Pravinchandra P Patel Mdpc

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on review of the Cell Dyn Emerald QC (quality control) records from 3/10 /2021 through 10/4/2022 and confirmation with TP #1 at 4:00 p.m., the laboratory failed to retain the QC assay sheets for each lot used. QC assay sheets include acceptable ranges, storage requirements, lot numbers and standard deviations and should be kept for a minimum of 2 years. Findings include: 1. Review of the Cell Dyn Emerald QC records indicated that QC lot #1319 was in use on the day of the survey. 2. Review of the Cell Dyn Emerald QC records from 03/10/2021 until 10/4/2022, revealed the following hematology QC lots had been used and no assay sheets retained. a. Cell Dyn QC lot #2038 low, normal, high b. Cell Dyn QC lot #2122 low, normal, high c. Cell Dyn QC lot #2206 low, normal, high d. Cell Dyn QC lot #1067 low, normal, high e. Cell Dyn QC lot #1151 low, normal, high 3. Interview with the TP #1 at 4:00 p.m. on 10/04/2022 confirmed the lab did not retain all QC assay sheets with the change of each lot number of QC material for the Cell Dyn Emerald hematology analyzer. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if 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 -- applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of laboratory records since 03/10/2021 and confirmation with the laboratory director/technical consultant (LD/TC) and TP #1 and #3 at 6:00 p.m. on 10 /04/2022, the laboratory failed to monitor and document the room temperature where hematology testing was performed. Findings include: 1. Observation of the laboratory room where hematology testing was performed revealed no thermometer to monitor the room temperature for optimal performance of the Cell Dyn Emerald hematology analyzer. 2. Cell Dyn Emerald manufacturer's instructions require: a) The Cell Dyn Emerald reagent, lyse and detergent should be stored at a temperature range of 18-32 degrees Celsius (C). b) Operating specifications for the Cell Emerald hematology analyzer require a room temperature of 18- 32 degrees C. c) Quality control and calibration materials for the Cell Dyn Emerald must be allowed to come to room temperature before testing. 3. Interview with the LD/TC, TP#1, and TP#3 at 6:00 p.m. on 10/04/2022 confirmed no room temperatures were being monitored and documented. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of the Cell Dyn Emerald hematology calibration records from 03/10 /2021 through 10/04/2022 and interview with TP #1 and TP #3 at 3:30 p.m. on 10/04 /2022, the laboratory failed to perform calibration on the Cell Dyn Emerald hematology analyzer every 6 months as required by the manufacturer. Findings include: 1. Review of the Cell Dyn Emerald calibration records revealed calibration was performed on 03/12/2021, 9/30/2022 and 10/04/2022. These calibration time frames exceed the 6 month mandatory calibration requirement of manufacturer. 2. Interview with the TP #1 and TP# 3 3:30 p.m. on 10/04/2022 confirmed CBC calibrations were not performed every 6 months. D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) 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 4 -- and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing (PT) records, the Centers for Medicare and Medicaid Services (CMS) proficiency data system report (CASPER 0155D), and interview with TP#1 at 5:30 p.m. on 10/04/2022, the laboratory director failed to ensure that results were returned within the timeframe established by the proficiency testing program for the 3rd event of 2021. Findings include: 1. Based on review of the proficiency records and the CMS proficiency data base--CASPER report 0155D, the laboratory performed the 3rd event of proficiency testing for CBC (complete blood count) but results were not submitted in time to be graded for participation. The PT event was graded as 0% for nonparticipation. 2. Interview with TP #1 at 5:30 p.m. on 10/04/2022 confirmed the proficiency samples were tested but were not returned within the timeframe in order to be graded. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of laboratory testing records from 03/10/2021 through 10/04/2022 and interview with the LD/TC, TP #1 and #3 at 6:00 p.m. on 10/04/2022, maintenance, QC (quality control), calibration, temperature and proficiency records listed below had not been documented as reviewed by the technical consultant (TC). Findings Include: 1. Review of the laboratory records from 03/10/2021 through 10/04 /2022 revealed the following records were not documented as reviewed by the TC: a. Cell Dyn Emerald hematology maintenance records from 3/25/2021 through 10/4 /2022 b. Temperature records (refrigerator, freezer) from 03/22/2021 through 10/04 /2022 c. Cell Dyn Emerald hematology QC records from 03/25/2021 through 10/04 /2022 d. Cell Dyn Emerald hematology calibration on 03/12/2021 and 09/30/2022 e. Proficiency records (1st and 3rd events of 2021 and 1st and 2nd events of 2022) 2. Interview with the LD/TC, TP #1 and TP #3 at 6:00 p.m. on 10/04/2022 confirmed there was no documented review of these records by the TC during this time period. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of laboratory testing personnel (TP) records including the Centers of Medicare and Medicaid Services (CMS) 209 personnel form and interview with the laboratory director (LD) and TP#1, the technical consultant failed to evaluate annually -- 3 of 4 -- and document the performance of testing personnel #2 who is responsible for performing moderate CBC (complete blood count) testing. Findings include: 1. Based on laboratory personnel records available for review on the day of survey, there was no annual evaluation/competency performed by the technical consultant on TP #2 since 01/13/2021. 2. Interview with the LD and TP #1, #2 and #3 on 10/04/2022 at 5: 30 p.m. confirmed no annual evaluation/competency for TP #2 had been documented as performed by the technical consultant for 2022. -- 4 of 4 --

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 12/20/2021, the laboratory has not successfully participated in proficiency testing for WHITE BLOOD CELL (WBC) DIFFERENTIAL. Findings include: Our records indicate the following proficiency testing scores for your laboratory for WHITE BLOOD CELL (WBC) DIFFERENTIAL: PROFICIENCY TESTING PROVIDER: American Academy of Family Physicians WHITE BLOOD CELL (WBC) DIFFERENTIAL: Year 2021 2nd Event 13% Year 2021 3rd Event 0% Scores less than 80% for this analyte or 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 -- 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. D2130 HEMATOLOGY CFR(s): 493.851(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 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 12/20/2021, the laboratory has not successfully participated in proficiency testing for WHITE BLOOD CELL (WBC) DIFFERENTIAL. Findings include: Our records indicate the following proficiency testing scores for your laboratory for WHITE BLOOD CELL (WBC) DIFFERENTIAL: PROFICIENCY TESTING PROVIDER: American Academy of Family Physicians WHITE BLOOD CELL (WBC) DIFFERENTIAL: Year 2021 2nd Event 13% Year 2021 3rd Event 0% 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 --