Jones Family Medicine Clinic Pllc

Summary Statement of Deficiencies 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: Based on review of quality control (QC) records for CK-MB and Troponin I testing on the Alere Triage Meter Pro from 4-17-19 through 11-1-19, the laboratory's Individualized Quality Control Plan (IQCP), instruments printouts of patient results, and confirmation by the technical consultant on 12-17-19 at 4:30 p.m., the laboratory failed to follow its IQCP for performing two levels of external quality control at least every thirty days and with each new lot or shipment of test cartridges, when a total of twenty-seven patients were tested for CK-MB and Troponin I. Findings include: Review of the laboratory's IQCP and interview with the technical consultant on 12-17- 19 at 4:30 p.m. revealed the laboratory's IQCP states that external controls for CK- MB and Troponin I testing on the Alere Triage Meter Pro will be performed at least every thirty days and with each new lot or shipment of test cartridges. Review of QC records for CK-MB and Troponin I testing on the Alere Triage Meter Pro from 4-17- 19 through 11-1-19 revealed external controls for CK-MB and Troponin I testing were not documented, as performed, from 6-17-19 until 11-1-19. The following patients were tested for CK-MB and Troponin I on the Alere Triage Meter Pro from 7-20-19 through 9-19-19, without external controls performed in the previous 30 days: 7-20- 19--Patients #26737, #2495. 7-21-19--Patient #10817. 7-27-19--Patient #7719. 7-30- 19--Patient #20087. 8-3-19--Patient #14207. 8-4-19--Patient #63446. 8-5-19--Patient #13007. 8-6-19--Patient #2359. 8-7-19--Patient #6700. 8-9-19--Patient #58334. 8-10- 19--Patient #6989. 8-15-19--Patient #14494. 8-22-19--Patient #13836. 8-23-19-- Patient #16483. 8-26-19--Patient #12908, #53821. 8-30-19--Patient #40664, #12977. 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 -- 8-31-19--Patient #59298. 9-1-19--Patient #10854. 9-5-19--Patient #25445. 9-6-19-- Patient #46660. 9-7-19--Patient #64510. 9-9-19--Patient #43270. 9-11-19--Patient #2562. 9-19-19--Patient #14679. 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 observation of the TOSOH AIA-Pack PSA (prostate specific antigen) reagent test pack in the laboratory refrigerator on 12-17-19 at 10:15 a.m. and review of instrument printouts for the TOSOH AIA-360 analyzer from 12-1-19 through 12- 16-19, the PSA reagent test pack, Lot #12128A9, was used for PSA testing on twenty- seven patient specimens after it had exceeded its expiration date of 11-30-19. Findings include: Observation of the TOSOH AIA-Pack PSA reagent test pack, Lot #12128A9, in the laboratory refrigerator on 12-17-19 at 10:15 a.m. revealed the manufacturer's expiration date for the test pack was 11-30-19. Review of instrument printouts of patient test results for the TOSOH AIA-360 analyzer from 12-1-19 through 12-16-19 revealed the PSA reagent test pack, Lot #12128A9, was used for testing on the following patient specimens for six days after it had exceeded its expiration date of 11- 30-19: 12-4-19--Patient #1032075, #1032076, #1032077, #1031980. 12-6-19--Patient #1032117, #1032118, #1031962, #1032019, #1032116. 12-9-19--Patient #1032172, #1032173, #1032174, #1032099, #1032130, #1032097. 12-11-19--Patient #1032234, #1032235, #1032236, #1032201. 12-13-19--Patient #1032342, #1032343, #1032344. 12-16-19--Patient #1032435, #1032436, #1032437, #1032422, #1032423. 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 review of calibration verification records for the TOSOH AIA-360 analyzer since the last survey on 12-19-17 and confirmation by the technical consultant, the laboratory failed to document, as performed, calibration verification for T3 Uptake testing at least once every six months since 11-12-18. Findings include: Review of calibration verification records for the TOSOH AIA-360 analyzer since the last survey on 12-19-17 revealed no documentation of calibration verification performed for T3 Uptake testing since 11-12-18. The technical consultant confirmed T3 Uptake calibration verification had not been performed since 11-12-18. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records for CK-MB and Troponin I testing on the Alere Triage Meter Pro from 4-17-19 through 11-1-19, the laboratory's Individualized Quality Control Plan (IQCP), instruments printouts of patient results, and confirmation by the technical consultant on 12-17-19 at 4:30 p.m., testing personnel, responsible for moderate complexity testing, failed to follow the laboratory's IQCP for performing two levels of external quality control at least every thirty days and with each new lot or shipment of test cartridges, when a total of twenty-seven patients were tested for CK-MB and Troponin I from 7-20-19 through 9- 19-19. Refer to D5401 (Failure to follow IQCP for CK-MB and Troponin I testing). -- 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 desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 7/26/18, the laboratory had not successfully participated in proficiency testing for SODIUM. Findings include: Our records indicate the following proficiency testing scores for your laboratory for SODIUM. PROFICIENCY TESTING PROVIDER: American Proficiency Institute SODIUM: Year 2017 3rd Event 40% Year 2018 2nd Event 40% Scores less than 80% for this 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 -- analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 7/26/18, the laboratory had not successfully participated in proficiency testing for SODIUM. Findings include: Our records indicate the following proficiency testing scores for your laboratory for SODIUM. PROFICIENCY TESTING PROVIDER: American Proficiency Institute SODIUM: Year 2017 3rd Event 40% Year 2018 2nd Event 40% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 2 of 2 --