Keefe Memorial Health Services District

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 review of the laboratory's personnel records, policies and procedures manual, and an interview with the laboratory's general supervisor 2 (GS2), the laboratory failed to document the initial competency of testing personnel (TP); assess or establish a written policy or procedure for assessing the competency of personnel in the positions of technical supervisor (TS) and general Supervisor (GS). The laboratory conducts approximately 157,470 tests annually. Findings include: 1. A review of the laboratory's personnel files revealed the laboratory was assessing semi-annual and annual competency for TP, but not assessing initial TP competency. 2. A review of the laboratory's policies and procedures manual revealed the laboratory was assessing semi-annual and annual competency for TP, but not assessing initial TP competency. 3. A review of the laboratory's policies and procedures manual revealed that the laboratory failed to assess the competency of, or establish a written policy or procedure for assessing the competency for one of one TS, and two out of two of the GS listed on the CMS-209 form. 4. Based on an interview with GS2, on October 2, 2024, at approximately 11:00 AM, confirmed that the laboratory failed to assess the competency of, or establish a written policy or procedure for assessing the competency of TP after completing their initial training, and failed to assess the competency of, or establish a written policy or procedure to assess the competency of personnel in the positions of TS, and GS. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) 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 -- 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 policies and procedures manual, and an interview with general supervisor 1 (GS 1), general supervisor 2 (GS 2), and the laboratory director (LD), the LD failed to ensure that the laboratory's policies and procedures manual for chemistry, hematology, microbiology and blood bank had been approved, signed, and dated by the current LD before use in the laboratory since the LD was hired in January of 2024. The laboratory performs approximately 157,470 tests annually. Findings include: 1. A review of the laboratory's policies and procedures manual for chemistry, hematology, microbiology and blood bank revealed that the current LD had not approved, signed, or dated the laboratory's policies and procedures prior to their use in the laboratory since the current LD started in January of 2024. 2. Based on an interview with GS 1 on October 2, 2024, at approximately 10:15 AM, confirmed that the current LD had not reviewed, signed, and dated the laboratory's policies and procedures manual for chemistry, hematology, microbiology, and blood bank prior to their use in the laboratory since the current LD started in January of 2024. 3. Based on an interview with GS 2 on October 2, 2024, at approximately 10:00 AM, confirmed that the current LD had not reviewed, signed, and dated the laboratory's policies and procedures manual for chemistry, hematology, microbiology, and blood bank prior to their use in the laboratory since the current LD started in January of 2024. 4. Based on an interview with the LD on October 2, 2024, at approximately 1:05 PM, confirmed that the current LD had not reviewed, signed, and dated the laboratory's policies and procedures manual for chemistry, hematology, microbiology, and blood bank prior to their use in the laboratory since their employment started in January of 2024. -- 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 a routine desk review of the CMS-155 Report for Proficiency Testing (PT), and telephone interview with the laboratory manager, the laboratory failed to achieve satisfactory performance in proficiency testing for Cell I.D. or WBC Differential for four consecutive events in 2022-2023 (Events 2 and 3 in 2022 and Events 1 and 2 in 2023), resulting in subsequent unsuccessful PT performance. (Refer to D2130). D2130 HEMATOLOGY CFR(s): 493.851(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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a routine desk review of the CMS-155 report for Proficiency Testing (PT) performance and telephone interview with the laboratory manager, the laboratory failed to achieve a score of at least 80% for Cell I.D. or WBC Differential for four consecutive PT events in 2022-2023 (Events 2 and 3 in 2022 and Events 1 and 2 in 2023) resulting in subsequent unsuccessful performance. Findings Include: 1. A review of the CMS-155 Individual Laboratory Profile report on 12/07/2023, revealed the American Proficiency Institute (API) PT scores for Cell I.D. or WBC Differential testing were: 2022 Event 2 0% 2022 Event 3 20% 2023 Event 1 28% 2023 Event 2 52% 2. A telephone interview with the laboratory manager on 12/08/2023, at 10:20 AM, confirmed the four consecutive unsuccessful PT scores for Cell I.D. or WBC Diff. 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 routine desk review of the CMS-155 report for Proficiency Testing (PT) performance and telephone interview with the laboratory manager, the laboratory director failed to fulfill the responsibility for overall operation of the laboratory by failing to review and evaluate the unsatisfactory proficiency testing for events 2 and 3 in 2022 and events 1 and 2 in 2023, resulting in subsequent unsuccessful PT participation for Cell I.D. or WBC Differential . (See D6091). 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: Based on a routine desk review of the CMS-155 report for Proficiency Testing (PT), test reports from the American Proficiency Institute (API), and communication with the laboratory chief of operations, the laboratory failed to successfully participate in PT during 2022 and 2023 . (Refer to D2096, D2107, D2108, and D2130). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a routine desk review of the CMS-155 report for Proficiency Testing (PT), American Proficiency Institute (API) reports, and communications with the laboratory chief of operations, the laboratory failed to achieve a satisfactory score for Lactate Dehydrogenase (LDH, Total) for event 3 in 2022 and event 1 in 2023. Findings: 1. A review of the CMS-155 Individual Laboratory Profile on 4/17/2023, at 11:52 AM, revealed the API PT results for LDH, Total testing scores for event 3 in 2022 was 0% and 0% for event 1 in 2023. 2. A phone call with the laboratory's Chief Operations Officer on 04/13/2023, at 11:32 AM, with the laboratory chief of operations confirmed the laboratory failed to achieve satisfactory test performance for LDH. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 a review of proficiency testing scores from the American Proficiency Institute (API) and an interview with the laboratory chief of operations, the laboratory failed to achieve a satisfactory proficiency testing score for Free Thyroxine (TY) in event 3 in 2022 and event 1 in 2023. Findings include: 1. A review of the proficiency testing scores from API and the CMS-155 Individual Laboratory Profile on 04/17 /2023, revealed the TY testing scores for event 3 in 2022 was 60% and event 1 in 2023 was 60%. 2. A phone call with the laboratory's Chief Operations Officer on 04 /13/2023, at 11:32 AM, confirmed unsuccessful proficiency scores for TY testing. D2108 ENDOCRINOLOGY CFR(s): 493.843(g) Failure to achieve an overall testing event score of satisfactory performance for 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 a review of proficiency testing scores from the American Proficiency Institute (API) and communication with the laboratory, the laboratory failed to achieve an overall satisfactory testing score for the subspecialty of Endocrinology for events 1 and 3 in 2022. Findings include: 1. A review of the proficiency testing scores from API and the CMS-155 Individual Laboratory Profile on 04/17/2023, revealed the overall testing scores for Endocrinology for events 1 and 3 in 2022 was 70% 2. A phone call with the laboratory's Chief Operations Officer on 04/13/2023, at 11:32 AM, confirmed the unsuccessful proficiency scores for the overall testing events for Endocrinology. D2130 HEMATOLOGY -- 2 of 3 -- 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. This STANDARD is not met as evidenced by: Based on a routine desk review of the CMS-155 report for Proficiency Testing (PT) performance and email communications with the laboratory director of operations, the laboratory failed to achieve a score of 80% for the American Proficiency Institute (API) PT for Cell I.D. or WBC Differential for Events 2 and 3 in 2022. Findings Include: 1. A review of the CMS-155 Individual Laboratory Profile on 04/17/2023, revealed the API PT for Cell I.D. or WBC Diff testing scores for 2022 event 2 was 0% and for event 3 was 20%. 2. A phone call with the laboratory's Chief Operations Officer on 04/13/2023, at 11:32 AM, confirmed two consecutive unsuccessful PT scores for Cell I.D. or WBC Diff. -- 3 of 3 --