Starling Physicians Pllc

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 record review and staff interview, the laboratory failed to have a policy in place to assess the competency of all laboratory personnel. Findings include: 1. Review of the laboratory's competency records on 10/29/19 revealed the following: a. The laboratory did not have policy in place to assess the competency of the technical consultant and clinical consultant. b. The laboratory did not have competency documentation for the above laboratory personnel. 2. Staff interview with the technical consultant on 10/29/19 at 10:45 AM confirmed the laboratory did not have a policy in place to assess the competency of the above laboratory personnel and they were not assessed. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor observation, record review and staff interview, the laboratory failed to follow established laboratory procedure for new reagent lot verification in 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 4 -- specialty of hematology. Findings include: 1. Record review of the "Pochi lot to lot verification (Reagent Validation)" procedure on 10/29/19 revealed: a. New reagent lots need to be tested in parallel with old lots before being placed in service. b. Testing personnel (TP) are to repeat two patient specimens from the old lot with the new lot and document on the new reagent lot validation worksheet. c. Acceptable difference on all specimens must be +/- 20% before new reagent is placed in service. 2. Surveyor observation of the Sysmex PocH 100i Complete Blood Count (CBC) analyzer, Serial Number G4929 on 10/29/19 at 10:50 AM revealed the following on board reagents: a. pocH pack D Lot # Y9020: handwritten on side of container received: 9/25/19; opened 10/28/19. b. pocH pack L Lot # Y8007: handwritten on label opened 10/3/19. 3. Record review of the New Reagent Lot Validation Worksheets on 10/29/19 revealed: a. One worksheet dated 12/29/17 for PocH Pack L reagent. b. One worksheet dated 2/2/18 for PocH Pack D reagent. c. One worksheet not dated and unknown for which reagent type. d. The above worksheets did not contain % difference; whether results were acceptable and were not reviewed and approved. 4. Staff interview with TP #1 on 10/29/19 at 11:00 AM stated he/she was unaware of the procedure when changing reagent lots and although a clipboard containing the new reagent lot validation worksheets was posted next to the instrument, it was not being used. 5. The laboratory performs 2,593 CBC tests annually. This is a repeat deficiency. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation, record review and staff interview, the laboratory failed to label reagents with the appropriate expiration dates in the specialty of hematology. Findings include: 1. Surveyor observation of the Sysmex PocH 100i Complete Blood Count (CBC) analyzer, Serial Number G4929 on 10/29/19 at 10:50 AM revealed the following on board reagents: a. pocH pack D Lot # Y9020: handwritten on side of container received: 9/25/19; Opened 10/28/19; Expiration 1/11 /21. b. pocH pack L Lot # Y8007: handwritten on label opened 10/3/19; expiration date printed on manufacturer label 12/26/19. 2. Record review of the PocH-100i Procedure manual on 10/29/19 revealed: a. pocH pack D: Unopened stable to expiration date on manufacturer label; On board reagent stability is 60 days. b. pocH pack L: Unopened stable to expiration date on manufacturer label; On board reagent stability is 90 days. 3. Staff interview with testing personnel #1 on 8/28/19 at 11:00 AM stated he/she was not aware of the change in expiration dates for the pack D and L reagents once they are placed into service. 4. The laboratory performs 2,593 CBC tests annually. 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 -- 2 of 4 -- least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to document routine maintenance and function checks for the Sysmex PocH-100i analyzer in the specialty of hematology. Findings include: 1. Record review of the Sysmex PocH-100i maintenance logs on 10/29/19 revealed the laboratory did not have documentation of maintenance and function checks for the following: a. Daily maintenance for 16 of 22 days January 2019. b. Daily, weekly and monthly maintenance for February, May, August and September 2019. c. 1 of 2 weeks cleaning of the transducer and 1 of 1 cleaning waste chamber for June 2019. d. 2 of 2 weeks cleaning of the transducer for July and October 2019. 2. Review of the manufacturer's operator manual for the above equipment on 10/29/19 revealed various maintenance protocols need to be performed on a daily, weekly, every 2 weeks, 3 months schedule in order to ensure accurate and reliable test results. 3. Staff interview with the technical consultant on 10/29/19 at 12: 05 PM confirmed the above findings. 4. The laboratory performs 2,593 Complete Blood Counts annually. 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 surveyor observation, record review and staff interview, the laboratory failed to perform and document calibration when a new Complete Blood Count (CBC) analyzer was placed in service to verify the accuracy of the test system in the specialty of hematology. Findings include: 1. Surveyor observation of the Sysmex PocH 100i Complete Blood Count (CBC) analyzer on 10/29/19 at 10:50 AM revealed an instrument serial number (S/N) of G4929. 2. Record review of calibration records on 10/29/19 revealed: a. Records were available for S/N B1111. b. The laboratory did not have calibration records for S/N G4929. 3. Staff interview with the technical consultant (TC) on 10/29/19 at 12:20 PM confirmed the above findings. The TC stated S/N G4929 was placed into service on 10/28/19 and the laboratory staff had only performed CBC controls prior to patient testing. 4. The laboratory performs 2,593 CBC tests annually. D5781