Stockbridge-Munsee Hlth & Wellness Center

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was completed on September 17, 2025, the laboratory was found out of compliance with the CLIA regulations. The conditions not met: D2016 - 42 C.F.R. 493.803(a)(b)(c) Condition: Successful Participation D6000 - 42 C.F.R. 493.1403 Condition: Moderate Complexity 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 surveyor review of the federal Certification and Survey Provider Enhanced Reports and American Proficiency Institute proficiency testing reports and interview 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 -- with the Technical Consultant (Staff A), the laboratory failed to successfully obtain an 80% satisfactory testing event score for the prothrombin time test for two of two consecutive events, the first and second events in 2025. See D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (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 surveyor review of federal Certification and Survey Provider Enhanced Reports (CASPER) and American Proficiency Institute (API) proficiency testing (PT) reports and interview with the Technical Consultant (Staff A), the laboratory failed to obtain satisfactory PT scores of at least 80% for two consecutive events for the prothrombin time test (analyte 0845) in the Hematology specialty in 2025, resulting in unsuccessful PT performance. Findings include: 1a. Review of 'CASPER Report 0153D', created September 3, 2025, showed this laboratory had unsuccessful performance for prothrombin time testing (analyte 0845). 1b. Review of 'CASPER Report 0155D', created September 4, 2025. showed the laboratory had unsatisfactory performance for prothrombin time testing in events one and two in 2025. Event one, score 0% Event two, score 60% 2a. Review of API 'Performance Summary' reports showed the following scores for prothrombin time testing in 2025: First Event, score 0% Second Event, score 60% 2b. The API 'Performance Summary, 2025 Hematology / Coagulation - 2nd Event' report identified the prothrombin time performance as unsuccessful. 3. During a video call with Staff A on September 17, 2025, at 2:00 PM, Staff A confirmed the laboratory received unsatisfactory scores for prothrombin time testing for two consecutive PT events in 2025 and confirmed the laboratory's prothrombin time PT performance was unsuccessful. 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 American Proficiency Institute Proficiency Testing (PT) reports and interview with the Technical Consultant (Staff A), the laboratory failed to obtain satisfactory PT scores for prothrombin time testing in the first and second events in 2025, two consecutive events, resulting in unsuccessful PT performance. The laboratory director did not ensure personnel were reporting PT results promptly and accurately to prevent unsuccessful PT performance. See D6004. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently -- 2 of 3 -- and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on proficiency testing desk review of American Proficiency Institute (API) Proficiency Testing (PT) reports and interview with the Technical Consultant (Staff A), the laboratory failed to obtain satisfactory PT scores for the prothrombin time test for two consecutive events in 2025, resulting in unsuccessful PT performance. The laboratory director did not ensure personnel reported PT results promptly and accurately to prevent unsuccessful PT performance. Findings include: 1a. Review of the API 'Performance Summary' report for the first hematology and coagulation event in 2025 showed the laboratory received a score of 0% for all tests included in the event, including the prothrombin time test. The report showed the laboratory failed to participate in the event. 1b. Review of the API 'Performance Summary' and 'Comparative Evaluation' reports for the second event in 2025 showed the laboratory received a score of 60% for prothrombin time testing with unacceptable results for samples COA-06 and COA-07. 2. During a video call with Staff A on September 17, 2025, at 2:00 PM, Staff A confirmed testing personnel did not report PT results from the first event in 2025 timely and confirmed testing personnel did not report prothrombin time results accurately in the second event in 2025. -- 3 of 3 --

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 survey review of chemistry records and procedures and interview the laboratory manager, staff A, the laboratory director did not sign and date twenty-four of twenty-four QuidelOrtho Vitros XT3400 chemistry procedures prior to patient use. Findings include: 1. Review of the QuidelOrtho Vitros XT3400 performance specification verification records showed the Vitros XT 3400 go-live date was May 28, 2024. 2. Review of the QuidelOrtho Vitros XT3400 chemistry procedures showed the laboratory director reviewed and signed the procedures on June 27, 2024. 3. Interview with the staff A on October 8, 2024, at 2:15 PM confirmed the laboratory director did not sign and date new chemistry procedures prior to patient use. 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). This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and procedures and interview with the laboratory manager, staff A, the laboratory did not maintain a copy of each procedure with the date the testing was discontinued for twenty-four of twenty-four retired chemistry procedures. Findings include: 1. Review of maintenance records for the QuidelOrtho Vitros 350 chemistry analyzer showed testing on the analyzer was 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 -- discontinued on May 25, 2024. 2. Review of the QuidelOrtho Vitros 350 chemistry analyzer procedures showed no documentation of discontinuation of the procedures. 3. Interview with staff A on October 8, 2024, at 2:15 PM confirmed the laboratory did not maintain a copy of the procedures related to the retired chemistry analyzer with date of discontinuance. 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 surveyor review of laboratory records and interview with the laboratory manager, staff A, the laboratory director did not review and approve the performance specification verification records for one of one new chemistry analyzers prior to reporting patient results. Findings include: 1. Review of the validation forms for the QuidelOrtho Vitros XT 3400 chemistry analyzer showed the laboratory director signed the performance specification verifications on October 8, 2024. 2. Interview with the staff A on October 8, 2024, at 2:15 PM confirmed the laboratory went live with the QuidelOrtho Vitros XT3400 chemistry analyzer on May 28, 2024, and the director did not review and approve the performance specification verification records prior to reporting patient results. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview the laboratory manager, staff A, the laboratory did not perform calibration verification every six months for three of three chemistry analytes on the QuidelOrtho Vitros XT3400 chemistry analyzer. Finding include: 1. Review of QuidelOrtho Vitros XT 3400 calibration verification records showed calibration verification was performed on all analytes as part of the implementation procedure on March 27, 2024. Further review showed no additional calibration verifications. 2. Review of quality control testing records showed testing was performed between September 27, 2024, when calibration verification was due, and October 8, 2024. 3. Interview with staff A on October 8, 2024, at 2:200 PM confirmed the laboratory did not perform calibration verification every six months for sodium, potassium and chloride on the QuidelOrtho Vitros XT3400 chemistry analyzer. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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 qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures and Individualized Quality Control Plan (IQCP) records and interview with the laboratory manager, staff A, the laboratory did not perform positive and negative quality control on each day of patient testing for the Quidel Sofia 2 Lyme antibody testing for one of one month of patient testing and had not developed an IQCP. Findings include: 1. Review of Quidel Sofia 2 procedure stated a positive and negative control were run with each new lot of reagents. 2. Review of IQCP records showed no evidence of an IQCP specific for the Sofia. 3. Interview with staff A on October 8, 2024, at 12:10 PM confirmed the laboratory did not perform a positive and negative quality control on each day of patient testing and had not developed an IQCP for the Quidel Sofia 2 Lyme antibody test. -- 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 surveyor review of the federal Certification and Survey Provider Enhancement Reports (CASPER) Proficiency Testing (PT) and American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory failed to successfully participate in PT for Thyroid Stimulating Hormone (TSH) analyte in the Specialty of Chemistry/sub-specialty of endocrinology for events 2022-3 and 2023-1. See D2107. 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 surveyor review of the federal Certification and Survey Provider Enhancement Reports (CASPER) Proficiency Testing (PT) and American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory failed to successfully participate in PT for the Thyroid Stimulating Hormone (TSH) analyte in the Specialty of Chemistry/sub-specialty of endocrinology for events 2022-3 and 2023-1. Findings include: 1. Review of the PT records in the CASPER reporting system showed the laboratory failed two consecutive PT events for the TSH analyte in the Specialty of Chemistry/sub-specialty of endocrinology: Event 2022-3: score 40% Event 2023-1: score 60% 2. Review of the API PT evaluation reports on March 21, 2023, confirmed the failed PT scores for the TSH analyte in the Specialty of Chemistry/sub-specialty of endocrinology. This results in failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events which is an unsuccessful performance. -- 2 of 2 --

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or 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 unacceptable analyte or 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 surveyor review of American Proficiency Institute (API) Chemistry Core proficiency testing (PT) records and interview with a technical consultant and testing personnel, the laboratory did not evaluate three of three unsatisfactory scores for event two in 2020 to employ the technical assistance necessary to correct problems associated and did not perform remedial action. Findings include: 1. Review of the API Chemistry Core PT event two in 2020 showed the following results: a. Prostate- Specific Antigen (PSA): 0% b. Thyroid Stimulating Hormone (TSH): 40% c. Vitamin B-12: 50% Further review showed no evidence the laboratory evaluated the scores to correct problems associated with the results and did not perform remedial action. 2. Interview with the technical consultant and testing personnel, staff A, on January 19, 2021 at 11:55 AM, confirmed the laboratory did not evaluate three of three unsatisfactory scores for Chemistry Core event two in 2020 to employ the technical assistance necessary to correct the problems associated with the results and did not perform remedial action. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(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 2 -- The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on surveyor review of American Proficiency Institute (API) proficiency testing (PT) records and interview with a technical consultant and testing personnel, the laboratory did not evaluate the accuracy for fifty-one of sixty-eight "Educational Blood Cell Identification" proficiency testing results in 2019 and 2020. Findings include: 1. Review of API Hematology PT records showed the laboratory did not evaluate the accuracy for fifty-one of sixty-eight ungraded "Educational Blood Cell Identification" results in 2019 and 2020. 2. Interview with a technical consultant and testing personnel, staff A, on January 19, 2021 at 11:55 AM, confirmed the laboratory did not evaluate the accuracy for fifty-one of sixty-eight "Educational Blood Cell Identification" PT results in 2019 and 2020. This is a repeat deficiency from September 15, 2010. 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 surveyor review of laboratory procedures and interview with the technical consultant and testing personnel, the laboratory director did not approve updates to two of two procedures prior to use. Findings include: 1. Review of the laboratory procedure manual showed the laboratory updated the "Daily Start Up" and "Daily Shut Down" procedures on May 19, 2020. The procedures show no evidence of review or approval by the laboratory director. 2. Interview with the technical consultant and testing personnel, staff A, on January 19, 2021 at 12:15 PM, confirmed the laboratory director did not review or approve two of two procedures prior to use. This is a repeat deficiency from July 27, 2016 and August 30, 2018. -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records and test volumes, and interview with testing personnel the laboratory does not verify the accuracy of the potassium hydroxide (KOH) testing performed on skin scrapings twice annually. Findings include: 1. Review of PT records showed the laboratory does not participate in a program that includes testing of skin scrapings with KOH. 2. Test volume records showed 15 KOH tests were performed in the last year. 3. Interview with testing personnel, staff A, on August 30, 2018 at 9:30 AM confirms the laboratory does not verify the accuracy of KOH testing of skin scrapings twice annually. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)