Rosebud Healthcare Center

Summary Statement of Deficiencies 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 record review, procedures and interview with the technical supervisor (TS) #1, the laboratory failed to follow their procedure to perform two levels of quality control (QC) every 24 hours with patient testing performed on the CLINITEK Status urinalysis analyzer for seven out of 17 days of patient testing in March 2023 and twelve out of 22 days of patient testing in December 2023 and failed to have a step-by- step procedure for how staff perform a historical record check of blood bank patient data to determine previously identified antibodies and any other serological anomalies and a procedure to detect and resolve ABO discrepancies from August 14, 2022, to August 14, 2024. Findings: 1. A review of American Proficiency Institute 2023 Hematology/Coagulation records revealed testing personnel failed to perform two levels of QC on 03/15/2023, the day of testing for Urinalysis Blood or Hgb Event 1. 2. A review of urinalysis QC logs revealed laboratory staff failed to perform two levels of quality control every 24 hours with patient testing per their "Clinitek Status Urinalysis" procedure for the following days of patient testing: 3/07/23, 3/08/23, 3/09 /23, 3/15/23, 3/17/23, 3/22/23, 3/23/23, 12/05/23, 12/06/23, 12/07/23, 12/08/23, 12/11 /23, 12/12/23, 12/21/23, 12/24/23, 12/25/23, 12/27/23, 12/28/23, and 12/19/23. 3. The laboratory failed to have a procedure for checking historical blood bank patient data to determine previously identified antibodies and any other serological anomalies and how to detect and resolve ABO discrepancies at the time of the survey. 4. An interview with TS #1 on August 14, 2024, at 1:00 PM and 2:45 PM confirmed staff failed to perform two levels of QC every 24 hours for the CLINITEK Status urinalysis 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 -- analyzer for the days listed above and failed to have a step-by-step procedure for how staff perform a historical record check of blood bank patient data to determine previously identified antibodies and any other serological anomalies and a procedures to detect and resolve ABO discrepancies from August 14, 2022, to August 14, 2024. 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: Based on a record review, procedure, and an interview with the technical supervisor (TS) #1, the laboratory failed to ensure eight of ten microbiology American type culture collection (ATCC) quality control swabs and two of four biochemical reagents were not used on patient urine cultures past their expiration date from March 1, 2023, to August 14, 2024. Findings: 1. A review of Microbiologic's packing slip revealed the laboratory used expired ATCC quality control swabs to perform quality control checks on MicroScan gram negative (NUC85) and gram positive (PC45) panels, Columbia-Colistin Nalidixic Acid Agar (CNA), Blood Agar, and MacConkey Agar (MAC), and biochemical reagents staphlatex, catalase, coagulase, and oxidase from February 29, 2024, to August 14, 2024, with the following ATTC strains: a. Escherichia coli ATCC control #24922 with an expiration date of 3/31/24 b. Enterococcus faecalis ATCC control #29212 with an expiration date of 4/30/24 c. Klebsiella quasipneumoniae ATCC control #700603 with an expiration date of 4/30 /24 d. Enterococcus faecalis ATCC control #51299 with an expiration date of 2/29/24 e. Proteus vulgaris ATCC control #49132 with an expiration date of 3/31/24 f. Streptococcus gallolyticus ATCC control #49147 with an expiration date of 6/30/24 g. Micrococcus luteus ATCC control #49732 with an expiration date of 2/29/24 h. Klebsiella oxytoca ATCC control #49131 with an expiration date of 4/30/24 2. A review of QC results for microbiology biochemical reagents and patient urine culture worksheets revealed the laboratory used expired Oxidase reagent lot #501335 with an expiration date of 2/06/23 on seven out of seven patients tested in March 2023 and Catalase reagent lot #61551 with an expiration date of 4/24 on 11 of 11 patients tested in April 2024. 3. An interview with TS #1 on August 14, 2024, at 3:14 PM with TS #1 confirmed the laboratory failed to ensure ATCC QC swabs and biochemical reagents oxidase and catalase were not used on patient urine cultures past their expiration dates from March 1, 2023, to August 14, 2024. D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, -- 2 of 3 -- as specified in this section. This STANDARD is not met as evidenced by: Based on a review of the blood bank's procedures and an interview with the technical supervisor (TS) #1, the laboratory failed to have a procedure for the method of collecting and identifying the blood samples of recipients to ensure positive identification, procedures to expedite transfusion in life-threatening emergencies, records to be maintained, including complete documentation justifying the emergency action, which shall be signed by a physician, and establish a policy for when testing for weak D must be performed from August 14, 2022, to August 14, 2024. Findings: 1. The laboratory failed to provide a procedure for the method of collecting and identifying the blood samples of recipients to ensure positive identification. 2. The laboratory failed to provide procedures to expedite transfusion in life-threatening emergencies, records to be maintained, including complete documentation justifying the emergency action, which shall be signed by a physician. 3. The laboratory failed to establish a policy for when testing for weak D must be performed. 4. An interview with TS #1 on August 14, 2024, at 2:45 PM confirmed the laboratory failed to have the above-listed procedures for blood bank from August 14, 2022, to August 14, 2024. -- 3 of 3 --

Summary Statement of Deficiencies D3021 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(1) Blood and blood products storage and distribution. If a facility stores or maintains blood or blood products for transfusion outside of a monitored refrigerator, the facility must ensure the storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product. This STANDARD is not met as evidenced by: Based on review of Immunohematology records, policy and procedure, and interview with Technical Supervisor (TS) #1, the laboratory failed to ensure the temperature is documented upon receipt of new shipments of blood and blood products and of returned blood and blood products not used for transfusion from March 18, 2021, to September 8, 2022. Findings: 1. Review of Vitalant's packing slips lacked documentation of temperatures for blood and blood products upon receipt of new shipments and the Blood Bank Worksheet lacked documentation of temperatures for unused blood or blood products returned to the laboratory. 2. Review "Donor Unit Disposition" policy lacked instruction for recording temperatures upon receipt or new shipments of blood or blood products or units returned to the laboratory. 3. Interview with TS #1 on September 8, 2022, at 10:38 AM, confirmed the laboratory failed to ensure the temperature is documented upon receipt of new shipments of blood and blood products and returned blood or blood products not used for transfusion. 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 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 -- 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 observation, record review, and interview with Technical Supervisor (TS) #1, the laboratory failed to perform quality checks (QC) for sterility and ability to support growth for each new lot or shipment for three of three medias from January 1, 2020, to August 8, 2022. Findings: 1. On August 8, 2022, media was observed in the laboratory refrigerator, including Blood agar (BAP), Colistin and Nalidixic Acid (CNA) and MacConkey Agar (MAC). 2. Review of the microbiology worksheet lacked documentation of media QC to support growth and sterility for BAP, CNA, and MAC media. 3. Review of procedures lacked an IQCP for alternative QC practices. 4. Interview with TS #1 on September 8, 2022, at 3:29 PM, confirmed these findings. D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of policy and procedures, records, and interview with Technical Supervisor (TS) #1, the laboratory failed to consistently document the required information including visual inspection checks for 12 out of 29 units of blood or blood products released for transfusion or returned for reissue from January 01, 2021, to August 24, 2022. Findings: 1. Review of "Donor Unit Disposition" policy revealed "With the nurse, complete the 'issue' portion of the Unit Disposition section of the Blood Bank Worksheet" and "The 'return' portion of the Unit Disposition section of the Blood Bank Worksheet must be completed." 2. Review of "Blood Bank Worksheet" lacked one or more of the required information for either units "Issued (Date/Time, visual inspection, issued to, issued by) " or "Returned (Date/Time, OK for Reissue By)" on the following dates: 01/01/2021, 07/08/2021, 08/09/2021,12/02 /2021, 04/17/2022, and 4/25/2022. 3. Interview with TS #1 on September 8, 2022, at 11:00 AM, confirmed these findings. -- 2 of 2 --

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 personnel files, Quality Assurance Plan policy, and communication with the general supervisor (GS)#1, the laboratory failed to perform annual competency assessments for the technical supervisor and testing personnel for years 2019 and 2020. Findings include: 1. Review of personnel files for 2019 and 2020 revealed the laboratory failed to perform annual competency for the technical supervisor and testing personnel. 2. Review of Quality Assurance Plan, Policy #018 states "Employee competency will be assessed at initial training, six months after hire, and yearly." 3. Interview with General Supervisor (GS) #1 on 3/17/2021 at 9:00 AM, confirmed the laboratory failed to perform annual competency assessment for 2019 and 2020. 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) 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 -- 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 D0000 Based on an on-site recertification survey conducted on 3/14/18-3/15/18, deficiencies were cited for Rosebud Health Care Center in Forsyth, MT. 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 record review and interview, the laboratory failed to enroll in proficiency testing for serum human chorionic gonadotropin (shCG) from 4/22/16 through 3/14 /18. The findings include: 1. A combination hCG kit was observed in the laboratory cupboard on 3/14/18 at 8:45 a.m. 2. On 3/14/18 at 8:45 a.m., staff member A stated both urine and serum samples were used on the kit. 3. A review on 3/14/18 at 11:00 a. m. of the American Proficiency Institute (API) documentation lacked shCG proficiency testing. 4. A review on 3/14/18 at 11:05 of the Rosebud Health Care Center test volume report included 32 shCGs performed annually. 5. On 3/14/18 at 11: 10 a.m., staff member A stated the laboratory had urine hCG enrollment but not serum hCG. 6. A review on 3/15/18 at 10:40 a.m. of the Rosebud Health Care Center API 2018 Order Confirmation lacked enrollment for shCG. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) 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 -- At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform accuracy verification on potassium hydroxide (KOH) from 4/22/16 through 3/14/18. The findings include: 1. A review on 3/14/18 at 11:00 a.m. of the American Proficiency Institute (API) documentation lacked KOH proficiency testing. Accuracy verification was not documented. 2. A review on 3/14/18 at 11:05 of the Rosebud Health Care Center test volume report included 22 KOHs performed annually. 3. On 3/14/18 at 11: 10 a.m., staff member A stated the laboratory did not have enrollment for KOH. 4. A review on 3/15/18 at 10:40 a.m. of the Rosebud Health Care Center API 2018 Order Confirmation lacked enrollment for KOH. 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 record review and interview, the laboratory failed to follow manufacturer directions for prostate specific antigen (PSA) from 4/22/16 through 3/14/18. The findings include: 1. A review on 3/14/18 at 2:20 p.m. of a PSA test report lacked the identity of the PSA assay used. 2. A review on 3/14/18 at 2:20 of the Siemens Dimension PSA manufacturer instructions stated the "results reported by the laboratory to the physician must include the identity of the PSA assay used." 3. On 3 /14/18 at 2:20 p.m., staff member A stated the identity was not on the report. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (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 quality control (QC) every day of patient testing for three of twenty days reviewed for prostate specific antigen. The findings include: 1. A review on 3/14/18 at 11:05 a.m. of the Rosebud Health Care Center test volume report included 141 PSAs performed annually. 2. A review on 3/15/18 at 9:00 a.m. of the days with a patient PSA result included twenty days of patient results between 4/1/17 and 6/30/17. 3. A review on 3 /15/18 at 9:08 a.m., of the PSA QC files lacked QC results for three of the twenty days with patient results. a. 4/21/17. b. 4/25/17. c. 4/28/17. 4. On 3/15/18 at 9:08 a.m., -- 2 of 3 -- staff member A stated the analyzer prompts for QC to be performed every 24 hours. 5. A review on 3/15/18 at 9:15 a.m. of the Rosebud Health Care Center Quality Control Policy states "two levels of Bio-Rad Immunoassay Control will be run each 24 hours the instrument is used for patient testing." 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 record review and interview, the laboratory failed to perform positive and negative reactivity for eight reagents in microbiology identification systems for one of one lot reviewed. The findings include: 1. A review on 3/15/18 at 10:15 a.m. of the Microscan Biochemical Quality Control Report Form included eight reactions without both positive and negative reactivity documented. a. Gram negative ID panel (NBPC34 panel, lot number B1017-404, received 2/14/18). 1. Urea lacks a documented positive reaction. 2. Oxidase lacks a documented positive reaction. 3. Tartrate lacks a documented positive reaction. 4. Tobramycin lacks a documented positive reaction. b. Gram positive ID panel (PBPC20 panel, lot number B1017-206, received 2/14/18). 1. Novobiocin lacks a documented positive reaction. 2. PGR glycosidase lacks a documented positive reaction. 3. ARA carbohydrate lacks a documented positive reaction. 4. Hemolysis lacks a documented negative reaction. 2. On 3/15/18 at 10:15 a.m., staff member A stated these reactions were missing. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform annual competency assessments on two of three testing personnel from 4/22/16 through 3/14 /18. The findings include: 1. A review on 3/14/18 at 12:20 p.m. of annual competency assessments were missing for 2016 for staff member A and B. A 2017 competency assessment was missing for staff member A. 2. On 3/14/18 at 12:20 p.m., staff member A stated the competency evaluations were not in the file. -- 3 of 3 --