Perry County Medical 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 observation of the laboratory, review of laboratory procedure, final patient test review, and staff interviews, the laboratory failed to follow its procedure when the laboratory used the incorrect reagent for vaginal wet prep patient testing in 2024 and 2025. The findings include: 1. Observation of the laboratory on 01/06/2025 at 9:45 a. m. revealed a microscope used for vaginal wet prep examination. A container labeled "Sterile Water for Irrigation" was noted with an additional handwritten label that stated "Wet Preps Nursing." The bottle had an open date of 03/20/2024. During the observation, testing person one stated that nursing personnel came to the laboratory and obtained liquid from the bottle in the laboratory for each patient wet collection. 2. A review of the laboratory procedure titled "Wet Preparation" revealed the following: Section "Specimen Collection and Handling" stated that the swab was to be collected and placed in one milliliter of saline which was obtained from the container in the laboratory. Section "Procedure" stated that the laboratory used a drop of the saline suspended specimen and placed it on a slide for microscopic examination. 3. A review of final patient test reports revealed patient 24137 had a vaginal wet prep reported on 11/19/2024. 4. An interview with testing person two on 01/06/2025 at 12:15 p.m. confirmed that the laboratory did not use saline to perform patient wet prep testing since 03/20/2024. 5. An electronic interview with testing person one on 01/07/2025 at 8:53 a.m. revealed that the laboratory had reported 46 patient wet preps from 03/20 /2024 through the survey date (01/06/2025) using sterile water instead of saline required by the laboratory procedure. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 observation of the laboratory, review of the laboratory's procedure manual and testing personnel records, and interview with the laboratory director, the laboratory failed to follow testing personnel policy/procedures in 2019, 2020 and 2021. The findings include: 1. Observation of the laboratory on January 24, 2022 at approximately 8:30 am revealed the following moderately complex test systems in use for patient testing: A microscope used for performing wet prep and urine microscopy, rheumatoid factor test kit, Sysmex XN430 used for performing complete blood count (CBC), and an Ace Axcel instrument used for performing chemistry tests. 2. Review of the laboratory's Quality Assessment policy/procedure for assessment of testing personnel competency revealed that personnel will have documentation training for the tests they perform, initial competency after training, a six month competency assessment and then annual competency assessments thereafter. Competency will also be assessed any time a new test methodology or instrument is put into use, prior to reporting patient test results. Additionally, the policy included "The Competency Checklist will be comprised of the six required elements. These include: 1. Direct Observation of Patient Testing 2. Monitoring of Test Results 3. Review of Records 4. Review of Maintenance 5. Blind Testing 6. Problem Solving. 3. Review of the laboratory's personnel records revealed the following: No competency assessment for use of the new Sysmex SN-430 complete blood instrument before use for testing personnel numbers one and two. No documented training for wet prep and urine microscopy for testing personnel number two. No interim competency performed in 2019 for testing personnel number two. The six competency assessment elements 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 -- were not addressed for each moderately complex test system as follows: Lead testing personnel: 2020 annual competency: Direct observation not performed for wet prep, urine microscopy, rheumatoid factor. Monitoring of test result and reporting not performed for wet prep, urine microscopy, rheumatoid factor. Direct observation of instrument maintenance not performed for Sysmex XN430 CBC. Assessment of blind testing not performed for Sysmex XN430 CBC, Ace Axcel chemistry, wet prep, urine microscopy, and rheumatoid factor. Assessment of problem solving skills not performed for wet prep, urine microscopy, rheumatoid factor, and Ace Axcel chemistry. 2021 annual competency: Direct observation not performed for wet prep, urine microscopy, rheumatoid factor, Sysmex XN430 CBC. Monitoring of test result and reporting not performed for wet prep, urine microscopy, rheumatoid factor, CBC. Review of worksheets, QC, PT & Maintenance Records not performed for rheumatoid factor. Direct observation of instrument maintenance not performed for Sysmex XN430 CBC. Assessment of blind testing not performed for Sysmex XN430 CBC, wet prep, and urine microscopy. Assessment of problem solving skills not performed for wet prep, urine microscopy, rheumatoid factor, and Sysmex XN430 CBC. Testing personnel number two: 2020 annual competency: Direct observation not performed for wet prep and urine microscopy. Monitoring of test result and reporting not performed for wet prep and rheumatoid factor. Review of worksheets, QC, PT & Maintenance Records not performed for rheumatoid factor. Direct observation of instrument maintenance not performed for Sysmex XN430 CBC. Assessment of blind testing not performed for Sysmex XN430 CBC, wet prep, ACE Axcel chemistry, rheumatoid factor and urine microscopy. Assessment of problem solving skills not performed for wet prep, urine microscopy, rheumatoid factor, and complete blood count. 2021 annual competency: Direct observation not performed for wet prep and rheumatoid factor. Monitoring of test result and reporting not performed for wet prep and rheumatoid factor. Review of worksheets, QC, PT & Maintenance Records not performed for rheumatoid factor. Assessment of blind testing not performed for complete blood count, wet prep, and urine microscopy. Assessment of problem solving skills not performed for wet prep, urine microscopy, and rheumatoid factor. 4. Interview with the laboratory director on January 24, 2022 at approximately 5:00 pm confirmed the laboratory failed to follow testing personnel policies/procedures for training and competency assessments in 2019, 2020, and 2021. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the laboratory procedure manual and interview with the lead testing personnel, the laboratory director failed to approve the procedure for complete blood count (CBC) in 2020. The findings include: 1. Observation of the laboratory on January 24, 2022 at approximately 8:30 am revealed the Sysmex XN-430 on the counter in use for patient testing for CBC. 2. Review of the laboratory's procedure manual revealed a procedure for the Sysmex XN-430 CBC instrument with an effective date of 10-21-2020 that had not been approved by the laboratory director. 3. Interview with the lead testing personnel on January 24, 2022 at approximately 5:00 pm confirmed the procedure for CBC on the Sysmex XN-430 had not been approved for use by the laboratory director. -- 2 of 3 -- D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(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-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of patient test reports and quality control (QC) records, and staff interview, the laboratory failed to include a titered control for rheumatoid arthritis (RA) factor in 2020. 1. Review of patient #130522 revealed RA factor reported as "Positive- 1:8 dilution" on 05.20.2020. 2. Review of the laboratory's QC records for RA factor revealed a titered control of known reactivity was not performed on 05.20.2020. 3. Phone interview with the lead testing person on February 1, 2022 at approximately 2:30pm confirmed the laboratory did not include a titered control on date when patient testing included titered results. The lead testing person confirmed the survey findings. -- 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: The laboratory failed to maintain satisfactory performance for the cell identification in 2019 events one and three resulting in the first unsuccessful occurrence for the cell identification analyte. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2019 proficiency testing (PT) records, the laboratory failed to maintain satisfactory participation for the blood cell identification in two out of three events, resulting in the first unsuccessful PT occurrence for blood cell identification. The findings include: 1) Review of the CMS 155 report revealed the following unsatisfactory blood cell identification scores: 2019 event one = 60%; 2019 event three = 60%. 2) Review of the laboratory's 2019 event one PT records revealed sample numbers BCI-04 and BCI-05 scored as Unacceptable, resulting in an overall blood cell identification score of 60%. 3) Review of the laboratory's 2019 event three PT records revealed sample numbers BCI-12 and BCI-14 scored as Unacceptable, resulting in an overall blood cell identification score of 60%, and the first unsuccessful PT occurrence. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CMS 209), the laboratory's proficiency testing attestation statements for 2016, 2017, and 2018, and interview with testing personnel number one, the laboratory failed to rotate proficiency testing (PT) in 2016, 2017, and 2018. The findings include: 1. Review of the CMS 209 revealed two testing personnel. 2. Review of the laboratory's proficiency testing attestation statements for 2016, 2017, and 2018 revealed the following: Chemistry PT: Testing personnel number one performed 5 of 6 events (2016-event 3, 2017-event 1 and 2, 2018-event 2 and 3). Immunology PT: Testing personnel number one performed 5 of 6 events (2017-event 1, 2, and 3, 2018-event 1 and 2). Hematology PT: Testing personnel number one performed 6 of 6 events (2016-event 3, 2017-event 1, 2, and 3, 2018-event 1 and 2) Microscopy PT: Testing personnel number two performed 6 of 6 events (2016 event 3, 2017 events 1, 2, and 3, 2018 event 1 and 2) 3. Interview with testing personnel one on October 23, 2018 at 1:05 pm confirmed that two testing personnel routinely perform patient testing in all specialties and the laboratory failed to ensure PT was rotated among all personnel who routinely perform patient testing in 2016, 2017 and 2018. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish 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 -- 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 the laboratory's quality assessment policy and interview with testing personnel number one, the laboratory's policy for testing personnel competency was not in compliance with the personnel requirements in subpart M in 2018. The findings include: 1. Review of the laboratory's quality assessment policy under the section titled "Personnel Training and Qualifications" revealed that methods of assessing competency were not included in the policy. The required six elements as specified in subpart M are: Direct observation of routine patient test performance, including patient preparation, if applicable, specimen handling, process, and testing; monitoring the recording and reporting of test results; Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; Direct observation of performance of instrument maintenance and function checks; Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and Assessment of problem solving skills. 2. Interview with testing personnel number one on October 23, 2018 at 4:30 pm confirmed the laboratory's policy for assessing testing personnel competency was not in compliance with the personnel requirements in subpart M when it failed to include methods of assessing competency in 2018. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of patient number nine test report, the laboratory's quality control limits for the complete blood count (CBC) instrument and the manufacturer package insert limits, the monthly quality assessment for February 2017, and interview with testing personnel number one, the laboratory's quality assessment process failed to detect and correct problems with quality control limits for lot numbers 078500 and 088500 in 2017. The findings include: 1. Review of patient number nine test report revealed patient testing for CBC on February 7, 2017. 2. Review of the laboratory's quality control limits in the laboratory's information system and the manufacturer package insert revealed the following: Lot 078500 Limit in use Correct limit Red Blood Cell 3.5 - 4.5 3.79 - 4.29 Lot 088500 Limit in use Correct Limit Platelet 223 - 523 313 - 433 3. Review of the February 2017 monthly quality assessment form signed by the laboratory director on March 5, 2017 revealed no