Harvey S Kleiner Do, Llc

Summary Statement of Deficiencies D0000 A recertification survey was conducted on March 17, 2022. Kleiner & Fernandez MDs clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 record review and interview, the Laboratory Director failed to have documentation of the signing of the attestation form for proficiency testing (PT) for six of six (2020 1st, 2nd, 3rd & 2021 1st, 2nd, 3rd events) for the specialty of hematology. Findings: Review of the American Proficiency Institute (API) Attestation Statement noted "Signatures Required - Testing personnel and laboratory director must physically sign an attestation statement for PT results, and retain the signed statement (or a copy) for a minimum of 2 years." Review of the API PT records showed the attestation statement were signed by the Office Manager. On 03/17/2021 at 9:55 AM, the Office Manager acknowledge the attestations were not signed by the Laboratory Director. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in 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 2 -- This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to document the review and evaluation of proficiency testing (PT) for five (2020 2nd, 3rd & 2021 1st, 2nd, 3rd) of six (2020 1st, 2nd, 3rd & 2021 1st, 2nd, 3rd) events for the specialty of hematology. Findings: Review of the American Proficiency Institute (API) PT showed the Laboratory Director failed to sign the "Proficiency Testing Performance Evaluation" forms for 2nd and 3rd events in 2020, and the 1st, 2nd, and 3rd events in 2021. On 03/17/2021 at 9:55 AM, the Office Manager acknowledge the attestations were not signed by the Laboratory Director. 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 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 record review and interview, the laboratory failed to record the room temperature of rooms where testing was performed from 03/17/2020 to 03/17/2022. Findings: Review of the operation manual for the laboratory's Abbott Cell-Dyn 1800 hematology analyzer noted "To ensure the instrument and reagents function properly, it is important to maintain the temperature between 64 degrees F and 86 degrees F (18 degrees C and 30 degrees C)". No room temperature logs was available for review. On 03/17/2022 at 10:32 PM, Testing Personnel A stated they did not record the room temperature of the laboratory. Word Key F = Fahrenheit C = Celsius -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on March 17, 2020. Kleiner & Fernandez MDs clinical laboratory was found not in compliance with 42 CFR 493, requirements for clinical laboratories. 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. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed provide documentation of calibration verification every six months between 10/11/18 and 10/11/19 on the 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 -- Abbott Diagnostic Cell Dyn 1800 Hematology analyzer. Findings: Review of calibration verification records for the hematology analyzer showed that calibration verifications were performed on 10/11/18 and 10/11/19 (12 months apart). During an interview on 3/17/16 at 2:22 PM, Testing Personnel A stated she was unable to locate the missing calibrations records. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory reported patient results on six days for 2 (lot #331803, #319030) out of 3 (lot #31712, #331803, #319030) lot numbers examined for the Abbott Diagnostic Cell Dyn 1800 Hematology analyzer when at least 2 out of 3 daily control values are in the acceptable range. Findings: The laboratory prints out a list of daily controls run per lot number for the low, normal and high controls. Review of two lot number of daily controls logs showed that the lymphocyte percentage was out of the acceptable range for at least 2 out of 3 controls for the following: 1. Lot number 31712 was used from 4/30/18 to 9/8/18 shows that the acceptable range for low is 28.3% - 38.3%, normal is 37.1% - 47.1%, and high is 49.2% - 59.2%. On 7/9/18 the hematology analyzer reported the normal control as 36.5%, and the high control as 48.2%. Three patient test results were reported. 2. Lot number 319030 was used from 4/17/19 to 7/11/19 shows that the acceptable range for low is 31.1% - 41.1%, normal is 40.2% - 50.2%, and high is 49.9% - 59.9%. On 6/1 /19 the hematology analyzer reported the low control as 29.2, the normal control as 39.6%, and the high control as 48.4%. Two patient test results were reported. On 6/24 /19 the hematology analyzer reported the normal control as 39.8% and the high control as 49.0%. One patient test result was reported. On 7/3/19 the hematology analyzer reported the normal control as 39.9% and the high control as 48.2%. Six patient test results were reported. On 7/5/19 the hematology analyzer reported the low control as 30.6%, the normal control as 39.3% and the high control as 47.8%. Two patient test results were reported. On 7/8/19 the hematology analyzer reported the low control as 29.5, and the normal control as 38.4%. Fifteen patient test results were reported. The Clinical Laboratory Improvement Amendments (CLIA) Application for Certificate signed and dated by the laboratory director on 3/12/19 states the total estimated annual test volume is 10,360. During an interview on 3/17/20 at 2:40 PM, the Office Manager stated the controls were out and that patients test results should not be reported until the controls are in. D5805 TEST REPORT CFR(s): 493.1291(c) 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 -- 2 of 3 -- acceptability. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory's patient reports failed to list the name and address of the laboratory where the hematology testing was performed for for 3 out of 3 (#1 #2 #3) patient results. Findings: Review of the hematology test results showed the name and address of the location where the testing was done was not on the copy of the Abbott Diagnostic Cell Dyn 1800 Hematology analyzer printout that was given to patients upon request. The Clinical Laboratory Improvement Amendments (CLIA) Application for Certificate signed and dated by the laboratory director on 3/12/19 states the total estimated annual test volume is 10,360. During an interview on 3/17/20 at 2:30 PM, Testing Personnel A stated that they gave patients a copy of the hematology analyzers reports and that the reports did not contain the name and address of where the hematology tests were performed. -- 3 of 3 --

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to score at least 80% for platelet counts for the proficiency testing (PT) 1st event in 2017. Findings include: Review of the proficiency testing scores from the 2nd event in 2016 through the 1st event in 2018 showed that a score of 20% was reported by the PT company College of American Pathologist (CAP) for platelet counts for the 1st event of 2017. During an interview on 6/13/18 at approximately 3:30 PM, Laboratory Director acknowledged the proficiency testing failure. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document remedial action for unsatisfactory proficiency testing (PT) in hematology for platelet counts. 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 -- Findings include: Review of the proficiency testing scores from the 2nd event in 2016 through the 1st event in 2018 showed that a score of 20% was reported by the College of American Pathologist (CAP) for platelet counts for the first event of 2017. There was no documentation in the laboratory's PT records to show that remedial action was taken for this unsatisfactory score. During an interview on 6/13/18 at approximately 3: 30 PM, Laboratory Director confirmed that the laboratory did not have documentation for remedial action taken for the platelet count score of 20% received on PT for the first testing event of 2017. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to establish and follow a written quality assessment (QA) policy. Findings included: Record review of the laboratory procedure manual showed that there was no QA policy. During an interview on 6/13/18 at 4:20 PM, Office Manager stated they did not have a QA policy for the laboratory. -- 2 of 2 --