarterly basis. She must have forgotten to give the laboratory director the PT book on her previous visits. 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, Vitek 2 ID card package inserts, and interview with the laboratory supervisor, the laboratory failed to check each lot number or shipment for two of two lot numbers reviewed of Vitek 2 gram positive and negative ID cards (lot 2420567103 and 21410317103) for their positive and negative reactivity in each biochemical well prior to use for patient testing to ensure accurate identification of microorganisms. Findings include: 1. Review of the bacteriology QC records of Vitek 2 gram negative ID cards (lot 21410317103) 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-glucosidase, lysine decarboxylase, L-histidine assimilation, coumarate, beta-glucoronidase, l-malate assimilation, ellman, and L-lactate assimilation biochemical wells. *The cards did not have the negative reactivity verified in the beta-n-acetyl-glucosaminidase, gamma-glutamyl-transferase, citrate, l- lactate alkalinization, and, succinate alkalinization biochemical wells. *Gram negative ID card lot 21410317103 was currently in use for patient testing at the time of this survey. 2. Review of the bacteriology QC records of Vitek 2 gram positive ID cards (lot 2420567103) revealed: *The cards did not have the positive reactivity verified in the alpha-glucosidase, Ala-Phe-Pro arylamidase, cyclodextrin, leucine arylamidase, beta-glucoronidase, D-orbital, and phosphatase biochemical wells. *The cards did not have the negative reactivity verified in the beta-glucosidase, D-glucose, D-maltose, lactose, growth in 6.5% sodium chloride, O/129 resistance, pullulan, saccharose /sucrose, D-mannitol, and D-trehalose biochemical wells. *Gram positive ID card lot 2420567103 was currently in use for patient testing. Review of the Vitek 2 ID IQCP policy approved and signed by the laboratory director on 4/28/17 revealed the IQCP did not address the identity and number of QC organisms to be tested. Review of the Vitek 2 GN ID package insert dated October 2016 revealed testing of seven additional organisms (Actintobacter baumanii ATCC BAA-747, Elizabethkingia meningoseptica ATCC 13253, Klebsiella oxytoca ATCC 700324, Ochrobactrum anthropi ATCC BAA-749, Proteus vulgaris ATCC 6380, Pseudomonas aerginosa ATCC 9721, and Pseudomonas aerginosa ATCC BAA-1744) was necessary to check the positive and negative reaction of all biochemical wells. Review of eht Vitek 2 GP ID package insert dated October 2016 revealed testing of seven additional organisms (Streptococcus salivarius ssp. thermophilus ATCC 19258, Kocuria kristinae ATCC -- 2 of 3 -- BAA-752, Listeria monocytogenes ATCC BAA-751, Streptococcus pneumoniae ATCC 49619, Staphylococcus sciuri ATCC 29061, Streptococcus equi ssp. zooepidemicus ATCC 43079, and Enterococcus saccharolyticus ATCC 43076) was necessary to check the positive and negative reactivity of all biochemical wells. Review of the annual testing volume survey form indicated 264 patient microorganism IDs had been performed in 2017. Interview on 9/13/18 at 12:30 p.m. with the laboratory manager revealed she thought the IQCP plan covered QC. She stated they were following streamlined QC. She was not aware the IQCP needed to specifically address the number and identity of the QC organisms tested. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require