Chickahominy Family Practice- Central Lab

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Chickahominy Family Practice-Central Lab on February 22-23, 2024 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows and include the Condition under 42 CFR part 493 CLIA Regulation: D6000 -42 CFR. 493.1403 Laboratory Director. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 a review of proficiency testing (PT) records and an interview, the laboratory failed to attain a score of at least eighty percent (80%) of acceptable responses for nine (9) analytes in one out of three 2023 Chemistry testing events. Findings include: 1. Review of the laboratory's 2023 American Proficiency Institute (API) Core Chemistry PT records (Events 1, 2, and 3) revealed unsatisfactory performance scores (less than 80%) for the following 9 analytes on the API 2023 3rd Event: Albumin - 60% (CH-14 resulted as 3.9 outside acceptable range of 2.9-3.7, CH-15 resulted as 3.5 outside acceptable range 2.6-3.3); AST/GOT - 60% (CH-14 resulted as 220 outside acceptable range of 138-208, CH-15 resulted as 179 outside acceptable range 112- 170); Calcium, Total - 60% (CH-14 resulted as 12.4 outside acceptable range of 9.2- 11.3, CH-15 resulted as 11.8 outside acceptable range 8.5-10.6); Creatinine - 60% (CH-14 resulted as 3.75 outside acceptable range of 2.64-3.58, CH-15 resulted as 3.11 outside acceptable range 2.2-2.98); Ferritin - 50% (IA-12 resulted as 9 outside acceptable range 134-167); Glucose - 60% (CH-14 resulted as 187 outside acceptable range of 144-177, CH-15 resulted as 162 outside acceptable range 123-152); LDL Cholesterol, Direct - 60% (CH-12 resulted as 17 outside acceptable range of 28-37, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- CH-15 resulted as 51 outside acceptable range 40-50); Phosphorus - 60% (CH-14 resulted as 5.2 outside acceptable range of 4.1-4.6, CH-15 resulted as 4.6 outside acceptable range 3.6-4.1); Urea Nitrogen - 60% (CH-14 resulted as 34 outside acceptable range of 25-31, CH-15 resulted as 189 outside acceptable range 117-196). 2. An exit interview with the laboratory lead on 2/23/24 at 12:30 PM confirmed the above findings. D2098 ENDOCRINOLOGY CFR(s): 493.843(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 a review of proficiency testing (PT) records and an interview, the laboratory failed to attain a score of at least eighty percent (80%) of acceptable responses for Parathyroid Hormone (PTH) and Prostate Specific Antigen (PSA) analytes in one out of three 2023 chemistry endocrinology module events. Findings include: 1. Review of the laboratory's 2023 American Proficiency Institute (API) PT records (Events 1, 2, and 3) revealed that the laboratory utilized API for accuracy verification for PTH and PSA patient testing. The inspector noted the following unacceptable PTH and PSA scores (less than 80%) on the API 2023 3rd Event: PTH scored 50% (challenge sample IAS-12 resulted as 18.4 outside acceptable range of 141.1-182.8), PSA scored 50% (challenge sample IA-11 resulted as 140.00 outside acceptable range of 7.51- 11.08). 2. An exit interview with the laboratory lead on 2/23/24 at 12:30 PM confirmed the above findings. D2099 ENDOCRINOLOGY CFR(s): 493.843(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services CASPER 0096D report form (CMS CASPER 96), proficiency testing (PT) records and an interview, the laboratory failed to attain an overall score of at least eighty percent (80%) of acceptable responses for the specialty of Endocrinology in one out of two module events reviewed for calendar year 2022. Findings include: 1. During pre- survey duties, the inspector noted that the CMS CASPER 96 report included an overall unsatisfactory PT score for the specialty of Endocrinology. The pre-survey review revealed the laboratory received 60 % score for 2022 Event 3. 2. During the onsite inspection on 2/22/24, the inspector reviewed of the laboratory's 2022 American Proficiency Institute (API) PT Events 2 and 3. The review revealed unsatisfactory scores on the API 2022 3rd Event: Endocrinology speciality overall scored at 60% - module specific Thyroid Stimulating Hormone scored 60%, (challenge sample CH-12 resulted as 2.27 outside acceptable range of 1.20-2.16, challenge CH-13 resulted as 4.38 outside acceptable range of 2.29-4.18). 3. An exit interview with the laboratory lead on 2/23/24 at 12:30 PM confirmed the above findings. -- 2 of 8 -- D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on tour, review of procedures, lack of documentation, quality assessment (QA) check lists, and interviews, the laboratory failed to document eye wash safety /maintenance per their protocol for forty (40) of ninety-two (92) weeks reviewed (April 2022 to February 23, 2024). Findings include: 1. During a tour of the laboratory on 2/22/24 at 10:00 AM, the inspector noted one safety eye wash in the chemistry laboratory entrance area. 2. Review of the laboratory's procedures revealed a protocol (titled: Quality Assessment) with subheading "Temperature, Humidity Monitoring, and Eyewash Maintenance" that stated: "The faucet mounted eyewash station will be tested each Monday and allowed to flush for 30-60 seconds. This testing will be documented on log." 3. Review of the available eyewash maintenance logs for timeframe of April 2022 to 2/23/24 revealed no documentation of weekly safety checks in the following months: Calendar year 2023: January (5 weeks), February (4 weeks), March (4 weeks), April (4 weeks), May (5 weeks), June (4 weeks), July (4 weeks), and August (5 weeks); Calendar year 2024: January (5 weeks). A total of 40 weeks during the nine months outlined above had no weekly eye wash safety checks recorded. 4. A review of monthly QA report/checklists for the timeframe outlined above revealed no

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Chickahominy Family Practice-Central Lab on 03/09/22 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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: **REPEAT DEFICIENCY** Based on the review of policy and procedures (P&P), 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 -- manufacturer's user manual, calibration verification records, lack of documentation and interview, the lab failed to follow the established P&P of performing calibration verification procedures twice a year for the Tosoh G8 A1C analyzer in 2020. Findings include: 1. Review of the P&P revealed the following statement, "Tosoh G8 Analyzer- Calibration verification is done twice a year and recorded." 2. Review of the manufacturer's user manual revealed the Tosoh G8 A1C analyte has a two-point calibration. 3. Review of calibration verification records for 2020 and 2021 revealed lack of documentation for the performance of calibration verification procedures twice a year in 2020. The inspector reviewed the documents for procedures performed on 10 /23/19 and 11/04/20. The inspector requested to review additional calibration verification procedures for the calendar year 2020. No additional documents were available for review. 4. An exit interview with the technical consultant and primary testing personnel on 03/09/22 at approximately 1210 confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Chickahominy Family Practice-Central Lab on November 15, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), procedure and policy manual, personnel files, and interviews, the laboratory did not establish/follow a policy for one (1) technical consultant's (TC) competency assessment in calendar year 2018 and up to the date of the survey on November 15, 2019. Findings include: 1. Review of the CMS 209 revealed that Personnel A serves as TC. (See Personnel Code Sheet.) 2. Review of the laboratory procedure and policy manual revealed no protocol outlining documentation of the competency assessment of the TC. 3. Review of the personnel files revealed that the laboratory director (LD) failed to document competency assessments in calendar year 2018 and year to date 2019 for Personnel A in the role of TC. 4. In an interview with the lead tech and LD, at approximately 2:30 PM, the above findings were confirmed. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of 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 -- the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), policies and procedures, manufacturer's package inserts, tour with review of temperature logs, and interviews, the laboratory failed to establish a policy that followed the manufacturer's instructions for storage of patient samples when testing was delayed, beyond the date of collection, for nine (9) chemistry analytes in the twenty-three (23) months reviewed. Findings include: 1. Review of the CMS 209 form revealed that one (1) testing personnel was identified as responsible for non-waived chemistry patient testing during the review timeframe of December 2017 to 11/15/19. The lead tech stated, at approximately 12:30 PM, "I am the only employee that runs the chemistry analyzers. On Friday afternoons, I leave at 2 PM and the nursing staff place patient samples in their refrigerator or freezer. I pick them up to run them on the following Monday. If I am off on vacation, the samples are handled in the same manner until I return". 2. Review of the laboratory's policy and procedure manual revealed a policy (titled "Stability for Siemens") that stated: "All samples are good refrigerated for 5-7 days with exception for albumin, calcium, cholesterol, CO2, and triglycerides which are good for 2 days refrigerated. Glucose is good for three days refrigerated and PSA is good for 8 hours and then must be frozen". The inspector noted that the policy failed to outline specific storage temperatures (refrigeration/freezer) when assays are delayed. 3. Review of the Siemens Dimension package inserts for Albumin (Alb), Calcium (Ca), Cholesterol (Chol), Carbon Dioxide (CO2), and Triglycerides (TGL) outlined in the policy above revealed manufacturer's specimen storage and stability requirements that stated: "Specimens are stable for 8 hours at room temperature; 2 days at 2-8 degrees C, for longer storage may be frozen at -20 C or colder". The inspector noted that the Siemens Glucose (GLU) package stated "sample is stable for as long as 8 hours at room temperature and up to 72 hours at 4 degrees C" and the Prostate Specific Antigen (PSA) package stated, "sample should be kept at 4 C and analyzed within 8 hours or frozen at -20 C or colder". Additionally, the following package insert instructions revealed specific time sensitive storage instructions: Total Protein (TP) - "specimens are stable for 8 hours at room temperature, 72 hours at 2-8 C, and stored 6 months if frozen at -20 C or cooler"; Uric Acid (URCA)- "specimens are stable 3-5 days at 2-8 C, and stored for up to 6 months if frozen at -20 C or cooler"; 4. During a tour of the nursing station in the facility, at approximately 1:30 PM, the inspector noted the facility utilized commercial (for home use) refrigerator freezers. Review of the nursing station laboratory temperature logs for: Frigidaire Model FRT173FW, Whirlpool 1583AW7, and Whirlpool W4TXNWFQ01 revealed that the freezer storage temperatures were not recorded for each day during 23 of the 23 months reviewed. The inspector reviewed the contents of Frigidaire Model FRT173FW and noted a thermometer reading of -10 C. The inspector stated the manufacturer's specimen storage requirements listed above to the lead tech and nurse. The lead tech and nurse, stated at approximately 2:00 PM, "our freezers in the nursing stations probably do not get as cold as -20 C". 5. In an interview with the lead tech and laboratory director, at approximately 2:30 PM, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Chickahominy Family Practice Central Lab on January 25, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's 2016 and 2017 chemistry proficiency testing (PT) documentation, policy manual, and an interview, the laboratory failed to retain copies of the attestation statements signed by the laboratory director and testing personnel for two (2) of six (6) PT testing events reviewed.. Findings include: 1. Review of the laboratory's 2016 and 2017 American Proficiency Institute (API) chemistry PT documentation, a total of six (6) events, revealed no signed attestation statements retained for: 2016 Chemistry Event 3, 2017 Chemistry Event 1. The inspector requested to review the attestation documentation. No documentation was available for review. 2. Review of the laboratory's policy manual revealed a written and approved Proficiency Testing policy that included the statement: "The Lab 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 -- Director and testing personnel must sign the Attestation Statement." 3. In an interview with the primary testing personnel at approximately 2:30 PM on January 25, 2018, it was confirmed that the laboratory failed to retain copies of the PT attestation statements for the events listed above in calendar years 2016 and 2017 D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of the laboratory's 2016 and 2017 proficiency testing (PT) records, policy manual, and an interview, the laboratory failed to document result evaluation of one (1) of six (6) PT events reviewed. Findings include: 1. Review of the laboratory's 2016 and 2017 American Proficiency Institute (API) PT documentation, a total of six (6) events, revealed no evidence of result evaluation for: 2016 Chemistry Event 3. The inspector requested to review evaluation documentation of the PT results for the event listed above. No documentation was available for review. 2. Review of the laboratory's policy manual revealed a written and approved Proficiency Testing policy that included the statement: "All proficiency testing results will be evaluated and reviewed by the laboratory director. A copy of the signed report form must be retained in the laboratory for a minimum of 2 years". 3. In an interview with the primary testing personnel at approximately 2:30 PM, it was confirmed that the laboratory failed to retain documentation of evaluation of the 2016 API Chemistry Event 3. 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 a review of the laboratory's procedures, calibration verification documentation, analyzer operations guide, a laboratory tour, patient test log review, -- 2 of 3 -- and an interview, the laboratory failed to perform calibration validation studies for Sodium (Na), Potassium (K), and Chloride (CL) according to the laboratory's written policy in calendar year 2016. Findings include: 1. Review of the laboratory's procedures revealed a policy to perform calibration verification for the Siemens Dimension xPand Plus chemistry analyzer testing. The policy states: "calibration validation linearity studies are performed twice yearly for assays that have calibration curves of less than 3 points". 2. Review of the laboratory's 2016 Siemens Dimension xPand Plus chemistry analyzer calibration verification documentation revealed one (1) calibration verification performed and accepted by testing personnel and lab director for Sodium (Na), Potassium (K), and Chloride (CL) using Verichem calibration verifier material on 07/05/16. The inspector requested to review additional documentation of calibration verification for Na, K, and CL performed in calendar year 2016. The documentation was not available for review. 3. Review of the manufacturer's Siemens Dimension xPand Plus operator's guide revealed a two-point calibration for electrolytes Na, K, and CL. 4. During a laboratory tour at approximately 1:30 PM, the inspector asked the primary testing personnel to describe how the calibration verification policy is followed for the electrolytes assayed on the Siemens Dimension analyzer. The primary testing personnel stated "it is our policy to run the verification studies every 6 months but, I am unable to find the documentation at this time that it was performed twice in 2016 for the electrolytes." 5. Review of the laboratory's patient test logs revealed eight thousand eight hundred seventy-four (8,874) Na, K, and CL patient results were reported in calendar year 2016. 6. In an interview with the primary testing personnel at approximately 2:30 PM on January 25, 2018, it was confirmed that the laboratory failed to document performance of calibration validation studies according to the laboratory's written policy for the three (3) Siemens Dimension chemistry test reagents outlined above while reporting eight thousand eight hundred seventy-four (8,874) patient results in calendar year 2016. -- 3 of 3 --