Weisbrod Memorial Hospital

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 policies and procedures manual, and an interview with general supervisor #1 (GS #1), and technical supervisor #3 (TS #3) the laboratory director (LD) failed to ensure that all the laboratory's policies and procedures manual for chemistry, hematology, and microbiology had been approved, signed, and dated by the current LD before use since the laboratory's last survey on 5 /18/2021. The laboratory conducts a total of approximately 32,289 tests annually. Findings include: 1. A review of the laboratory's policies and procedures manual for chemistry, hematology, and microbiology revealed that the current LD had not approved, signed, or dated all the laboratory's policies and procedures prior to their use in the laboratory. 2. Based on an interview with GS #1 on January 18, 2024, at approximately 10:30 AM, confirmed that the current LD had not reviewed, signed, and dated all the laboratory's policies and procedures manual for chemistry, hematology, and microbiology prior to their use in the laboratory. 3. Based on an interview with TS #3 on January 18, 2024, at approximately 10:30 AM, confirmed that the current LD had not reviewed, signed, and dated all the laboratory's policies and procedures manual for chemistry, hematology, and microbiology prior to their use in the laboratory. D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). 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 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures manual, an interview with general supervisor #1 (GS #1), and technical supervisor #3 (TS #3), the laboratory failed to include the effective dates of approved policies and procedures used by the laboratory for testing since the laboratory's last survey was conducted on 5 /18/21. The laboratory performs approximately 32,289 tests annually. Findings include: 1. Based on a review of the laboratory's policies and procedures manual, the laboratory failed to include the effective dates of approved policies and procedures used by the laboratory for testing since the last survey was conducted on 5/18/21. 2. Based on an interview with GS #1, on January 18, 2024, at approximately 10:30 AM, confirmed that the laboratory failed to include the effective dates of their approved policies and procedures manual used by the laboratory for testing since the last survey was conducted on 5/18/21. 3. Based on an interview with TS #3, on January 18, 2024, at approximately 10:30 AM, confirmed that the laboratory failed to include the effective dates of their approved policies and procedures manual used by the laboratory for testing since the last survey was conducted on 5/18/21. 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 direct observation and an interview with general supervisor #1 (GS#1), the laboratory failed to replace the Potassium Hydroxide (KOH) reagent after it had exceeded the expiration date and approximately 5 KOH preparations had been performed using this reagent. Findings include: 1. An observation of the laboratory's reagents on January 18, 2024, at approximately 12:30 PM, revealed one bottle of KOH reagent, lot number: B05E014M, expired on: 10/31/23. 2. An interview with GS#1 on January 18, 2024, at approximately 12:30 PM, confirmed that the KOH reagent had expired and had been used for KOH preparation for approximately 5 patients. 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 a records review, and an interview with general supervisor #1 (GS #1), and technical supervisor #3 (TS #3), the laboratory failed to verify manufacturer's -- 2 of 3 -- performance specifications of instrumentation following the movement of the laboratory from one physical location to another on or about 12/18/21. The laboratory conducts a total of approximately 32,289 tests annually. Findings include: 1. Based on a records review, it was revealed that the laboratory failed to verify the performance specifications set by the instrument's manufacturers for their Cepheid Genexpert, Ortho Vitros, Abbott ID NOW, Werfen Hemochron, Alere Triage, and Optimed Blood Gas instruments since the laboratory moved physical locations on or about 12 /18/21. 2. Based on an interview with GS #1, on January 18, 2024, at approximately 11:30 AM, confirmed that the laboratory failed to verify the performance specifications set by the instrument's manufacturers for their Cepheid Genexpert, Ortho Vitros, Abbott ID NOW, Werfen Hemochron, Alere Triage, and Optimed Blood Gas instruments since the laboratory moved physical locations on or about 12 /18/21. 3. Based on an interview with TS #3, on January 18, 2024, at approximately 11:30 AM, confirmed that the laboratory failed to verify the performance specifications set by the instrument's manufacturers for their Cepheid Genexpert, Ortho Vitros, Abbott ID NOW, Werfen Hemochron, Alere Triage, and Optimed Blood Gas instruments since the laboratory moved physical locations on or about 12 /18/21. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on a records review, a review of the laboratory's policies and procedures manual, and an interview with general supervisor #1 (GS #1), and technical supervisor #3 (TS #3)), the laboratory failed to evaluate, or establish a policy or procedure that evaluates at least semi-annually molecular test results obtained using the Cepheid Genexpert and Biomerieux Biofire instruments since the last survey was performed on 5/18/21. The laboratory conducts approximately 1,084 microbiology tests annually. Findings include: 1. Based on a records review, the laboratory failed to evaluate at least semi-annually SARS CoV-2/Flu A&B/RSV test results obtained using the Cepheid Genexpert and Biomerieux Biofire instruments since the last survey was performed on 5/18/21. 2. Based on a review of the laboratory's policies and procedures manual, the laboratory failed to establish a policy or procedure that evaluates at least semi-annually SARS CoV-2/Flu A&B/RSV test results obtained from the Cepheid Genexpert and Biomerieux Biofire instruments since the last survey was performed on 5/18/21. 3. Based on an interview with GS #1, on January 18, 2024, at approximately 11:00 AM, confirmed that the laboratory failed to evaluate, or establish a policy or procedure that evaluates SARS CoV-2/Flu A&B/RSV results at least semi-annually since the last survey was performed on 5/18/21. 4. Based on an interview with TS #3, on January 18, 2024, at approximately 11:00 AM, confirmed that the laboratory failed to evaluate, or establish a policy or procedure that evaluates SARS CoV-2/Flu A&B/RSV results at least semi-annually since the last survey was performed on 5/18/21. -- 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: Based on a routine proficiency test desk review of the CMS-155 report for proficiency testing performance and interview with the laboratory manager, the laboratory failed to achieve satisfactory performance scores for Alanine Aminotransferase (ALT /SGPT) for two consecutive events (Event 3 in 2022 and Event 1 in 2023). See 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 -- 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 interview with the laboratory manager, the laboratory failed to achieve a satisfactory score of at least 80 percent for Alanine Aminotransferase (ALT /SGPT) testing performed on Event 3 of 2022 and Event 1 of 2023, resulting in unsuccessful performance. Findings include: 1. A review of the proficiency testing scores from API and the CMS-155 Individual Laboratory Profile on 04/12/2023 at 9: 00 AM, revealed the ALT/SGPT testing score for Event 3 in 2022 was 0% and Event 1 in 2023 was 60%. 2. An interview with the laboratory manager on 04/17/2023 at 12: 45 PM confirmed two consecutive unsuccessful proficiency test scores for ALT/SGPT testing due to laboratory error. -- 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 American Proficiency Institute proficiency testing record and staff interview, the laboratory failed to achieve satisfactory performance in proficiency testing for the analyte Thyroid Stimulating Hormone (TSH) for two of three consecutive events in 2021 (event 3) and 2022 (event 1), resulting in unsuccessful proficiency testing performance. Refer to 2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 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 proficiency testing record review and staff interview, the laboratory failed to achieve satisfactory performance in proficiency testing for the analyte Thyroid Stimulating Hormone (TSH) in two of three consecutive events in 2021 (Event 3) and 2022 (Event 1), resulting in unsuccessful performance. Findings include: 1. Review of 2021 and 2022 American Proficiency Institute(API) proficiency testing reports on 4/12 /22 for the analyte TSH revealed the following results: Event 3-2021 - 0% Event 1- 2022 - 0% The specialty of Endocrinology requires a score of 80% or greater for satisfactory performance. 2. During a telephone interview at 2:35 p.m. on 4/18/22, the laboratory manager confirmed the laboratory had scored less than 80% in Event 3 in 2021 and Event 1 in 2022 for TSH. -- 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 records of proficiency testing performance and interview during the onsite recertification survey, the laboratory failed to achieve satisfactory performance for Partial Thromboplastin Time (PTT) for two of three events (2020 Event 1 and 2020 Event 3), resulting in unsuccessful proficiency testing performance. See D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing scores and staff confirmation, the laboratory failed to achieve satisfactory performance for the analyte Partial Thromboplastin Time (PTT) in the specialty of Hematology in two out of three proficiency testing (PT) events. The findings include: 1. During an onsite survey on 05-18-2021 at 11:00 am, and the review of the CMS-153 Unsuccessful Proficiency Testing Report included Weisbrod Memorial Hospital with unsatisfactory proficiency testing scores for Partial Thromboplastin Time (PTT). 2. During an onsite survey on 05-18-2021 at 11:00 am, and the review of the CMS-155 report, the American Proficiency Institute (API) Partial Thromboplastin Time (PTT) score for event 1 of 2020 was 0%. 3. During an onsite survey on 05-18-2021 at 11:00 am, and the review of the CMS-155 report, the American Proficiency Institute (API) Partial Thromboplastin Time (PTT) score for event 3 of 2020 was 40%. 4. On 05-18-2021 at 11:00 am, the General Supervisor stated that the laboratory failed to submit results by the required submission date for 2020 event 1 and that review of 2020 event 3 revealed probable testing personnel error. -- 2 of 2 --