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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 laboratory's American Proficiency Institute (API) proficiency testing (PT) records and staff interview, the laboratory director/designee failed to sign three of nine attestation statements from 2024. The findings include: 1. A review of the laboratory's 2024 API proficiency testing attestation statements revealed the laboratory director/designee failed to sign the attestation statements for the following: - Hematology 2024 third event - Chemistry 2024 third event - Microbiology 2024 third event 2. An interview with the laboratory lead on 02.14.2025 at 12:30 p.m. confirmed the above survey findings. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) (a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and staff interview, the laboratory failed to retain all records for nine of nine proficiency testing events in 2023. The findings include: 1. A review of the laboratory's API PT records revealed the following: - No records were available for the laboratory's 2023 Hematology first, second, or third events. - No 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 -- records were available for the laboratory's 2023 Chemistry first, second, or third events. - No records were available for the laboratory's 2023 Microbiology first, second, or third events. 2. An interview with the laboratory lead on 02.14.2025 at 8:45 a.m. confirmed the above survey findings. 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 a review of the Centers for Medicare & Medicaid Services Laboratory Personnel Report form (CMS-209), a review of laboratory policy, testing personnel (TP) records, and staff interview, the laboratory failed to follow the "Laboratory Competency" policy for evaluating annual competency for two of eight moderately complex testing personnel performing Potassium Hydroxide (KOH) and Direct Wet Mount patient testing in 2024. The findings include: 1. A review of the CMS-209 revealed eight persons (TP1, TP2, TP3, TP4, TP5, TP6, TP7 and TP8) who perform moderately complex patient testing. 2. A review of the "Laboratory Competency" policy revealed the following statement: -"Documentation of competency for new staff member will be maintained at 30, 60, 90 days and annually thereafter in the employees' folder." 3. A review of the laboratory's testing personnel records revealed no documentation of 2024 annual competency assessments for moderately complex testing personnel TP7 and TP8 that performed KOH and Direct Wet Mount patient testing in 2024. 4. An interview with the laboratory lead on 02.14.2025 at 12:30 p.m. confirmed the above survey findings. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of laboratory procedures, request for -- 2 of 3 -- calibration verification records and staff interview, the laboratory failed to perform calibration verification on the Beckman Coulter AU480 and the Abbott Architect i1000 in 2024. The findings include: 1. Observation of the laboratory on 02.14.2025 at 10:05 am revealed the Beckman Coulter AU480 (serial # 2014093539) and the Abbott Architect i1000 (serial # ISR51897) in use for patient testing for serum chemistry and endocrinology. 2. Review of the laboratory "Calibration Testing" procedure revealed the following frequency for linearity (calibration verification): -Beckman Coulter AU480-every 6 months -Abbott Architect i1000- every 6 months 3. Request for calibration verification records for the Beckman Coulter AU480 and the Abbott Architect i1000 revealed no calibration verification studies had been performed in 2024. 4. An interview with the laboratory lead on 02.14.2025 at 12:30 p.m. confirmed the findings. -- 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 review of the Centers for Medicare and Medicaid Services CASPER Report 155 (CMS 155) and the laboratory's proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory participation for two consecutive proficiency testing events in 2024, resulting in initial unsuccessful participation for the automated white blood cell differential (WBC DIFF) analyte. (See 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 desk review of the CMS 155 and the laboratory's American Proficiency Institute (API) PT evaluation reports, the laboratory failed to maintain satisfactory performance for two consecutive test events for the automated white blood cell differential (WBC DIFF) analyte, resulting in initial unsuccessful PT occurrence. The findings include: 1. A review of the CMS 155 report revealed the following unsatisfactory WBC DIFF scores: - 2024 Event one: 0% - 2024 Event two: 0% 2. A review of the laboratory's API PT evaluation report revealed the following unsatisfactory WBC DIFF scores: - 2024 Event one: 0% - 2024 Event two: 0% -- 2 of 2 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and staff interview, determined the laboratory director failed to sign the attestation sheets for 6 of 6 PT events for 2022. The findings include: 1. Request of the laboratory's PT records revealed the following: -Attestation pages not signed by the laboratory director for the following: Chemistry 2022 event one, two, and three Hematology/Coagulation 2022 event one, two, and three 2. Interview with the lead testing person (TP#1) at approximately 1:00 p.m. on 07.26.2023 confirmed the above findings. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Citation 1 Based on review of the laboratory's procedure manual, review of the laboratory's monthly quality control reports and staff interview, determined that the laboratory failed to follow its' own written policy for reviewing quality issues monthly Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- for 17 of 17 months from January 2022 through May 2023. The findings include: 1. Review of the laboratory's procedure manual under the section titled, "Quality Improvement Plan" revealed the following statement, "Quality issues will be reviewed monthly. Records of any problems identified, actions taken, and results of such actions will be maintained, evaluated by the Medical Director and shared will all staff members on a regular basis." 2. Review of the laboratory's monthly quality control reports for January 2022 through May 2023 revealed no documented laboratory director/medical director review and/or signature for 17 of 17 months. 3. Interview with the lead testing person (TP#1) at approximately 1:00 p.m. on 07.26.2023 confirmed the laboratory failed to follow its' own written policy for reviewing quality issues monthly for 17 of 17 months from January 2022 through May 2023. Citation 2 Based on direct observation, document request, and staff interview, determined the laboratory failed to have a procedure for performing KOH/Wet Prep patient testing for 19 of 19 months, from January 2022 through the survey date of 07.26.2023 The findings include: 1. Direct observation of the "nurse's station" beside the laboratory at approximately 9:45 a.m. on 07.26.2023 revealed an OMAX microscope, EDM 3 Solutions Potassium Hydroxide 10% solution, and NaCl solution on the counter. 2. Request for the procedure for performing KOH/Wet Prep testing revealed there was no procedure available. 3. Interview with the lead testing person (TP#1) at approximately 1:00 p.m. on 07.26.2023 confirmed the laboratory did not have a procedure for performing KOH/Wet Prep testing for 19 of 19 months, from January 2022 through the survey date of 07.26.2023. Word Key: NaCl= Sodium chloride D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on direct observation, record request, review of instrument reference guide, and staff interview, determined the laboratory failed to perform quality control (QC) each day of patient testing or develop and implement an Individualized Quality Control Plan (IQCP) for Chlamydia, Neisseria, and Trichomonas for patient testing on the Cepheid GeneXpert after 07.06.2022 through the survey date of 07.26.2023 The findings include: 1. Direct observation of the laboratory at approximately 1:00 p.m. on 07.26.2023 revealed a Cepheid GeneXpert in use for patient testing. 2. Request for QC for Chlamydia, Neisseria, and Trichomonas on the Cepheid GeneXpert revealed none had been performed since 07.06.2022 with 737 patient results from 07.06.2023 through the survey date of 07.26.2023. 3. Review of the GeneXpert Reference guide revealed, "Positive and negative external controls should be used in accordance with local, state, and federal accrediting organizations' requirements as applicable." 4. No IQCP for Chlamydia, Neisseria, and Trichomonas on the Cepheid GeneXpert was available for review at the time of survey on 07.26.2023. 5. Interview on at approximately 11:00 a.m on 07.26.2023 with the lead testing persone (TP#1) confirmed the laboratory did not perform QC daily and did not have an IQCP in place -- 2 of 4 -- for Chlamydia, Neisseria, and Trichomonas for patient testing on the Cepheid GeneXpert after 07.06.2022 through the survey date of 07.26.2023. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that 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 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 competency policy, the Centers for Medicare and Medicaid Services Laboratory Personnel Report (Form CMS-209), testing personnel records, and interview with the lead testing person, the laboratory failed to follow the policy for competency assessment in 2020 and 2021. 1) Review of the laboratory's competency policy revealed that "Documentation of competency for new staff member will be maintained at 30, 60, 90 days and annually therafter in the employee's folder." 2) Review of the CMS-209 revealed seven of seven testing personnel were performing moderately complex testing. 3) Review of testing personnel records revealed no documentation of annual competency assessments for seven of seven testing personnel for 2020 and 2021. 4) Interview with the laboratory lead testing person at approximately 12:45pm on February 23, 2022 confirmed the laboratory failed to follow the policy for competency assessment in 2020 and 2021. =================================== Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --