Mobridge Regional Hospital

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 11/6/24. Mobridge Regional Hospital laboratory was found not in compliance with the following requirements: D6125 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. 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 five of five testing personnel (A, B, C, D and E) in 2024. Assessment of blind testing and/or external proficiency testing (PT) helps ensure competency of staff reporting patient test results. Findings include: 1.Review on 11/6 /24 at 12:00 p.m. of the laboratory staff's annual competency assessment records revealed: *Technical supervisor A's annual competency evaluation had been completed on 2/5/24. -No blind sample testing or PT events had been documented for the departments of immunohematology, microbiology, hematology and coagulation. - Technical supervisor A had performed testing in immunohematology, microbiology, hematology and coagulation. *Technical supervisor B's annual competency evaluation had been completed on 2/20/24. -No blind sample testing or PT events had been documented for urinalysis. -Technical supervisor B had performed urinalysis testing. *Testing personnel C's annual competency evaluation had been completed on 2/6/24. - No blind sample testing or PT events had been documented for urinalysis. -Testing personnel C had performed urinalysis testing. *Testing personnel D's annual competency evaluation had been completed on 2/15/24. -No blind sample testing or PT events had been documented for coagulation. -Testing personnel D had performed 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 -- coagulation testing. *Testing personnel E's annual competency evaluation had been completed on 2/25/24. -No blind sample testing or PT events had been documented for the departments of immunohematology, chemistry, urinalysis and hematology. - Testing personnel E had performed testing in immunohematology, chemistry, urinalysis and hematology. Review on 11/6/24 of the competency assessment policy last revised 11/24 revealed: *The following six procedures were required for assessment of competency for all personnel performing laboratory testing: -Direct observation of routine patient test performance. -Monitor the recording and reporting of test results. -Review of intermediate test results or worksheets, quality control records, PT testing and preventative maintenance records. -Direct observation of instrument maintenance and function checks. -Assessment of test performance through testing of previously analyzed specimens, internal blind testing, or external proficiency testing. -Assessment of problem-solving skills. Interview on 11/6/24 at 1: 00 with technical supervisor B revealed: *She confirmed she had completed the 2024 annual competency assessments for testing personnel C, D, E and technical supervisor A. *She confirmed testing personnel A, B, C, D and E all had processed patient specimens on all testing areas within the laboratory. *PT events were rotated between staff. There were only two to three PT events each year and staff complete each PT event every other year. *She had not been aware that blind testing or external PT testing was required for competency assessment in all areas within the laboratory annually. Interview on 11/6/24 at 2:00 with technical supervisor A revealed: *She confirmed she had completed the 2024 annual competency assessment for technical supervisor B. *She confirmed annual competency assessments had not included blind testing or external proficiency for all areas in the lab. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 2/8/23. Mobridge Regional Hospital was found not in compliance with the following requirements: D2007, D2009, D2015, D5209, D5449, D6107, and D6120. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to ensure all testing personnel routinely testing patient samples participated in proficiency testing (PT) during 18 of 18 months (8/21 through 1/23) reviewed. Performance of PT verifies laboratory staff were competent to correctly process patient specimens to ensure the accuracy of the patient specimen results reported. Findings include: 1. Review of the American Proficiency Institute PT attestation statements for 2021 and 2022 revealed respiratory therapist D had not performed blood gas PT during that time. Review of the laboratory's Quality Assurance Plan revealed, "Each employee who performs lab testing will complete proficiency testing events according to the P.T. [proficiency testing] schedule and will participate in an annual competency evaluation." Review of the CMS 209 Laboratory Personnel Form revealed respiratory therapist D had been listed as testing personnel. Review of the laboratory's test count form revealed a total of 124 blood gas specimens during 2022. Interview on 2/8/23 at 1:10 p.m. with laboratory supervisor A revealed she confirmed respiratory therapist D processed arterial blood gas specimens and had not participated in PT in the past. D2009 TESTING OF 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 6 -- 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 record review and interview, the laboratory failed to ensure the the attestation statements had been signed by authorized personnel for 10 of 44 proficiency testing (PT) events reviewed (2022 1st, 2nd, and 3rd Immunology /Immunohematology events; 2022 HPS-A and B H. pylori stool antigen events; 2022 COVS-B SARS CoV-2 Serology event; 2022 S-B Diagnostic Immunology event; 2022 Chemistry Miscellaneous 2nd event; 2022 Hematology/Coagulation 3rd event; and 2022 J-C Transfusion Medicine event). The attestation statements confirmed the PT samples had been tested in the same manner as patient specimens. Findings include: 1. Review on 2/8/23 of the 2021 and 2022 completed American Proficiency Institute (API) and College of American Pathologists (CAP) PT events revealed: a. The following testing event attestation statements lacked the laboratory director or the designee's signature on the attestation statement: -2022 API Immunology /Immunohematology 1st testing event -2022 API Immunology/Immunohematology 2nd testing event -2022 API Immunology/Immunohematology 3rd testing event -2022 API Hematology/Coagulation 3rd testing event b. The following testing event attestation statements had been signed by laboratory personnel B, who had not been authorized to sign as the laboratory director's designee: -2022 CAP HPS-A H. pylori stool antigen testing event -2022 CAP HPS-B H. pylori stool antigen testing event -2022 CAP COVS-B SARS CoV-2 Serology testing event -2022 CAP S-B Diagnostic Immunology testing event -2022 API Chemistry Miscellaneous 2nd event c. The following testing event attestation statement had been signed by laboratory supervisor A, who had not been authorized to sign as the laboratory director's designee for the specialty of immunohematology. -2022 CAP J-C Transfusion Medicine testing event d. The following testing event attestation statement had not been signed by the testing personnel who processed the PT samples: *2022 API Immunology /Immunohematology 1st testing event On 2/8/23 at 12:45, a copy of the laboratory's PT policy had been requested from laboratory supervisor A. No policy was provided during the survey. Interview on 2/8/23 at 12:45 p.m. with laboratory supervisor A revealed she confirmed: *The attestation statements had not been signed by the laboratory director or their designee. *Laboratory personnel B had not had written designation from the laboratory director to sign the PT attestation statements as his designee. *She had been designated, in writing, by the laboratory director to sign the attestation statements for all PT events, except for the specialty of immunohematology. *Only the laboratory director was designated to sign the PT event attestation statements for the specialty of immunohematology. 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 -- 2 of 6 -- 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 record review and interview, the laboratory failed to maintain a copy of required documentation related to the processing of 9 of 44 proficiency testing (PT) events reviewed (2021 Chemistry Miscellaneous 2nd event; 2021 Microbiology 2nd and 3rd events; 2021 Hematology/Coagulation 3rd event; 2022 Chemistry Miscellaneous 1st event; 2022 Chemistry Core 1st event; 2022 Microbiology 2nd event, 2022 CGL-B 2nd event; and 2022 FH9-B 2nd event). That documentation would ensure the results submitted for evaluation had been the results obtained by the laboratory processing the PT samples. Findings Include: 1. Review on 2/8/23 of the laboratory's 2021 and 2022 American Proficiency Institute (API) and College of American Pathologists (CAP) PT event records revealed: *The laboratory subscribed to PT events through API and CAP. *PT specimens were processed and the results submitted electronically via the company's website upon completion of testing. *The laboratory had the ability to print a copy of the final PT results submitted for evaluation. *The laboratory had not retained copies of final electronically submitted results for evaluation for the following events: -2021 API Chemistry Miscellaneous 2nd testing event -2021 API Hematology/Coagulation 3rd testing event -2021 API Microbiology 3rd testing event -2022 API Chemistry Miscellaneous 1st testing event -2022 API Chemistry Core 1st testing event -2022 CAP FH9-B Hematology Automated Differential Series 2nd testing event *The laboratory had the ability to print a copy of the completed results from the analyzer. *The laboratory had not retained copies of analyzer printouts documenting the results obtained from processing the PT samples for the following events: -2021 API Microbiology 2nd testing event -2022 API Microbiology 2nd testing event -2022 CAP CGL-B Coagulation Limited 2nd testing event On 2/8/23 a copy of the laboratory's PT policy had been requested from laboratory supervisor A. No policy was received during the survey. Interview on 2/8/23 at 12:45 p.m. with laboratory supervisor A revealed she confirmed: *PT results were electronically reported after PT samples had been processed. *The laboratory could print a copy of all final PT results submitted for evaluation. *The laboratory had not printed copies of all final submitted PT results. *The analyzer printouts had not been retained for all PT performed. *Analyzer printouts were routinely shredded after results were entered into the laboratory information system. 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 assess the competency of the technical consultant (C) for 18 of 18 months (8/21 through 1/23) reviewed. Competency assessments ensured the laboratory personnel were competent and had completed the assigned duties. Findings include: 1. Review of the laboratory's CMS -- 3 of 6 -- 209 Laboratory Personnel Form revealed technical consultant C was listed as a technical consultant for the laboratory. Review of the technical consultant reports revealed that technical consultant C visited the laboratory on the dates of 11/2/21, 5/2 /22, 9/8/22 and 11/2/22. Review of the laboratory Quality Assurance Plan revealed that competency assessments were to have been completed yearly on all laboratory personnel. A copy of the laboratories competency assessment policy was requested on 2/8/23 at 12:30 p.m. from laboratory supervisor A. The laboratory staff was unable to provide a copy of the policy. Interview on 2/8/23 at 1:00 p.m. with laboratory supervisor A revealed: *She confirmed a competency assessment for technical consultant C was not completed in 2021 or 2022. *She was unaware that competency assessments were required for the technical consultant. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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 qualitative procedure, include a negative and positive control material; (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 a positive and negative control to verify the accuracy of specimen test results for 11 of 31 days reviewed (1/7/23, 1/8/23, 1/9/23, 1/11/23, 1/12/23, 1/13/23, 1/21/21, 1/22/23, 1/24/23, 1/28/23, and 1/29/23). Performance of quality control (QC) ensures the accuracy of patient specimen results reported. Findings include: 1. Review of the laboratory's records revealed: *The laboratory had begun testing of patient SARS CoV-2, Influenza A, Influenza B, and Respiratory Syncytial Virus (RSV) panel specimens using the Cepheid GeneXpert analyzer on 4/7/21. *External positive and negative QC samples had been processed monthly and with each change of lot number or new shipment. *The laboratory did not have an individual quality control plan (IQCP) in effect which would have allowed the laboratory to process QC at the minimum number and frequency required by the manufacturer. Review of the laboratory's January 2023 Cepheid GeneXpert analyzer records revealed: *QC samples had been processed on 1/3/23. *QC results had not been documented on the 11 dates listed above. *Patient specimen testing had been reported to the provider on these days without QC having been performed to ensure the accuracy of the test results. Review of the laboratory's annual test volume form revealed the laboratory had reported a total of 286 patient specimen SARS CoV-2, Influenza A, Influenza B, and RSV panel results in 2022. Interview with technical supervisor A on 2/8/23 at 12:45 p.m. revealed she confirmed: *QC had not been performed on the dates listed above. *The laboratory had performed QC monthly and with each new lot or shipment. *The laboratory had not had an established IQCP signed by the laboratory director. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether -- 4 of 6 -- supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory director failed to specify in writing the duties delegated to one of one laboratory personnel (B), including the duty of signing proficiency testing (PT) attestation statements as the designee. Findings Include: 1. Review of the 2022 American Proficiency Institute (API) and the College of American Pathologists (CAP) PT testing event signed attestation statements revealed the following attestation forms had been signed by laboratory personnel B: *2022 CAP HPS-A H. pylori stool antigen testing event *2022 CAP HPS-B H. pylori stool antigen testing event *2022 CAP COVS-B SARS CoV-2 Serology testing event *2022 CAP S-B Diagnostic Immunology testing event On 2/8/23 the surveyor requested a copy from laboratory supervisor A of the laboratory director's designation of duties for laboratory personnel B that would have authorized her to sign the PT attestation forms as the laboratory director's designee. No documentation was provided during the survey. Interview on 2/8/23 at 12:45 p.m. with laboratory supervisor A revealed she confirmed the laboratory did not have a written delegation of duties signed by the laboratory director that designated laboratory personnel B to sign the attestation statements as the designee. The laboratory director was unavailable for interview at the time of the survey. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on record review and interview, laboratory supervisor A failed to ensure that one of six laboratory personnel (respiratory therapist D) had received a competency evaluation in 2022 for the test methods they had performed under the laboratory's certificate. Competency assessment verifies testing personnel were competent to correctly process patient specimens and to ensure the accuracy of the patient specimen results reported. Findings include: 1. Review on 2/8/23 at 12:50 p.m. of the employee competency records revealed: *Respiratory therapist D did not have a competency evaluation documented in 2022. *A request was made to laboratory supervisor A for any additional documentation of the competency assessments. *No additional documentation was provided during the survey. Review of the CMS 209 Laboratory Personnel Form revealed respiratory therapist D had been listed as testing personnel. Review of the laboratories Quality Assurance Plan revealed, "IV. Personnel Competency ... Indicators: Each laboratory employee who performs lab testing will complete proficiency testing events according to the P.T. [proficiency testing] schedule and will participate in an annual competency evaluation. Monitor: The laboratory supervisor will review the results of the P.T for each employee and will conduct annual competency evaluations in the first quarter of the new year." Review -- 5 of 6 -- of the laboratory's annual testing count form revealed the laboratory had reported a total of 124 blood gas patient specimens in 2022. Interview on 2/8/23 at 1:00 p.m. with technical supervisor A revealed she confirmed: *Respiratory therapist D had performed arterial blood gas testing in 2022. *She was aware a yearly competency had been required but had not completed one in 2022. -- 6 of 6 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 7/12/21. The Mobridge Regional Hospital laboratory was found not in compliance with the following requirements: D2015, D5435, and D5471. 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 record review, and interview, the laboratory failed to maintain a copy of the submitted results for sixty-four of sixty-four proficiency testing (PT) events reviewed (2019 and 2020). These reports documented the results submitted by the laboratory for evaluation by the PT company. Findings include: 1. Review of the laboratory's PT event records on 7/12/2021 revealed: *The laboratory subscribed to PT events through the American Proficiency Testing Institute and the College of American Pathologists. *PT specimens were processed and the results submitted via the company's website upon completion of testing. *The laboratory had completed and received evaluation reports for the following testing events: a. 2019 API PT events -Immunology /Immunohematology- testing events 1, 2, and 3. -Hematology/Coagulation- testing 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 -- events 1, 2 and 3. -Microbiology- testing events 1, 2, and 3. -Chemistry Core- testing events 1, 2, and 3. -Chemistry Miscellaneous- testing events 1 and 2 b. 2019 CAP PT events -UDS 6 Urine Drug Screen Testing, Limited- testing events A and B. -ALC 2 AACC Alcohols/Volatiles- testing events A and B -NB 2 Neonatal Bilirubin, 2 Challenges- testing events A and B -HPS H. pylori Antigen, Stool -J Transfusion Medicine (Comprehensive)- testing events A, B, and C -CM Clinical Microscopy- Testing events A and B -FH 9 Hematology Automated Differentials- testing events A, B, and C -CGL Coagulation, Limited- testing events A, B, and C c. 2020 API PT events -Immunology/Immunohematology- testing events 1, 2, and 3. -Hematology /Coagulation- testing events 1, 2 and 3. -Microbiology- testing events 1, 2, and 3. - Chemistry Core- testing events 1, 2, and 3. d. 2020 CAP PT events -UDS 6 Urine Drug Screen Testing, Limited- testing events A and B. -ALC 2 AACC Alcohols /Volatiles- testing events A and B -NB 2 Neonatal Bilirubin, 2 Challenges- testing events A and B -HPS H. pylori Antigen, Stool -J Transfusion Medicine (Comprehensive)- testing events A, B, and C -CM Clinical Microscopy- Testing events A and B -FH 9 Hematology Automated Differentials- testing events A, B, and C -K 2 Ligand, Limited- testing events A and B -CGL Coagulation, Limited- testing events A, B, and C Interview on 7/12/21 at 2:45 p.m. with the laboratory manager revealed: *She confirmed the laboratory had not kept the submitted result forms for the PT events they had completed. *She printed the submitted result forms for API testing events only. *She discarded the submitted result forms once the PT evaluation forms had been reviewed. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on observation, interview, and record review the laboratory failed to retain the results of the daily background checks on the Sysmex XS-1000i analyzer for eleven of twelve months (7/12/19 through 6/17/20) to ensure critical operating characteristics that affected the stability of the analyzer met specific criteria defined by the manufacturer. Findings include: 1. Observation on 7/12/21 at 2:55 p.m. of the Sysmex XS-1000i hematology analyzer's electronic files revealed: *The laboratory manager was able to pull up a record of the analyzer's electronic files. *The oldest retained daily background check was dated 6/18/20. * Daily background counts prior to 6/18 /20 were unavailable. *There was no way to verify if the background counts prior to 6 /18/20 had been acceptable. *Increased background counts could lead to inaccurate patient specimen test results. Review of the annual test volume form revealed 7,321 hematology patient test specimens had been reported in 2020. Interview with the laboratory manager on 7/12/212 at 2:55 p.m. revealed: *She stated the XS-1000i was installed in 2014. *She verified daily background counts had not been printed out or -- 2 of 3 -- maintained. *She believed the Sysmex XS-1000i hematology analyzer's memory was sufficient to maintain the required 2 years of background counts. *She confirmed no other log or spreadsheet was available to document the daily background test results. 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 observation, record review and interview, the laboratory failed to verify each lot number or shipment of the potassium hydroxide (KOH) reagent for its positive reactivity to ensure accurate results prior to testing patient specimens for thirty-five of thirty-five months (7/24/18 through 7/13/21). Findings include: 1. Observation on 7/13/21 at 3:15 p.m. revealed a bottle of KOH reagent (lot number 937457, expiration date 8/12/21) was available for use on patient specimens. The bottle of KOH reagent was less than one quarter full. There was no documentation as to whether or not the missing reagent had been used on patient specimens or discarded. Review of available records revealed KOH quality control (QC) had not been documented in 2018 or to date in 2021 for any lot number or different shipments of the same lot number. Review of the annual testing volume survey form indicated approximately seventy-two KOH patient tests had been performed during 2020 without reagent QC to ensure accurate patient test results. Interview at the above time with the laboratory manager revealed: *She confirmed QC had not been performed on the current bottle of KOH reagent before use on patient samples. *She confirmed the laboratory had not performed QC on the KOH reagent as long as she had worked there. She had worked there for approximately twenty-one years. -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on proficiency testing (PT) record review and interview with the laboratory supervisor, the laboratory failed to achieve successful particpation for the human chorionic gonadotropin (HCG) test method. Unsatisfactory results had been received in two of three PT events (2018 Chemistry-Core-2nd and 3rd events) resulting in unsuccessful PT participation. Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the CASPER Reports 153D and 155D and interview with the laboratory supervisor, the laboratory failed to achieve satisfactory proficiency testing (PT) performance for the human chorionic gonadotropin (HCG) test method in two out of three events (2018 Chemistry Core second and third events) resulting in unsuccessful performance. Findings include: 1. Review of the laboratory's CASPER Reports 153D and 155D revealed the American Proficiency Institute (API) PT scores were less than the 80% required to pass the HCG test per CLIA requirements found at CFR 493.861(a): a. API Chemistry Core 2018 second event HCG score = 60% (HCG- 07 and HCG-08 were graded as unacceptable). b. API Chemistry Core 2018 third event HCG score = 60% (HCG-13 and HCG-14 were graded as unacceptable). 2. Interview with the laboratory supervisor on 11/01/18 at 8:30 am confirmed the failure. She stated the laboratory had reviewed the data for the two surveys and found no clerical errors, quality control and calibration were accetable. The laboratory retested the missed samples and results fell within the acceptable range. The laboratory has ordered a self evaluation study and an off cycle survey to assist with the investigation of the unacceptable PT results. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted from 7/23/18 through 7/24/18. The Mobridge Regional Hospital laboratory was found not in compliance with the following requirements: D2009, D5775, D6127, D6128. 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 proficiency testing (PT) events and interview with testing personnel A, the laboratory failed to ensure the director had signed 6 of 26 forms (American Proficiency Institutue [API] 2017 immunology/immunohematology first event, chemistry miscellaneous first event, chemistry second event, and hematology /coagulation third event, and College of American Pathologists [CAP] S-C-2017 diagnostic immunology third event and 2018 CAP J-A-2018 immunohematology first event PT events) that attested PT samples had been tested in the same manner as patient specimens. Findings include: 1. Review of PT events for 2017 and 2018 revealed the six attestation statements above had not been signed by the laboratory director or designee. Interview on 7/24/18 at 9:30 a.m. with testing personnel A revealed she was designated to sign the attestation statements for all PT testing with the exception of immunohematology that was signed by the lab director. She was unaware the PT forms had not been signed. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) 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 -- (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on quality assessment (QA) activities review and interview with testing personnel A, the laboratory failed to monitor the differences between three of three tests performed by multiple methodologies or instruments (human chorionic gonadotropin [hCG] qualitative versus quantitative, white blood cell differential manual versus automated, and complete blood counts [CBC] performed on the Sysmex XS-100i versus Sysmex 300). Those methods or instruments had not been evaluated twice a year in 2017 to determine if their differences had been acceptable. Findings include: 1. Review of the laboratory's 2017 twice yearly comparison reports revealed comparison testing had been completed only once for hCG qualitative versus (vs.) quantitative (7/16/17) and once for white blood cell differential manual vs. automated. No comparison testing had been performed for CBCs performed on the Sysmex XS-100i vs. Sysmex 300 during 2017. Review of the laboratory's 2017 quarterly QA activity reports revealed "all comparisons complete and acceptable." Interview on 7/24/18 at 11:40 a.m. with testing personnel A revealed the lab had not performed the twice a year comparisons between methods or instruments. The technologist who normally performed the comparisons was out sick most of 2017. D6127 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of personnel files and interview with laboratory personnel A, the technical supervisor failed to evaluate the competency testing personnel B for their level of competency in performing testing done on patient specimens. Findings include: 1. Review of testing personnel B's personnel file revealed he had completed his orientation in 2016. He had a had a competency assessment performed 1/12/17. He had not have a second competency assessment until 3/19/18. Interview at 5:00 p.m. on 7/23/18 with laboratory personnel A revealed the laboratory did not have a competency assessment policy. She was unaware two competency assessments were required in the first year. She believed only a single evaluation was needed on a yearly basis. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of personnel files, annual test volume form, and interview with laboratory personnel A, the technical supervisor failed to evaluate the competency of testing personnel C for their level of competency in performing testing done on 132 patient specimens performed in 2017. Findings include: 1. Review of testing personnel C personnel file revealed she had not had a competency assessment performed in 2017. Testing personnel C performs only blood gas testing. Review of the annual testing form revealed 132 patient blood gas specimens had been reported during 2017. Interview at 8:05 a.m. on 7/24/18 with laboratory personnel A revealed she was unaware yearly competency assessments were required for testing personnel C. -- 3 of 3 --