Sidney Health Center

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 a record review of testing personnel files, the CMS-209 Laboratory Personnel Report, procedure, and an interview with the general supervisor (GS) #1, the laboratory lacked annual competency for seven out of 28 testing personnel (TP) and failed to perform five of the six required procedures for 19 out of 28 testing personnel (TP) per their competency assessment form from December 16, 2022, to December 17, 2024. Findings: 1. A review of seven testing personnel files listed on the CMS 209 form (TP-4, TP-10, TP-22, TP-24, TP-25, TP-26, and TP-27) lacked annual competency assessments for years 2023 and 2024. 2. A review of testing personnel (TP) annual competency forms and procedures revealed the laboratory failed to perform "direct observations of test performance, monitoring test results recording and reporting, review of worksheets, quality control (QC), proficiency testing (PT) and maintenance records, direct observation of instrument maintenance, and assessment of test performance (PT/blind samples) records" for 19 testing personnel (TP10-TP28) for the AmniSure Rupture of [fetal] Membranes (ROM) for years 2023 and 2024. 3. An interview on December 17, 2024, at 8:45 a.m. with GS #1 confirmed the laboratory failed to complete five of the six required procedures as part of their competency assessment forms for 19 out of 28 testing personnel and lacked annual competency on seven testing personnel from December 16, 2022, to December 17, 2024. 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 4 -- 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 a review of proficiency testing records from the American Proficiency Institute (API), biannual verification records, the test volume report, and an interview with general supervisor (GS) #1, the laboratory failed to perform two out of two biannual verifications for ammonia and haptoglobin for the year 2024. Findings: 1. A review of the Test Volume Report revealed 84 ammonia and 174 haptoglobin patient tests were performed from November 30, 2023 to November 30, 2024 (12 months). 2. A review of API records and biannual verification records lacked biannual verification of ammonia and haptoglobin in 2024. 3. Interview on December 17, 2024, at 4:23 p.m. with the GS #1 confirmed the laboratory failed to perform biannual verification of ammonia and haptoglobin in 2024. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Repeat Deficiency from August 24, 2021 Based on a record review, procedure, and interview with the technical supervisor (TS) #1, the pathology laboratory failed to document reagent lot numbers, expiration dates, and dates in use from January 1, 2023, to December 17, 2024. Findings: 1. A review of the frozen section policy /procedure listed the following reagents: Scott's tap water, bluing reagent solution, eosin Y stain, alcoholic formalin solution, formaldehyde, hematoxylin, glacial acid, alcohol, and xylene. 2. A review of pathology records lacked documentation of reagent tracking of lot numbers, expiration dates, and dates in use. 3. An interview on December 16, 2024, at 8:35 AM with TS #1 confirmed reagent lot numbers, expiration dates, and dates in use were not documented from January 1, 2023, to December 17, 2024. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of pathology records, procedures, and an interview with the technical supervisor (TS #1), the pathology laboratory failed to check and document -- 2 of 4 -- the intended staining characteristics for each day Hematoxylin and Eosin (H&E) stain was used from December 16, 2022, to December 17, 2024. Findings: 1. A review of pathology records revealed the laboratory failed to check and document the intended staining characteristics for each day H&E stain was used on 2/21/24, 3/7/24, 3/21/24, 4 /15/24, 6/3/24, 6/26/24, 7/10/24, and 8/22/24. 2. The Frozen Section Policy/Procedure lacked the criteria for acceptable H&E staining characteristics and how to document the quality control checks onsite and remotely for each day H&E stain was used. 3. An interview on December 17, 2024, at 8:40 a.m. with TS #1 confirmed that the laboratory failed to check and document the intended staining characteristics for each day H&E stain was used from December 16, 2022, to December 17, 2024. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on a record review, the CMS-209 Laboratory Personnel Report (CLIA) form, personnel files, procedures, and an interview with the technical supervisor (TS) #1 and pathology staff #1 (not listed on the CMS-209 form), the laboratory failed to ensure testing personnel were qualified prior to performing high-complexity gross examination on patient specimens. (Refer to D6171). D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved -- 3 of 4 -- by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on a record review, the CMS-209 Laboratory Personnel Report (CLIA) form, personnel files, procedures, and an interview with the technical supervisor (TS) #1 and pathology staff #1 (not listed on the CMS-209 form), the laboratory failed to ensure two out of two pathology staff had the appropriate educational background prior to performing high complexity gross examination from December 16, 2022, to December 17, 2024. Findings: 1. An interview with pathology staff #2 (1 of 2) (not listed on the CMS-209 form) on December 17, 2024, at 8:10 a.m. confirmed grossing notes documented on the patient "Pathology Remote Frozen Section Form" were performed by the two onsite pathology staff members. 2. A review of the "Frozen Section Policy/Procedure" revealed onsite pathology staff were to weigh, measure, orient, ink, and section surgical specimens and document notes of gross examination. 3. No records of an associate degree or higher in a chemical, physical, biological science, or medical laboratory technology prior to performing high complexity testing were available for the two pathology staff (not listed on the CMS-209 form). 4. A review of nine out of nine patients ' Pathology Remote Frozen Section forms revealed gross examination was performed on 2/21/24, 3/7/24, 3/21/24, 4/15/24, 6/3/24, 6/26 /24, 7/10/24, and 8/22/24 by unqualified testing personnel. 4. An interview with technical supervisor #1 on December 17, 2024, at 8:50 a.m. confirmed that the two onsite pathology staff were not qualified to perform high-complexity testing but were overseen remotely during the gross examination by the remote pathologist from December 16, 2022, to December 17, 2024. -- 4 of 4 --

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records from the Wisconsin State Laboratory of Hygiene (WSLH) and the College of American Pathologists (CAP) and an interview with Technical Supervisor (TS) #1, the laboratory failed to review proficiency testing results not evaluated or scored by the vendor from April 12, 2021, to April 12, 2023. Findings: 1. A review of WSLH 2021 PT results revealed the laboratory failed to evaluate the results not scored by the provider for the following: 2021 Cardiac 3 (NB-11 - NB-15); 2021 Special Chemistry 2 (CS-4 - CS-6) and (SF-4 - SF-6) 2. A review of CAP 2022 PT results revealed the laboratory failed to evaluate the results not scored by the provider for the following: 2022 Hemocytometer Fluid Count HFC-A (HFC-01 - HFC-03); 2022 Crystals CRS-B (BFC-03, BFC-04) and 2022 Bacteriology D-C (D15, D-19). 3. No documentation for WSLH 2021 Coag2, HemReg 2 proficiency was available for review. 4. An interview with TS #1 on April 12, 2023, at 3:43 PM confirmed the laboratory failed to have a mechanism to review PT results not evaluated or scored by the vendor from April 12, 2021, to April 12, 2023. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic 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 -- systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: REPEAT CONDITION CITE Based on a review of chemistry, hematology, and immunohematology records and procedures, the laboratory failed to verify new lots of reagents for Activated Partial Thrombin Time (aPTT) normal reference range (Refer to D5421); failed to provide documentation of tHb calibration every three months and perform calibration verification every six months (Refer to D5535); failed to follow their procedure to perform daily visual inspection checks of blood units during storage (Refer to D5553); failed to perform and document alarm inspection checks at the frequency required by their procedure (Refer to D5555); and failed to perform instrument comparison REPEAT DEFICIENCY CITE (Refer to D5775). D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of coagulation records, procedures and interview with Technical Supervisor (TS) #2, the laboratory failed to verify the Activated Partial Thrombin Time (aPTT) normal reference range for the new lots of reagents performed on the Sysmex CA-500 series from April 12, 2021 to April 12, 2023. Findings: 1. A review of "HEM.21 Coagulation Studies" revealed the laboratory failed to follow their procedures and verify new lots of reagents for aPTT as stated, "Yearly Procedures (PT, INR, and PTT): Once a year SHC Lab does a roll over to a new lot of reagents & controls." 2. No rollover studies containing a calculated geometric mean, standard deviation and refence range check for aPTT were available for review. 3. A review of the test volume sheet revealed 333 aPTT tests were performed from January 1, 2022 to December 31, 2022. 4. Interview with the TS #2 on April 12, 2023, at 3:43 PM, confirmed the laboratory failed to verify new lots of reagents for aPTT per laboratory procedure from April 12, 2021 to April 12, 2023. D5535 ROUTINE CHEMISTRY CFR(s): 493.1267(a)(d) For blood gas analyses, the laboratory must perform the following: (a) Calibrate or verify calibration according to the manufacturer's specifications and with at least the frequency recommended by the manufacturer. (d) Document all control procedures performed, as specified in this section. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on a review of blood gas calibration records, Individualized Quality Control Plan (IQCP), and an interview with Technical Supervisor (TS) #2, the laboratory failed to provide documentation of tHb calibration every three months and perform at least a three-point (a minimal, mid-point, and maximum) calibration verification every six months from April 12, 2021 to April 12, 2023. Findings: 1. A review of patient results report #22SD296C0023 resulted on 10/23/2022 revealed results for Blood Gas Arterial for analytes pH, carbon dioxide partial pressure (pCO2), oxygen partial pressure (pO2), hydrogencarbonate ion (HCO3), Base Excess, and hemoglobin oxygen saturation (O2 SAT). 2. A review of the IQCP lacked instructions to perform calibration verification every six months and revealed the laboratory failed to follow their procedures and perform tHb calibration every three months. 3. A review of calibration verification records lacked one of two studies for the years 2021 and 2022 4. No records of tHb calibrations were available for review at the time of the survey. 5. A review of the test volume sheet revealed 267 patient tests performed for analytes pH, pCO2, pO2, HCO3, Base Excess, and O2 SAT from January 1, 2022, to December 31, 2022 6. Interview with the TS #2 on April 12, 2023, at 3:00 PM, confirmed the laboratory failed perform at least a three-point calibration verification on the OPTI CCA-TS Blood Gas Analyzer every six months and couldn't locate the records for tHb calibrations from April 12, 2021 to April 12, 2023. 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 procedures, records, and interview with Technical Supervisor (TS) #1, the laboratory failed to follow their procedure to perform daily visual inspection checks of blood units during storage from January 01, 2022 to December 31, 2022. Findings: 1. A review of blood bank records lacked daily visual inspection of blood units during storage for 25 days out of 365 for 2022. 2. A review of " Blood Bank Duties" procedure revealed the laboratory failed to document and perform visual inspections as stated, "4. Visually check inventory of units daily for quantity and quality." 3. An interview with TS #1 on April 12, 2023, at 2:30 PM, confirmed the laboratory failed to perform daily visual inspection of stored blood units from January 01, 2022 to December 31, 2022. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. -- 3 of 5 -- This STANDARD is not met as evidenced by: Based on review of procedures, records of blood bank alarm checks, and interview with the Technical Supervisor (TS) #1, the laboratory failed to follow their procedure to perform and document alarm checks every other month for one of one blood bank refrigerator and freezer from April 12, 2021 to April 12, 2023. Findings: 1. A review of Verifying Blood Bank Alarms Performance procedure revealed the laboratory failed to perform alarm tests as stated, "Complete an Alarm Test every other month." 2. A review of the alarm check logs revealed that the laboratory failed to perform alarm checks for the month of September 2021 and the months of September and November 2022. 3. An interview with TS #1 on April 12, 2023, at 2:30 PM. confirmed the laboratory failed to perform alarm checks at the frequency dictated by their procedure from April 12, 2021 to April 12, 2023. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (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: REPEAT DEFICIENCY CITE Based on record review of instrument comparison documentation, procedure, and interview with Technical Supervisor (TS) #1, the laboratory failed to perform instrument comparison between the Ortho Vison and Ortho Workstation, the Sysmex XN-2000 Hematology System two analytical modules, and the two Siemens Dimension EXL chemistry instruments for overlapping analytes every six months from January 01, 2022, to April 12, of 2023. Findings: 1. Review of laboratory instrument comparison documentation lacked a second comparison studies for the year 2022 and one for the year 2023 between the Ortho Vison and Ortho Workstation, the Sysmex XN-2000 Hematology System two analytical modules, and the two Siemens Dimension EXL chemistry instruments for overlapping analytes. 2. Review of Lab-Hem-063 revealed the laboratory staff failed to follow their procedure as stated, "Twice per year, perform and evaluate a patient or proficiency sample(s) on each side of the XN-2000 to verify the two sides (instruments) results are performing equivalently." 3. Interview with TS #1 on April 12, 2023, at 4:30 PM, confirmed the laboratory failed to perform instrument comparison to evaluate and define the relationship between test results using different methodologies or instruments every six months from January 01, 2022, to April 12, of 2023 D6101 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(11) The laboratory director must employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart. -- 4 of 5 -- This STANDARD is not met as evidenced by: Based on the review of chemistry, hematology and immunohematology record review, proficiency testing (PT) results, employees' annual competency files, procedures, and an interview with the technical supervisor (TS) #1, the laboratory director failed to employ a sufficient number of personnel to properly supervise the analytic processes of the laboratory from April 12, 2021, to April 12, 2023 Findings: 1. A review of the GEN.13 Competency Program revealed the laboratory director failed to ensure enough staff was available to perform annual competency duties as stated, "The Laboratory Director has delegated the Laboratory General Supervisor or a Technical Supervisor to perform competency". (Cross refer 6120) 2. A review of HEM.21 Coagulation Studies, CHIQCP.4-6: IQCP Opti CCA-TS2, BB.32 Blood Bank Duties, Lab-Hem-063 and BB.30 Verifying Blood Bank Alarms Performance revealed the lack of supervisory oversite to prevent a repeat condition cite and ensure procedures are being performed at the frequency required from April 12, 2021, to April 12, 2023. (Cross refer D5400) 3. A review of 2021 recertification survey's

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 review of laboratory policies and procedures, patient results report with corresponding case slides and interview with the Histotechnician (HT)#1 (not listed on the CMS-209 Laboratory Personnel Report), the laboratory failed to establish and follow written policies and procedures for specimen and quality control (QC) slide labeling. Findings include: 1. No pathology slide labeling policies and procedures were available for review. 2. Review of patient file 19Y00242S report, patient specimen slide and quality control (QC) slide, revealed the following: a. Patient specimen slide label lacked second identifier and date processed b. Patient report indicates specimen ID A; source as Stomach, no source was labeled on the specimen slide. 3. Review of patient file 20Y00598S report, patient specimen slide and quality control (QC) slide revealed the following: a. QC slide "B-H" lacked date processed. b. Report indicates specimen ID B; source as Esophagus which is crossed out and handwritten "stomach" which is inconsistent with the patient slide labeled "B1-1 Gastric Biopsy". c. Addendum report for change of specimen source from Esophagus to Stomach was not available for review 4. Interview with HT#1 on August 24, 2021 at 9:20 AM, stated collection date is not always the same as the processing date 5. Interview with HT#1 on August 24, 2021 at 9:25 AM, confirmed the lack of consistent labeling for specimen slides and quality control slides. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of hematology, pathology and urinalysis procedures, the laboratory failed to record pathology reagent lot number and expiration dates (see D5415), failed to maintain Tissue tek cryostat (see D5435), failed to perform stain quality checks for microscopic urinalysis (see D5473), and failed to perform intstrument comparison of hematology analytes (see D5775). D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on record review and interview with the Histotechnician (HT)#1 (not listed on the CMS-209 Laboratory Personnel Report), the Pathology section failed to document reagent lot numbers and expiration dates for years 2019 and 2020. Findings: 1. Review of Pathology's Daily/Weekly/Monthly Maintenance Records for 2019 and 2020, lacked entry of reagent lot numbers and expiration dates. 2. Interview on August 24, 2021 at 9:30 AM with the HT #1, confirmed reagent lot numbers and expiration dates were not documented for years 2019 and 2020. 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 a review of maintenance documentation, observation of cryostat, and interview with the Histotechnician (HT)#1 (not listed on the CMS-209 Laboratory -- 2 of 4 -- Personnel Report), the laboratory failed to certify the Tissue tek cryostat for years 2019 and 2020. Findings: 1. No Tissue Tek cryostat maintenance documentation was available for review for years 2019 and 2020. 2. Observation of the Tissue tek cryostat available for use showed the certification sticker was performed in 2018. 3. Interview on August 26, 2021 at 9:40 AM with HT #1, confirmed the laboratory failed to have the Tissue tek cryostat certified for years 2019 and 2020. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the Technical Supervisor (TS)#1, the laboratory failed to document the intended staining characteristics for each day microscopic urinalysis slides were stained with KOVA Stain for years 2019 and 2020. Findings include: 1. Review of laboratory records revealed the laboratory failed to document KOVA Stain lot number, expiration date and the staining quality of microscopic urinalysis slides for each day of testing for years 2019 and 2020. 2. Interview on August 24, 2021 at 8:45 AM with TS #1, confirmed the laboratory failed to document staining quality for microscopic urinalysis slides stained with KOVA Stain. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (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 record review of instrument comparison documentation and interview with Technical Supervisor (TS) #1, the laboratory failed to perform instrument comparison for analyzers, Sysmex XN-2000 Hematology System two analytical modules for overlapping analytes two times a year for 2020. Findings: 1. Review of laboratory instrument comparison documentation showed the laboratory failed to perform and document comparison studies for analyzers, Sysmex XN-2000 Hematology System two analytical modules for complete blood counts in year 2020. 2. Interview with TS #1 on August 25, 2021 at 10:10 AM confirmed the laboratory failed to perform twice a year instrument comparison. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are -- 3 of 4 -- established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory director failed to ensure the quality assessment programs were established and maintained to identify failures in pathology specimen slide labeling (see D5311), failed to monitor and evalute the overall quality of the analytic systems (see D5400), failed to record pathology reagent lot number and expiration dates (see D5415), failed to maintain verification of cryostat (see D5435), failed to perform stain quality checks for microscopic urinalysis (see D5473), and failed to perform hematology comparison of test results (see D5775) for years 2019 and 2020. -- 4 of 4 --

Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on 11/14/18-11/15/18, deficiencies were cited for Sidney Health Center in Sidney, MT. 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 positive and negative quality controls every day of patient testing on the rapid test for fetal membrane rupture (ROM Plus kit) for 17 of 17 patients between 4/1/18 and 11/14/18. The findings include: 1. A review on 11/14/18 at 11:00 a.m. of the ROM Plus logs lacked controls run every day of patient testing for 17 days. a. 4/18/18, 5/1/18, 5/2/18, 5/13/18, 5/23/18, 7/17/18, 7/18/18, 7/28/18, 8/16/18, 8/20/18, 9/13/18, 9/22/18, 10/2 /18, 10/5/18, 10/9/18, 10/13/18, and 10/30/18. 2. On 11/14/18 at 11:00 a.m., staff member A stated the laboratory did not have an Individualized Quality Control Plan (IQCP) for the ROM kit. 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 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 -- 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, the laboratory technical supervisor failed to evaluate the competency of 8 of 8 testing personnel in 2017 and 2018. The findings include: 1. A review on 11/14/18 at 11:20 a.m. of the competency assessments lacked four of the six required elements of competency for testing personnel B, C, D, E, F, G, H, and I. a. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b. Monitoring the recording and reporting of test results. c. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. d. Direct observation of performance of instrument maintenance and function checks. 2. On 11/14/18 at 11:20 a.m., staff member A stated the competency assessments consisted of proficiency sample testing records and continuing education webinars. -- 2 of 2 --