Sharp & Stone Ob/Gyn

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with the new Laboratory Director, the laboratory failed to ensure the previous Laboratory Director signed the attestation statements for four of four events reviewed in 2023 through 2024. The findings include: 1. A review of the API PT records revealed the no signature by the previous Laboratory Director (or designee) on attestation statements for the following surveys: a) 2023 Hematology 1st Event. b) 2023 Hematology 2nd Event. c) 2023 Hematology 3rd Event. d) 2024 Hematology 1st Event. 2. During an interview on 7/31/2025, at 12:37 PM, the new Laboratory Director confirmed the above findings. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on a review of Hematology records and an interview with the Office Manager, the laboratory failed to retain documentation of daily CBC (Complete Blood Counts) 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 -- calibrations performed on the Medonic Hematology analyzer in 2023 and 2024. This was noted for two possible calibrations, one for the second half of 2023 and one for the first half of 2024. The findings include: 1. A review of the Medonic Hematology analyzer revealed the laboratory discontinued CBC testing in May 2024. The last documented calibration provided was performed on 5/13/2023. There was no evidence of a documented calibration performed the second half of 2023 and the first half of 2024. 2. In an interview on 7/31/2025 at 12:37 PM, the Office Manager told the Surveyor she would email the calibration documentation. As of 8/15/2025, no calibration documentation has been received by the Surveyor. 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 a review of the lack of bi-annual accuracy verification for Wet Prep documentation, and an interview with the new Laboratory Director, the laboratory failed to implement a mechanism for performing accuracy verification or perform proficiency testing on Saline Wet Prep testing. This was noted since the previous survey on 3/21/23 to the current survey on 7/31/25. The findings include: 1. A review of the bi-annual accuracy verification documentation for Saline Wet Prep revealed the laboratory discontinued proficiency testing through American Proficiency Institute (API) and failed to implement an alternative accuracy verification method twice yearly. 2. During an interview on 7/31/25 at 12:37 PM, the new Laboratory Director confirmed the above findings. 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 a review of the 2023-2024 API (American Proficiency Institute) Proficiency Testing records and an interview with the Office Manager, it was determined the Laboratory Director failed to document review of returned results, and/or failed to perform and document

Summary Statement of Deficiencies D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of the API (American Proficiency Institute) proficiency testing (PT) records, training and competency evaluations for the testing personnel listed on CMS Form-209, and an interview with Testing Personnel (TP) #1, the laboratory failed to ensure proficiency testing samples were rotated between all personnel who routinely performed Hematology testing on patients. This was noted on all 2016-2018 surveys. The findings include: 1. A review of API attestation statements revealed Testing Personnel TP #1 performed the Hematology testing (all samples) on all 2016- 2018 surveys: Event #1-2016 thru Event #2-2018 (eight surveys). 2. A review of training and competency evaluations in the personnel records revealed the following: A) TP #2 and #3 were full time, and had been qualified as a testing personnel since the previous CLIA survey, and B) TP #4 had been performing patient testing since November 2017. 3. During an interview on 11/27/2018 at 11:50 AM, the surveyor reviewed the PT records and the testing personnel on the CMS Form-209 with TP #1. When asked if the PT had been rotated between all personnel who performed patient testing, TP #1 stated, "I am the only one who does PT". Thus the above noted findings were confirmed. . D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. 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 API (American Proficiency Institute) proficiency testing (PT) records and an interview with Testing Personnel #1, the laboratory failed to document reviews of two out of three of the returned 2017 Hematology survey results evaluations (scores). The findings include: 1. A review of the API PT records revealed no documentation of review (as indicated by a signature and date) of returned evaluations for the Events #2 and #3 2017 Hematology surveys. 2. In an interview and review of the records on 11/27/2018 at 12:50 PM, Testing Personnel #1 confirmed the laboratory had failed to document a review of the above noted surveys. . D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on reviews of the Hematology quality control records, and an interview with Testing Personnel #1, the surveyor determined the laboratory failed to implement a mechanism to monitor quality control (QC) shifts and trends over time from May 2017 till the date of the current survey (11/27/2018). The findings include: 1. A review of the 2016-2018 Medonic Hematology analyzer QC records revealed only the daily QC instrument printouts had been printed and retained after May 2017. 2. During an interview on 11/27/2018 at 12:55 PM, Testing Personnel #1 was asked if the laboratory had implemented a new mechanism to routinely monitor control shifts and trends, such as submission of the QC results to an Interlaboratory Quality Assurance Program (IQAP), or printing cumulative Levy-Jennings (L-J) charts (as they had until May 2017). Testing Personnel #1 explained in May 2017, the Medonic company had changed the QC reporting mechanism from paper to "a stick" [electronic data], and the laboratory never received any QC reports thereafter. The laboratory had been unsuccessful in their attempts to receive any assistance from the company to resolve the issue, and had not been able to print L-J charts since May 2017. Thus the above noted findings were confirmed. . D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of the 2017 Hematology quality control (QC) records, the patient results log, and an interview with Testing Personnel #1, the laboratory failed to ensure at least two levels of quality control were run and acceptable, prior to analyzing patient specimens and reporting the results. The findings include: 1. A review of the QC records for Medonic Hematology analyzer revealed no record of QC for 10/13 /2017. 2. A review of the cumulative patient log printed from the instrument revealed one patient CBC (Complete Blood Count) was performed on 10/13/2017. 3. During an interview on 11/27/2018 at 3:50 PM, Testing Personnel #1 reviewed the Hematology records and was unable to find QC results for the above mentioned date, and found one patient CBC had been run and reported. Thus the above findings were confirmed. . D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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 and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on a lack of documentation in the personnel file for Testing Personnel #4 and an interview with TP #1, the Laboratory Director failed to ensure training for TP #4 was performed and documented before patient CBC (Complete Blood Count) testing began. This was noted on the records for one of four testing personnel. The finding include: 1. A review of the documentation provided for TP #4 revealed no evidence of training on the Medonic Hematology analyzer procedures. 2. During an interview on 11/27/2018 at 11:50 AM, the surveyor asked TP #1 about the scope of responsibilities for TP #4. TP #1 stated TP #4 only performed CBC (Complete Blood Count) testing on the quality control and patients samples. When asked if TP #4 received training to perform this procedure, TP #1 stated she had trained TP #4 "in the Fall 2017" (November 2017 according to Quality Assurance records), however she had no documentation of the training. Thus the above noted findings were confirmed. SURVEYOR:Laura T. Williams, BS, MT (ASCP) Licensure and Certification Surveyor -- 3 of 3 --