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Summary Statement of Deficiencies D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: The laboratory failed to follow the manufacturer's instructions (Refer to D5411); the laboratory failed to follow the Centers for Medicare and Medicaid Services (CMS) Individualized Quality Control Plan (IQCP) Procedure (Refer to D5445); the laboratory failed to run two external controls for the Alere Oratect Oral Fluid Drug Screen for moderate complexity testing (Refer to D5449); the laboratory failed to have an effective plan for correction and resolution of analytical problems and procedures in place to prevent recurrence (Refer to D5793) resulting in Immediate Jeopardy. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: 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 -- BASED ON STATEMENT NUMBER ONE: Based on review of the manufacturer's instructions for the Qualigen FastPack instrument, calibration logs, Quality Control (QC) logs, and interview with the Laboratory Director determined the laboratory failed to follow the manufacturer's instructions for performing QC with each calibration in 2018, resulting in Immediate Jeopardy. The findings include: 1. Review of the Qualigen FastPack manufacturer's instructions revealed under Individualized Quality Control Plan (IQCP): "QC testing frequency may be decreased from daily to weekly* if: a. If the IQCP Risk Assessment determined that the lab's risk level are manageable b. All QC testing performed over the initial 10 day period is satisfactory c. There are no other quality problems noted on the monthly QA Assessment *Even if you adopt a weekly QC frequency, performing QC should still be performed ... after calibration ..." 2. Review of the calibration and QC logs for the Qualigen instrument revealed: a. Thyroid Stimulating Hormone (TSH) with QC not performed after calibrations from January 26 through the date of initial survey on September 7, 2018, for 138 patients. b. Vitamin D with QC not performed after calibrations from January 26 through the date of initial survey on September 7, 2018, for 153 patients. c. Prostatic Specific Antigen (PSA) with QC not performed after calibrations from January 26 through the date of initial survey on September 7, 2018, for 36 patients. d. Testosterone (Testo) with QC not performed after calibrations from January 26 through the date of initial survey on September 7, 2018, for 53 patients. 3. Interview with the Laboratory Director on September 7, 2018, at approximately 1:30 PM confirmed the laboratory failed to perform QC after each calibration for the TSH, Vitamin D, PSA, and Testosterone analytes according the manufacturer's instructions for 2018. 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 review of the Qualigen manufacturer's instructions for performance of IQCP, laboratory IQCP documentation, and interview with the Laboratory Director determined the laboratory failed to follow the CMS IQCP procedure guidelines before decreasing the frequency of QC performed in 2018, resulting in Immediate Jeopardy. The findings include: 1. Review of the Qualigen manufacturer's instructions revealed under Individualized Quality Control Plan (IQCP): a. Perform QC daily for 10 business days during the initial period. Record the QC results from the 10 day period in the Quality Assurance Log. b. Complete the 30-day Risk Assessment Checklist. c. Go to www.qualigeninc.com/IQCP to complete the IQCP Risk Assessment (RA) and QC Plan (QCP). d. Complete a Monthly QA Assessment. 2. Review of CMS IQCP procedure guidelines revealed the requirement to completely document the three components of IQCP to include RA, QCP, and QA assessments with the laboratory director's approval/signature. 3. Review of the laboratory IQCP documentation revealed: a. Thyroid Stimulating Hormone (TSH) with QC evaluations only for 1/29 -- 2 of 5 -- /18, 1/30/18, 1/31/18, 2/1/18 and 2/9/18 and then no QC performed after calibrations from January 26 through the date of initial survey on September 7, 2018, for 138 patients. b. Vitamin D with QC evaluations only for 1/30/18, 1/31/18, 2/1/18 and 2/6 /18 and then no QC performed after calibrations from January 26 through the date of initial survey on September 7, 2018, for 153 patients. c. Prostatic Specific Antigen (PSA) with QC evaluations only for 1/30/18, 1/31/18, 2/1/18, and 2/7/18 and then no QC performed after calibrations from January 26 through the date of initial survey on September 7, 2018, for 36 patients. d. Testosterone (Testo) with QC evaluations only for 1/31/18, 2/1/18, and 2/16/18 and then no QC performed after calibrations from January 26 through the date of initial survey on September 7, 2018, for 53 patients. 4. Interview with the Laboratory Director on September 7, 2018, at approximately 1:30 PM confirmed the laboratory failed to follow the Qualigen manufacturer's instructions for performance of IQCP, CMS CMS IQCP procedure guidelines before decreasing the frequency of QC performed and after each calibration for the TSH, Vitamin D, PSA, and Testosterone analytes according the manufacturer's instructions for 2018. 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 observation of the laboratory, review of the manufacturer's instructions for the Alere Oratect Oral Fluid Drug Screen, lack of Quality Control (QC) records, review of patient records, and interview with Laboratory Director, the laboratory failed to perform external positive and negative controls at least once per day with three patients in 2018, resulting in Immediate Jeopardy. The findings include: 1. Observation of the laboratory on September 7, 2018, at 10:00 AM revealed the the Alere Oratect Oral Fluid Drug Screen for moderate complexity testing. 2. Review of the Alere Oratect Oral Fluid Drug Screen manufacturer's instructions revealed " that negative and positive saliva controls be used to initially test each new lot of product to ensure proper kit performance. 3. The laboratory was lacking any QC records for the patient testing on the Alere Oratect Oral Fluid Drug Screen for July 5 and 19, 2018. 4. Review of 3 of 3 patient records revealed testing results for the Alere Oratect Oral Fluid Drug Screen for July 5 and 19, 2018. 5. Interview with the Laboratory Director on September 7, 2018, at approximately 1:30 PM confirmed the laboratory failed to perform external positive and negative controls at least once per day with three patients in 2018. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of