Satish A Shah Md Laboratory

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 competency records and interview with the laboratory director (LD), the laboratory failed to establish and follow the competency of 11 of 12 testing personnel (TP) through internal blind testing or external proficiency testing (PT) samples for hematology testing performed from 08/11/2022 to the date of the survey. Findings include: 1. A review of the laboratory's competency evaluation policy revealed, the laboratory failed to include the following competency requirements- Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. 2. On the day of the survey, 04/29/2024 at 11:45 am, review of the laboratory's competency evaluation checklist revealed the TC failed to evaluate and document test performance of 11 of 12 testing personnel through internal blind sampling, external proficiency testing or previously analyzed samples for complete blood count testing performed from 08/11 /2022 to 04/29/2024. 3. TC #2 confirmed the finding above on 04/29/2024at 01:30 pm. 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 5 -- 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 temperature records, observation of the laboratory, and interview with the laboratory director (LD), the laboratory failed to monitor and document refrigerator and room temperatures to ensure operating conditions were met for the proper storage of hematology reagents and to ensure reliable test system operation of the Medonic M series analyzer from 8/11/2022 to the day of survey. Findings Include: 1. On the day of the survey, 04/29/2024 at 12:30 pm, review of 2 of 2 (07/2022, 08 /2023) months of laboratory's temperature logs revealed the laboratory failed to monitor and document refrigerator and room temperatures for weekends and holidays from 5/24/2022 to the day of survey. 2. During observation of the laboratory the surveyor discovered the following reagents to be stored in the laboratory. 1 of 1 Boule Con Diff quality control High- acceptable storage temperature: 2-10 degrees Celsius 1 of 1 Boule Con Diff quality control Normal- acceptable storage temperature: 2-10 degrees Celsius 1 of 1 Boule Con Diff quality control Low- acceptable storage temperature:2-10 degrees Celsius 2 of 2 Boule Con Diff Tri Level- acceptable storage temperature: 2-8 degrees Celsius. 1 of 1Medonic M Series Pack- acceptable storage temperature: 4-35 degrees Celsius. 3. The LD confirmed the findings above on 04/29 /2024 at 1:30 pm. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on observation of the laboratory, lack of records, and interview with the laboratory director (LD), the laboratory failed to provide documentation of maintenance activities that ensures equipment performance for 3 of 3 thermometers used for temperature monitoring in the laboratory from 08/11/2022 to the day of the survey. Findings include: 1. The laboratory's Maintenance Policy for Digital Thermometer stated, " Temperature and humidity on the primary thermometer should be verified against the secondary thermometer." 2. At the time of survey, 04/29/2024 at 12:30 pm, the laboratory failed to provide documentation of maintenance activities performed for following 3 of 3 thermometers from 08/11/2022 to the day of survey. BCR- refrigerator temperature ACU.RITE- room temperature and humidity THERMPRO- room temperature and humidity 3. The LD confirmed the findings above on 04/29/2024 at 01:30 pm. D5805 TEST REPORT CFR(s): 493.1291(c) -- 2 of 5 -- The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview with the laboratory director (LD) the laboratory failed to include the location where hematology examinations were performed on the patient test report from 08/11/2022 to the day of survey. Findings include: 1. On the day of survey, 04/29/2024 at 11:30 am, review of 2 of 2 patient test report (07/18/2022 and 08/21/2023) revealed documentation of complete blood count test results that did not include the address of where the tests were performed from 08 /11/2022 to 04/29/2024. 2. The LD confirmed the above findings on 04/29/2024 at 01: 30 pm. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of laboratory records, and interview with the laboratory director (LD), the LD failed to provide overall management and direction of the laboratory in accordance with 493.1407 for a moderate complexity laboratory from 08/11/2022 to 04/29/2024. Refer to 6004 and 6022. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on lack of personnel competency records and interview with the laboratory director (LD), the LD failed to evaluate the annual competency of 11 of 12 testing personnel (TP) who performed Hematology testing in 2023. Findings include: 1. According to the laboratory's competency evaluation policy, "evaluations will be -- 3 of 5 -- performed annually for each laboratory tests a person performs." 2. On the day of survey 04/29/2024 at 11:50 am, review of the laboratory's personnel competency records revealed, the TC failed to evaluate the annual competency of 11 of 12 TP who performed complete blood count testing on the Medonic M series hematology analyzer in 2023. 3. The LD confirmed the findings above on 04/29/2024 at 01:30 pm. D6022 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control and quality assessment programs are established and maintained to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records and interview with the laboratory director (LD), the LD failed to ensure that quality control (QC) programs are established and maintained to identify failures as they occur for 4 of 10 analytes on 04 /26/2024 for the Medonic M series analyzer used to perform hematology testing from 08/11/2022 to 04/29/2024. Findings Included: 1. On the day of survey, 04/29/2024 at 01:01 pm, review of laboratory's QC records revealed that the following 4 of 10 hematology analytes failed to meet the laboratory's established acceptable QC criteria for the Medonic M series analyzer on 4/26/2024. - White Blood Cell High QC result 22.6 acceptable ranges 18.7-22.3 - Red Blood Cell High QC result 5.56 acceptable ranges 4.82-5.26 - Hemoglobin High QC result 17.4 acceptable ranges- 15.5-16.5 - Hematocrit High QC result 50.6 acceptable ranges- 42.9-49.9 2. The laboratory could not provide documentation of the

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with the Laboratory Director (LD), the laboratory failed to establish a maintenance policy to assess the maintenance /function for 1 of 1 Acu Rite digital thermometer used to monitor the room temperature and humidity for Medonic M series reagents from July 23, 2020 to the day of survey. Findings Include: 1. On the day of survey, 08/11/2022 at 11:22 AM, the laboratory failed to provide a maintenance policy for 1 of 1 Acu Rite digital thermometer. 2. The following reagent was stored at the room temparature 1 of 1 Medinic M seris pack( Lot# 2205-002, Exp- 2025-01-31). 3. No expiration date or serial number was observed on the Acu Rite digital thermometer. 4. LD confirmed the findings above on 08/11/2022 at 11:40 AM. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under 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 the review of American Proficiency Institute (API) proficiency test (PT) records and interview with the Laboratory Director (LD), the LD failed to ensure that 1 of 6 proficiency testing attestations were signed by the LD in 2022 for Hematology Coagulation PT. Findings include: 1. On the day of the survey 08/11/2022 at 10:08 AM, a review of the PT records revealed that the Laboratory Director failed to sign the API Event 1 2022 Hematology Coagulation proficiency attestations. 2. Interview with LD confirmed these findings above on 08/11/2022 at 11:40 AM. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of competency assessment records and interview with Laboratory Director (LD), the Technical Consultant (TC) failed to evaluate the test performance of 11 of 12 testing personnel (TP) through internal blind testing samples or external Proficiency Testing (PT) samples for Complete Blood Count (CBC) assay examinations from 07/23/2020 to 08/11/2022. . Findings Include: 1. At the time of survey, 08/11/2022 at 10:39 AM, a review of the competency assessment records revealed, the laboratory failed to establish a procedure to assess test performance of 11 of 12 TP through internal blind testing samples or external PT samples from 2020 to 2022 who performed CBC examinations on the Medonic M series analyzer. 2. A review of 11 of 12 TP competency assessments revealed that they were missing the following point "Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples;" 3. The LD confirmed the findings above on 06/08/2022 around 11:40 am. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of the CLIA ' s Laboratory Personnel Report (Form CMS-209), review of personnel qualification records, and interview with the Laboratory Director (LD) the laboratory failed to ensure that each individual performing Moderate Complexity testing 1 of 12 testing personnel is qualified. Refer to D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology -- 2 of 3 -- from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of the CLIA's laboratory Personnel Report (Form CMS-209), review of Personnel Qualification records, and interview with the Laboratory Director (LD), the laboratory failed to ensure that 1 of 12 performing moderate complexity testing from April, 2022 to August 11, 2022 is qualified. Findings include: 1. At the time of the survey (08/11/2022 at 09:50 am) the laboratory failed to provide the educational credential for 1 of 12 TP (CMS 209 personnel #2) who performed complete blood count (CBC) from april, 2022 to August 2022. 2. LD confirmed the findings above on 08/11/2022 at 11:40 am. -- 3 of 3 --