Piggott Community Hospital Laboratory

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 2025 CMS Casper Reports 0153D, 096D, and the American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have initial successful participation in proficiency testing for the analyte Uric Acid. 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 as cited at D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 -- (f) 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 2025 CMS Casper Reports 0153D, 096D, and API proficiency testing results, it was determined the laboratory failed to have satisfactory participation in proficiency testing for the analyte Uric Acid. Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received a score of 60% for the analyte Uric Acid in the second proficiency testing event of 2025. B. A review of the proficiency testing results revealed the laboratory received a score of 60% for the analyte Uric Acid in the third proficiency testing event of 2025. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of 2025 proficiency testing results, the laboratory director failed to ensure that the proficiency testing samples are tested as required under Subpart H of this part. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on the 2025 proficiency testing event results, the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for the Chemistry test uric acid. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Review of the laboratory's policy and procedure for "Temperature Checks of Blood Bank Refrigeration", the continuous monitoring charts for the blood bank refrigerator and plasma storage freezer, records of the blood bank refrigerator and plasma storage freezer alarm checks, lack of documentation and interview demonstrated that the laboratory failed to perform periodic alarm checks for the blood bank blood storage refrigerator and plasma storage freezer for the calendar year 2022 through 2024 Findings follow: A) Review of the laboratory's policy and procedure for " Temperature Checks of Blood Bank Refrigeration " revealed " Daily monitoring and quarterly temperature verification of the temperature alarms will be conducted and the results recorded on the appropriate log ". B) Review of the laboratory documentation for blood bank refrigerator alarm check revealed that no alarm check was documented in 2022 through 2024 for the Blood Bank refrigerator and Fresh Frozen Plasma (FFP) freezer. C) Upon request, the laboratory was unable to provide documentation of blood bank refrigerator, or FFP freezer alarm checks performed for 2022 through 2024. D) In an interview on November 19, 2024, at 1:10 p.m., the Technical Consultant stated that the laboratory had not performed alarm checks on the blood storage refrigerator and FFP freezer. 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 D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of Hematology quality control (QC) Summary Reports for July, August, November, and December of 2022 as well as February 2023, the laboratory failed to document QC each day of patient hematology testing on three of ninety- seven days reviewed. Survey findings include: A. The QC Summary Report for Coulter 6C Cell controls (three levels) for 7/17/2022 through 8/12/2022 did not include quality control documented on 8/4/2022 for Level 1, Level 2, or Level 3 controls. B. A review of a list of patients who had complete blood counts reported on 8 /4/2022 revealed that thirty-one patients were tested and reported on that date when no QC was documented. C. The QC Summary Report for Coulter 6C Cell controls (three levels) for 11/12/2022 through 12/17/2022 did not include QC documented on 11/19 /2022 or 11/20/2022. D. A review of a list of patients with complete blood counts reported on 11/19/2022 and 11/20/2022 revealed nineteen patients reported on 11/19 /2022 and seventeen patients reported on 11/20/2022. E. In an interview, on 4/12/2022 at 9:13 a.m., the laboratory technical supervisor (as listed on the form CMS-209) confirmed that patients were tested on the above dates without quality control documentation. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on a review of personnel records for six of six testing personnel (listed as #2 through #7 on the form CMS-209) and interviews with laboratory staff, the technical supervisor failed to evaluate the competency of one of seven testing personnel at lease annually after the first year. Survey findings include: A. A review of personnel records for laboratory testing personnel (listed as #7 on the form CMS-209 form) revealed competency assessments were performed on 5/8/2021 and then again on 3/31 /2023 (22 months after the 2021 competency). B. During an interview, at 1:44 p.m. on 4/11/2023, the technical supervisor (as listed on the form CMS-209) confirmed there were no competencies performed for employee #7, between 5/8/2021 and 3/31/2023. -- 2 of 2 --

Summary Statement of Deficiencies 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 effectiveness of

Summary Statement of Deficiencies D0000 Piggott Community Hospital Laboratory was not in compliance with the following condition: CFR 493.1215 Hematology as cited at D5547 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: Through review of patient result reports, quality control reports, lack of documentation and interview it was determined that the laboratory failed to document quality control results for prothrombin times as cited at: D5547 D5547 HEMATOLOGY CFR(s): 493.1269(c)(d) (c) For manual coagulation tests-- (c)(1) Each individual performing tests must test two levels of control materials before testing patient samples and each time a reagent is changed; and (c)(2) Patient specimens and control materials must be tested in duplicate. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Through review of patient result reports, quality control reports, lack of documentation and interview it was determined that the laboratory failed to document quality control results for prothrombin time testing on seven of thirty-one days of testing in November 2017, two of thirty-one days of testing in March 2018 and two of 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 -- thirty-one days of testing in July 2018. Findings follow: A. Review of quality control reports for prothrombin time testing revealed that no quality control results were provided for 11/3/17, 11/4/17, 11/5/17, 11/6/17, 11/12/17, 11/18/17, 11/26/17, 3/23 /18, 3/24/18, 7/7/18 and 7/20/18. B. Review of patient results for November 2017 revealed that prothrombin times were performed on seven patients, identified as numbers one through seven on a patient identification list "A", on 11/3/17; five patients, identified as numbers eight through twelve on a patient identification list "A", on 11/4/17; five patients, identified as numbers thirteen through seventeen on a patient identification list "A", on 11/5/17; seven patients, identified as numbers eighteen through twenty-four on a patient identification list "A", on 11/6/17; nine patients, identified as numbers twenty-five through thirty-three on a patient identification list "A", on 11/12/17; twelve patients, identified as numbers thirty-four through forty-five on a patient identification list "A", on 11/18/17; thirteen patients, identified as numbers forty-six through fifty-eight on a patient identification list "A", on 11/26/17. C. . Review of patient results for March 2018 revealed that prothrombin times were performed on ten patients, identified as numbers one through ten on a patient identification list "B", on 3/23/18 and twenty patients, identified as numbers eleven through thirty on a patient identification list "B", on 3/24/18. D .Review of patient results for July 2018 revealed that prothrombin times were performed on twelve patients, identified as numbers one through twelve on a patient identification list "C", on 7/7/18 and fourteen patients, identified as numbers thirteen through twenty-six on a patient identification list "C", on 7/20/18. E. Upon request, the laboratory was unable to provide documentation of quality control results for prothrombin time testing for the dates identified above. F. In an interview on 8/29/18 at approximately 09:45AM the technical consultants identified as numbers 2, 3, and 4 on the CMS 209 form confirmed that the laboratory was unable to provide documentation of quality control results for prothrombin time testing for the dates identified above. D5781

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 2017 CMS Casper Reports 155D, 153D and the American Proficiency Institute(API) proficiency testing results, it was determined the Laboratory failed to have successful participation in proficiency testing for compatibility testing as evidenced by: Failure to attain a testing event score of at least 100 percent in compatibility testing is unsatisfactory performance as cited at 2173. D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) 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 attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: . Based on review of 2017 CMS Casper Reports 155D, 153D and the American Proficiency Institute(API) proficiency testing results, it was determined the Laboratory failed to have successful participation in two out of three proficiency testing for compatibility testing which is unsuccessful performance as evidenced by: A. The Laboratory received a score of 80% for compatibility testing in the third proficiency testing event of 2017. B. The Laboratory received a score of 80% for compatibility testing in the first proficiency testing event of 2017. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: . Based on a review of the 2017 proficiency testing results, it was determined the Laboratory Director failed to ensure that