Donald M Birch, Md, Pc

Summary Statement of Deficiencies 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 with Technical Consultant (TC) #1, the laboratory failed to monitor and document the room temperature, humidity, and the refrigerator temperature each day of patient testing for 7 months (July 2018 to January 2019) of 2 years reviewed. Findings include: 1. Review of the "Temperature/Humidity Record" log revealed the laboratory did not record the room temperature, humidity, and refrigerator temperature every day of patient testing as follows: a. room temperature, humidity, and refrigerator in 2018 i. July - 12, 19, 23, 26, and 30 ii. August -6, 9, 13, 23, and 27 iii. September - 20, 24, and 27 iv. October - 22, 25, and 29 v. November - 8, 12, and 29 vi. December - 6, 10, 13, 17, and 20 b. refrigerator in 2018 i. August - 2, and 16 ii. October - 1, 4, 8, 11, 15, and 19 iii. November - 1, 5, and 26 iv. December - 3 c. refrigerator - 2019 i. January - 7, 10, 14, 21, and 31 2. During the interview on 3/09/2020 at 10:21 am, TC1 confirmed the laboratory did not monitor and document the room temperature, humidity and the refrigerator temperatures every day of patient testing. D5803 TEST REPORT CFR(s): 493.1291(b) 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 -- Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: . Based on document review and interview with Technical Consultant (TC) #1, the laboratory failed to have the final hematology report maintained as part of the patient's electronic medial record (EMR) for 1 (#9) of 11 patient charts audited. Findings include: 1. Record review revealed the final hematology complete blood cell count (CBC) report was not maintained as part of the patient's EMR for patient #9 tested on 7/05/2018. 2. On 3/09/2020 at approximately 11:15 am when queried, the office manager was not able to provide the surveyor the final report requested. 3. During the interview on 3/09/2020 at approximately 11:15 am, TC1 confirmed the final CBC report was not part of the patient's EMR report. 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 acceptability. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant (TC) #1, the laboratory failed to include the patient's scanned final hematology report into the electronic medical records (EMR) for 3 (#1, #4, and #5) of 11 patient charts audited. Findings include: 1. Record review revealed for 3 (#1, #4, and #5) of 11 patient charts audited the final hematology complete blood cell (CBC) report was not scanned into the patient's EMR file. 2. On 3/09/2020 at approximately 11:30 am when queried, the office manager was not able to locate the final patient report in the EMR system. 3. During the interview on 3/09/2020 at approximately 11:30 am, TC#1 confirmed the final CBC reports were not scanned into the EMR system. D5893 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(b)(c) (b) The postanalytic systems quality assessment must include a review of the effectiveness of

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 record review and interview, the laboratory failed to retain the 1) Beckman Coulter AcT diff 2 maintenance, temperature, and humidity reading logs and 2) Beckman Coulter AcT diff 2 background counts and quality control data for two years. Findings include: 1. On May 24, 2018 at 10:45 AM, record review of the Beckman Coulter AcT diff 2 maintenance, temperature, and humidity reading logs revealed for six (June to December 2016) of 24 months reviewed the laboratory did not retain the documentation for two years. 2. On May 24, 2018 at 11:45 AM, record review of the Beckman Coulter AcT diff 2 records revealed for six (#1 - #5, and #7) of nine patient charts audited the laboratory did not retain the background counts and the daily quality control data for two years as follows: a. six (#1-#5 and #7) of nine patient charts audited - no background counts b. three (#1-#3) of nine patient charts audited - no quality control data 3. During the interview on May 24, 2018 at 10:45 and 11:45 AM, technical consultant #2 as listed on the CMS-209 confirmed the records were not retained for two years. . D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported 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 -- from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to establish a system to ensure the manually scanned patient final test results were entered into the patient's electronic medical record (EMR) file for one (#8) of nine patient charts audited. Findings include: 1. On May 24, 2018 at 11:45 AM, record review for one (#8) of nine patient charts audited revealed the final patient test result for the hematology complete blood cell count was not scanned into the patient's EMR file. 2. On May 24, 2018 at 11:45 AM when queried, testing personnel #1 as listed on the CMS-209 was unable to provide the surveyor the final scanned patient test result in the patient's EMR file. 3. During the interview on May 24, 2018 at 11:45 AM, technical consultant #2 as listed on the CMS-209 confirmed the final hematology testing results were not scanned into the patient's EMR file. -- 2 of 2 --