Memorial Hospital And Manor

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on November 21, 2025 At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex Laboratory Director 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 CASPER 155 report and review of the American Proficiency Institute (API) reports, the laboratory failed to maintain satisfactory proficiency 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 -- testing (PT) participation for Hemaglobin A1C (A1C) in 2025 events 2 & 3, resulting in an initial unsuccessful participation for A1C. Refer to D 2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of American Proficiency Institute (API) reports, the laboratory failed to maintain satisfactory participation in two consecutive testing events ( 2nd & 3rd events of 2025), resulting in an initial unsuccessful participation for A1C. Findings: 1. A review of Casper Report 155 revealed the laboratory failed A1C on the following: 2025 Event 2 Score 40% 2025 Event 3 Score 60% 2. A review of the laboratory's API Reports confirmed the laboratory failed A1C with the aforementioned scores. 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 the CMS CASPER 155 report and review of American Proficiency Institute (API) reports, the laboratory director failed to provide overall management and direction for proficiency testing performance. The laboratory director failed to ensure proficiency testing samples were tested as required. 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 review of the CMS CASPER Report 155 and the American Proficiency Institute (API) 2025 events 2 & 3 PT evaluation reports, the laboratory director failed to ensure successful proficiency testing performance in A1C in 2 consecutive testing events (2025 events 2 & 3 ), resulting in the initial unsuccessful participation for A1C.. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on June 9, 2021. Condition and Standard level Citations were found. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 American Proficiency Institute (API) Proficiency Testing (PT) provider documents, the laboratory failed to submit results in 2019 for the first event for Subspecialty Chemistry-Miscellaneous , and 2019, second event Chemistry Core.. Reference : D2093 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 -- D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT), and staff interview, the laboratory failed to submit the 2019, PT results for the first event for Chemistry-Miscellaneous, and 2019 for the second event Chemistry- Core, second event, before the deadline. Findings: 1 Review of the API PT, 2019 first event for Chemistry-Miscellaneous, the laboratory failed to submit results before the deadline. 2. Review of the API PT, 2019 second event for Chemistry-Core, the laboratory failed to submit results before the deadline 2: Interview with staff, #1, 2, 3, Laboratory Manager, Hospital Administrator, and Assistant Administrator, on June 9, at 3:30pm in the conference room across the hall from the laboratory, confirmed aforementioned statements. 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 review of the American Proficiency Institute (API) Proficiency Testing (PT) documents and staff interview, the laboratory failed to score 100% for the Immunohematology Blood Bank Compatability Testing for the first event of 2020. Findings: 1 Review of the API PT results for the first event for 2020 for Blood Bank Compability Testing, the laboratory reported sample SER-01 as Compatible, the expected result was Non- Compatible. The performance was determined to be unacceptable and the score received was 80%. The laboratory failed to attain an overall testing event score of at least 100 %. 2 Interview with the laboratory manager, on June 9, 2021, at approximately 3 pm in the conference room across the hall from the laboratory, confirmed that the laboratory failed to attain an overall testing of at least 100 % for Blood Bank Compability Testing for the first event 0f 2020. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) documents for Immunohematology, year 2020, the laboratory failed to receive a -- 2 of 3 -- minimum score of 100% for the first event, for Compatibility Testing. The laboratory received an unsuccessful score of 80%. The minimum score of Immunohematology Testing for PT is 100% Refer: D2173 -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on July 18, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following Condition and deficiencies were cited: D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory failed to maintain a copy of all PT records as required. Findings: For details refer to D2015. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. 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 -- This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory director (LD) and/or the testing personnel (TP) failed to attest to the routine integration of the PT samples into the patient workload as required. Findings include: 1. American Proficiency Institute(API) PT document review revealed the LD and TP performing the testing of the PT samples did not sign the attestation statement for the following PT events: 2018 -- Immunohematology (Event 1). 2. API PT document review revealed the LD not sign the attestation statement for 2018 Miscellaneous Chemistry (Event 1). 2. An interview with Staff #2 (CMS 209) in a conference room on 7/18/2019 at approximately 7:45 p.m. confirmed the LD and TP did not attest to the aforementioned PT events. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory failed to maintain a copy of all PT records as required. Findings include: 1. American Proficiency Institute (API) document review revealed the laboratory was unable to provide the following PT attestation statements at the time of survey: 2018 Immunohematology (First Event), 2018 Chemistry (Second Event), and 2019 Hematology/Coagulation (First Event). 2. American Proficiency Institute (API) document review revealed the laboratory was unable to provide the following PT reports at the time of survey: 2017 Third Event -- Bacteriology and Hematology /Coagulation; 2018 Second Event -- Chemistry; 2019 First Event -- Hematology /Coagulation. 3. An interview with Staff #2 (CMS 209) in a conference room on 7/18 /2019 at approximately 7:45 p.m. confirmed the aforementioned documents were unavailable at the time of survey. This is a REPEAT deficiency. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory failed to evaluate and verity all PT activities as required. Findings include: 1. API (American Proficiency Institute) PT document review revealed the laboratory failed to perform

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on January 2, 2018. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two consecutive events (2nd and 3rd events of 2017), resulting in 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 2 -- first unsuccessful occurrence for analyte # 575, Triiodothyronine (T3). Findings include: Refer to D 2107 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to maintain satisfactory performance in two consecutive events (2nd and 3rd events of 2017), resulting in the first unsuccessful occurrence for analyte # 575, Triiodothyronine (T3). Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte # 575 T3 on event 2 of 2017 with a score of 0% and event 3 of 2017 with a score of 60%. 2. Desk review of the laboratory's proficiency testing reports from API confirmed the laboratory failed T3 on events 2 and 3 of 2017 resulting in the first unsuccessful performance. -- 2 of 2 --