Perry County Medical Center

Summary Statement of Deficiencies D0000 During an onsite recertification survey conducted on September 10, 2024, the laboratory was out of compliance with the following condition: 493.1210 Condition: Routine chemistry D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of quality control records, patient activity logs, chemistry maintenance records, calibration verfication records, and staff interviews, the laboratory failed to ensure patient creatinine test results were evaluated when patient testing was performed on a date with unacceptable quality control (QC) (Refer to D5783), and failed to ensure an effective quality assessment process was in place to detect and correct errors (Refer to D5793). 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: 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 -- Based on laboratory observation, a review of the manufacturer's package inserts, and a staff interview, the laboratory failed to label five of five controls and one of one calibrators observed on the survey date (09/10/24) with corrected expiration dates after opening. The findings include: 1. Observation of the laboratory on 09/10/24 at 8: 45 a.m. revealed the following: Sysmex Complete Blood Count (CBC) control lot 4181 (3 Levels) labeled as 9-9-24. Chemistry Control Level one (lot 1501 UNCM), Chemistry control Level Two (1166UECM), and GEMCAL (Lot 1319UECM) labeled as 9-9. During observation, the lead testing person stated the dates on the vials were open dates. 2. A review of manufacturer package inserts revealed expiration dates that changed once the product was opened as follows: Sysmex CBC Controls: 15 days Chemistry Controls Level one and Level two: Reconstituted at 2-8 degrees Celsius: ALP, ALT and AST: 5 days, All other analytes 7 days. GEMCAL: 'Reconstituted at 2- 8 degrees C-All analytes 5 days. 3. The lead testing person confirmed during an interview on 09/10/24 at 4:15 p.m. that controls and calibrators observed on the survey date were not labeled with corrected expiration dates after opening. 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 of the laboratory, a review of the laboratory procedure manual, a lack of documentation and staff interview, the laboratory failed to verify the accuracy of the timer for the urine centrifuge in 2023 and 2024. The findings include: 1. Observation of the laboratory on 09/10/24 at 8:45 a.m. revealed a centrifuge used for processing patient samples for urine microscopy. 2. A review of the laboratory procedure for urine microscopy revealed the laboratory centrifuges the urine for five minutes to prepare the sample for microscopic examination. 3. The laboratory did not have documentation that the time setting on the urine centrifuge had been verified in 2023 or 2024. 4. The lead testing person confirmed the survey findings during an interview on 09/10/24 at 4:15 p.m. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on observation of the laboratory and staff interview during observation, a review of the Sysmex XN 430 Basic Operation manual, a review of the Sysmex XN 430 reagent replacement log, a review of quality control (QC) records, a review of patient activity logs, a review of the laboratory's procedure for the Sysmex XN 430 Complete Blood Count with White Blood Cell Automated Differential (CBC w/Diff) and staff interview, the laboratory's QC procedure for the Sysmex XN 430 was not consistent with the manufacturer's requirements, resulting in the performance of patient testing after reagent changes without performance of QC for two of three dates selected in 2023 and 2024 with a total of 17 patients reported. The findings include: 1. Observation of the laboratory on 09/10/2024 at 8:45 a.m. revealed the Sysmex XN 430 (serial number 11355) instrument used for CBC w/Diff patient testing. During an interview at the time of observation, the lead testing person stated the laboratory did not perform QC after reagent changes. 2. A review of the Sysmex XN 430 Basic Operation manual under section 3.2.2 "When QC analysis is performed' revealed the following: "QC is performed at the following times. Before sample analysis After replacement/replenishment of reagents After instrument maintenance When there is a concern about the accuracy of analysis values" 3. A review of the Sysmex XN430 reagent replacement log revealed reagent changes on 11/13/23 at 8:57 a.m. (Sulfolyser), on 03/12/24 at 2:59 p.m. (CellPack), and on 06/11/2024 at 9:37 a.m. (CellPack). 4. A review of the QC records for the Sysmex XN 430 serial #11355 revealed no documentation that QC was performed immediately after the reagent changes on 11/13/23, 03/12/24, and 06/11/24. 5. A review of patient activity logs for the affected dates revealed the following: On 11/13/23, 13 patients were reported after the reagent change but before the next QC was performed. On 03/12/24, no patients were reported after the reagent change. On 06/11/24, four patients were reported after the reagent change but before the next QC was performed. 6. A review of the laboratory's procedure for the Sysmex XN 430 CBC instrument revealed the CBC QC protocol was not consistent with the manufacturer's requirements when it did not require QC performance after replacement/replenishment of reagents, after instrument maintenance or concerns regarding the accuracy of results, or before patient testing is performed. 7. The laboratory director and testing persons one and two confirmed the laboratory procedure for CBC QC was not consistent with the manufacturer's requirements during an interview on 09/10/24 at 4:15 p.m. D5783

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 08/30/2023. The facility was found NOT to be in compliance with the following 42 CFR part 493, Requirements for Laboratories for the specialties/subspecialties for which it was surveyed: 493.1210 Condition: Routine chemistry 493.1441 Condition: Laboratories performing high complexity testing; laboratory director 493.1447 Condition: Laboratories performing high complexity testing; technical supervisor D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation of the laboratory, staff interviews, review of manufacturer's instructions for use, patient test reports, laboratory procedure manuals, and calibration verification studies, the laboratory failed to meet the condition of routine chemistry. The laboratory failed to have a procedure for chemistry that was approved by the laboratory director (Refer to D5407), failed to establish the performance specifications for use of the Total Bilirubin reagent outside the manufacturer's specified specimen type (Refer to D5423), failed to have an effective quality assessment in place for review of calibration verifications (Refer to D5793), and failed to ensure the final patient test report for the total bilirubin performed on neonatal samples included appropriate reference ranges (Refer to D5807). D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- effectiveness of

Summary Statement of Deficiencies D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: The laboratory failed to follow manufacturer instructions for entry of mean normal patient value used in calculation of International Normalized Ratio (INR) (Refer to D5411) and failed to verify the performance specifications of the current coagulation instrument in use for patient testing for Prothrombin Time (PT) and INR (Refer to D5421), resulting in IMMEDIATE JEOPARDY. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of patient normal mean study, manufacturer thromboplastin package insert, manufacturer procedure manual, review of patient test reports, and interview with testing person number one, the laboratory failed to follow manufacturer instructions for entering the patient normal mean value in the Helena Cascade M-4 instrument, resulting in incorrect calculation of patient International Normalized Ratio (INR) values and resulting in immediate jeopardy. 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 -- The findings include: 1. Observation of the laboratory on September 8, 2021 at approximately 10:45 am revealed the Helena Cascade M-4 instrument in use for patient testing for Prothrombin time and INR. The current lot number of thromboplastin in use was 1-21-5249. The patient normal mean setting in the instrument was 13.5. 2. Review of the patient normal mean study conducted on the current lot of thromboplastin revealed a value of 13.76. 3. Review of the manufacturer thromboplastin package insert revealed that ""Normal range" is re-established with each new lot of reagent." 4. Review of the manufacturer procedure manual revealed the following: "INR-Normal Mean Value: If using INR conversion, you must enter a normal mean PT value for your laboratory here." 5. Review of patient test reports revealed eight patient INRs were reported incorrectly since beginning the use of lot 1- 21-5249 on August 2, 2021 for patient accession numbers 143280, 143407, 143493, 144037, 144120, 144178, 144744, and 144763. 6. Interview with testing person number one on September 8, 2021 at approximately 11:15 am confirmed the patient normal mean setting in the instrument was incorrect for the current lot of thromboplastin, resulting in incorrect INR calculations beginning August 2, 2021 until current date with eight patients reported. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation of the specimen collection area and interview with testing person number three, the laboratory failed to ensure expired reagents were not used for patient wet prep testing in 2021. The findings include: 1. Observation of the area used for collection of patient specimens for vaginal wet prep on September 8, 2021 at approximately 9:15 am revealed normal saline (Lot number 1905108) in use for transport and testing of specimens for vaginal wet prep testing with an expiration date of 2021-05-22. 2. Interview on September 8, 2021 at approximately 9:15 am with testing person number three confirmed the expired saline was in use for patient testing for vaginal wet prep testing. 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 observation of the laboratory, review of previous survey notes, request for performance verification studies, and interview with testing person number one, the laboratory failed to perform performance verification studies for the current Helena -- 2 of 4 -- Cascade M-4 instrument in use for patient testing for Prothrombin Time (PT) and International Normalized Ratio (INR), resulting in immediate jeopardy. 1. Observation of the laboratory on September 8, 2021 at approximately 8:30 am revealed the Helena Cascade M-4 instrument, serial number 411834501, in use for patient testing for PT/INR. 2. Review of notes from the previous survey conducted on August 2, 2018 revealed a different instrument serial number from the one currently in use. 3. Request on September 8, 2021 at approximately 8:30 am for performance verification studies for the Helena Cascade M-4 instrument currently in use revealed no documents were present. 4. Interview with testing person number one on September 8, 2021 at approximately 9:15 am confirmed no performance verification documents were available for the current instrument in use for performing PT/INR patient testing. The laboratory was unable to provide the date the instrument was placed into use. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Citation Number One Based on review of final patient test reports, manufacturer procedure manuals, and interview with testing person number three, the laboratory failed to use correct units of measure for red blood cell (RBC) and International Normalized Ratio (INR) in 2019, 2020, and 2021 for six of six patient RBC results and twelve of twelve patient INR results. The findings include: 1. Review of final patient test reports for RBC and INR revealed the following units of measure on the final patient test report: RBC = 10^3/uL (six of six patients reviewed; accession numbers 121218, 131177, 135287, 136972, 143959, and 144892). Patient report dates range from 08.12.19 to current date of 09.08.21. INR = % (twelve of twelve patients reviewed; accession numbers 118140, 129754, 134798, 140925, 144178, 143280, 144763, 143407, 144037, 143493, 144744, 144120). Patient report dates ranged from 05.23.2019 to 09.03.2021. 2. Review of the manufacturer procedure manuals for the Sysmex XN-430 and the Helena Cascade M-4 revealed the following: Units of measure for RBC = 10^6/uL INR = No units of measure 3. Interview on September 8, 2021 at approximately 4:30 pm with testing person number three confirmed incorrect units of measure were used on the final patient test report for RBC and INR in 2019, 2020 and 2021. Citation Number Two Based on review of final patient test reports, and interview with testing person number three, the final patient test report failed to include units of measure for three of three wet preps and one of one urine microscopic in 2019, 2020, and 2021. The findings include: 1. Review of final patient test reports for urine microscopic and wet prep revealed the following: Wet Prep-No units of measure for Bacteria, Tricomonisis, and Yeast for patient accession numbers 116523, 134178, 142714. Patient report dates range from 04.11.2019 to 07.15.2021. Urine microscopic-No units of measure for bacteria, amorphous, mucous, crystals, or casts for patient accession number 144892, reported on 09.08.2021. 2. Interview on -- 3 of 4 -- September 8, 2021 at approximately 4:30 pm with testing person number three confirmed the final patient test reports for wet prep and urine microscopic did not contain units of measure for all analytes reported in 2019, 2020 and 2021. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records and interview with the technical consultant, the technical consultant failed to perform annual competency assessments for testing personnel numbers one and two (two of two established testing personnel) in 2019. The findings include: 1. Review of laboratory personnel records revealed no annual competency assessments were available for testing personnel numbers one and two. 2. Interview with the technical consultant on September 8, 2021 at approximately 5 pm confirmed that annual competency assessments were not performed for testing personnel number one and two in 2019. -- 4 of 4 --

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 blood cell identification in 2019 events one and three, resulting in the first unsuccessful occurrence for the blood 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 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 review of the Centers for Medicare and Medicaid Services Casper Report 155 (CMS 155), the laboratory's proficiency testing records and interview with testing personnel number one, the laboratory failed to maintain satisfactory performance for the creatinine analyte for 2017 events one and three, resulting in the first unsuccessful occurrence. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) 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 -- (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services Casper report 155 (CMS 155), the laboratory's proficiency testing records, the performance evaluation report for chemistry for 2018 event two, and interview with testing personnel number one, the laboratory failed to perform