Pioneer Memorial Hospital Lab

Summary Statement of Deficiencies D2026 BACTERIOLOGY CFR(s): 493.823(d) (1) For any unsatisfactory 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) 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 the review of the laboratory's proficiency testing (PT) results from the College of American Pathologists (CAP), and an interview with the laboratory Technical Supervisor (TS), the laboratory failed to document the remedial actions taken for unacceptable PT results. Findings include: 1. Review of the CAP PT results revealed unacceptable results for organism identification, unacceptable Morphology identification, and MIC susceptibility interpretation. Year Event Sample Intended Response 2022 D-C D-19 Bacilli Coccobacilli 2022 D-C D-19 Resistant Susceptible 2022 D-C D-15 K. pneumoniae K. ozaena 2022 D-B D-12 Resistant Susceptible 2022 D-A D-04 K. Kanga Strep Species 2. The laboratory had no documentation for the remedial training as indicated on the laboratory's PT

Summary Statement of Deficiencies D2004 ENROLLMENT CFR(s): 493.801(a)(3) For each specialty, subspecialty and analyte or test, participate in one approved proficiency testing program or programs, for one year before designating a different program and must notify CMS before any change in designation; This STANDARD is not met as evidenced by: Based on review of the laboratory's Casper Report 0155D and phone conversation with the Technical Supervisor (TS) the laboratory switched proficiency testing providers from American Association of Bioanalyst (AAB) to the College of American Pathologist (CAP) in the middle of the calendar year. Findings include: 1. AAB 2nd event 2021 - Compatibility Testing - 80% 2. AAB 1st event 2022 - Compatibility Testing - 60% 3. CAP 2nd event 2022 - Compatibility Testing - 80% 4. The laboratory performs a total of sixty (60) compatibility testing per year. 5. The TS confirmed these findings during the phone conversation on 10/05/2022 @ 15:27. 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 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 -- assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on Proficiency Testing (PT) desk review of the American Association of Bioanalyst (AAB) and the College of American Pathologists (CAP) proficiency testing revealed the laboratory had unsuccessful participation for compatibility testing for three (3) out of four (4) consecutive testing events. Refer to D2173 and D2179. D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) 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 Proficiency Testing (PT) desk review of the American Association of Bioanalysts (AAB) proficiency testing and the College of American Pathology (CAP) and phone conversation with the Technical Supervisor (TS) the laboratory had failed to attain an overall testing event score of 100% for three (3) out of four (4) consecutive events for Compatibility Testing in the specialty Immonohematology. Findings include: 1. AAB 2nd event 2021 - Compatibility Testing - 80% 2. AAB 1st event 2022 - Compatibility Testing - 60% 3. CAP 2nd event 2022 - Compatibility Testing - 80% 4. The laboratory performs a total of sixty (60) compatibility testing per year. 5. The TS confirmed these findings during the phone conversation on 10/05 /2022 @ 15:27. D2179 COMPATIBILITY TESTING CFR(s): 493.863(d) (1) For any unsatisfactory 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 unsatisfactory 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 Proficiency Testing (PT) desk review of the American Association of Bioanalysts (AAB) proficiency testing and the College of American Pathology (CAP) and phone conversation with the Technical Supervisor (TS) the laboratory had failed to employ technical assistance and to follow the standard operating procedures (SOP) for compatibility testing EOC #3 Gel SOP and antibody screening EOC #1 SOP procedures that resulted in Compatibility Testing failures in three (3) out of four (4) consecutive testing events in the specialty Immonohematology. Findings include: 1. AAB 2nd event 2021 - Compatibility Testing - 80% 2. AAB 1st event 2022 - -- 2 of 4 -- Compatibility Testing - 60% 3. CAP 2nd event 2022 - Compatibility Testing - 80% 4. The laboratory performs a total of sixty (60) compatibility testing per year. 5. The TS confirmed these findings during the phone conversation on 10/05/2022 @ 15:27. 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 review of the Proficiency Testing (PT) records the Laboratory Director (LD) did not fulfill his responsibilities to provide overall management and direction of the laboratory. Refer to D6091 and D6092. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

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: Proficiency Testing (PT) desk review of the American Association of Bioanalysts (AAB) proficiency testing (PT) showed the laboratory had unsuccessful participation for the 2nd event 2021 and 1st event 2022 for the Specialty Immunohematology. Refer to D2173, D2179, and D2181. D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory 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 -- performance. This STANDARD is not met as evidenced by: PT desk review of the American Association of Bioanalyst (AAB) PT reveals that the laboratory failed to achieved a 100% for compatibility testing. Findings include: 1.. AAB PT 2nd Event 2021 Compatibility Testing - 80%. 2. AAB PT 1st Event 2022 Compatibility Testing - 60%. D2179 COMPATIBILITY TESTING CFR(s): 493.863(d) (1) For any unsatisfactory 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 unsatisfactory 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: PT desk review of the AAB PT reveals that the laboratory failed two testing events for compatibility testing. Findings include: 1. AAB PT 2nd Event 2021 Compatibility Testing - 80%. 2. AAB PT 1st Event 2022 Compatibility Testing - 60%. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: PT desk review of the AAB PT reveals that the laboratory failed two out of three consecutive testing events for compatibility testing. Findings include: 1. AAB PT 2nd Event 2021 Compatibility Testing - 80%. 2. AAB PT 1st Event 2022 Compatibility Testing - 60%. -- 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: Proficiency Testing (PT) desk review of the American Association of Bioanalysts (AAB) proficiency testing (PT) showed the laboratory had unsuccessful participation for 1st event 2021 and 3rd event 2021 for Antibody Identification. Refer to D2191. D2191 ANTIBODY IDENTIFICATION CFR(s): 493.865(f) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful 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 -- performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing records the laboratory had 2 out of 3 PT event failures for Antibody Identifications. Findings include: 1. AAB 1st event 2021 - Antibody Identification = 0% 2. AAB 3rd event 2021- Antibody Identification = 0% -- 2 of 2 --

Summary Statement of Deficiencies 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 review of the laboratory's procedure manuals and discussion with the staff the new laboratory director hired 12/01/2019 did not sign and date the procedure manuals used in the laboratory. Findings include: 1. Review of all procedures manuals revealed that the new laboratory director did not sign the following procedure manuals. a. Bacteriology Procedure Manuals. b. Blood Bank Procedure Manuals. c. Chemistry Procedure Manuals. d. Coagulation Procedure Manuals. e. Hematology Procedures Manuals. f. IQCP Procedure Manuals. g. Serology Procedure Manuals. h. Urinalysis Procedure Manuals. 2. The Laboratory Manager/Technical Supervisor and Lead Tech/ General Supervisor concurred with these findings on 09/22/2020 at 15: 30PM. 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 --